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 Status
Claims 1-12 and 21-28 were canceled.
Claims 13-20 and 29-34 are pending and under consideration.
Election/Restrictions
Applicant’s election of Group II in the reply filed on 7/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/22/2022 and 7/18/2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
NPL document number 22 of 7/18/2025 IDS was crossed out and was not considered because it does not contain retrieved date or published date.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “relative to the level before a previous dose was administered to the subject”. Claim 18 depends from claim 17 and claim 17 recites detecting a level of iron deposit after the administration of the composition, but claim 17 does not recite detecting a level of iron deposit before the administration of the composition. Furthermore, claim 18 indirectly depends from claim 13 and claim 13 does not recite detecting a level of iron deposit before the administration of the composition. Therefore, it is not clear how one of ordinary skill in the art can compare a level of iron deposit after the administration of the composition with that before the administration of the composition.
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.
Claim(s) 13-16, 19-20, 29, and 32-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dharmakumar et al (US2016/0183815; 4/22/2022 IDS).
Regarding claims 13, 15, 29 and 32, Dharmakumar teaches “A method of treating a subject who had myocardial infarction (MI), comprising: imaging the subject's heart; identifying persistent microvascular obstruction (PMO), and/or iron deposition, and/or fat accumulation in the subject's heart; and administering to the subject a therapeutically effective amount of a therapeutic agent, thereby treating the subject” (claim 1). Dharmakumar teaches that the therapeutic agent is a chelating agent (claim 6). A patient who had myocardial infarction as taught by Dharmakumar and a patient who is recovering from cardiovascular disease associated with myocardial microbleeding (i.e. myocardial hemorrhage) as claimed by instant claim 13 are same patient population because the myocardial hemorrhage is a complication that can occur during or after a myocardial infarction. Furthermore, limitation “treating a subject recovering from a cardiovascular disease associated with myocardial microbleeding” of instant claim 13 is an expected result of the claimed process and the same active process step (e.g. in instant case, administering chelating agent) will have same result. The process taught by Dharmakumar has same active process step (i.e. administering chelating agent) as instantly claimed process and therefore instant claim 13 is anticipated by Dharmakumar. Dharmakumar teaches that iron deposition is identified in the heart (claim 5).
Regarding claim 14, Dharmakumar teaches hypertensive heart disease [0053]. The hypertensive heart disease is a long-term condition resulting from chronic hypertension.
Regarding claim 16, Dharmakumar teaches that the chelating agent is deferoxamine, deferasirox, or deferiprone (claim 7).
Regarding claim 19, Dharmakumar teaches “As used herein, a “subject” means a human or animal” [0055].
Regarding claim 20, Dharmakumar teaches that the subject has no hemorrhage in the heart (claim 3).
Regarding claim 33, Dharmakumar teaches “The invention provides various methods of identifying myocardial infarction (MI) patients who are at risk of prolonged inflammation burden in heart, adverse cardiac remodeling, electrical abnormality, mechanical abnormality, malignant cardiac arrhythmia, ischemic heart failure, and/or sudden cardiac death. The invention also provides various methods of treating these MI patients with chelation drugs, anti-inflammatory drugs, fat-lowering drugs, cooling therapies, or device therapies, or their combinations” (abstract).
Regarding claim 34, Dharmakumar teaches that imaging the subject's heart is performed with cardiac magnetic resonance imaging (CMR), late-gadolinium enhancement CMR (LGE-CMR), cine CMR, T2* CMR, chemical shift-encoded T2* CMR, T2 CMR, T1 CMR, T1ρ CMR, SPECT, PET, CT, or echocardiography (ECG), or a combination thereof (claim 4).
