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, 21-29, and 31 were canceled.
Claims 13-20, 30, and 32-34 are pending and under consideration.
Withdrawn Rejections
Rejection of Claim 18 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claims 17-18, thereby obviating this rejection/objection.
Rejection of Claim(s) 13-16, 19-20, 29, and 32-34 under 35 U.S.C. 102(a)(1) as being anticipated by Dharmakumar et al (US2016/0183815) is withdrawn. Applicant amended the claim 13 to recite limitation of now canceled claim 31, thereby obviating this rejection/objection. However, the same reference will be used in the new 103 rejection below.
NEW - Claim Objections
(necessitated by amendments)
Claim 15 is objected to because of the following informalities: “further comprising the detecting and/or measuring of the presence” should read “further comprising detecting and/or measuring the presence” because method claim must recite active process step of action (i.e. verb), not noun. Appropriate correction is required.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 recites “detecting and/or measuring the presence of the at least one iron deposit in the heart of the subject”. Amended claim 13 now recites “wherein the subject has been detected with a presence of at least one iron deposit”. Because amended claim 13 already recites that the subject has been detected with a presence of at least one iron deposit, claim 15 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
NEW - Claim Rejections - 35 USC § 103
(based on reconsideration)
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.
Claim(s) 13-20, 30, and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dharmakumar et al (US2016/0183815; 4/22/2022 IDS).
Regarding claims 13, 15, 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). The limitation “treating myocardial microbleeding in a subject recovering from a cardiovascular disease” 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. Dharmakumar teaches that iron deposition is identified in the heart (claim 5).
Regarding new claim limitation “wherein a difference in the cardiac image or in the blood level of the hemoglobin breakdown product or the ferroptosis marker relative to that from a reference sample is indicative of at least one microbleed in the myocardium of subject”, this limitation is obvious to one of ordinary skill in the art because one of ordinary skill in the art would understand that the difference in the cardiac image relative to that from a reference sample results from bleeding in the myocardium of subject and therefore the difference in the cardiac image indicates microbleed in the myocardium of subject.
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 30, Dharmakumar teaches “In various embodiments, the method further comprises 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.” [0090].
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).
However, Dharmakumar does not expressly teach imaging the subject’s heart both before and after the administration of the composition as recited by claims 17-18.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed imaging the subject’s heart before and after the administration of the composition to determine whether the treatment is complete or not. It is well known in the art that the further treatment is not necessary when the myocardial bleeding has been completely treated. Therefore, one of ordinary skill in the art would be motivated to detect iron deposit in the myocardium or another portion of the heart before and after the administration of the composition to decide whether the subject needs subsequent dose of the composition. One of ordinary skill in the art would have administered to the subject subsequent dose of the composition if a same or higher level of the iron deposit in the response is indicated in the myocardium or the other portion of the heart because the first administration of the composition had not completely treated the myocardial microbleed. One of ordinary skill in the art would have discontinued administration of the composition if the iron deposit is absent in the response in the myocardium or the other portion of the heart because the first administration of the composition had treated myocardial microbleed completely and therefore the subject would not need further treatment. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because it is well known in the art that the subsequent administration of the composition is required when the first dose did not completely cure myocardial microbleed. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
MAINTAINED - Double Patenting
(based on reconsideration)
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.
The new NSDP rejections NSDP1 – NSDP3 reject claim limitation of canceled claim 31 (now last wherein-clause of claim 13) and claims 17-18 which were not rejected by NSDP rejections NSDP1 – NSDP3 in previous office action.
NSDP 1
Claims 13, 15-18, 20, 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, 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). The limitation “treating myocardial microbleeding in a subject recovering from a cardiovascular disease” 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 new claim limitation of claim 13, “wherein a difference in the cardiac image or in the blood level of the hemoglobin breakdown product or the ferroptosis marker relative to that from a reference sample is indicative of at least one microbleed in the myocardium of subject”, this limitation is obvious to one of ordinary skill in the art because one of ordinary skill in the art would understand that the difference in the cardiac image relative to that from a reference sample results from bleeding in the myocardium of subject and therefore the difference in the cardiac image indicates microbleed in the myocardium of subject.
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).
However, Patent’962 does not expressly claim imaging the subject’s heart both before and after the administration of the composition as recited by claims 17-18.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed imaging the subject’s heart before and after the administration of the composition to determine whether the treatment is complete or not. It is well known in the art that the further treatment is not necessary when the myocardial bleeding has been completely treated. Therefore, one of ordinary skill in the art would be motivated to detect iron deposit in the myocardium or another portion of the heart before and after the administration of the composition to decide whether the subject needs subsequent dose of the composition. One of ordinary skill in the art would administer to the subject subsequent dose of the composition if a same or higher level of the iron deposit in the response is indicated in the myocardium or the other portion of the heart because the first administration of the composition had not completely treated the myocardial microbleed. One of ordinary skill in the art would have discontinued administration of the composition if the iron deposit is absent in the response in the myocardium or the other portion of the heart because the first administration of the composition had treated myocardial microbleed completely and therefore the subject would not need further treatment. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because it is well known in the art that the subsequent administration of the composition is required when the first dose did not completely cure myocardial microbleed. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
NSDP 2
Claims 13, 15-19, 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). 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 new claim limitation of claim 13, “wherein a difference in the cardiac image or in the blood level of the hemoglobin breakdown product or the ferroptosis marker relative to that from a reference sample is indicative of at least one microbleed in the myocardium of subject”, this limitation is obvious to one of ordinary skill in the art because one of ordinary skill in the art would understand that the difference in the cardiac image relative to that from a reference sample results from bleeding in the myocardium of subject and therefore the difference in the cardiac image indicates microbleed in the myocardium of 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 claim 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.”
