DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 6 April 2026, is acknowledged.
Claim 5 has been amended.
Claims 5-10 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the specific material to be transplanted is rat pancreatic islet cells;
the crosslinked polymer is PVA117; and
the specific immunoisolation membrane is a PVA-based polymer.
Maintained Rejections
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 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hubbell et al. (WIPO International Patent Publication No. WO 93/16687, published on 2 September 1993, provided by Applicant in the IDS filed on 6 May 2024, hereafter referred to as Hubbell) in view of Fujifilm Corp. (WIPO International Patent Publication No. WO 2019/044990 A1, published on 7 March 2019, provided by Applicant in the IDS filed on 26 April 2023, references to English translation, hereafter referred to as Fujifilm), Kurary Co., LTD (WIPO International Patent Publication No. WO 2020/153382 A1, published on 30 July 2020, provided by Applicant in the IDS filed on 26 April 2023, references to English translation, hereafter referred to as Kurary), and Opara (U.S. Patent No. 6,365,385 B1, published on 2 April 2002).
Hubbell teaches polymeric materials forming gels that are used for the encapsulation of biological materials, including the pancreatic cells islets of Langerhans, which are vital to treating diseases such as diabetes (Title, Abstract, and pg. 7, para. 2). The invention of Hubbell is taught to encapsulate living tissue in polymers, initiated using visible light, which are water-soluble and “too large to diffuse into the cells to be coated” (pg. 6, Summary of the Invention). In a preferred embodiment, the polymers create a three-dimensional structure around islets of Langerhans which is semipermeable, creating a barrier that protects the cells “by preventing the passage of immunoglobulins molecules or cells, while allowing free transfer of nutrients, gases and small cell products” (pg. 7, para. 2). In a preferred method of delivering cells, the encapsulated cells are designed for implantation in an animal (pg. 17, para. 2).
In one embodiment, the water-soluble polymer is made from poly(vinyl alcohol) (PVA) (pg. 12, Synthetic Polymeric Macromers) and is polymerized in water (pg. 16-17, Polymerization and claims 1 and 27). The photoinitiated polymerization is taught to preferably be performed using light sources with wavelengths in the range of 320-800 nm, “most preferably about 365 nm or 514 nm” (pg. 15, para. 1). The pancreatic islet cells to be encapsulated are taught to be capable of originating from any species, in particular embodiments from mammals (pg. 16, para. 1 and claims 39 and 47). The permeability of the polymeric gel is taught to be important for selectivity and is taught to be modifiable by varying the size of macromers forming the polymer, polymer chain lengths, and crosslinking (pg. 22-23, Control of Polymer Permeability). The thickness of the encapsulating membrane is taught to affect a variety of parameters, including selectivity, rigidity, and size, and in some embodiments, the thickness is taught to be 50-300 microns (pg. 23-25, Thickness and Conformation of Polymer Layer).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the wavelength of light used to photoinitiate polymerization and the thickness of the hydrogel immunoisolation membrane. In each instance, the values and ranges taught by Hubbell fall within or significantly overlap with the ranges recited in the instant claims, rendering them prima facie obvious.
Hubbell does not teach the arrangement of cells within the transplantation material, the islet cells to originate from rats, nor the degree of polymerization in the PVA polymer. These deficiencies are offset by the teachings of Fujifilm, Kurary, and Opara.
Fujifilm teaches cell transplantation devices that are biocompatible and capable of delivering a plurality of cells which are disposed in a particular arrangement in polymer blocks and encapsulated in an immunoisolation membrane (Abstract). The immunoisolation membrane is described as a porous membrane containing a polymer, which in some embodiments is PVA (pg. 9, Composition of porous membrane, pg. 10, Other layer, and claims 2 and 6). The device is further taught to comprise an implantation chamber, which is considered equivalent to the embedding chamber recited in the instant claims, inside of which are the cells, and the biocompatible polymer may be on the inside, outside, or both (pg. 10-11, Method of Manufacturing Device for Cell Transplantation). To provide space for vascularization and permeation of necessary biomolecules, Fujifilm teaches that a gap should exist between cells, (pg. 2, para. 1-2 and 5 and claims 1 and 13) an arrangement referred to as a “mosaic form” in which biocompatible polymer blocks fill the gaps between cells (pg. 3, Cell structure, para. 1). The preferred gap between the cells is taught to be between 20-200 mm, which falls within the range recited in instant claim 5 (pg. 6, para. 6).
