Ex Parte BENEDICTDownload PDFPatent Trial and Appeal BoardSep 14, 201814924136 (P.T.A.B. Sep. 14, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/924,136 10/27/2015 William F. BENEDICT 22925 7590 09/18/2018 PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 MADISON A VENUE 4THFLOOR MORRISTOWN, NJ 07960-7397 UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. Canji - 60/528525 9792 EXAMINER ANGELL, JONE ART UNIT PAPER NUMBER 1674 NOTIFICATION DATE DELIVERY MODE 09/18/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docket@LicensingLaw.net administration@LicensingLaw.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WILLIAM F. BENEDICT Appeal2017-008598 Application 14/924, 136 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and JACQUELINE T. HARLOW, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a composition of matter. The Examiner rejected the claims as anticipated under 35 U.S.C. 102(b), or alternatively under 35 U.S.C. 102(e), and obvious under 35 U.S.C. § 103(a). The Examiner also rejected claim 3 under 1 Appellant identifies the Real Party in Interest as FKD Therapies Oy (see App. Br. 1). 2 We have considered and herein refer to the Specification of October 27, 2015 ("Spec."); Final Office Action of Apr. 22, 2016 ("Final Act."); Appeal Brief of Sept. 12, 2016 ("App. Br."); Examiner's Answer of Jan. 18, 2017 ("Ans."); Provisional Application 60/528,525 ("'525 application"), filed Dec. 10, 2003; Application 11/009,689 ("'689 application"), filed Dec. 10, 2004; Application 12/706,625 ("'625 application"), filed Feb. 16, 2010; Examination Support Document of October 27, 2015 ("ESD"); and Petition to Make Special dated Oct. 27, 2015 ("Pet.") Appeal2017-008598 Application 14/924, 13 6 35 U.S.C. 112, 1st paragraph. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background "The present invention further provides compositions useful in the treatment of interferon resistant tumors using recombinant vectors encoding interferons" (Spec. iF). "[M]any patients present cancer which is 'interferon-resistant'; that is, showing little or no response to intravenously- injected interferon polypeptide" (App. Br. 1:14--16). "Gene therapy employing recombinant vectors encoding interferon species provides a promising alternate approach to the treatment of refractory superficial bladder cancer" (Spec. i-f6). The "experiments demonstrate that recombinant vector delivered interferons possess unique properties distinct from commercially available recombinant IFN protein and that vectors encoding IFN can overcome resistance to the IFN protein" (Spec. ,I46). The Claims Claims 1-9 are on appeal. Claim 1 is representative and reads as follows: 1. A composition of matter comprising: a non-interferon agent which induces interferon production in human cells which are exposed to it, said agent being replication-deficient, said agent formulated in normal saline as a non-emulsified suspension suitable for intravesical irrigation, said formulation providing said agent in an amount sufficient to induce interferon production in human bladder cells, said formulation further providing said agent in an amount effective to treat non- muscle invasive bladder cancer. 2 Appeal2017-008598 Application 14/924, 13 6 The Rejections3 A. The Examiner rejected claims 1--4 and 6-8 under 35 U.S.C. § 102(b) as anticipated by Ahmed4 (Ans. 9--11). B. The Examiner rejected claims 1-9 under 35 U.S.C. § 103(a) as obvious over Ahmed and Yamashita5 (Ans. 13-14). C. The Examiner rejected claims 1-8 under 35 U.S.C. § 102(b), or alternatively under 35 U.S.C. 102(e), as anticipated by Connor6 (Ans. 8). D. The Examiner rejected claims 1-9 under 35 U.S.C. § 103(a) as obvious over Connor (Ans. 11 ). E. The Examiner rejected claims 1-9 under 35 U.S.C. § 103(a) as obvious over Benedict7 and Connor (Ans. 12-13). F. The Examiner rejected claim 3 under 35 U.S.C. 112, 1st paragraph as failing to comply with the written description requirement (Ans. 5-7). 3 The Examiner objected to the specification for failing to provide support for the claimed subject matter but did not reject the claims under 35 U.S.C. § 112, first paragraph as containing new matter (Final Act. 4--6). The propriety of the Examiner's objections relate to petitionable matters and not to appealable matters. Objections are petitionable matters under 3 7 C.F .R. § 1.181 to the Director of the US PTO. See MPEP § 706.01. Accordingly, we will decline to address the objections of record. 