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 .
Restriction/Election
Applicant's election, in the reply filed July 15, 2026 of Group I, claims 1 - 17, directed to a method for making a decellularized smECM, the decellularized smECM, and the compositions comprising the decellularized smECM, without traverse, is acknowledged.
Claims 18 - 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 1 – 17 are under consideration to which the following grounds of rejection are applicable. Claims 9, 10, 11, 2 16 and 17 are independent claims.
Information Disclosure Statement
No information disclosure statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to the patentability as defined in 37 C.F.R. 1.56.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Priority
The present application filed May 1, 2024, claims the benefit of Provisional Application 63/463,096, filed May 1, 2023.
Therefore, the earliest priority date is May 1, 2023.
Product-by-Process
Independent claims 9 – 12, and claims 13 – 17 (the claims that depend on claims 9 – 12) are determined to be product-by-process claims. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. Moreover, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Claim Rejection - 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.
Claims 1- 17 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 1 is indefinite for the recitation of “to substantially remove” in line 3. It is unclear what is quantified by the term “substantially,” and how much of the non-skeletal muscle tissue is removed in the purification step. Thus, the metes and bounds of the claim cannot be determined.
Claims 2 – 8 are indefinite insofar as they ultimately depend on claim 1.
Claim Rejection - 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 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 1 – 6, 9, and 11, 13 – 15, and 16 are rejected under 35 U.S.C. 103 as being
unpatentable over Chameettachal and Pati (hereinafter referred to as “Pati”) (US 20210113740 A1, published April 22, 2021), in view of Rowley et al. (hereinafter referred to as “Rowley”) (US20230079141 A1, published March 16, 2023).
Regarding claims 1 and 9, Pati teaches a method for preparation of decellularized corneal matrix-based hydrogel (Abstract). Pati teaches decellularization of corneal samples (Abstract). Pati teaches a method for decellularizing corneal ECM by treating ECM with a decellularizing agent such as α-galactosidase, and further treating the ECM with RNAse and DNAse (Paragraph [0009]. Further, Pati teaches that the decellularized corneal matrix is pulverized into powder by using a mill (Paragraph [0099]) (interpreted as lyophilizing and cryo-milling the lyophilizing tissue to generate the ECM in a powdered form).
Pati does not specifically teach the use of a skeletal muscle tissue, decellularizing the tissue by mechanical disruption, and purifying and grinding the skeletal muscle tissue (claim 1 (in part)), does not use a detergent (claim 2), the skeletal muscle is from a pig (claims 3 – 4), and the mechanical disruption is at least one freeze-thaw cycle (claim 5).
Regarding claims 1 (in part), 2- 5 Rowley teaches a method of producing a decellularized porcine tissue scaffold (Abstract). Rowley teaches that the method comprises subjecting the tissue to at least one freeze/thaw cycle to obtain a decellularized scaffold (Paragraph [0041]) (interpreted as no detergent is used, and the mechanical disruption comprises at least one freeze-thaw cycle, claims 2 and 5) Rowley teaches that the term “tissue scaffold” refers to a biological structure support designed to mimic the natural extracellular matrix, which facilitate attachment, migration, proliferation, and/or three-dimensional organization of cells growing therein (Paragraph [0055]). Rowley teaches that the starting tissue can be a porcine muscle (Paragraph [0057]) (interpreted as skeletal muscle is from a pig, claims 3 – 4). Rowley teaches that the scaffold is substantially free from cellular components and/or nucleic acids (Paragraph [0061]) (interpreted as purifying the skeletal muscle tissue). Rowley teaches incubating the tissue with a DNA removal agent, such as DNAse Type I, and RNAse (Paragraph [0302]). Rowley teaches that incubating the tissue at least once with a hypotonic solution and at least once with a hypertonic solution achieves a similar effect as subjecting the tissue to at least one freeze/thaw cycle (Paragraph [0134]).
