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
Claims 1, 4-5, 7-10, and 12-23 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 05/26/2025 are acknowledged. Claims 1, 17, and 20 have been amended and new claims 21-23 have been added. Claims under consideration in the instant office action are claims 1, 4-5, 7-10, and 12-23.
Applicants' arguments, filed 05/26/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
Claims 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 21-23 recite the limitation of “further comprising measuring or having measured a level of EPA in the cells of the patient to determine whether the baseline level of EPA has accumulated in the cells of the patient.”, which is not described in the specification.
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, 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.
Claims 1, 4-5, 7-10, and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. (US 6,407,075) in view of Chilton (US 2015/0005382).
Regarding claim 1, Scott et al. teaches “a medicament for treating and preventing the side effects of anti-cancer chemotherapy of a polyunsaturated fatty acid with a carbon chain length of 14 to 26 and with 2 to 6 double bonds in the molecule in cis or trans configuration, and a method of such treatment or prevention wherein said fatty acid is used as an active.” (see abstract). Regarding claim 9, Scott et al. teaches that the drugs that have been used in the anti-cancer chemotherapy include methotrexate, which is well known in the art as an HDAC inhibitor (col. 3, lines 25-28). Regarding claim 14, Scott et al. teaches gamma-linoleic acid (GLA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) as preferred fatty acids that can be used with one another (col. 3, lines 20-25). Regarding claims 11-13, Scott et al. teaches administering doses ranging from 1 mg to 100 g per day (col. 3, lines 62-65). Regarding claim 4, Scott et al. teaches that treatment can include prior to and during chemotherapy treatment (col. 6, lines 5-8).
Scott et al. does not explicitly recite the claimed dosages. Scott et al. does not teach EPA as the first dosage and GLA as the second dosage.
Chilton is drawn towards “methods of identifying a subject as responsive to treatment of an inflammatory disease and/or inflammation with one or more polyunsaturated fatty acids (PUFAs)” (see abstract). Chilton teaches the use of EPA and GLA as a combination (paragraph 0015). Chilton teaches that “the one or more PUFAs can be administered in any form or manner effective to achieve a therapeutic and/or beneficial effect.” (paragraph 0045). Chilton teaches “the one or more PUFAs can be comprised in any combination in more than one (e.g., 2, 3, 4, 5, 6, 7, and the like) composition and/or formulation, and therefore can be administered to a subject as more than one composition/formulation.” (paragraph 0052). Chilton teaches “more than one administration ( e.g., two, three, four, or more administrations) can be employed over a variety of time intervals (e.g., hourly, daily, weekly, monthly, etc.) to achieve therapeutic effects.” (paragraph 0065).
It would have been obvious to one of ordinary skill in the art to administer EPA as the first dosage and GLA as the second dosage, as suggested by Chilton, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since it would have been obvious to try a sequential administration of EPA and GLA based on the teachings of Chilton (see paragraphs 0045, 0052, 0065), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Even though the range for dosages as taught by Scott et al. is not the same as the claimed dosages, Scott et al. does teach an overlapping range of dosages, and it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of dosages is well within the purview of those skilled in the art through routine experimentation, and it has been held that “it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the dosages of EPA and GLA in order to increase the efficacy of the dosage forms.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc.; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
With regards to the limitation claimed in instant claim 2, which claims a period of time of at least two weeks, Scott et al. does not specifically teach the exact time period claimed in instant claim 2. However, it would be within the skill of an ordinary artisan to be able to modify the period of time in order to obtain the desired bioavailability of the agent. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 20). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). (MPEP 2111.04 I).
Response to Arguments
Applicant argues that “Applicant has amended the independent claims to clearly differentiate from the prior art. Each of the independent claims has been amended to explain that the first period of time continues "until a baseline level of EPA accumulates in the cells of the patient." The claims have been further amended to clarify that "the accumulated EPA in the cells of the patient during the first period of time promotes production of 8-HOA instead of arachidonic acid (AA) from the GLA administered during the second period of time." Accordingly, Applicant respectfully submits the amended claims are non-obvious.” The Examiner respectfully disagrees since although the prior art does not teach a motivation to pre-dose EPA for the purpose to later limit conversion of GLA to Arachidonic Acid in favor of 8-HOA production, the prior art still reads on the active steps of the claimed invention. Chilton teaches the use of EPA and GLA as a combination (paragraph 0015). Chilton teaches that “the one or more PUFAs can be administered in any form or manner effective to achieve a therapeutic and/or beneficial effect.” (paragraph 0045). Chilton teaches “the one or more PUFAs can be comprised in any combination in more than one (e.g., 2, 3, 4, 5, 6, 7, and the like) composition and/or formulation, and therefore can be administered to a subject as more than one composition/formulation.” (paragraph 0052). Chilton teaches “more than one administration ( e.g., two, three, four, or more administrations) can be employed over a variety of time intervals (e.g., hourly, daily, weekly, monthly, etc. .) to achieve therapeutic effects.” (paragraph 0065). Thus, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 1). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). (MPEP 2111.04 I).
Conclusion
Claims 1, 4-5, 7-10, and 12-23 are rejected.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691