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 .
This action is in response to the papers filed on 07/14/2026. Claims 1-27 are
currently pending as per claims filed on 07/14/2026.
Applicant’s election of Group I, without traverse, of claims 1-12 in the reply filed on 07/14/2026 is acknowledged.
Therefore, claims 13-27 are withdrawn from further consideration
pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no
allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 1-12 are subject to examination to which the following grounds of
rejection are applicable. Claim 1 is an independent claim.
Priority
The instant application is a CIP of 17/770,971 filed 04/21/2022 (PAT 12576113). Application number 17/770,971 is a 371 of PCT/US2020/057323 filed 10/26/2020, PCT/US2020/057323 has PRO application 62/926,841 filed10/28/2019, and
PCT/US2020/057323 has PRO application 62/925,432 filed 10/24/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/29/2024, 12/10/2024, 06/09/2025, and 09/25/2025 were filed before the mailing date of the current office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 is objected to because abbreviations such as PLGA in line 17 should be spelled out at the first encounter in the claims. Appropriate correction is required.
Claim 10 is objected to because abbreviations such as RUNX and LIM in line 24 and 25, respectively, should be spelled out at the first encounter in the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 1-12 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.
Claims 1, and by dependence, claims 2-11 are vague and indefinite in the recitation of “…capable of…” , since this phrase refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention.
Note, it has been held that the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138.
Claim 3 recites the limitation "the aspect ratio" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is vague and indefinite in the recitation of “the dMFFs are treated with heparin”. It is unclear how the dMFFs are treated with heparin as the heparin treatment could be treated before use of the composition, the heparin could be included in the composition, or other approaches of treating. As such the metes and bounds of the claim are indefinite.
Claim 8 is vague and indefinite in the recitation of “the dMFFs are treated with heparin then treated with adjuvant”. It is unclear how the dMFFs are treated with heparin and then adjuvant as both treatments could occur before use of the composition, the heparin could be included in the composition and then adjuvant is added to the composition, or other approaches of treating. As such the metes and bounds of the claim are indefinite.
Claim Rejections - 35 USC § 112 (a)
Written Description
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 1-12 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.
M.P.E.P. § 2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number
of species by actual reduction to practice (see i)(A), above), reduction to drawings (see
i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or
other physical and/or chemical properties, by functional characteristics coupled with a
known or disclosed correlation between function and structure, or by a combination of
such identifying characteristics, sufficient to show the applicant was in possession of the
claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
Further, the written description inquiry is limited to that which is contained within the four corners of the specification, not the extent to which the skilled artisan, given his or her
knowledge of the art, would have considered it to expand with only routine
experimentation. See Ariad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc); see also id. at 1352 (“[I]t is the specification itself that must
demonstrate possession A description that merely renders the invention obvious does
not satisfy the requirement.").
Claim 1 is directed to a muscle regenerating composition comprising a population of decellularized muscle fiber fragments (dMFFs), that are capable of reconstructing elongated muscle fibers from the dMFFs and orienting in alignment with native muscle fibers when injected or implanted in a target muscle site in a patient, wherein the dMFFs have an average size of less than 150 pm. Claim 7 further limits claim 1 wherein the dMFFs are treated with heparin. Claim 8 further limits claim 1 wherein the dMFFs are treated with heparin then treated with adjuvant. The specification discloses that the dMFFs conjugated with heparin permit immobilization of the adjuvant insulin-like growth factor (IGF-1) (Pages 41-43, Examples 14-16). More specifically, the heparinization (i.e. treating with heparin) was performed by treating the dMFFs with 1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride/N-hydroxysuccinimide/heparin sodium salt solution for 2 hours at 37°C per their previously established protocol (Page 43, IGF-1 immobilization).
