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 .
DETAILED ACTION
Election/Restriction
Applicant’s election of Group I, claims 1-16 and 26, drawn to a cell support and cells held by the cell support, in the reply filed on 11/07/2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 17-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
In the reply filed on 11/07/2025, Applicant further elects the species of the base material being a molded body of a biocompatible substance in claim 2, and the species of a two-dimensional shape of claim 13.
Claims 3 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Status
Claims 1-26 are pending.
Claims 3, 14 and 17-25 are withdrawn.
Claims 1-2, 4-13, 15-16 and 26 are considered on the merits.
Priority
This application is a 371 of PCT/JP2021/011903 (filed on 03/23/2021), which claims benefit from foreign application PCTJP2020035197 (filed on 09/17/2020). The priority claim of the instant application has been granted and the earliest benefit date is 09/17/2020 from the application PCTJP2020035197.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/28/2023, 06/18/2024 and 02/05/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. The corresponding signed and initialed PTO forms 1449 have been mailed with this action.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites the phrase “a biocompatible substance” in line 2. Since base claim 1 recites a biocompatible substance, it is recommended to change the phrase in claim 2 to “the biocompatible substance”, if they refer to the same substance.
Appropriate correction is required.
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 1-2, 4-13, 15 and 26 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nair et al., (Sci Rep. 2019 January;9(1):1072, p. 1-20).
With respect to claim 1, Nair teaches gelatin based colloidal gels for supporting endothelial cell networks (e.g., abstract), thus teaches a cell support.
In regard to a base material containing a biocompatible substance, Nair teaches a base material of polyacrylic acid (see e.g., Fig 1 middle row) and a base material of negatively charged gelatin particles from gelatin B (see e.g., Fig 1 bottom row). It is noted that both polyacrylic acid and gelatin particles from gelatin B are biocompatible substances. Thus, Nair teaches a base material containing a biocompatible substance.
In regard to gelatin particles, Nair teaches cationic colloidal gelatin particles (see e.g., Fig 1, left panel) that are incorporated into the colloidal gel (see e.g., Fig 1 the columns of “aggregation of positive gelatin colloid by different mode” and “colloid gel with variable mechanomorphology”), thus teaches gelatin particles held by the biocompatible substance of the base material.
With respect to claim 2, Nair teaches the colloid gel is formed by aggregation of gelatin colloidal particles mediated by different mechanisms of electrostatic interaction with biocompatible substances including polyacrylic acid and negatively charged gelatin particles from gelatin B (see e.g., Fig 1 middle row and bottom row). It is noted that the biocompatible substances are used to prepare the colloidal gel. Thus, Nair teaches the base material in the colloidal gel is a molded body of the biocompatible substance.
With respect to claim 4 and claim 5, as stated supra, Nair teaches a biocompatible substance of polyacrylic acid (see e.g., Fig 1 middle row) and a biocompatible substance of negatively charged gelatin particles from gelatin B (see e.g., Fig 1 bottom row). It is noted that gelatin particles from gelatin B is a polymer derived from a living body (i.e., from bovine skin, see p. 12, para. “Materials”) in claim 4 and is gelatin in claim 5, and polyacrylic acid is a biodegradable synthetic polymer in claim 4.
With respect to claim 6, Nair teaches “we have developed gelatin-based colloidal gels from electrostatic interaction-mediated assembly of positively charged gelatin colloidal particles (from cationic gelatin A from porcine skin with isoelectric point ≈ 9) either through addition of electrolytes or negatively charged gelatin colloidal particles (from anionic gelatin B from bovine skin with isoelectric point ≈ 5), as described in Fig. 1.” (e.g., p. 2, last para.), thus teaches a Coulomb interaction occurs between the biocompatible substance and the gelatin particles (i.e., the electrostatic interaction-mediated assembly) in a culture environment (i.e., see Fig 1 for endothelial networks).
With respect to claim 7, Nair teaches the colloidal gel formed by gelatin A and gelatin B (“AB”) has a potential of about 2 mV (see p. 20, Fig S2 (b) “AB” at 4:1 with a potential of about 2 mV). Thus, Nair teaches a sum of charges on a surface to which cells are attached is positive.
With respect to claim 8 and claim 9, Nair teaches the zeta potential of the positive gelatin (A) colloidal particles is about 10 mV in HEPES buffer at pH 7 (see e.g., Fig 2 (b) rightmost panel), thus teaches a zeta potential of a surface to which cells are attached (i.e., gelatin (A) colloidal particles, see e.g., Fig 1 right column) in a solution having a pH of 7.4 is more than 0 mV and 30 mV or less in claim 8, and is 4 mV or more and 15 mV or less in claim 9.
