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 .
Claims Status
Claims 3-6, 11-12, 15, and 23-27 are canceled.
Claim 1 is amended.
Claims 1-2, 7-10, 13-14, and 16-22 are pending.
Election/Restrictions
Applicant’s election without traverse of claims 1 and 2 in the reply filed on November 14, 2025 is acknowledged.
Claims 7-10, 13-14, and 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
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 (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 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.
(Previous rejection, maintained) Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt sequence (Database entry ID: K9TJJ9_9CYAN; release 2013_03/2013_03; 06-Mar-2013) hereinafter referred to as R1 as evidenced by Woo et al. (KR101971481B1; published April 23, 2019).
R1 teaches a lipoxygenase (Oscillatoria acuminata PCC 6304) that shares 100% sequence identity with SEQ ID NO: 1 of claim 1. Given that the sequence of the lipoxygenase (Oscillatoria acuminata PCC 6304) is identical with SEQ ID NO: 1, it would be inherent for both to share the same biochemical and substrate activity for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) as evidenced by Woo et al. who teach a lipoxygenase (Volvox carteri) that processes docosahexaenoic acid into a di-hydroxy derivative of DHA (Paragraph 0008, pg. 4 of the translated patent application publication).
Therefore, claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt sequence (Database entry ID: K9TJJ9_9CYAN; release 2013_03/2013_03; 06-Mar-2013) hereinafter referred to as R1 as evidenced by Woo et al. (KR101971481B1; published April 23, 2019).
(Previous rejection, maintained) Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt sequence (Database entry ID: K9VMV7_9CYAN; release 2013_03/2013_03; 06-Mar-2013) hereinafter referred to as R2 as evidenced by Woo et al. (KR101971481B1; published April 23, 2019).
R2 teaches an arachidonate 15-lipoxygenase (Oscillatoria nigro-viridis PCC 7112) that shares 100% sequence identity with SEQ ID NO: 2 of claim 1. Given that the sequence of the arachidonate 15-lipoxygenase (Oscillatoria nigro-viridis PCC 7112) is identical with SEQ ID NO: 2, it would be inherent for both to share the same biochemical and substrate activity for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) as evidenced by Woo et al. who teach a lipoxygenase (Volvox carteri) that processes docosahexaenoic acid into a di-hydroxy derivative of DHA (Paragraph 0008, pg. 4 of the translated patent application publication).
Therefore, claim 1 is rejected under 35 U.S.C. 102(a1) as being anticipated by UniProt sequence (Database entry ID: K9VMV7_9CYAN; release 2013_03/2013_03; 06-Mar-2013) as evidenced by Woo et al. (KR101971481B1; published April 23, 2019).
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered but they are not persuasive.
Applicants argue that the amended claim is directed toward the improvement of skin condition and that the reference of Woo does not disclose the use of the mono-hydroxy or the di-hydroxyl derivatives having any effect of improving skin conditions and thus amended claim 1 is not anticipated by Woo (see pg. 7).
The Examiner does not find this persuasive as the claim recitation of “wherein the mono-hydroxy derivative or the di-hydroxy derivative of the polyunsaturated fatty acid improves skin condition” is an intended use of the composition of claim 1 and does not hold patentable weight (see MPEP section 2111.02).
Thus, the rejection is maintained for the reasons previously made of record and for those reasons repeated herein.
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.
(previous rejection, maintained) Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12291736B2 to Seo et al., hereinafter referred to as ‘736. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Pending claim 1 is drawn to an enzyme for producing mono- or di-hydroxy derivatives of polyunsaturated fatty acids having an amino acid sequence having at least 90% homology with an amino acid sequence represented by SEQ ID NO: 1 or 2.
Patented claim 1 of ‘736 is drawn to an enzyme for producing di-hydroxy derivatives of polyunsaturated fatty acids, having the amino acid sequence of SEQ ID NO: 1 (the sequence of SEQ ID NO: 1 shares 99.9% sequence identity with SEQ ID NO: 2 of instant pending claim 1).
Thus, a comparison of claim 1 of ‘736 and instant pending claim 1 shows that the ‘736 claim 1 is encompassed by and anticipates instant pending claim 1.
(previous rejection, maintained) Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12291736B2 to Seo et al. hereinafter referred to as ‘736. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Pending claim 2 is drawn to the enzyme of instant pending claim 1, wherein the polyunsaturated fatty acid is docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA).
Patented claim 2 of ‘736 is drawn to the enzyme (of claim 1) for producing the di-hydroxy derivatives of polyunsaturated fatty acids of the enzyme for producing the di-hydroxy derivatives of polyunsaturated fatty acids of wherein a substrate of the enzyme is docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA).
Thus, a comparison of claim 2 of ‘736 and instant pending claim 2 shows that the ‘736 claim 2 is encompassed by and anticipates instant pending claim 2.
(previous rejection, maintained) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 19/080,532 (Seo et al.). hereinafter referred to as ‘532. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Pending claim 1 is drawn to an enzyme for producing mono- or di-hydroxy derivatives of polyunsaturated fatty acids having an amino acid sequence having at least 90% homology with an amino acid sequence represented by SEQ ID NO: 1 or 2.
Pending claim 2 is drawn to the enzyme of pending claim 1, wherein the polyunsaturated fatty acid is docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA).
Copending claim 2 of ‘532 is drawn to a method for producing the compound of claim 1, comprising reacting the enzyme having the amino acid sequence of SEQ ID NO: 1 with docosahexaenoic acid (DHA). The amino acid sequence of SEQ ID NO:1 shares 99.9% sequence identity with SEQ ID NO: 2 of instant pending claim 1.
Thus, a comparison of claim 2 of copending ‘532 and instant pending claims 1 and 2 shows that the copending ‘532 claim 2 is encompassed by and anticipates instant pending claims 1 and 2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicants argue that patented claims 1 and 2 of ‘736 and co-pending claims 1 and 2 of ‘532 do not disclose or teach that the mono-hydroxy derivatives or di-hydroxy derivatives of the polyunsaturated fatty acid improves skin conditions as recited by amended claim 1 of the current instant application (see pg. 9-10).
The Examiner does not find this persuasive as the claim recitation of “wherein the mono-hydroxy derivative or the di-hydroxy derivative of the polyunsaturated fatty acid improves skin condition” is an intended use of the composition of claim 1 and does not hold patentable weight (see MPEP section 2111.02).
Thus, the rejection is maintained for the reasons previously made of record and for those reasons repeated herein.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 GEORGE T LOUNTOS whose telephone number is (571)272-0502. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE THEMISTOCLIS LOUNTOS/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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