DETAILED ACTION
Claims 1-29 were pending. Claims 1 and 29 have been amended; claims 23-28 have been canceled; and claims 30-34 have been newly added per the Reply of 8/1/2025.
Claims 1-22 and 29-34 are pending.
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 .
Priority
The instant application filed 12/6/2024 is a Continuation of 18924797, filed 10/23/2024 and claims foreign priority to 2319559.7, filed 12/19/2023 and to 2401289.0, filed 1/31/2024.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 8/1/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement are being considered by the Examiner.
Amendment to the Specification
The Amendment to the Specification Title has been entered per the reply of 8/1/2025.
Claim Rejections - 35 USC § 103
(NEW Rejection based on Amendment)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Abdelmoaty et al. “KAND567, the first selective small molecule CX3CR1 antagonist in clinical development, mediates anti-inflammatory cardioprotective effects in rodent models of atherosclerosis and myocardial infarction,” Advances in Science: Emerging treatments in acute coronary syndromes, ESC Congress 2019 together with World Congress of Cardiology 31 August – 4 September 2019, Paris – France; Kancera AB, “KAND567—A candidate to counteract hyperinflammation in COVID-19 and heart attack,” Nature, December 2020.
Claim 1 states a “method of treating a human patient undergoing reperfusion therapy for a diagnosed ST-elevation myocardial infarction, comprising administering a therapeutically effective amount of a compound of formula I,
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wherein R1 is selected from hydrogen and -PO(OR2)(OR3), wherein R2 and R3 are each independently selected from the group consisting of hydrogen, C1-4 alkyl and C2-4 alkenyl, or a pharmaceutically acceptable salt thereof, to a patient in need thereof, wherein the compound is administered in an amount effective to treat formation and/or growth of a thrombus in the human patient's heart and to reduce risk of haemorrhage to a patient in need thereof.
Claim 1 requires the chemical compound of formula I, when R1 is hydrogen the compound is the known CX3CR1 antagonist KAND567, see the “Background of the Invention” section in the Specification on page 2 line 14.
Abdelmoaty teaches fractalkine is a chemokine that mediates recruitment and extravasation of CX3CR1-expressing subsets of leukocytes and monocytes and has been implicated in the inflammation-driven pathology of cardiovascular disease. More specifically, fractalkine signaling has been proposed to contribute to increased infarct size and enhanced atherosclerotic plaque vulnerability in patients and experimental models. Blocking fractalkine/CX3CR1 signaling is suggested as a promising anti-inflammatory strategy for the treatment of both acute and chronic cardiovascular disease. KAND567 is a small molecule, selective, noncompetitive, allosteric antagonist of the fractalkine receptor CX3CR1, that is under preparation for a clinical phase IIa study in AMI patients. AMI is Acute Myocardial Infarction.
Abdelmoaty teaches using KAND567 in the rodent model of atherosclerosis and myocardial infarction. Abdelmoaty teaches the drug when given before the simulated myocardial infarction that the drug reduced the infarct size after the ischemia reperfusion event. Abdelmoaty teaches reduced macrophage infiltration in the thoracic arch and reduced lesion area in the aorta in the model for atherogenesis. Abdelmoaty concludes stating, “Specific inhibition of fractalkine-driven inflammation by KAND567 provides cardioprotective, anti-atherosclerotic and plaque stabilizing effects via mechanisms related to immune cell infiltration, in rodent models. Further studies should be initiated to test if KAND567 is a potential candidate drug, targeting the excessive inflammatory injury associated with ischemia/reperfusion in myocardial infarction and providing plaque stabilization by reducing inflammatory risk for recurrent coronary events.”
Abdelmoaty teaches using KAND567 in myocardial infarction, but doesn’t discuss a human patient undergoing reperfusion therapy for a diagnosed ST-elevation myocardial infarction specifically, or the amount effective to treat formation and/or growth of a thrombus in the human patient's heart and to reduce risk of haemorrhage to a patient in need thereof.
