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 .
Specification
The disclosure is objected to because of the following informalities: the status of application 16/910,668 needs to be updated. Appropriate correction is required.
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 1-20 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,709,490. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '490 patent 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.
Claims 11-16 are 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 11 recites the limitation "the occlusion element" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim. It is not clear if a new element is being claimed or if the occlusion element is the same as the expansion element recited in line 2 of the claim.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1 and 5-10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Frank Ingle (2011/0264086).
Referring to claim 1, Ingle teaches a catheter comprising: an expandable element (230) configured to transition to an expanded configuration in a blood vessel; a control member (paragraph 0092 such as 232); and a neuromodulation element (212), wherein the control member and the neuromodulation element are disposed within the expandable element (230) (Figure 12), wherein the control member is configured to transition from a low-profile delivery state to a radially expanded state to place the neuromodulation element in contact with an inner wall of the expandable element adjacent to an inner wall of the blood vessel, wherein the control member defines a helical shape, a spiral shape, or a ring shape in the radially expanded state, and wherein the neuromodulation element is configured to deliver neuromodulation energy to a nerve adjacent to or near the blood vessel to inhibit neural communication along the nerve (paragraph 0067 and 0091-0094; Figures 11-12).
Referring to claim 5, Ingle teaches a system comprising: the catheter of claim 1 (as discussed above); and an energy generator (paragraph 0067; such as 320 in Figure 23A) configured to: generate the neuromodulation energy (paragraph 0067 and 0091-0094), monitor a parameter of the catheter or tissue before and during delivery of the neuromodulation energy by the neuromodulation element, and adjust the delivery of the neuromodulation energy by the neuromodulation element in response to the monitored parameter (paragraphs 0042, 0104, 0138 and 0178).
Referring to claim 6, Ingle teaches wherein the expandable element comprises an expandable balloon (paragraphs 0092-0094; Figures 11-12).
Referring to claim 7, Ingle teaches wherein the expandable element is configured to transition to the expanded configuration in response to inflation of the expandable ballon via a fluid (paragraphs 0042, 0092-0094, 0106 and 0178; Figures 11-12 and 17A).
Referring to claim 8, Ingle teaches wherein the neuromodulation element (212) is configured to deliver neuromodulation energy to the nerve to at least partially ablate the nerve (paragraphs 0011 and 0092-0094).
Referring to claim 9, Ingle teaches wherein the neuromodulation element (212) is disposed about the control member (232) (paragraphs 0093).
Referring to claim 10, Ingle teaches wherein the expandable element is configured to occlude the blood vessel when the expandable element is in the expanded configuration in the blood vessel (shown in Figures 6B, 23A and 28; paragraphs 0042, 0080, 0155 and 0178).
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Frank Ingle (2011/0264086) in view of Nagy Habib (2013/0211176).
Referring to claim 2, Ingle teaches a catheter comprising: an expandable element (230) configured to transition to an expanded configuration in a blood vessel; a control member (paragraph 0092 such as 232); and a neuromodulation element (212), wherein the control member and the neuromodulation element are disposed within the expandable element (230) (Figure 12), wherein the control member is configured to transition from a low-profile delivery state to a radially expanded state to place the neuromodulation element in contact with an inner wall of the expandable element adjacent to an inner wall of the blood vessel, wherein the control member defines a helical shape, a spiral shape, or a ring shape in the radially expanded state, and wherein the neuromodulation element is configured to deliver neuromodulation energy to a nerve adjacent to or near the blood vessel to inhibit neural communication along the nerve (paragraph 0067 and 0091-0094; Figures 11-12).
Ingle teaches an energy generator (paragraph 0067; such as 320 in Figure 23A) wherein the neuromodulation element comprises a heating element, and wherein the energy generator is configured to apply an electrical current to the heating element to cause the resistive heating element to deliver heat, wherein the neuromodulation energy comprises the heat (paragraph 0067 and 0091-0094; Figures 11-12), however fails to teach resistive heating. Habibi teaches an analogous catheter with an element (16/18) that is a resistive heating element and an energy generator (energy source) configured to apply an electrical current to the resistive heating element to cause the resistive heating element to deliver heat (paragraphs 0099 and 0127). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the neuromodulation element and generator, as taught by Ingle, to deliver resistive heating, as taught by Habib, because this is a simple substitution for one known energy source for another that was well known by those of ordinary skill in the art (See MPEP 2143).
Referring to claim 3, the modified Ingle teaches wherein the energy generator is configured to apply the electrical current to the resistive heating element to cause a temperature of the resistive heating element to increase to a determined temperature or a temperature within a determined range of temperatures for a period of time (paragraphs 0042, 0104, 0138 and 0178).
Referring to claim 4, the modified Ingle reference teaches wherein the energy generator is further configured to: determine a temperature of the resistive heating element, and adjust the electrical current to cause the resistive heating element to achieve a desired temperature (paragraphs 0042, 0104, 0138 and 0178).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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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.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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