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 .
Receipt is acknowledged of the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 5/14/26.
Claims 1, 2, 5, 8-12, 15-17, 19 and 20 are pending and have been rejected in this action. Claims 3-4, 6-7, 13-14, 18 and 21 were cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/14/26 has been entered.
Withdrawn Rejections
The 112(a) rejection of the specification has been withdrawn due to the Applicant’s satisfaction of the Budapest Treaty.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5, and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mylari et al. (WO 2014/011895, published 16 January 2014, cited in PTO-892 of 16 January 2025).
Regarding Claims 1, 2, 5, and 10-12: Mylari discloses salts of omega 3 fatty acid eicosapentaenoic acid (EPA), or of docosahexaenoic acid (DHA), in which the cation is metformin, piperazine, meglumine or lysine (page 4, lines 21-23), and a preparation which is a nutraceutical, food product or drink product comprising a salt of a fatty acid wherein the fatty acid is EPA or DHA (page 5, lines 8-11), and the cation of the salt is metformin, piperazine, meglumine or lysine.
Therefore, Mylari teaches a preparation comprising EPA lysine salt or DHA lysine salt, as in instant claims, wherein the fatty acid is EPA or DHA, (claim 5). Mylari teaches that the salts of the invention have high solubility and bioavailability (page 7, line 16). Mylari teaches (page 5, lines 8-11) a nutraceutical product comprising a salt of EPA or DHA with lysine; such nutraceutical product/preparation can be in the form of a capsule (page 18, line 11) (claim 10).
Regarding the disclosure of the microorganisms and the formation of Resolvin E3, these limitations are not necessarily positive recitations in the claims. Instead, they are the effective results of administering the lysine salt of an omega fatty acid to/through the gastrointestinal tract a human subject. Therefore, the claim has also been interpreted as reciting a lysine salt of omega-3 or omega-6 fatty acid wherein the fatty acid portion of the lysine salt is selected from the group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), alpha linolenic acid, stearidonic acid, eicosatetraenoic acid, docosapentaenoic acid, linoleic acid, γ-linolenic acid, arachidonic acid (ARA) and combinations thereof.
“Products of identical chemical composition cannot have mutually exclusive properties.” 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, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”). See 2112.01.
MPEP 2112.01 further states: "When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions (in the instant case: formation of one or more SPM by microorganisms in the GI tract) are presumed to be inherent". "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPO2d 1655, 1658 (Fed. Cir. 1990).
Therefore, a preparation comprising EPA lysine salt or DHA lysine salt, is also anticipated by Mylari.
Claim Rejections- 35 USC 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5, 10-12, 15-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mylari et al. (WO 2014/011895, published 16 January 2014, cited in PTO-892), in view of Isobe et al. (Scientific reports 2018, 8, 7954, published on line 21 May 2018, cited in IDS) and Hou et al. (New Biotechnology 2009, 26 1-2).
Regarding Claims 1, 2, 5, and 10-12: Mylari discloses salts of omega 3 fatty acid eicosapentaenoic acid (EPA), or of docosahexaenoic acid (DHA), in which the cation is metformin, piperazine, meglumine or lysine (page 4, lines 21-23), and a preparation which is a nutraceutical, food product or drink product comprising a salt of a fatty acid wherein the fatty acid is EPA or DHA (page 5, lines 8-11), and the cation of the salt is metformin, piperazine, meglumine or lysine.
Therefore, Mylari teaches a preparation comprising EPA lysine salt or DHA lysine salt, as in instant claims, wherein the fatty acid is EPA or DHA, (claim 5). Mylari teaches that the salts of the invention have high solubility and bioavailability (page 7, line 16). Mylari teaches (page 5, lines 8-11) a nutraceutical product comprising a salt of EPA or DHA with lysine; such nutraceutical product/preparation can be in the form of a capsule (page 18, line 11) (claim 10).
Isobe discloses (page 7954, first paragraph) that dietary (which is consistent with EPA in the gastrointestinal tract of humans or animals) EPA or DHA are precursors to anti-inflammatory lipid mediators such as E-series resolvins, resulting from biochemical oxygenation reactions in the GI tract, as in instant claim 2.
Further regarding the formation of resolving E3, Mylari does not specifically teach formation of Resolvin E3 from EPA, DHA or their salts.
However, based on the disclosure in Isobe, it would have been obvious to one of ordinary skill in the art that the ability to cause formation of Resolvin E3 is a property of an omega 3 fatty acid such as EPA or DHA, as disclosed in Isobe.
