DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to applicant’s communication of 11/08/2024. Currently claims 11-30 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/18/2024 is being considered by the examiner.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 11-17, 19-20, 23-26, 30 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Seward (US 2003/0171734 A1).
Seward discloses a kit (see para [0014]) for treating hypertension in a patient, the kit comprising: a catheter comprising one or more needle at a distal portion of the catheter (see para [0025]); a therapeutic agent capable of modulating a nerve function (see para [0067] and TABLE 1 (i.e. nitric oxide releasing agents and cell cycle modulators); and an instruction for using the kit (see para [0025]), wherein the one or more needle is configured to be deployable through a wall of a blood vessel and into a target site in the perivascular region surrounding the blood vessel to inject the therapeutic agent (see para [0015]).
Concerning claim 12 and the perivascular region is bound by an external elastic lamina (EEL) of the blood vessel and an outer extent of a connective tissue that surround the blood vessel (see para [0021]).
Concerning clam 13 and the instruction comprises using a radio-opaque dye to monitor an injection of the therapeutic agent from the one or more needle deployed into the target site (see para [0048], and [0067]).
Concerning claim 14 and the instruction comprises repositioning the one or more needle from the target site to a second target site as needed to complete the injection (see para [0024] i.e. different artery).
Concerning claim 15 and the injection results in a reduction of systolic blood pressure of the patient (examiner is of the position that the kit structures and elements are positively taught in Seward and the agents included in para [0067] and table 1 would be capable of reduction of systolic blood pressure depending on the patient).
Concerning claim 16 and the injection results in reduced norepinephrine release from sympathetic nerve terminals (examiner is of the position that the positively claimed kit structures and elements are taught in Seward and the agents included in para [0067] and table 1 would be capable of reduced norepinephrine release from sympathetic nerve terminals depending on the patient).
Concerning claim 17 and a volume of the therapeutic agent in the kit ranges from about 0.1 ml to about 10 ml (see para [0021]).
Concerning claim 19 and the injection results in little to no toxicity in the target site around the blood vessel. (examiner is of the position that the positively claimed kit structures and elements are taught in Seward and the agents included in para [0067] and table 1 would be capable of no toxicity in the target site depending on the patient).
Concerning claim 20 and the blood vessel is an artery or a vein (see para [0041]-[0042] i.e. artery or vein).
Concerning claim 23 and the distal portion of the catheter comprises a sheath and wherein the one or more needle is enclosed by the sheath before the one or more needle is deployed. (see para [0042] i.e. sheath).
Concerning claim 24 and enclosing the one or more needle with the sheath allows for the catheter to be navigated through the blood vessel and for the one or more needle to avoid injuring the walls of the blood vessel (see para [0042] again).
Concerning claim 25 and the one or more needle is uncovered from the sheath when the one or more needle is deployed (see para [0042] again).
Concerning claim 26 and the one or more needle comprises one or more of a polymer, a metal, a metal alloy, a semiconductor material, or glass (see para [0053]).
Concerning claim 30 and the hypertension in the patient is a resistant hypertension (examiner is of the position that the positively claimed kit structures and elements are taught in Seward and the condition of resistant hypertension would be a condition of the patient).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18, 21-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seward (US 2003/0171734 A1).
Concerning claim 18 and a dose of the therapeutic agent in the kit ranges from about 0.1 mg to about 200 mg (see para [0074]) but does not expressly state a range of 0.1 mg to about 200 mg. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the ranges from about 0.1 mg to about 200 mg, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). 0.1 mg to 200 mg is in the range a PHOSITA would administer pharmaceutical drugs to treat a patient and the Seward discloses 125 and 500 micrograms which would fall in this range. It is examiners position that a PHOSITA would include the ranges from about 0.1 mg to about 200 mg in order to effectively treat a patient in the correct dosage.
Concerning claim 21-22 and the artery is a renal artery or the vein is a renal vein examiner is of the position that Seward discloses all arteries or veins as potential area targets (see para [0041]-[0042]) if not inherent that the vein would be a renal artery or renal vein as the location than examiner is of the position that this would be an obvious modification to make to have the target be a renal artery or renal vein as a PHOSITA knows that the renal artery and vein may be used to treat a patient.
Claims 27-29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seward (US 2003/0171734 A1).
Seward discloses the claimed invention except for explicitly stating the use of the chemical sympathectomy agent comprises one or more of 6-hydroxyldopamine (6-OHDA), bretylium tosylate, guanacline, and N-(2- chloroethyl)-N-ethyl-2-bromobenzylamine (DSP4), phenol and ethanol. It would have been obvious to one having ordinary skill in the art at the time the invention was made to the chemical sympathectomy agent comprises one or more of 6-hydroxyldopamine (6-OHDA), bretylium tosylate, guanacline, and N-(2- chloroethyl)-N-ethyl-2-bromobenzylamine (DSP4), phenol and ethanol., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Seward discloses a long list of potential classes of agents to use (table 1) to treat a patient including Antiproliferative agents, immunosuppressive agents, cytostatic, and anti-inflammatory agents, Antineoplastic agents, antivirals, antibodies, gene therapy, antisense agents, anti-angiogensis agents, and antithrombotic agents. It is examiner’s position that the chemical sympathectomy agent of 6-hydroxyldopamine (6-OHDA), bretylium tosylate, guanacline, and N-(2- chloroethyl)-N-ethyl-2-bromobenzylamine (DSP4), phenol and ethanol., would fail under one of the disclosed classes of table 1. A PHOSITA would know to select one of chemical sympathectomy agent comprises of 6-hydroxyldopamine (6-OHDA), bretylium tosylate, guanacline, and N-(2- chloroethyl)-N-ethyl-2-bromobenzylamine (DSP4), phenol and ethanol., in order to treat a patient for the desired procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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