Kurary teaches a composition for forming a sterilized hydrogel from PVA that has high mechanical strength (Abstract). PVA is taught to be capable of forming hydrogels with high flexibility and strength, while maintaining biocompatibility, making it suitable for molding into shapes capable of encapsulating cells (pg. 1, final para.). To achieve a hydrogel with sufficiently high mechanical strength to be used in cell transplantation, Kurary teaches a degree of polymerization in the PVA of 450 or higher (pg. 2, para. 7-8). One particular species of PVA that is taught to be suitable for the above application is PVA117, taught to be a PVA polymer with a degree of polymerization of 1700 and a degree of saponification of 98-99 mol% (pg. 8, Materials used, Synthesis Examples 1-4, Examples 1-8, and Comparative Example 4).
Opara teaches a method of treating isolated, living pancreatic islet cells with a composition, prior to encapsulation, to maintain functionality (column 3, lines 31-57). The method comprises culturing the islet cells with an antibiotic, an antioxidant, an anti-cytokine, and/or an anti-endotoxin (column 3, lines 31-57). The inventors teach that islet cells encapsulated via their method responded to a glucose challenge better than non-cultured islet cells (column 9, para. 36-42). The islet cells used in the invention of Opara were taught to be mammalian in origin, and in the case of Examples 1 and 3-4, were obtained from rats.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Fujifilm, Kurary, and Opara with the invention of Hubbell because combining prior art elements in similar inventions to impart known benefits yields predictable results. The ordinary artisan would be motivated to combine the teachings of Fujifilm and Hubbell because Hubbell does not teach the arrangement of cells within their device. Fujifilm provides missing information that would better enable an artisan to complete the invention of Hubbell and would provide the added benefit, taught by Fujifilm, that the spacing of cells allows for better vascularization and permeation of necessary biomolecules.
One of ordinary skill in the art would further be motivated to modify the invention of Hubbell with the teachings of Kurary because Hubbell does not teach a specific degree of polymerization for PVA polymers used in their invention and Kurary teaches that a degree of polymerization above 450 provides the benefits of high mechanical strength and flexibility to resulting hydrogels made with the PVA polymer. In particular, Kurary teaches that PVA117 is useful for forming hydrogels for cell transplantation applications, which an ordinary artisan would recognize as useful in the invention of Hubbell. Finally, a person of ordinary skill would be motivated to combine the teachings of Opara with those of Hubbell because, while Hubbell teaches that the pancreatic islets in their invention may be mammalian, they do not teach a specific species of origin. The teachings of Opara provide missing information, in particular teaching that pancreatic islet cells derived from rats are suitable for transplantation via encapsulation within a hydrogel.
"[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195 ; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374 , 1381 , 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578 , 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 , 249 , 66 S. Ct. 81 , 90 L. Ed. 43 , 1946 Dec. Comm'r Pat. 611 (1945).
Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195. Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, 26 C.C.P.A. 937, 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531, 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511-96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, 26 C.C.P.A. 937, 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)). See MPEP § 2112.
In Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), Persion contended that the district court erred in applying the inherency doctrine in its obviousness analysis because prior art reference Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581); Reply Br. 19.
To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to the court’s prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607, 610. In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
These guidelines apply to the limitations in claims 8-9, specifically the capability of the PVA-based polymer immunoisolation membrane to remove ≥50% of immunoresponsive cells and immune system humoral factors and its permeability to insulin, glucose, immune system humoral factors, and immunoresponsive cells. Because the invention of rat islet cells encapsulated in a PVA117 hydrogel, in the spacing recited in instant claim 5, and covered with a PVA-based polymer immunoisolation membrane has been rendered obvious (vide supra), it inherently possess the capabilities and permeabilities recited in instant claims 8-9. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 5-10 in view of the teachings of Hubbell, Fujifilm, Kurary, and Opara.