The specification does not disclose any other treating of the dMFFs with heparin, other than using 1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride/N-hydroxysuccinimide/heparin sodium salt solution using an established protocol which results in heparin-conjugated dMFFs. Additionally, the specification does not disclose any dMFFs being treated with heparin then treated with any other adjuvant other than IGF-1 as the adjuvant wherein the IGF-1 is immobilized on the dMFFs, such that the function of being capable of reconstructing elongated muscle fibers from the dMFFs and orienting in alignment with native muscle fibers when injected or implanted in a target muscle site in a patient is elicited. The specification does not disclose any structure other than heparin-conjugated dMFFs which is generated using a cited protocol, nor what adjuvant could also be used and how to treat with said adjuvant. There are no details in the specification pertaining to the structure of the heparin- and/or the adjuvant-treated dMFFs, rather the only structure described of the dMFFs are dMFFs with conjugated heparin and dMFFs with IGF-1-immobilized and heparin-conjugation. The disclosure does not indicate that any other treating with heparin, other than conjugation, nor any other adjuvant other than IGF-1, would result in the claimed function. Together, the disclosure lacks description to establish the relationship between the genus of treatments with heparin and an adjuvant and their capability to reconstruct elongated muscle fibers from the dMFFs and orient in alignment with native muscle fibers when injected or implanted in a target muscle site in a patient.
Applicant were referred to the guidelines for Written Description Requirement
published January 5, 2001 in the Federal Register, Vol.66, No.4, pp.1099-1110 (see
http://www.uspto.gov). The disclosure of a single species is rarely, if ever, sufficient to
describe a broad genus, particularly when the specification fails to describe the features
of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue
Pharma L. P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000). The possession may
be shown by actual reduction to practice, clear depiction of the invention in a detailed
drawing, or by describing the invention with sufficient relevant identifying characteristics
(as it relates to the claimed invention as a whole) such that a person skilled in the art
would recognize that the inventor had possession of the claimed invention. See, e.g.,
Pfaff v. WellsElectronics, Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,
1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai
Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991).
The “written description” requirement may be satisfied by using such descriptive
means as words, structures, figures, diagrams, formulas, etc., that fully set forth the
claimed invention. See Noelle v. Lederman, 355 F.3d 1343, 1349, 69 USPQ2d 1508,
1514 (Fed. Cir. 2004) and Lockwood v. American Airlines, Inc., 107 F.3d at 1572, 41
U.S.P.Q.2d at 1966. A definition by function alone “does not suffice” to sufficiently describe a coding sequence “because it is only an indication of what the gene does,
rather than what it is.” Regents of the University of California v. Eli Lilly & Co., 119 F.3 at
1568, 43 USPQ2d at 1406 (Fed. Cir. 1997) (discussing Amgen Inc. v. Chugai
Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016 (Fed. Cir. 1991)). In Fiers v.
Ravel, 984 F.2d at 1169-71, 25 U.S.P.Q.2d at 1605-06 (1993), the CAFC found that “a
mere wish or plan for obtaining the claimed chemical invention” is not sufficient to
describe a chemical invention (discussed in Eli Lilly at 1404).
In view of the large breadth of treating with heparin and treating with a genus of adjuvants claimed by their function of capability to reconstruct elongated muscle fibers from the dMFFs and orient in alignment with native muscle fibers when injected or implanted in a target muscle site in a patient and the lack of adequate description of the structure-function relationship of the claimed genus, one of ordinary skill in the art would not have recognized Applicant as being in possession of the claimed genus of heparin treatments and adjuvant treatments. The limited disclosure in the specification is not deemed sufficient to reasonably convey to one skilled in the art that the applicants were in possessions of the genera of ways to treat with heparin and ways to treat with an adjuvant, let alone that adjuvant being any adjuvant as recited in the claims at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genera.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Atala et al (US 20160296667 A1; as cited in IDS).
The applied Atala reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1). The publication dated for Atala is October 13, 2016. The earliest effective filing date of the instant application is October 24, 2019.
Therefore, rejection under 35 U.S.C. 103 CANNOT be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(c) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Because the reference qualifies as prior art under 102(a)(1), the provisions of MPEP 717.02 do not apply.
Regarding claims 1-6, Atala teaches compositions of uniform sized muscle fiber fragments that are able to reconstitute into long fibers that are oriented along native tissue upon implantation to a muscle site of a patient (abstract, para 0005). Atala teaches that the muscle fiber fragments can be decellularized (example 3, para 0102) and can be less than 150 μm (para 0005) and in some instances more preferably between about 80 μm and 120 μm or between about 90 μm and 110 μm (para 0006). Atala teaches that the muscle fiber fragments have an aspect ratio of the long-to-short dimensions being between about 2:1 and 1:1 (para 0006) and the muscle fiber fragment composition can be suspended in a physiologically compatible fluid (para 0008). Atala teaches that the muscle fiber fragments can be combined with a scaffold wherein the scaffold can be an injectable scaffold selected from collagen gel, fibrin gel, alginate gel, or PGLA (para 0010).
