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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on July 8, 2026. Claim(s) 1-10 are pending. Applicant’s election of species of losartan (angiotensin II receptor antagonist) without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1-10 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 102
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.
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 of this title, 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 1-10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Yoshiji (BMC Research Notes, 2009) of record.
Regarding the intended use limitations of the instant claims (a pharmaceutical composition for inhibiting fibrosis in an organ), such limitations fail to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition, which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Pitney Bowes Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473,378, 42 USPQ2d 1550, 1554 and MPEP 2112.02(II). In the instant composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Yoshiji teaches losartan, an angiotensin-II type antagonist, is employed as a method to attenuate liver fibrosis (title; abstract; page 3, Figure 2). Said teaching meets the limitation of hydrostatic pressure as the biomechanical change, as required by claims 9 and 10. Since the same disease is taught, then the biomechanical change is the same.
Regarding the dosing limitation, fibrosis and hypertension are clinically and pathologically distinct diseases with different etiologies and therapeutic endpoints. Consequently, even if a therapeutically effective dose for treating fibrosis is established, it remains well within the purview of a person skilled in the art to determine an appropriate and effective dosage for treating hypertension using pharmacological assays, preclinical models and clinical evaluation techniques.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-10 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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