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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 11/04/2025, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
DETAILED ACTION
Applicant's response to restriction requirement and election of group I corresponding to claims 32-41 with traverse, in the reply filed on 01/06/2026 is acknowledged.
In light of applicants arguments, and to avoid delay in the prosecution, previous restriction requirement is withdrawn and claims 32-47 are examined on merits in this office action.
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 35 and 37 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 pre-AIA the applicant regards as the invention.
Claims recite “Z/X” in the claim language and in the recited chemical groups, which is confusing because it is unclear whether the slash stands for “and”, “or”, or “and/or”.
Accordingly, claim are rendered indefinite.
Claim Rejections - 35 USC § 112 – 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 32-47 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
First independent claim 32 is drawn to a kit comprising a substrate comprising at least one microneedle, and a composition comprising at least one pro-myogenic agent, dispersed in a hydrogel matrix, wherein the hydrogel matrix comprises a crosslinked hydrophilic polymer network covalently bonded to a plurality of adhesion peptides, wherein the crosslinked hydrophilic polymer network has the recited general formula.
Second independent claims 42 is drawn to a kit comprising: a) a syringe comprising a hydrogel precursor; b) a mixing vessel comprising a crosslinking agent; and c) an injection needle; wherein either of the syringe or mixing vessel comprise at least one pro-myogenic agent; and wherein the syringe is in fluid communication with the mixing vessel and injection needle, in which the mixing vessel is disposed between the needle and syringe; wherein the hydrogel precursor has the recited general formula.
Crosslinked hydrophilic polymer network or precursor is common in both cases, and species of this component in combination with adhesion peptide is associated with a specific property, which is repairing muscle tissues.
Dependent claims define species of recited variables from the independent claims.
Claimed hydrogel matrix or precursor is represented by several divergent groups in the claimed general formula, which can generate thousands of divergent species and their end property is expected to be different. So, claims are extremely broad with respect crosslinked hydrophilic polymer network, and there is no defined core structure for the recited formulas. The core structure or domain is responsible for the property of the product, and in absence of a clear definition or description, it makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
Specification shows two examples. The first one is limited to the preparation and evaluation of MuSC loaded hydrogels and the second one is preparation and evaluation of MuSC and/or Wnt7a loaded hydrogels animals. It appears that cell lines are limited to MuSC, polymer is limited PEG-4MAL macromer, cell adhesion peptide is limited to GRGDSPC, crosslinking peptide is limited to GCRDVPMSMRGGDRCG, protein for pro-myogenic is shown with Wnt7a etc. So, the shown data is very limited.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a variability in the genus or broadly claimed subject matter, and if the variability expects unpredictability for the claimed subject matter, then specification must describe the genus with divergent species, so that a skilled person in the art can understands claimed invention and can reproduce applicants claimed invention. In this case, at least linkers and peptides, and their chemistry is probably one of the most unpredictable areas of biotechnology and consequently, the effects of linkers and sequence dissimilarities upon thier structure and function cannot be predicted. So, the absence of description with divergent species makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP 2163(3)a(II)).
The number of species that describe the genus must be adequate to describe the entire genus. However, if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers the following:
(a) actual reduction to practice,
(b) disclosure of drawings or structural chemical formulas,
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and
(d) representative number of samples.
The issue is, will the recited composition combination with all possible crosslinked hydrophilic polymer networks, all possible pro-myogenic agents etc., capable of retaining their property? Do applicants provide enough description for all the variables in the broadly claimed subject matter and their association towards the end property, so that a skilled person in the art understands the claimed invention?
(a) Determine whether the application describes an actual reduction to practice of the claimed invention:
Specification limits to (i) the preparation and evaluation of MuSC loaded hydrogels and (ii) the preparation and evaluation of MuSC and/or Wnt7a loaded hydrogels animals. In light of broadly claimed subject matter, it appears that cell lines are limited to MuSC, polymer is limited PEG-4MAL macromer, cell adhesion peptide is limited to GRGDSPC, crosslinking peptide is limited to GCRDVPMSMRGGDRCG, protein for pro-myogenic is shown with Wnt7a etc.
Tested data is limited to mice with the composition comprising the above components in it. So, the shown data or description is very limited.
