The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-20 are presented for examination.
Acknowledgement is made of the present application as a continuation of U.S. Patent Application No. 16/843,416, filed April 8, 2020, now U.S. Patent No. 11,559,529 B2, which is a continuation of U.S. Patent Application No. 15/757,023, filed March 2, 2018, now U.S. Patent No. 10,653,703 B2, which is a National Stage (371) entry of PCT Application No. PCT/US2016/050397, filed September 6, 2016, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/213,958, filed September 3, 2015.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed January 20, 2023 (13 pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08A, the Examiner has considered the cited references, except for Non-Patent Literature Citation Nos. 89 and 108.
The Information Disclosure Statement filed January 20, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it fails to provide a clearly stated date of publication as required by MPEP §609.04(a)(I) (“37 CFR 1.98(b) requires that each item of information be identified properly … [e]ach publication must be identified by publisher, author (if any), title, relevant pages of the publication and date and place of publication … [t]he date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the application points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue”). It has been placed in the application file, but the information referred to therein as to Non-Patent Literature Citation Nos. 89 and 108 has not been considered as to the merits.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Priority
Acknowledgement is made of the present application as a continuation of U.S. Patent Application No. 16/843,416, filed April 8, 2020, which is a continuation of U.S. Patent Application No. 15/757,023, filed March 2, 2018, which is a National Stage (371) entry of PCT Application No. PCT/US2016/050397, filed September 6, 2016, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/213,958, filed September 3, 2015. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of prior-filed U.S. Provisional Patent Application No. 62/213,958, filed September 3, 2015, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. §112(a) or pre-AIA 35 U.S.C. §112, first paragraph, for one or more claims of this application. The ‘958 disclosure fails to provide adequate written support for a composition comprising omega-3 fatty acids in an amount of about 20-95% by weight of the composition, with 18-hydroxy-5Z,8Z,11Z,14Z,16E-eicosapentaenoic acid (18-HEPE), 12-hydroxy-5Z,8Z,10E,14Z,17Z-eicosapentaenoic acid (12-HEPE), and 15-hydroxy-5Z,8Z,11Z,13E,17Z-eicosapentaenoic acid (15-HEPE) as recited in instant claim 1, in the absence of 17-hydroxy-4Z,7Z,10Z,13Z,15E,19Z-docosahexaenoic acid (17-HDHA). Additionally, there is also no written support for the specific quantities of 18-HEPE recited in instant claims 1 and 8-15. At best, the ‘958 disclosure appears to support the use of 17-HDHA and 18-HEPE in a total amount within the range of about 0.0005% to about 1% by weight of the composition (see, e.g., ‘958, p.10), but provides no clear written support for the discrete ranges of 18-HEPE individually as now recited in instant claims 1 and 8-15. Moreover, the ‘958 disclosure also fails to provide adequate written support for the inclusion of 12-HEPE and/or 15-HEPE as free fatty acids, esters, phospholipids, monoglycerides, diglycerides, triglycerides or combinations thereof as in claim 7, or the inclusion of 12-HEPE and/or 15-HEPE in ethyl ester form as in claim 6. As such, Applicant’s claims 1-20 are not entitled to the benefit of the earlier effective filing date of the ‘958 provisional application.
The disclosure of prior-filed PCT Application No. PCT/US2016/050397, filed September 6, 2016, U.S. Patent Application No. 15/757,023, filed March 2, 2018, and U.S. Patent Application No. 16/843,416, filed April 8, 2020, also fail to provide adequate support or enablement in the manner provided by 35 U.S.C. §112(a) or pre-AIA 35 U.S.C. §112, first paragraph, for one or more claims of this application for the same reasons that the ‘958 provisional application lacks adequate support or enablement as required under 35 U.S.C. §112(a) (pre-AIA first paragraph).
Accordingly, the effective filing date of claims 1-20 is January 20, 2023 (the filing date of the instant application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
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.
