preparing for pharma pgrs: lessons for patent owners from...

Preparing for Pharma PGRs:

Lessons for Patent Owners From PGR Denials Leveraging Successful IPR Arguments, Strengthening Patent Applications to Survive PGR Petitions

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THURSDAY, JANUARY 19, 2017

Presenting a live 90-minute webinar with interactive Q&A

Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Amanda K. Murphy, Ph.D., Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Kerry Flynn, Vice President, Chief IP Counsel, Vertex Pharmaceuticals, Boston

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These materials have been prepared solely for educational and informational

purposes to contribute to the understanding of U.S. intellectual property law.

These materials reflect only the personal views of the authors and are not

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which any liability is disclaimed.

4

NUTS & BOLTS COMPARISON: IPRS AND PGRs

Post-Grant Review (PGR)

Inter Partes Review (IPR)

When Within nine months

of grant

More than nine months after grant (but one exception)

Threshold showing

More likely than not or novel legal question

Reasonable likelihood of success

Grounds 101, 102, 103, 112 102, 103 (Pats/pubs only)

Time at PTO 12-18 months 12-18 months

Anonymity No No

5

NUTS & BOLTS COMPARISON: IPRS AND PGRs (con’t)



Estoppel Issues raised or

reasonably could have been raised

Issues raised or reasonably could have been raised

Before whom PTAB PTAB

Discovery/ evidence

Declaration and discovery

Declaration and discovery

Appeal Both parties may appeal

to Federal Circuit* Both parties may appeal to

Federal Circuit*

6

Note: Phigenix, Inc. v. Immunogen, Inc., --F.3d__ (Fed. Cir. Jan. 9, 2017) that right to appeal does not

automatically confer standing.



Petition grant rate* 55% (16/29)*

(FY2014-FY2017 to date)

70% (2566/3690)* (2335 granted + 231 joinder)


Final decisions**

83% all instituted claims unpatentable (5/6)

69.63% all instituted claims unpatentable

17% all instituted claims survived (1/6)

16.79% all instituted claims survived

13.59% mixed outcome

NUTS & BOLTS COMPARISON: IPRS AND PGRs (con’t)

*As of Jan. 9, 2017. Finnegan research

**“Mixed outcome”: at least one instituted claims survived and at least one

instituted claim was canceled.

**As of Dec. 1, 2016. (by case) Source: Finnegan research, http://www.aiablog.com/claim-and-case-disposition/

**As of Jan. 11, 2017 (by case).

*As of Nov. 30, 2016 https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf

7

As of Nov. 30, 2016 https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf

PGR PETITION FILING STILL LOW COMPARED TO IPR PETITION FILING

8

BUT GROWING

As of Nov. 30, 2016 https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf

9

PETITIONS BY TECHNOLOGY

Source of PGR data: Finnegan research; 36 PGR Petitions filed. As of Sept. 23, 2016;

Source of IPR data: https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf Average of FY 2015, 2016, and 2017 to date; As of Nov. 30, 2016

10

PGR PETITION ASSERTED GROUNDS

As of Jan. 9, 2017; Finnegan research; 38 PGR Petitions filed. Note, more than one ground may be asserted per petition.

11

PGR INSTITUTED GROUNDS

As of Jan. 9, 2017; Finnegan research; 16 instituted PGRs.

Note: 5 FWDs holding all instituted claims unpatentable so far; 3 based on § 101; 1 based on §102, §112(a); 1 based on §112(b). As of Jan. 9, 2017.

12

PGR INSTITUTION RATE LOWER THAN IPRs, BUT NUMBERS STILL VERY SMALL

(2335 granted + 231 joinder)


USPTO stats

(16 granted/partially granted)


Finnegan research

13

PGR INSTITUTION RATE

As of Jan. 9, 2017; Finnegan research; 29 institution decisions. An additional 3 petitions terminated prior to an institution decision (2 settled and 1 was dismissed as an improperly-filed PGR). “Partially granted” means instituted on fewer than all challenged claims.

Trial going ahead in 55% of

petitions filed

14

PGR CLAIM SURVIVAL RATE (BY CASE) SAME AS IPRs

As of Jan. 4, 2017; Finnegan research; 6 Final Written Decisions on the merits. In addition, 2 instituted PGRs settled prior to FWD.

As of Dec. 1, 2016. Source: Finnegan research, http://www.aiablog.com/claim-and-case-disposition/ “all instituted claims survived” Also, 13.59% (153/1126) cases had mixed outcome (some

instituted claims survived, some held unpatentable)

16.7% 1/6

15

http://www.aiablog.com/claim-and-case-disposition/









PGR FWDs

• American Simmental Assoc. v. Leachman Cattle of Colorado, LLC,

2015-00003, Paper 56 (P.T.A.B. June 13, 2016)

• Claim 16. A computer-implemented method to determine relative

market value of a sale group, the sale group including cattle that

are fed and harvested for beef production, the method

comprising: . . .

• PGR instituted on §101 and §103 grounds.

• PTAB: FWD all instituted claims unpatentable for failing to recite

statutory subject matter.

― Unpersuaded that Petitioner showed obviousness by a

preponderance of the evidence.

― Found that the claims were directed to a patent-ineligible

abstract idea and did not recite “something more.”

― Denied Patent Owner’s Motion to Amend.

16

PGR FWDs (con’t)

• American Simmental Assoc. v. Leachman Cattle of Colorado,

LLC, 2015-00005, Paper 52 (P.T.A.B. June 13, 2016) • Claim 8. A computer-implemented method to determine relative

market value of a sale group, the computer implemented method

comprising the steps of:: . . .

• PGR instituted on §101 and §103 grounds.

• PTAB: FWD all instituted claims unpatentable for failing to recite

statutory subject matter and obviousness. ― Petitioner showed obviousness of several claims by a preponderance of the

evidence.

― Rejected Patent Owner’s objective evidence of nonobviousness as

“cursory”

― Found that the claims were directed to a patent-ineligible abstract idea and did

not recite “something more.”

― Denied Patent Owner’s Motion to Amend.

17

• NetSirv v. BoxBee, Inc., 2015-00009, Paper 20 (P.T.A.B. Aug. 2, 2016)

• Claim 1. A method for stored item distribution to a user,

the user associated with a user identifier, the method comprising:…

• PGR instituted on §101 grounds.

• PTAB: FWD all instituted claims unpatentable for failing to recite statutory subject matter.

―“claim 1 is directed to the abstract idea of a bailment scheme using storage containers.”

―“we do not find claim language that recites significantly more than the abstract idea.”