(b) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole:
Drawings are limited to MuSC, PEG-4MAL, protease sensitive crosslinking peptide etc. Fig. 1-4 are limited to characterization of hydrogels, Fig. 5 and 6 show synthetic matrix enhances engraftment in dystrophic muscle trauma, and in aged muscle trauma. Fig.7 shows encapsulation of MuSC in PEG-4MAL. Fig.8 and 9 show that RGD-presenting hydrogels promote MuSC activation and proliferation and differentiation. Fig.10 shows Pax7/MyoD expression of MuSCs. Fig.11-12 shows characterization and comparison of hydrogels. Fig.13-14 shows release of Wnt7a from hydrogels and its characterization. Fig.15 shows binding of PEG-4MAL macromer adheres to the muscle surface. Fig.16 engineered PEG-4MAL hydrogel enables effective local delivery of Wnt7a to the injured skeleton. Fig. 17-19 characterization of Wnt7a in the muscle.
All the drawings are limited to a single polymer, which is PMG-4MAL, single cell line and single protein which is Wnt7a for pro-myogenic agent.
(C) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics, such as structure/function correlations, as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention:
The property of the composition in the kit, which is repairing muscle tissue, which is most challenging and unpredictable area in medicine and the repairing depends on many factors, such as cell types, up and down regulation of various gene expressions etc., see some evidenced from the following art:
Laumonier [Laumonier and Menetrey Journal of Experimental Orthopaedics, 2016, 3:15, 1-9 ] teaches muscle regeneration is coordinated through different mechanisms, which imply cell-cell and cell-matrix interactions as well as extracellular secreted factors and further states that cellular dynamics during muscle regeneration are highly complex [see Abstract].
Karalaki [in vivo, 2009, 23, 779-796] further states that muscle regeneration is a far more complex process than was initially believed. The various cell populations involved, the precise regulation of gene expression, the multifunctional role of the known and unknown growth factors and connective tissue components suggest that a new field of research is opening up. Although studies concerning muscle regeneration after injury have been performed mainly in
animal models, these models provide a way to an understanding of the cellular and molecular signaling pathways involved in muscle degeneration and regeneration and, hence, could potentially lead to clinical interventions and cell-based therapies. The use of such models could hold great promise in treating age-related muscle atrophy or congenital and acquired myopathies, such as Duchenne dystrophy, which are common and, as yet, untreatable and fatal. Thus, future studies are expected to further define the molecular pathways and interactions that are essential for effective muscle regeneration, which would contribute to the development of new therapies in humans. [See section Conclusion in page 791].
Musaro [Advances in Biology, 2014, article ID 612471, 1-16] teaches that muscle regeneration is affected in several pathological conditions and these can be due to intrinsic alterations that render muscle stem cells defective in responding to regenerative stimuli and to a hostile microenvironment that inhibits stem cell activity. [See section Muscle regeneration is affected in aging and muscle diseases, in pages 9-10]. This suggests patient population plays critical role in repairing muscle tissue.
With regard to linkers, the properties of conjugates are sensitive to the linker moiety [see section 6 in He et al, Molecules, 2019, 24, 1855, 1-34; see abstract and conclusion in Lu et al, International Journal of Molecular Sciences, 2016, 17, 561, 1-22].
The art also recognizes that the choice of a linker has great impacts on biological activity, expression yield, and pharmacokinetic properties of a fusion partner (see Chen et al. Adv. Drug Deliv. Rev. 65:1357-1369, 2013).
In view of above evidences, a skilled person in the art can expect unpredictability for broadly claimed subject matter. However, there is no guidance as to which of the large genus of claimed subject matter in the disclosure. There are no physical/chemical/structural features that applicants have tied to this property in a relevant teaching manner, making it impossible for an individual of ordinary skill in the art to determine which of the very large genus of claimed subject matter would be effective. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.
(d) representative number of samples:
As explained above, shown data is limited a single example and also drawings are also limited to single type of polymer and protein or peptide etc. So, the shown data is very limited.
Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure species to make and possibly use of the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 32-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 12,397,084 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of present application are drawn to a product, which is a kit with the recited components, viz., crosslinked hydrophilic polymer and adhesion peptides, and pre-myogenic agent etc.
The claims of US patent are drawn to a method of repairing muscle tissue by administering the composition comprising crosslinked hydrophilic polymer network, adhesion peptides, and pre-myogenic agent etc.
So, the product is common in both cases. The difference is that the claims of present application do not recite the method limitations in the claims.
First, product is not distinct from its process of using, and so these are not separable. Second, the specification of present application disclosed the benefits of product in repairing muscle tissue [see pages 18-19].
Further, MPEP 804 says:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).I gu
Accordingly, the claims are obvious over the claims of US patent.
Conclusion
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658