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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 12/31/2025 is acknowledged.
Claims 16-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/31/2025.
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.
Claims 1-15 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 is unclear. Claim 1 recites multiple limitations in parentheses in lines 3-5, however it is not clear if the recitations in parentheses are limiting steps (a) and (b) as claimed. Thus, the metes and bounds of claim 1 is unclear since it is not clear if the steps are limited to only diced tissue and water or are just a preferred embodiment for practicing the method.
Claim 2 is unclear. Claim 2 recites a limitation in parentheses in lines 1-2, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 2 is unclear since it is not clear if the step of incubating without a detergent is a limitation or is just a preferred embodiment for practicing the method.
Claim 5 is unclear. Claim 5 recites multiple limitations in parentheses in lines 3-9, however it is not clear if the recitations in parentheses are limiting steps (c)-(e) as claimed. Thus, the metes and bounds of claim 5 is unclear since it is not clear if the steps are limited to only enzyme, time, enzyme deactivator and hypoosmotic solution or are just a preferred embodiment for practicing the method.
Claim 6 is unclear. Claim 6 recites a limitation in parentheses in lines 2-3, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 6 is unclear since it is not clear if the rpm is a limitation or is just a preferred embodiment for practicing the method.
Claim 10 is unclear. Claim 10 recites a limitation in parentheses in line 3, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 10 is unclear since it is not clear if the temperature is a limitation or is just a preferred embodiment for practicing the method.
Claim 11 is unclear. Claim 11 recites a limitation in parentheses in line 2, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 11 is unclear since it is not clear if the temperature is a limitation or is just a preferred embodiment for practicing the method.
Claim 12 is unclear. Claim 12 recites a limitation in parentheses in lines 2-3, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 12 is unclear since it is not clear if the incubation with an antibiotic or disinfectant is a limitation or is just a preferred embodiment for practicing the method.
Claim 13 is unclear. Claim 13 recites a limitation in parentheses in line 2, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 13 is unclear since it is not clear if the lyophilization is a limitation or is just a preferred embodiment for practicing the method.
Claim 15 is unclear. Claim 15 recites a limitation in parentheses in lines 2-3, however it is not clear if the recitations in parentheses are limiting the method as claimed. Thus, the metes and bounds of claim 15 is unclear since it is not clear if the pepsin is a limitation or is just a preferred embodiment for practicing the method.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2011/0045566 A1).
Claim Interpretation: as set forth above in the 112(b) rejection it is not clear if the recitations in parentheses are claim limitations or just preferred embodiments and thus not required by the claim. It is interpreted that the recitations within parentheses are not claim limitations.
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.
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 is/are 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).
Claim Interpretation: as set forth above in the 112(b) rejection it is not clear if the recitations in parentheses are claim limitations or just preferred embodiments and thus not required by the claim. It is interpreted that the recitations within parentheses are not claim limitations.
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.
Conclusion
No claims are allowed.
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