With respect to claim 10, Nair teaches the biocompatible substance of negatively charged gelatin particles from gelatin B (see e.g., Fig 1 bottom row) interacts with positively charged gelatin (A) colloidal particles, and the colloidal gel formed by gelatin A and gelatin B (“AB”) has a potential of about 2 mV (see p. 20, Fig S2 (b) “AB” at 4:1 with a potential of about 2 mV). Thus, Nair teaches the biocompatible substance of negatively charged gelatin particles from gelatin B is cationized.
With respect to claim 11, as stated supra, Nair teaches the zeta potential of the positive gelatin (A) colloidal particles is about 10 mV in HEPES buffer at pH 7 (see e.g., Fig 2 (b) rightmost panel), thus teaches the gelatin particles are cationized.
With respect to claim 12, directed to “wherein the biocompatible substance is a material selected according to an introduction ratio of the gelatin particles to be achieved for cells supported by the cell support”, this limitation is being examined under the broadest reasonable interpretation as “wherein the biocompatible substance is a material selected according to the cell support capability achieved by the gelatin particles”. Nair teaches different biocompatible substances are used in forming colloidal gels (see e.g. Fig 1) and tests the endothelial cell support capability achieved by the gelatin particles in the colloidal gels (e.g., p. 9, last section “Endothelial morphogenesis in colloidal gel” and Fig 7). Thus, Nair teaches the biocompatible substance is selected according to the cell support capability achieved by the gelatin particles.
With respect to claim 13, Nair teaches the colloidal gel is settled in a 96 well plate, and endothelial cells are seeded onto the colloidal gels (p. 14, para 1), thus teaches the base material has a two-dimensional shape.
With respect to claim 15, Nair teaches the gelatin based material ensured that these gel are cell-compatible and degradable, as it is derived from collagen and contains cell-recognizable functionalities e.g. RGD for cell adhesion (p. 2, last sentence – p. 3, para 1), thus teaches the gelatin particles carry a reagent.
With respect to claim 26, directed to a cell structure comprising the cell support and cells held by the cell support, as stated supra, Nair tests the endothelial cell support capability of the colloidal gels (e.g., p. 9, last section “Endothelial morphogenesis in colloidal gel” and Fig 7) and teaches endothelial cells are seeded onto the colloidal gels (p. 14, para 1). Thus, Nair teaches a cell structure comprising the cell support and cells held by the cell support.
Accordingly, Nair anticipates instant claims.
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 1-2, 4-13, 15-16 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Nair et al., (Sci Rep. 2019 January;9(1):1072, p. 1-20) in view of Murata et al., (Sci Rep. 2018 Oct 4;8(1):14839, p. 1-11).
Claims 1-2, 4-13, 15 and 26 are anticipated by Nair, thus Nair makes obvious instant claims.
Claim 16 is directed to the reagent being a molecular beacon.
However, although Nair teaches hydrogels have been designed to investigate the endothelial morphogenesis where the gels are designed with bioadhesive ligands (e.g. RGD), degradable linkages (e.g. MMP sensitive), and growth factors (p. 1, last para.), Nair is silent on the gelatin particles carrying a reagent that is a molecular beacon.
Murata teaches preparation of gelatin nanospheres (i.e., gelatin particles) incorporating molecular beacon to visualize cell apoptosis (e.g., title and abstract). Murata teaches besides proteins and low-molecular weight drugs, gelatin nanospheres are also applicable to the carrier of an imaging probe (p. 1, last para – p. 2, para 1), and teaches molecular beacon (MB), being a mRNA detectable activatable probe of a stem-loop structured nucleic acid derivative (p. 1, para. 2 of main text) can be incorporated into gelatin particles to visualize the cell biological functions such as apoptosis, and this may be a powerful tool to realize a prolonged visualization of apoptosis and other biological functions (p. 7, last para. of main text).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gelatin particle-based cell support disclosed by Nair, by combining incorporating a molecular beacon to the gelatin particles as suggested by Murata with a reasonable expectation of success. Since Nair teaches the gelatin nanoparticles (p. 12, last para. “Preparation of colloidal gelatin particles”) are designed with functionalities e.g. RGD and growth factors to support endothelial morphogenesis (p. 1, last para.), and since Murata teaches molecular beacon can be incorporated into gelatin nanospheres to visualize the cell biological functions such as apoptosis, and this may be a powerful tool to realize a prolonged visualization of apoptosis and other biological functions (p. 7, last para. of main text), one of ordinary skill in the art would have had a reason to combine a molecular beacon to the gelatin nanoparticles of Nair in order to visualize the cell biological functions as suggested by Murata.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Provisional Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4-13, 15-16 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-9, 11-12, 16-17, 19-23 and 25 of copending Application No. 18/026,482 (‘482) in view of Nair et al., (Sci Rep. 2019 January;9(1):1072, p. 1-20). Although the claims at issue are not identical, they are not patentably distinct from each other.
