Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s amendment of 17 April 2025, in which claim 14 has been amended, and new claim 22 has been added, is acknowledged.
Claims 1-22 are pending in the instant application.
Claims 4, 5, 15-21 are withdrawn, as being drawn to a non-elected invention or to a non-elected species.
Claims 1-3, 6-14, 22 are being examined herewith.
Response to arguments of 17 April 2025
In view of Applicant’s amendment of 17 April 2025, the objection to claims 4, 5, 15-21 is herein withdrawn. Applicant has corrected the status indicators.
In view of Applicant’s amendment of 17 April 2025, the rejection of claim 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein withdrawn. Applicant has deleted the broad/narrow recitation from claim 14.
Applicant’s arguments (Remarks of 17 April 2025, pages 3-4) against the rejection of claims 1-3, 6-14 under 35 U.S.C. 101, have been considered.
The Declaration under 37 CFR 1.132 by Dr. Raffaele Migliaccio, submitted on 17 April 2025, is acknowledged.
Dr. Migliaccio provides (page 2, last paragraph, page 3, first three paragraphs) literature references describing pro-inflammatory activity of myristic acid and palmitic acid (Lee, Hubbard), the pro-inflammatory properties of linoleic acid (Fritsche), and the pro-inflammatory effects of palmitic acid and stearic acid (Harvey), and argues (pages 2-3, Declaration) that not all fatty acids possess anti-inflammatory activity, and that the presently claimed mixture exhibits markedly different characteristics than the individual fatty acid components.
In response, this argument is found persuasive, and the rejection of claims 1-3, 6-14 under 35 U.S.C. 101 is herein withdrawn.
Applicant’s arguments (pages 4-5) against the rejection of claims 1-3, 6, 7, 9, 12 under 35 U.S.C. 102(a)(1) over “New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy”, 2012, have been considered.
Dr. Migliaccio states on the record (Declaration, page 3, last paragraph, page 4, first two paragraphs) that the active ingredient (adelmidrol) in GutLife and EvaLife, which are products of the Applicant, commercially available since 2012, was changed after the present application was filed. Dr. Migliaccio argues that the claimed mixtures are novel over the disclosure of “New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy”, 2012.
In response, first, it is noted that the “comprising” language in the instant claims allows for the presence of additional ingredients besides those listed in the claims. Additional ingredients such as adelmidrol are not excluded by the claim language.
Further, the instant Specification teaches (page 39, last paragraph) that GutLife and EvaLife are creams that contain the mixture of the present invention (see Example 10).
Applicant is requested to provide additional information, in the format of a signed Declaration, related to all ingredients present in GutLife and EvaLife, at the time the reference “New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy”, 2012, was published.
Since Applicant has indicated that the ingredients present in GutLife and EvaLife were changed after the present application was filed, Applicant is also requested to provide information regarding any changes in ingredients and the date such changes occurred since the publication of “New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy”, 2012.
In the absence of such additional information, the rejection of claims 1-3, 6, 7, 9, 12 under 35 U.S.C. 102(a)(1) over “New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy”, 2012, is herein maintained.
Applicant’s arguments (pages 5-7) against the rejection of claims 1-3, 6-14 under 35 U.S.C. 103 over Loftsson and Williams, have been considered.
Applicant argues (page 6, last two paragraphs, page 7, first paragraph) that Loftsson discloses fatty acid compositions having laxative effect; that Example 1 in Loftsson is an extract comprising 16 fatty acids, and that the extract does not suggest to a POSITA that the % in the extract would be suitable for any and all mixtures comprising fatty acids, let alone the instantly claimed mixtures comprising at least 5 fatty acids recited by the instant claims.
In response, this argument is not persuasive. The extract in Table 2 Loftsson is a mixture of at least 5 fatty acids, as instantly claimed, with fatty acids palmitic acid 11.4 %, stearic acid 2.5%, oleic acid 18.8%, linoleic acid 1.3%; the oleic acid includes alpha-linolenic acid (18:3 n-3) less than 1%, where the palmitic, stearic, oleic and linoleic acids are present in the composition in concentrations within the ranges in instant claims 1, 6.