18

PGR FWDs (con’t)

• Altaire Pharms., Inc. v. Paragon Bioteck, Inc.,

PGR2015-00011, Paper 48 (P.T.A.B. Nov. 14, 2016)

• Claim 1. A method of using an ophthalmic composition for

pupil dilation, the composition comprising R-phenylephrine

hydrochloride having an initial chiral purity of at least 95% and

an aqueous buffer, wherein the chiral purity of R-

phenylephrine hydrochloride is at least 95% of the initial chiral

purity after 6 months, the method comprising:

• administering the composition into an eye of an individual in

need thereof, wherein the composition is stored between –10

to 10 degree Celsius prior to administration, and wherein the

composition comprises R-phenylephrine hydrochloride having a

chiral purity of at least 95% when administered after storage.

19

PGR FWDs (con’t)

• Altaire (con’t)

• Asserted ground: obviousness over Altaire’s Product

(phenylephrine hydrochloride ophthalmic solution Lot # 11578

and Lot # 11581)

• PTAB: Preamble phrase, “wherein the chiral purity of R-

phenylephrine hydrochloride is at least 95% of the initial chiral

purity after 6 months” describes property of the composition to

be administered. It is not a claim limitation requiring an active

step of cold storage for six months.

• PTAB rejected Petitioner’s evidence showing the HPLC data of

Altaire’s Product meets the recited chiral-purity limitations –

“the tests and data submitted with the Petition do not meet the

requirements of 37 C.F.R. § 42.65.” ― For example, fails to explain how the test was performed and how

the data was generated. 20

PGR FWDs (con’t)

• Altaire (con’t)

• Similar objections to Petitioner’s optical-rotation data:

― “Petitioner does not point to any credible evidence to show

the lot number of the phenylephrine hydrochloride P6126 it

used as control, when the lot was manufactured, or how long

after the manufacturing date Petitioner used it as the

control. Indeed, for the optical-rotation data, as for the

HPLC data, Petitioner has not provided any affidavit in

compliance with 37 C.F.R. § 42.65(b).”

― “Patent Owner has presented sufficient evidence to

challenge the accuracy of estimating enantiomer purity

based on the specific rotation.”

21

PGR FWDs (con’t)

• US Endodontics, LLC v. Gold Standard Instruments, LLC,

PGR2015-00019, Paper 54 (P.T.A.B. Dec. 28, 2016)

• 12. A method for manufacturing or modifying an endodontic

instrument for use in performing root canal therapy on a tooth,

the method comprising:

― (a) providing an elongate shank having a cutting edge extending from

a distal end of the shank along an axial length of the shank, the shank

comprising a superelastic nickel titanium alloy, and

― (b) after step (a), heat-treating the entire shank at a temperature

above 25° C. up to but not equal to the melting point of the

superelastic nickel titanium alloy,

• wherein the heat treated shank has an angle greater than 10

degrees of permanent deformation after torque at 45 degrees of

flexion when tested in accordance with ISO Standard 3630-1.

22

PGR FWDs (con’t)

• US Endodontics (con’t)

• PGR instituted on 102, 103, and 112 grounds.

• Patent Owner disputed eligibility for PGR (see slide 29).

― Issued claims same as application filed Jan. 29, 2014.

― PTAB agreed with Petitioner that no priority to earlier applications for

lack of WD and enablement -> claims only entitled to actual filing

date.

• PTAB: All instituted claims unpatentable.

― Lack of enablement.

― “the guidance the Specification provides regarding how to achieve the

deformation characteristic recited in the “wherein” clause is quite limited

compared to the broad scope of claims 12–16.”

― Specification teaches deformation achieved using heat-treatment at

500°C for 75 minutes or “inherent heat-treatment” of undisclosed

parameters but Claims 12–16 encompass temperature ranges from

above 25°C or 300°C up to but not equal to about 1300°C, and are

not limited to any duration.

23

PGR FWDs (con’t)


• PTAB: Lack of enablement (con’t)

― Claims include heat-treatment times and temperatures that do not

provide the deformation characteristic (inoperative species – relevant

though not determinative of lack of enablement).

― PTAB credited Petitioner’s testing evidence.

― Undue experimentation required for POSITA to practice full scope of

claims.

― Inventor testimony expressing doubt at specific temperatures.

• PTAB: Lack of written description

― “the Specification does not reasonably convey to those skilled in the

art that Dr. Luebke had possession of the subject matter of claims 12–

16.”

― Species disclosed in Ex. 4 does not support genus claimed.

24

PGR FWDs (con’t)


• PTAB: Anticipated.

― Article qualified as prior art because claims not entitled to priority.

25

PGR FWDs (con’t)

• Telebrands Corp. v. Tinnus Enterprises, LLC, PGR2015-

00018, Paper 75 (P.T.A.B. Dec. 30, 2016)

• Claim 1. An apparatus comprising:

― a housing …; a plurality of flexible hollow tubes, …; a plurality of

containers, …; and a plurality of elastic fasteners, …each elastic

fastener configured to provide a connecting force that is not less

than a weight of one of the containers when substantially filled

with water, and to automatically seal its respective one of the

plurality of containers upon detaching the container from its

corresponding hollow tube, such that shaking the hollow tubes in a

state in which the containers are substantially filled with water

overcomes the connecting force and causes the containers to detach

from the hollow tubes thereby causing the elastic fasteners to

automatically seal the containers, wherein the apparatus is

configured to fill the containers substantially simultaneously with a

fluid.”

26

PGR FWDs (con’t)

• Telebrands (con’t)

• PTAB instituted PGR on §112(b) and §103 grounds.

• PTAB FWD: all instituted claims unpatentable for indefiniteness.

― “apply the test for indefiniteness approved by the Federal Circuit in

Packard [751 F.3d 1307, 1313 (Fed. Cir. 2014)], i.e., ‘a claim is indefinite

when it contains words or phrases whose meaning is unclear.’”

― “We do not understand Nautilus, however, to mandate the Board’s

approach to indefiniteness in patent examination or reexamination

matters9 or in AIA proceedings, in which the claims are interpreted under

the broadest reasonable interpretation standard, and an opportunity to

amend the claims is afforded.10”

― FN 10 “We need not, and do not, decide in this case the approach to

indefiniteness to be applied in Board proceedings where the BRI standard is

inapplicable and an opportunity to amend is unavailable, such as when the

patent being challenged has expired. See In re CSB-System Int’l, Inc., 832

F.3d 1335, 1342 (Fed. Cir. 2016).”

27

PGR FWDs (con’t)

• Telebrands (con’t)

• PTAB FWD: Claim 1 is indefinite.

― “Specification consistently teaches that whether a container is ‘filled’

depends, subjectively, on whether a desired size or volume has been

reached.”

― “the level of water in a ‘substantially filled’ container is not ascertainable

or measurable by reference to any objective standard.”

― Note: Patent Owner warned of need for objective standard in

Institution Decision: “In our Institution Decision, we informed Patent

Owner of the significance of the absence of an objective standard, but

Patent Owner did not identify persuasively any such standard in the

Patent Owner Response.”

