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 1-2 are currently pending.
Claim Interpretation
In the instant case, applicant's invention is interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product. It is not clear that applicant’s culture method produces an insulin-producing cell markedly different from other methods (e.g., culturing in a different proliferation media). For examination purposes applicant’s composition is consequently interpreted as a insulin-producing cell, with a spindle-shaped morphology, demonstrating positive expression of IPF-1, ISL-1, CD73, CD90, and negative expression of CD90.
Claim Objections
Claim 2 is objected to because of the following informalities. Appropriate correction is required.
Claim 2 appears to contain a typographical error and should read “wherein an [[the]] expression level”.
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 1-2 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
The term “high” in claim 1 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 recites the limitation "the quantity". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the peripheral wall". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "culture container". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the conditions". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the high-secreting insulin-producing cells". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the genes". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 contains the limitation “the high secretion insulin-producing cell demonstrates positive expression of CD73 and CD90, and negative expression of CD45, which are the same with the stem cell”. It is unclear what is intended by this limitation.
Claim Rejections - 35 USC § 102/103
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.
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. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dave et al., (2014) In-vitro generation of human adipose tissue derived insulin secreting cells: up-regulation of Pax-6, Ipf-1 and Isl-1. Cytotechnology, 66:299-307 (hereinafter Dave)
Regarding claim 1, Dave discloses methods of transdifferentiating adipose derived mesenchymal stem cells (ADMSCs) into insulin secreting cells (Abstract). Dave discloses isolating ADMSCs, culturing in a proliferation media, and culturing in a differentiation media (Isolation of MSC from h-AD, Differentiation of h-AD-MSC into insulin secreting cells). Dave discloses that the resultant cells secrete insulin, demonstrate the MSC expression profile CD45 negative, and CD73, CD90 positive, and demonstrate positive expression of the genes ISL-1 and IPF-1 (PDX1) (Flow-cytometric analysis, Chemiluminescence assay, IF study for Pax-6, Isl-1 and Pdx-1, Discussion, Figs. 2, 4).
Dave is silent as to the morphology of the insulin-secreting cells and expression of INS. Dave is also silent as to upregulated expression of CD47.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the insulin secreting cells of the prior art differ, and if so to what extent, from applicant’s insulin secreting cells. The prior art discloses a population of insulin secreting cells which is similar to applicant’s insulin secreting cells for these reasons: the prior art discloses a population of insulin secreting cells which secretes insulin in response to glucose, demonstrates the expression profile CD45-/CD73+/CD90+, and demonstrates the genes ISL-1 and IPF-1. Additionally, Dave discloses that the insulin secreting cells are transdifferentiated from ADMSCs using a differentiation media comprising the same components as the claimed differentiation media: DMEM/F-12, nicotinamide, activin A, exendin, pentagastrin, HGF, B-27, N-2, and antibiotics.Where an examiner cannot determine whether or not the reference inherently possesses properties which anticipate, or render obvious, the claimed invention a rejection under §§102/103 is appropriate. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the insulin secreting cells of the prior art are either identical or sufficiently similar to the claimed insulin secreting cells that whatever differences exist, they are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. See MPEP § 2112(v). Clear evidence that the insulin secreting cells of the cited prior art does not possess a critical characteristic that is possessed by the claimed insulin secreting cells would advance prosecution and might permit allowance of claims to applicant’s cells. Applicant is requested to specifically point out the support for any amendments made to the disclosure and arguments in response to this Office Action, including the claims. See MPEP §§ 714.02 and 2163.06. Applicant is also requested to refer to pages and line numbers in the as-filed specification. It is noted that other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Conclusion
No claims are allowed.
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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