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 .
Applicant’s arguments and amendments filed on 5/2/2026 have been entered.
Claims 1, 5, 6, 10-13 and 15 have been amended.
In view of Applicant’s amendments to the claims, the 112b rejections are withdrawn.
Claims 1 and 3-15 are examined in the instant application.
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.
Claim(s) 1-6 and 9-12 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2011/0045566 A1) for reasons of record in the Non-Final Office Action mailed on 2/5/2026 (and repeated as amended below)
Regarding claims 1-3, Wang et al. teach a detergent-free method of decellularizing a tissue comprising providing the tissue and incubating the tissue in a hypoosmotic solution for a time of 12 to 24 hours (parags. 7-10, 45, 83 and Embodiments 1 and 2).
Wang does not teach using any detergents, proteases or toxins in their method, thus it is interpreted that Wang’s method is free of these compounds.
Regarding claim 4, Wang teaches using the enzyme phospholipase to digest cellular material (parag. 21).
Regarding claims 5 and 9, Wang teaches incubating porcine tissue in a composition comprising phospholipase, incubating the tissue in a solution that deactivates the phospholipase and then incubating in a second hypoosmotic solution (parags. 67-74 Embodiment 4).
Regarding claim 6, Wang teaches that the incubating steps are carried out with mechanical agitation (parags. 67-74).
Regarding claim 10, Wang teaches that their method can be done a temperature range of 0oC to 56oC (parag. 43).
Regarding claim 11, Wang teaches practicing their method at 37oC (parags. 67-74).
Regarding claim 12, Wang teaches disinfecting their tissue with an antibiotic (parag. 73).
Thus the teachings of Wang clearly anticipate the invention of claims 1-6 and 9-12.
Response to Arguments
While Applicants’ arguments have been fully considered they are not found persuasive. While it is agreed that the Wang teaches detergents such as sodium deoxycholate and Triton X-100, Wang teaches these as additional or alternative embodiments to their method of decellularizing tissue. As taught in parag. 44, Wang teaches (emphasis added) “According to different tissues and organs and different requirements to the quality of the decellularized matrix, one or more of the surfactants can be added into the solution containing the phospholipase to facilitate the decellularization speed without damaging the extracellular structure and the functional protein”. The preceding paragraphs 42 and 43 clearly teach that the phospholipase used in Embodiments 1 and 2 can be fully used without the addition of a surfactant (i.e. a detergent).
Thus the teachings of Wang remain anticipatory over the claimed invention.
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.
Claim(s) 1, 7, 8 and 13-15 remain rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2011/0045566 A1) in view of Leach et al. (WO 2012/142569) for reasons of record in the Non-Final Office Action mailed on 2/5/2026 (and repeated as amended below)
Regarding claim 1, Wang et al. teach a detergent-free method of decellularizing a tissue comprising providing the tissue and incubating the tissue in a hypoosmotic solution for a time of 12 to 24 hours (parags. 7-10, 45, 83 and Embodiments 1 and 2).
While Wang does teach that their method can be used for any organ (parag. 2), Wang does not explicitly teach pancreas.
Wang does not teach:
Pancreas tissue.
Regarding pancreas tissue in claims 7 and 8, Leach et al. teach a method of
decellularizing tissue which can be used to decellularize pancreas tissue (parag. 107).
Regarding claim 13, Leach teaches that they can dehydrate their decellularized tissue (parag. 96).
Regarding claim 14, Leach teaches that they turn their decellularized tissue into a powder (parag. 111).
Regarding claim 15, Leach teaches that can remove lipids from their decellularized tissue (parag. 94).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Wang regarding a method of decellularizing tissue with the teachings of Leach regarding decellularizing and processing tissues such a pancreas to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Wang teaches that their method can be used on any organ and Leach teachings that organs such as pancreas can be successfully decellularized.
There would have been a reasonable expectation of success that the pancreas of Leach could be decellularized with the method of Wang and further processed since Wang teaches that their method can be used with any organ.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Response to Arguments
While Applicants’ arguments have been fully considered they are not found persuasive. While it is agreed that the Wang and Leach both teach detergents such as Triton X-100, Wang teaches these as additional or alternative embodiments to their method of decellularizing tissue. As taught in parag. 44, Wang teaches (emphasis added) “According to different tissues and organs and different requirements to the quality of the decellularized matrix, one or more of the surfactants can be added into the solution containing the phospholipase to facilitate the decellularization speed without damaging the extracellular structure and the functional protein”. The preceding paragraphs 42 and 43 clearly teach that the phospholipase used in Embodiments 1 and 2 can be fully used without the addition of a surfactant (i.e. a detergent).
Further it is maintained that the detergent free method of Wang would work with the pancreas tissue of Leach
Thus the rejection is maintained for the reasons above and of record.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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DAVID A. MONTANARI
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