Applicant argues (page 7, paragraphs 1-5) that the Office conclusion that the fatty acids taught by Williams and Loftsson are useful for the same purpose is without base. Applicant argues that [0010] in Loftsson somehow refers only to paragraph [0002] in Loftsson, which refers only to ricinoleic acid having “some anti-inflammatory effect”, which then leads Applicant to argue that “some anti-inflammatory effect” with one fatty acid does not represent a general teaching that all fatty acids have anti-inflammatory effect. In response, Applicant’s argument is misleading. Paragraph [0010] in Loftsson refers to pharmaceutical compositions/dosage forms of the invention based on anti-inflammatory effects of fatty acids. This is a general statement related to the disclosed fatty acid compositions of the invention, such compositions include the mixture of at least 5 fatty acids in Table 2, having anti-inflammatory effect. As such, the fatty acids taught by Loftsson and Williams are anti-inflammatory and useful for the same purpose.
Applicant argues (page 7, last paragraph) that the Migliaccio Declaration provides additional data showing unexpected effects with the instantly claimed composition.
The Declaration of Dr. Migliaccio has been considered.
Dr. Migliaccio details (Declaration, pages 5-15) experiments conducted under his supervision, and argues that the claimed mixtures exhibit synergistic anti-inflammatory activity.
Dr. Migliaccio shows (page 14, last paragraph- page 15) that a composition of five fatly acids, namely stearic acid, linoleic acid, oleic acid, EPA and DHA (Formulation 2 below)
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inhibits the release of IL-6 from THP-1 cells by 34% at the maximum concentration (25 mg/mL) (Figure 2, Table 8), whereas PEA (Formulation 1) inhibits the release of IL-6 by 32%; in contrast, Formulation 3 (mixture consisting of 70% wt. of Formulation 2 and 30% wt. of Formulation 1) inhibits the release of the pro-inflammatory cytokine IL-6 from THP-1 cells by 55% at the maximum concentration (25 mg/ml) and by 53% at the minimum concentration (12.5 mg/L).
Dr. Migliaccio states on the record (Declaration, page 15, second paragraph) that this represents clear evidence of synergistic effect.
Further, Dr. Migliaccio shows that Formulation 3 also inhibits the release of the pro-inflammatory cytokine IL-8 from THP-1 cells by 76% al the maximum concentration (25 mg/mL), whereas Formulation 2 and Formulation 1 inhibit the release of IL-8 by only 45% and 39% at the maximum concentration, respectively.
Dr. Migliaccio states on the record (Declaration, page 15) that the data presented in the Declaration demonstrates synergistic effect with the instantly claimed mixtures.
In response, the data in the Declaration is acknowledged.
However, the data presented is not commensurate in scope with the full scope of the claimed invention. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." Thus, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ289,296 (CCPA 1980). See MPEP 716.02(d). In the instant case, claim 1 is drawn broadly to a composition comprising a mixture of at least 5 fatty acids selected from 10 fatty acids listed, and N-2 hydroxyethyl palmitamide. Yet, the data presented is limited to a mixture of five fatty acids, namely stearic acid, linoleic acid, oleic acid, EPA and DHA, in combination with N-2-hydroxyethyl palmitate, present in a certain weight ratio. The data is not commensurate with the full scope of instant claim 1, because the data is limited to 5 fatty acids and PEA, and one data point is not enough to establish proof of synergistic results over an entire range of concentrations.
For all the reasons above, the rejection of claims 1-3, 6-14 under 35 U.S.C. 103 over Loftsson and Williams, is herein maintained.
Applicant’s arguments (pages 8-9) against the rejection of claims 1-3, 6-14 under 35 U.S.C. 103 over Askanazi and Williams, have been considered.
Applicant argues (page 8, last paragraph, page 9, first two paragraphs) that Askanazi discloses fatty acid compositions for treating ulcerative colitis, but does not provide a general teaching related to the usefulness of fatty acids in treating inflammation; that Tables 2, 3 in Askanazi contain 14 or 15 fatty acids, and that the extract does not suggest to a POSITA that the % in the extract would be suitable for any and all mixtures comprising fatty acids, let alone the instantly claimed mixtures comprising at least 5 fatty acids recited by the instant claims.