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.
(1) Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Serhan et al. (U.S. Patent No. 11,020,406 B2; 2021) in view of Bannenberg et al. (U.S. Patent Application Publication No. 2015/0126602 A1; 2015).
Serhan et al. teaches a polyunsaturated fatty acid (PUFA) composition comprising about 20% to about 95% omega-3 fatty acids by weight of the composition with about 0.0005% to about 1% 17-HDHA and 18-HEPE, collectively by weight of the composition, in which the omega-3 fatty acids are further defined as docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA) (col.4, l.57-61; col.5, l.6-9; col.7, l.61-65). Serhan et al. teaches that the individual amount of 18-HEPE present in the composition is an amount of, e.g., 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09% or 1% by weight of the composition (col.8, l.21-40). Serhan et al. teaches that the omega-3 fatty acids, 17-HDHA and 18-HEPE are incorporated into the composition in ethyl ester form, or as free fatty acids, esters, phospholipids, monoglycerides, diglycerides, triglycerides or combinations thereof (col.14, l.12-18; col.14, l.23-24). Serhan et al. teaches that the composition may be used as a pharmaceutical composition, dietary supplement, nutraceutical product, medical food, nutritional composition for infant formulae and/or prenatal formulae, vaccine coadjuvant, chemotherapeutic coadjuvant, or formulated into a variety of forms, including, e.g., a capsule or emulsion (col.10, l.40-46; col.12, l.25-27; col.13, l.18-26). Serhan et al. further teaches that the composition also contains at least one additional SPM compound, e.g., 5S-HEPE, 15R/S-HEPE, 14R/S HDHA, etc. (col.12, l.49-52). Serhan et al. teaches that the composition is used in a method for treating or resolving inflammation in a subject, including a human subject, when administered to the subject in an effective amount, particularly wherein the inflammation is associated with a disease such as, e.g., asthma, pulmonary inflammation, metabolic syndrome, obesity, etc. (col.17, l.26-46).
Serhan et al. differs from the instant claims only insofar as it does not explicitly teach the further incorporation of 12-HEPE into the disclosed PUFA composition (claim 1).
Bannenberg et al. teaches oils with one or more specialized proresolving mediators (SPMs) or SPM precursors for the treatment of inflammation and diseases associated with inflammation, wherein the oil further contains long-chain PUFA, such as EPA and DHA (p.3, para.[0020]; p.4, para.[0032]). Bannenberg et al. teaches that the SPMs or SPM precursors include, e.g., 12R-HEPE, 12S-HEPE, etc. (p.4, para.[0038]-p.5, para.[0108]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in modifying the anti-inflammatory fatty acid composition of Serhan et al. to further incorporate the anti-inflammatory SPM compound 12-HEPE (claim 1), as disclosed by Bannenberg et al. to be suitable for combination with long-chain PUFA such as DHA and/or EPA, because each was known in the art to exhibit anti-inflammatory activity. The skilled artisan would have been motivated to make such a combination because this shared activity would have provided, at minimum, additive (if not synergistic) anti-inflammatory effects when combined. MPEP §2144.06(I) states that it is generally prima facie obvious to use in combination two or more compounds to be used separately for the same purpose. See In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069, at page 1072 (CCPA 1980) [“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.3d 274, 276-77, 126 USPQ 186, 188 (CCPA 1960)”] and In re Diamond and Kellman, 149 USPQ 562 (CCPA 1966).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
(2) Claims 1-3, 5 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,653,703 B2 in view of Bannenberg et al. (U.S. Patent Application Publication No. 2015/0126602 A1; 2015).