Copending claims of ‘482 recite a cell-supporting body comprising a base material including a biocompatible substance and a gelatin particle retained on the base material, wherein the biocompatible substance is selected from the group consisting of collagen, gelatin and others (reference claim 1, related to instant claims 1 and 4-5), the base material is a formed body of the biocompatible substance (reference claim 2, related to instant claim 2), the biocompatible substance is a material selected according to an introduction rate of the gelatin particle into a cell to be supported by the cell-supporting body, or is a material selected according to an introduction rate of the gelatin particle to be achieved for a cell supported by the cell-supporting body (reference claim 8 and 19, related to instant claim 12), the base material has a two-dimensional shape (reference claim 9, related to instant claim 13), the gelatin particle carries a reagent or an agent and wherein the reagent of the agent is a molecular beacon (reference claims 11-12, related to instant claims 15-16), a cell structure comprising the cell-supporting body according to claim 1 and a cell retained on the cell-supporting body (reference claim 16, related to instant claim 26).
However, copending claims are silent on a Coulomb interaction between the biocompatible substance and the gelatin particles in instant claim 6, nor recite the charges in instant claims 7-11.
Nair teaches gelatin based colloidal gels for supporting endothelial cell networks (e.g., abstract), thus teaches a cell-supporting body. Nair teaches “we have developed gelatin-based colloidal gels from electrostatic interaction-mediated assembly of positively charged gelatin colloidal particles (from cationic gelatin A from porcine skin with isoelectric point ≈ 9) either through addition of electrolytes or negatively charged gelatin colloidal particles (from anionic gelatin B from bovine skin with isoelectric point ≈ 5), as described in Fig. 1.” (e.g., p. 2, last para.), thus teaches a Coulomb interaction occurs between the biocompatible substance of gelatin B and the gelatin particles (i.e., the electrostatic interaction-mediated assembly) in a culture environment (i.e., see Fig 1 for endothelial networks), related to instant claim 6. Nair teaches the colloidal gel formed by gelatin A and gelatin B (“AB”) has a potential of about 2 mV (see p. 20, Fig S2 (b) “AB” at 4:1 with a potential of about 2 mV), thus teaches a sum of charges on a surface to which cells are attached is positive, related to instant claim 7. Nair teaches the zeta potential of the positive gelatin (A) colloidal particles is about 10 mV in HEPES buffer at pH 7 (see e.g., Fig 2 (b) rightmost panel), thus teaches a zeta potential of a surface to which cells are attached (i.e., gelatin (A) colloidal particles, see e.g., Fig 1 right column) in a solution having a pH of 7.4 is more than 0 mV and 30 mV or less in instant claim 8, and is 4 mV or more and 15 mV or less in instant claim 9. Nair teaches the biocompatible substance of negatively charged gelatin particles from gelatin B (see e.g., Fig 1 bottom row) interacts with positively charged gelatin (A) colloidal particles, and the colloidal gel formed by gelatin A and gelatin B (“AB”) has a potential of about 2 mV (see p. 20, Fig S2 (b) “AB” at 4:1 with a potential of about 2 mV). Thus, Nair teaches the biocompatible substance of negatively charged gelatin particles from gelatin B is cationized in instant claim 10. Nair teaches the zeta potential of the positive gelatin (A) colloidal particles is about 10 mV in HEPES buffer at pH 7 (see e.g., Fig 2 (b) rightmost panel), thus teaches the gelatin particles are cationized in instant claim 11.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell-supporting body comprising a base material including a biocompatible substance gelatin and a gelatin particle recited in copending application, by choosing anionic gelatin B as the biocompatible substance gelatin and choosing cationic gelatin A as the gelatin particle as suggested by Nair with a reasonable expectation of success. Since the copending application recites a cell-supporting body that comprises the same material as suggested by Nair, and since Nair reduces to practice the gelatin based colloidal gels formed with biocompatible substance gelatin and the gelatin particle and teaches the gelatin-based gels are capable for supporting endothelial cell networks (e.g., abstract), one of ordinary skill in the art would have had a reason to choose the biocompatible substance gelatin and the cationic gelatin A particles as suggested by Nair in order to obtain gelatin-based gels for supporting endothelial cell networks.
Since the instant application claims are obvious over cited application claims, in view of Nair, said claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims in the copending application have not in fact been patented.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631