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 .
Status of Claims
Examined Herein: 1-22
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 62/884,012 on 8/7/2019, PRO 62/942,516 on 12/2/2019, PRO 62/947,737 on 12/13/2019, PRO 62/961,514 on 1/15/2020, and PCT/US20/15225 on 1/27/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/1/2021, 4/2/2024, and 10/3/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 1/27/2020 are accepted.
Claim Rejections - 35 USC § 103
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 1-8, 10-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 2003/0208123 A1, Published 11/6/2003), in view of Sutermeister (US 2019/0350649 A1, Filed 5/21/2019).
With respect to claim 1 and 12, Panescu discloses a method of delivering an agent to a target coronary tissue of a subject, comprising:
a) delivering an agent to a segment of coronary vasculature of a subject, the coronary artery; and
b) targeting the agent to agent to a target coronary tissue, the left ventricle, by ablating the left ventricle of the subject,
wherein the target coronary tissue is different from the segment of coronary vasculature. [Panescu, 0028, 0033, 0034]
The limitation “thereby distributing the agent to the target coronary tissue” recites language that does not require a step to be performed. This limitation simply expresses the intended result of the positively recited step of electroporating the target coronary tissue and as a result does not limit the claim scope. MPEP 2111.04
Panescu further discloses the ablation is performed by heating the tissue at the targeted site by applying direct current to the tissue. [Panescu, 0028]
With respect to claim 2 and 13, Panescu discloses the target coronary tissue is the left ventricle. [Panescu, 0028, 0033, 0034]
With respect to claim 3, 4, 16 and 17, Panescu discloses the segment of the coronary vasculature is the coronary artery. [Panescu, 0028, 0033, 0034]
With respect to claim 5 and 18, Panescu discloses the ablation is performed prior to delivery of the agent. [Panescu, 0028, 0033, 0034]
With respect to claim 6 and 19, Panescu discloses the ablation is performed by endocardial ablation. [Panescu, 0006]
With respect to claim 7, Panescu discloses the agent includes OPTISON or ALBUMEX. [Panescu, 0031] OPTISON and ALBUMEX comprise a therapeutic agent, albumin. The limitation “for the treatment of a cardiac disorder in the subject” recites an intended use but does not result in a structural difference between the claimed invention and the prior art. The prior art structure is an agent comprising a therapeutic agent, which is structurally capable of performing the intended use of treating a cardiac disorder in a subject. Therefore, this limitation does not patentably distinguish the claimed invention from the prior art.
With respect to claim 10, 11, 14, and 15, the limitation “for the treatment of a cardiac disorder [heart arrythmia or atrial fibrillation or ventricular tachycardia] in the subject” recites an intended use but does not result in a structural difference between the claimed invention and the prior art. The prior art structure is an agent comprising a therapeutic agent, which is structurally capable of performing the intended use of treating a heart arrythmia or atrial fibrillation or ventricular tachycardia in a subject. Therefore, this limitation does not patentably distinguish the claimed invention from the prior art.
With respect to claim 8 and 20, Panescu discloses the agent is OPTISON or ALBUMEX. OPTISON and ALBUMEX comprises a protein. [Panescu, 0031]
With respect to claim 22, Panescu implicitly discloses the subject is human, as the exemplary illustrations depict a human heart. [Panescu, 0033, 00334, Figure 6]
Panescu does not disclose the ablation of the target coronary tissue of the subject is performed by electroporation.
However, with respect to claim 1, Sutermeister discloses ablation performed by applying direct current to the tissue is referred to as irreversible electroporation. [Sutermeister, 0071]
Modifying the method disclosed by Panescu so that the step of ablating the target coronary tissue of the subject is carried out using irreversible electroporation, results in the method of claim 1.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Panescu so that the step of ablating the target coronary tissue of the subject is carried out using irreversible electroporation and have a reasonable expectation of success. Panescu discloses a method comprising a step of ablating the target coronary tissue of a subject, wherein the ablation is performed by heating the tissue at the targeted site by applying direct current to the tissue. Sutermeister discloses ablation performed by applying direct current to the tissue is referred to as irreversible electroporation. Thus, the combined teachings of Panescu and Sutermeister suggest the step of ablating the target coronary tissue of a subject may be carried out via irreversible electroporation. Therefore, it is reasonable to expect the method disclosed by Panescu may be modified so that the step of ablating the target coronary tissue of the subject is carried out using irreversible electroporation. One would have been motivated to do so because the selection of a known technique based on its suitability for its intended use is prima facie obvious. In the instant case, Panescu discloses the step of ablating the target coronary tissue of a subject by applying direct current to the tissue and Sutermeister discloses that ablation performed by applying direct current to the tissue is referred to as irreversible electroporation. Therefore, the selection of electroporation based on its suitability to apply direct current to tissue as an ablation technique is prima facie obvious.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Panescu and Sutermeister, as applied to claim 1-8, 10-20, and 22 above, and further in view of Morishita (US 2005/0147589 A1, Published 7/7/2005).
