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. Election/Restrictions Applicant’s election without traverse of Group I claims 36-42 and 48 in the reply filed on 03/10/2026 is acknowledged. Claims 43-47,49-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/10/2026. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 36 and 38-42 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, claim(s) 36 and 38-42 are determined to be directed to a natural product and do not recite something significantly different than the natural product . The rationale for this determination is explained below: Base claim 3 6 is directed to an isolated hydrogel composition comprising one or more of a number of collagens and fibrillin-1, derived from mammalian adipose tissue and being free of nucleic acids and lipids. T h e source of the hydrogel composition has no patentable weight. Thus, claim 36 reads on collagen 1A1 . Collagen 1a1, collagen 1a2 and the other recited collagens are products of nature as discussed by Zynda ( Antioxidants 2025, 14, 389 , 34 pages ) who teaches that “ Collagen type I, composed of two α1 and one α2 chains, is the most abundant component of the extracellular matrix (ECM) of the connective tissue ” . Isolation fails to impart any new or additional properties to the collagen. Dependent claims 38-41 recite limitations to various combinations and ratios of collagen proteins, which do not necessarily alter or add to the properties of any collagen protein existing in nature. The claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a collagen protein or mixture of collagen proteins, which can be found in nature. This judicial exception is not integrated into a practical application there are no additional elements that add a meaningful limitation to the product because isolating a protein does not add a meaningful limitation and merely stating two natural products are part of product fails to alter either natural product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. More detailed analysis is set forth below. The Office published Office’s new guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published December 16, 2014. Applicant is directed to the Federal Register at page 74621. The Office published Office’s new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621. The Office published the guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published December 16, 2014. Step 2A was revised to include two prongs (Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019): Step 1: The claim is directed to a composition of matter ( collagen protein ; Step 1: Yes). Step 2A – Prong 1: Examiners evaluate whether the claim recites a judicial exception. The composition of matter (a cell and an inhibitor in proximity as a kit) is directed to a natural phenomenon (Step 2A, prong 1: Yes). MPEP §2106.04(b)(I) which shows that isolated DNA, cloned animals are considered natural phenomenon, for example. Step 2A- Prong 2: Examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This judicial exception is not integrated into a practical application because the do not recite additional elements that integrate the judicial exception into a practical application as no other elements are recited. Step 2B- Step 2B the claim is evaluated as to whether it recites additional elements that amount to significantly more than the judicial exception. The claim(s) are directed to a composition of matter (Step 1). This composition of matter is directed to a natural phenomenon (Step 2A) without additional elements (Step 2B). The claimed composition of matter fails to differ markedly from that found in nature. Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. Even in claims 39-41 where the collagens are present at varying concentrations , the proteins still fail to have properties that differ from th ose in nature. The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include: Biological or pharmacological functions or activities; Chemical and physical properties; Phenotype, including functional and structural characteristics; and Structure and form, whether chemical, genetic or physical. It is concluded, here, that the claimed natural products are not markedly different from their natural counterparts as a result of their co mbination, which is not even required by claim 36 Step2B then asks if the claim(s) include additional elements that are sufficient to amount to significantly more than the judicial exception. Based on the guidance, The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include: Improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. Limitations that were found not to be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include: Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use. In this case, reciting isolation of the collagen or fibrillin protein or its combination with other collagens are recitation s with a high level of generality that fail to alter the cells or agent and fail to add significantly more to the judicial exceptions. A claim to an inoculant comprising a plurality of strains of different bacterial species whereby the strains are unaffected by each other was found to not add significantly more to the judicial exception of a nature-based product. The inoculant of claim 1 was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co. , 333 U.S. 127, 131 (1948): Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Myriad , 133 S. Ct. at 2117. In the instant case, the combination of cells and agent is unchanged one by the presence of the other. Similarly, any isolation or combination with pother proteins as generically claimed, fa il to add significantly more to the judicial exceptions. Significantly more includes i mprovements to function, applying the judicial exception with, or by use of, a particular machine; effecting a transformation to a different state; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application. None of these additions or alterations to the judicial exception occur. 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 39 -41 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " ( Wands , 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." ( Wands , 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below. MPEP §2164.01(a), 4 th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright , 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The nature of the invention relates to obtaining an extracellular matrix (EC M ) from adipose tissue that is free of cells, nucleic acids and lipids. The claims are broad with regard to the protein content and source material of the hydrogel composition. The specification teaches obtaining ECM from human adipose using a method that comprises freezing human adipose tissue, slicing the tissue, denaturing the slice of tissue with guanidine H C l, mechanically homogenizing the tissue to lyse the cellular material, contacting the tissue with nuclease s, followed by acid/pepsin and dialysis. These steps affect the composition in terms of what proteins remain and the size of their fragments. With regard to species, Mariman (Cellular and Molecular Life Sciences, Volume 67, pages 1277–1292, 2010 ) taught that the function of ECM depends on its molecular makeup and that overall, adipocyte ECM comprises