Since Mylari teaches a preparation comprising EPA lysine salt or DHA lysine salt, as in instant claims, wherein the fatty acid is EPA or DHA, the property of such a claimed composition will also be taught by the prior art teachings, since the properties are inseparable from the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
MPEP 2112.01 further states: "When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions (in the instant case: formation of one or more SPM by microorganisms in the GI tract) are presumed to be inherent". "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPO2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claims 15, 16, 17, 19, and 20: Mylari discloses salts of omega 3 fatty acid eicosapentaenoic acid (EPA), or of docosahexaenoic acid (DHA), in which the cation is metformin, piperazine, meglumine or lysine (page 4, lines 21-23), and a preparation which is a nutraceutical, food product or drink product comprising a salt of a fatty acid wherein the fatty acid is EPA or DHA (page 5, lines 8-11), and the cation of the salt is metformin, piperazine, meglumine or lysine.
Therefore, Mylari discloses a preparation comprising EPA lysine salt or DHA lysine salt, as in instant claims, wherein the fatty acid is EPA or DHA, as in instant claim 15.
Mylari discloses that the salts of the invention have high solubility and bioavailability (page 7, line 16].
Mylari does not specifically teach formation of one or more specialized pro-resolving lipid mediators (SPM) from EPA, DHA or their salts, the ability to cause formation of one or more specialized pro-resolving lipid mediators (SPM) is an inherent property of an omega 3 fatty acid such as EPA or DHA, as evidenced by Isobe.
Isobe discloses (page 7954, first paragraph) that dietary (which is consistent with EPA in the gastrointestinal tract of humans or animals) EPA or DHA are precursors to anti-inflammatory lipid mediators such as E-series resolvins, 5-HEPE, or 18-HEPE, which are SPMs, resulting from biochemical oxygenation reactions in the GI tract.
Since Mylari teaches a preparation comprising EPA lysine salt or DHA lysine salt, as in instant claims, wherein the fatty acid is EPA or DHA, the property of such a claimed composition will also be taught by the prior art teachings, since the properties are inseparable from the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Mylari does not teach a composition comprising one or more microorganisms comprising Bacillus megaterium DSM 33296, or Bacillus megaterium DSM 33299 and a lysine salt of EPA, or docosahexaenoic acid (DHA), as in instant claim 15, as a capsule, as in instant claim 19, nor does he teach the amount of lysine salt and of the Bacillus strain present in the composition, as in instant claims 16, 17, and 20.
Hou discloses a composition comprising B. megaterium and a fatty acid [abstract]. Hou discloses that the fatty acid can be EPA, DHA, alpha-linolenic, linoleic acid, which are fatty acids of the instant claims [abstract; pages 6-8]. Hou discloses production of oxygenated unsaturated fatty acids by Bacillus megaterium ALA2 [Abstract].
It would have been obvious for a person of ordinary skill in the art to use the teachings of Mylari and Hou to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to replace fatty acid EPA, or DHA, with the corresponding lysine salts in a composition comprising B. megaterium and a fatty acid taught by Hou, because Mylari teaches the advantages of replacing fatty acids such as EPA, DHA with their corresponding lysine salts, for improved solubility and bioavailability. Therefore, one of ordinary skill in the art would have reasonably expected that replacing EPA, DHA with the corresponding lysine salts in a composition with B. megaterium strain will result in a composition with improved solubility and bioavailability/properties for delivery.
Despite Applicant’s recitation of Bacillus megaterium DSM 33296, or Bacillus megaterium DSM 33299 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Hou as also having fatty acid converting ability, absent any clear and convincing evidence otherwise. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shifts to the Applicant to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the teachings of Hou, one would have been motivated to routinely screen out the identified strains with fatty acid converting properties and utilize such strains in the method of Hou.
Further, regarding claims 16-17, 19-20, the person ordinary skill in the art would have optimized the amount of lysine salts of EPA, DHA, and of the B. megaterium in the composition, and would have placed the composition in a capsule, because such optimization of amounts of ingredients in a composition, and the use of capsules, are routine steps in the preparation of pharmaceutical compositions, well within the skill of the artisan.
As such, claims 15-17, 19-20 are rejected as prima facie obvious.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mylari et al. (WO 2014/011895, published 16 January 2014,), in view of Isobe et al. (Scientific reports 2018, 8, 7954, published on line 21 May 2018), as applied to claim 1 above and in further view of Nehen et al. (US 5,874,470).
Regarding Claims 8 and 9: Mylari discloses as discussed above in claim 1.
Mylari does not teach that the preparation contains a dispersion of at least one phospholipid and a lysine salt of EPA, or docosahexaenoic acid (DHA), as in instant claim 8, as a solid composition, as in instant claim 9.
