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 Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/2/26 has been entered.
Claims 1-21, 23, 30-34, 38-51 have been cancelled. Claims 22, 24-29, 35-37, 52-55 are pending and examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejection of the last Office Action is maintained for reasons of record and repeated below for Applicant’s convenience.
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 22, 24-29, 35-37, 55 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,310,937. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims recite a fatty acid composition comprising oleic acid, myristic acid, palmitic acid, arachidonic acid, lauric acid, capric acid, linoleic acid, behenic acid, and mineral oil.
Response to Arguments
Examiner acknowledges Applicant’s request that the double patenting rejection be held in abeyance until allowable subject matter is identified.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 22, 24-29, 35-37, 52-55 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US Patent Application 2011/0144141, of record).
The instant claims are directed to a fatty acid composition.
Hu et al. teach a hair regrowth composition comprising minoxidil in combination with a fatty acid mixture (title and abstract). In one embodiment, the fatty acid mixture comprises 36.0-36.5% oleic acid, 2.8-8.5% myristic acid, 23.2-24.6% palmitic acid, 7-9% arachidonic acid, 0.9-5.5% lauric acid, 2.2-3.5% capric acid, 20-20.6% linoleic acid, 3-4% behenic acid, and 0.1% caproic acid (paragraph 0091). The composition may be in the form of a solution, spray, gel, or aerosol comprising a suitable carrier, such as petrolatum, which is a known mineral oil, in about 50-99.99% by weight (paragraph 0118). The compositions can also comprise alcoholic solubilizers in an amount of 1-60% or 20-50% (paragraph 0075).
However, Hu et al. fail to disclose palmitic acid in an amount of 17 wt/wt%.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have optimized the amount of palmitic acid, taught by Hu et al., to 17 wt/wt%.
A person of ordinary skill in the art would have been motivated to optimize the amount of palmitic acid from 23.2-24.6% to 17% because this small decrease is within the realm of routine optimization since the general utility of this fatty acid is known. One of ordinary skill in the art would have had a reasonable expectation of success in formulating an effective hair regrowth composition comprising 17% of palmitic acid.
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); “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.” In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382; lt has been held that it is within the skills in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. In re Boesch, 205 USPQ 215 (CCPA 1980) MPEP 2114.04
Response to Arguments
Applicant's arguments have been fully considered but found not persuasive. In particular, Applicant argues that there is no motivation to specifically pick the claimed formulation from hundreds or thousands of formulations disclosed in Hu. Furthermore, there is no reason why a person of ordinary skill in the art would modify the amount of palmitic acid to 17% since the claimed formulations are completely unrelated to hair regrowth.
This is not persuasive because there is no picking and choosing as alleged by the Applicant. Attention is pointed to paragraph 0091, which teaches a single embodiment of the claimed formulation, except for the claimed amount of palmitic acid. One of ordinary skill in the art would be motivated to optimize the amount from 23.2% to 17% because palmitic acid is already known to be useful in a hair regrowth formulation in an amount of 23.2-24.6%. Therefore, the skilled artisan would have had a reasonable expectation of success in formulating a similar hair regrowth formulation comprising 17% of palmitic acid. Lastly, the instant claims are drawn to a composition, therefore any preamble or intended use is given little patentable weight.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623