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 .
102 Rejections Withdrawn
The rejection of claims 31-38 and 42-48 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment narrows the scope of the claimed subject matter such that it no longer reads on the cited art.
The rejection of claim 49 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
103 Rejections Withdrawn
The rejection of claim 39-41 under 35 USC 103, outlined in the previous Office Action, is withdrawn and reformulated below in light of inventor’s amendment. (The amendment cancels claim 39.)
The rejection of claim 50 under 35 USC 103, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
Claim Rejections - 35 USC § 103, NEW
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31-38 and 40-48 are rejected under 35 U.S.C. 103 as being unpatentable over American Heart Journal (September 2019), Vol. 215, pp. 62-69, prior art or record, and further in view of CN 1692902 A, whose corresponding English machine translation (Google) has been relied upon for purposes of this Office Action.
Inventor teaches a method of treating a patient after a MI comprising initiating administration of colchicine, in tablet form, at a daily low dose within about 3 days of the MI (independent claim 31). Dependent claim 32 (from claim 31) teaches that percutaneous coronary intervention was performed to treat the MI. Dependent claim 33 (from claim 31) teaches that the patient was prescribed a medication. Dependent claim 34 (from claim 33) teaches the medication is at least one of an antiplatelet agent, aspirin and a statin. Dependent claim 35 (from claim 31) teaches that the patient is at a lower risk of a cardiovascular event relative to a patient not administered colchicine. Dependent claim 36 (from claim 35) teaches the cardiovascular event is an ischemic cardiovascular event, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. Dependent claim 37 (from claim 31) teaches that the patient has atherosclerotic coronary artery disease. Dependent claim 38 (from claim 31) teaches that the administration of colchicine is initiated upon assessment in an emergency department, or a medical office. Dependent claim 40 (from claim 31) teaches that the table is coated. Dependent claim 41 (from claim 40) teaches that the tablet is film coated. Dependent claim 42 (from claim 31) teaches a dosage of colchicine of 0.3-0.7 mg. Dependent claim 43 (from claim 42) teaches a dosage 0.4-0.6 mg. Dependent claim 44 (from claim 36) teaches a dosage of colchicine of 0.5 mg. Dependent claim 45 (from claim 31) teaches administration of colchicine once, twice or three times per day. Dependent claim 46 (from claim 45) teaches once per day. Dependent claim 47 (from claim 31) teaches administration of colchicine without preloading. Dependent claim 48 (from claim 31) teaches that the patient is an adult human.
American Heart Journal (September 2019), Vol. 215, pp. 62-69 teaches a method of treating adult human patients (>18 years old) after a myocardial infarction (MI) comprising administering low dose (0.5 mg once daily) colchicine within 7 days of the MI (abstract; page 63, column 1, Methods). The examiner notes for clarity of the record that the prior art teaching of administration within 7 days fully encompasses the instant teaching of within about 3 days of the MI.
The reference is drawn to a pilot, randomized, double blind, placebo-controlled trial whose patients were recruited at Royal Perth Hospital, Perth Australia (abstract; page 63, column 1, Methods).
The patients, in some cases, had been prescribed medications such as antiplatelet agents, aspirin, or a statin (page 65, Table 1). Patients, in some cases, had had a prior myocardial revascularization (page 65, Table 1).
Patients administered colchicine were at a lower risk of a cardiovascular event, such as MI, relative to a patient not being administered colchicine (page 66, column 1, Clinical outcomes, tolerability and safety).
CN 1692902 A teaches a film-coated tablet of colchicine (abstract; translation page 3, Summary of the Invention).
Inventor principally distinguishes over American Heart Journal (September 2019), Vol. 215, pp. 62-69 in that a particular oral delivery vehicle for the colchicine is taught: tablet, coated tablet, film-coated tablet. However, colchicine formulated as tablets, coated tablets and/or film-coated tablets are well-known in the art, as evidenced by, for instance, CN 1692902 A. One of ordinary skill (a highly skilled individual such as, for instance, a clinical physician) would have found it obvious, before the effective filing date of the instant invention and with a reasonable expectation of success, to formulate an oral dose of colchicine in the form or a tablet, coated tablet or film-coated tablet. One ordinary skill would have done so in order to take advantage of, for instance, the ease and simplicity of administering a dosage formulated as a tablet once - or multiple times - per day for both the physician and the patient.
Claim 32 is included in this rejection because its limitation “…percutaneous coronary intervention…” is encompassed by the prior art teaching - because a percutaneous coronary intervention is simply a type myocardial revascularization.
Claim 37 is included in this rejection because its limitation “…the patient has atherosclerotic coronary artery disease…” is intrinsic to the prior art. This is so because the cited art explicitly teaches that inflammation is central to the pathogenesis of atherosclerosis and its acute manifestations (page 62, column 1, line 1) and the point of the American Heart Journal (September 2019), Vol. 215, pp. 62-69 study, and those of prior related studies, is the targeting of inflammatory mechanisms in order to reduce the risk of atherosclerosis and its acute complications (page 67, column 2, Prior Studies) - such as myocardial infarction, stroke, etc.
Double Patenting Rejections Withdrawn
The statutory double patenting rejection of claims 49 and 50, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claims.
The nonstatutory double patenting rejection of claim 39, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
Double Patenting Rejections, MAINTAINED
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 31-38 and 40-48 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 12-19, and 24-26 of (parent) U.S. Patent No. 11,400,063 B2, prior art of record. Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims and those of the instant invention are drawn, essentially, to the same method of treating a patient after having a myocardial infarction. In fact, the subject matter of patented claims 2-6 is identical to that of instant claims 33-35 (where instant claim 34 is a condensed recitation of limitations spread over 3 claims in the patent: claims 3-5); the subject matter of patented claims 7 and 9 is drawn to 2 separate limitations recited in instant claim 36 (which also adds several more limitations with respect to the cardiovascular event); and the subject matter of patented claims 12, 13, 15-19 and 24-26 is identical to that of instant claims 37-38, 40-46 and 48. Significantly, the limitations of instant independent claim 31 and instant dependent claims 32 and 47 are all recited in patented independent claim 1.
As can be seen from the brief outline above, the claims of the patent and those of the instant invention are related, essentially, in a species/genus fashion. That is, the patented method is, essentially, a narrower teaching of the broader method taught by the instant application. Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Inventor has not addressed the rejection other than to state that a Terminal Disclaimer will be filed, if appropriate, upon indication of otherwise allowable subject matter.
Conclusion
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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 4/10/2026
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