DETAILED ACTION
Applicant’s amendment and Arguments/Remarks received on 05 March 2026 have been entered. Claims 1-11 and 13-22 were previously pending in the application. Claims 11 and 13 have been cancelled by Applicant. Claims 1-10 and 14-22 are currently pending in the application. Claims 1, 16, 18, and 20 are independent claims.
The election of Group I, drawn to a cell transplantation kit and a therapeutic agent for diabetes, remains in effect in the instant application. The following election of species remains in effect in the instant application:
A material of the first sac-shaped structure: nylon
A material of the second sac-shaped structure: sodium alginate.
Claim 20 remains withdrawn from consideration as being directed to a nonelected invention, there being no allowable generic or linking claim.
Claims 16-17 have been amended to be directed to a method of transplanting, and as such, are no longer directed towards the elected invention. Therefore, claims 16-17 are newly withdrawn as being directed to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-10, 14-15, 18-19, and 21-22 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a CON of 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2019/050494, filed 24 December 2019, which claims priority to JAPAN 2018-241499, filed 25 December 2018, and JAPAN 2019-024592, filed 14 February 2019. Filing of a certified copy of the JAPAN 2018-241499, filed 25 December 2018, and JAPAN 2019-024592, filed 14 February 2019, is acknowledged.
Thus, the earliest possible priority for the instant application is 25 December 2018.
Specification
The objection to the specification of the disclosure for new matter is withdrawn in view of the amendment to the specification filed 05 March 2026 removing the new matter.
Claim Rejections - 35 USC § 112(b)
The rejection of amended and cancelled claims 11, 13, and 16-17 under 35 U.S.C. 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor(s) regards as the invention for multiple issues of indefiniteness is withdrawn in view of Applicant’s cancellation of claims 11 and 13 and amendments to the claims such that claims 16 and 17 are now directed to a method of transplanting and have been withdrawn as being directed to a nonelected invention.
Claim Rejections - 35 USC § 103
The rejection of amended, previously presented, original, and cancelled claims 1-11 and 13-19 under 35 U.S.C. 103 as being unpatentable over Hasilo et al. [US20150209479A1, published 30 July 2015]; in view of Krishnan et al. [2011, Transplantation Proceedings, Vol. 43, 3256-3261]; De Vos [1999, Diabetes, Vol. 48, 1381-1388]; Vaithilingam [2017, Scientific Reports, Vol. 7, 1-13]; Gabriel [2016, Journal of Visualized Experiments, Vol. 114, e54272, 1-7]; and Chue [2004, Journal of Vascular Surgery, Vol. 39(4), 859-867]; is withdrawn over cancelled claims 11, 13, withdrawn over newly withdrawn amended claims 16-17, and maintained over previously presented and original claims 1-10, 14-15, and 18-19 in view of Applicant’s cancellation of claims 11 and 13, amendments to the claims such that claims 16 and 17 are now directed to a method of transplanting and have been withdrawn as being directed to a nonelected invention. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant has not amended any of claims 1-10, 14-15, and 18-19, and as such, Applicant’s amendments do no overcome a finding of obviousness.
Applicant argues that:
Applicant’s filed Declaration of Ryo Kogawa under 37 CFR 1.132 provides strong evidence of the patentability of the claimed invention by explaining the art-recognized definition of the term “block” as supported by evidentiary references;
in Vaithilingam, the alginate within the microcapsule does not form a block and there are no gaps between the plurality of cells within a single capsule, such that an ordinarily skilled artisan would not construe “block” as an alginate capsule, and so the alginate is different from “a cell structure in which a plurality of the polymer blocks are arranged in a gap between a plurality of the cells”.
However, this is not agreed.
Regarding Applicant’s argument 1), the Kogawa Declaration states, ‘paragraph [0082] of US2013/0071441A1, which is assigned to FUJIFOLM Corporation, defines the term “block” as follows:
for example, amorphous, spherical, particulate, powdery, porous, fibrous, spindle-like, flat, and sheet-like shapes, preferably amorphous, spherical, particulate, powdery, and porous shapes, more preferably an amorphous shape. The term “amorphous” represents a nonuniform surface shape, for example, matter having surface irregularities, such as rocks.’ [page 2 ¶ 3].
