DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
For clarity of the record, claim 9 was improperly grouped in the restriction requirement dated 10/23/2025 and not Group III, and should be part of invention Group II. Any confusion is regretted.
Applicant's election with traverse of Group II, presently claims 6 and 9, in the reply filed on 12/16/2025 is acknowledged. The traversal is on the ground(s) that the enumerated groups of inventions are linked by a common inventive concept and that there would be no serious burden on the examiner to examine all of the groups This is not found persuasive of error. First, Applicant’s arguments regarding the “inventive concept” are highly generalized and do not allege or otherwise point out any particular flaw in the restriction requirement of record that Groups II and III lack a priori unity of invention with Groups I, II, IV, and V, and that the shared technical feature common to Groups I, II, IV, and V is reasonably taught by Henry as cited. Second, search burden is not a consideration in a finding of lack of inventive unity for national stage US Applications restricted according to 35 U.S.C. § 371; rather, according to M.P.E.P. §1850, the only consideration is whether the inventions share a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5, 7, 8, and 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/16/2025.
Claims 6 and 9 are under consideration on the merits.
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 6 and 9 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.
Independent claim 6 incorporates product-by-process limitations from withdrawn claim 1, and so is rejected as indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as his invention or discovery, as claim 6 therefore is not a proper independent claim. See M.P.E.P. § 608-01(i). Correction is required.
Separately, claim 6 incorporates product-by-process limitations from claim 1 which renders claim 6 indefinite as “hydrogel matrix powder composition” is entirely confusing as to what is (or is not) the final physical form of the claimed composition. In this context, “powder” and “hydrogel” are mutually exclusive formulations, with the terminal lyophilization step of claim 1 implying a “powder” but the further recitation of “hydrogel” implying additional yet unrecited manipulation(s). Correction is required.
Because claim 9 depends from claim 6 and does not resolve the point of confusion, this claim must be rejected with claim 6 as indefinite.
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.
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 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Henry et al. (Advanced Healthcare Materials (published online Nov. 28th, 2019), 9(2), 1-16; provided in the IDS dated 5/31/2023).
In view of the indefiniteness rejections above and in the interest of compact prosecution, this rejection addresses the embodiment of a powdered formulation that is capable of being further formulated as a hydrogel
Henry teaches a composition comprising a lyophilized (e.g. powdered) and decellularized matrix composition made from human amniotic membrane matrix which is effective to remove greater than 96% of DNA content and which is made by dialysis against water to remove excess reagents (p5-6, subheadings “Decellularization of hAM”, and p5, left column, paragraph staring “The composition of ECM…”) and which is capable of being further formulated as a hydrogel (p6, subheading “Preparation of Injectable hAM matrix”), anticipating or reading on claim 6. Henry teaches that the decellularized matrix composition made from human amniotic membrane matrix has a shear modulus of 7.5 ± 2.4 as measured by oscillatory rheometry (the paragraph spanning p1-2), anticipating or reading on claim 9.
Claim 6 is a product-by-process claim, importing process limitations from method claim 1. See M.P.E.P. § 2113; product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Furthermore, alternate grounds of rejection under both 102 and 103 is permissible given the lack of physical description of product-by-process claims and the inability of the USPTO to manufacture and compare products. See M.P.E.P. § 2113 (III). Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claims impart any novel and/or non-obvious structural characteristics to the claimed product as compared to the composition taught by Henry. Particularly, if the product-by process limitations encompassed by claim 6 impart no structural difference then the claims are anticipated. In this case, Henry teaches both the same source of decellularized matrix (i.e. human amniotic membrane), removal of nucleic acids (e.g. DNA), dialysis to remove excess reagents, and the same final formulation (i.e. powdered) as claimed. At this time, there is no persuasive evidence that the product-by-process limitations towards a 1st lyophilization step to form a 1st dry powder, solubilizing, pH adjusting, and a 2nd and final lyophilization step imported from claim 1 into claim 6 impart any structural difference to the claimed composition as compared to Henry. If the product-by process limitations encompassed by claim 6 impart a structural difference, then Applicant must clearly set forth why any structural difference between the claimed composition and the composition of Henry is non-obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/
Primary Examiner, Art Unit 1653