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
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.
Claim Rejections - 35 USC § 112(a)/1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 11 contains the limitation “wherein the cell culture substrate further comprises at least one growth factor”. The specification as originally filed is silent as to the incorporation of a growth factor into the cell culture substrate. The specification is limited to including a growth factor into a cell culture media utilized in conjunction with the cell substrate (See p8 ln 28-38). Therefore, it is not clear that, at the time of invention, applicants had full possession of the invention as presently claimed. Claim 12 is included in this rejection as dependent on claim 11.
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 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).
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.
Conclusion
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.
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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