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 13, 15-16, 20, 29, 32 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,694,962 (hereinafter patent’962; 4/22/2022 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 13, 15, 29 and 32, Claim 1 of patent’962 claims “A method of treating a subject who had myocardial infarction (MI), comprising: imaging the subject's heart; identifying persistent microvascular obstruction (PMO), and/or iron deposition, and/or fat accumulation in the subject's heart; and administering to the subject a therapeutically effective amount of a therapeutic agent, thereby treating the subject”. Patent’962 claims that the therapeutic agent is a chelating agent (claim 6). A patient who had myocardial infarction as taught by patent’962 and a patient who is recovering from cardiovascular disease associated with myocardial microbleeding (i.e. myocardial hemorrhage) as claimed by instant claim 13 are same patient population because the myocardial hemorrhage is a complication that can occur during or after a myocardial infarction. Furthermore, limitation “treating a subject recovering from a cardiovascular disease associated with myocardial microbleeding” is an expected result of the claimed process and the same active process step (e.g. in instant case, administering chelating agent) will have same result. The process claimed by Patent’962 has same active process step (i.e. administering chelating agent) as instantly claimed process. Patent’962 claims that iron deposition is identified in the heart (claim 5).
Regarding claim 16, Patent’962 claims that the chelating agent is deferoxamine, deferasirox, or deferiprone (claim 7).
Regarding claim 20, Patent’962 claims that the subject has no hemorrhage in the heart (claim 3).
Regarding claim 34, Patent’962 claims that imaging the subject's heart is performed with cardiac magnetic resonance imaging (CMR), late-gadolinium enhancement CMR (LGE-CMR), cine CMR, T2* CMR, chemical shift-encoded T2* CMR, T2 CMR, T1 CMR, T1ρ CMR, SPECT, PET, CT, or echocardiography (ECG), or a combination thereof (claim 4).
Claims 13, 15-16, 19, 29-30 and 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 10,694,961 (hereinafter patent’961; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 13, 15, and 33-34, claim 1 of patent’961 claims “A method for diagnosing and treating a subject with reperfusion hemorrhage, wherein the subject has had reperfusion therapy following a myocardial infarction (MI), comprising: obtaining magnetic resonance imaging (MRI) images of the subject's heart; detecting an increase in iron oxide deposition in a hemorrhagic infarcted region of the subject's heart relative to a remote region of the subject's heart from the obtained MRI images; and administering, at least in chronic phase of the MI, an effective amount of a composition comprising a chelating agent, carbon monoxide, a haem-oxygenase regulating drug, or a combination thereof, based on knowledge of an increase in iron oxide deposition in the chronic phase in the infarcted region relative to the remote region following reperfusion hemorrhage, so as to treat the subject and to decrease the risk of sudden cardiac death in the subject”.
Regarding claim 16, claim 14 of patent’961 claims “The method of claim 1, wherein the composition comprises an iron chelating agent.” Claim 15 of patent’961 claims “The method of claim 14, wherein the iron chelating agent is Deferoxamine, Deferasirox, Deferiprone or a combination thereof.”
Regarding claim 19, claim 9 of patent’961 claims “The method of claim 1, wherein the subject is a human”.
Regarding claims 29-30, claim 2 of patent’961 claims “The method of claim 1, further comprising measuring blood levels of any one or more of hepcidin, carbon monoxide, bilirubin, unbound iron binding capacity (UIBC), Fe bound to transferrin, ferritin, heme (heam) oxgenase, biliverdin or a combination thereof, in the subject, wherein an increase in hepcidin biliverdin, bilirubin, carbon monoxide, heme (haem) oxygenase, Fe bound to transferrin, ferritin and/or a decrease in UIBC is indicative of hemorrhagic myocardial infarction in the subject.”
Claims 13, 16, 19 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,696,686 (hereinafter patent’686; 7/18/2025 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 13, patent’686 claims “A method for treating a subject at an increased risk of sudden cardiac death associated with having regional iron deposition in the heart comprising: administering to the subject, at least in chronic phase of a myocardial infarction (MI), an effective amount of a composition comprising a chelating agent, based on knowledge of an increase in iron oxide deposition in the chronic phase in the infarcted region relative to a remote region following reperfusion hemorrhage, so as to treating the subject at an increased risk of sudden cardiac death associated with regional iron deposition in the heart, wherein the subject has been detected to have an increase in iron oxide deposition in a hemorrhagic infarcted region of the subject's heart relative to the remote region of the subject's heart” (claim 1).