‘703 recites a composition comprising omega-3 fatty acids in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA, 14-HDHA, and 18-HEPE in an amount of about 0.02% to about 1% by weight of the composition (patent claims 1, 5, 7-8). ‘703 further recites the composition as being present in a capsule form (patent claim 2). ‘703 further defines the omega-3 fatty acids as DHA and/or EPA (patent claim 3). ‘703 defines the omega-3 fatty acids, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 4). ‘703 further limits the amount of 18-HEPE to about 0.03% by weight of the composition (patent claim 6). ‘703 further recites that the composition is in the form of a dietary supplement, nutraceutical product, nutritional composition for infant formulae and/or prenatal formulae, pharmaceutical composition, vaccine coadjuvant, chemotherapeutic coadjuvant, or medical food (patent claim 9). ‘703 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 10).
‘703 recites a composition comprising omega-3 fatty acids in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of about 0.0002% to about 1% by weight of the composition, 18-HEPE in an amount of 0.02% to about 1% by weight of the composition, and 14-HDHA in an amount of about 0.001% to about 0.1% by weight of the composition (patent claims 11-12). ‘703 further limits the amount of 18-HEPE to about 0.03% by weight of the composition (patent claim 13). ‘703 further defines the omega-3 fatty acids as DHA and/or EPA (patent claim 14). ‘703 recites that the omega-3 fatty acids, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 15). ‘703 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 16).
‘703 also recites a composition comprising omega-3 fatty acids in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of about 0.01% by weight of the composition, 14-HDHA in an amount of about 0.01% by weight of the composition, and 18-HEPE in an amount of about 0.03% by weight of the composition (patent claim 17). ‘703 further defines the omega-3 fatty acids as DHA and/or EPA (patent claim 19). ‘703 recites that the omega-3 fatty acids, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 18). ‘703 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 20).
In the ‘703 disclosure, the patentee defines the inflammation as being associated with a disease, in which the disease is, e.g., infectious disease, Alzheimer’s disease, metabolic syndrome, obesity, etc. (col.17, l.26-46), thereby establishing that the specific forms of inflammation of instant claim 20 were embodiments within the objective scope of the ‘703 method.
‘703 differs from the instant claims only insofar as it does not explicitly teach the further incorporation of 12-HEPE and 15-HEPE into the composition (claim 1), or additionally 5S-HEPE (claim 16).
Bannenberg et al. teaches oils with one or more SPMs or SPM precursors for the treatment of inflammation and diseases associated with inflammation, wherein the oil further contains long-chain PUFA, such as EPA and DHA (p.3, para.[0020]; p.4, para.[0032]). Bannenberg et al. teaches that the SPMs or SPM precursors include, e.g., 12R-HEPE, 12S-HEPE, 15S-HEPE, 5S-HEPE, etc. (p.4, para.[0038]-p.5, para.[0108]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the anti-inflammatory fatty acid composition of the ‘703 claims with the anti-inflammatory SPM or SPM precursor compounds 12R/S-HEPE and 15S-HEPE (claim 1), as well as 5S-HEPE (claim 16), disclosed by Bannenberg et al. to be suitable for combination with long-chain PUFA, such as DHA and/or EPA, because each was known in the art to exhibit anti-inflammatory activity. The skilled artisan would have been motivated to make such a combination because this shared activity would have provided, at minimum, additive (if not synergistic) anti-inflammatory effects when combined. MPEP §2144.06(I) states that it is generally prima facie obvious to use in combination two or more compounds to be used separately for the same purpose. See In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069, at page 1072 (CCPA 1980) [“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.3d 274, 276-77, 126 USPQ 186, 188 (CCPA 1960)”] and In re Diamond and Kellman, 149 USPQ 562 (CCPA 1966).
This is a nonprovisional nonstatutory double patenting rejection.
(3) Claims 1-3, 5 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,020,406 B2 in view of Bannenberg et al. (U.S. Patent Application Publication No. 2015/0126602 A1; 2015).