Kancera teaches using KAND567 in both COVID-19 and heart attack. Kancera’s CEO, Thomas Olin states, “When major heart attack patients undergo primary percutaneous coronary intervention (PPCI) the reperfusion triggers a hyperinflammation which, as with COVID-19, increases risks for serious complications and organ failure. Following a heart attack, some 25% will suffer another severe cardiac complication or will die within five years, partly because of hyperinflammation.” A PHOSITA would understand that a major heart attack can be interpreted to include a ST-elevation myocardial infarction.
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PPCI is primary percutaneous coronary intervention. This is the procedure used to open a blocked coronary artery after a myocardial infarction, including the severe MI which is characterized by a ST-elevation in the electrocardiogram. Thereby a ST-elevation myocardial infarction.
These 2 references teach a person of ordinary skill in the art that KAND567 should be given to patients having a MI, and in patients before, during, and after a PPCI procedure needed after a sever MI. The drug, being an inhibitor of fractalkine/CX3CR1 signaling, one would determine the dose by administering an amount of the compound to inhibit fractalkine/CX3CR1 signaling in the patient.
Claim 2 requires KAND567, this is the compound taught in the Abdelmoaty and Kancera references.
Claim 3 requires wherein the thrombus is a left ventricular thrombus. This claim requires prevention of a thrombus in a specific location. Given the art of record the location of the thrombus appears to be irrelevant to the drug’s action. The drug is given systemically and will stabilize plaques and prevent I/R injury systemically.
Claim 4 requires wherein the myocardial infarction is an anterior ST-elevation myocardial infarction, with occlusion of the left anterior descending coronary artery. Given the Abdelmoaty reference teaching the treatment of the genus of myocardial infarction and the model was performed by ligation of the left anterior descending coronary artery. The difference is the ST-elevation. Given that Kancera notes use in severe MI with PPCI, it would be obvious to treat an anterior ST-elevation myocardial infarction with KAND567.
Claim 5 requires wherein the patient has a left ventricular ejection fraction of less than 50%. Given the normal LVEF is around 50% to 75% Thus, a low ejection fraction is often the first indicator of heart failure. It can be caused by various factors, such as dilated cardiomyopathy, coronary artery disease, hypertension, and diabetes. Given this is an indication of heart issues, this patient would be ideal for treatment with KAND567 in order to attempt to reduce infart size and R/I.
Claim 6 requires wherein the method further comprises preventing or suppressing expansion of myocardial infarct size. Abdelmoaty teaches reduced infarct/risk area in the infarct model. Therefore one would assume this outcome of treatment in humans.
Claim 7 requires wherein the method further comprises reducing the risk of haemorrhage; and claim 8 states wherein the haemorrhage is intramyocardial haemorrhage. This claim is obvious as the treatment of a patient with MI is obvious, and the drug will be given to inhibit CX3CR1 (an effective amount). The outcome of the treatment is inherent to the drug given to the patient in a sufficient amount to inhibit the receptor. As such while the art does not explicitly state the property of reducing the risk of hemorrhage, the outcome will be present when treating the MI patient with the drug, as such the outcome will occur naturally. This logic holds true for claim 9 as well which requires wherein the wherein the method further comprises preventing or suppressing expansion of myocardial infarct size.
Claim 10 requires the patient to be undergoing reperfusion therapy for ST-elevation myocardial infarction. Again the teaching makes clear use in myocardial infarction and PPCI as the drug mitigated reperfusion injury. As such this is obvious. Claim 11 requires wherein the prevention of thrombus formation and/or thrombus growth further comprises prevention of reperfusion injury. Again the teaching makes clear use in myocardial infarction as the drug mitigated reperfusion injury.
Claim 12 requires the patient to wherein the patient has been treated with or is being treated with percutaneous coronary intervention. Given that a patient having a myocardial infarction is having ischemia (much like the ligation in the model of MI) and then one would want to open the artery, the common practice is percutaneous coronary intervention (using antithrombotic drugs, a catheter, or other method) to open the artery (remove ligation) one would expect R/I injury to occur and look to mitigate it. Given the drug KAND567 has been shown to prevent I/R injury, one would obviously want to give this drug to this patient.
