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 .
Claim Objections
Claims 1, 6 and 7 are objected to because of the following informalities:
Regarding claim 1, the claim recites in line 5 the language of “positioning an RF ablation catheter at least one selected target position” therein. The Examiner respectfully requests that Applicant amend the language of the claim to read as “positioning an RF ablation catheter at at least one selected target position” to correct the grammar of the claim. Appropriate correction is required.
Regarding claims 6 and 7, the Examiner respectfully requests that Applicant amend the language of “the catheter” to “the RF ablation catheter” for the sake of language consistency and claim clarity. Appropriate correction is required.
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 2-7, 9-13 and 15 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.
Regarding claim 2, the claim recites the limitation of “at least one of the plurality of RF ablation electrodes” therein. This requirement of “the plurality of RF ablation electrodes” fails to have proper antecedent basis in the claims as neither of claim 1 nor 2 introduce “a plurality … electrodes”. Claims 3-4 and 9 are rejected due to their dependency on claim 2. Appropriate correction is required.
Regarding claim 3, the claim recites the limitation of “the catheter assembly” therein. This limitation fails to have proper antecedent basis in the claim as none of claims 1-3 properly introduce “a catheter assembly”. Claims 4 and 9 are rejected due to its dependency on claim 3. Appropriate correction is required.
Regarding claim 3, the claim recites “the selected target position” therein. This limitation renders the scope of the claim as indefinite given that it is unclear if this limitation is the same as the “at least one selected target position” set forth in claim 1 or, alternatively, is directed to a different selected target position altogether. The Examiner respectfully requests Applicant amend the language of claim 3 to read as “the at least one selected target position” to correct the indefiniteness. Appropriate correction is required.
Regarding claim 5, the claim recites the limitation of “the insertion part”, “the body part” and “the plurality of RF ablation electrodes” therein. Each limitation fails to have proper antecedent basis in the claims as none of claims 1 or 5 properly introduce any one of “an insertion part”, “a body part” or “a plurality of RF ablation electrodes”. Claims 6-7 are rejected due to their dependency on claim 5. Appropriate correction is required.
Regarding claim 6, the claim recites the language of “the first guidewire insertion hole” therein. This limitation fails to have proper antecedent basis in the claims as neither of claim 1 nor 5 nor 6 introduce “a first guidewire insertion hole”. Claim 7 is rejected due to its dependency on claim 6. Appropriate correction is required.
Regarding claim 7, the claim recites the language of “recycling a coolant within the catheter”. Parent claim 6 has previous set forth “discharging a cooling from the catheter”. It is the Examiner’s position that the recitation of “a coolant” in claim 7 renders the scope of the claim as indefinite given that it is unclear if the “a coolant” of claim 7 is the same coolant as that in claim 6 or, alternatively, is directed towards a materially distinct and different coolant from that in claim 6. Appropriate correction is required.
Regarding claim 10, the claim recites the limitation of “providing a hydrophilic polymer coating layer on a proximal part thereof”. The Examiner is of the position that this limitation renders the scope of the claim as indefinite given that such render the claim as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships include any manner of relationship of a) the proximal part and b) the hydrophilic coating layer to any one or more of 1) the guidewire of parent claim 1 or 2) the RF ablation catheter of parent claim 1. Said differently, there is no manner to reasonably determine the scope of claim 10 when none of a) or b) is positively related to any other structure as set forth in either claims 1 and 10. The Examiner further notes that none of 1) or 2) of claim 1 inherently require any of a) or b) so as to implicitly provide for the required structural relationship requested above. Claims 11 and 12 are rejected due to their dependency on claim 10. Appropriate correction is required.
Regarding claim 11, the claim is, first, indefinite for substantially the same rationale set forth with respect to claim 10 above due to the lack of structural relationship of the elements to any of the structural features set forth in parent claim 1. The Examiner further notes that the recitation in claim 11 of “the insertion part” fails to have proper antecedent basis in the claims given that none of claims 1, 10 or 11 provide for a proper basis for “an insertion part”.
