DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim 109 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 128-129, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement across Groups I – IV and species election requirement (A)-(D) as set forth in the Office action mailed on 05/19/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Note, MPEP § 706.07(a) states that if rejoinder occurs after a first Office action on the merits and if any of the rejoined claims are unpatentable, the next Office action may be made final if the rejection of the rejoined claims was necessitated by Applicant’s amendment. Because Applicant’s amendment caused Claim 109 to be directed to an allowable product and the subsequent rejoinder, the rejection of rejoined claims is made final.
Claim Status
Claim listing filed on March 5, 2026 is pending. Claims 109-110 and 126 are amended. Claims 1-108, 113-125, and 127 are canceled. Claims 130-137 are new. Claims 109-112, 126, and 128-137 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 113-114, 125, and 127 have rendered all previous rejections directed to these claims moot.
Applicant’s amendments to the abstract, specification, and claims have overcome all objections of record. As such, the specification objections and claim objections are withdrawn.
The rejection of Claims 109-112 and 126 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments. In particular, Claim 109 no longer recites the indefinite phrase “interferon-α2 activity,” and Claim 110 defines an appropriate control as “compared to a wild-type interferon-α2b polypeptide.”
The rejection of Claims 109-112 and 126 under 35 U.S.C. 112(a) as failing to comply with the written description and enablement requirements is withdrawn in view of Applicant’s amendments. Claim 109 is now directed to two specific species of polypeptides comprising SEQ ID NOs: 4 and 6 which have proper written description and enablement (of record).
Claim Objections (New, necessitated by amendment)
Claim 128 is objected to because of the following informalities:
“acute and chronic non-A, non-B hepatitis” as recited in Claim 128 is one disease but could be interpreted as separate diseases in the instant list of diseases separated by commas. To avoid confusion in the list of diseases, Examiner recommends separating the diseases with semicolons to read: “melanomas (including malignant melanoma); chronic hepatitis C (including in patients with compensated liver disease); acute and chronic hepatitis B; acute and chronic non-A, non-B hepatitis; Kaposi's sarcoma (including AIDS-related Kaposi's sarcoma); multiple sclerosis; genital warts; leukemia (including Hairy cell leukemia); lymphomas (including follicular lymphoma); condylomata acumiate; SARS-CoV-2 infection; ZIKV infection; CHIKV infection; and influenza A infection.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 126 and 128 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 126 recites “wherein has a relative antiviral activity” which is unclear as it lacks a noun. For the purpose of compact prosecution, Claim 126 is interpreted as “wherein the polypeptide has a relative antiviral activity…”
Claim 128 recites the limitation "said disease" in line 3. There is insufficient antecedent basis for this limitation in the claim because “one or more diseases” is defined in line 1 which encompasses a plurality of diseases, not just a singular disease. For the purpose of compact prosecution, Claim 128 line 3 is interpreted as “said one or more diseases is selected from…”
Note, it is reiterated that Claims 110-111 and 126 are interpreted as inherent functional properties of the polypeptide structures recited in Claim 109 (of record; MPEP § 2112.01.I-II).
Note, in regard to Claim 112, the specification defines that “hyperglycosylated” refers to a molecule comprising more than three additional glycosylations to those of native interferon-α2 (page 16, lines 13-14). The specification further defines that GMOP comprising SEQ ID NO: 26 contains four potential glycosylation sites (page 16, lines 7-9), and SEQ ID NOs: 4 and 6 both comprise SEQ ID NO: 26. Therefore, SEQ ID NOs: 4 and 6 are both considered “hyperglycosylated.”
Claim 128 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating hepatitis, does not reasonably provide enablement for treating all of the diseases listed in Claim 128. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure
does not satisfy the enablement requirement and whether any necessary experimentation is
“undue”. These factors include, but are not limited to:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex. As understood with the broadest reasonable interpretation, Claim 128 encompass a method of treating one or more diseases in a subject by administering to the subject one or more of the modified interferon-α2 polypeptides of Claim 109, wherein said one or more diseases is selected from the group consisting of melanomas (including malignant melanoma); chronic hepatitis C (including in patients with compensated liver disease); acute and chronic hepatitis B; acute and chronic non-A, non-B hepatitis; Kaposi's sarcoma (including AIDS-related Kaposi's sarcoma); multiple sclerosis; genital warts; leukemia (including Hairy cell leukemia); lymphomas (including follicular lymphoma); condylomata acumiate; SARS-CoV-2 infection; ZIKV infection; CHIKV infection; and influenza A infection. Note, “treating” is not defined in the specification and is interpreted as alleviating the symptoms or complications of an established disease, delaying the progression of an established disease, and/or curing or eliminating an established disease.
When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
Level of skill in the art:
The level of skill would be high encompassing virology, oncology, immunology, in vivo treatment assays, etc.
Amount of direction provided by inventor and the existence of working examples:
The specification teaches that the polypeptide comprising SEQ ID NO: 4 (GMOP-IFN-VAR2) and the polypeptide comprising SEQ ID NO: 6 (GMOP-IFN-VAR3) retained 72% and 35% antiviral activity as compared to control GMOP-IFN-α2b as determined by the ability to inhibit the cytopathic effect caused by vesicular stomatitis virus (VSV) on MDBK cells (Table 1 and page 81). Note, quantifying antiviral activity of interferons by assaying VSV activity in MDBK cells is a standard method in the art as evidenced by Chen et al. J Virol Methods 2017 and is therefore interpreted to represent antiviral activity to one of ordinary skill. However, GMOP-IFN-VAR2 and GMOP-IFN-VAR3 exhibited “null antiproliferative properties” in Daudi Burkitt’s lymphoma cells (0.5% and 0.4% respectively as compared to control GMOP-IFN-α2b) (specification pages 81-82). In summary, the specification supports that the claimed polypeptide variants retain antiviral activity (although reduced as compared to control), but the variants have no antiproliferative activity in a cancer model. No other disease models are taught by the specification.
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. Paul, et al. Gene. 2015 teaches that IFN-α2 was approved for the treatment of chronic viral hepatitis B (HBV) and chronic viral hepatitis C (HCV) prior to the effective filing date (section 5, paragraph 2). Therefore, in light of the specification that teaches that SEQ ID NOs: 4 and 6 retain antiviral activity, one of ordinary skill could administer the IFN-α2 variants to treat hepatitis with a reasonable expectation of success given that IFN-α2 was an approved hepatitis treatment prior to the effective filing date. From the specification and the state of the art prior to filing, there is proper enablement for a method of treating “chronic hepatitis C (including in patients with compensated liver disease); acute and chronic hepatitis B; and acute and chronic non-A, non-B hepatitis” as recited in Claim 128.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The specification is not enabling for treating the diseases listed in Claim 128 other than hepatitis. Given that the nature of the claims is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials or in animal models, that are predictive of treatment in a representative number of cancer, multiple sclerosis, ZIKV infection, CHIKV infection, and influenza A infection models in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the treatment with a reasonable expectation of success. As such, Claim 128 is rejected for lack of enablement.
Note, Claim 129 is enabled because immunoaffinity chromatography and the anti-non glycosylated rhIFN-2b mAb CA5E6 were both known in the art prior to filing as evidenced by Ceaglio et al. J. of Biotech. 2010 (section 2.1). Anti-hGM-CSF monoclonal antibodies that bind the APARSPS epitope were also known in the art prior to filing as evidenced by Perotti et al. Protein Expr Purif. 2013 (introduction paragraph 4). Note, epitope APARSPS is equivalent to residues 1-7 of both SEQ ID NOs: 4 and 6.
Allowable Subject Matter
Claims 109-112 and 129-137 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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