Claim 13 requires wherein the method comprises commencing administration the compound of formula I, or pharmaceutically acceptable salt thereof, within a time period of from about 4 hours to about 2 minutes before reperfusion of the occluded vessel by percutaneous coronary intervention, and, optionally, continuing to administer the compound of formula I, or pharmaceutically acceptable salt thereof, for a period of at least about 72 hours after percutaneous coronary intervention. The animal model shows the drug works best when in the system prior to ligation and reperfusion. As such while the timeframe is not exact, the teaching in the art clearly teaches having the drug started before reperfusion and continuing some time after. As such this claim is obvious.
Claim Rejections - 35 USC § 103
(NEW Rejection based on Amendment)
Claims 1-22 and 29-34 are rejected under 35 U.S.C. 103 as being unpatentable over Abdelmoaty et al. “KAND567, the first selective small molecule CX3CR1 antagonist in clinical development, mediates anti-inflammatory cardioprotective effects in rodent models of atherosclerosis and myocardial infarction,” Advances in Science: Emerging treatments in acute coronary syndromes, ESC Congress 2019 together with World Congress of Cardiology 31 August – 4 September 2019, Paris – France; Kancera AB, “KAND567—A candidate to counteract hyperinflammation in COVID-19 and heart attack,” Nature, December 2020, as applied to claims 1-13 in view of Zijlstra et al. “Influence of Prehospital Administration of Aspirin and Heparin on Initial Patency of the Infarct-Related Artery in Patients With Acute ST Elevation Myocardial Infarction,” Journal of the American College of Cardiology Vol. 39, No. 11, 2002.
Claims 14-17 are directed to a combination treatment using KAND567 with an antiplatelet medication in the patient discussed above.
Claim 14 to in conjunction with at least one antiplatelet medication. Claim 15 to wherein the antiplatelet medication is selected from the group consisting of a P2Y12 receptor inhibitor an adenosine reuptake inhibitor, a glycoprotein IIb/IIIa inhibitor, an (irreversible) cyclooxygenase inhibitor, a phosphodiesterase inhibitor, a protease-activated receptor-1 antagonist, a thromboxane inhibitor, a thromboxane receptor antagonist and a thromboxane synthase inhibitor, and combinations thereof. C1aim 16 to at least one antiplatelet medication comprises an (irreversible) cyclooxygenase inhibitor and/or a P2Y12 receptor inhibitor, and, optionally, a glycoprotein IIb/IIIa inhibitor. Claim 17 to wherein the (irreversible) cyclooxygenase inhibitor is aspirin, the P2Y12 receptor inhibitor is prasugrel and/or the glycoprotein IIb/IIIa inhibitor is tirofiban.
Claims 18-20 are directed to a combination treatment using KAND567 with an anticoagulant medication.
Claim 18 states, wherein the compound of formula I, or pharmaceutically acceptable salt thereof, is administered in conjunction with at least one anticoagulant. Claim 19 wherein the at least one anticoagulant is selected from the group consisting of a vitamin K antagonist, a heparin, a synthetic pentasaccharide inhibitor of factor Xa, a direct factor Xa inhibitor, a direct thrombin inhibitor, and combinations thereof. Claim 20, wherein the at least one anticoagulant is unfractionated heparin or a low molecular weight heparin.
Claims 21-22, and 29 are directed towards using 3 drugs in combination; the method as conjunction with at least one antiplatelet medication and at least one anticoagulant. Claim 22 states wherein the at least one antiplatelet medication comprises an (irreversible) cyclooxygenase inhibitor and/or a P2Y12 receptor inhibitor, and, optionally, a glycoprotein IIb/IIIa inhibitor and the at least one anticoagulant is selected from the group consisting of a vitamin K antagonist, a heparin, a synthetic pentasaccharide inhibitor of factor Xa, a direct factor Xa inhibitor, a direct thrombin inhibitor, and combinations thereof.
Claim 1-13 were rejected using Abdelmoaty, Barrett, and Adnan. Rendering obvious the use of KAND567 in ST elevation myocardial infarction. These references do not mention using aspirin (an antiplatelet medication) and heparin (an anticoagulant medication) along with KAND567.
Zijlstra teaches using aspirin and heparin in patients experiencing a ST elevation myocardial infarction. Zijlstra shows the administration of aspirin and heparin in patients with acute MI results in a higher rate of early patency of the infarct related artery.
