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 with traverse of Group I, claims 1-4, 6, 8 and 10-12 in the reply filed on 12/22/2025 is acknowledged. The traversal is on the ground(s) that each of the groups is centered on the same integrated technical solution and that the chemically defined culture medium of Group I is not merely a generic background feature but is expressly formulated to enabled to drive the biological effects in Groups II-IV. Applicants argue that Deng is misplaced to break the technical feature since Deng does not teach all of the claimed coordinated inhibitor combinations, concentration ranges and functional relationships between the Groups and claims. This is not found persuasive because the Application of Deng to break unity by addressing the special technical feature is not required to address all the claim limitations, only those shared among the groups and in this regard, Deng teaches the claimed medium supplemented with a HDAC inhibitor and a EZH2 inhibitor, thus the use of Deng is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13, 14, 16, 19-23, 25, 26, 32 and 34-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/22/2024.
Claims 1-4, 6, 8 and 10-12 are examined in the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: the first use of the acronym “PSC” should be preceded by the phrase “pluripotent stem cells”. Appropriate correction is required.
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, 8 and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 10 and 11 of copending Application No. 18/036,588 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant defined culture medium comprises the same factors and concentration of said factors in the defined culture medium of ‘588. Further instant claims 2-4, 6, 8 and 10-12 are either are identical to or are of similar scope to dependent claims 2-4, 6, 8, 10 and 11 of ‘588
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 6, 8, 10 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitations:
"the final concentration of L-ascorbic acid"
“the final concentration of the activator JAK/STAT3”
“the final concentration of the inhibitor MAPK/ERK”
“the final concentration of the tankyrase inhibitor”
“the final concentration of the activator of ACTIVIN/NODAl”
“the final concentration of the ROCK inhibitor”
“the amount of the extracellular matrix” in lines 12, 13, 15, 17, 19, 22 and 25. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 4 should be amended to depend from claim 3.
Claims 4, 6, 8, 10 and 12 contain numerous instances of listing a limitation and subsequently providing multiple subsequent limitations using the phrase “preferably”, for example claim 4, line 4 states “preferably, the final concentration of DZNep in the culture medium is from 5 to 80 nM” which renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 4 contains the trademark/trade name “MatrigelTM”, “GeltrexTM” and “ECMTM”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. ... In the present case, the trademark/trade name is used to identify/describe MatrigelTM, GeltrexTM and ECMTM and, accordingly, the identification/description is indefinite.
Claim 12 contains the trademark/trade names “B27” and “GlutamaxTM”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. ... In the present case, the trademark/trade name is used to identify/describe B27 and GlutamaxTM and, accordingly, the identification/description is indefinite.
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) 1-3 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deng et al. (US 2016/0145581 Al).
Claim Interpretation: the claims recite multiple instances of the limitation “optional”. For the purposes of applying art, all of the limitations following the recitation optional are treated as such and thus are interpreted as not being required by the claim.
Regarding claims 1 and 2, Deng et al. teach a chemically defined culture medium for culturing PSCs comprising a basal medium for culturing stem cells supplemented with VPA (an HDAC inhibitor) and DZNep (an EZH2 and SAH inhibitor) (col. 1 parags. 2-7 and 14).
Regarding claim 3, Deng teaches that the culture medium can further comprise one or more components selected from KO Serum Replacement from Invitrogen (which comprises ascorbic acid/Vitamin C), LIF (a JAK/STAT3 activator) and PD0325901 (a MAPK inhibitor)(col. 1 parag. 73 and col. 11 parag. 121).
Regarding claim 11, Deng teaches supplementing their media with non-essential amino acids (parag. 121).
Thus the teachings of Deng clearly anticipate the invention of claims 1-3 and 11.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 2, 4, 6, 8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (US 2016/0145581 Al) in view of Hanna et al. (US 2017/0275593 A1).
Claim Interpretation: the claims recite multiple instances of the limitation “optional”. For the purposes of applying art, all of the limitations following the recitation optional are treated as such and thus are interpreted as not being required by the claims.
Regarding claims 1 and 2, Deng et al. teach a chemically defined culture medium for culturing PSCs comprising a basal medium (KO DMEM) for culturing stem cells supplemented with VPA (an HDAC inhibitor) and DZNep (an EZH2 and SAH inhibitor) (col. 1 parags. 2-7 and 14).
Regarding claim 11, Deng teaches supplementing their media with non-essential amino acids (parag. 121).
Deng teaches using:
DZNep at a concentration of 20 nM to 0.1 μM (parag. 71),
VPA at a concentration of 500 μM to 0.5 mM (parag. 71),
LIF at a concentration of 1000U/ml, which equals 10 ng/mL (parag. 121),
PD0325901 at a concentration of 1 μM (parag. 121).
Deng does not teach:
Ascorbic acid, XAV939, Activin, Y27632 and an extracellular matrix.
Regarding XAV939, Activin, Y27632, an extracellular matrix and claims 4, 6, 8
and 10, Hanna et a. teach a chemically defined medium for culturing PSCs comprising a basal medium (DMEM/F12 and Neurobasal medium in a ratio of 1:1-parag. 74) comprising:
ascorbic acid at a concentration of 50 μg/ml (Fig. 7),
XAV939 at a concentration of 2 to 8 μM (parag. 318),
Activin A at a concentration of 20 ng/ml (Fig. 7),
Y27632 at a concentration of 2 μM (Fig. 7); and
Matrigel at 0.1% to 0.5% (v/v) (parag. 578).
Regarding claim 12, Hanna teaches using B27, pyruvate, L-glutamine and streptomycin (parasg. 651 and 653, see Example 1).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Deng regarding a chemically defined culture medium for culturing PSCs with the teachings of Hanna regarding a chemically defined media comprising specific species of tankyrase inhibitor, activin activator, ROCK inhibitor and ECM to arrive at the claimed invention.
One or ordinary skill in the art would have been motivated to make such a combination since Hanna is teaching that specific cell culture factors and components are useful for the culturing of PSCs.
There would have been a reasonable expectation of success that the specific factors and concentrations taught by Hanna would work in the chemically define culture medium of Deng since Hanna teaches that their chemically defined media was effective for culturing PSCs.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632