‘406 recites a composition comprising omega-3 fatty acids in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of about 0.01% to about 0.04% by weight of the composition, 14-HDHA in an amount of about 0.008% to about 0.04% by weight of the composition, and 18-HEPE in an amount of 0.02% to about 0.07% by weight of the composition (patent claims 1, 5, 8). ‘406 further defines the omega-3 fatty acids as DHA and/or EPA (patent claim 3). ‘406 recites that the composition is present in a capsule (patent claim 2). ‘406 further recites that the omega-3 fatty acids, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 4). ‘406 further limits the amount of 18-HEPE to about 0.03% by weight of the composition (patent claim 6) or about 0.04% by weight of the composition (patent claim 7). ‘406 recites that the composition may be formulated as a dietary supplement, nutraceutical product, nutritional composition for infant formulae and/or prenatal formulae, pharmaceutical composition, vaccine coadjuvant, chemotherapeutic coadjuvant, or medical food (patent claim 9). ‘406 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 10).
‘406 also recites a composition comprising omega-3 fatty acids in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of about 0.2% by weight of the composition, 18-HEPE in an amount of about 0.03% to about 0.06% by weight of the composition, and 14-HDHA in an amount of about 0.01% to about 0.1% by weight of the composition (patent claims 11-13). ‘406 further defines the omega-3 fatty acids as DHA and/or EPA (patent claim 16). ‘406 further limits the amount of 18-HEPE to about 0.03% by weight of the composition (patent claim 14) or about 0.06% by weight of the composition (patent claim 15). ‘406 further recites that the omega-3 fatty acids, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 17). ‘406 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 18).
In the ‘406 disclosure, the patentee defines the inflammation as being associated with a disease, in which the disease is, e.g., infectious disease, Alzheimer’s disease, metabolic syndrome, obesity, etc. (col.17, l.26-46), thereby establishing that the specific forms of inflammation of instant claim 20 were embodiments within the objective scope of the ‘406 method.
‘406 differs from the instant claims only insofar as it does not explicitly teach the further incorporation of 12-HEPE and 15-HEPE into the composition (claim 1), or additionally 5S-HEPE (claim 16).
Bannenberg et al. teaches oils with one or more SPMs or SPM precursors for the treatment of inflammation and diseases associated with inflammation, wherein the oil further contains long-chain PUFA, such as EPA and DHA (p.3, para.[0020]; p.4, para.[0032]). Bannenberg et al. teaches that the SPMs or SPM precursors include, e.g., 12R-HEPE, 12S-HEPE, 15S-HEPE, 5S-HEPE, etc. (p.4, para.[0038]-p.5, para.[0108]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the anti-inflammatory fatty acid composition of the ‘406 claims with the anti-inflammatory SPM or SPM precursor compounds 12R/S-HEPE and 15S-HEPE (claim 1), as well as 5S-HEPE (claim 16), disclosed by Bannenberg et al. to be suitable for combination with long-chain PUFA, such as DHA and/or EPA, because each was known in the art to exhibit anti-inflammatory activity. The skilled artisan would have been motivated to make such a combination because this shared activity would have provided, at minimum, additive (if not synergistic) anti-inflammatory effects when combined. MPEP §2144.06(I) states that it is generally prima facie obvious to use in combination two or more compounds to be used separately for the same purpose. See In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069, at page 1072 (CCPA 1980) [“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.3d 274, 276-77, 126 USPQ 186, 188 (CCPA 1960)”] and In re Diamond and Kellman, 149 USPQ 562 (CCPA 1966).
This is a nonprovisional nonstatutory double patenting rejection.
(4) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,559,529 B2 in view of Serhan et al. (U.S. Patent No. 11,020,406 B2; 2021) and Bannenberg et al. (U.S. Patent Application Publication No. 2015/0126602 A1; 2015).
