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 .
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.
Priority
Receipt is acknowledged of certified copies of papers (JAPAN 2020-180919 10/28/2020) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 4/26/2023, 2/20/2024 and 10/2/2024 have been considered and made of record.
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 14 and 18-20 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.
In claim 14, “the hydrogel” lacks antecedent basis. Note: claim 14 depends from claim 1 which is devoid of language providing antecedent basis for “the hydrogel”. Clarification and/or correction is requested.
In claims 18-20, “the thickness of multiple layers” lacks clear antecedent basis. Note: Claims 18-20 depend from claim 1 which is devoid of language providing antecedent basis for “the thickness of multiple layers”.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 9, 12-14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mochizuki et al. (US 2019/0262509).
With respect to claim 1, the reference of Mochizuki et al. discloses:
An immunoisolation device comprising an embedding chamber (chamber) (¶[0131]-[0140] for a material to be transplanted, the embedding chamber being covered with an immunoisolation membrane (membrane for immunoisolation)(¶[0131]).
With respect to claims 2, 3, 9 and 12, the reference of Mochizuki et al. discloses that the immunoisolation membrane can comprise a porous membrane layer (porous membrane) and a hydrogel layer (hydrogel membrane)(¶[0049] and [0119]-[0120]). With respect to claim 12, the structure resulting from the product by product language of claim 12 would be structurally the same as the layered membrane disclosed by the reference of Mochizuki et al.
With respect to claim 4, the immunoisolation membrane suppresses entry of immunoresponsive cells and immune system humoral factors into the embedding chamber (¶[0046]-[0048]).
With respect to claim 13, the immunoisolation membrane of the reference of Mochizuki et al. comprises a porous membrane of an ethylene-vinyl alcohol copolymer (¶[0088]).
With respect to claim 14, the hydrogel of the reference of Mochizuki et al. can be a polyvinyl alcohol-based polymer (¶[0120]).
With respect to claims 17 and 18, the reference of Mochizuki et al. discloses that the membrane can have a thickness meeting the limitations of claim 17 (¶[0051] and [0066]).
Claim Rejections - 35 USC § 103
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.
Claims 5-7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mochizuki et al. (US 2019/0262509).
The reference of Mochizuki et al. has been discussed above with respect to claim 1.
Claims 5-7 differ by reciting properties of the membrane that are not specifically disclosed in the disclosure of the reference of Mochizuki et al.
However, the reference of Mochizuki et al. discloses that the selective permselectivity of the membrane can be adjusted according to the application (¶[0048]).
In view of this disclosure and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal permselectivity and strength of the membrane based on design considerations such as the cells to be used, the environment to be use, the size and structure of the chamber, etc. while maintaining the efficiency of the device.
With respect to claim 15, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine which side of the membrane would be optimal for contact with the cells and/or external environment through routine experimentation.
Claims 8, 10, 11, 16, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mochizuki et al. (US 2019/0262509) in view of Bou Aoun et al. (US 2018/0311282).
The reference of Mochizuki et al. has been discussed above with respect to claims 1-4, 9, 12-14, 17 and 18.
Claims 8, 10, 11, 16, 19 and 20 differ by reciting that the immunoisolation membrane includes a fiber structure layer.
The reference of Bou Aoun et al. discloses that it is known in the art to strengthen an immunoisolation membrane while minimizing thickness that is detrimental to diffusion by including a fiber structure layer (non-woven polymer)(¶[0012]-[0017] and [0023]-[0033]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to include a fiber structure layer with the immunoisolation membrane of the reference of Mochizuki et al. for the known and expected result of increasing the mechanical structure of the membrane as evidenced by the reference of Bou Aoun et al.
With respect to claims 10, 11 and 16, in the absence of a showing of unexpected results, it would have been obvious to determine the optimal manner in which to form the multiple layered membrane while providing the final structure required for the intended use of the device.
With respect to claims 19 and 20, both the references of Mochizuki et al. and Bou Aoun et al. discloses that the membrane can have a thickness meeting the limitations of claim 17 (¶[0051] and [0066] of Mochizuki et al. and ¶[0101]-[0111] of Bou Aoun et al.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Kawagoe et al. (US 2019/0015547) and Fournier et al. (WO 97/17129) are cited as prior art which pertain to immunoisolation membrane devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB