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 .
DETAILED ACTION
Applicant’s amendment of 24 December 2025, in which claims 1, 2, 4, 11, 12 have been amended, claims 13-14 have been cancelled, and new claims 15-21 have been added, is acknowledged.
Claims 1-2, 4-5, 8-12, 15-21 are pending in the instant application.
Claims 1-2, 4-5, 8-12, 15-21 are being examined herewith.
Response to arguments of 24 December 2025
In view of Applicant’s amendment of 24 December 2025, all the objections and rejections to claims 13-14 are herein withdrawn. Claims 13, 14 have been cancelled.
Applicant argues (Remarks of 24 December 2025, page 6, last paragraph, page 7) that the recitation
PNG
media_image1.png
142
624
media_image1.png
Greyscale
in claim 1 is not a preamble or intended use limitation, but rather is a functional limitation that “further limits the language of claim 1 to preparations able to increase formation of SPMs”.
Applicant argues that the language in claim 1 is a functional limitation because it defines a part of the claimed formulation by what it does, increase SPM formation.
This argument is not persuasive. This is not a case of functional language. See MPEP 2181.
The claims under examination are drawn to a preparation comprising a lysine salt of EPA or of DHA. Mylari teaches a preparation comprising a lysine salt of EPA or a lysine salt of DHA.
The properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition, then the properties are also taught 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.
The recitation in claims 1, 21, “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” is interpreted to be an intended use for the preparation.
Applicant’s arguments (pages 7-9) seem to refer to the claim amendments of 24 December 2025.
New and modified rejections are made below, based on Applicant’s amendment of 24 December 2025.
Applicant’s arguments (pages 8-9) against the rejection of instant claims on the ground of nonstatutory double patenting over claims of co-pending U.S. Patent Application 17/296,465, have been considered. Applicant argues that the claims in co-pending U.S. Patent Application 17/296,465 do not recite a lysine salt. In response, 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 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.
Applicant argues that the examiner has not shown that omission of Bacillus from the claims in the copending application would necessarily result in a composition having the functional properties related to SPM formation. In response, the instant claims are drawn to a composition. The recitation in instant claim 1 “the preparation increases a formation of SPMs from the lysine salt […] by microorganisms […] Bacillus” is a property of the composition. Since the claims in co-pending U.S. Patent Application 17/296,465 render 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.
Applicant’s amendment of 24 December 2025 necessitated the following new or modified objection and rejections.
Claim Rejections- 35 USC 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-5, 8-12, 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ specific strains of Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, or Bacillus megaterium DSM 33299. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further, it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted on page 5 of the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR
1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
PNG
media_image2.png
150
660
media_image2.png
Greyscale
PNG
media_image3.png
712
642
media_image3.png
Greyscale
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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” is interpreted to be an intended use for the preparation. "[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002).
“Products of identical chemical composition can not 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)
"The recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
Claims 1, 2, 4-5, 10-12, 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mylari et al. (WO 2014/011895, published 16 January 2014, cited in PTO-892 of 16 January 2025), as evidenced by Isobe et al. (Scientific reports 2018, 8, 7954, published on line 21 May 2018, cited in IDS).
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.
Thus, Mylari teaches 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 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), as instant claim 10.
Even though 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 teaches (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 of instant claim 4, resulting from biochemical oxygenation reactions in the GI tract, as in instant claim 2.
Regarding “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 megaterium” in claim 21, or the strains of Bacillus megaterium in instant claim 1, these recitations are properties of the composition. 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.
As such, a preparation comprising EPA lysine salt or DHA lysine salt, is anticipated by Mylari.
Claims 1-2, 4-5, 10-12, 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mylari et al. (WO 2014/011895, published 16 January 2014, cited in PTO-892 of 16 January 2025).
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.
Thus, Mylari teaches 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 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), as instant claim 10.
As such, a preparation comprising EPA lysine salt or DHA lysine salt, is anticipated by Mylari.
“Products of identical chemical composition can not 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)."
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, 8, 9 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), in further view of Nehen et al. (US 5,874,470, cited in PTO-892 of 24 September 2025).
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.
Thus, Mylari teaches 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 5.
Mylari teaches that the salts of the invention have high solubility and bioavailability (page 7, line 16).
Even though 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 teaches (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.
Regarding “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 megaterium” of certain the strains in instant claim 1, these recitations are properties of the composition. 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 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 et al. (US 5,874,470) teach (Example 7) 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.
As such, claims 1, 8, 9 are rejected as prima facie obvious.
Claims 15-20 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), in further view of Hou et al. (New Biotechnology 2009, 26 (1-2), 2-10, cited in PTO-892).
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.
Thus, Mylari teaches 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 teaches that the salts of the invention have high solubility and bioavailability (page 7, line 16).
Regarding claim 18, even though 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 teaches (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.
Regarding claim 18, “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,” these recitations are properties of the composition. 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 32963, 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, 20.
Hou et al. (New Biotechnology 2009, 26 (1-2), 2-10) teach (Abstract) a composition comprising B. megaterium and a fatty acid. Hou discloses (pages 6-8) that the fatty acid can be EPA, DHA, alpha-linolenic, linoleic acid, which are fatty acids of the instant claims. 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 B. megaterium DSM 32963, 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 15-20 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 1-2, 4-5, 8-12, 15-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-3, 5, 7-12, 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 1-3, 5, 7-12, 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 1-3, 5, 7-12, 18 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.
Conclusion
Claims 1-2, 4-5, 8-12, 15-21 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IRINA NEAGU/Primary Examiner, Art Unit 1629