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
This action is in response to the papers filed August 3, 2026.
Claim Amendments
Applicant’s amendment to the claims filed 08/03/2026 is acknowledged.
Claims 1-14, 16-17, 23, 28, 30-31 have been cancelled.
Claims 15, 18, 20, 22 and 29 are amended.
Claims 15, 18-22, 24-27 and 29 are pending.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 15, 18-22, 24-26 and 29 are under examination.
Election/Restrictions
The following is a summary of the restriction/election requirements in the application. See, the Requirement for Restriction/Election mailed 04/08/2026.
In the reply filed 05/14/2026, Applicant elected without traverse of the invention of Group 1, drawn to a method of making inner ear stria vascularis marginal cells, and an agent assessment method requiring said method of making.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/14/2026.
Priority
The instant application 18/686,638 was filed on 02/26/2024. This application is a national stage of international application PCT/JP2022/033140 filed 09/02/2022, claiming priority based on Japanese patent application JP2021-144125 filed 09/03/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. While a certified copy of the foreign patent application is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Withdrawn Rejections
The previous rejections under 35 U.S.C. 112(b) and 35 U.S.C. 112(a) are withdrawn in light of applicant’s amendments to the claims.
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 15, 18-22, 24-26 and 29 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.
In claim 15, the limitations “the cell population obtained in the (1)” recited in step (b), “the cell population obtained in the (2)” recited in step (c), and “the cell population obtained in the (3)” recited in step (d), each lack antecedent basis.
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
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.
Claims 15, 18-21, 24-26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over JP6218152B2, of record in IDS filed 02/26/2024.
JP6218152B2 was published in a non-English language. This rejection relies on the machine translation provided with the IDS filed 02/26/2024.
JP6218152B2 discloses a process of inducing stria vascular marginal cells from pluripotent stem cells, the process comprising:
(1) inducing inner ear stem cells from pluripotent stem cells, comprising the steps of:
(a) culturing the pluripotent stem cells in the presence of a ROCK inhibitor;
(b) culturing in the absence of growth factors, in the absence of a ROCK inhibitor, and in a serum-free medium;
(c) culturing in a serum-free medium containing bFGF, FGF3, FGF10, FGF19, and BMP4; and
(d) culturing in a serum-free medium containing bFGF, FGF3, FGF10 and FGF19; and
(2) inducing stria vascular marginal cells from inner ear stem cells, comprising:
(a) culturing the inner ear stem cells in the presence of bFGF, EGF, IGF1, FGF3, FGF10 and heparin.
See, claims 1 and 5. The stria vascular marginal cells are reported to express Na+/K+-ATPase and NKCC1. See, paragraphs 16, 63-67.
The claims further recite that the culture medium is insulin-free. Claims 1 and 5 of JP6218152B2 do not recite that the culture medium contains insulin. Accordingly, the scope of the invention claimed in JP6218152B2 broadly includes (1) a culture medium containing insulin and (2) an insulin-free culture medium. Furthermore, the specification of JP6218152B2 does not expressly teach that the culture medium comprises insulin, nor is there a suggestion that insulin is critical for inner ear cell differentiation.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning).
"[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
In this case, one of ordinary skill in the art, when reading the claims and specification of JP6218152B2, would not have been led to find that insulin was required or critical to the generation of stria vascular marginal cells. Rather, one of ordinary skill in the art would have reasonably inferred that the culture medium may not contain insulin because (1) claims 1 and 5 do not recite that the process of making stria vascular marginal cells includes insulin, and (2) the specification does not expressly teach that the culture medium contains insulin. For these reasons, absent a secondary consideration, the limitation where the culture medium is “insulin-free” would have been prima facie obvious over the prior art.
Accordingly, claim 15 would have been prima facie obvious over the prior art.
Regarding dependent claims 18, Claim 5 of JP6218152B2 recites the medium contains bFGF, EGF, IGF1, FGF3, FGF10 and heparin. The specification discloses that the medium compositions may further contain BMP4. See, paragraphs 25, 40.
Regarding dependent claims 19-20, JP6218152B2 discloses a step of dissociating into single cells and culturing in suspension containing extracellular matrix, such as fibronectin. See, Claims 1, 3 and 5; and paragraphs 29, 43, 47-48, 63-64.
