The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of claims
The amendment filed on 3/16/20268 is acknowledged. Claims 1-24 have been canceled. New claims 25-43 have been added. Claims 25-43 are under examination in the instant office action.
Applicants' arguments, filed on 3/16/20268, have been fully considered but they are moot in view of new ground rejections necessitated by the amendments (new claims). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Double Patenting Rejections
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 25-43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of US patent 9,956,166.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘166 patent encompass a method of administering the same effective amount of resiniferatoxin (RTX) directly to a tissue site selected from the group consisting of epicardium, dorsal root ganglion and the subarachnoid space of the T1-T4 region of the spinal column via a technique selected from the group consisting of pericardiocentesis, catheter based administration into the coronary artery circulation, intrathecal administration to a T1-T4 location and intraganglionic administration to a T1-T4 ganglion for preventing or reducing physiological changes associated with myocardial infarction selected from: increased sympatho-excitation, cardiac hypertrophy, increased left ventricular end-diastolic pressure (LVEDP), lung edema, and combinations thereof.
Thus, the instant claims are anticipated by the claims of ‘166 patent.
Claims 25-43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-25 of US patent 10729643 in view of US 2004/0146590 (Iadarola et al., prior art of record).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘643 patent are drawn to a method of intrathecally administering the same effective amount of resiniferatoxin (RTX) directly to the T1-T4 space of the spinal column wherein the patient has or is at risk of having one or more of: heart failure, cardiac inflammation, or cardiac fibrosis, which are induced by myocardial infarction, wherein the concentration of RTX in the formulation is sufficient to ablate dorsal root ganglion cells that express transient receptor potential vanilloid 1 receptor (TRPV1) channels.
The claims of the patent do not recite specifically recite intraganglionic administration into T1-T4 ganglion of the spinal column of the subject. However, it was known in the art that resiniferatoxin could be applied via intraganglionic administration as well as intrathecal administration to a dorsal root ganglion or an autonomic ganglion for ablating vanilloid receptor-1 (VR1)-expressing neurons as evidenced by Iadarola et al. ([0013], [0033], [0071], [0075], [0102] and claim 1). Thus, it would have been prima facie obvious to one of ordinary skill in the art in the art before the effective filing date of the claimed invention to use RTX via intraganglionic administration to T1-T4 ganglion instead of intrathecal administration for treating the same conditions.
As such, the instant claims would have been obvious over the claims of ‘643 patent.
Claims 25-43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of US patent 11,679,075 in view of US 2004/0146590 (Iadarola et al., prior art of record).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘075 patent are drawn to a method of administering the same effective amount of resiniferatoxin (RTX) via catheter-based administration into the coronary artery circulation or pericardiocentesis (application directly to epicardium) wherein the patient has or is at risk of having one or more of: heart failure, cardiac inflammation, or cardiac fibrosis, which are induced by myocardial infarction. The claims of the patent do not recite specifically recite intraganglionic administration into T1-T4 ganglion of the spinal column of the subject. However, it was known in the art that resiniferatoxin could be applied via intraganglionic administration to a dorsal root ganglion or an autonomic ganglion for ablating vanilloid receptor-1 (VR1)-expressing neurons as evidenced by Iadarola et al. ([0013], [0033], [0071], [0075], [0102] and claim 1). Thus, it would have been obvious to one of ordinary skill in the art in the art before the effective filing date of the claimed invention to use RTX via intraganglionic administration to T1-T4 ganglion of the spinal column for treating the same conditions.
As such, the instant claims would have been obvious over the claims of ‘075 patent.
Allowable Subject Matter
New claims 25-46 are directed to a method of treating a patient who has or is risk of having one or more of heart failure, cardiac inflammation or cardiac fibrosis which are induced by myocardial infarction comprising intraganglionic administration of a formulation comprising RTX into a T1-T4 ganglion of the spinal column. While the closest prior of US 2004/0146590 (Iadarola et al., prior art of record) teaches intraganglionic administration of a formulation comprising RTX in the treatment of pain, Iadarola et al. do not teach or suggest intraganglionic administration of a formulation comprising RTX to a T1-T4 ganglion of the spinal column for treating patient having myocardial infarction. Accordingly, the claims will be allowable once a terminal disclaimer is filed over the above patents (US 9956166, US 10729643, and US 11679075).
Conclusion
No claims are 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 extension fee 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 date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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