the same proteins as other ECMs but the relative quantity affects the properties of the ECM from various sources . At page 1278, col. 2, Mariman states that findings suggest species- or fat depot-specific differences. Table 1 lists many different known ECM proteins and shows variability in the presence of the proteins between species of mammal and between subtypes of adipocyte within a species. Song ( MOLECULAR MEDICINE REPORTS 17: 138-146, 2018 ) taught a method of preparing human subcutaneous adipose ECM that comprised 6 freeze-thaw cycles to dis ru pt cells followed by exposure to a polar solvent to remove lipids, then subjected to trypsin and DNase and RNase to digest proteins and nucleic acids. The resulting ECM comprised a collagen fiber scaffold comprising mostly collagen IV and laminin (page 143) . Brown (2011, Tissue Engineering Part C: Methods, 17, pages 411-421) taught “ Numerous studies have shown that the methods by which ECM scaffold materials are prepared have a dramatic effect upon both the biochemical and structural properties of the resultant ECM scaffold material as well as the ability of the material to support a positive tissue remodeling outcome after implantation ” (Abstract). A comparison of three different protocols demonstrated that the resulting scaffold structures were distinct from a biochemical and structural perspective. The specification teaches a method that comprises use of guanidine HCl which mainly denatures globular proteins but at higher concentrations, can pa rtially denature fibrous proteins (collagen and fibrillin, for example) . This step will alter the ECM structure. Accordingly, rather than being comprise d of large collagen fibers over 100 kDa, the specification teaches the presence of collagen fragments ranging from 10-30 kDa with an average of 20 kDa. Didangelos ( Mol Cell Proteomics. 2010 Jun 15;9(9):2048–2062 ) taught 4M guanidine HCl is effective in solubilizing most ECM components leaving behind only the insoluble, heavily cross-linked type I and III collagens and elastin. This is consistent with the use of 4M guanidine HCl in the specification that results in smaller collagen fragments. With regard to claims 39, 40 and 41, the specification does not characterize the resulting hydrogel to support that it meets the claimed amount of fibrillin (claim 39) or claimed ratios of proteins (claims 40-41) . Given the guidance in the art with regard to the variability of ECM scaffolds following different decellularization prot o cols, evidence supporting the claimed ratios is a result of the method used in the specification is necessary . It is noted that the specification teaches that the defined size fragments from collagens and fibrillin was achieved through specific chemical extraction and digestion protocols. Thus, the specification and art support that it would require undue experimentation to determine how to make a hydrogel composition as specifically set forth by claims 39-41. Claim 48 is 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. Claim 48 is drawn to an isolated hydrogel composition prepared by the method of claim 43. The specification fails to describe th e characteristics of a hydrogel obtained by the claimed method such that one of skill in the art could envision the properties of a hydrogel made by the process of nonelected claim 43 . The specification teaches a highly specific protocol that uses guanidine H C l to denature proteins, which leads to fragments of fibrous proteins, while the process of the product by process claim 48, generically recites use of a denaturant to denature all non-fibrous proteins. Thus, the specification only describes the product made using Guanidine HCl. As set forth above, Didangelos ( Mol Cell Proteomics. 2010 Jun 15;9(9):2048–2062 ) taught 4M guanidine HCl is effective in solubilizing most ECM components leaving behind only the insoluble, heavily cross-linked type I and III collagens and elastin. This is consistent with the use of 4M guanidine HCl in the specification that results in smaller collagen fragments. The size of the collagen fragments affects the gelling properties of the hydrogel. The product of claim 48 is obtained also by exposure to a protease followed by dialysis to remove certain sized polypeptides. The specification teaches use of pepsin as a protease. Pepsin is an aspartic protease that works in an acidic environment. Other proteases used in ECM derivation include trypsin (see Song, for example), which is a serine protease works in an alkaline environment. Pepsin hydrolyzes peptide bonds between large hydrophobic amino acid residues, whereas trypsin hydrolyzes peptide bonds at the C-terminal side of lysine or arginine . See Giansanti (N ature P rotocols | VOL.11 NO.5 | 2016 | 993 -1006). Thus, the specification does not provide the guidance necessary for the skilled artisan to envision the properties of the hydrogel made by the process as recited in claim 48. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 36-38 and 42 is/are rejected under 35 U.S.C. 102 (A)(1) and (a)(2) as being anticipated by US 20120264190 (Christman) as evidenced by Brown ( 2011, Tissue Engineering Part C: Methods, 17, pages 411-421 ). Claim 36 is drawn to an isolated , mammalian hydrogel comprising one or more of collagen 1A1, collagen 1A2, collagen 3A1, collagen 4A2, collagen 5A2 and fibrillin wherein the hydrogel is derived from mammalian adipose tissue, and is substantially free of nucleic acids and lipids. Regarding claim 36 , Christman teaches an isolated hydrogel composition . Christman teaches c ompositions comprising decellularized (claim 38 ) and delipidized extracellular matrix derived from adipose (Abstract). Christman teaches the adipose can be human, primate, mouse or from other mammals, as required by claim 36 (see para 12). Christman teaches the ECM comprises extracellular proteins including collagen I, II, III and laminin (para 16). Brown evidences that Collagen I comprises 2 fibrils of collagen 1A1 and one fibril of collagen1a2. Decellularizing and delipidizing leads to an ECM su b stantially free of nucleic acids and lipi d s. This is supported by Figure 1 showing absence of nuclei and lipids. Christman also teaches treating the ECM with DNase and RNase which digests nucleic acids (para 41). Christman teach es the composition can contain fibrillins (para 64) and thus anticipates claim 36 ( mammalian hydrogel composition comprising fibrillin and is free of nucleic acids and lipids). Regarding claim 37, p eptide bands characteristic of collagen fibers were present within the digest, in addition to multiple fragment peptides below 28 kDa (FIG. 4 , lane C is collagen control ). Regarding claim 42, Christman taught that the liquid ECM self-assembled into a gel when the temperature was raised to 37 degre e s Celsius (para 94). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT VALARIE BERTOGLIO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0725 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 6AM-2:30PM . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Peter Paras can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-4517 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT VALARIE E. BERTOGLIO, Ph.D. Examiner Art Unit 1632 /VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632