With respect to claim 1, 7, and 12, Panescu and Sutermeister disclose the teachings above.
Recall, with respect to claim 7, Panescu discloses the agent is OPTISON. [Panescu, 0031]
Panescu and Sutermeister do not disclose the agent comprises DNA.
However, with respect to claim 8, 9, 20, and 21, Morishita discloses OPTISON may function as a
carrier for plasmid DNA. [Morishita, 0023] DNA is a macromolecule.
Modifying the method disclosed by Panescu and Sutermeister so that the agent, OPTISON, comprises DNA, results in the method of claim 8, 9, 20, and 21.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Panescu and Sutermeister so that the agent, OPTISON, comprises DNA and have a reasonable expectation of success. Panescu and Sutermeister disclose a method comprising a step of delivering OPTISON to a segment of coronary vasculature of a subject. Morishita discloses OPTISON may function as a carrier for plasmid DNA. Thus, the combined teachings of Panescu/Sutermeister and Morishita suggest that OPTISON, when delivered to a segment of coronary vasculature of a subject, may function as a carrier for plasmid DNA. Therefore, it is reasonable to expect the method disclosed by Panescu and Sutermeister may be modified so that the agent, OPTISON, comprises DNA. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Morishita discloses OPTISON carrying plasmid DNA, may be delivered to a specific site and introduced into the cells of that site. [Morisihita, 0024] Therefore, one would have been motivated by the expectation that OPTISON carrying DNA may deliver said DNA to a segment of coronary vasculature of a subject.
Response to Arguments
Applicant's arguments filed 2/27/2026 have been fully considered but they are not persuasive.
Applicant asserts “Nonetheless, solely to expedite prosecution, independent claims 1 and 12 are amended to recite "targeting the agent to a target coronary tissue by electroporating a target coronary tissue of the subject, thereby distributing the agent to the target coronary tissue". As such, the claims recite an active step of targeting the agent to a target coronary tissue by electroporating the target coronary tissue, which step must be given patentable weight.” [Remarks 2/27/2026, Page 6, Paragraph 2]
For clarity of the record, the previous limitation “electroporating the target coronary tissue of the subject” [Claims, 5/29/2024] was given patentable weight, as it indeed recites an active step. Accordingly, the present limitation “targeting the agent to a target coronary tissue by electroporating the target coronary tissue of the subject” is given patentable weight, as it also recites an active step. The previous limitation “thereby achieving targeted distribution of the agent to the target coronary tissue” was not given patentable weight for the reasons previously provided. [Claims, 5/29/2024] The present limitation “thereby distributing the agent to the target coronary tissue” does not distinguish the claimed invention from the prior art because the distribution is achieved by performing the active step. Accordingly, the claim scope is not limited by this limitation because it simply expresses the result of performing the active step.
Applicant asserts “As such, if the skilled artisan were to apply the irreversible electroporation of Sutermeister into the method of Panescu to ablate the cardiac tissue as suggested by the Examiner, this would distinctively not result in a method of targeting the agent (e.g. the contrast agent) to the target coronary tissue by electroporating the target coronary tissue. Rather, irreversibly electroporating the target coronary tissue would result in the opposite effect - the contrast agent would deliberately be prevented from entering the target coronary tissue due to the closing of capillaries therein…” [Remarks 2/27/2026, Page 6, Paragraph 3]
Applicant’s arguments are not persuasive because Applicant is attempting to construe the claim limitation “targeting the agent to a coronary tissue” as requiring the agent to be delivered into the ablation lesion itself. The claim only requires that the agent is delivered to the target coronary tissue. Panescu discloses the contrast agent perfuses into the live tissue surrounding the ablation lesion. While Panescu does state the contrast agent does not perfuse in the necrotic tissue of the ablation lesion, the contrast agent is nonetheless distributed to the coronary tissue (the live coronary tissue surrounding the ablation lesion) as required by the claim. Applicant’s remarks narrow the claim limitations beyond what is actually recited by the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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