Given this is standard of care for patient with a MI, it would be obvious to use standard care and then add in KAND567 to further benefit the patient by reducing infarct size as shown by Abdelmoaty. Therefore these claims are prima facie obvious at the time of filing.
Claims 29-34 require all the limitations of claim 1 while requiring, “in conjunction with at least one anti-platelet medication and at least one anti-coagulant.” These claims are therefore obvious for the same reasons as claims 14-22.
Response to Arguments including the Affidavit by Thomas Olin: Applicant argues, it is well-established that, even if a prima facie obviousness case is established, "the presumption will be rebutted if it can be shown ... that there are new and unexpected results relative to the prior art." Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). In the instant case, it has been surprisingly found that compounds such as KAND567 beneficially exhibit both a significant reduction in the incidence of left ventricular thrombus formation and a significant reduction in the incidence of intramyocardial haemorrhage. See, e.g., as filed application at page 4, lines 6-34. This combination of properties renders them particularly well-suited for treating ST-elevation myocardial infarction (STEMI) patients undergoing reperfusion therapy, which are known to have a high risk of post-STEMI thrombi. This result is new and unexpected, particularly in view of the prior art.
This line of reasoning is correct; however the evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (Claims directed to a method of effecting analgesia without producing physical dependence by administering the levo isomer of a compound having a certain chemical structure were rejected as obvious over the prior art. Evidence that the compound was unexpectedly nonaddictive was sufficient to overcome the obviousness rejection. Although the compound also had the expected result of potent analgesia, there was evidence of record showing that the goal of research in this area was to produce an analgesic compound which was nonaddictive, enhancing the evidentiary value of the showing of nonaddictiveness as an indicium of nonobviousness.). See MPEP § 716.01(d) for guidance on weighing evidence submitted to traverse a rejection
MPEP § 716.01(d): When an applicant timely submits evidence traversing a rejection, the examiner must reconsider the patentability of the claimed invention. The ultimate determination of patentability must be based on consideration of the entire record, by a preponderance of evidence, with due consideration to the persuasiveness of any arguments and any secondary evidence. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). The submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed. Cir. 1987). Facts established by rebuttal evidence must be evaluated along with the facts on which the conclusion of a prima facie case was reached, not against the conclusion itself. In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). In other words, each piece of rebuttal evidence should not be evaluated for its ability to knockdown the prima facie case. All of the competent rebuttal evidence taken as a whole should be weighed against the evidence supporting the prima facie case. In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed. Cir. 1984). Although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989); Richardson-Vicks, Inc., v. The Upjohn Co., 122 F.3d 1476, 1484, 44 USPQ2d 1181, 1187 (Fed. Cir. 1997) (showing of unexpected results and commercial success of claimed ibuprofen and pseudoephedrine combination in single tablet form, while supported by substantial evidence, held not to overcome strong prima facie case of obviousness). See In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984) for a detailed discussion of the proper roles of the examiner’s prima facie case and applicant’s rebuttal evidence in the final determination of obviousness.
In this case the prima facie case of obviousness is strong, as one would clearly use the known drug for it’s known indication in an amount to inhibit fractalkine/CX3CR1 signaling. The references clearly teach to use this drug to alleviate R/I with PPCI, and while Applicant has shown some interesting evidence of anti-thrombotic effect. The evidence provided however is in the context of combination therapy. The data provided are in patients receiving standard care, which includes anti-thrombotic treatment with the anti-platelet medications aspirin, prasugrel, and heparin. Moreover 50% of patients further received tirofiban. These data point to a combination effect. Applicant has not provided any showing of unexpected results from the monotherapy in patients with STEMI undergoing PPCI (or in simple 2 drug combinations), as such the unexpected results are not probative to the entire claim scope. Applicant has not provided a showing of any other compounds than KAND567, ass such one would not know if the results are only provided by KAND567, or if other compounds would have similar results. Therefore claims 1-13 are clearly not commensurate in scope to the unexpected results.
As to claims 14-22 and 29-34, the claims directed to a combination, these claims are also not commensurate as not one claim specifically claims the unexpected result. Without further evidence to provide proof that more than one single embodiment provides the unexpected results, the current claims stand rejected.
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 § 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 1-22 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 18/924,797 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to treating the same patient populations with the same drug.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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 MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629