In response, this argument is not persuasive. First, the Abstract in Askanazi clearly teaches that the compositions of the invention are used for treating inflammatory diseases. Thus, Applicant’s argument that Askanazi does not disclose inflammation is incorrect. Further, the compositions in Tables 2, 3 Askanazi are mixtures of at least 5 fatty acids, as instantly claimed, with fatty acids (Table 2) palmitic acid (C16:0) 13.13%, stearic acid (C18:0) 2.5%, oleic acid (C18:1) 11.20%, linoleic acid (C18:2) 2.30%, alpha-linolenic acid (18:3) 0.71%, and where the palmitic, stearic, oleic and linoleic acids and alpha-linolenic acid are present in the composition in concentrations within the ranges in instant claims 1, 6.
Applicant argues (page 8, paragraph 3) that the Office conclusion that the fatty acids taught by Williams and Askanazi are useful for the same purpose is without base. This is not persuasive. Askanazi teaches in the Abstract that the compositions of the invention treat inflammation. As such, the fatty acids taught by Askanazi and Williams are anti-inflammatory and useful for the same purpose.
Applicant argues (page 8, paragraphs 4-5) that the Migliaccio Declaration provides additional data showing unexpected effects with the instantly claimed composition. The data in the Declaration has been considered (see above).
For all the reasons above, the rejection of claims 1-3, 6-14 under 35 U.S.C. 103 over Askanazi and Williams, is herein maintained.
Applicant’s arguments (pages 9-11) against the rejection of claims 1-3, 6-14 under 35 U.S.C. 103 over Kawada and Williams, have been considered.
Applicant argues (page 10, last two paragraphs) that Table 1 in Kawada contains 12 fatty acids, and that the extract does not suggest to a POSITA that the % in the extract would be suitable for any and all mixtures comprising fatty acids, let alone the instantly claimed mixtures comprising at least 5 fatty acids recited by the instant claims.
In response, this argument is not persuasive. The composition in Table 1 Kawada is a mixture of at least 5 fatty acids, as instantly claimed, with fatty acids palmitic acid (C16:0), stearic acid (C18:0), oleic acid (C18:1), linoleic acid (C18:2), alpha-linolenic acid (18:3), and where the palmitic, stearic, oleic and linoleic acids and alpha-linolenic acid are present (the five columns at the right of Table 1) in the composition in concentrations within the ranges in instant claims 1, 6.
Applicant argues (page 11, paragraph 1) that the Office conclusion that the fatty acids taught by Williams and Kawada are useful for the same purpose is without base. This is incorrect. Kawada teaches that the unsaturated fatty acids of the invention are PPAR agonists; Williams teaches that PEA is a PPAR agonist. As such, the fatty acids taught by Kawada and Williams are anti-inflammatory PPAR agonists and useful for the same purpose.
Applicant argues (page 11, paragraphs 2-3) that the Migliaccio Declaration provides additional data showing unexpected effects with the instantly claimed composition.
The data in the Declaration has been considered (see above).
For all the reasons above, the rejection of claims 1-3, 6-14 under 35 U.S.C. 103 over Kawada and Williams, is herein maintained.
Applicant has put forth no arguments against the rejection of claims 1-3, 6-14 on the ground of nonstatutory double patenting over claims 1-14 of U.S. Patent No. 11,020,365. As a result, this rejection is maintained.
Applicant’s amendment of 17 April 2025 necessitated the following modified rejections.
Claim Rejections- 35 USC 102
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 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 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, 7, 9, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy”, 2012 (cited in IDS).
“New: skin damage in the intimate area treated with Again Life products- especially important in cancer therapy” (2012) teaches that GutLife and EvaLife are products of the Applicant, Again Life, commercially available since 2012, formulated for topical use, as in instant claim 7, as a gel, as in instant claim 9. EvaLife is a gel for vaginal use, as in instant claim 12.
The instant Specification teaches (page 39, last paragraph) that GutLife and EvaLife are creams that contain the mixture of the present invention (see Example 10).
As such, a composition of Example 10
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, formulated as a gel, for topical or vaginal form, is anticipated by commercial products GutLife and EvaLife.