― “Neither claim 1 nor the Specification provides an objective standard for

measuring the scope of ‘a connecting force that is not less than a weight of

one of the containers when substantially filled with water’ as applied to an

expandable container[.]”

― Found Patent Owner’s expert’s testimony conclusory and unpersuasive as to

understanding of a POSITA.

28

PGR FWDs (con’t)

PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR

• Front Row Tech., LLC v. MLB Advanced Media, L.P., 2015-00023,

Paper 8 (P.T.A.B. Feb. 22, 2016)

• Filing date Jan. 29, 2010; no claim for priority or benefit.

• Petitioner said PGR-eligible because of amendments submitted Sept.

23, 2013.

• PTAB: Claims not eligible for PGR.

― “Nowhere does the statute contemplate that the effective filing date

might depend on the date of a later-filed amendment to a claim.”

― “as a matter of law, if a claim in the application is not entitled to an

earlier filing date, then the effective filing date is the actual filing

date of the application (per subparagraph (A)), regardless of whether

a later-filed amendment to a claim finds sufficient support in the

application.”

29


• Mylan Pharms. Inc. v. Yeda Research & Development

Co. Ltd., 2016-00010, Paper 9 (P.T.A.B. Aug. 16, 2016)

• Petitioner: claims PGR-eligible because not entitled to benefit of

priority claim to August 20, 2009 (priority applications do not provide

written description support for all claim limitations); effective filing

date is actual filing date of May 22, 2015.


― Examiner specifically addressed that pre-AIA applied to claims.

― Examiner found claims supported by priority document.

― Petitioner did not show break in priority chain; “Petitioner has not

demonstrated that it is more likely than not that the ’776 patent

has at least one claim having an effective filing date on or after

March 16, 2013.”

30


• David O.B.A. Adepbimpe v. Johns Hopkins Univ., 2016-

00020, Paper 14 (P.T.A.B. July 25, 2016)

• Parties filed briefs on PGR eligibility prior to Patent Owner filing

POPR.

• Priority claim to Oct. 4, 2012 and Feb. 25, 2013.

• Amended claims filed March 17, 2015.


― “Section 100(i)(1) does not make any provision for the effective

filing date to be later than the actual filing date of the application

in question, even when the application is amended later, and even

when thelater amendment introduces claims that lack written-

description support in the original specification.

31

PATENT OWNER UNSUCCESSFUL WITH INELIGIBILITY ARGUMENT

• US Endodontics, LLC v. Gold Standard Instruments, LLC, PGR2015-00019

• PTAB: Instituted PGR over Patent Owner’s argument that claims not eligible

for PGR because of priority date benefit.

• Accepted Petitioner’s arguments that claims not supported by priority document

and therefore only entitled to actual filing date.

• Claims eligible for PGR

• “a patent that issues from an application filed after March 16 [15 sic], 2013,

that claims priority to an application filed before March 16, 2013,3 is

available for post-grant review ‘if the patent contains . . . at least one claim

that was not disclosed in compliance with the written description and

enablement requirements of § 112(a) in the earlier application for which the

benefit of an earlier filing date prior to March 16, Inguran, LLC v. Premium

Genetics (UK) Ltd., Case PGR2015-00017, slip op. 11 (PTAB Dec. 22, 2015)

(Paper 8).”

• Initial burden on petitioner: • “a petitioner seeking post-grant review carries the burden to show that the

patent is subject to the first-inventor-to-file provisions of the AIA and, therefore, eligible for post-grant review[.]”

32

PTAB GUIDANCE:

Precedential

• http://www.uspto.gov/patents-application-process/appealing-

patent-decisions/decisions-and-opinions/precedential

Representative


patent-decisions/decisions-and-opinions/representative-orders

Informative


patent-decisions/decisions-and-opinions/informative-opinions-0

33

http://www.uspto.gov/patents-application-process/appealing-patent-decisions/decisions-and-opinions/precedential













http://www.uspto.gov/patents-application-process/appealing-patent-decisions/decisions-and-opinions/representative-orders















http://www.uspto.gov/patents-application-process/appealing-patent-decisions/decisions-and-opinions/informative-opinions-0

















CAFC/USSC AFFIRMED PTAB’S APPROACH

• In re Cuozzo Speed Technologies, LLC, 793 F.3d 1268 (Fed. Cir. 2015)

• No jurisdiction to review PTAB’s IPR institution decision (See 35 U.S.C. § 314(d)).

• Affirm PTAB’s Final Written Decision in full (all instituted claims unpatentable as obvious)

― No error in PTAB’s application of BRI claim construction standard;

― No error in obviousness determination; and

― No error in denial of Cuozzo’s motion to amend.

― Lack of written description support;

― Improper broadening

• Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131 (U.S., June 20, 2016)

― Affirmed Federal Circuit decision not allowing attack of the decision to institute. ― In this case, §314(d) bars judicial review of whether PTAB wrongly instituted an IPR on grounds not

specifically mentioned in a third party’s review request.

― Affirmed Federal Circuit decision (unanimous), as to the BRI standard. ― USPTO has authority under §316(a)(4) to enact 37 CFR §42.100(b) (BRI is the claim construction standard

in IPRs).

34

PGR PETITIONS DENIED

• Dr. Reddy’s Laboratories, Ltd. v. Helsinn Healthcare

S.A., PGR2016-00008, Paper 11 (P.T.A.B. Aug. 17, 2016)

• PTAB: Petition denied.

• Patent Owner laid the groundwork for defending against the

§102 and §112 attacks during prosecution.

• PTAB: ― “Here, it is undisputed that the specification describes

formulations comprising the same ingredients, in the same

amounts, concentrations, and combinations required by the

challenged claims. Given this disclosure, one of ordinary skill in the

art could hardly fail to recognize a description of the claimed

formulations in the specification, whether or not the claims recite

that the formulations are stable.”

35


• DRL v. Helsinn, PGR2016-00008 (con’t)

• PTAB:

― “The AIA enlarged the scope of prior art under § 102 with

respect to territory, and also added the clause ‘otherwise

available to the public.’ …As an AIA first-inventor-to-file

patent, the ’942 patent is subject to AIA § 102(a)(1).”

― “The court in Helsinn Healthcare…concluded ‘that §102(a)(1)

requires a public sale or offer for sale of the claimed invention’

and ‘[t]he new requirement that the on-sale bar apply to public

sales comports with the plain language meaning of the

amended section, the USPTO’s interpretation of the

amendment, and the legislative history of the AIA.” Id. at *45.”

(issue in Teva v. Helsinn appeal, argued October 4, 2016).