Nehne discloses a preparation /composition comprising a dispersion of a phospholipid and an omega 3 fatty acid such as eicosapentaenoic acid (EPA) [Example 7] or an ester thereof [Examples 3, 8, 9].
It would have been obvious for a person of ordinary skill in the art to use the teachings of Mylari and Nehne to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to prepare a dispersion of eicosapentanenoic acid or a salt thereof taught by Mylari in a phospholipid, because Nehne teaches the advantages of dispersing omega 3 fatty acids in phospholipids, said phospholipids being known as emulsifiers or dispersing agents in microparticle preparations drug carriers. Therefore, one of ordinary skill in the art would have reasonably expected that adding a phospholipid to an omega 3 fatty acid such as EPA or a salt thereof, would result in a dispersion with improved properties for delivery.
The recitation “wherein the preparation increases a formation of one or more specialized pro-resolving lipid mediators (SPM) by microorganisms in a gastrointestinal tract of humans or animals, wherein the microorganisms are Bacillus” in claim 1, refers to properties of the composition. Mylari in view of Nehne render instant composition obvious. If the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Claims 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mylari et al. (WO 2014/011895, published 16 January 2014, cited in PTO-892), in view of Isobe et al. (Scientific reports 2018, 8, 7954, published on line 21 May 2018, cited in IDS) and Hou et al. (New Biotechnology 2009, 26 1-2) as applied to claims 15 and 19 above and in further view of Molinaro et al. (US 2006/0247150).
Regarding Claims 16, 17, and 20: Mylari discloses as discussed above in claims 15 and 19. Molinaro discloses B. megaterium [0038]. Molinaro discloses bacteria including B. megaterium provided at 1 x103 to 1x109 CFU/ml [0043].
It would have been obvious for a person of ordinary skill in the art to use the teachings of Mylari and Nehne to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of modified Mylari to include the B. megaterium at amounts as disclosed in Molinaro in order to provide effective and beneficial amounts in the composition.
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 1-2, 5, 8-12, 15-17, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1, 2, 5, 7-9, 11-18 of co-pending U.S. Patent Application 17/296,465 (cited in PTO-892 of 16 January 2025), in view of Mylari et al. (WO 2014/011895, published 16 January 2014, cited in PTO-892 of 16 January 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because a preparation/composition of claims of co-pending U.S. Patent Application 17/296,465 anticipates or renders obvious the instant claims.
Claims 1-2, 5, 7-9, 11-18 of co-pending U.S. Patent Application 17/296,465 are drawn to a preparation, comprising: a probiotic strain of a genus Bacillus megaterium, and a polyunsaturated fatty acid component comprising an omega-3 or omega-6 fatty acid selected from the group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and arachidonic acid (ARA), wherein the polyunsaturated fatty acid component comprises an omega-3 or omega-6 fatty acid salt.
Thus, the preparation of claims 1-2, 5, 7-9, 12, of co-pending U.S. Patent Application 17/296,465 comprises a salt of an omega-3 or omega-6 fatty acid selected from the same fatty acids as in instant claim 1, 21, and it further comprises a strain of a genus Bacillus megaterium, as in newly added claims 15-20. Further, claim 8 of co-pending U.S. Patent Application 17/296,465 recites a preparation comprising a dispersion of at least one phospholipid and at least one of EPA, DHA or ARA, which is similar to instant claim 8.
Claims 1-3, 5, 7-12, 18 of co-pending U.S. Patent Application 17/296,465 broadly recite a salt of an omega-3 or omega-6 fatty acid selected from EPA, DHA, and ARA, but do not specifically recite a lysine salt, as in the instant claims.
Mylari et al. (WO 2014/011895) teach a lysine salt of EPA or DHA having high solubility and bioavailability.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of claims 1-3, 5, 7-12, 18 of co-pending U.S. Patent Application 17/296,465 and Mylari to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to choose a lysine salt of EPA or DHA as the salt in a composition of claims 1-3, 5, 7-12, 18 of co-pending U.S. Patent Application 17/296,465, because Mylari teaches that a lysine salt of EPA or DHA has high solubility and bioavailability.
Response to Arguments
The 112(a) rejection of the specification has been withdrawn due to the Applicant’s satisfaction of the Budapest Treaty.
The Applicants assert that the term “when” is a functional feature of the claims and that functional language is not improper.
The Examiner maintains that although functional language may not be per se improper, in this instance it does limit the claim. The prior art reference discloses the claimed composition and therefore any feature of the composition would therefore flow through it. Examiner has addressed this in the rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
