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 .
Claim Rejections - 35 USC § 102
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 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 31-38 and 42-48 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by American Heart Journal (September 2019), Vol. 215, pp. 62-69, cited in the IDS.
The reference 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).
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.
Claim 49 is rejected under 35 U.S.C. 102(a)(1)as being clearly anticipated by Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT), 3/8/2017 update, 8 pages.
The reference teaches the administration of colchicine (0.5 mg per day for an estimated 2 years), or a matching placebo, to patients who have suffered a documented acute myocardial infarction within the last 30 days, in order to evaluate whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction (page 1/8, Purpose).
The examiner notes for clarity of the record that a daily dose of 0.5 mg of colchicine is considered by inventor to be a “low dose” of colchicine (specification page 2, line 13).
The examiner further notes for clarity of the record that the preamble of the claim “A method of reducing the risk of a stroke…” cannot be considered limiting, and as such is given no patentable weight, because it simply expresses an intended result of the one positively recited method step in the body of the claim. That is, the body of the claim defines a structurally complete invention. Note the discussion at MPEP 2111.02 (II).
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.
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 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over American Heart Journal (September 2019), Vol. 215, pp. 62-69, cited in the IDS.
Inventor teaches a method of treating a patient after having a myocardial infarction (MI) by administering daily low dose colchicine within about 3 days of the MI and where the colchicine is in the form of a tablet (claim 39), a coated tablet (claim 40), or a film-coated tablet (claim 41).
American Heart Journal (September 2019), Vol. 215, pp. 62-69 has been outlined above (102 rejection).
Inventor principally distinguishes over the cited art in that a particular oral delivery vehicle for the colchicine is taught: tablet, coated tablet, film-coated tablet. However, as the cited art explicitly states, colchicine is known in the art as is a cheap, once daily, oral treatment for the targeting of inflammatory mechanisms (page 68, column 1, text line 2). One of ordinary skill (a highly skilled individual such as, for instance, an experienced cardiologist or compounding pharmacist) would have found it obvious, before the effective filing date of the instant invention and absent unexpected results, to administer an oral dosage of colchicine by any convenient orally appropriate means - such a tablet, a coated tablet or a film-coated tablet - motivated and guided by ordinary clinical considerations (efficacy, ease of use and thus patient compliance, ability to tailor dissolution rates, etc.).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT), 3/8/2017 update, 8 pages and further in view of Journal of Clinical Medicine (2018), 7, 564, 13 pages.
Inventor teaches a method reducing the risk of a stroke in a patient after having a myocardial infarction comprising administering colchicine at a daily low dose within about 4 to 7 days of the myocardial infarction.
Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT) teaches the administration of colchicine (0.5 mg per day for an estimated 2 years), or a matching placebo, to patients who have suffered a documented acute myocardial infarction within the last 30 days, in order to evaluate whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction (page 1/8, Purpose). As the reference notes, atherosclerosis is the most common cause of myocardial infarction, stroke and peripheral arterial disease and research has clearly demonstrated that inflammation plays a key role in the initiation, progression and manifestations of atherosclerosis (page 4/8, Detailed Description). Patients are first treated according to national guidelines and, after completing any planned percutaneous revascularization procedures associated with the initial myocardial infarction, treatment with colchicine begins (page 1/8, Purpose).
The examiner notes for clarity of the record that a daily dose of 0.5 mg of colchicine is considered by inventor to be a “low dose” of colchicine (specification page 2, line 13).
Journal of Clinical Medicine (2018), 7, 564, 13 pages, teaches that for low-risk patients, after an uncomplicated myocardial infarction, that hospital discharge occurs after 3 days (abstract; page 1/13, 1. Introduction).
Inventor distinguishes over the cited art in that a narrower treatment window of 4 to 7 days after the myocardial infarction is explicitly taught. However, one of ordinary skill in the art, before the effective filing date of the instant invention, would have found it obvious to optimize this treatment window because it is in essence a results effective variable.
As Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT) makes clear, it is already known in the art that inflammation plays a key role in the initiation, progression and manifestations of atherosclerosis and that atherosclerosis is the most common cause of inter alia stroke. That being the case, one of ordinary skill (a highly skilled individual such as an experienced cardiologist) would have been motivated, and with a reasonable expectation of success, to mitigate the body’s inflammatory response soon after the initial myocardial infarction has been treated according to national guidelines and after completing any planned percutaneous revascularization procedures. This treatment according to national guidelines, and any necessary revascularization is, essentially, the period in which the patient would be initially hospitalized (typically 3 days, as evidenced by Journal of Clinical Medicine (2018), 7, 564, 13 pages). That is, Colchicine Cardiovascular Outcomes Trial (COLCOT) (COLCOT) teaches, essentially, that colchicine administration begins after at least 3 days (i.e. after discharge). The instant treatment window of 4-7 days is simply the optimization of the initiation of colchicine treatment in order to begin to mitigate inflammation - essentially, the sooner the better - which contributes to the initiation, progression and manifestations of atherosclerosis, after a patient’s initial hospital stay for a myocardial infarction.
The examiner notes for clarity of the record that the preamble of the claim “A method of reducing the risk of a stroke…” cannot be considered limiting, and as such is given no patentable weight, because it simply expresses an intended result of the one positively recited method step in the body of the claim. That is, the body of the claim defines a structurally complete invention. Note the discussion at MPEP 2111.02 (II).
Double Patenting, Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 49 and 50 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 27 and 28 of prior (parent) U.S. Patent No. 11,400,063 B2, cited in the IDS. The claims are identical. This is a statutory double patenting rejection.
Double Patenting, Nonstatutory
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 31-48 are 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, cited in the IDS. 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 limitation with respect to the cardiovascular event); and the subject matter of patented claims 12-19 and 24-26 is identical to that of instant claims 37-46 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. That being the case, 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 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).)
Conclusion
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.
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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 10/24/2025