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 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 1-3, 6-14, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Loftsson (US 2010/0113387, cited in IDS) and Williams et al. (WO 2008/075978, published 26 June 2008, cited in PTO-892 of 28 October 2024).
Loftsson (US 2010/0113387) teaches usage of fatty acids in pharmaceutical compositions (Abstract).
Loftsson specifically teaches (Table 2, page 5) fatty acid extract composition comprising
palmitic acid 11.4 %, stearic acid 2.5%, oleic acid 18.8%, linoleic acid 1.3%; the oleic acid includes alpha-linolenic acid (18:3 n-3) less than 1%, which are the fatty acids of instant claim 3, where the palmitic, stearic, oleic and linoleic acids are present in the composition in concentrations within the ranges in instant claims 1, 6.
Loftsson teaches the fatty acids as a medicament, formulated in oral, topical, or rectal form, as in instant claims 7; where formulation can be for rectal administration in the form of a suppository ([0036], Example 2, [0052]), as in instant claim 11.
Loftsson further teaches the fatty acid compositions as oral dosage forms such as tablets or capsules ([(0043]), as in instant claim 8; as well as topical administration such as ointments (Example 3), creams or gels ([0049]), as in instant claim 9.
Loftsson teaches dosage forms such as [0020] a gel, as in instant claims 9, 12, cream, ointment [0020], as in instant claims 9, 13, or an oily suspension [0049], as in instant claim 10.
Loftsson teaches (Table 3) that the mixture of fatty acids is 30% wt. based on the total weight of the composition, which is within the range in instant claims 14, 22.
Loftsson teaches that the pharmaceutical dosage forms of the invention are used for medical conditions based on the anti-inflammatory effects of the fatty acids [0010].
Loftsson does not teach that the composition comprises N-hydroxyethyl palmitamide, as in the instant claims.
Williams (WO 2008/075978) teaches compositions (page 11, lines 25-31, page 12, lines 1-18) comprising N-hydroxyethyl palmitamide (PEA, page 2, lines 11-12)
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and at least one polyunsaturated fatty acid (PUFA), preferably an omega-3 PUFA, such as, for example, 9,12,15-octadecatrienoic acid (synonyms ALA, 18:3n3, alpha linolenic acid).
Williams specifically teaches (Table 2, page 19) a composition (oil) comprising (invention extract) PEA (present in a concentration of 57 mg /g oil) and a mixture of 4 fatty acids, one of the four being alpha linolenic acid (1.1 g/100g oil).
Williams teaches that N-hydroxyethyl palmitamide (PEA) is naturally occurring, found in many different cells of animal, marine and plant origin. Williams teaches (page 9, lines 13-16) a composition containing an oil extract from marine based organism/a mussel containing at least 0.10 mg/g PEA, or greater than 30 mg/g (page 10, lines 11-12), as measured in the wet weight on the marine organism flesh prior to extraction (see Table 1, page 16, for PEA concentrations in three different mussel species).
Williams teaches that PEA has anti-inflammatory properties (page 3, line 4; page 4, line 14), and the compositions of the invention are useful to treat inflammation (page 13, lines 24-26).
Williams teaches (page 12, lines 30-31) that the composition of the invention are formulated for oral or topical administration, as in instant claim 7; oral forms include (page 12, lines 19-20) tablet, solution, as in instant claim 8; topical forms include (page 12, line 21) cream, ointment, as in instant claim 9.
It would have been obvious for a person of ordinary skill in the art to use the teachings of Loftsson and Williams to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to add N-hydroxyethyl palmitamide to a composition comprising palmitic acid, stearic acid, oleic acid, linoleic acid and alpha-linolenic acid taught by Loftsson, because Loftsson teaches compositions comprising mixtures of fatty acids having anti-inflammatory effects; Williams teaches that N-hydroxyethyl palmitamide has anti-inflammatory properties, and Williams teaches compositions comprising N-hydroxyethyl palmitamide and mixtures of any acids, such as alpha-linoleic acid, being effective to treat inflammation. Therefore, one of ordinary skill in the art would have reasonably expected that adding N-hydroxyethyl palmitamide to a mixture of fatty acids comprising palmitic acid, stearic acid, oleic acid, linoleic acid and alpha-linolenic acid taught by Loftsson, known to be useful for the same purpose, i.e. treating inflammation, would result in a composition having anti-inflammatory properties. Since N-hydroxyethyl palmitamide and the mixture of fatty acids taught by Loftsson are known to be useful to treat inflammation, it is considered prima facie obvious to combine them in a composition used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, regarding claims 1, 6, 14, 22, it would have been obvious to vary the amounts of the fatty acids in the composition, within the ranges in instant claims 1, 6, 14, 22, in order to optimize the desired anti-inflammatory effect achieved with the composition.