4 Ahmed et al., Interferon a2b gene delivery using adenoviral vector causes inhibition of tumor growth in xenograft models from a variety of cancers, 8(10) CAN. GENE THERAPY, 788-795 (2001). 5 Yamashita et al., Syn3 provides high levels of intravesical adenoviral- mediated gene transfer for gene therapy of genetically altered urothelium and superficial bladder cancer, 9 CAN. GENE THERAPY, 687-691 (2002). 6 Connor et al., US 7,355,056 B2, issued April 8, 2008. 7 Benedict et al., lntravesical Ad-IFNa Causes Marked Regression of Human Bladder Cancer Growing Orthotopically in Nude Mice and Overcomes Resistance to IFN-a Protein, 10(3) MOL. THERAPY, 525-532 (2004). 3 Appeal2017-008598 Application 14/924, 13 6 A andB. Anticipation over Ahmed and Obviousness over Ahmed and Yamashita Because both of these rejections tum on the same issue and rely upon Ahmed, we will consider them together. We begin with claim interpretation. The Specification states that recombinant adenoviral vectors have been demonstrated to be safe and effective in human beings in the dosage range between lx105 and lxl0 12 viral particles per dose in a multiple dosing regimen over a period of several weeks. Consequently, administration of recombinant adenoviral vectors encoding interferon may be used in such dosage ranges. In the preferred practice of the present invention for the treatment of superficial bladder cancer in human beings, [a] course of treatment comprising a dose of from lxl0 10/ml to lxl0 12/ml (most preferably approximately 1x10 11 /ml) recombinant adenoviral particles encoding interferon a2b in a volume of approximately 100 ml is instilled intravesically for a period of approximately one hour. (Spec. ifif58-59). Therefore, consistent with the Specification, we interpret a formulation providing said agent in "an amount sufficient to induce interferon production in human bladder cells" as required by claim 1 as encompassing an amount in the range of lxl0 10/ml to lx10 12/ml. The Examiner finds that Ahmed teaches "a composition of matter comprising a non-interferon agent which induces interferon production in human cells which are exposed to it[,] said agent being replication-deficient, said formulation providing said agent in an amount sufficient to induce interferon production in human bladder cells" (Ans. 9). The Examiner finds that "Ahmed specifically teaches that lxl0 10 particles of the recombinant adenovirus was formulated in 100µ1 PBS for 4 Appeal2017-008598 Application 14/924, 13 6 administration" and that this formulation is "suitable for intravesical irrigation" (Ans. 18). The issue with respect to these rejections is: Does the evidence of record support the Examiner's conclusion that Ahmed anticipates the claims or, in combination with Yamashita, renders the claims obvious? Findings of Fact "A composition of matter comprising a non-interferon agent which induces interferon production in human cells which are exposed to it" 1. Ahmed teaches a "recombinant adenovirus expressing human interferon a2b driven by the cytomegalovirus promoter, IACB was shown to produce and secrete biologically active ... human interferon" (Ahmed abstract). 2. The recombinant adenovirus is non-interferon, because it is a recombinant adenovirus that expresses interferon and not interferon itself (see ESD 2). 3. The recombinant adenovirus is a composition of matter (see ESD 2). "said agent being replication-deficient" 4. Ahmed teaches "the use of a replication-deficient adenovirus expressing interferon a2b" (Ahmed 788). "said agent formulated in normal saline as a non-emulsified suspension" 5. Ahmed teaches that "[p ]hosphate buffered saline [PBS] ... was used as the 'vehicle control' for in vivo studies," thereby indicating that the vehicle is PBS. (Ahmed 789). 5 Appeal2017-008598 Application 14/924, 13 6 "suitable for intravesical irrigation" 6. Ahmed teaches that "lxl010 particles of IACB ... in 100 µL were administered" (Ahmed 789). 