36


• PTAB (con’t):

― “Moreover, the court emphasized that ‘the post-AIA on-sale bar inquiry is not focused on

the public disclosure of the sale or offer for sale; rather, the ‘sale’ prong of the on-sale

bar requires that the sale make the claimed invention available to the public one year

prior to its critical date.’ Id. at *52.”

― “Petitioner has established that MGI’s Form 8-K SEC filings and Helsinn’s press releases

made public the existence of the Supply and Licensing Agreements, but Petitioner has

not shown that the heavily redacted SEC filings or the press releases, devoid of detail,

made the claimed invention available to the public. Thus, we determine that the Supply

and Licensing Agreements did not make the claimed invention available to the public

one year prior to the critical date at issue here. Accordingly, we determine that

Petitioner has failed to show that it is more likely than not that claims 1–19 are in

violation of the on-sale bar under 35 U.S.C. § 102(a)(1).”


37


• DRL v. Helsinn, PGR2016-00007, Paper 12 (P.T.A.B. Aug.

17, 2016)

• PTAB: Petition denied.

• Patent Owner laid the groundwork for defending against the

§103 attacks during prosecution.

― At least one of the asserted references was before the

examiner during prosecution.

38

PGR PETITIONS DENIED • DRL v. Helsinn, PGR2016-00007 (con’t)

• PTAB:

― “We agree with Patent Owner that a person of ordinary skill

in the art would have considered Tang to be relevant to a

“palonosetron development project.” …We need not

determine whether Tang actually teaches away from the

claimed formulations—it is enough that we agree with Patent

Owner that Tang would not have led a person of ordinary

skill in the art to expect that a solution of palonosetron at a

concentration of 0.05 mg/mL would be effective in treating

emesis. Id. at 39 (citing Ex. 1008, 466). If anything, Tang

would have suggested amounts and concentrations still

higher than the highest dose and concentration evaluated by

Tang.”

39



• PTAB:

―“We agree with Patent Owner that Petitioner has

not established that one of ordinary skill in the art

would have had a reason to formulate a

pharmaceutical sterile intravenous solution

comprising “palonosetron hydrochloride . . . at a

concentration of 0.05 mg/mL,” as required by all

the challenged claims..”

40

USE OF OBJECTIVE EVIDENCE

41

LOAD UP ON YOUR EVIDENCE DURING PROSECUTION!

The “objective evidence of nonobviousness” (also known as “secondary

considerations,” as the term was coined in Graham v. John Deere) can, for

example, include:

• Long-felt but unsolved need,

• Failure of others,

• Commercial success,

• Unexpected results created by the claimed invention, and

• Skepticism of skilled artisans before the invention.

See In re Rouffet, 149 F.3d 1q350, 1355 (Fed. Cir. 1998).

These objective considerations, when present, are important evidence, as

they protect against the prejudice of hindsight bias, which frequently

overlooks the fact that “[t]he genius of invention is often a combination of

known elements which in hindsight seems preordained.”

McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1351 (Fed. Cir. 2001).

42

LOAD UP ON YOUR EVIDENCE DURING PROSECUTION!

Indeed, secondary consideration evidence “may be the

most probative and cogent evidence in the record.”

Apple Inc. v. ITC, 725 F.3d 1356, 1366 (Fed. Cir. 2013)

(internal quotation marks and citations omitted).

Objective evidence of these secondary considerations

can establish that “an invention appearing to have been

obvious in light of the prior art was not.” Stratoflex,

Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir.

1983).

43

OBJECTIVE EVIDENCE OF NONOBVIOUSNESS:

USE EVIDENCE FROM PROSECUTION

• Strong patentability positions during drafting and

prosecution.

Analyze carefully considered strong arguments and/or

declarations supporting §112 positions (written

description and enablement) and §103 positions

(nonobviousness)

• Consider Therasense

Careful thought and planning.

44

DECLARATIONS

• Declarations need to be as solid as possible. PTAB has found that

defective declarations relied on for patentability during

prosecution can form an independent basis for instituting an IPR.

• K-40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6 (PTAB

Aug. 29, 2013)

― PTAB reviewed a § 1.131 declaration from the prosecution,

found it deficient, and reapplied the prior art the declaration

had antedated, instituting the IPR.

― Case also had live testimony from inventor at oral hearing.

― One might want declarations from the inventor during prosecution

that can then by referred to by the Patent Owner in the optional

Preliminary Response to try to ward off institution.

45

SAMPLE EXPERT DECLARATION DEALING WITH OBJECTIVE EVIDENCE

These declarations establish that there would have been no reasonable

expectation of success of the claimed subject matter by showing:

1) significant unexpected results in the teeth of strong skepticism by

FDA experts and fulfillment of a long-felt need;

2) the claimed subject matter is reasonably commensurate in scope

with commercial success, coupled with a nexus between that

commercial success and the merits of the claimed invention;

3) the claimed subject matter relating to NMR chemical shifts and

solvent used is neither necessarily present or inherently anticipated,

nor in any way suggested …patent relied on for the ODP rejection.

46

OBJECTIVE EVIDENCE MUST BE SUPPORTED WITH MORE THAN

CONCLUSORY STATEMENTS

• In re Ethicon, --F.3d__ (Fed. Cir. Jan. 3, 2017)(LOURIE, Dyk,

Newman; Newman dissenting)

• PTAB upheld rejection for obviousness.

• FC: Affirmed.

― Substantial evidence supported factual findings and

conclusion of obviousness.

― Not outweighed by objective evidence of nonobviousness. ― “Ethicon relied solely on its expert’s conclusory testimony to

support its copying allegations.”

― “Ethicon’s expert never even opined that the results pointed to

would have been unexpected to a person of ordinary skill in the

art.”

• Note: Judge Newman considered that the Board erred in refusing to consider

the objective evidence.

47

PTAB REQUIRES NEXUS

• Gnosis S.p.A. v. Merck & Cie, IPR2013-00117, Paper 71 (P.T.A.B.

June 20, 2014)

― PTAB: Instituted claims held unpatentable (or canceled by Patent

Owner)

― “Merck argues, and Gnosis does not dispute, that administration of

each of the above Pamlab products to a patient falls within the scope

of the claims under review. ...It is not sufficient, however, that a

product or its use merely falls within the scope of a claim in order for

objective evidence of nonobviousness tied to that product to be given

substantial weight. There must also be a causal relationship, termed

a “nexus,” between the evidence and the claimed invention. . . . A

showing of sufficient nexus is required in order to establish that the

evidence relied upon traces its basis to a novel element in the claim,

not to something in the prior art. . . . Objective evidence that results

from something that is not ‘both claimed and novel in the claim’

lacks a nexus to the merits of the invention.” [citations omitted]

48

PTAB REQUIRES NEXUS (con’t)

• Gnosis (con’t)

― PTAB rejected objective evidence

― “Nexus must exist in relation to all types of objective

evidence of nonobviousness. GPAC, 57 F.3d at 1580

(generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)

(commercial success); In re Antor Media Corp., 689 F.3d

1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co.

v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir.

