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 .
Status of the Application
The amendment and remarks of 5 May 2026 are entered.
The election requirement remains in effect
Claims 1-8 and 17-20 have been canceled. Claims 9-16 are pending and are being examined on the merits.
The objection to claim 14 is withdrawn in light of the amendment filed 5 May 2026.
The rejection of claims 9-13, 15, and 16 under 35 U.S.C. 112(a) for scope of enablement is withdrawn in light of the amendment filed 5 May 2026.
The rejection of claim 14 under 35 U.S.C. 112(a) for scope of enablement is maintained, with the Examiner’s response found below.
The rejection of claims 9-16 under 35 U.S.C. 112(b) is maintained, with the Examiner’s response found below.
The rejection of claims 9-13, 15, and 16 under 35 U.S.C. 103 as being unpatentable over Nakashima et al. and Piganis et al. is withdrawn in light of the amendment filed 5 May 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 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 a method of treating a subject having pulmonary fibrosis, does not reasonably provide enablement for a method of treating a subject having a disease or conditions characterized by excess matrix deposition or fibrosis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to administration of a composition comprising a SOCS box protein of sequence VRPLQELCRQRIVAAVGRENLARIPLNPVLRDYLSSFPFQI. Administration is claimed to treat a subject who has a disease or condition characterized by excess matrix deposition.
Breadth of the Claims
The composition is narrowly claimed. The method claims a broad genus of diseases or conditions.
State of the Prior Art
The prior art recognizes a variety of human fibrotic diseases of varying etiologies.
Rosenbloom et al. (Methods Mol. Biol. 1627:1-23, published 2017) discuss various fibrotic diseases and note that causative mechanisms for fibrosis can be diverse (see e.g. p.2). Rosenbloom also notes that fibrotic diseases can target a number of organs (see e.g. Table 1). Highly different mechanisms can result in fibrosis including myofibroblast activation, TFG-β pathways, bone morphogenic protein signaling, oxidative stress, and others (see e.g. Sections 2-5). Rosenbloom notes that the complexity of the fibrotic pathways makes development of anti-fibrotic therapies difficult (see e.g. Section 6.2).
Zhao et al. (Signal Transduction and Therapy 7:206) notes that “The high mortality and complex pathogenesis of fibrotic diseases pose great challenges in clinical therapy. Various cells and signaling pathways are involved in the progression of fibrosis. Drugs targeting these abnormal pathways are constantly being developed, and most of them demonstrate good anti-fibrotic activity in clinical trials. However, the side effects of these drugs often lead to drug discontinuation”. Zhao further reinforces that the art considered treatment of fibrosis challenging at best.
Relative Skill of those in the Art
The relative skill of those in the art is high. However, it is not within the skill of those in the art to prepare a single composition that treats all manners of diseases or conditions marked by excess matrix deposition.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
As noted above, the prior art also reflects unpredictability in noting the challenges in developing anti-fibrotic drugs.
Amount of Direction or Guidance Given
The guidance on fibrosis focuses on pulmonary fibrosis. No other forms of fibrosis are discussed. A model using differentiation of fibroblasts to myofibroblasts are used in vitro but not specifically correlated to forms of fibrosis other than pulmonary fibrosis. Notably, the only fibroblasts utilized were lung fibroblasts.
Presence/Absence of Working Examples
The working examples concern differentiation of lung fibroblasts to myofibroblasts and a mouse model of idiopathic pulmonary fibrosis. No other forms of fibrosis are studied or discussed in the working examples.
Quantity of Experimentation Necessary
While it would not take any unnecessary experimentation to prepare the claimed 40 amino acid-long peptide of claim 1, applying it in a generic manner to any disease or condition characterized by excess matrix deposition would involve undue experimentation.
The Applicants have provided a single peptide and asserted a broad link between application of it and treatment of any disease or condition marked by excess matrix deposition. Yet the only examples show that the focus is solely on pulmonary fibrosis. The only actual examples of in vivo usage require a murine model of bleomycin-induced idiopathic pulmonary fibrosis.
