DETAILED ACTION
Claim Status
As of the Non-Final Office Action mailed 1/26/2026, claims 1-19 were pending and claim 12 was withdrawn for being drawn to nonelected invention.
In Applicant's Response filed on 3/18/2026, claims 1-4 and 11 were amended and claims 5-8, 10, and 16-19 were canceled.
As such, claims 1-4, 9, and 11-15 are pending and claims 1-4, 9, 11, and 13-15 have been examined herein.
Withdrawn Objections/Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
Claim Objections – Necessitated by Amendment
Claim 2 is objected to because of the following informalities: Claim 2 recites “wherein the digesting is the pulverized tissue by . . .” where there is an improperly placed “the” following “is”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) – Necessitated by Amendment
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 1-4, 9, 11, and 13-15 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 recites, inter alia, “adjusting the pH by adding a basic solution to the lysate”. There is insufficient antecedent basis for this limitation in the claim because there is no previous recitation of any lysate in the claim. Thus, the claim is indefinite. Claims 2-4, 9, 11, and 13-15 are included in this rejection for being ultimately dependent on indefinite claim 1.
Claim Rejections - 35 USC § 102 - Maintained
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) 9 and 13-15 remain rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ozbolat et al (US 20190331662 A1, 1/12/2018; published 10/31/2019; of record).
Claims 9 and 13-15 remain rejected as anticipated by Ozbolat for the reasons stated in the Non-Final office action of record mailed 1/26/2026.
Response to Arguments
Applicant has not provided any arguments related to the Ozbolat teachings as they relate to instant claims 9 and 13-15 nor has Applicant attempted to distinguish these claims from the teachings of Ozbolat. Thus, the rejection has been maintained.
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.
Claim(s) 1-4, 9, 11, and 13-15 remain rejected under 35 U.S.C. 103 as being unpatentable over Badylak et al (WO2015143310 A1, 3/20/2015; published 9/21/2016; of record) in view of Hines et al (Cell Reports, 13 March 2014; of record).
Claims 1-4, 9, 11, and 13-15 remain rejected as prima facie obvious over Badylak in view of Hines for the reasons stated in the Non-Final office action of record mailed 1/26/2026.
Response to Arguments
On p. 7-10 of Remarks, Applicant argues, in sum, that while Hines teaches “robust stirring tissue at 300-500 rpm for 1-7 hours, until the digest is deemed to be complete (time depends on the amount of starting material)”, the instant method requires spinning at 330 to 500 rpm for 72 hours to 96 hours. Applicant argues that the speed and time conferred “excellent rheological properties and culture effects,” citing para 32-35, and 60 of the instant disclosure to support the contention. Applicant argues that the stirring time depending on the amount of starting material means that the stirring time can be varied for 1-7 hours, that the minimum amount of stirring time for the instant invention is more than 10 times longer than the maximum stirring time described by Hines, and thus, is not obvious over Badylak and Hines.
In response, the examiner disagrees. As previously stated in the prior Office action, Badylak renders prima facies obvious the instantly claimed steps of decellularizing, lyophilizing, pulverizing, digesting, and pH adjusting (see Balydak disclosure and previously mailed Office action). Hines discusses, in sum collagenase digestion of tissue digested into organoids (see p. 780 of Hines). Of note, Hines teaches that, for example, breast tissue can be digested in the presence of collagenase (a proteopeptic enzyme), stirred at 300-500 rpm during digestion (which overlaps with the instantly claimed speed), and that the amount of time to digest (i.e., “until digestion is deemed complete” as sated in Hines) depends on the amount of starting material. The examiner disagrees with Applicant’s characterization that the stirring time can be varied for 1-7 hours. Rather, it is the examiner’s position that, while the tissue could be stirred for 1-7 hours, one of ordinary skill, reading the Hines disclosure, would understand that the amount of time stirred would depend when one of ordinary skill deems to be “complete” based on the amount of tissue being digested and not be limited to 1-7 hours as argued. Thus, Applicant’s arguments are not persuasive.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.R./Examiner, Art Unit 1632 /KARA D JOHNSON/Primary Examiner, Art Unit 1632
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