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 04/24/2024, has been entered.
Claims 14, 18-20, 22 have been canceled.
Claims 1-13, 15-17, 21, 23-25 are pending and currently under examination.
Independent Claim
1. A method for eliminating a patient's need for lipoprotein apheresis therapy, or reducing the frequency of lipoprotein apheresis therapy required by a patient to achieve a target lipoprotein level, the method comprising selecting a patient with hypercholesterolemia who is being or has been treated with lipoprotein apheresis at an initial (pre-treatment) frequency, and administering one or more doses of an antibody or antigen-binding fragment thereof that specifically binds PCSK9 and that comprises a heavy chain variable region (HCVR) that comprises the heavy chain complementarity determining regions (CDRs) of a HCVR comprising the amino acid sequence set forth in SEQ ID NO: 1; and a light chain variable region (LCVR) that comprises the light chain CDRs of a LCVR comprising the amino acid sequence set forth in SEQ ID NO: 6, and one or more selected from the group consisting of: atorvastatin, atorvastatin & ezetimibe, rosuvastatin, cerivastatin, pitavastatin, fluvastatin, lovastatin, simvastatin, simvastatin & ezetimibe, pravastatin, and combinations thereof, to the patient, thereby lowering the level of at least one lipoprotein in the serum of the patient and reducing frequency of lipoprotein apheresis required by the patient to achieve a target lipoprotein level.
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 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 1-13, 15-17, 21, 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Clube (US Patent 8,945,560) in view of Bambauer et al. (The Scientific World Journal, 2012, Article ID 314283, Pages 1-19).
Clube taught administering anti-PCSK9 antibody, alirocumab, to patients indicated for LDL apheresis (see entire document, in particular, see, e.g., column 162, line 54 and paragraph bridging columns 182-183). Clube taught that the target patient population is being diagnosed with HeFH and is on a low or high dose of statin (see, e.g., columns 164 and 222). Moreover, Clube taught the antibody is to be administered at a dose of 150 mg every two weeks (see paragraph bridging columns 223-224). Given the prior art taught alirocumab, it would have the same CDR and HCVR/LCVR sequences as recited in the present claims. Although Clube did not specify the types of lipoprotein apheresis therapy, given that Clube disclosed LDL apheresis, he implicitly taught cascade filtration, immunoadsorption, heparin-induced LDL precipitation, dextran sulfate LDL adsorption, and the LDL hemoperfusion because these are the known types of LDL-apheresis systems available as evidenced by Bambauer et al. (see Abstract).
The only difference between Clube and the present claims is that Clube taught the patient is indicated for LDL apheresis but did not teach the patients is being or has been treated with lipoprotein apheresis. However, it would have been obvious to one of ordinary skill in the art to select a patient who is or has been treated for lipoprotein apheresis given that the patient has been suffering from hypercholesterolemia, hyperlipidemia, indicated for LDL apheresis as taught by Clube. Moreover, one of ordinary skill in the art would have been motivated to select a patient who is being or has been treated with LDL apheresis because apheresis methods have the disadvantage of being expensive and prone to infection as taught by Bambauer (see Table 1).
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 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 1-13, 15-17, 21, 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,550,837 in view of Clube (US Patent 8,945,560) in view of Bambauer et al. (The Scientific World Journal, 2012, Article ID 314283, Pages 1-19).
Both the patented claims and the pending claims of the present application are directed to a method treating patients indicated for LDL apheresis comprising administering alirocumab. The difference between the present claims and the patented claims can be rendered obvious in view of Clube and Bambauer for reasons discussed in the 103 Rejection (see supra). Therefore, the present claim and the patented claims anticipate and/or render obvious of each other.
Claims 1-13, 15-17, 21, 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,772,956 and claims 1-20 of U.S. Patent No. 11,904,017.
Both the patented claims and the pending claims of the present application are directed to a method treating hypercholesterolemia in patients indicated for LDL apheresis comprising administering alirocumab. Therefore, the claims anticipate and/or render obvious of each other.
Conclusion
No claim is allowed.
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/SHARON X WEN/Primary Examiner, Art Unit 1641