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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/13/2025 has been entered.
No claims have been amended, newly added or newly canceled.
Claims 1-6, 8, 11-12, 14, 17, 20, 24, 33-34, 37-38, and 40-42 are currently pending.
Claims 6, 8, 11-12, 14, 17, 20, 24, 33-34, 37-38, and 40-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/07/2025.
Claims 1-5 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claim 4 is 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 4 is indefinite because it is unclear how the digestion concentrations of 7 mg/ml and 8 mg/ml are to be excluded from claim 1, but included for claim 4 and thus the metes and bounds of the claim are indefinite.
Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 fails to include all the limitations of claim 1 upon which it depends.
Claim 1 excludes digestion concentrations of 7 mg/ml and 8 mg/ml while claim 4 includes these digestion concentrations.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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) 1 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Christman et al (US 2013/0251687).
Regarding claim 1, Christman disclose a method of preparing an ECM pre-gel by providing a decellularized, processing the decellularized tissue to derive ECM powder from the tissue and digesting the ECM powder at a concentration of 1 mg/ml in proteolytic solution (pepsin) and thereby forming the ECM pre-gel (page 11 para 155).
Therefore, the teaching of Christman anticipates Applicant’s invention as claimed.
Claim Rejections - 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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Christman et al (US 2013/0251687).
Regarding claims 1 and 4, Christman disclose a method of preparing an ECM pre-gel by providing a decellularized, processing the decellularized tissue to derive ECM powder from the tissue and digesting the ECM powder at a concentration of 1 mg/ml in proteolytic solution (pepsin) and thereby forming the ECM pre-gel (page 11 para 155).
Regarding claims 2-3, Christman disclose that in one embodiment that the ECM is derived from small intestinal submucosa (SIS) (small intestinal tissue) (page 4 para 52).
Christman do not disclose digestion concentrations of 2 mg/ml to 6 mg/ml or 2 mg/ml to 8 mg/ml.
With regard to the concentrations of the digestion solution of ECM and proteolytic solution in the method, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viscosity of the digested ECM would have been affected by these concentrations.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to modify and raise the concentration of the digested ECM in the method of Christman through routine optimization and experimentation because Christman teach and suggest that various alternatives to their embodiments may be employed in practicing their invention (page 8 para 97, page 12 para 164).
Therefore, the teaching of Christman et al renders obvious Applicant’s invention as claimed.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Christman et al (US 2013/0251687) as applied to claims 1-4 above, and further in view of Badylak et al (WO 2008/109407).
Regarding claim 5, Christman renders obvious Applicant’s claim as described above, and further includes wherein prior to digestion that ECM is sterilized (page 1 para 14, page 2 para 20).
Christman do not specifically disclose wherein the ECM powder is sterilized with gamma radiation prior to digestion.
Badylak is drawn to methods of making decellularized tissue matrix and teach wherein the ECM can be sterilized by any number of standard techniques including gamma radiation (page 12 3rd paragraph).
One of ordinary skill in the art would have been motivated to use gamma radiation to sterilize the ECM powder of Christman because Badylak teach and suggest that this is standard technique for sterilizing ECM. Since Badylak suggest that sterilization and decellularization can be performed simultaneous (page 12 last paragraph), one of ordinary skill would be aware that there is flexibility in the timing of the sterilization and that it can be performed on the ECM at various points in time in the process, such as when it is in powder form. One of ordinary skill in the art would have had a reasonable expectation of success because Christman also suggest that sterilizing their ECM is suitable and beneficial for their method.
Therefore, the combined teachings of Christman et al and Badylak et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Freytes et al., “Preparation and rheological characterization of a gel form of the porcine urinary bladder matrix”, Biomaterials, 2008, Vol. 29, pp. 1630-1637.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631