DETAILED ACTION
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 .
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.
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 7-26 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,736,692 and claims 1-20 of U.S. Patent No. 11,350,992. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 10,736,692 and U.S. Patent No. 11,350,992 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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 26 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 26, lines 2-3 recites “at least one of reduce muscle sympathetic nerve activity (MSNA) in the patient or reduces whole body norepinephrine spillover in the patient.” It is at most unclear to the Examiner what Applicant is attempting to claim as this limitation is not clear. For examination purposes, the limitation has been interpreted to mean -- includes at least one of reduced muscle sympathetic nerve activity (MSNA) in the patient or reduced whole body norepinephrine spillover in the patient --. It is also noted that this limitation is written in the alternative, and therefore does not require both reduced muscle sympathetic nerve activity (MSNA) in the patient and reduced whole body norepinephrine spillover in the patient. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Toth et al., (hereinafter ‘Toth,’ U.S. PGPub. No. 2016/0213313).
Regarding claim 21, Toth (Fig. 1) discloses a method comprising: delivering neuromodulation therapy to a first sympathetic nerve (renal artery 2) via an intravascular neuromodulation assembly (micro surgical tool 1610) to attenuate neural traffic along the first sympathetic nerve ([0053] “Where the methods are directed to treatment of subjects having one or more solid tumors, aspects of such embodiments may include methods where tumor tissue itself is not modulated as described herein. Instead, only nerve(s) operatively coupled to the tumor is modulated, e.g., ablated. As such, in these embodiments the tumor itself is not ablated.” See [0155] for application to sympathetic nerves associated with various organs), wherein the first sympathetic nerve innervates a secondary tissue site that is different than a primary tissue site that includes a malignant tumor in a patient ([0053]; [0096], “The non-limiting examples disclosed herein may be directed towards such configurations (e.g., to controllably provide neuromodulation procedures to an organ within a body, so as to controllably ablate renal nerves along a renal artery via an endoscopic or percutaneous procedure, to treat a cancerous tumor, to limit perineural invasion of cancerous cells into a nearby nerve, to alter a tumor microenvironment, etc.).” Also see [0109]-[0110] for treatment of progression of a cancerous tumor; [0122]); and delivering neuromodulation therapy to the second sympathetic nerve to attenuate neural traffic along the second sympathetic nerve (see [0122]-[0126], for “neuromodulating one or more nerves coupled to the tumor”), wherein attenuating neural traffic along the first sympathetic nerve and the second sympathetic nerve results in one or more of: a reduction in a tumor growth rate of the malignant tumor in the patient, a decrease in a frequency of metastasis of the malignant tumor, at least partial inhibition of vascularization of the malignant tumor, a decrease in a number of metastatic tumors derived from the malignant tumor in the patient, a decrease in a rate of colonization of circulating tumor cells at the secondary tissue site, or increased effectiveness of a chemotherapy agent on cancer cells derived from the malignant tumor (see [0109] for a method to “treat and/or slow the progression of a cancerous tumor”; also see [0110], “the present disclosure may be used to slow, hinder, and/or prevent perineural invasion of a cancerous tumor into a surrounding nerve structure. In aspects, a system, device, and/or method in accordance with the present disclosure may be used to interrupt, decrease, and/or stop neural communication to a cancerous tumor and/or the microenvironment surrounding the tumor (i.e., to interrupt nerve traffic to/from a cancerous tumor or the tissues thereby to the rest of the body).”).
Regarding claim 22, Toth discloses wherein delivering neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering at least one of radio frequency energy, ultrasound energy, laser energy, or microwave energy via the neuromodulation assembly ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 23, Toth discloses wherein delivering neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises cooling tissue of the patient ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 24, Toth discloses wherein delivering neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering a chemical to tissue of the patient (see [0017], for use of a “ highly specific denervating agent may be a neural targeting chemical, etc.” also see [0056], “In aspects, the method may include providing energy and/or a bolus of a chemical agent in an amount sufficient to provide a neural block to one or more regions of the neural circuit, and/or ablate one or more regions of the neural circuit.”).
Regarding claim 25, Toth discloses wherein delivering neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises at least partially ablating a respective one of the first sympathetic nerve or the second sympathetic nerve ([0053] “… only nerve(s) operatively coupled to the tumor is modulated, e.g., ablated. As such, in these embodiments the tumor itself is not ablated.” See also [0096], “The non-limiting examples disclosed herein may be directed towards such configurations (e.g., to controllably provide neuromodulation procedures to an organ within a body, so as to controllably ablate renal nerves along a renal artery via an endoscopic or percutaneous procedure, to treat a cancerous tumor, to limit perineural invasion of cancerous cells into a nearby nerve, to alter a tumor microenvironment, etc.).”).
