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 .
Response to Amendment
Applicants’ response filed on 09/19/2025 has been received and entered in the application file.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-15 and 19-21 under 35 U.S.C. 112(b):
The cancelation of claims 2-3, 6, 9, and 12-13 renders the rejections thereof moot.
Applicants assert the recitation of the trademark/trade name StemPro-34 is a widely used and understood term and is sufficiently definite. This argument has been considered and is found unpersuasive. Despite it being widely used, trademarks are not permissible in claims to describe a particular product. See MPEP 2173.05(u).
Applicants assert the amendment to claim 1 reciting components listed in parentheses after the terms HSC cocktail and EHT cocktail is sufficient to overcome the indefiniteness rejection over lack of definition. However, the use of parentheses has introduced new grounds of indefiniteness, set forth below, without overcoming the previous rejection. See MPEP 2173.05(u).
Therefore, the remaining rejections of record are maintained.
RE: Rejection of claims 1-3, 6, 9, 14-15, and 19-21 under 35 U.S.C. 102(a)(1) and (a)(2) over Valamehr, et al.:
The cancelation of claims 2-3, 6, and 9 renders the rejections thereof moot.
The amendment to independent claim 1 requiring a step of culturing the pluripotent stem cells in medium supplemented with BMP4, bFGF, and Y-27632 in step b); culturing the stem cells in medium supplemented with bFGF, VEGF, and SB 431542 in step c); culturing the stem cells in medium supplemented with VEGF in step d); and culturing the stem cells in medium supplemented with SCF, IL-6, IL-3, FLT3L, IGF-1, IL-11, and EPO in step e) is sufficient to obviate the remaining rejections of record.
The rejections are withdrawn.
RE: Rejection of claims 4-5, 7-8, 10-11, and 12-13 under 35 U.S.C. 103 over Valamehr, et al.:
The cancelation of claims 12-13 renders the rejections thereof moot.
The amendment to independent claim 1 requiring a step of culturing the pluripotent stem cells in medium supplemented with BMP4, bFGF, and Y-27632 in step b); culturing the stem cells in medium supplemented with bFGF, VEGF, and SB 431542 in step c); culturing the stem cells in medium supplemented with VEGF in step d); and culturing the stem cells in medium supplemented with SCF, IL-6, IL-3, FLT3L, IGF-1, IL-11, and EPO in step e) is sufficient to obviate the remaining rejections of record.
The rejections are withdrawn.
RE: Rejection of claims 1-15 under 35 U.S.C. 103 over Daigh, et al. in view of Valamehr, et al.:
The cancelation of claims 2-3, 6, 9, and 12-13 renders the rejections thereof moot.
The amendment to independent claim 1 requiring a step of culturing the pluripotent stem cells in medium supplemented with BMP4, bFGF, and Y-27632 in step b); culturing the stem cells in medium supplemented with bFGF, VEGF, and SB 431542 in step c); culturing the stem cells in medium supplemented with VEGF in step d); and culturing the stem cells in medium supplemented with SCF, IL-6, IL-3, FLT3L, IGF-1, IL-11, and EPO in step e) is sufficient to obviate the remaining rejections of record.
The rejections are withdrawn.
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 1, 4-5, 7-8, 10-11, 14-15, and 19-21 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 1 contains the trademarks/trade names B27, GlutaMax, and StemPro-34. 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. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, B27 is used to identify/describe a specific growth supplement for the serum-free culture of neurons, GlutaMax is used to identify/describe an L-alanyl-L-glutamine dipeptide alternative to L-glutamine, and StemPro-34 is used to identify/describe a cell culture medium; accordingly, the identifications/descriptions are indefinite.
Claim 1 recites the limitations HSC cocktail and EHT cocktail without a further clear or precise description or definition; thus, there is insufficient antecedent basis for the limitations in this claim, rendering the claim indefinite.
Claim 1 recites elements within parentheses in steps b) and d). The use of parentheses renders the claim indefinite because it is unclear whether the limitations recited therein are required as part of the claimed invention or merely examples of said limitation. See 2173.05(d).
Claims 4-5, 7-8, 10-11, 14-15, and 19-21 depend from the rejected claim, inherit its deficiencies, and thus are likewise rejected under 35 U.S.C. 112(b).
Conclusion
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.
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/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633