Response to Arguments
The Applicant’s arguments, filed on 6 April 2026, have been fully considered but are not persuasive.
In response to applicant's arguments against the references individually in para. 2 of pg. 6 and the penultimate para. of pg. 7, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In para. 2 of pg. 6, Applicant argues that the previous Office Action, mailed on 12 January 2026, does not identify where the FujiFilm reference teaches embedding cells in a hydrogel within an embedding chamber while maintaining separation between cells. As stated above, the FujiFilm reference was used for its teachings regarding separation of cells to provide space for vascularization and permeation of necessary biomolecules. This teaching was used to render obvious cells embedded in a hydrogel within an embedding chamber with a spacing of 20-200 mm when combined with the teachings of Hubbell, Kurary, and Opara and was not argued to teach the above in one reference. Applicant’s argument is therefore found unpersuasive.
Applicant also argues in para. 2 of pg. 6 that the Hubbell reference does not teach a thickness of an immunoisolation membrane but instead teaches a thickness of “a polymer layer described as forming around the biological material to be transplanted”. This is not found persuasive because Applicant elected polyvinyl alcohol-based polymers as both the specific crosslinked polymer comprising the hydrogel and the immunoisolation membrane in the response to the requirement for restriction/election received on 3 November 2025. Hubbell teaches the above range to apply to the PVA polymer in their invention, which is equivalent to the immunoisolation membrane recited in instant claims 5-10.
In the penultimate para. of pg. 7, Applicant argues that via the method taught by the Fujifilm reference to produce their invention “it is not conceivable to arrange cells or cell clusters in two dimensions, at an interval of 10 mm or more and 500 mm or less without contacting each other”. The claims pending in the instant application, claims 5-10, are drawn to the transplantation material, not the method by which it is produced. As stated in MPEP § 2113, “patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As stated above, the FujiFilm reference was used for its teachings regarding separation of cells by 20-200 mm to provide space for vascularization and permeation of necessary biomolecules.
In addition, Fujifilm teaches the cells and spacing polymer blocks of their invention to be “three-dimensionally arranged”. Applicant is reminded that "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." (bold added for emphasis) Id. at 418, 82 USPQ2d at 1396. The ordinary artisan would be able to make the inferences and/or creative steps necessary to arrange the cells on a plane to achieve arrangement in “two dimensions” as recited in amended claim 5. As a result, the arguments are not found to be persuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-16 of copending Application No. 18/859,610 in view of Hubbell (WIPO International Patent Publication No. WO 93/16687, published on 2 September 1993, provided by Applicant in the IDS filed on 6 May 2024), Fujifilm (WIPO International Patent Publication No. WO 2019/044990 A1, published on 7 March 2019, provided by Applicant in the IDS filed on 26 April 2023, references to English translation), Kurary (WIPO International Patent Publication No. WO 2020/153382 A1, published on 30 July 2020, provided by Applicant in the IDS filed on 26 April 2023, references to English translation), and Opara (U.S. Patent No. 6,365,385 B1, published on 2 April 2002).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/859,610 recites an immunoisolation device comprising a cell-capturing layer (A) and an immunoisolation layer (B) covering layer (A) (claims 1 and 15). The cell-capturing layer (A) further comprises a fiber structure (a1), which has a thickness of 100-2,000 mm and comprises ethylene-vinyl alcohol copolymers and/or cellulose acetate, and a dense fiber structure (a2) surrounding the fiber structure (a1) to prevent the escape of cells, which has a thickness of <1500 mm and also comprises ethylene-vinyl alcohol copolymers and/or cellulose acetate (claims 3-8). The immunoisolation layer (B) is recited as further comprising a porous membrane (b1) or a fiber structure (b2), both comprising ethylene-vinyl alcohol copolymers and/or cellulose acetate, and a hydrogel (b3) (claims 9-10). The hydrogel may be the innermost layer, directly contacting the cell-encapsulating layer (A), or the outermost layer, and the entire immunoisolation layer (B) is recited as being ≤500 mm thick (claims 11-13). The hydrogel is recited as comprising a polyvinyl alcohol polymerized to a degree of polymerization of 300-10,000 (claims 14 and 16).
