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 .
Status of Claims
Claims 1-5 are pending and under examination.
Sequence Requirements
The substitute specificaiton filed 7-31-2026 in response to a sequence notice is not fully compliant with the sequence rules. The statement must provide the size of the text file in bytes not kilobytes. Correction is required.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
Specification
The disclosure is objected to because of the following informalities: The specification at page 2, last line references the VL CDRs to be in Table 1, however the VL CDRs are in Table 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claims 1-5 the structure of the MEDI5884 chemical cannot be reasonably ascertained. The specification appears to define the MEDI5884 as “an antibody or an antigen-binding fragmnet thereof that is defined by the three heavy chan CDRs provided in Table 1 and the three light chan CDRs provided in Table 2 (see paragraph [0009]). However, in paragraphs [0018-0019] defined the antibody as the Clothia CDRs of the MEDI5884 or in paragraphs [0020-0022] other numbering systems. As such, the base antibody of the MEDI5884 is not apparently defined with any particularity and the scope of the term MEDI5884 and the antibody associated with it is indefinite.
As to claim 5, the claim sets forth “not below XXX”, however XXX does not define a level of plasma endothelial lipase. Neither the specification nor the claims define the level of “XXX”. As such, the claim is prima facie indefinite.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 99-102 and 104-117 of copending Application No. 17/775,143 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘143 application administers the same antibody, MEDI5884, to the same patient population at a dose 100-350 mg and regimen (monthly) (see claims 99-102; 114-115) by a subcutaneous (claim 105) or parenteral route (claim 104) that falls within the scope of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grimsby et al (WO2021/092421; May 14, 2021).
Grimsby et al teach the administration of MEDI5884 antibody having a heavy chain of SEQ ID NO:9 and light chain of SEQ ID NO:10. Grimsby et al teach the same CDRs having the same sequences as the instantly disclosed MEDI5884 antibody (see paragraph [0105-0161]).
SEQ ID NO:9
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650
728
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And
SEQ ID NO:10:
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376
770
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The MEDI5884 antibody that was administered is identical to the MEDI5884 antibody of the instant claims. Grimsby et al teach the administration of the MEDI5884 antibody for treating cardiovascular disease or reducing atherosclerosis in a subject (paragraph 0011]). Grimsby et al also teach the methods of reducing the risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and/or coronary revascularization in a subject with prior acute coronary syndrome. Grimsby et al also teach methods of reducing the risk of a major adverse cardiovascular event in a subject all by the administration of an antibody or an anti-binding fragment thereof the binds to human endothelial lipase (EL) (see paragraphs [0012-0014]). The methods provide for administering to the subject about 100 mg to about 350 mg of an antibody or antigen-binding fragment thereof where the antibody binds to human endothelial lipase [see paragraph [0009]) and is MEDI5884 or has the VL and VH CDRs thereof. The amounts and administration frequency is set forth at paragraphs [0017-0021] and can be administered parenterally or subcutaneously. Example 3, pages 48-50 provide for administration of the MEDI5884 antibody to healthy subjects. Example 4, provides for a clinical evaluation of MEDI5884 where the subjects had stable coronary heart disease receiving concomitant high-intensity statin therapy. A total of 132 subject received 3 monthly subcutaneous doses of placebo or MEDI5884 at disease of 0,50, 100, 200, 350 and 500mg. (see paragraphs [0210-0211]; Figure 1B). See also claims 86-98 at pages 89-90. As such, the treatment of the cardiovascular patients with elevated EL levels with the MEDI5884 antibody that binds/neutralizes EL and modulates HDL-C, HDL-C phenotype parameters, ApoA1 and CEC in the subject. See claims 1-26 at pages 78-81. As such, the administration of the same antibody to the same patient population at a dosage and frequency within the claimed range anticipates the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