7. The Specification states that "[ w ]hen the delivery system is formulated as a solution or suspension, the delivery system is in an acceptable carrier, preferably an aqueous carrier. A variety of aqueous carriers may be used, e.g., water, buffered water, 0.8% saline, 0.3% glycine, hyaluronic acid and the like" (Spec. ,r 51 ). "said formulation providing said agent in an amount sufficient to induce inteiferon production in human bladder cells" 8. Ahmed teaches a "recombinant adenovirus expressing human interferon a2b driven by the cytomegalovirus promoter, IACB was shown to produce and secrete biologically active ... human interferon" (Ahmed abstract). "said formulation further providing said agent in an amount effective to treat non-muscle invasive bladder cancer" 9. Ahmed teaches "lxl010 particles ofIACB ... in 100 µL were administered" (Ahmed 789). lxl0 10 particles in 100 µL= 100 µL of a lxl0 11 particles/mL solution, because 100 µL = 0 .1 mL. 10. The Specification states [i]n the preferred practice of the present invention for the treatment of superficial bladder cancer in human beings, [a] course of treatment comprising a dose of from lxl0 10/ml to lxl0 12/ml (most preferably approximately lxl0 11/ml) recombinant adenoviral particles encoding interferon a2b in a volume of approximately 100 ml is instilled intravesically for a period of approximately one hour (Spec. i-f 59). 6 Appeal2017-008598 Application 14/924, 13 6 11. Yamashita teaches that "Syn3, when injected intravesically for 1 hour at 1 mg/ml on two consecutive days, markedly increases rAd-B-gal intravesical gene transfer and expression" in "human bladder cancer" (Yamashita abstract). Principles of Law Anticipation under 35 U.S.C. § 102 requires that "'each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference"' In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). "It is well settled that 'anticipation is the epitome of obviousness."' In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002). Analysis We adopt the Examiner's findings of fact and conclusions of law (see Ans. 9-24; FF 1-11) and agree that Ahmed anticipates the claims and therefore renders the claims obvious. We also find the combination with Yamashita renders the rejected claims obvious. We address Appellant's arguments below. Appellant contends that claim "1 requires an amount sufficient to induce interferon in human bladder. In contrast, Ahmed teaches treating Buffalo rats and mice" (App. Br. 16). We find this argument unpersuasive because Claim 1 requires "an amount sufficient to induce interferon production in human bladder cells." Ahmed teaches, consistent with our claim interpretation, treatment with lxl0 11 particles/mL solution (FF 6, 9), a dosage amount squarely within the range of lxl0 10/ml to lxl0 12/ml disclosed as functional by the Specification (Spec. ,r 59). We therefore agree with the Examiner that the formulation 7 Appeal2017-008598 Application 14/924, 13 6 necessarily provides an amount sufficient to induce interferon production in human bladder cells (see Ans. 18). We further note that Claim 1 does not require the administration of the composition to a human, but rather simply requires an "amount sufficient to induce interferon production in human bladder cells." At best, this limitation is an attempt to import a method step into a product claim. However, the "addition of a method step in a product claim, which product is not patentably distinguishable from the prior art, cannot impart patentability to the old product." In re Dilnot, 300 F.2d 945, 950 (CCPA 1962). Moreover, even if the claim recited the intended use of treatment of humans, a "mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable." In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Appellant contends that "[ c ]laim 1 requires an agent formulated to be 'suitable for intravesical irrigation.' In contrast, Ahmed teaches formulating an agent for intravenous injection and intra-tumoral injection, not intravesical irrigation." (App. Br. 16). We do not find this argument persuasive. While Claim 1 requires the formulation of the agent to be "suitable for intravesical irrigation," neither the Specification nor Claim 1 identify any specific structural formulation requirements necessary for "intravesical irrigation" that distinguish the claimed composition from the composition of Ahmed prepared in PBS (FF 5). "[ A Jpparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). The same principle applies to a claimed composition of matter. Appellant provides no evidence, as opposed to attorney argument, that the 8 Appeal2017-008598 Application 14/924, 13 6 composition of Ahmed would not be suitable for intravesical irrigation. