DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 11/18/2025, has been entered.
Claims 1-98, 103 have been canceled.
Claims 120-125 have been added.
Claims 99-102, 104-125 are currently pending.
Claims 118-119 have been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 99-102, 104-117, 120-125 are currently under examination as they read on a method of treating cardiovascular disease or reducing atherosclerosis comprising administering an anti-endothelial lipase (EL) antibody.
The previous Enablement rejection under 35 USC 112(a) has been withdrawn in view of Applicant’s amendment, filed 11/18/2025.
The previous rejection under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Naito et al. has been withdrawn in view of Applicant’s amendment, filed 11/18/2025.
(US 2017/0260290 A1; cited in IDS; see entire document).
Naito et al. disclosed an anti-EL antibody that has the same CDR, VH and VL sequences as recited in the present claims (see sequence alignments at the end of this Office Action). Moreover, Naito taught a method of treatment of atherosclerosis comprising administering the antibody via parenteral or subcutaneous routes (see, e.g., paragraphs 0353 and 0377). Given that the prior art taught the same method step of administering the same antibody, it would perform the outcomes recited in the claims, e.g., increases HDL-C or reducing the risk of a MACE. 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 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
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.
Claims 99-102, 104-117, 120-125 are rejected under 35 U.S.C. 103 as being unpatentable over Naito et al. (US 2017/0260290 A1) in view of Shi et al. (PDA J Pharm Sci Technol. 2018;72(1):50-61; Abstract only) and Nichols et al. (J Clin Endocrinol Meta, 2018, 103(8):3019-3027).
New Grounds of Rejection are necessitated by Applicant’s amendment, filed 11/18/2025.
Naito et al. disclosed an anti-EL antibody that has the same CDR, VH and VL sequences as recited in the present claims (see sequence alignments at the end of this Office Action). Moreover, Naito taught a method of treatment of atherosclerosis comprising administering the antibody via parenteral or subcutaneous routes (see, e.g., paragraphs 0353 and 0377). Given that the prior art taught the same method step of administering the same antibody, it would perform the outcomes recited in the claims, e.g., increases HDL-C or reducing the risk of a MACE. 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 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Naito did not teach the recited dosage or frequency (i.e., administering 100 mg to 350 mg or 200 to 350 mg or about 250 mg; administering once a month for at least three, 12 or 24 months) and or via an accessorized pre-filled syringe (APFS) or an auto-injector. With regards to the dosage and frequency of administration, it is noted that such manipulations routinely practiced by the ordinary artisan at the time the invention were made were known as result effective variables to increase efficacy of the treatment. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
With respect to APFS or auto-injector, it is noted that these were well-known in the pertinent art before the effective filing dating of the claimed invention. For example, Shi et al. taught that “use of prefilled syringes to self-administer biologics via subcutaneous administration provides convenience to patients”. Therefore, one of ordinary skill in the art would have been motivated to use a pre-filled syringe to administer the antibody as taught by Naito.
Naito also did not teach the subject is receiving statin therapy or has triglyceride (TG) levels <500 mg/dL. However, these are well known characterizations of patients with high cardiovascular disease risk. For example, Nichols et al. taught that patients with high CVD risk had high TG levels between 200 and 499 mg/dL and were on statin. Upon reading such teachings, one of ordinary skill in the art would have been motivated to treat these patients with the antibody taught by Naito to treat atherosclerosis in order to reduce CVD risks.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time of the effective filing of the present application, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Applicant’s argument
Applicant argues that Naito taught arteriosclerosis which is different from atherosclerosis recited in the present claims. In response, it is noted that Naito taught treating atherosclerosis using the anti-EL antibody (see paragraphs 0353, 0425 and 0463). With respect to the dosage and frequency, it is noted that Applicant has not provided evidence of criticality showing the recited dosage and frequence would not be obvious. Therefore, the rejection is maintained as it applies to amended and newly added claims.
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.
New Grounds of Rejection are necessitated by Applicant’s amendment, filed 11/18/2025.
Claims 99-102, 104-117, 120-125 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 101-120 of co-pending Application No. 17/801,670 in view Shi et al. (PDA J Pharm Sci Technol. 2018;72(1):50-61; Abstract only) and Nichols et al. (J Clin Endocrinol Meta, 2018, 103(8):3019-3027).
The co-pending claims disclosed a pharmaceutical comprising the same anti-human EL antibody and a method for reducing risk of cardiovascular death comprising administering the antibody. As such, the co-pending claims would render obvious of the present claims in view of Shi and Nichols as discussed above in 103.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s argument
Applicant argues that the copending claims are directed to an independent and distinct invention. In response, it is noted that there was no restriction between product and use of the product in the present application. Therefore, the argument does not apply here.
Therefore, the rejection is maintained as it applies to amended and newly added claims.
Conclusion
No claim is allowed.
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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641