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 7-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Gnanashanmugam et al., (hereinafter ‘Gnanashanmugam,’ U.S. PGPub. No. 2013/0204068).
Regarding claim 7, Toth (Fig. 1) discloses a method comprising: intravascularly positioning a catheter assembly (micro surgical tool 1610) adjacent to a first sympathetic nerve (renal artery 2) innervating a first tissue site that is proximate to a malignant tumor in a patient ([0053] “Where the methods are directed to treatment of subjects having one or more solid tumors, aspects of such embodiments may include methods where tumor tissue itself is not modulated as described herein. Instead, only nerve(s) operatively coupled to the tumor is modulated, e.g., ablated. As such, in these embodiments the tumor itself is not ablated.” See [0155] for application to sympathetic nerves associated with various organs); delivering neuromodulation therapy to the first sympathetic nerve via the catheter to attenuate neural traffic along the first sympathetic nerve ([0053]; [0096], “The non-limiting examples disclosed herein may be directed towards such configurations (e.g., to controllably provide neuromodulation procedures to an organ within a body, so as to controllably ablate renal nerves along a renal artery via an endoscopic or percutaneous procedure, to treat a cancerous tumor, to limit perineural invasion of cancerous cells into a nearby nerve, to alter a tumor microenvironment, etc.).” Also see [0109]-[0110] for treatment of progression of a cancerous tumor; [0122]); and delivering neuromodulation therapy to a second sympathetic nerve innervating a second tissue site that is at risk of forming a metastatic tumor to attenuate neural traffic along the second sympathetic nerve (see [0122]-[0126], for “neuromodulating one or more nerves coupled to the tumor”).
Although Toth discloses neuromodulating one or more nerves coupled to the tumor, Toth is silent regarding wherein the second sympathetic nerve is associated with a different organ or tissue from the first tissue site and does not innervate the first tissue site.
However, in the same field of endeavor, Gnanashanmugam teaches a similar method of performing neuromodulation, including innervating various organs and tissue sites. For example, in one embodiment, the method comprises performing bilateral pulmonary neuromodulation in either or both of the patient's left pulmonary artery or right pulmonary artery, and additionally or alternatively performing treatment concurrently on both right and left neural fibers that contribute to pulmonary function ([0191]; Figs.25A-26B). It is well known in the art (as can be seen in Gnanashanmugam) to provide neuromodulation to various sympathetic nerves associated with different organs and tissues in order to achieve a more full and complete treatment of the patient, thereby increasing efficacy and efficiency. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Toth to include wherein the second sympathetic nerve is associated with a different organ or tissue from the first tissue site and does not innervate the first tissue site, as taught by Gnanashanmugam, in order to achieve a more full and complete treatment of the patient, thereby increasing efficacy and efficiency.
Regarding claim 8, Toth discloses wherein delivering the neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering ablative energy via the catheter ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 9, Toth discloses wherein delivering the neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering electrical energy via the catheter ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 10, Toth discloses wherein delivering the neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering thermal energy via the catheter ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 11, Toth discloses wherein delivering the neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises cooling tissue of the patient ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 12, Toth discloses wherein delivering the neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises neuromodulation therapy via an ultrasound transducer ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 13, Toth discloses wherein delivering the neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering a chemical to tissue of the patient (see [0017], for use of a “ highly specific denervating agent may be a neural targeting chemical, etc.” also see [0056], “In aspects, the method may include providing energy and/or a bolus of a chemical agent in an amount sufficient to provide a neural block to one or more regions of the neural circuit, and/or ablate one or more regions of the neural circuit.”).
Regarding claim 14, Toth discloses wherein delivering neuromodulation therapy to at least one of the first sympathetic nerve or the second sympathetic nerve comprises delivering at least one of radio frequency energy, ultrasound energy, laser energy, or microwave energy via a neuromodulation assembly carried by the catheter ([0016], “The energy may be thermal energy, RF (radio frequency) current, MW (microwave) current, ultrasound, MR (magnetic resonance) guided HIFU (high intensity focused ultrasound), radiation, cryotherapy, combinations thereof, or the like.”).
Regarding claim 15, Toth discloses wherein delivery of the neuromodulation therapy to the first sympathetic nerve (2) results in one or more of: a reduction in a tumor growth rate of the malignant tumor in the patient; a decrease in a frequency of metastasis of the malignant tumor; at least partial inhibition of vascularization of the malignant tumor; a decrease in number of metastatic tumors derived from the malignant tumor in the patient; or increased effectiveness of a chemotherapy agent on cancer cells derived from the malignant tumor (see [0109] for a method to “treat and/or slow the progression of a cancerous tumor”; also see [0110], “the present disclosure may be used to slow, hinder, and/or prevent perineural invasion of a cancerous tumor into a surrounding nerve structure. In aspects, a system, device, and/or method in accordance with the present disclosure may be used to interrupt, decrease, and/or stop neural communication to a cancerous tumor and/or the microenvironment surrounding the tumor (i.e., to interrupt nerve traffic to/from a cancerous tumor or the tissues thereby to the rest of the body).”).