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (Arguments and conclusions unsupported by factual evidence carry no evidentiary weight.) Appellant contends the Examiner erred in finding inherency for two reasons (App. Br. 17-18). Appellant contends "Ahmed teaches that the allegedly inherent characteristic is not necessarily present. To the contrary, Ahmed shows how the claimed efficacy might not be present" (App. Br. 18). Appellant notes that "Ahmed's own data therefore show that even between two very similar routes of systemic injection, either intravenous or intratumoral, response varied unpredictably" (App. Br. 19). We do not find this argument persuasive because none of the claims rejected based on Ahmed are drawn to a methods of treatment, but rather these claims are drawn to particular compositions. Appellant provides no specific evidence related to either intravesical administration or bladder cancer that rebuts the Examiner's inherency position; instead, Appellant points to evidence related to other modes of administration or other types of cells (see App. Br. 18-20). We find this unpersuasive because"[ w ]here, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product." In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Appellant has not satisfied this burden of production by directly comparing the product of Ahmed by intravesical administration into human bladder cells to demonstrate that the product would not necessarily produce interferon in these cells in a sufficient amount as required by Claim 1. In other words, "[ w ]hen the claimed 9 Appeal2017-008598 Application 14/924, 13 6 compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). Appellant argues that the "Examiner correctly notes that Ahmed fails to teach Syn3, as is required by claims 5 and 9. Yamashita and Ahmed fail to establish prima facie obviousness" (App. Br. 21 ). In the Petition to Make Special Under Accelerated Examination Program, filed on October 27, 2015, Appellant agreed "not to separately argue the patentability of any dependent claim during any appeal in the application. Specifically, the applicant agrees that the dependent claims will be grouped together with and not argued separately from the independent claim from which they depend in any appeal brief filed in the application" (Pet. 1 b) We summarily affirm the Examiner's rejection, because Appellant agreed not to argue the dependent claims (in this case, claims 5 and 9) separately. Conclusion of Law The evidence of record supports the Examiner's conclusion that Ahmed anticipates the claims. Moreover, the evidence of record supports the Examiner's conclusion that Ahmed and Yamashita render the claims obvious. C, D, andE. Anticipation over Connor and Obviousness over Connor, or alternatively, Benedict and Connor Because all of the rejections tum on the same issue, we will consider them together. 10 Appeal2017-008598 Application 14/924, 13 6 This application is a continuation of Application 12/706,625 ("'625 application"), filed Feb. 16, 2010. The '625 application is a continuation of 11/009,689 ("'689 application"), filed December 10, 2004. Application 11/009,689 claims the benefit of 60/528,525 ("'525 application"), filed December 10, 2003. The Examiner denies these priority claims, finding the claim limitations of "non-interferon agent which induces interferon production in human cells which are exposed to it, said agent being replication deficient" and "non-emulsified" were not described by the '525 application, the '689 application, or the '625 application (Ans. 3-5). The Examiner therefore finds that "the effective filing date of the examined claims is 10/27/2015" (Ans. 5). The issue with respect to these rejections is: Does the evidence of record support the Examiner's conclusion that the instant claims are not entitled to the benefit of priority to the '525 application, the '689 application and the '625 application? Findings of Fact "a non-inteiferon agent which induces interferon production in human cells which are exposed to it, said agent being replication deficient" 12. The '525 provisional application teaches antigenic viruses ( adenovirus) which produce interferon, specifically teaching interferon "concentrations reached almost 10,000,000 pg/ml (-2,500,000 IU) six days after treatment with 50 MOI of Ad-IFNa2b" ('525 Spec. 19:20-21). 13. The '525 provisional application teaches interferon transgenes, in teaching "promoters that facilitate transcription of the interferon transgene" ('525 Spec. 9:26-27). 