Note that paragraph [0082] of US2013/0071441A1, hereafter referred to as the ‘441 application, recites, “The shape of the polymer blocks according to the present invention is not particularly limited and is,” immediately before the opening “for example” quoted in the Kogawa Declaration. The description of the polymer block provided in the ‘441 application paragraph [0082] is not a limiting definition in that it describes a shape which is not particularly limited and provides merely exemplary descriptions of options for the shape of the blocks. Additionally, the options for the shapes provided in the ‘441 application [0082] include “porous”, which encompass a polymer gel structure.
Further, the Kogawa Declaration states, ‘The “block” used in the cell transplantation structure of the claimed invention was a pioneering and original concept developed by FUJIFILM Corporation, and therefore, no prior third-party publications preceding the filing date, nor subsequence third-party patent application, have been identified that use the term “block” in this specific technical context.’ [page 2 ¶ 4]. Therefore, the Declaration indicates that the present use of the term “polymer block” is not consistent with an art recognized term.
The Declaration goes on to assert, ‘However, the “µ-piece” fabricated by the present inventors, which corresponds to the structural concept of the “block” portion in the claimed invention, has been accepted and used in academia, as shown, for example, in the following publications:’ and provides references for Ikemoto et al. 2019, Kami et al. 2020, and Takamiya et al. 2022. Note that providing post-filing art teaching term which “corresponds to the structural concept” of the term used in the present application is not indicative of an art-recognized limiting definition for the term known at the time of filing. See MPEP 2173.01(I), which states:
“Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art… The presumption that a term is given its ordinary and customary meaning may be rebutted by the applicant by clearly setting forth a different definition of the term in the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997) (the USPTO looks to the ordinary use of the claim terms taking into account definitions or other "enlightenment" contained in the written description); But c.f. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1369, 70 USPQ2d 1827, 1834 (Fed. Cir. 2004) ("We have cautioned against reading limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification."); In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1211 (Fed. Cir. 2004) (The claims at issue were drawn to a "hair brush." The court upheld the Board’s refusal to import from the specification a limitation that would apply the term only to hairbrushes for the scalp. "[T]his court counsels the PTO to avoid the temptation to limit broad claim terms solely on the basis of specification passages.")…
If an Office action has issued where the plain meaning of the claim terms was used, applicant may point out that the term has been given a special definition. Since there is a presumption that claim terms are given their plain meaning, and the use of special definitions is an exception, the applicant must point to where the specification as filed provides a clear and intentional use of a special definition for the claim term to be treated as having a special definition.
An applicant may not add a special definition or disavowal after the filing date of the application. However, an applicant may point out or explain in remarks where the specification as filed contains a special definition or disavowal.”
Therefore, reliance on post-filing art to provide a definition of a claim term by demonstrating use of an analogous structural concept is not an acceptable means for establishing a special definition or disavowal for the term.
Regarding Applicant’s argument 2), as discussed above, Applicant’s filed Declaration has not adequately established a special definition for the term “block” as used in independent claim 1. Accordingly, the term “block” has still been afforded it’s broadest reasonable interpretation to encompass any unit of structure as applied in the prior actions.
Additionally, regarding the presence of gaps among the plurality of cells, as discussed in the prior action, Figure 4A (ii) and (iii) of Vaithilingam show beads which are formed from co-encapsulation of pancreatic islets and MSCs, wherein the small green dots are MSC and dark spaces between the green dots represent gaps between the cells. Further, Supplemental Figure 5A shows images of encapsulated MSCs co-transplanted with separately encapsulated pancreatic islets. In these images, the green signal comes from 6-carboxy fluorescein diacetate (6-CFDA) which accumulates in the cytoplasm of viable cells. Therefore, the dark (green-less) spaces between the green signals represent gaps between cells, which, given that the cells are suspended in an intact alginate hydrogel bead structure, indicates that the alginate polymers are in fact present within the gaps among the cells such that a plurality of polymer units/blocks are arranged within the spaces/gaps between the plurality of the cells.
Therefore, Applicant’s arguments do not overcome a finding of obviousness under 35 U.S.C. 103 over Hasilo, Krishnan, De Vos, Vaithilingam, Gabriel, and Chue, and the rejection is maintained.