Therefore, in view of the benefits of producing a decellularized porcine tissue ECM as taught by Rowley, it would have been prima facia obvious for one of ordinary skill in the art before the effective filing date to replace the corneal tissue used to make the decellularized corneal ECM, wherein this method comprises the step of decellularizing with a detergent, as taught by Pati, with the porcine muscle, wherein this method comprises subjecting the tissue to a freeze/thaw cycle, as taught by Rowley with a reasonable expectation of making a decellularized porcine muscle ECM. Moreover, it would have been prima facia obvious to combine the cited sources because Pati only teaches a method for decellularizing corneal ECM, and Rowley teaches how to make a decellularized tissue construct of any tissue, specifically comprising subjecting the tissue to at least one freeze/thaw cycle, wherein incubating the tissue at least once with a detergent achieves a similar effect as subjecting the tissue to at least one freeze/thaw cycle (Paragraph [0134]).
Regarding claim 6,11, and 16, the combined teachings of Pati and Rowley render obvious the teachings of claim 1. Moreover, Pati taches a method for preparation of hydrogel base by decellularizing the ECM, digesting the ECM, adjusting the ECM to obtain pre-gel, and mixing the culture media with pre-gel to obtain a decellularized corneal matrix-based hydrogel (Paragraph [0013]). Pati teaches that the pH of the hydrogel is adjusted by dropwise addition of any basis solution to bring the pH of the solution in a range from 7-8 (Paragraph [0105]) (interpreted as adjusting the pH of the ECM (claim 6), and interpreted as a decellularized hydrogel, claims 11 and 16). Pati teaches that the hydrogel is prepared by allowing the pre-gel to form a gel at a temperature in the range of 34-38° C. for about 30-45 minutes (Paragraph [0107]) (interpreted as incubating the ECM to form a hydrogel).
Regarding claims 13 - 15, the combined teachings of Pati and Rowley render obvious the teachings of claims 1, 6 and 11. Moreover, Pati teaches that it was observed that around 140% of GAGs and 78% total collagen were retained in the decellularized tissue compared to native corneal tissue, which revealed that high quantity of decellularized extracellular matrix components are being preserved after decellularization (Paragraph [0143]) (interpreted as the total smECM protein is statistically equivalent to an equivalent ECM that is not decellularized, and that the sGAG is equivalent to an equivalent smECM that is not decellularized). (Please note: a smECM that is not decellularized is interpreted as a skeletal muscle).
(II) Claims 1, 7 – 8, 10, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over
Pati and Rowley, as shown supra, and further in view of Kamperman et al. (hereinafter referred to as “Kamperman”) (US 11414483 B2, published August 16, 2022).
The teachings of Pati and Rowley pertaining to claims 1 – 6, 9, and 11, 13 – 15, and 16 are supra.
Regarding claims 7-8, 10 12, and 17, Pati and Rowley do not specifically teach making a smECM-PhF (claim 7 and 10 and 17), forming a smECM-PhF hydrogel (claim 8 and 12).
Regarding claims 7 - 8, 10, 12, and 17, Kamperman teaches a hydrogel that comprises cross-linked hydrogel polymers, wherein the gel, after cross-linking, acquires more chemical stability (Paragraph [42]). Kamperman teaches that the cross-linking moiety is a phenolic compound, and the method comprises using horseradish peroxidase and an oxidizer (Paragraph [43]).
Therefore, in view of the benefits of making a hydrogel with more chemical stability as taught by Kamperman, it would have been prima facia obvious for one of ordinary skill in the art to further modify the hydrogel as taught by Pati and Rowley and cross-link the hydrogel polymers, as taught by Kamperman, with a reasonable expectation of success of adding a phenol group to the hydrogel. It would have been prima facia obvious to combine the cited sources because Pati and Rowley teach a decellularized skeletal muscle ECM that is used to prepare a hydrogel, and Kampeman teaches a method of making a more stable hydrogel.
Conclusion
Claims 1 – 17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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, Maria Leavitt can be reached on (571) 272-1085. 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
/VYOMA SHUBHAM TIWARI/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Prosecution Insights