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
A preliminary amendment to the claims has not been filed. Thus claims 1-11 filed on 04/25/2024 are currently pending and are under examination.
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 3-4, 6 and 10-11 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3-4, 6 and 10-11 recite the broad recitation before preferably, and the claim also recites a narrower statement of the range/limitation after preferably. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Patent number CN104710320A (CN’320; cited in IDS 04/25/2024 and machine translation attached herein) in view of BestTechnology (“June 2015 – Centrifugal Industrial Spin Parts Dryers, DuoSolvent Vapor Degreaser and Job Shop Parts Washer” Jun. 2015, pages 1-2).
Regarding claim 1, CN’320 teaches a method for purifying pregabalin, comprising: (1) raising the temperature of a reaction solution, maintaining the temperature and removing impurities; and (2) adding an acid into the reaction solution obtained in step (1) to adjust the pH value, crystallizing, filtering and drying to obtain pregabalin ([0011], [0017]-[0020] and all examples).
Regarding claims 2 and 7-11, the limitation “the reaction solution is prepared by…” is a product by process claim language as a result of the catalyst product. The product by process limitation is not limited to the manipulations of the recited steps for preparing the reaction solution, but only to the structure implied by the steps, in this case, only to the reaction solution. See MPEP § 2113:
"[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) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See also Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ( "a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim" ).
Regarding claim 3, the temperature in step (1) is 40° C. to 60° C. ([0017]).
Regarding claim 4, the duration for maintaining the temperature in step (1) is 1 h to 2 h ([0017]).
Regarding claim 5, CN’320 teaches the acid in step (2) is hydrochloric acid or sulfuric acid ([0024]).
Regarding claim 6, the pH value in step (2) of the reference is adjusted to 6-8 ([0025]).
Regarding claim 1, while CN’320 teaches filtering and drying after crystallization of pregabalin, the reference fails to teach centrifugally drying to obtain pregabalin.
The deficiency is cured by BestTechnology and it discloses centrifugal dryer is able to dry nested parts and speed drying times by the spinning basket action causes centrifugal force which wrings out or throws off excess water, solvents, paints, oils, or other liquids and while the basket is spinning, a turbine fan below the basket creates a powerful suction that pulls heated air from the top/lid through the parts. Thus, substituting filtering and drying of CN’320 with the centrifugal drying of BestTechnology a skilled artisan would still have a reasonable expectation of success in obtaining nothing more than dried pregabalin at a reduced speed drying times.
It would thus have been prima facie obvious to a skilled artisan before the effective filing date of the instant invention to conduct a method for purifying pregabalin, comprising the following steps (1) raising the temperature of a reaction solution, maintaining the temperature and removing impurities; and (2) adding an acid into the reaction solution obtained in step (1) to adjust the pH value, crystallizing and centrifugally drying to obtain pregabalin in view of the teachings of CN’320 and BestTechnology.
Conclusion
Claims 1-11 are rejected and no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDHANIT W BAHTA whose telephone number is (571)270-7658. The examiner can normally be reached Monday-Friday 8am-5pm.
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/MEDHANIT W BAHTA/ Primary Examiner, Art Unit 1692