Regarding claims 7-13, it would have been obvious to formulate the composition for oral, topical, rectal, vaginal, ophthalmic or parenteral form, because Loftsson teaches compositions comprising mixtures of fatty acids formulated in oral, topical, or rectal form, as a tablet, capsule, solution, gel, an oily suspension, or a cream, and Williams teaches compositions comprising N-hydroxyethyl palmitamide and mixtures of fatty acids, for oral or topical administration. While ophthalmic or vaginal forms are not explicitly taught by Loftsson and Williams, formulating therapeutic agents as a gel, an oily suspension, or a cream for ophthalmic or vaginal or parenteral administration is routine, well within the skill of the artisan.
As such, claims 1-3, 6-14, 22 are rejected as prima facie obvious.
Claims 1-3, 6-14, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Askanazi et al. (EP 0637957, published July 23, 1997, cited in PTO-892 of 28 October 2024) and Williams et al. (WO 2008/075978, published 26 June 2008, cited in PTO-892 of 28 October 2024).
Askanazi (EP 0637957) teaches compositions comprising mixtures of omega-3 fatty acids parenterally administered for treating inflammatory diseases.
Askanazi specifically teaches (Table 2, column 9) a composition as an emulsion comprising palmitic acid (C16:0) 13.13%, stearic acid (C18:0) 2.5%, oleic acid (C18:1) 11.20%, linoleic acid (C18:2) 2.30%, alpha-linolenic acid (18:3) 0.71%, which are the fatty acids of instant claim 3, and where the palmitic, stearic, oleic and linoleic acids and alpha-linolenic acid are present in the composition in concentrations within the ranges in instant claims 1, 6.
Askanazi specifically teaches (Table 3, column 10) a composition as an emulsion comprising palmitic acid (C16:0) 9.03%, stearic acid (C18:0) 1.79%, oleic acid (C18:1) 11.50%, linoleic acid (C18:2) 2.80%, alpha-linolenic acid (18:3) 1.65%, which are the fatty acids of instant claim 3, and where the palmitic, stearic, oleic and linoleic acids and alpha-linolenic acid are present in the composition in concentrations within the ranges in instant claims 1, 6.
Askanazi teaches that the composition is formulated as a parenteral form, as in instant claim 7.
Askanazi teaches (English translation, page 5, third paragraph) that the fatty acids represent 1 to 40% weight with respect to the emulsion, which overlaps with the range in instant claims 14, 22.
Askanazi does not teach that the composition comprises N-hydroxyethyl palmitamide, as in the instant claims.
Williams is as above.
It would have been obvious for a person of ordinary skill in the art to use the teachings of Askanazi and Williams to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to add N-hydroxyethyl palmitamide to a composition comprising palmitic acid, stearic acid, oleic acid, linoleic acid and alpha-linolenic acid taught by Askanazi, because Askanazi teaches compositions comprising mixtures of fatty acids having anti-inflammatory effects; Williams teaches that N-hydroxyethyl palmitamide has anti-inflammatory properties, and Williams teaches compositions comprising N-hydroxyethyl palmitamide and mixtures of any acids, such as alpha-linoleic acid, being effective to treat inflammation. Therefore, one of ordinary skill in the art would have reasonably expected that adding N-hydroxyethyl palmitamide to a mixture of fatty acids comprising palmitic acid, stearic acid, oleic acid, linoleic acid and alpha-linolenic acid taught by Askanazi, known to be useful for the same purpose, i.e. treating inflammation, would result in a composition having anti-inflammatory properties. Since N-hydroxyethyl palmitamide and the mixture of fatty acids taught by Askanazi are known to be useful to treat inflammation, it is considered prima facie obvious to combine them in a composition used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, regarding claims 1, 6, 14, 22, it would have been obvious to vary the amounts of the fatty acids in the composition, within the ranges in instant claims 1, 6, 14, 22, in order to optimize the desired anti-inflammatory effect achieved with the composition.