The rejection of previously presented claims 21-22 under 35 U.S.C. 103 as being unpatentable over Hasilo et al. [US20150209479A1, published 30 July 2015]; in view of Krishnan et al. [2011, Transplantation Proceedings, Vol. 43, 3256-3261]; De Vos [1999, Diabetes, Vol. 48, 1381-1388]; Vaithilingam [2017, Scientific Reports, Vol. 7, 1-13]; Gabriel [2016, Journal of Visualized Experiments, Vol. 114, e54272, 1-7]; and Chue [2004, Journal of Vascular Surgery, Vol. 39(4), 859-867]; as previously applied to claims 1-11 and 13-19 and now modified to apply to claims 1-10, 14-16, and 18-19 above, and further in view of Hashemi & Kalalinia [2015, Life Sciences, 143, 139-146]; is maintained. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant has not amended either claim 21-22, and as such, Applicant’s amendments do not overcome a finding of obviousness for claims 21-22 under 35 U.S.C. 103.
As discussed above, Applicant argues that:
Applicant’s filed Declaration of Ryo Kogawa under 37 CFR 1.132 provides strong evidence of the patentability of the claimed invention by explaining the art-recognized definition of the term “block” as supported by evidentiary references;
in Vaithilingam, the alginate within the microcapsule does not form a block and there are no gaps between the plurality of cells within a single capsule, such that an ordinarily skilled artisan would not construe “block” as an alginate capsule, and so the alginate is different from “a cell structure in which a plurality of the polymer blocks are arranged in a gap between a plurality of the cells”.
However, this is not agreed.
Regarding Applicant’s argument 1), as discussed in detail above, the Kogawa Declaration does not provide a limiting definition for the term “block”, and so the term has been afforded its broadest reasonable interpretation of “any unit of structure” as applied in the prior actions.
Regarding Applicant’s argument 2), as discussed in detail above, Applicant’s filed Declaration has not adequately established a special definition for the term “block” as used in independent claim 1. Additionally, as discussed in detail above, Figures 4A (ii) and (iii) and 5A of Vaithilingam show alginate beads which are formed from co-encapsulation of pancreatic islets and MSCs (4A), as well as encapsulated MSCs co-transplanted with separately encapsulated pancreatic islets (5A). In these images, the dark (green-less) spaces between the green signals represent gaps between cells, which, given that the cells are suspended in an intact alginate hydrogel bead structure, indicates that the alginate polymers are in fact present within the gaps among the cells such that a plurality of polymer units/blocks are arranged within the spaces/gaps between the plurality of the cells.
Therefore, Applicant’s arguments do not overcome a finding of obviousness under 35 U.S.C. 103 over Hasilo, Krishnan, De Vos, Vaithilingam, Gabriel, Chue, and Hashemi, and the rejection is maintained.
Double Patenting
The rejection of amended, previously presented, original, and cancelled claims 1-11, 13-19, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,439,960, hereafter referred to as the ‘960 patent, in view of Hasilo et al. [US20150209479A1, published 30 July 2015]; Krishnan et al. [2011, Transplantation Proceedings, Vol. 43, 3256-3261]; De Vos [1999, Diabetes, Vol. 48, 1381-1388]; Vaithilingam [2017, Scientific Reports, Vol. 7, 1-13]; Gabriel [2016, Journal of Visualized Experiments, Vol. 114, e54272, 1-7]; Chue [2004, Journal of Vascular Surgery, Vol. 39(4), 859-867]; and Hashemi & Kalalinia [2015, Life Sciences, 143, 139-146], is withdrawn over cancelled claims 11 and 13, withdrawn over newly withdrawn amended claims 16-17, and maintained over previously presented and original claims 1-10, 14-15, 18-19, and 21-22.
Applicant has not amended claims 1-10, 14-15, 18-19, nor 21-22.