11 Appeal2017-008598 Application 14/924, 13 6 14. The '525 provisional application teaches that the recombinant adenovirus "may be engineered to be replication deficient" ('525 Spec. 11 :20-22). "said agent formulated in normal saline as a non-emulsified suspension" 15. The '525 provisional application teaches that the composition can be formulated in saline as well as other aqueous carriers. ('525 Spec. 23:2-3). 16. The '525 provisional application teaches that the agent can be encapsulated in liposomes and liposomes can include emulsions ('525 Spec. 21:29 to 22:9). Principles of Law Under 35 U.S.C. § 120, "in a chain of continuing applications, a claim in a later application receives the benefit of the filing date of an earlier application so long as the disclosure in the earlier application meets the requirements of 35 U.S.C. § 112, ,r 1, including the written description requirement, with respect to that claim." Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008). Analysis We adopt the Examiner's findings of fact and conclusions of law (see Ans. 3-27; FF 12-16) and agree that Connor and Benedict are prior art under 35 U.S.C. § 102(b). We therefore find that Connor anticipates the claimed invention, and Benedict and Connor render the claims obvious. We address Appellant's arguments below. Appellant contends "the Examiner alleges that the inventor's priority application fails to enable the instant claims. See Office Action (22 April 12 Appeal2017-008598 Application 14/924, 13 6 2016) at 2-4. As support, the Examiner raises two arguments. The Examiner, however, fails to provide the Board the evidence you would need to affirm either one" (App. Br. 9). We do not find Appellant's general statement of the issue persuasive because it mischaracterizes the Examiner's priority issue as enablement rather than written description. The Examiner found that the "prior applications were searched but support for the composition as claimed in claim 1 could not be found" (Final Act. 3). That is, the Examiner's priority issue revolved around a failure to satisfy the written description requirement. Under the written description requirement of 35 U.S.C. § 112, first paragraph, the disclosure of the application relied upon must reasonably convey to the artisan that, as of the filing date of the application, the inventor had possession of the later-claimed subject matter. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562---63 (Fed. Cir. 1991). Therefore, the written description requirement necessitates that in order for a claim in an application to receive the benefit of priority to a particular parent application, that parent application must provide descriptive support for each and every element of that claim. Applying that rule here, Appellant's independent claim 1 must be fully supported by the disclosures provided in the '525 application, the '689 application, or the '625 application in order for the claims to receive priority benefit. "Non-emulsified suspension" Appellant contends "a disclosure contains not only its explicit teachings, but also the inherent properties thereof' (App. Br. 9). Appellant then contends that "formulating in buffered saline inherently produces a non-emulsified suspension" and that a "'non-emulsified' suspension is 13 Appeal2017-008598 Application 14/924, 13 6 therefore inherent in the priority application teaching of formulation in saline" (App. Br. 10). We agree with Appellant that the Examiner acknowledged that a saline solution may be non-emulsified (see Final Act. 9: "Connor teaches a composition ... formulated in normal saline ( and thus is a non-emulsified solution"). In addition, the priority documents, as exemplified by the '525 provisional application, do teach that a "variety of aqueous carriers may be used, e.g., water, buffered water, 0.8% saline" ('525 Spec. 23:2-3). Therefore, we agree with Appellant that there is descriptive support for a "non-emulsified suspension" as recited in claim 1. "Replication deficient agents" Appellant contends the "Examiner again errs by ignoring the applicable legal standard. That legal standard says that claims need not be limited to the specific examples in a disclosure. Rather, a specification satisfies the enablement requirement as long as the specification discloses at least one method to make the claimed invention" (App. Br. 11 ). We find this argument unpersuasive because the Examiner's priority issue was descriptive support, not enablement. The Examiner found that the prior applications do not appear to provide support for the broadly claimed "non-interferon agent which induces interferon production in human cells which are exposed to it, said agent being replication deficient". This limitation is very broad in the sense that it encompasses any replication-deficient non- interferon agent which induces interferon production in human cells, and is much broader than that which is disclosed in any of the prior applications. The prior applications do not provide direct or implicit support for this broad limitation. (Final Act. 3). 