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 .
Claims 1-12, and 14 have been cancelled. Claims 16-29 have been newly introduced.
Election/Restrictions
Applicant’s election of Group II, claims 13 and 15, in the reply filed on 11/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The non-elected claims have been cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13, 15-17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Patent Application Publication 2003/0225355) in view of Vrijbloed et al. (U.S. Patent No. 11,407,799).
Butler et al. discloses composite materials for wound repair comprising a biodegradable barrier material integrated with a support material and methods of using them. The barrier material can be agrin. See at least claims 1, 7-8, and 23-24. Chronic wounds (i.e. non-healing wounds as in instant claim 15) can be treated. See paragraph [0061]. Butler et al. does not specify any particular form of agrin.
Vrijbloed et al. discloses that SEQ ID NO: 10 (194 amino acids) would have been a well-known splice variant with insert of agrin. Instant SEQ ID NO: 7 corresponds to amino acids 6-194 of SEQ ID NO: 10. Instant SEQ ID NO: 1 corresponds to amino acids 26-33 of SEQ ID NO: 10. Instant SEQ ID NO: 7 corresponds to amino acids 17-191 of SEQ ID NO: 10. SEQ ID NO: 7 corresponds to instant SEQ ID NO: 1. The y4z8 version of agrin has a four amino acid insertion in the y-site and an eight amino acid insertion at the z-site. This would include the LG2 and LG3 domains of agrin. See at least columns 5-6.
It would have been obvious to use the agrin of SEQ ID NO: 10 of Vrijbloed et al. in the method of treatment disclosed by Butler et al. Butler et al. indicates any agrin could be used and Virjbloed et al. discloses a suitable agrin. One would have been motivated to do so in order to have additional methods of treating wounds, including chronic wounds.
The z-site of instant SEQ ID NO: 5 with the insert of SEQ ID NO: 1 as in claim 13 corresponds to instant SEQ ID NO: 6.
Note that SEQ ID NOS: 7 and 8 would have been known to have been soluble. See at least SEQ ID NO: 36 (492 amino acids); Example 16; column 8, lines 46-55; column 10, lines 21-31; and Figures 9A-D and Figures 15A-B of Valenzuela et al. (U.S. Patent No. 6,852,838, of record). Instant SEQ ID NO: 7 corresponds to amino acids 304-492 of SEQ ID NO: 36. SEQ ID NO: 36 contains a 4 amino acid insert KSRK at the y-site (amino acids 187-190 of SEQ ID NO: 36).
Claims 13 and 15-29 are rejected under 35 U.S.C. 103 as being unpatentable over Rahmo et al. (WO 2020/068432, published 2 April 2020) in view of Stitt et al. (U.S. Patent No. 7,632,503, of record), Biel et al. (U.S. Patent Application Publication 2006/0173514), and Sobreira Correia et al. (U.S. Patent Application Publication 2020/0138851).
Rahmo et al. discloses compositions of agrin that have been cross-linked (i.e. a scaffold as recited in instant claim 22; see at least claims 1-5). The composition can be formulated as a gel (see at least claim 9). Insulin-like growth factors such as IGF-1 can be included. See at least claim 13 and paragraph [0091]. The compositions can be used in methods of treating wounds, including lacerations, sores, and chronic ulcers. See at least claims 25-36 and paragraphs [0015-0016]. Rahmo et al. does not specify the agrin sequences recited in the instant claims.
Stitt et al. (U.S. Patent No. 7,632,503, of record) discloses an IGF-1/agrin fusion protein of SEQ ID NO: 4 (574 amino acids). Stitt et al. discloses a pharmaceutical composition comprising the soluble muscle-targeting fusion polypeptide comprising IGF-1 and an Agrin fragment (i.e. the fusion polypeptide is considered to be a derivative of an Agrin fragment). In addition, SEQ ID NO: 4 contains the human agrin without the signal sequence (i.e. a fragment of human agrin). See at least Example 1 and column 13, lines 23-28. Instant SEQ ID NO: 8 corresponds to amino acids 138-574 of SEQ ID NO: 4. (Note that instant SEQ ID NO: 8 contains the LG2 domain of Agrin without any insert at the y-site as in instant SEQ ID NO: 2. See instant claims 18-20 and 26-28.) Instant SEQ ID NO: 7 corresponds to amino acids 386-574 of SEQ ID NO: 4. Instant SEQ ID NO: 1 corresponds to amino acids 406-413 of SEQ ID NO: 4. Stitt et al. also discloses SEQ ID NO: 53 (729 amino acids) as a fragment of human agrin. See at least Example 5. Amino acids 293-729 of SEQ ID NO: 53 correspond to instant SEQ ID NO: 8. Amino acids 541-729 of SEQ ID NO: 53 correspond to instant SEQ ID NO: 7. Instant SEQ ID NO: 1 corresponds to amino acids 561-568 of SEQ ID NO: 53.
Biel et al. discloses that gels such as inert hydrogels would have been known to be useful for treating wounds. See at least paragraph [0034].
Sobreira Correia et al. discloses that thermoresponsive hydrogels would have been known to be useful for treating skin wounds. See at least paragraphs [0018 and 0098].
It would have been obvious to use at least SEQ ID NO: 4 or SEQ ID NO: 53 of Stitt et al. as the agrin fragment or derivative in the composition of Rahmo et al. and use this composition to treat wounds, including slow healing or non-healing wounds such as chronic ulcers as taught by Rahmo et al. Rahmo et al. indicates any agrin could be used and Stitt et al. discloses a suitable agrin. In particular, as Rahmo et al. discloses using IGF-1 along with agrin the choice of the IGF-1/agrin fusion protein of Stitt et al. would have been obvious. Rahmo et al. discloses using gel formulations and Biel et al. and Sobriera Correia et al. make clear that inert hydrogels and thermoresponsive hydrogels would have been well known gels for use in treating wounds. See at least instant claims 22-23. One would have been motivated to use inert hydrogels or thermoresponsive hydrogels containing the suggested agrin constructs in order to have additional methods of treating wounds, including chronic wounds.
Claim Rejections - 35 USC § 112
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 16 and 24 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 16 is confusing in reciting that the LG3 domain of Agrin without any insert at the z-site comprises the amino acid sequence of SEQ ID NO: 5. Claim 1 (upon which claim 16 depends) requires the insert. It is unclear why the claim does not recite that the LG3 domain of Agrin comprises SEQ ID NO: 6 (corresponding to SEQ ID NO: 5 with the insert of SEQ ID NO: 1 at the z-site). See also claim 24. Clarification is requested.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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