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 06/30/2025, has been entered.
Claims 1-19 have been canceled.
Claims 20-41 have been added and are pending.
Election/Restrictions
Applicant’s election without traverse of Group II and species heterozygous familial hypercholesterolemia (HeFH) in the reply filed on 06/30/2025 is acknowledged.
Claims 31-41 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 20-30 are currently under examination as they read on a method for treating HeFH comprising administering an anti-PCSK9 antibody.
Claim Rejections - 35 USC § 103
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 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 20-30 are rejected under 35 U.S.C. 103 as being obvious over Li et al. (US 2018/0024131 A1) in view of Chan et al. (US 2013/0064825 A1).
Li et al. disclosed anti-PCSK9 monoclonal antibody, MAB1, that is the same antibody as recited in the present claims (see column 9, lines 5-10; also see sequence alignments at the end of the office action). Moreover, Li et al. taught treating hypercholesterolemia using said antibody (column 4, lines 11-17) and that the antibody is humanized (claim 3). Li also taught various doses that fall within the recited range 0.1mg/kg – 60 mg/kg and subcutaneous injection (column 16, Example 7).
Li et al. did not specify that hypercholesterolemia was heterozygous familial hypercholesterolemia (HeFH). However, it would have been obvious to one of ordinary skill in the art to use the antibody for treating HeFH as taught by Chan et al. (see entire document). In particular, Chan et al. taught using a PCSK9 monoclonal antibody to treat familial hypercholesterolemia, including heterozygous FH and homozygous FH (paragraph 0024). Given that HeFH is one of the two species of FH, it would have been obvious for one of ordinary skill in the art to treat HeFH upon reading the teachings of Chan et al. Moreover, Chan taught administering in a cycle of 2 weeks or 4 weeks (paragraph 0026) and further administering a statin and ezetimibe (paragraph 0036). Furthermore, Chan et al. taught autosomal dominant mutation in PCSK9 that cause hypercholesterolemia (paragraph 0455). Moreover, Chan et al. taught selecting patients with LDL-C level greater than 160 mg/dL. Given that Chan taught treating FH, the patient would have a first degree relative with FH.
Chan’s teachings remedied the deficiency of Li as discussed.
Therefore, the invention, as a whole, was 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.
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 20-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,670,604 in view of Chan et al. (US 2013/0064825 A1).
The patent claims disclosed the same anti-PCSK9 monoclonal antibody and method of treating hypercholesterolemia using the antibody. Therefore, the claims in view of the teachings by Chan et al. would render obvious of the present claims for reason stated above (see 103).
Claims 20-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,402,383 in view of Li et al. (US 2018/0024131 A1) and Chan et al. (US 2013/0064825 A1).
The patent claims disclosed polynucleotide encoding the same anti-PCSK9 monoclonal antibody and method of producing the antibody. Li et al. taught polynucleotide encoding the antibody and method of producing the antibody (paragraphs 0076-0079 and 0101-0106). Therefore, the claims in view of the teachings by Li et al. and Chan et al. would render obvious of the present claims for reason stated above (see 103).
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.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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