Regarding claims 7-13, it would have been obvious to formulate the composition for oral, topical, rectal, vaginal, ophthalmic or parenteral form, because Askanazi teaches compositions comprising mixtures of fatty acids formulated in parenteral form, as an emulsion, and Williams teaches compositions comprising N-hydroxyethyl palmitamide and mixtures of fatty acids, for oral or topical administration. Formulating therapeutic agents as a gel, an oily suspension, or a cream for ophthalmic or vaginal or parenteral or oral administration is routine, well within the skill of the artisan.
As such, claims 1-3, 6-14, 22 are rejected as prima facie obvious.
Claims 1-3, 6-14, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kawada et al. (EP 1175901, published January 30, 2002, cited in PTO-892 of 28 October 2024) and Williams et al. (WO 2008/075978, published 26 June 2008, cited in PTO-892 of 28 October 2024).
Kawada (EP 1175901) teaches compositions comprising mixtures of free fatty acids obtained from plant seed oils (Example 1), said compositions having PPAR agonist activity [0046], [0048]. Kawada teaches [0006] that long-chain fatty acids are known to exhibit PPAR alpha agonist activity, and highly unsaturated fatty acids exhibit PPARgamma agonist activity. The ligand selectivity among the various PPAR subtypes is quite broad, and one of the characteristics of PPARs is that a substance that acts as an agonist for one particular subtype often exhibits agonist activity toward the other subtypes [0006].
Kawada specifically teaches (Table 1, page 8)
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compositions comprising mixtures of fatty acids from plant seed oils comprising palmitic acid (C16:0), stearic acid (C18:0), oleic acid (C18:1), linoleic acid (C18:2), alpha-linolenic acid (18:3), which are the fatty acids of instant claim 3, and where the palmitic, stearic, oleic and linoleic acids and alpha-linolenic acid are present (the five columns at the right of Table 1) in the composition in concentrations within the ranges in instant claims 1, 6.
Kawada teaches [0035] that the composition of the invention can be administered orally as a tablet, a capsule, granules, a suspension, a solution (oral form, as in instant claim 8), or non-orally as an injection (parenteral form, as in instant claim 10), or a suppository (rectal form, as in instant claim 11).
Kawada teaches [0032] that the fatty acid composition having PPAR agonist activity of the invention can be used as a food/beverage, and the content of the fatty acid composition in the food/beverage is 0.1 to 90% wt., which encompasses the range in instant claims 14, 22.
Williams (WO 2008/075978) teaches compositions (page 11, lines 25-31, page 12, lines 1-18) comprising N-hydroxyethyl palmitamide (PEA, page 2, lines 11-12)
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and at least one polyunsaturated fatty acid (PUFA), preferably an omega-3 PUFA, such as, for example, 9,12,15-octadecatrienoic acid (synonyms ALA, 18:3n3, alpha linolenic acid).
Williams specifically teaches (Table 2, page 19) a composition (oil) comprising (invention extract) PEA (present in a concentration of 57 mg /g oil) and a mixture of 4 fatty acids, one of the four being alpha linolenic acid (1.1 g/100g oil).
Williams teaches that PEA has anti-inflammatory properties (page 3, line 4; page 4, line 14). Williams teaches that PPARalpha is of key importance to the anti-inflammatory actions of PEA (page 5, lines 1-2).
