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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6 and 10) and species liver in the reply filed on 08/17/2026 is acknowledged.
Claims 1-11 are currently pending.
Claims 7-9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/17/2026.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/17/2026.
Claims 1-4, 6, and 10 have been examined on their merits.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-4, 6, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enomoto et al (ACS Applied Bio Materials, 2021-from IDS filed 07/25/2024).
Regarding claims 1, 3, 4, Enomoto disclose a cell cluster of liver cells (endodermal cells) and an amphiphilic block polymer present with the cell cluster wherein the polymer has a hydrophilic block chain having a sarcosine unit and a hydrophobic block chain having a lactic acid unit (HYDROX) (pages A-B). Aggregates (cell clusters) of human-induced pluripotent stem cell derived hepatocyte-like cells (HLCs) cultured with HYDROX effectively as well as primary human hepatocytes (PHHs) (page B).
Applicant has identified an example of the claimed polymer that has a hydrophilic block chain having a sarcosine unit and a hydrophobic block chain having a lactic acid unit as HYDROX (pages 16-17 para 23). Applicant has also defined an organoid composition as referring to a composition further including a polymer component or the like in a cell cluster for forming an organoid (page 16 para 23) and an organoid as referring to a cell cluster that the cells form a cluster in a culture container (page 8 para 14). Thus, the cell cluster HYDROX cultures of Enomoto meet the claim limitations for an organoid composition.
Regarding claim 2, Enomoto disclose wherein the amphiphilic block polymer has the hydrophilic block chain having the 20 or more sarcosine units (109 sarcosine units) and the hydrophobic block chain as having the 10 or more lactic acid units (33 lactic acid units) (page H, Dried Gel preparations).
Regarding claim 6, Enomoto disclose wherein the HYDROX cell cluster cultures might be more useful for the evaluation of pharmaceutical products (suitable for the intended use of evaluating pharmacokinetics and/or evaluating drug toxicity) than collagen cultures (page G, column 2).
Regarding claim 10, Enomoto disclose the HYDROX cell cluster cultures are formed in a culture plate (device that can be used for evaluating pharmacokinetics or drug toxicity) (page B, Figure 1).
Therefore, the teachings of Enomoto anticipate Applicant’s invention as claimed.
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 1-4, 6, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,905,527 in view of Enomoto et al (ACS Applied Bio Materials, 2021-from IDS filed 07/25/2024).
The claims of the patent ‘527 are drawn to methods of producing a gel composition for cell culture comprising mixing an amphiphilic block polymer having a hydrophilic block chain and a hydrophobic block chain to form a gel, wherein the amphiphilic block polymer has 20 or more sarcosine units in the hydrophilic block and 10 or more lactic acid units in the hydrophobic block chain.
However, the ‘527 patent claims do not include wherein the gel composition is combined with endodermal cells, such as liver cells, to form a cell cluster and organoid composition.
Enomoto disclose a cell cluster of liver cells (endodermal cells) and an amphiphilic block polymer present with the cell cluster wherein the polymer has a hydrophilic block chain having a sarcosine unit and a hydrophobic block chain having a lactic acid unit (HYDROX) (pages A-B). Aggregates (cell clusters) of human-induced pluripotent stem cell derived hepatocyte-like cells (HLCs) cultured with HYDROX effectively as well as primary human hepatocytes (PHHs) (page B).
Applicant has identified an example of the claimed polymer that has a hydrophilic block chain having a sarcosine unit and a hydrophobic block chain having a lactic acid unit as HYDROX (pages 16-17 para 23). Applicant has also defined an organoid composition as referring to a composition further including a polymer component or the like in a cell cluster for forming an organoid (page 16 para 23) and an organoid as referring to a cell cluster that the cells form a cluster in a culture container (page 8 para 14). Thus, the cell cluster HYDROX cultures of Enomoto meet the claim limitations for an organoid composition.
Regarding claim 2, Enomoto disclose wherein the amphiphilic block polymer has the hydrophilic block chain having the 20 or more sarcosine units (109 sarcosine units) and the hydrophobic block chain as having the 10 or more lactic acid units (33 lactic acid units) (page H, Dried Gel preparations).
Regarding claim 6, Enomoto disclose wherein the HYDROX cell cluster cultures might be more useful for the evaluation of pharmaceutical products (suitable for the intended use of evaluating pharmacokinetics and/or evaluating drug toxicity) than collagen cultures (page G, column 2).
Regarding claim 10, Enomoto disclose the HYDROX cell cluster cultures are formed in a culture plate (device that can be used for evaluating pharmacokinetics or drug toxicity) (page B, Figure 1).
One of ordinary skill in the art would have been motivated to include endodermal cells, such as liver cells, as the cells for culturing with the gel composition of the ‘527 patent in order to create an organoid endodermal cell cluster culture because Enomoto teach and suggest that this type of gel composition when used for culturing endodermal cells can be useful for the evaluation of pharmaceutical products. One of ordinary skill in the art would have had a reasonable expectation of success because both patent ‘527 and Enomoto are using a gel composition for cell culture comprising an amphiphilic block polymer having a hydrophilic block chain and a hydrophobic block chain as a gel, wherein the amphiphilic block polymer has 20 or more sarcosine units in the hydrophilic block and 10 or more lactic acid units in the hydrophobic block chain.
Therefore, the combined teachings of the patent ‘527 and Enomoto render obvious Applicant’s claimed invention.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Makino et al., “Preparation of Novel Polymer Assemblies, ‘‘Lactosome’’, Composed of Poly(L-lactic acid) and Poly(sarcosine)”, Chemistry Letters, 2007, Vol.36, No.10, pp. 1220-1221.
Makino disclose amphiphilic block polymers composed of poly(L lactic acid) (PLLA) and poly(sarcosine) (PS) were synthesized by successive polymerizations of lactide and sarcosine N-car boxy anhydride (NCA) suitable for drug delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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