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.
Information Disclosure Statement
The information disclosure statement dated 4/14/2026 has 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 1, 4-14 and 17-20 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.
With respect to claim 1, it is not clear if the recited “a fiber structure of an ethylene-vinyl alcohol copolymer” is a further limitation of the previously recited “fiber structure layers” or an additional layer to the previously recited “at least two layers”. The indefiniteness of this claim language is supported by the limitations of dependent claims 8-14 and 17-20 which appear to include embodiments with do not required the “fiber structure of an ethylene-vinyl alcohol copolymer” or include a fiber structure that is different from that recited in claim 1. Clarification and/or correction is requested.
Claims 4-14 and 17-20 are also indefinite based on their dependency from indefinite claim 1 and because they do not cure the deficiencies of claim 1.
It is suggested that claim 1 be rewritten in the following manner:
An immunoisolation device comprising an embedding chamber for a material to be transplanted, the embedding chamber being covered with an immunoisolation membrane;
wherein the immunoisolation membrane is a multilayer membrane comprising an outermost layer surface of a fiber structure of an ethylene-vinyl alcohol copolymer that is smoothly compressed and at least one additional layer selected from the group consisting of porous membrane layers and hydrogel layers.
It is suggested that claim 8 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer comprises a porous membrane layer and/or a hydrogel layer formed on the fiber structure layer.
It is suggested that claim 9 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer comprises a porous membrane layer and a hydrogel layer formed on the porous membrane layer.
It is suggested that claim 10 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the immunoisolation membrane is obtainable by applying a polymer raw material to the fiber structure used as a substrate to form a porous membrane among short fibers of the fiber structure.
It is suggested that claim 11 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the immunoisolation membrane is obtainable by directly applying a hydrosol solution to the fiber structure used as a substrate and performing hydrogelation by using heat, temperature, light, or chemical action.
It is suggested that claim 12 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer is obtainable by directly applying a hydrosol solution to a porous membrane used as a substrate and performing hydrogelation by using heat, temperature, light, or chemical action.
It is suggested that claim 13 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer comprises a porous membrane of an ethylene-vinyl alcohol copolymer.
It is suggested that claim 18 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer comprises a hydrogel and a porous membrane and the thickness of the immunoisolation membrane is 10 µ or more and 300 µ or less.
It is suggested that claim 19 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer comprises porous membrane and the thickness of the immunoisolation membrane is 10 µ or more and 300 µ or less.
It is suggested that claim 20 be rewritten in the following manner to address antecedent basis issues resulting from the claim language of claim 1:
The immunoisolation device according to claim 1, wherein the at least one additional layer comprises a hydrogel and the thickness of the immunoisolation membrane is 10 µ or more and 300 µ or less.
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 1, 4-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (JP 2009213573 and corresponding English language machine translation) (Attached PTO-892) in view of Fournier et al. (WO 97/17129) (IDS dated 10/2/2024).
With respect to claim 1, the reference of Kobayashi discloses:
An immunoisolation device (Figs. 7a, 7b and 8) comprising an embedding chamber (area defined by membrane (12 or 14) for a material to be transplanted, the embedding chamber being covered with an immunoisolation membrane (12 or 14);
wherein the immunoisolation membrane is formed of an ethylene-vinyl alcohol copolymer (page 8, third paragraph, and page 11, fourth paragraph, of the machine translation).
Claim 1 differs because the reference of Kobayashi fails to teach:
i) the immunoisolation membrane is a multilayer membrane comprising at least two layers selected from the group consisting of fiber structure layers, porous membrane layers, and hydrogel layers;
ii) an outermost layer surface of the immunoisolation membrane is formed of a fiber structure of ethylene-vinyl alcohol copolymer which is smoothly compressed.
With respect to differences i) and ii) above, the reference of Fournier et al. discloses that it is known in the art to provide a bioartificial liver device with an immunoprotective membrane that is a multilayer membrane formed by coating or impregnating a micro-porous, supportive member with a hydrogel (pages 3-4). The reference discloses that the structure of the supporting membrane can be a compacted (smoothly compressed) non-woven web (fiber structure).
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 employ a multilayer membrane in the device of the primary reference of Kobayashi for the known and expected result of providing an immunoprotective membrane with sufficient strength to withstand the pressure differentials associated with implantation and cell loading within the body (page 3, lines 13-15, of Fournier et al.). The use of an ethylene-vinyl alcohol copolymer as a non-woven outermost layer would have been well within the purview of one having ordinary skill in the art in view of the disclosure of the reference of Kobayashi as an art recognized material to be in contact with the implant environment. Note: a compacted non-woven web is considered to meet that limitations of a fiber structure layer and smoothly compressed because ¶[0043] of the instant disclosure defines “fiber structure” to include “a non-woven fabric” and the instant disclosure does not specifically device “smoothly compressed”.
With respect to claims 4-7, if the structure resulting from the combination of the references as discussed above with respect to claim 1 does not intrinsically meet the limitations of claims 4-7, it would have been obvious to one of ordinary skill in the art to optimize the properties of the multilayer immunoprotective membrane through routine experimentation while providing the desired immunoprotection.
With respect to claim 8, the structure resulting from the combination of the references as discussed above with respect to claim 1 would encompass a membrane with a fiber structure layer and a hydrogel layer formed on the fiber structure layer.
With respect to claim 9, in the absence of a showing of unexpected results, in view of the disclosure of Fournier et al., it would have been well within the purview of one having ordinary skill in the art to employ a fiber structure layer and/or a porous membrane layer within the immunoprotective membrane structure.
With respect to claims 10-12, the method of manufacture of the final multilayer structure, carries no patentable weight if the final resulting structure is the same as that encompassed by the combination of the references as discussed above with respect to claim 1.
With respect to claims 13 and 14, the reference of Kobayashi clearly discloses the desirability of the use of ethylene-vinyl alcohol copolymer as a membrane material.
With respect to claims 17-20, the reference of Fournier et al. discloses the use of a supporting membrane with a thickness up to about 200µm (page 3, lines 16-22). As result, it would have been obvious to one of ordinary skill in the art to determine the optimal thickness of the multiple layered membrane through routine experimentation while maintaining the structural integrity of the membrane during its intended use.
Response to Arguments
Claim Rejections under 35 USC 112
The rejections of claims 14 and 18-20 under 35 USC 112(b) have been withdrawn in view of the amendments to the claims and related comments on page 6 of Applicants’ response dated 4/14/2026. Note: New grounds of rejection under 35 USC 112(b) have been made in view of the amendments to the claims.
Claim Rejections under 35 USC 102
The rejection of claims 1-4, 9, 12-14, 17 and 18 under 35 USC 102 over the reference of Mochizuki et al. (US 2019/0262509) has been withdrawn in view of the amendments to the claims and related comments on page 7 of Applicants’ response dated 4/14/2026.
Claim Rejections under 35 USC 103
The rejections of claims 5-7 and 15 under 35 USC 103 over the reference of Mochizuki et al. (US 2019/0262509) and claims 8, 10, 11, 16, 19 and 20 over the combination of the references of Mochizuki et al. (US 2019/0262509) and Bou Aoun et al. (US 2018/0311282) have been withdrawn in view of the amendments to the claims and related comments on page 7 of Applicants’ response dated 4/14/2026. Note: New grounds of rejection under 35 USC 103 have been made over Kobayashi (JP 2009213573) in view of Fournier et al. (WO 97/17129) in view of the amendments to the claims.
Conclusion
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.
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
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