2012) (copying); Ormco Corp. v. Align Tech., Inc., 463 F.3d

1299, 1313 (Fed. Cir. 2006) (failure of others); Rambus Inc.

v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need);

Kao, 639 F.3d at 1069 (unexpected results); Stamps.com

Inc. v. Endicia, Inc., 437 F. App’x 897, 905 (Fed. Cir. 2011)

(skepticism); Muniauction, Inc. v. Thomson Corp., 532 F.3d

1318, 1328 (Fed. Cir. 2008) (praise).”

49

PTAB REQUIRES NEXUS (con’t) • Gnosis (con’t)

― PTAB rejected objective evidence

― “Thus, for objective evidence to be accorded substantial

weight, the record ‘must establish a nexus between the

evidence and the merits of the claimed invention.’ . . . .

Moreover, establishing nexus involves a showing that novel

elements in the claim, not prior-art elements, account for the

objective evidence of nonobviousness. . . . As the Federal

Circuit explains, ‘[t]o the extent that the patentee

demonstrates the required nexus, his objective evidence of

nonobviousness will be accorded more or less weight.’ . . .

Thus, the stronger the showing of nexus, the greater the

weight accorded the objective evidence of nonobviousness.”

[citations omitted]

50

NEXUS REQUIRED FOR OBJECTIVE EVIDENCE OF NONOBVIOUSNESS IS

NOT A NEW CONCEPT

• CCPA, Federal Circuit, PTAB case law and

MPEP:

• All rely on Graham v. John Deere Co., 383 U.S. 1

(1966):

― (1) the scope and content of the prior art;

― (2) differences between the prior art and the claims at

issue;

― (3) the level of ordinary skill in the pertinent art; and

― (4) evaluation of any relevant secondary considerations.

51

RECENT FEDERAL CIRCUIT CASE REITERATING NEXUS REQUIREMENT

• In re Ethicon, --F.3d__ (Fed. Cir. Jan. 3,

2017)

• FC: “the evidence relied on by Ethicon to

support its claims of commercial success,

industry praise, and unexpected results did not

establish that any success, praise or unexpected

results were due to the 85:15 VDF:HFP coating,

rather than to an unclaimed feature such as the

drug or stent design, is supported by substantial

evidence.”

―

52

“NEXUS” BETWEEN EVIDENCE AND CLAIMED INVENTION

• Manual of Patent Examining Procedure

§716.01(b)

• “The term “nexus” designates a factually and

legally sufficient connection between the

objective evidence of nonobviousness and the

claimed invention so that the evidence is of

probative value in the determination of

nonobviousness. Demaco Corp. v. F. Von

Langsdorff Licensing Ltd., 851 F.2d 1387, 7

USPQ2d 1222 (Fed. Cir.), cert. denied, 488 U.S.

956 (1988).”

53

SO FAR, ONLY A FEW EXAMPLES OF SUCCESSFUL USE OF OBJECTIVE EVIDENCE OF NONOBVIOUSNESS

Objective evidence of nonobviousness must have

nexus.

Patent Owners not much success so far with

objective evidence of nonobviousness - not

showing nexus (linking the objective evidence of

obviousness to the merits of the claimed

invention).

54

OBJECTIVE EVIDENCE IN “RECORD” SUCCESSFULLY USED BY PATENT OWNER

TO GET IPR PETITION DENIED

Omron Oilfield & Marine, Inc. v. Md/Totco, A

Division Of Varco, L.P., IPR2013-00265, Paper 11

(PTAB Oct. 31, 2013)

― Patent Owner requested PTAB exercise its discretion

to deny the petition because of the same

art/arguments before the Office during

reexamination.

― Patent Owner was able to rely on evidence in the record

in a reexamination of the patent of commercial success.

55

OBJECTIVE EVIDENCE IN “RECORD” SUCCESSFULLY USED BY PATENT OWNER

TO GET IPR PETITION DENIED

Omron (con’t)

― PTAB: Petition denied.

― Found Petitioner established a prima facie case of

obviousness, and then reviewed the objective evidence of

nonobviousness provided to the examiner during a

reexamination, and agreed that it was persuasive.

― “we determine that Patent Owner has presented sufficient

evidence to establish a prima facie case of nexus.”

― No rebuttal by Petitioner.

― “We find that the ’142 Patent had significant commercial

success, which, here, overcomes the prima facie case of

obviousness.” 56

PETITIONER’S FAILURE TO ADDRESS OBJECTIVE EVIDENCE BASIS FOR DENIAL

• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products,

IPR2016-00777, -00778, -00779, -00780, Paper 10 (P.T.A.B.

Sept. 22, 2016)

• PTAB: Denied petitions under 35 U.S.C. § 325(d). ― Patent Owner’s evidence of a clinical study showed unexpected

results.

― In prior proceedings, PTAB found the study “compelling

evidence” of nonobviousness.

― Petitioner did not address any of these arguments in its earlier

petitions or in its present petitions.

― Petitioner “does not explain why the many experts in the field

would have designed a study that did not exclude patients with

pre-existing LVD if it were obvious to do so.” ― “Petitioner’s argument is substantially the same as before[.]”

― Petitioner’s arguments that couldn’t find references earlier

contradicted by testimony of its own expert.

57

OBJECTIVE EVIDENCE SUCCESSFULLY USED BY PATENT OWNER AVOID

UNPATENTABILITY DETERMINATION IN FWD

Intri–Plex Technologies, Inc. v. Saint–Gobain Performance Plastics Rencol Ltd.,

IPR2014–00309, Paper 83 (PTAB March 23, 2014)

• Patent Owner submitted objective evidence of nonobviousness via a declaration

(prepared for the IPR) supporting the Patent Owner Response.

• PTAB: Final Written Decision that Intri-Plex did not meet its burden of showing

challenged claims unpatentable.

― “we determine that the first three Graham factors favor a determination that the

challenged claims are obvious. However, a proper obviousness determination requires a

consideration of all factors, and we determine that Saint-Gobain’s case for

nonobviousness based on secondary considerations is particularly strong, and outweighs

the other three factors. In particular, we are persuaded that our finding of commercial

success is particularly strong, …. Indeed, we determine that commercial success alone

sufficiently outweighs the other three factors, and that our finding of copying merely

strengthens further our finding that secondary considerations weigh in favor of Saint-

Gobain.”

58

PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE

Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676

• Petition challenged 8 claims; 8 asserted grounds. ― Submitted prosecution declarations as exhibits.

― Argued that the declarations submitted to overcome examiner’s rejection

did not in fact prove unexpected results and lack of reasonable

expectation of success.

• POPR: ― Petitioner failed to establish a reason to combine the prior art with a

reasonable expectation of success

― Petitioner failed to properly account for objective indicia of

nonobviousness as discussed in prosecution declarations. ― Unexpected results from clinical trials

― Praise in the industry

― long-felt need

― commercial success

― Cited Omron Oilfield & Marine, Inc. v. MD/Totco, to support denial because

petition fails to "challenge the merits of Patent Owner's secondary consideration

evidence" of record.

59


Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676 • PTAB instituted IPR on all challenged claims on one asserted

ground. ― “Petitioner has established a reasonable likelihood that it would prevail in

showing prima facie obviousness, i.e., that an ordinary artisan would have

had reason to make immunoconjugates as described in Chari 1992 using

huMAB4D5-8 disclosed in the HERCEPTIN® Label, with a reasonable

expectation of success in making them.”

― Considered objective evidence, but decided that Petitioner had made

sufficient showing for institution. ― The prosecution declarations addressed “a rejection during prosecution based on different

references than those cited in asserted grounds in the Petition.”

― “In addition, Patent Owner evidence of record at this time do not address adequately

considerations such as whether evidence of objective indicia are reasonably commensurate

with the scope of the challenged claims, whether a sufficient nexus exists between such

evidence and the merits of the claimed invention, or whether evidence of unexpected results

establishes a difference between the results obtained and those of the closest prior art.”

Maybe could have obtained denial

60


Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper

39 (PTAB Oct. 27, 2015)

• PTAB FWD: All claims survived (not shown to be unpatentable).

― “viewing the record as a whole, Petitioner does not persuade us that a

preponderance of the evidence establishes that a skilled artisan would

have had a reasonable expectation of success in 2000 that a Herceptin®-

maytansinoid immunoconjugate would be useful in the treatment of breast

tumors in humans[.]”

― “Petitioner has not established by a preponderance of the evidence that a

skilled artisan would have had reason to combine the teaching of the cited

references to make the immunoconjugates of claim 6 and 8.”

― “Although failure to establish a reason to combine the cited teachings is

sufficient, by itself, to conclude non-obviousness, Patent Owner cites

substantial evidence of objective indicia of non-obviousness in relation to

claim 8, which is directed to the T-DM1/Kadcyla® commercial product.”

61


Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper

39 (PTAB Oct. 27, 2015) • PTAB FWD: (con’t)

― Objective evidence ― unexpected superior results as compared to closest prior art compositions

― fulfilling a long-felt and unmet need for an immunoconjugate capable of targeting a solid

tumor in patients without excessive toxicity.

― praise in the field

― commercial success: sales and prescription data, marketing and promotional efforts.

― “we are persuaded that Patent Owner establishes a sufficient nexus in

relation to the cited objective evidence of nonobviousness.”

― “The specification of the 856 patent discloses, and claim 8 recites, the

very components that led to the unexpected results, praise and

commercial success. . . . Patent Owner sufficiently establishes that it is

the exact combination of those components recited in claim 8, rather than

different components previously combined in the prior art, that provided

the unexpected results at issue, and led to praise and commercial

success.”

62

REMEMBER: parallel and inconsistent outcomes VERY REAL POSSIBILITY

AND END OF LITIGATION MAY NOT BE

END OF CASE

Fresenius v. Baxter (Fed. Cir. 2013) – litigation decision was not final, PTAB decision wiped out award.

SAP v. Versata (Fed. Cir. 2014) – Litigation decision final (because

Versata waived injunction), but appeal dismissed after PTAB canceled claims.

63

Prosecution issues in view of the opportunities and pitfalls

afforded by the AIA,

including Jedi-Master-Mixer (JMM), particularly for avoiding

certain on-sale bars that could be raised in future PGRs

64

AIA TRANSITION PROVISIONS RELEVANT TO JMM

65

“section 3(n)(2) does indicate that the provisions of 35 U.S.C.

102(g), 135, and 291 as in effect on March 15, 2013, shall apply

to “each claim” of an application for patent, and not simply

the claim or claims having an EFD that occurs before March 16,

2013, if the condition specified in section 3(n)(2) occurs.

Therefore, “each claim” of an application presenting a claim to

a claimed invention that has an effective filing date before

March 16, 2013, but also presenting claims to a claimed

invention that has an effective filing date on or after March 16,

2013, is subject to AIA 35 U.S.C. 102 and 103 and is also subject

to the provisions of 35 U.S.C. 102(g), 135, and 291 as in effect

on March 15, 2013.”

FITF EXAMINATION GUIDELINES: SEC. 3(n)(2)

See pp. 11069, 11072 of Examination Guidelines (2/14/13)

66

Enactment: Sept. 16, 2011

PCT

Filing

First to Invent System Applies

STRADDLING THE EFFECTIVE DATE

“First To Invent” System or “FITF” System? (see SEC.

3(n)(1)(A) and (n)(2))

(Even if one claim not supported at priority date is

eventually canceled, still in FITF.)

PCT

Filing

Priority

Date

Enactment: Sept. 16, 2011 Effective Date:

March 16, 2013

Priority

Date

“FITF” System Applies

PCT

Filing

Enactment: Sept. 16, 2011

Scenario 1: no claims entitled to priority date: FITF

Scenario 2: all claims entitled to priority date: first-to-invent

Scenario:3: at least 1 claim not entitled to priority date: mixed

Assumes “priority date” is ex-US

67

Some may seek out SEC.3(n)(2), owing to advantages of AIA.

• Elimination of Metallizing Engineering forfeiture (according to

USPTO, see p. 11062 of Examination Guidelines (2/14/13);

• liberalization of the CREATE ACT and common ownership in

102(c);

• possible elimination of pre-AIA statutory bars that are not AIA

prior art!!!

Lab notebooks maybe even more important than before!

• Proving conception still important for antedating references,

including in IPRs/PGRs.

SEC. 3(n)(2): JEDI MASTER MIXER!

68

EXPLAIN CHOICE OF LAW TO EXAMINER

69

INTERVIEW GETTING EFD’S CORRECTED

70

CLEARING THE PATH, PARTICULARLY IN

ADVANCE, TO FORTIFY AGAINST IPR/PGR

71

CONSIDER PURSUING SEVERAL PATENTS

FROM ONE APPLICATION Keeping a family member alive may help a patent owner facing

IPR or PGR. • If PTAB does not allow the patent owner to enter a particular proposed

substitute claim, if the subject matter of the proposed substitute claim is

patentably distinct from any canceled claims, such subject matter can still be

pursued in a pending family member.

• Perhaps avoid the need to amend claims in an IPR/PGR against potential

novelty and obviousness attacks based on patents and printed publications.

• Divisionals all protected from ODP attacks in litigation and could lead to

several patents each having numerous claims of varying scope that a petitioner

will have to challenge.