‘529 recites a composition comprising DHA in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of about 0.02% to about 1% by weight of the composition, 14-HDHA and 18-HEPE (patent claims 1-2, 10-16). ‘529 recites that the DHA, 17-HDHA, 14-HDHA and 18-HEPE are in ethyl ester form (patent claim 3), or in free fatty acid, ester, monoglyceride, diglyceride, triglyceride form or combinations thereof (patent claim 4). ‘529 recites that the composition may be formulated as a dietary supplement, nutraceutical product or nutritional composition (patent claim 5), infant formulae or prenatal formulae (patent claim 6), pharmaceutical composition (patent claim 7), or medical food composition or nutritional composition (patent claim 19). ‘529 recites that the composition further comprises resolvin D5 and/or protectin DX (patent claim 15), a compound that is, e.g., resolvin E1 (patent claim 17), or a compound that is, e.g., 5S-HEPE, 12R/S-HEPE, 15S-HEPE, etc. (patent claim 18). ‘529 further recites a method of treating inflammation in a subject having a disease with an inflammatory component comprising administering the composition to the subject (patent claim 8), wherein the disease is, e.g., asthma, pulmonary inflammation, infectious disease, etc. (patent claim 9), or a method of promoting wound healing in a subject in need thereof comprising administering to the subject the composition (patent claim 20).
‘529 differs from the instant claims only insofar as it does not explicitly teach modifying the claimed composition to incorporate 18-HEPE in an amount of “about 0.02% to about 1%” by weight of the composition (claim 1), or to further incorporate 12-HEPE and 15-HEPE into the base composition (claim 1).
Serhan et al. teaches a PUFA composition comprising about 20% to about 95% omega-3 fatty acids by weight of the composition with about 0.0005% to about 1% 17-HDHA and 18-HEPE, collectively by weight of the composition, in which the omega-3 fatty acids are further defined as DHA and/or EPA (col.4, l.57-61; col.5, l.6-9; col.7, l.61-65). Serhan et al. teaches that the individual amount of 18-HEPE present in the composition is an amount of, e.g., 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09% or 1% by weight of the composition (col.8, l.21-40). Serhan et al. teaches that the omega-3 fatty acids, 17-HDHA and 18-HEPE are incorporated into the composition in ethyl ester form, or as free fatty acids, esters, phospholipids, monoglycerides, diglycerides, triglycerides or combinations thereof (col.14, l.12-18; col.14, l.23-24). Serhan et al. teaches that the composition may be used as a pharmaceutical composition, dietary supplement, nutraceutical product, medical food, nutritional composition for infant formulae and/or prenatal formulae, vaccine coadjuvant, chemotherapeutic coadjuvant, or formulated into a variety of forms, including, e.g., a capsule or emulsion (col.10, l.40-46; col.12, l.25-27; col.13, l.18-26). Serhan et al. further teaches that the composition also contains at least one additional SPM compound, e.g., 5S-HEPE, 15R/S-HEPE, 14R/S HDHA, etc. (col.12, l.49-52). Serhan et al. teaches that the composition is used in a method for treating or resolving inflammation in a subject, including a human subject, when administered to the subject in an effective amount, particularly wherein the inflammation is associated with a disease such as, e.g., asthma, pulmonary inflammation, metabolic syndrome, obesity, etc. (col.17, l.26-46).