The Examiner also notes that the recitation of “at least the insertion part” further renders the scope of the claim as indefinite because it is unclear what other structural features are encompassed by the claim language of “at least”. Said differently, since claim 11 fails to have proper structural relationship with other structural features including those in claim 1, the Examiner fails to find what structure other than the “insertion part” would be encompassed by the open-ended language of “at least” as set forth in claim 11. Appropriate correction is required.
Regarding claim 12, the claim is, first, indefinite for substantially the same rationale set forth with respect to claim 10 above due to the lack of structural relationship of the elements to any of the structural features set forth in parent claim 1. The Examiner further notes that the recitation in claim 12 of “the at least one of the plurality of RF ablation electrodes” fails to have proper antecedent basis in the claims given that none of claims 1, 10 or 12 provide for a proper basis for “at least one of the plurality of RF ablation electrodes”. Appropriate correction is required.
Regarding claim 13, the claim recites the limitation of “at least the body part” therein. The Examiner first notes that the recitation in claim 13 of “the body part” fails to have proper antecedent basis in the claims given that none of claims 1 or 13 provide for a proper basis for “a body part”.
The Examiner also notes that the recitation of “at least the body part” further renders the scope of the claim as indefinite because it is unclear what other structural features are encompassed by the claim language of “at least”. Said differently, since claim 13 fails to have proper antecedent basis in the claims, the Examiner fails to find what structure other than the “body part” itself would be encompassed by the open-ended language of “at least” as set forth in claim 13. Appropriate correction is required.
Regarding claim 15, the claim recites the limitations of “the guidewire ablation catheter” and “the pklurality of RF ablation elements” therein. Each limitation fails to have proper antecedent basis in the claims as none of claims 1 or 15 provide a proper basis for either “a guidewire ablation catheter” or “a plurality of RF ablation elements”. The Examiner further notes, with respect to the “the guidewire ablation catheter” recitation that such renders the scope of the claim as indefinite given that the relationship of this catheter to the already recited “RF ablation catheter” is not clearly defined in the claims. 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,279,810 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, the Examiner is of the position that, upon review of instant claim 1 and patented claim 1, it is clear that all the elements of instant claim 1 are to be found in patented claim 1. The difference between the respective instant and patented claims lies in the fact that the patent claim 1 includes many more elements and is thus much more specific. Thus the invention of patented claim 1 is in effect a “species” of the “generic” invention of instant claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since instant claim 1 is anticipated by patented claim 1, it is not patentably distinct from the patented claim.
With respect to instant claim 2, see patented claim 1;
With respect to instant claim 3, see patented claim 2;
With respect to instant claim 4, see patented claim 3;
With respect to instant claim 5, see patented claim 4;
With respect to instant claim 6, see patented claim 5;
With respect to instant claim 7, see patented claim 6;
With respect to instant claim 8, see patented claim 7;
With respect to instant claim 9, see patented claim 8;
With respect to instant claim 10, see patented claim 9-10;
With respect to instant claim 11, see patented claims 9-10;
With respect to instant claim 12, see patented claims 9-10;
With respect to instant claim 13, see patented claim 11;
With respect to instant claim 14, see patented claim 12;
With respect to instant claim 15, see patented claim 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Werneth et al. (US Pat. Pub. 2008/0281312 A1)
Starksen (US Pat. Pub. 2009/0209950 A1)
Machold et al. (US Pat. Pub. 2005/0288422 A1)
While the Examiner has identified each of the above references as particularly pertinent with respect to the instant subject matter set forth in independent claim 1 including the particular focus the treatment of hypertrophic cardiomyopathy. The Examiner notes, however, that any of the above noted references, whether taken alone or in any combination disclose, fairly suggest or make obvious a specific manner of positioning the guidewire and subsequently placing the RF ablation catheter such that the guidewire to be placed in the interventricular septum through a septal vein of the heart, and the for the ablation catheter to be positioned proximate the HIS bundle via the positioning of the guidewire through the septal vein and into the interventricular septum.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