Regarding claim 16, Toth in view of Gnanashanmugam teach each and every limitation of the method according to claim 7. In view of the prior modification of Toth in view of Gnanashanmugam, Gnanashanmugam necessarily teaches wherein there is a delay between delivering neuromodulation therapy to the first sympathetic nerve and delivering neuromodulation therapy to the second sympathetic nerve (see Figs. 25A-25H for delay caused by removal and readjustment of device to second tissue site).
Regarding claim 18, Toth discloses wherein delivering neuromodulation therapy to the second sympathetic nerve decreases a rate of colonization of circulating tumor cells at the second tissue site by altering a microenvironment at the second tissue site to be less habitable to colonization ([0050], “Aspects of the invention include treatment of subjects suffering from neoplastic disease conditions, i.e., disease conditions characterized by the occurrence of unwanted cellular proliferation, e.g., as manifested by the appearance/growth of one or more solid tumors. By treatment is meant at least an amelioration of the symptoms associated with the disease condition afflicting the subject (i.e., host), where amelioration is used in a broad sense to refer to at least a reduction in the magnitude of a parameter, e.g., symptom, associated with the pathological condition being treated, such as size of tumor, rate of growth of tumor, spread of tumor, pain, etc.”).
Regarding claim 19, Toth discloses wherein attenuating neural traffic along the first sympathetic nerve at least one of decreases a number of circulating tumor cells in the patient; or inhibits at least one of lymphatic spread or hematogenous spread of tumor cells from the malignant tumor in the patient ([0050]).
Regarding claim 20, Toth discloses wherein the malignant tumor is located in the breast, colon, kidney, pancreas, liver, prostate, cervix or ovary of the patient (Fig. 1; [0052]; [0132], “micro surgical tool 1610 in accordance with the present disclosure is shown as placed into the renal artery 2 of a subject as coupled to a target organ 1 (i.e., here shown as a kidney)”).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Gnanashanmugam, as applied to claim 7, and further in view of Brennan (hereinafter ‘Brennan’ U.S. PGPub. No. 2015/0088111).
Regarding claim 17, Toth in view of Gnanashanmugam teach each and every limitation of the method according to claim 7, but are silent regarding wherein delivering neuromodulation therapy to the second sympathetic nerve reduces a level of whole body norepinephrine spillover.
However, in the same field of endeavor, Brennan teaches a similar method for neuromodulation comprising performing renal neuromodulation, thereby decreasing sympathetic renal nerve activity, wherein a marker of reducing sympathetic neural activity includes reducing whole body norepinephrine spillover ([0030]; [0036]). Further, in some instances the whole body norepinephrine spillover can be reduced by at least about twenty-percent within about three months ([0036]), wherein it is plausible that the majority of the reduction is within the first month. It is well known in the art (as can be seen in Brenan) to use such a reduction as a marker of treatment progression and effectiveness ([0030]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Toth to include wherein delivering neuromodulation therapy to the second sympathetic nerve reduces a level of whole body norepinephrine spillover, as taught by Brennan. Doing so provides a measurable marker to monitor a decrease in sympathetic renal nerve activity ([0030]), thereby providing an improved method for monitoring progression and effectiveness of treatment.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Brennan.
Regarding claim 26, Toth discloses all of the limitations of the method according to claim 21, but is silent regarding wherein attenuating neural traffic along the first sympathetic nerve at least one of reduce muscle sympathetic nerve activity (MSNA) in the patient or reduces whole body norepinephrine spillover in the patient.
However, in the same field of endeavor, Brennan teaches a similar method for neuromodulation comprising performing renal neuromodulation, thereby decreasing sympathetic renal nerve activity, wherein a marker of reducing sympathetic neural activity includes reducing whole body norepinephrine spillover ([0030]; [0036]). Further, in some instances the whole body norepinephrine spillover can be reduced by at least about twenty-percent within about three months ([0036]), wherein it is plausible that the majority of the reduction is within the first month. It is well known in the art (as can be seen in Brenan) to use such a reduction as a marker of treatment progression and effectiveness ([0030]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Toth to include wherein attenuating neural traffic along the first sympathetic nerve reduces whole body norepinephrine spillover in the patient, as taught by Brennan. Doing so provides a measurable marker to monitor a decrease in sympathetic renal nerve activity ([0030]), thereby providing an improved method for monitoring progression and effectiveness of treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE A DEDOULIS whose telephone number is (571)272-2459. The examiner can normally be reached M-F, 8am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
Prosecution Insights