DETAILED ACTION
The examiner of record has changed. Please direct all further correspondence to ZACHARY J MIKNIS whose telephone number is (571) 272-7008.
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 11 May 2026 are entered.
Claim 3 has been canceled. Claims 1, 2, and 4-10 are pending and are being examined on the merits.
The rejection of claims 1, 2, and 4-10 under 35 U.S.C. 112(a) for written description and scope of enablement is maintained, with the Examiner’s response found below.
The rejection of claims 1-10 under 35 U.S.C. 103 as being unpatentable over Honisch as evidenced by Apostolopoulous and Hart is withdrawn in light of the remarks filed 11 May 2026.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.
Claims 1, 2, and 4-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With regard to claims 1-10, Applicant claims the use of and incorporation of ARMS2 or an active fragment thereof into a pharmaceutical composition. The active fragment is claimed in a functional manner: one that “comprises the activity of ARMS2 to bind to extracellular matrix (ECM) proteins”. Applicant has not, however, disclosed any embodiments of the ARMS2 protein in a fragment form or explained what residues are required for ECM protein binding. Rather, Applicant has disclosed the full form of the protein via SEQ ID NO: 1. Given that Applicant has not demonstrated the possession or use of a functional or active fragment of the protein nor elaborated what residues are critical for activity, a person having ordinary skill in the art would not know that Applicant has possession of a representative sample of embodiments of the claimed scope of proteins. More specifically, given that only certain fragments of proteins may retain the desired function in the instant application, it would not be obvious to one having ordinary skill in the art which fragments maintain this function. As such, without disclosure or evidence of experimentation to arrive at said fragments, Applicant has not fulfilled the requirements of written description for the active fragments. It is advised that Applicant revise the claims to encompass only the embodiments that fulfill written description in the specification.
Claims 1, 2, and 4-10 are 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 making and using the ARMS2 protein, does not reasonably provide enablement for making and using active fragments thereof. 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 or use the invention commensurate in scope with these claims.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). 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.
With regard to the breadth of the claims, the nature of the invention, and the level of unpredictability in the art, Applicant claims in claims 1, 2, and 4-10 the use and incorporation of an active fragment of ARMS2, which includes any fragment of any length and amino acid composition derived from ARMS2 that can be considered functional as long as it maintains ECM protein binding activity. Here, the breadth of the claim is broad, and the nature of the invention as a peptide necessarily implies that only certain fragments will retain the function of the peptide as a whole. Given that Applicant has not disclosed any fragments in the specification, a person having ordinary skill in the art would not necessarily know which fragments retain the desired function, particularly considering that the functionality of protein fragments is unpredictable. There is no explicit disclosure of what residues in ARMS2 result in the claimed function. Here, Apostolopoulos et al. teach that modeling of the peptides is challenging the size and flexibility of peptides are prohibitive for exact calculations, and full understanding of the peptides requires further progress on both modelling and thermodynamic aspects of their interactions (see pages 14 and 15, paragraphs 2 and 1, respectively). Further, Apostolopoulos et al. discuss some of the challenges of using short peptide fragments as opposed to entire proteins, and these challenges include lack of receptor selectivity, short half-life in vivo, low binding affinity, and more (see Table 1). Similarly, with regard to the amount of direction given by Applicant and the existence of working examples, Applicant does not disclose working examples or fragments or direction for making and using fragments, as discussed above. Without direction for active fragments of the protein, a person having ordinary skill in the art would not reasonably be able to model functional portions of the protein without significant and undue experimentation.
Similarly, with regard to the level of ordinary skill in the art, state of the prior art, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure, a person having ordinary skill in the art would not be able to predict which protein fragments would maintain the active function of ARMS2. As discussed above, Apostolopoulos et al. teach that modeling of the peptides is challenging the size and flexibility of peptides are prohibitive for exact calculations, and full understanding of the peptides requires further progress on both modelling and thermodynamic aspects of their interactions (see pages 14 and 15, paragraphs 2 and 1, respectively). As such, significant and undue experimentation would be required to arrive at active fragments, as it is a difficult and unpredictable process.
Response to Arguments:
The Applicant argues the claims are narrowed to limit the scope of the fragments to those that maintain the ability to bind to ECM proteins. The Applicant argues the claims are not directed to arbitrary fragments but rather the class expressly described in the specification as filed.
The Examiner agrees that the amendment narrows the claims. However, there is no explanation to guide the skilled artisan to what residues of ARMS2 are important for such function. There is no guidance on what specific ECM proteins are to be considered, i.e. as written the breadth of the claim encompasses binding to any and all ECM proteins. No framework is provided for determining what regions are critical for binding. The onus is placed entirely on the skilled artisan. Functional claiming as supported by the specification is permissible, but the function must be correlated with structure. Such a correlation is not present in the disclosure as filed.
The Applicant argues the specification provides this support, pointing to [0010]-[0013].
The Examiner argues that while the specification contains the literal support for the functional claiming, it offers no further information to guide one of ordinary skill in understanding what structure is required for the fragments to maintain the function as claimed.
The Applicant argues claim 3 as originally filed contained the functional language.
The Examiner agrees, and notes that this claim was previously considered and determined to be rejected under 35 U.S.C. 112(a).
The Applicant argues [0032] guides Fibulin 6, Fibronectin-1, and EMILIN2 as preferred ECM proteins involved in wound healing.
The Examiner agrees these are disclosed in the specification. However, no guidance is provided on what regions of ARMS2 are critical for interaction with these proteins. Even considering these, the claim language encompasses all ECM proteins, not just Fibulin 6, Fibronectin-1, and EMILIN2.
The Applicant argues the claims are directed to specifically defined and disclosed subset of ARMS2 fragments charactered by ECM binding described in the specification. The Applicant argues possession and guidance to avoid undue experimentation.
The Examiner disagrees that the claims are amended to provide a sufficiently defined subset of ARMS2 fragments to comply with 35 U.S.C. 112(a) with respect to possession for the purposes of written description, and guidance to comply with enablement. The Examiner disagrees that the amendment overcomes the rejections.
The Applicant’s arguments have been considered but are not persuasive. The rejection is modified and maintained.
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 Monday - Friday 9 am - 5 pm.
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/Z.J.M/Patent Examiner, Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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