Dependent claim 21 further recites a step of culturing the cell population in the presence of feeder cells. Feeder cells, such as fibroblasts, were known in the art to support the growth of cells in culture by contributing an extracellular matrix components and growth factors (Official Notice taken, if necessary). Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of JP6218152B2 by further culturing the cell population in the presence of feeder cells, such as fibroblasts, as previously known in the art, with a reasonable expectation of success because feeder cells support the growth of cells in culture by contributing an extracellular matrix components and growth factors.
Regarding dependent claim 24, JP6218152B2 discloses serum-free conditions. See, claims 1 and 5; see also, paragraphs 9, 29-33.
Regarding dependent claim 25, JP6218152B2 reports the stria vascular marginal cells express Na+/K+-ATPase and NKCC1. See, paragraphs 16, 63-67. Although JP6218152B2 does not expressly disclose that the stria vascular marginal cells express tight junction proteins, claim scope is not limited by claim language that does not limit a claim to a particular structure. See, MPEP 2111.04. In this case, expression of tight junction proteins indicate an intended result that naturally flows from performing the process of claim 15, which would have been prima facie obvious of the prior art. The limitation is not found to necessarily limit the claims to a particular structure which patentably distinguishes the claimed invention over the prior art.
Regarding dependent claims 26 and 29, JP6218152B2 suggests the invention is useful for research and drug discovery (paragraphs 2-6), and the obtained inner ear cells can be used as a research tool, such as a model for evaluating drug-induced inner ear sensory epithelial damage (paragraph 68). Example 4 (paragraphs 59-61) further describes a process of administering a drug to the inner ear cells and assessing the state of the cell thereafter.
In the reply filed 08/03/2026, Applicant argues that the specification of JP6218152B2 used a media composition comprising B27 and N2 supplements, which are known to contain an amount of insulin. Accordingly, since JP6218152B2 does not recognize the importance of the insulin content in the medium, it cannot be assumed that JP6218152B2 discloses an insulin-free culture medium.
The argument is not persuasive. As an initial matter, the Examiner respectfully notes that paragraphs 63-64 of JP6218152B2 describe a medium composition containing N2 and B27 supplements for inducing differentiation of stria vascularis marginal cells, at least according to the machine translation provided with the IDS filed 02/26/2024. The Examiner also agrees that, although JP6218152B2 does not expressly identify the presence of insulin in the media composition, N2 and B27 supplements would be expected to contain insulin. However, as explained in the rejection, JP6218152B2 neither claims or expressly describes the presence of insulin in the differentiation medium. Provided a lack of clear guidance to add insulin alone, and given the claims evidencing that insulin is nonessential, one of ordinary skill in the art would not have been necessarily led to add insulin to the differentiation medium when considering JP6218152B2. Therefore, absent a showing of criticality or unexpected results or other secondary consideration for using an insulin-free media composition in the claimed invention, the limitation of an insulin-free medium is not found to patentably distinguish the claimed invention over JP6218152B2.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over JP6218152B2, as applied above; in view of WO 2004/038012 A1 to Xie et al.
WO 2004/038012 A1 was published in a non-English language. This rejection relies on the machine translation provided with this Office action.
Dependent claim 22 recites the feeder cells are melanocytes.
Xie is relevant prior art for disclosing feeder cell layers, such as fibroblasts, for in vitro culturing embryonic stem cells. See, e.g., Abstract. Xie further discloses that melanocytes can be used as feeder cells to increase the viability of desired cells in vitro. See, page 2 of the machine translation.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to further modify the invention of JP6218152B2 by selecting melanocytes as the feeder cells, in view of Xie, with a reasonable expectation of success because feeder cells support the growth of cells in culture by contributing an extracellular matrix components and growth factors, and melanocytes, in particular, were known to increase the viability of desired cells in vitro.
Duplicate Claims
Applicant is advised that should claim 26 be found allowable, claim 29 will be objected to under 37 CFR 1.75 as being a duplicate thereof. When two claims in an application are duplicates, it is proper after allowing one claim to object to the other as being a duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached at (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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