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 03/10/2026, has been entered.
Claims 19 and 34-39 are pending and currently under examination as they read on a method of reducing a risk of a cardiovascular event comprising administering an anti-PCSK9 antibody.
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 § 102
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.
Claims 19 and 34-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chan et al. (US 2013/0064825 A1; cited in IDS; see entire document).
With regards to claim 19, Chan et al. taught administering anti-PCSK9 antibodies, in particular, 21B12 (aka evolocumab) in a subject that has a LDL-C level of greater than 70 mg/dL (paragraphs 0010, 0428). Moreover, Chan et al. taught lowering the LDL-C level by at least 50% thereby lowering to less than 40 mg/dL (paragraph 0409). Moreover, Chan et al. taught administering once a year which implies keeping the LDL-C level lowered for at least one year (paragraph 0022). Given that Chan taught the same method steps of administering evolocumab, it would reduce a risk of cardiovascular event.
With regards to claims 34-39, Chan et al. taught treating subjects who have been on cholesterol-lowering agents such as statins. Therefore, they would have a serum LDL-C level of less than 60 mg/dL (paragraph 0036). Chan further taught administering the statin concurrently with evolocumab (paragraph 0036). Chan also taught subcutaneous route, dosages that fall within the recited range and frequency of once every 2 weeks (paragraphs 0021 and 0022). Given that Chan taught the same steps of administering, it would reduce PAV by at least 1% and TAV by at least 2%.
Response to Applicant’s argument
Applicant argues that the Office Action has failed to establish that “administering once a year” as allegedly disclosed in Chan necessarily results in lowering the LDL-C level to less than 90% (paragraph 0401) and administering once every 12 months (paragraph 0022). The prior art teaching would lower the LDL-C to less than 40 mg/dL for at least a year. Under the broadest reasonable interpretation, the claim limitation “administering…a PCSK9 inhibitor in an amount sufficient and time sufficient to lower the LDL-C level to less than 40 mg/dL for at least one year” does not require administering only once a year.
With regards to claim 34, it is noted that given Chan taught subjects who have been on a cholesterol lowering agent such as statin, they would have a serum LDL-C level of less than 60 mg/dL. Furthermore, it is noted that the claim does not recite any level of reduction and therefore reads on any level of reduction. As such, Chan’s method comprising the same steps of administering would reduce PAV and TAV.
Therefore, the rejection is maintained.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 19 and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following in view of Chan et al. (US 2013/0064825 A1).
US Patent (cited in IDS)
Claims
US 11464857 B2
1-12
US 8168762 B2
1-22
US 8829165 B2
1-29
US 8871913 B2
1-25
US 8883983 B2
1-30
US 8981064 B2
1-29
US 9056915 B2
1-23
US 9920134 B2
1-17
US 9994923 B2
1-19
US 8030457 B2
1-27
US 8563698 B2
1-6
US 8859741 B2
1-24
US 8871914 B2
1-25
US 8889834 B2
1-20
US 9045547 B2
1-66
US 9493576 B2
1-43
US 10611850 B2
1-33
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to an anti-PCSK9 antibody known for lowering cholesterol and/or a method of lowering cholesterol comprising administering the same anti-PCSK9 antibody. Given the teaching by Chan et al. as discussed above in 102, one of ordinary skill in the art would have arrived at the present claims upon reading Chan’s disclosure of combined treatment of a PCSK9 antibody and statin for reducing a risk of a cardiovascular event or reducing PAV and/or TAV. Therefore, the patent claims would anticipate and/or render obvious of the present claims in view of Chan et al..
Applicant’s argument and Examiner’s response are essentially same as above.
Therefore, the rejection is maintained.
Claim 19 and 34-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 14/316,587; claims 39-59, 86-91,94-98, 100, 102-105, 107-118 of copending Application No. 13/469,032; claims 1-21, 29-30, 33-46 of copending Application USSN 13931716; claims 2-30 of copending application USSN 17011433; claims 1-42, 44, 46-50, 52, 54-56, 60-85, 87-88, 90-91, 94-98, 100, 102-105 and 107-138 of copending application USSN 13469032; claims 118-121, 125-127, 157-164 and 170-197 of copending application USSN 13886180; claims 16-17, 20, 22-88 of copending application USSN 14562546 in view of Chan et al. (US 2013/0064825 A1) and further in view of Kamens et al. (US 2013/0197055 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims disclosed the same anti-PCSK9 antibody and/or are directed to methods of lowering cholesterol comprising administering the same anti-PCSK9 antibody. Given the teaching by Chan et al. as discussed above in 102, one of ordinary skill in the art would have arrived at the present claims upon reading Chan’s disclosure of combined treatment of a PCSK9 antibody and statin for reducing a risk of a cardiovascular event or reducing PAV and/or TAV. Therefore, the co-pending claims would anticipate and/or render obvious of the present claims in view of Chan et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s argument and Examiner’s response are essentially same as above.
Therefore, the rejection is maintained.
Conclusion
No claim is 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 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 on 571-272-0839. 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.
/SHARON X WEN/Primary Examiner, Art Unit 1641