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 .
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.
Claim Status
Applicant’s arguments and amendments dated 6/26/26 have been received and entered in the application.
Claims 1-4, 11-12 are currently pending and examined on the merits.
Claim Interpretation
With respect to claims 1-4, 11-12, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of an apparatus is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. For example, “[a]n otic neural progenitor” does not clearly define a structural limitation of the apparatus or composition. Consequently, this limitation is not considered in analyzing the patentability of the apparatus or composition.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections and rejections not specifically reiterated are hereby withdrawn.
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.
Claim(s) 1-2, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa, F. US Patent No. 10,870,824 (hereinafter Kitagawa).
Regarding claim 1-2, Kitagawa discloses cell substrates comprising at least one laminin molecule (Abstract). The laminin may be one or more of laminin-111, laminin-211, laminin-521 (col 4 ln 51-54, col 5 ln 23-27, col 7 ln 22-28). The laminin-111 may be present at a concentration of greater than 30 µg/ml (col 7 ln 45-60). The laminin-211 may be present at a concentration of greater than 8.0 µg/ml (col 7 ln 61-col 8 ln 9). The laminin-521 may be present at a concentration of greater than 4.5 µg/ml ( (col 9 ln 25-40). In some embodiments, Kitagawa discloses utilizing a recombinant laminin-521 (col 4 ln 58-col 5 ln 7).
Kitagawa does not explicitly disclose that the laminins are present at a certain ratio. However, Kitagawa discloses concentration ranges which fall within the claimed parameters. For example, the ratio of 30 µg/ml laminin-211:15 µg/ml laminin-521: 15 µg/ml laminin-111 falls within the ranges disclosed by Kitagawa for each of the laminin isoforms.
Claim(s) 3-4, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa as applied to claims 1-2 above, and further in view of Miyazaki et al., (2008) Recombinant human laminin isoforms can support the undifferentiated growth of human embryonic stem cells. Biochemical and Biophysical Research Communications, 375(1):27-32 (hereinafter Miyazaki).
Regarding claim 3, Kitagawa does not disclose that the laminins are human laminins. Regarding claim 4, Kitagawa does not disclose that each of the laminins are recombinant.
Miyazaki examines the use of recombinant human laminin isoforms on the growth of human embryonic stem cells (hESCs) (Abstract). Miyazkai explains that laminins derived from mouse EHS tumor may not be suitable for the culture of human cells due to animal derivation (Introduction). Laminins derived from human placenta are limited in availability (Introduction). Miyazaki explains that recombinant human laminins are abundantly available, are well characterized, and are of human origin (Introduction). Miyazaki discloses culturing hESCs on each of recombinant laminin-111 and laminin-211 (Preparation of culture vessels coated with recombinant laminins).
Regarding claims 11-12, Miyazaki discloses that the hESCs are cultured in a culture media comprising FGF-2 (Cell culture).
As both Kitagawa and Miyazaki are directed to culture substrates comprising laminins, it would be obvious to one of ordinary skill in the art. A skilled artisan would be motivated to utilize the recombinant human laminins in Miyazaki in the methods of Kitagawa, as Kitagawa explicitly teaches that human recombinant laminins are advantageous.
Response to Arguments
Applicant's arguments dated 6/26/26 have been fully considered but are not persuasive as explained in detail below.
Claim(s) 1-2, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa.
Applicant argues the prior art provides the specific ratios as claimed (Response p5). Applicant argues that Kitagawa is silent as to selecting a combination of LN211, LN521, and LN111, let alone in any specific combinations; the ranges are open ended (Response p5-6).
In response, patents are relevant as prior art for all they contain; a reference may be relied upon “for all that it would have reasonably suggested”. See MPEP § 2123. Kitagawa explicitly discloses that the laminin may be “one or more of Laminin-111, Laminin-211, Laminin-311, Laminin-332, Laminin-421, Laminin-511, Laminin-521” (emphasis added; col 4 ln 51-54, col 5 ln 23-27, col 7 ln 22-28). Kitagawa also discloses each of the claimed laminins in concentrations that fall within the claimed ratios. Therefore, Kitagawa reasonably suggests that the laminins could be present in the recited ratios.
Applicant argues that even if the combination of laminins is considered obvious, the particular ratios demonstrate unexpected results; that the claimed ranges successfully maintain ONP morphology and promotes cellular expansion (Response p6).
As noted in the section on claim interpretation, the present claims are directed to an apparatus, not a method of using the apparatus. Applicants asserted unexpected results arise in an intended use of the claimed apparatus. See MPEP §§ 2111.02 and 2111.04. The behavior of ONP cells in a method of using the apparatus has no bearing on the patentability of the cell culture substrate itself.
Claim(s) 3-4, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa in view of Miyazaki.
Applicant argues that Miyazaki fails to correct the deficiencies noted in Kitagawa (Response p7).
For the reasons set forth above, the examiner disagrees that the prior art fails to obviate the claims as amended.
Conclusion
THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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