Applicant requests reconsideration of the rejections in view of the remarks against the obviousness rejections under 35 U.S.C. 103. As discussed above, Applicant argues that:
Applicant’s filed Declaration of Ryo Kogawa under 37 CFR 1.132 provides strong evidence of the patentability of the claimed invention by explaining the art-recognized definition of the term “block” as supported by evidentiary references;
in Vaithilingam, the alginate within the microcapsule does not form a block and there are no gaps between the plurality of cells within a single capsule, such that an ordinarily skilled artisan would not construe “block” as an alginate capsule, and so the alginate is different from “a cell structure in which a plurality of the polymer blocks are arranged in a gap between a plurality of the cells”.
However, this is not agreed.
Regarding Applicant’s argument 1), as discussed in detail above, the Kogawa Declaration does not provide a limiting definition for the term “block”, and so the term has been afforded its broadest reasonable interpretation of “any unit of structure” as applied in the prior actions.
Regarding Applicant’s argument 2), as discussed in detail above, Applicant’s filed Declaration has not adequately established a special definition for the term “block” as used in independent claim 1. Additionally, as discussed in detail above, Figures 4A (ii) and (iii) and 5A of Vaithilingam show alginate beads which are formed from co-encapsulation of pancreatic islets and MSCs (4A), as well as encapsulated MSCs co-transplanted with separately encapsulated pancreatic islets (5A). In these images, the dark (green-less) spaces between the green signals represent gaps between cells, which, given that the cells are suspended in an intact alginate hydrogel bead structure, indicates that the alginate polymers are in fact present within the gaps among the cells such that a plurality of polymer units/blocks are arranged within the spaces/gaps between the plurality of the cells.
Therefore, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over claims 1-11 of the ‘960 patent, and the rejection is maintained.
The rejection of amended, previously presented, original, and cancelled claims 1-11, 13-19, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,471,564, hereafter referred to as the ‘564 patent, in view of Hasilo et al. [US20150209479A1, published 30 July 2015]; Krishnan et al. [2011, Transplantation Proceedings, Vol. 43, 3256-3261]; De Vos [1999, Diabetes, Vol. 48, 1381-1388]; Vaithilingam [2017, Scientific Reports, Vol. 7, 1-13]; Gabriel [2016, Journal of Visualized Experiments, Vol. 114, e54272, 1-7]; Chue [2004, Journal of Vascular Surgery, Vol. 39(4), 859-867]; and Hashemi & Kalalinia [2015, Life Sciences, 143, 139-146], is withdrawn over cancelled claims 11 and 13, withdrawn over newly withdrawn amended claims 16-17, and maintained over previously presented and original claims 1-10, 14-15, 18-19, and 21-22.
Applicant has not amended claims 1-10, 14-15, 18-19, nor 21-22.
Applicant requests reconsideration of the rejections in view of the remarks against the obviousness rejections under 35 U.S.C. 103. As discussed above, Applicant argues that:
Applicant’s filed Declaration of Ryo Kogawa under 37 CFR 1.132 provides strong evidence of the patentability of the claimed invention by explaining the art-recognized definition of the term “block” as supported by evidentiary references;
in Vaithilingam, the alginate within the microcapsule does not form a block and there are no gaps between the plurality of cells within a single capsule, such that an ordinarily skilled artisan would not construe “block” as an alginate capsule, and so the alginate is different from “a cell structure in which a plurality of the polymer blocks are arranged in a gap between a plurality of the cells”.
However, this is not agreed.
Regarding Applicant’s argument 1), as discussed in detail above, the Kogawa Declaration does not provide a limiting definition for the term “block”, and so the term has been afforded its broadest reasonable interpretation of “any unit of structure” as applied in the prior actions.
Regarding Applicant’s argument 2), as discussed in detail above, Applicant’s filed Declaration has not adequately established a special definition for the term “block” as used in independent claim 1. Additionally, as discussed in detail above, Figures 4A (ii) and (iii) and 5A of Vaithilingam show alginate beads which are formed from co-encapsulation of pancreatic islets and MSCs (4A), as well as encapsulated MSCs co-transplanted with separately encapsulated pancreatic islets (5A). In these images, the dark (green-less) spaces between the green signals represent gaps between cells, which, given that the cells are suspended in an intact alginate hydrogel bead structure, indicates that the alginate polymers are in fact present within the gaps among the cells such that a plurality of polymer units/blocks are arranged within the spaces/gaps between the plurality of the cells.
Therefore, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over claims 1-12 of the ‘564 patent, and the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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