• Additionally, evidence and arguments submitted in the prosecution history of

other applications could be referenced in a POPR or Patent Owner Response

(POR) for the patent at issue in the IPR/PGR.

72

Caution on keeping a pending application: Study cases

discussing “unreasonable and unexplained delay.”

• Tafas v. Doll, 559 F.3d 1345 (Fed. Cir. 2009)

• In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002)

• Symbol Tech., Inc. v. Lemelson Medical, Educ. & Research Foundation, 422

F.3d 1378 (Fed. Cir. 2005)

73

CONSIDER PURSUING SEVERAL PATENTS

FROM ONE APPLICATION (cont.)

CONSIDER KEEPING CONTINUATION APPLICATION PENDING (con’t)

Consider estoppel impact on a patent owner receiving an adverse

written decision and how it would likely preclude seeking

patentability of a claim in the continuation that is not

patentably distinct from the claim determined to be

unpatentable in the written decision.

• 37 C.F.R. §42.73(d)(3): “(3) Patent applicant or owner. A patent

applicant or owner is precluded from taking action inconsistent

with the adverse judgment, including obtaining in any patent: ― (i) A claim that is not patentably distinct from a finally refused

or canceled claim; or

― (ii) An amendment of a specification or of a drawing that was

denied during the trial proceeding, but this provision does not

apply to an application or patent that has a different written

description.

74

AC Dispensing Equipment, Inc. v. Prince Castle, LLC, IPR2014-00511,

Paper (PTAB Oct. 17, 2014)

• Petitioner requested permission to file a motion to stay the prosecution of

the continuation patent application.

• PTAB: Denied.

― “Patent Owner will not be permitted to obtain in a patent any claims that are

not patentably distinct from any claim that is canceled as a result of this

proceeding. But whether any of the claims in the ’497 patent will be canceled

is an issue that is not yet decided and will not necessarily be decided until a

final written decision is entered in this case and appeals from it are

exhausted. To bar Patent Owner from prosecuting claims now that may be

patentably indistinct from the claims under review thus would be premature.

It is sufficient, under the current circumstances, for Patent Owner to continue

to take reasonable steps to apprise the Examiner of the status of this

proceeding.”

KEEP CONTINUATION PENDING…

75

KEEP CONTINUATION PENDING… (con’t)

• PTAB indicated continuation application prosecution will not be

stayed.

• Telebrands Corp. v. Tinnus Enterprises, LLC, PGR2015-00018, Paper 62

(P.T.A.B. Aug. 29, 2016)

― PTAB denied Petitioner’s request to file a motion to suspend prosecution of 4 pending

continuation patent applications.

― “We deny Petitioner’s request for authorization to file a motion to suspend

prosecution of the co-pending applications. … Petitioner has not persuaded us that

any of the co-pending patent applications meets the ‘every involved application

and patent’ requirement, which triggers our authority under § 42.3(a).”

― “During the call, moreover, Petitioner was unable to cite any Board decision

granting a request to suspend prosecution of a related application (Ex. 1037, 11),

while Patent Owner cited several Board decisions denying such requests (id. at 13–

14 (citing EMC Corp. v. Personal Web Technologies, LLC., Case IPR2013-00083, slip

op. at 3 (PTAB March 19, 2013) (Paper 12); Apotex Inc. v. Wyeth LLC, Case IPR2014-

00115, slip op. at 5–6 (PTAB May 29, 2014) (Paper 19); Chums, Inc. v. Cablz, Inc.,

Case IPR2014-01240, slip op. at 2 (PTAB May 8, 2015) (Paper 22))).”

76

CONTINUATION APPLICATION MAY BE FILED ON DAY PARENT ISSUES

• Immersion Corp. v. HTC Corp., 826 F.3d 1357 (Fed. Cir. 2016)

• Immersion filed a continuation application on August 6, 2002,

the same day that the parent application issued.

• DC: Patent invalid.

― Priority for the continuation was unavailable because it was

not “filed before the patenting” of the parent application.

― See 35 U.S.C. §120.

• FC:

― “an application may be ‘filed before patenting’ of the

earlier application when both legal acts, filing and

patenting, occur on the same day.”

77

CONSIDER HAVING PATENT OWNER USE REISSUE

• Patent Owner Estoppel can be quite severe, reminiscent of

the body of law of interference estoppel.

• So maybe Patent Owner doesn’t amend claims in IPR/PGR

and rather provides a patentably distinct but useful claim

amendment in reissue, particularly if no continuation

pending.

• Reissue likely stayed pending disposal of IPR/PGR within the

one year period from institution.

• If claims of patent canceled in IPR/PGR, look for patentably

distinct claims in reissue that are enforceable and still

infringed.

78

REISSUE AND POST-GRANT PROCEDURES

Reissue applications can be merged with ex parte

reexaminations.

Reissue rules govern merged proceeding.

Timing with concurrent PGR/IPR: stays? PTAB discretion.

PGR/IPR

PGR applicable for 9 months after reissue on new reissue claims.

Reissue “effective filing date” is patent filing date.

IPR/PGR is available as normal.

What may the role of reissue be in these PGR/IPR proceedings?

79

PGR/IPR/REISSUE— TIMING REQUIREMENTS RELATED TO

LITIGATION

Cannot file if challenger also filed civil action challenging validity of patent (IPR

or PGR, §315(a)/§325(a)). • Petitioner, real party, or privy of petitioner.

• Does not include counterclaim.

Cannot file IPR more than 12 months after the petitioner is served with a

complaint alleging infringement of patent. (§315(b))

If a civil action alleging infringement of a patent is filed within 3 months patent

issues, the court may not stay its consideration of the patent owner’s motion for a

preliminary injunction on the basis that a petition for PGR filed or PGR instituted.

(§325(b))

No such timing requirements on reissue/pending applications other than the

normal ones.

80

PTAB DISCRETION

35 U.S.C. §315(d)/§325(d)

• (d) MULTIPLE PROCEEDINGS.—Notwithstanding sections 135(a), 251, and

252, and chapter 30, during the pendency of an inter partes review, if

another proceeding or matter involving the patent is before the Office,

the Director may determine the manner in which the inter partes review

or other proceeding or matter may proceed, including providing for stay,

transfer, consolidation, or termination of any such matter or proceeding.

• §325(d) continues: “In determining whether to institute or order a

proceeding under this chapter, chapter 30, or chapter 31, the Director

may take into account whether, and reject the petition or request

because, the same or substantially the same prior art or arguments

previously were presented to the Office. (applies to both IPRs and PGRs).

