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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 11-18) in the reply filed on 08/13/25 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 19-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 11-18 are included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 01/29/24 and 11/18/24 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claims 13, 17, and 18 are objected to because of the following informalities:
In claim 13, line 2, either the phrase “comprises the composition” or the phrase “the composition contains” should be deleted because it is redundant.
In claim 13, the empty space between lines 3 and 4 should be deleted.
In claim 17, line 1, a space should be inserted between “EPA-E” and “is.”
In claim 18, line 1, a space should be inserted between “EPA-E” and “is.”
Appropriate correction is required.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
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 of this title, 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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claims 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Peet et al. (US 2004/0162348 A1) in view of Szilbereky et al. (WO 2006/059169 A2).
Instant claim 11 is drawn to a pharmaceutical composition comprising ethyl eicosapentaenoate (EPA-E), lecithin, and one or more surfactants, wherein the EPA-E is present in an amount of at least about 90% by weight of all omega-3 fatty acids in the composition.
Peet teaches a pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA (claim 1). The EPA is in the form of ethyl-EPA (claim 4). Pure ethyl-EPA was provided at a dose of 2 g/day in the form of four 0.5 g soft gelatin capsules ([0034]). Peet teaches that natural emulsifying agents, including phospholipids or galactolipids (reads on surfactants), may be used in the composition ([0081]). The pharmaceutical preparation preferably contains less than 3% docosahexaenoic acid (DHA) (claim 1), or preferably less than 3% of DHA, DPA (docosapentaenoic acid) or AA (arachidonic acid) or other competing fatty acids individually ([0080], [0088], claims 2-3).
Peet does not expressly teach lecithin.
Szilbereky teaches a pharmaceutical composition comprising EPA ethyl ester and lecithin filled into soft gelatin capsules (Example 1 – Page 11, line 29 to Page 12, line 6, and Example 3 – Page 12, lines 19-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA, wherein the EPA is in the form of ethyl-EPA, and pure ethyl-EPA was provided at a dose of 2 g/day in the form of four 0.5 g soft gelatin capsules, as taught by Peet, in view of the pharmaceutical composition comprising EPA ethyl ester and lecithin filled into soft gelatin capsules, as taught by Szilbereky, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references are drawn to capsule formulations comprising ethyl-EPA and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
Furthermore, since Peet teaches that natural emulsifying agents, including phospholipids, may be used in the composition ([0081]), one of ordinary skill in the art would have found it obvious to include natural phospholipids, such as the lecithin taught by Szilbereky, in the capsule composition taught by Peet.
Also, MPEP 2144.06 states: "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 to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said lecithin and ethyl-EPA with a reasonable expectation of success because both components are taught to be useful for the same purpose (inclusion in a capsule) and it is prima facie obvious to combine said components to form a third composition to be used for the very same purpose.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 11, the limitation of a pharmaceutical composition comprising EPA-E, lecithin, and one or more surfactants, wherein the EPA-E is present in an amount of at least about 90% by weight of all omega-3 fatty acids in the composition would have been obvious over the pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA (claim 1), wherein the EPA is in the form of ethyl-EPA (claim 4), pure ethyl-EPA was provided at a dose of 2 g/day in the form of four 0.5 g soft gelatin capsules ([0034]), and natural emulsifying agents, including phospholipids, used in the composition ([0081]), as taught by Peet, in view of the pharmaceutical composition comprising EPA ethyl ester and lecithin filled into soft gelatin capsules (Example 1 – Page 11, line 29 to Page 12, line 6, and Example 3 – Page 12, lines 19-29), as taught by Szilbereky.
Regarding instant claim 12, the limitation of the EPA-E present in an amount of at least about 96% by weight of all omega-3 fatty acids in the composition would have been obvious over the pharmaceutical preparation comprising more than 96% pure ethyl EPA ([0027], [0030], [0072]), as taught by Peet.