Regarding claim 16, claim 14 of patent’686 claims that the chelating agent is any one or more of Deferoxamine, Deferasirox, and Deferiprone.
Regarding claim 19, claim 5 of patent’686 claims “The method of claim 1, wherein the subject is a human.”
Regarding claim 33, claim 6 of patent’686 claims “A method for treating a subject with localized iron-containing deposits in myocardial tissue, or associated electrical conduction abnormalities and/or mechanical abnormalities in myocardium, comprising: administering, at least in chronic phase of myocardial infarction (MI), an effective amount of a composition comprising a chelating agent to the subject, based on knowledge of an increase in iron oxide deposition in the chronic phase in the infarcted region relative to a remote region following reperfusion hemorrhage, so as to treat the subject with localized iron-containing deposits in the myocardial tissue or associated electrical conduction abnormalities and/or mechanical abnormalities in myocardium, wherein the subject has been detected to have an increase in iron oxide deposition in a hemorrhagic infarcted region of the subject's heart relative to the remote region of the subject's heart.” Claim 7 of patent’686 claims “The method of claim 6, wherein the localized iron-containing deposits in the myocardial tissue results in cardiac arrhythmia.”
Claims 13, 15-18, 29-32 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,690,524 (hereinafter patent’524; 7/18/2025 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 13, 15, 29 and 32, claim 1 of patent’524 claims “A method for treating a subject with myocardial infarction, comprising: administering to the subject an effective amount of a composition comprising a chelating agent, at least in chronic phase of the myocardial infarction, based on knowledge of an increase in iron oxide deposition in the chronic phase in the infarcted region relative to a remote region following reperfusion hemorrhage, wherein the subject has undergone reperfusion following the myocardial infarction, the subject has hemorrhage in the myocardial infarct, and the subject has been detected to have an increase in iron oxide deposition in a hemorrhagic infarcted region of the subject's heart relative to the remote region of the subject's heart.” Claim 7 of patent’524 claims “The method of claim 1, further comprising selecting a subject having the hemorrhage in the myocardial infarct for the treatment based on imaging of the subject's heart, before the administration of the composition to the subject.”
Regarding claim 16, claim 9 of patent’524 claims “The method of claim 1, wherein the chelating agent comprises Deferoxamine, Deferasirox, Deferiprone, or a combination thereof.”
Regarding claim 17, claim 4 of patent’524 claims “The method of claim 1, further comprising imaging the subject's heart after the administration of the composition to detect a subsequent level of iron or deposits that contain iron in an infarcted region relative to the remote region.”
Regarding claim 18, claim 5 of patent’524 claims “The method of claim 4, further comprising administering to the subject a subsequent dose of a chelating agent if a higher level of iron or deposits that contain iron is indicated in the infarcted region relative to a remote region, or discontinuing administration of the chelating agent if the level of iron or deposits that contain iron is not indicated as higher in the infarcted region relative to the remote region.”
Regarding claims 30-31, claim 8 of patent’524 claims “The method of claim 1, further comprising measuring blood levels of any one or more of hepcidin, carbon monoxide, bilirubin, unbound iron, Fe bound to transferrin, ferritin, heme (heam) oxgenase, and biliverdin in the subject, wherein an increase in the hepcidin, the biliverdin, the bilirubin, the carbon monoxide, the heme (haem) oxygenase, the Fe bound to transferrin, the ferritin and/or a decrease in the UIBC indicates the subject has the hemorrhage in the myocardial infarct.”
Regarding claim 34, claim 11 of patent’524 claims “The method of claim 4, wherein the imaging is performed with cardiac magnetic resonance (CMR) imaging, T2* CMR, chemical shift-encoded T2* CMR, T2 CMR, Ti CMR, T1ρ CMR, late-gadolinium enhancement CMR (LGE-CMR), cine CMR, single-photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT), or a combination thereof.”
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645 /GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645