It would have been obvious for a person of ordinary skill in the art to use the teachings of Kawada and Williams to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to add N-hydroxyethyl palmitamide to a composition comprising palmitic acid, stearic acid, oleic acid, linoleic acid and alpha-linolenic acid taught by Kawada, because Kawada teaches compositions comprising mixtures of fatty acids having PPAR agonist activity; and Williams teaches that N-hydroxyethyl palmitamide has PPARalpha agonist activity. Therefore, one of ordinary skill in the art would have reasonably expected that adding N-hydroxyethyl palmitamide to a mixture of fatty acids comprising palmitic acid, stearic acid, oleic acid, linoleic acid and alpha-linolenic acid taught by Kawada, known to be PPAR agonists, would result in a composition having PPAR agonist properties. Since N-hydroxyethyl palmitamide and the mixture of fatty acids taught by Kawada are known to be PPAR agonists, it is considered prima facie obvious to combine them in a composition used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, regarding claims 1, 6, 14, 22, it would have been obvious to vary the amounts of the fatty acids in the composition, to arrive at the relative amounts in instant claims 1, 6, 14, 22, in order to optimize the desired therapeutic effect achieved with the composition.
Regarding claims 7-13, it would have been obvious to formulate the composition for oral, topical, rectal, vaginal, ophthalmic or parenteral form, because Kawada teaches compositions comprising mixtures of fatty acids formulated in oral form as tablet, capsule, suspension, solution, or in parenteral form, or as suppositories, and Williams teaches compositions comprising N-hydroxyethyl palmitamide and mixtures of fatty acids, for oral or topical administration. Formulating therapeutic agents as a gel, an oily suspension, or a cream for ophthalmic or vaginal or parenteral administration is routine, well within the skill of the artisan.
As such, claims 1-3, 6-14, 22 are rejected as prima facie obvious.
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-14, 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,020,365 (cited in PTO-892 of 28 October 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because a composition of claims 1-14 of U.S. Patent No. 11,020,365 anticipates or renders obvious the instant claims.
Claims 1-14 of U.S. Patent No. 11,020,365 are drawn to a mixture of nine fatty acids selected from palmitic acid, oleic acid, stearic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), azelaic acid and myristic acid, wherein the palmitic acid, if present, is contained in said mixture in a quantity between 0.2% and 48% by weight; the oleic acid, if present, is contained in said mixture in a quantity between 0.2% and 38% by weight; the stearic acid, if present, is contained in said mixture in a quantity between 0.2% and 42% by weight; the linoleic acid, if present, is contained in said mixture in a quantity between 0.2% and 40% by weight; the alpha-linoleic acid, if present, is contained in said mixture in a quantity between 0.2% and 38% by weight; the gamma-linolenic acid, if present, is contained in said mixture in a quantity between 0.2% and 30% by weight; the eicosapentaenoic acid, if present, is contained in said mixture in a quantity between 0.2% and 25% by weight; the docosahexaenoic acid, if present, is contained in said mixture in a quantity between 0.2% and 25% by weight; the azelaic acid, if present, is contained in said mixture in a quantity between 0.2% and 40% by weight; and the myristic acid, if present, is contained in said mixture in a quantity between 0.005% and 0.01% by weight, with respect to the total weight of the mixture; claim 4 recites that the composition is formulated in oral, topical, rectal, vaginal, ophthalmic or parenteral form, as in instant claim 7; claim 5 recites that the oral form is tablet, capsule, granule, oily capsule, solution, suspension, carrier, and aerosol, as in instant claim 8; claim 6 recites that the topical form is a cream, ointment, gel, solution, suspension, spray, patch, and lyophilised granular powder, as in instant claim 9; claim 7 recites that the parenteral form is an aqueous buffer solution or an oily suspension, as in instant claim 10; claim 8 recites a rectal form which is a suppository, an enema, or a solution for endocavitary use, as in instant claim 11; claim 9 recites a vaginal form as a gel, as in instant claim 12; claim 10 recites an ophthalmic form as eyedrops, a wash, a cream, or an ointment, as in instant claim 13; claim 11 recites that the mixture of fatty acids is present in said composition in a quantity between 10% and 60% by weight, as in instant claim 14; claim 14 of U.S. Patent No. 11,020,365 recites N-2-hydroxyethyl palmitamide present in the composition.
Thus, claims 1-14 of U.S. Patent No. 11,020,365 recite a composition comprising the instant elected species palmitic acid, linoleic acid, oleic acid, stearic acid, and alpha-linolenic acid, present in similar amounts as in the instant claims, the composition further comprising N-2-hydroxyethyl palmitamide (PEA).
Conclusion
Claims 1-3, 6-14, 22 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 IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629