Copending Application No. 18/859,610 does not recite the PVA-based polymer to be crosslinked via visible light irradiation, the arrangement of cells in the immunoisolation device, the specific PVA-based polymer PVA117, nor the cells to be rat pancreatic islets. These deficiencies are offset by the teachings of Hubbell, Fujifilm, Kurary, and Opara.
Hubbell, Fujifilm, Kurary, and Opara have been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention recited in copending Application No. 18/859,610 with the teachings of Hubbell, Fujifilm, Kurary, and Opara to arrive at the invention of instant claims 5-10 because combining prior art elements from similar inventions according to known methods yields predictable results. The ordinary artisan would be motivated to crosslink the PVA-based polymer with visible light as taught by Hubbell because Application ‘610 does not teach a method of crosslinking and the teachings of Hubbell provide missing information an artisan would need to create the invention. The ordinary artisan would further be motivated to arrange the encapsulated cells with spacings as taught by Fujifilm because Application ‘610 is silent on the arrangement of the encapsulated cells and Fujifilm teaches that a spacing of 20-200 mm allows for proper vascularization and permeation of necessary biomolecules, which the person of ordinary skill would recognize as important in a device intended to transplant functional cells.
One of ordinary skill would be motivated to select PVA117 as the specific PVA-based polymer because ‘610 recites a degree of polymerization for the PVA used in their invention, but does not recite a specific species. The teachings of Kurary would inform the ordinary artisan of a specific species to be used in a similar invention which satisfies the range recited by copending Application No. ‘610. Finally, the invention of ‘610 does not recite specific cells to be encapsulated by their invention. In view of the teachings of Hubbell and Opara, the ordinary artisan would be motivated to encapsulate pancreatic islet cells because Hubbell teaches their importance in treating diseases like diabetes and specifically islet cells derived from rats because Opara teaches this source to be viable in hydrogel transplantation materials. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 5-10 in view of claims 1 and 3-16 of copending Application No. 18/859,610 and in view of the teachings of Hubbell, Fujifilm, Kurary, and Opara.
Claims 5-10 are directed to an invention not patentably distinct from claim 1 and 3-16 of commonly assigned copending Application No. 18/859,610. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 18/859,610, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-9 of copending Application No. 18/860,198 in view of Hubbell (WIPO International Patent Publication No. WO 93/16687, published on 2 September 1993, provided by Applicant in the IDS filed on 6 May 2024), Fujifilm (WIPO International Patent Publication No. WO 2019/044990 A1, published on 7 March 2019, provided by Applicant in the IDS filed on 26 April 2023, references to English translation), Kurary (WIPO International Patent Publication No. WO 2020/153382 A1, published on 30 July 2020, provided by Applicant in the IDS filed on 26 April 2023, references to English translation), and Opara (U.S. Patent No. 6,365,385 B1, published on 2 April 2002).
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/860,198 recites an immunoisolation device comprising a “sheet-like” cell aggregate, which comprises cells and an extracellular matrix, covered by an immunoisolation layer, which comprises a porous membrane or fiber structure comprising ethylene-vinyl alcohol copolymers and/or cellulose acetate (claims 1-2 and 4). The immunoisolation layer is recited as comprising a porous membrane or fiber structure and a hydrogel, which may be the innermost or outermost layer of the immunoisolation layer (claims 5-8). Finally, Application ‘198 recites the hydrogel as comprising PVA and/or polyethylene glycol (claim 9).
