DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group 1, claims 1-5 in the reply filed on 23 March 2026 is acknowledged. The traversal is on the ground(s) that Rogers et al. teach a pericyte(-like) cell obtained by differentiation induction from pluripotent cells, whereas the claimed invention requires a pericyte modified by external introduction of a bFGF gene.
This is not found persuasive because a pericyte into which a basic fibroblast growth factor (bFGF) gene has been introduced, is a pericyte produced by the claimed process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Here, the pericyte of Rogers et al. is likewise a pericyte as claimed. Functionally, the pericyte is the same as the claimed pericyte. Therefore, the pericyte is the same as, or would have rendered obvious, the pericyte produced by the claimed process.
It is further noted that there is no requirement in the claims that the pericyte be modified by external introduction of a bFGF gene.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1-5 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 Wang et al. (The Effect of Hypoxia on Expression of Basich Fibroblast Growth Factor in Pulmonary Vascular Pericytes, Journal on Tongji Medical University, Vol. 20, No. 4, (2000), pp. 265-267).
With regard to claims 1-5, Wang et al. teach that hypoxia effects bFGF gene expression in pulmonary vascular pericytes, which are primary pericytes (Abs.; p. 267, Table 1). Thus, pulmonary vascular pericytes have a bFGF gene.
Claims 1-5 are directed to a pericyte/pericyte-like cell, which is produced by the claimed process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Here, Wang et al. teach pericytes that contain a bFGF gene. Structurally, the pericytes of Wang et al. are the same as the claimed pericytes (i.e. both contain a bFGF gene). Therefore, the pericytes of Wang et al. are the same as, or would have rendered obvious, the pericytes/pericyte-like cells produced by the claimed process of introducing a bFGF gene, and inducing differentiation of a pluripotent stem cell (PSC), including a human PSC, an embryonic stem cell, or an induced PSC.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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