81

PETITIONER ESTOPPEL: PGR AND IPR

PGR and IPR

Becomes effective once the Board issues a final written decision

Applies to any ground that petitioner raised or reasonably could have raised

Estoppel applies in subsequent proceedings before the PTO, in civil actions, and in ITC

proceedings

One-way: Only runs from PTAB to PTO/court

No estoppel if terminate by settlement

82

PATENT OWNER ESTOPPEL

Patent owner estoppel. Substantive rule making?

• § 42.73(d)(3) A patent applicant or owner is precluded

from taking action inconsistent with the adverse

judgment, including obtaining in any patent:

i. A claim that is not patentably distinct from a

finally refused or canceled claim; or

ii. An amendment of a specification or of a drawing

that was denied during the trial proceeding, but

this provision does not apply to an application or

patent that has a different written description.

83

Ossia, Inc. v. Energous Corp., PGR2016-00023 and -00024, Paper 18 (P.T.A.B. Sept. 27, 2016)

• PGR petition filed May 31, 2016.

• PTAB and parties held conference call to discuss:

―Patent Owner request for Certificate of Correction to correct priority claim;

―Patent Owner request for Certificate of Correction to correct alleged errors in written description and claims;

―Patent Owner request for ex parte reexamination filed Aug 12, 2016.

PGR AND STAY OF EX PARTE REEXAM

84

Ossia (con’t)

• Requests for Certificates of Correction moot:

―PTO dismissed request to change priority claim

because that would mean a “change in the statutory

regime under which the application should have been

examined[.]”

―PTO denied request to correct errors finding that they

were not minor and “affect the scope of the

claims[.]”


85

Ossia (con’t)

• Appropriate to exercise discretion to stay reexam (35 U.S.C. §325(d) and 37 C.F.R.

§42.222(a)).

― PGR petition challenged claims as unpatentable under §112.

― Patent Owner amended all independent claims in the reexam.

― But PTO examines amended claims for compliance with §112 only with respect

to subject matter added in the reexam.

― So Petitioner’s PGR §112 arguments, directed to original claims, would

not/could not be evaluated in reexam.

― “[P]ermitting the reexamination to proceed could have the effect of

circumventing Petitioner’s §112 challenges, as well as the estoppel provisions

for post-grant review, if a reexamination certificate were to issue with all

amended claims.”


86

Ossia (con’t)

• PTAB explained further:

― “if the amended claims were found patentable in the

reexamination, and the instant proceedings terminated, Petitioner

would be time-barred from raising § 112 challenges to the

amended claims in another petition for post-grant review…. Also,

if a post-grant review were instituted and Petitioner were to

ultimately prevail in its § 112 challenges, Patent Owner would be

unable to obtain any claim that is not “patentably distinct” from a

claim cancelled as a result of the post-grant review. See 37 C.F.R.

§ 42.73(d)(3). Therefore, to the extent any of Patent Owner’s

amended claims in the reexamination are not patentably distinct

from an existing claim (an issue we need not, and do not, decide

at this time), Patent Owner potentially could obtain claims that

may not be permitted otherwise.”


87

Ossia (con’t)

• There is also overlap between the PGR and the reexamination - §103

arguments and prior art references.

• “Having two proceedings at the Office involving many of the same

claims and much of the same prior art taking place at the same time

is inconsistent with the Board’s rules designed to ‘secure the just,

speedy, and inexpensive resolution of every proceeding.’”

• The PGR may simply or obviate issues in the reexam.


88

SURVIVING CLAIMS: WHAT PATENT OWNERS DID

Strong foundation in prosecution history to draw on.

Consider requesting briefing/conference call on just the

PGR-eligibility issue prior to POPR.

89


Put your best foot forward in the Preliminary Response

(POPR)

• Best case – institution denied

• Even if trial instituted, may narrow issues

• Have a clear and succinct section summarizing why AIA proceeding

should not be instituted.

• Get to see Board’s reaction to arguments and tailor future submissions

accordingly

Hold the Petitioner's feet to the fire • Focus on the weaknesses in the petitioner's case and aim to convince

the board that the burden of establishing likelihood of unpatentability

has not been met and thus there should be no institution.

90


Expert testimony may be critical

• No page limits on declarations.

• Involve expert in development of every position the patent owner is

taking.

• Consider having declarations in the file history of the patent being

challenged in IPR/PGR for use with POPR/POR.

• Consider declarations that were prepared for other patent

applications but which have relevance in defeating institution of the

patent challenged.

91


Get ready to get technical

• Patentable differences rooted in patent claims.

• Expertise of PTAB judges in science and law.

• Focus closely on the technology.

• But a key is to have a powerful summary, backed by

technical evidence, as to why PTAB either should not

institute, or if instituted, why the full record compels

PTAB to find patentability.

92

TAKE AWAYS

• Strategic use of prosecution or litigation

declarations.

• Best practices for establishing nexus

between the objective evidence and the

merits of the claimed invention.

93

TAKE AWAYS

• Provide detailed explanation linking the

objective evidence with the claimed

invention.

• If objective evidence of nonobviousness

arises late in the IPR/PGR proceeding, it may

still be possible for Patent Owner to get that

evidence before the PTAB.

94

TAKE AWAYS

• Best case scenario for a Patent Owner is to have the

petition denied and avoid an IPR/PGR, particularly

since denial cannot be judicially reviewed.

• Even if this is not achieved, the POPR may lead to the

trial being instituted on fewer grounds and/or fewer

claims than challenged in the petition -> still a

positive development for a Patent Owner now faced

with a trial narrower in scope.

• Patent Owner consider loading evidence into her

prosecution, along with crisp and compelling

arguments to show no prima facie case of obviousness,

at least in applications likely to end up in litigation or

an IPR/PGR. 95

TAKE AWAYS

• Solid evidentiary showings and/or possibly

declarations, in addition to on-point legal

arguments, may help to develop strong

patentability records.

• Prudently establishing such records during

prosecution could support Patent Owner's

efforts to persuade the PTAB that Petitioner

does not have a “reasonable likelihood” of

success and thus achieve denial of institution.

96

TAKE AWAYS

• The PTAB desires to have cases front-loaded to make the most

efficient use of the its resources by allowing it to make the

institution decision based on the most information possible.

• If Patent Owner has relevant and compelling information in the

prosecution history, or in related proceedings, such as

reexamination or litigation, that could well help Patent Owner

convince the PTAB to deny the petition. In particular, in the

POPR, Patent Owner can tell the PTAB in a concise, compelling

argument why the petition should be denied.

• Such concise and compelling arguments can help the PTAB

achieve both the policy objective that IPR proceedings be

“just, speedy, and inexpensive” and the statutory objective of

resolution 12-18 months from institution.

97

Thank You!

Contact Information:

Tom Irving

(202) 408 4082

[email protected]

Amanda Murphy

(202) 408 4114

[email protected]

Kerry Flynn

[email protected]

98

mailto:[email protected]



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