Copending Application No. 18/860,198 does not recite the PVA-based polymer to be crosslinked via visible light irradiation, the arrangement of the cells, the specific PVA-based polymer PVA117, using the device to transplant cells, the specific cells in the immunoisolation device, nor the thickness of the immunoisolation layer. These deficiencies are offset by the teachings of Hubbell, Fujifilm, Kurary, and Opara.
Hubbell, Fujifilm, Kurary, and Opara have been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention recited in copending Application No. 18/860,198 with the teachings of Hubbell, Fujifilm, Kurary, and Opara to arrive at the invention of instant claims 5-10 because combining prior art elements from similar inventions according to known methods yields predictable results. The ordinary artisan would be motivated to crosslink the PVA-based polymer with visible light as taught by Hubbell because Application ‘198 does not teach a method of crosslinking and the teachings of Hubbell provide missing information an artisan would need to create the invention. The ordinary artisan would further be motivated to arrange the encapsulated cells with spacings as taught by Fujifilm because Application ‘610 is silent on the arrangement of the encapsulated cells and Fujifilm teaches that a spacing of 20-200 mm allows for proper vascularization and permeation of necessary biomolecules, which the person of ordinary skill would recognize as important in a device intended to transplant functional cells.
One of ordinary skill would be motivated to select PVA117 as the specific PVA-based polymer because ‘198 recites a degree of polymerization for the PVA used in their invention, but does not recite a specific species. The teachings of Kurary would inform the ordinary artisan of a specific species to be used in a similar invention which satisfies the range recited by copending Application No. ‘198. Finally, the invention of ‘198 does not recite specific cells to be encapsulated by their invention, transplanting cells with the invention, nor the thickness of the immunoisolation layer. In view of the teachings of Hubbell and Opara, the ordinary artisan would be motivated to encapsulate pancreatic islet cells because Hubbell teaches their importance in treating diseases like diabetes via transplantation and specifically islet cells derived from rats because Opara teaches this source to be viable in hydrogel transplantation materials, which the ordinary artisan would recognize as a useful application of the invention. In addition, Hubbell teaches an appropriate thickness to be 50-300 microns, which provides missing information the artisan would require to complete the invention. The As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 5-10 in view of claims 1-2 and 4-9 of copending Application No. 18/860,198 and in view of the teachings of Hubbell, Fujifilm, Kurary, and Opara.
Claims 5-10 are directed to an invention not patentably distinct from claims 1-2 and 4-9 of commonly assigned copending Application No. 18/860,198. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned copending Application No. 18/860,198, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Remarks
The Applicant’s response to the provisional double patenting rejections, filed on 6 April 2026, has been fully considered but is not persuasive in overcoming the rejections.
In para. 3 of pg. 5, Applicant states that they “will consider further action upon an indication that the claims are otherwise in condition for allowance”. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by the Applicant showing that the claims subject to the restriction are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
In para. 4 of pg. 5, Applicant notes that the instant application has an earlier priority date than copending Application Nos. 18/859,610 and 18/860,198 and that the NSDP rejections may be ultimately be removed “at such time that the provisional [NSDP] rejection is the only rejection remaining”. This is noted, but as the provisional NSDP rejections are not the only remaining rejections they are maintained.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 was amended to recite “arranged in two dimensions”. The remarks filed on 6 April 2026, state that support can be found “at least in Figure 4 and the description thereof”. Figure 4 depicts a three-dimensional grid of boxes which functions as a mold for producing a hydrogel which are described as having a certain height and width in para. [0099]. However, the mold for producing a hydrogel is three dimensional and has a depth in addition to a height and width. The original disclosure did not contemplate arrangement in only two dimensions and there is therefore no support for the amendment.
In addition, because Figure 4 depicts a three-dimensional object used as a mold for producing the hydrogels, it is insufficient support for the new limitation as the limitations result in a shift in scope from the original disclosure. Claims 6-10 depend from claim 5, incorporate all of its limitations, and are therefore also rejected as introducing new matter and shifting the scope of the originally claimed invention. Applicant may overcome this rejection by removing the limitation “arranged in two dimensions”.
Conclusion
No claims are 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 Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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