14 Appeal2017-008598 Application 14/924, 13 6 The issue is not one of enablement, but one of adequate written description. "Although there is often significant overlap" between the enablement and written description requirements, "they are nonetheless independent of each other." University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 921 (Fed. Cir. 2004). An "invention may be enabled even though it has not been described." Id. To satisfy the written description requirement an applicant must describe the invention is such a way as to convey to one skilled in the art that applicant had the invention in his possession when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). In cases such as the instant application where a genus is claimed, the specification must contain "either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Id. at 1350. The '525 application identifies only two types of "non-interferon agent which induces interferon production in human cells which are exposed to it" with general descriptions of viral and nonviral vectors (see '525 Spec. 9: 1-16). The '525 application details a single specific adenoviral vector (see '525 Spec. 29: 12-21) with only general guidance ofnonviral vectors (see '525 Spec. 10: 18 to 11 :2). However, the unbounded claim recitation of a "non-interferon agent which induces interferon production" encompasses any agent that induces production of any interferon species, any viral vector, and any non-viral vector, whether described in the prior art or not. Accordingly, this claim recitation reasonably encompasses agents not described in any way in the 15 Appeal2017-008598 Application 14/924, 13 6 Specification or in the priority applications, such as small molecules that function to induce interferon production such as endotoxin or BCG (see ESD 10:2 "live BCG in stimulating cytokine signaling and interferon expression.") Therefore, we agree with the Examiner that neither the instant Specification nor the '525 provisional application provide descriptive support for a representative number of species sufficient to demonstrate possession of the genus of "a non-interferon agent which induces interferon production" as recited in Claim 1. Therefore, because the priority documents do not provide sufficient description support of Claim 1, this application is not entitled to the December 10, 2003 filing date of the '525 application. Therefore, Connor and Benedict are prior art under at least 35 U.S.C. § 102(b) and (e). 8 Appellant also argues that Connor is disqualified as prior art under 3 5 U.S.C. § 103(c), because it was commonly owned by the assignee of the instant application (App. Br. 14--15). The cited statute, however, states that "[s]ubject matter developed by another person,which qualifies as prior art only under one or more ofsubsections (e), (!), and (g) of section 102 of this title,shall not preclude patentability." 35 U.S.C. § 103(c) (emphasis added). For the reasons discussed above, we conclude that Connor qualifies as prior art under 35 U.S.C. § 102(b), and thus 35 U.S.C. § 103(c) does not apply. Appellant does not address the merits of the 35 U.S.C. § 102(b) rejection over Connor or the 35 U.S.C. § 103(a) rejection over Benedict in 8 We note that Appellant indicates an intention to submit a Declaration that would antedate Connor (see App. Br. 14, footnote). However, no such Declaration is currently of record, and we therefore do not address this issue. 