Bannenberg et al. teaches oils with one or more SPMs or SPM precursors for the treatment of inflammation and diseases associated with inflammation, wherein the oil further contains long-chain PUFA, such as EPA and DHA (p.3, para.[0020]; p.4, para.[0032]). Bannenberg et al. teaches that the SPMs or SPM precursors include, e.g., 12R-HEPE, 12S-HEPE, 15S-HEPE, 5S-HEPE, etc. (p.4, para.[0038]-p.5, para.[0108]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in incorporating the 18-HEPE component of the ‘529 composition in an amount of “about 0.02% to about 1%” by weight of the composition (claim 1) because Serhan et al. teaches long-chain PUFA compositions, such as DHA and/or EPA, further combined with 17-HDHA and 18-HEPE, for anti-inflammatory use, in which the individual amount of 18-HEPE present in the composition is an amount of, e.g., 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09% or 1% by weight of the composition. The skilled artisan would have found it prima facie obvious to utilize amounts between 0.02% and 1% by weight as described by Serhan et al. because Serhan et al. explicitly teaches that such individual amounts of 18-HEPE were suitable for therapeutic use in an anti-inflammatory composition when coupled with long-chain PUFA, such as DHA and/or EPA, and 17-HDHA.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the anti-inflammatory fatty acid composition of the ‘529 claims as modified above by Serhan et al. with the anti-inflammatory SPM or SPM precursor compounds 12R/S-HEPE and 15S-HEPE (claim 1), disclosed by Bannenberg et al. to be suitable for combination with long-chain PUFA, such as DHA and/or EPA, because each was known in the art to exhibit anti-inflammatory activity. The skilled artisan would have been motivated to make such a combination because this shared activity would have provided, at minimum, additive (if not synergistic) anti-inflammatory effects when combined. MPEP §2144.06(I) states that it is generally prima facie obvious to use in combination two or more compounds to be used separately for the same purpose. See In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069, at page 1072 (CCPA 1980) [“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.3d 274, 276-77, 126 USPQ 186, 188 (CCPA 1960)”] and In re Diamond and Kellman, 149 USPQ 562 (CCPA 1966).
This is a nonprovisional nonstatutory double patenting rejection.
(5) Claims 1-3, 5 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,833,158 B2 in view of Bannenberg et al. (U.S. Patent Application Publication No. 2015/0126602 A1; 2015).
‘158 recites a composition comprising DHA in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of 0.01% to about 1% by weight of the composition, 18-HEPE in an amount of 0.02% to about 1% by weight of the composition, 14-HDHA and 15-HEPE (patent claims 1, 6-7). ‘158 defines the composition as further comprising EPA (patent claim 3). ‘158 recites that the composition is present in a capsule or emulsion (patent claim 2). ‘158 further recites that the DHA, 14-HDHA, 15-HEPE, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 4). ‘158 further limits the amount of 18-HEPE to about 0.03% by weight of the composition (patent claim 5). ‘158 recites that the composition may be formulated as a dietary supplement, nutraceutical product, nutritional composition for infant formulae and/or prenatal formulae, pharmaceutical composition, vaccine coadjuvant, chemotherapeutic coadjuvant, or medical food (patent claim 8). ‘158 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 9).
In the ‘158 disclosure, the patentee defines the inflammation as being associated with a disease, in which the disease is, e.g., infectious disease, Alzheimer’s disease, metabolic syndrome, obesity, etc. (col.17, l.26-46), thereby establishing that the specific forms of inflammation of instant claim 20 were embodiments within the objective scope of the ‘158 method.
‘158 differs from the instant claims only insofar as it does not explicitly teach the further incorporation of 12-HEPE into the composition (claim 1), or additionally 5S-HEPE (claim 16).
Bannenberg et al. teaches oils with one or more SPMs or SPM precursors for the treatment of inflammation and diseases associated with inflammation, wherein the oil further contains long-chain PUFA, such as EPA and DHA (p.3, para.[0020]; p.4, para.[0032]). Bannenberg et al. teaches that the SPMs or SPM precursors include, e.g., 12R-HEPE, 12S-HEPE, 15S-HEPE, 5S-HEPE, etc. (p.4, para.[0038]-p.5, para.[0108]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the anti-inflammatory fatty acid composition of the ‘158 claims with the anti-inflammatory SPM or SPM precursor compounds 12-HEPE (claim 1), as well as 5S-HEPE (claim 16), disclosed by Bannenberg et al. to be suitable for combination with long-chain PUFA, such as DHA and/or EPA, because each was known in the art to exhibit anti-inflammatory activity. The skilled artisan would have been motivated to make such a combination because this shared activity would have provided, at minimum, additive (if not synergistic) anti-inflammatory effects when combined. MPEP §2144.06(I) states that it is generally prima facie obvious to use in combination two or more compounds to be used separately for the same purpose. See In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069, at page 1072 (CCPA 1980) [“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.3d 274, 276-77, 126 USPQ 186, 188 (CCPA 1960)”] and In re Diamond and Kellman, 149 USPQ 562 (CCPA 1966).