In this case, there are no other models provided or discussed for other diseases or conditions marked by excess matrix deposition. The onus is solely on the skilled artisan to handle all experimentation for a broad genus of treatment. Such a level of experimentation is undue.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
Response to Arguments:
The Applicants indicate that claim 9 is amended to recite pulmonary fibrosis, rendering the rejection moot as pertaining to 35 U.S.C. 112(a).
The Examiner agrees the rejection over claim 9 and its dependents is rendered moot by the amendment of 5 May 2026. However, the amendment to claim 14 alters it to an independent claim reciting largely the same subject matter previously rejected under 35 U.S.C. 112(a), i.e. the claim language drawn to treatment of a subject having a disease or condition characterized by excess matrix deposition. The rejection based upon this language was not addressed on the merits in the remarks filed 5 May 2026. Therefore, it is appropriate to maintain the rejection and modify in light of the amendment.
The Applicants’ arguments have been considered and are persuasive regarding claim 9 but not persuasive regarding claim 14.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-16 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.
In claims 9 and 14, the claims are indefinite because they are amenable to multiple plausible interpretations: claims 9 and 14 recites “…administering a composition comprising a polypeptide comprising the following amino acid sequence VRPLQELCRQRIVAAVGRENLARIPLNPVLRDYLSSFPFQI (SEQ ID NO: 1)”. This language is directed to a 40-amino acid long peptide. However, an examination of SEQ ID NO: 1 indicates that it is a 213 amino acid-long peptide. The skilled artisan could interpret the method as requiring the 213 amino acid-long peptide of SEQ ID NO: 1 but also could interpret the claim as requiring only the 40 amino acid-long peptide recited in claims 9 and 14. Ex parte Kenichi Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential) “hold[s] that if a claim is amenable to two or more plausible constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.” The dependent claims do not remedy this deficiency with respect to the amino acid sequence utilized in the method of treatment.
Response to Arguments:
The Applicant argues the claim is amendment to recite “comprising administering a composition comprising a polypeptide comprising the following amino acid sequence VRPLQELCRQRIVAAVGRENLARIPLNPVLRDYLSSFPFQI (SEQ ID NO: 1) to a subject”. The Applicants argue the entire 40 amino-acid polypeptide sequence (SEQ ID NO: 1) must be present, however that a peptide comprising the specified 40 amino-acid polypeptide sequence (SEQ ID NO: 1) is administered to the patient.
The Examiner disagrees that the amendment renders the claims definite. The claim recites that the amino acid sequence comprises VRPLQELCRQRIVAAVGRENLARIPLNPVLRDYLSSFPFQI and claims this as SEQ ID NO: 1. However, as noted in the previous rejection SEQ ID NO: 1 is a 213 amino-acid long polypeptide. The claimed sequence occurs within SEQ ID NO: 1, but claiming the administered composition as both the 40-mer as well as SEQ ID NO: 1 renders it such that the skilled artisan cannot be assured of what is being administered to the subject: a 40-mer or the full-length Mus musculus SOCS protein. The language of the claim does not distinguish the 40-mer from the full-length protein.
The Examiner has considered the Applicants’ arguments and not found them persuasive. The rejection is maintained.
The Examiner suggests the following:
1. Submission of a new sequence listing including the 40-mer as found in the claim as a new sequence (SEQ ID NO: 3) and the claiming of said SEQ ID in place of SEQ ID NO: 1, i.e. “a polypeptide comprising of the following amino acid sequence VRPLQELCRQRIVAAVGRENLARIPLNPVLRDYLSSFPFQI (SEQ ID NO: 3)”, or
2. An indication that particular residues of SEQ ID NO: 1 are being claimed, i.e. “comprising a polypeptide comprising the amino acid sequence of residues 173-213 of SEQ ID NO: 1”.
Conclusion
No claims are allowed.
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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/Z.J.M/Patent Examiner, Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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