16 Appeal2017-008598 Application 14/924, 13 6 view of Connor. Appellant merely asserts that these references are not prior art (App. Br. 8-15; 23). Therefore, we affirm the rejection of claims 1-8 under 35 U.S.C. § 102(b), or alternatively 35 U.S.C. § 102(e), as anticipated by Connor. We also affirm the rejections of claims 1-9 under 35 U.S.C. § 103(a) based on 35 U.S.C. § 102(b) as obvious over Connor, or alternatively, the combination of Benedict and Connor. Conclusion of Law The evidence of record supports the Examiner's conclusion that Connor anticipates the claims. Moreover, the evidence of record supports the Examiner's conclusion that Connor, or alternatively, Benedict and Connor, render the claims obvious. F. Rejection of Claim 3 under 35 US.C. 112, 1st Paragraph The Examiner finds Claim 3 was amended by the claim amendment submitted 12/10/2015. The amendment introduced the new limitation indicating that the antigen comprises a viral antigen of a replication-deficient virus. Applicant has not indicated where support for the new limitation can be found, and a search of the original disclosure did not identify support for the new limitation. Therefore, the claim is rejected under 35 USC 112, first paragraph as it include[s] new matter not supported by the original disclosure. (Ans. 6). Appellant contends: "Whatever 'new matter' is, it does not include the inherent physical properties of materials discussed in a specification. To the contrary, inherent properties of materials discussed in the specification are inherently disclosed in that specification" (App. Br. 6: 18-21 ). Appellant contends "the Specification teaches a variety of antigenic viruses. See 17 Appeal2017-008598 Application 14/924, 13 6 Specification 10: 15-17. These viruses inherently have antigens. Those antigens inherently induce interferon expression. See e.g., Specification at 10:32 (adenovirus elicits an antibody response in humans; antibodies are made in response to antigen)" (App. Br. 7:12-16). We agree with the Examiner that the disclosure is not commensurate in scope with the new limitation because the newly claimed genus of antigens that is any viral antigen of any replication-deficient virus is much broader than that which was disclosed in the application as filed, and there is nothing in the specification that would indicate that applicant envisioned the newly claimed genus of antigens at the time the application was filed. (Ans. 29). The Federal Circuit confronted facts analogous to those here in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2004). In that case, the patent claimed a method of selectively inhibiting the enzyme PGHS-2 (also known as COX-2) by "administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human." Id. at 918. The patent "describe[d] in detail how to make cells that express either COX-I or COX-2, but not both ... as well as 'assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product.[']" Id. at 927. Rochester held that the disclosure of general classes of compounds such as the "viral antigen of a replication-deficient virus" in instant claim 3 was not adequate to describe compounds having the desired activity without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, and therefore the claims failed to meet the 18 Appeal2017-008598 Application 14/924, 13 6 description requirement of§ 112. See id. ("As pointed out by the district court, ... the '850 patent does not disclose just 'which "peptides, polynucleotides, and small organic molecules" have the desired characteristic of selectively inhibiting PGHS-2.' ... Without such disclosure, the claimed methods cannot be said to have been described."). Similar to Rochester, the present application discloses a broad genus of viruses (see Spec. 10:14--17) including genetically modified viruses (see Spec. 10: 18-25), but the claims are limited to only those antigens having the desired function for the agent "which induces interferon production in human cells which are exposed to it" as recited in claim 1. The present Specification does not identify an example of antigen that induces interferon, nor does the Specification describe such an antigen. It is the breadth of that function of inducing interferon, unconstrained by structure or representative species, which underlies the Examiner's written description rejection. See Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) ("[N]aming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.") SUMMARY In summary, we affirm the rejections of claim 1 as anticipated by Ahmed and Connor. We affirm the rejections of claim 1 as obvious over Ahmed, Connor, and the combination of Benedict and Connor. Pursuant to 37 C.F.R. § 41.3 7 ( c )(1) and the Petition to Make Special, we also affirm the prior art rejections over claims 2-9. 19 Appeal2017-008598 Application 14/924, 13 6 We affirm the rejection of claim 3 under 35 U.S.C. 112, 1st paragraph as failing to comply with the written description requirement. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 20 Copy with citationCopy as parenthetical citation