However, Patent’961 does not expressly claim imaging the subject’s heart both before and after the administration of the composition as recited by claims 17-18.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed imaging the subject’s heart before and after the administration of the composition to determine whether the treatment is complete or not. It is well known in the art that the further treatment is not necessary when the myocardial bleeding has been completely treated. Therefore, one of ordinary skill in the art would be motivated to detect iron deposit in the myocardium or another portion of the heart before and after the administration of the composition to decide whether the subject needs subsequent dose of the composition. One of ordinary skill in the art would administer to the subject subsequent dose of the composition if a same or higher level of the iron deposit in the response is indicated in the myocardium or the other portion of the heart because the first administration of the composition had not completely treated the myocardial microbleed. One of ordinary skill in the art would have discontinued administration of the composition if the iron deposit is absent in the response in the myocardium or the other portion of the heart because the first administration of the composition had treated myocardial microbleed completely and therefore the subject would not need further treatment. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because it is well known in the art that the subsequent administration of the composition is required when the first dose did not completely cure myocardial microbleed. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
NSDP 3
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 new claim limitation of claim 13, “wherein a difference in the cardiac image or in the blood level of the hemoglobin breakdown product or the ferroptosis marker relative to that from a reference sample is indicative of at least one microbleed in the myocardium of subject”, this limitation is obvious to one of ordinary skill in the art because one of ordinary skill in the art would understand that the difference in the cardiac image relative to that from a reference sample results from bleeding in the myocardium of subject and therefore the difference in the cardiac image indicates microbleed in the myocardium of subject.
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.”
However, Patent’686 does not expressly claim imaging the subject’s heart both before and after the administration of the composition as recited by claims 17-18.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed imaging the subject’s heart before and after the administration of the composition to determine whether the treatment is complete or not. It is well known in the art that the further treatment is not necessary when the myocardial bleeding has been completely treated. Therefore, one of ordinary skill in the art would be motivated to detect iron deposit in the myocardium or another portion of the heart before and after the administration of the composition to decide whether the subject needs subsequent dose of the composition. One of ordinary skill in the art would administer to the subject subsequent dose of the composition if a same or higher level of the iron deposit in the response is indicated in the myocardium or the other portion of the heart because the first administration of the composition had not completely treated the myocardial microbleed. One of ordinary skill in the art would have discontinued administration of the composition if the iron deposit is absent in the response in the myocardium or the other portion of the heart because the first administration of the composition had treated myocardial microbleed completely and therefore the subject would not need further treatment. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because it is well known in the art that the subsequent administration of the composition is required when the first dose did not completely cure myocardial microbleed. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
NSDP 4
Claims 13, 15-18, 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, 30 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.” 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 new claim limitation of claim 13, “wherein a difference in the cardiac image or in the blood level of the hemoglobin breakdown product or the ferroptosis marker relative to that from a reference sample is indicative of at least one microbleed in the myocardium of subject”, this limitation is obvious to one of ordinary skill in the art because one of ordinary skill in the art would understand that the difference in the cardiac image relative to that from a reference sample results from bleeding in the myocardium of subject and therefore the difference in the cardiac image indicates microbleed in the myocardium of 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 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.”
Response to Arguments
In the response filed on 4/17/2026, Applicant argued at page 7,
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Based on reconsideration, explanation about the claim limitation of canceled claim 31 (now last wherein-clause of claim 13) was added to NSDP 1-3 as discussed above.
Regarding NSDP 4,
Applicant argued at page 8,
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Applicant's arguments have been fully considered but they are not persuasive. Applicant’s argument is based on that microbleed in the heart is a small area of bleeding within the heart and in contrast, the myocardial infarction hemorrhage is a large, significant bleed. One of ordinary skill in the art would understand that administering same chelating agent will also be able to treat small scale microbleed if the same chelating agent can treat a large, significant bleed of myocardial infarction hemorrhage. Therefore, one of ordinary skill in the art would be motivated to use same chelating agent taught by patent’524 to treat small scale microbleed. Furthermore, treating microbleed is expected result of the claimed process. Because patent’524 claims same active process step of administering same chelating agent, the same active process step of patent’524 will have same expected result.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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