This is a nonprovisional nonstatutory double patenting rejection.
(6) Claims 1-3, 5 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-18 of U.S. Patent No. 11,833,158 B2 in view of Bannenberg et al. (U.S. Patent Application Publication No. 2015/0126602 A1; 2015).
‘158 recites a composition comprising DHA in an amount of about 20% to about 95% by weight of the composition, with 17-HDHA in an amount of 0.01% to about 1% by weight of the composition, 18-HEPE in an amount of 0.02% to about 1% by weight of the composition, 14-HDHA and 12-HEPE (patent claims 10, 15-16). ‘158 defines the composition as further comprising EPA (patent claim 12). ‘158 recites that the composition is present in a capsule or emulsion (patent claim 11). ‘158 further recites that the DHA, 14-HDHA, 12-HEPE, 17-HDHA and/or 18-HEPE are present in the composition as a free fatty acid, ester, phospholipid, monoglyceride, diglyceride, triglyceride or a combination thereof (patent claim 13). ‘158 further limits the amount of 18-HEPE to about 0.03% by weight of the composition (patent claim 14). ‘158 recites that the composition may be formulated as a dietary supplement, nutraceutical product, nutritional composition for infant formulae and/or prenatal formulae, pharmaceutical composition, vaccine coadjuvant, chemotherapeutic coadjuvant, or medical food (patent claim 17). ‘158 further recites a method of treating inflammation comprising administering the composition to a subject having inflammation (patent claim 18).
In the ‘158 disclosure, the patentee defines the inflammation as being associated with a disease, in which the disease is, e.g., infectious disease, Alzheimer’s disease, metabolic syndrome, obesity, etc. (col.17, l.26-46), thereby establishing that the specific forms of inflammation of instant claim 20 were embodiments within the objective scope of the ‘158 method.
‘158 differs from the instant claims only insofar as it does not explicitly teach the further incorporation of 15-HEPE into the composition (claim 1), or additionally 5S-HEPE (claim 16).
Bannenberg et al. teaches oils with one or more SPMs or SPM precursors for the treatment of inflammation and diseases associated with inflammation, wherein the oil further contains long-chain PUFA, such as EPA and DHA (p.3, para.[0020]; p.4, para.[0032]). Bannenberg et al. teaches that the SPMs or SPM precursors include, e.g., 12R-HEPE, 12S-HEPE, 15S-HEPE, 5S-HEPE, etc. (p.4, para.[0038]-p.5, para.[0108]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the anti-inflammatory fatty acid composition of the ‘158 claims with the anti-inflammatory SPM or SPM precursor compound 15S-HEPE (claim 1), as well as 5S-HEPE (claim 16), disclosed by Bannenberg et al. to be suitable for combination with long-chain PUFA, such as DHA and/or EPA, because each was known in the art to exhibit anti-inflammatory activity. The skilled artisan would have been motivated to make such a combination because this shared activity would have provided, at minimum, additive (if not synergistic) anti-inflammatory effects when combined. MPEP §2144.06(I) states that it is generally prima facie obvious to use in combination two or more compounds to be used separately for the same purpose. See In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069, at page 1072 (CCPA 1980) [“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.3d 274, 276-77, 126 USPQ 186, 188 (CCPA 1960)”] and In re Diamond and Kellman, 149 USPQ 562 (CCPA 1966).
This is a nonprovisional nonstatutory double patenting rejection.
Conclusion
Rejection of claims 1-20 is proper.
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
January 7, 2026