Regarding claim 12, the teachings of Atala anticipate claim 1. Moreover, Atala teaches that the matrix comprising uniformed myofibers fragments can be in a lyophilized-state (para 0090).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Atala et al (US 20160296667 A1; as cited in IDS), and further in view of Zhang et al (Tissue Engineering: Part A, 2017, pages 784-794).
The applied Atala and Zhang reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1). The publication dated for Atala and Zhang is October 13, 2016 and May 2, 2017, respectively. The earliest effective filing date of the instant application is October 24, 2019.
Therefore, rejection under 35 U.S.C. 103 CANNOT be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(c) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Because the reference qualifies as prior art under 102(a)(1), the provisions of MPEP 717.02 do not apply.
Regarding claim 1-8, Atala teaches compositions of uniform sized muscle fiber fragments that are able to reconstitute into long fibers that are oriented along native tissue upon implantation to a muscle site of a patient (abstract, para 0005). Atala teaches that the muscle fiber fragments can be decellularized (example 3, para 0102) and can be less than 150 μm (para 0005) and in some instances more preferably between about 80 μm and 120 μm or between about 90 μm and 110 μm (para 0006). Atala teaches that the muscle fiber fragments have an aspect ratio of the long-to-short dimensions being between about 2:1 and 1:1 (para 0006) and the muscle fiber fragment composition can be suspended in a physiologically compatible fluid (para 0008). Atala teaches that the muscle fiber fragments can be combined with a scaffold wherein the scaffold can be an injectable scaffold selected from collagen gel, fibrin gel, alginate gel, or PGLA (para 0010) and can be co-administered with an adjuvant (para 0009). Atala does not teach wherein the decellularized muscle fiber fragments are treated with heparin and the decellularized muscle fiber fragments are treated with heparin and then treated with an adjuvant (claims 7 and 8).
Zhang teaches a decellularized skeletal tissue which generate extracellular matrices (ECM) wherein the ECM can be used to expand human muscle precursor cells (MPCs) for cell-based therapy for skeletal muscle dysfunction (abstract, page 1). Zhang teaches that when human muscle pre-cursor cells (MPCs) were cultured on heparin-coated hydrogels comprising skeletal muscle ECM, MCPs proliferation was greater and the number of differentiated myotubes was significantly increased compared to MPCs cultured on the hydrogels alone or ECM alone (abstract, page 1; table 2, page 792). Zhang teaches muscle ECM combined with the hydrogel heparin gel “could provide an alternative approach for cell replacement therapy by improving cell survival, myogenic differentiation, and integration cells or bioactive factors in the host tissue” and suggests further studies of skeletal muscle ECM and an injectable heparin gel for skeletal muscle regeneration in vivo (page 793, right col, Conclusions).
It would have been prima facie obvious to one of ordinary skill, in the art at the time of the effective filing date, to modify the teachings of a decellularized muscle fiber fragment composition as taught by Atala to further treat the muscle fiber fragments with heparin since Zhang teaches that heparin provides several beneficial effects to muscle precursor cells when exposed to skeletal ECM combined with heparin and suggests using heparin-skeletal ECM for in vivo muscle regeneration purposes. One would be motivated to combine these teachings to augment muscle cell proliferation and survival when implanting/injecting the muscle fiber fragment compositions in a patient and would have a reasonable expectation of success.
Regarding claim 9-11, the teachings of Atala and Zhang anticipate claim 1 and 8. Moreover, Atala teaches that the muscle fiber fragment composition can comprise an adjuvant which can be a growth factor such as bone morphogenic protein (BMP), a RUNX-2 protein, a LIM mineralization protein, a fibroblast growth factor, a platelet derived growth factor, an epidermal growth factor, an insulin-like growth factor, a transforming growth factor-α, a transforming growth factor-β, a nerve growth factor (NGF), a brain-derived neurotrophic factor (BDNF), neuregulin (NRG), and agrin (para 0009).
Regarding claim 12, the teachings of Atala anticipate claim 1. Moreover, Atala teaches that the matrix comprising uniformed myofibers fragments can be in a lyophilized-state (para 0090).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliana Candelaria whose telephone number is (571)272-5488. The examiner can normally be reached Monday - Friday 8am - 5pm.
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/JULIANA IRENE CANDELARIA/Examiner, Art Unit 1634
/MARIA MARVICH/Primary Examiner, Art Unit 1634
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