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 1, 2026. Claim(s) 1-20 are pending. Claim(s) 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a method for preparation of a drug for treating pulmonary fibrosis using a Galectin-1 inhibitor without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1-8 and 11-20 are examined herein insofar as they read on the elected invention.
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.
Claims 1-3, 6-8 and 11-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Xue (Cellular and Molecular Biology, 2023).
Examiner notes that the limitation regarding " modulator capable of reducing a Galectin-1 expression level and a modulator capable of reducing a Galectin-1 product” (claims 2 and 3) and “a protease and a nuclease that degrade the Galectin-1 product” (claim 6) are considered properties inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Xue teaches, “Gal-1, as a positive pro-fibrotic marker, could promote lung fibroblast activation and proliferation. Inhibition of Gal-1 reduced fibroblast activation and proliferation through negative regulation of TGF-β/ Erk1/2 and AKT pathway. In vivo, Gal-1 inhibition ameliorates lung fibroblast accumulation and protects lung histology and function. Gal-1 is verified to be a pro-fibrotic gene in IPF pathogenesis, which promotes fibroblast activation and proliferation via TGF-β/Erk1/2 and AKT pathway. Moreover, inhibition of Gal-1 in lung fibrosis model attenuates lung fibroblast bioactivity and reduces ECM, leading to improved pulmonary histology and function” (Abstract; page 213, column 2; page 216, Discussion).
Xue teaches the Gal-1 inhibitor as OTX-008 (abstract).
Xue teaches OTX-008 (Sigma, 20 mg/kg) dissolved by 2% dimethyl sulfoxide was conducted for 7 days (page 214, column 1, Animals and Modeling).
Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Claim Rejections - 35 USC § 103
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.
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.
Claim 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Selleckchem (https://www.selleckchem.com/products/otx008.html; 12/7/21) as applied to claims 1-3, 6-8 and 11-20 in the 102(a)(1) rejection above.
Xue does not specifically teach OTX008, DMSO and corn oil in the amounts as required by the limitations of the instant claims.
Selleckchem exemplifies a catalog entry for OTX008. The catalog entry enables the purchaser to calculate an in vivo formulation wherein the desired dosage is entered, animal weight, dosing and so forth. The purchaser may also enter the vehicle for the formulation, including the % DMSO and corn oil.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the concentration of OTX008, DMSO and corn oil in the composition. The motivation, provided by Selleckchem, enables the purchaser to calculate an in vivo formulation wherein the desired dosage, animal weight, dosing are applied in addition to the vehicle comprising DMSO and corn oil. Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-8 and 11-20 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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