Regarding instant claims 13 and 14, the limitations of the pharmaceutical composition comprising not more than 0.6% of any individual fatty acid other than EPA-E (instant claim 13) and free of DHA (instant claim 14) would have been obvious over the pharmaceutical preparation preferably containing less than 3% DHA (claim 1), or preferably less than 3% of DHA, DPA or AA or other competing fatty acids individually ([0080], [0088], claims 2-3), as taught by Peet. The range taught by Peet, i.e., less than 3%, overlaps and contains the claimed ranges of not more than 0.6% (instant claim 13) and free of DHA (instant claim 14). According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” One of ordinary skill in the art would have found it obvious to prepare a composition with less than 3% of the competing fatty acids and the recited ranges in instant claims 13 and 14 would have been obvious variants based on the teaching of Peet, unless there is evidence of criticality or unexpected results.
Regarding instant claim 15, the limitation of two surfactants would have been obvious over the natural emulsifying agents, including phospholipids, which may be used in the composition ([0081]), as taught by Peet, and the lecithin (Example 1 – Page 11, line 29 to Page 12, line 6, and Example 3 – Page 12, lines 19-29), as taught by Szilbereky. One of ordinary skill in the art would have found it obvious to include multiple surfactants or emulsifiers based on the desired emulsification in the final capsule preparation.
Regarding instant claim 16, the limitation of a capsule shell would have been obvious over the soft gelatin capsules ([0034]), as taught by Peet, and the soft gelatin capsules (Example 1 – Page 11, line 29 to Page 12, line 6, and Example 3 – Page 12, lines 19-29), as taught by Szilbereky.
Regarding instant claim 17, the limitation of 100 mg to about 1000 mg of EPA-E would have been obvious over the 0.5 g (500 mg) soft gelatin capsules ([0034]), as taught by Peet.
Regarding instant claim 18, the limitation of about 800 mg of EPA-E would have been obvious over the four 0.5 g (500 mg) soft gelatin capsules ([0034]), as taught by Peet. One of ordinary skill in the art would have found it obvious to include various dosages of the EPA-E in the capsules based on the desired loading dose, therapeutic efficacy, and stability. The dosage of EPA-E is a parameter that one of ordinary skill in the art could easily modify during formulation in order to provide appropriate dosing as needed.
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 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-14 of U.S. Patent No. 8,298,554 B2 (the ‘554 Patent) in view of Szilbereky et al. (WO 2006/059169 A2).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a pharmaceutical composition comprising EPA-E, lecithin, and one or more surfactants, wherein the EPA-E is present in an amount of at least about 90% by weight of all omega-3 fatty acids in the composition, and therefore, encompass overlapping or coextensive subject matter.
The difference is that instant claims recite at least about 90% by weight of EPA-E and lecithin, whereas claims of the conflicting patents do not recite these limitations.
However, as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the pharmaceutical composition comprising at least 95% by weight of the total fatty acids present EPA-E enclosed in a capsule shell, as recited in claims of the ‘554 Patent, in view of the pharmaceutical composition comprising EPA ethyl ester and lecithin filled into soft gelatin capsules, as taught by Szilbereky, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both claims of the ‘554 Patent and Szilbereky are drawn to capsule formulations comprising ethyl-EPA and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
Furthermore, MPEP 2144.06 states: "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 to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the ethyl EPA capsule composition recited in claims of the ‘554 Patent with said capsule of lecithin and ethyl-EPA (taught by Szilbereky) with a reasonable expectation of success because both components are taught to be useful for the same purpose (inclusion in a capsule) and it is prima facie obvious to combine said components to form a third composition to be used for the very same purpose.
Therefore, instant claims are obvious over claims of the ‘554 Patent in view of Szilbereky and they are not patentably distinct over each other.
Claims 11-18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 18-20, 23-24, and 53 of commonly assigned copending Application No. 18/472,875 (the ‘875 Application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a pharmaceutical composition comprising EPA-E, lecithin, and one or more surfactants, wherein the EPA-E is present in an amount of at least about 90% by weight of all omega-3 fatty acids in the composition, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 1 of the ‘875 Application broadly recites one or more polyunsaturated fatty acids (PUFAs) or derivatives thereof; and a source of phospholipid, whereas instant claim 1 recites EPA-E, lecithin, and one or more surfactants. However, claim 19 of the ‘875 Application recites ethyl-EPA and claim 24 of the ‘875 Application recites lecithin, thereby rendering these limitations obvious.
Therefore, instant claims are obvious over claims of the ‘875 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615