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.
Claim Objections
Claim 12 is objected to because of the following informalities: In line 5, “and” should be deleted. 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 1-7, 11, 13, 14, 19, 21, and 22 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 1 recites the limitation "a steerable dilator" in line 14. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 4 recites the limitation "the wall" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 is found to be indefinite because it recites the limitation “wherein advancing the operative distal tip toward the target location comprises” as though it has been previously recited. There does not appear to be sufficient antecedent basis for this limitation in the claims. Applicant is encouraged to clarify the link between this limitation and a prior claim.
Claim 6 recites the limitation "the sinotubular junction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is found to be indefinite because it recites the limitation “further comprising advancing the steerable dilator along the flexible wire” as though it is a new limitation. However, since it has already been recited, the antecedent basis for this limitation is confusing. Applicant is encouraged to clarify the link between this limitation and its initial occurrence in claim 1.
Claim 13 is found to be indefinite because Examiner is unsure of its scope, since it appears to contradict the preceding claim 12. More specifically, claim 12 recites ‘creating a perforation with a flexible wire when it is energized’, while claim 13 discloses that the wire may be “a mechanical puncture wire”. Appropriate correction is required.
Claim 14 recites the limitation "the perforation" in lines 2-3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited ‘first/second perforation’.
Claim 19 recites the limitation "the perforation" in line 2. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited ‘first/second perforation’.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 12-20 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-20 of copending Application No. 18/192,378 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the claims of the instant application. Accordingly, the application claims are not patentably distinct from the copending claims. Here, the more specific copending 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 12-17, 19, 20, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham, U.S. 2012/0059459 (hereinafter Asirvatham) in view of Davies, U.S. 2016/0175009 (hereinafter Davies) and Garibotto, U.S. 2002/0123698 (hereinafter Garibotto).
Regarding claims 12, 15, 16, 20, and 23, Asirvatham discloses (note figs. 6A-E) a system/kit for creating perforations comprising: a flexible wire (‘needle’ in paragraph 40) having an operative distal tip for creating a perforations in the patient’s heart when energized (note paragraph 40); and a flexible dilator (‘sheath’ in paragraph 40) configured to position the operative distal tip adjacent the target location and enlarge the perforations, the dilator necessarily having at least one open lumen for receiving the flexible wire. However, Asirvatham fails to explicitly disclose a tapered dilator comprising a steerable curvature. Davies teaches (note figs. 6A-D) a similar system for creating a perforation within the heart, said system comprising a flexible wire (‘200’ – note paragraph 138) and a tapered dilator with a steerable curvature (composed of ‘100’ and ‘300’). It is well known in the art that this ‘steerable dilator’ configuration would increase the versatility of the device, and that the tapered tip would facilitate its insertion (thereby increasing its efficiency). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system/kit of Asirvatham to comprise tapered dilator having a steerable curvature (as taught by Davies) in order to increase versatility and efficiency. While Asirvatham discloses (see above) a method of advancing a wire and a dilator to perforate the wall between the aorta and the left atrium of a patient (going in either direction), wherein a catheter is waiting for this wire in order to engage it and ‘floss’ the tissue therewith (note paragraph 46), Asirvatham fails to explicitly disclose wherein this catheter comprises a lasso catheter. Garibotto teaches (note fig. 15C) a method that utilizes a lasso catheter (110) in order to engage a separate device and floss tissue therewith (note abstract; paragraph 116). It is well known in the art that these different catheter configurations for engaging a separate device are widely considered to be interchangeable (as can be seen in the different embodiments of Garibotto). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the system/kit of Asirvatham to comprise a lasso catheter capable of engaging the wire and flossing tissue therewith. This is because this modification would have merely comprised a simple substitution of interchangeable ‘engaging catheter’ configurations in order to produce a similar/predictable result (see MPEP 2143). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 13, Asirvatham discloses (see above, as best understood by Examiner) a system wherein the flexible wire is a radio frequency wire (note paragraph 40).
Regarding claim 14, Asirvatham discloses (see above) a system wherein the flexible wire is necessarily capable of providing support for placement of a device (which has not been positively recited) between the aorta and the left atrium across the perforation at the target location (also note paragraph 40). As above, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 17, Asirvatham in view of Davies and Garibotto teaches a system comprising a steerable dilator, but this combination of references (as modified above) fails to expressly teach a fixed curve dilator that can be interchanged therewith. Davies further teaches (see above) a similar system that can utilize either an adjustable dilator/sheath or a fixed curve dilator/sheath (note paragraph 40). It is well known in the art that these different dilator configurations (i.e., one adjustable dilator vs multiple fixed curve dilators) are widely considered to be interchangeable (as can be seen be seen in Davies), and that any combination of different dilators could be used depending on the needs of the user. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Asirvatham to further comprise fixed curve dilators. This is because this modification would have merely comprised a simple substitution of interchangeable dilator configurations in order to produce a similar/predictable result (see MPEP 2143). As above, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding claim 19, Asirvatham discloses (see above) a system comprising a flexible wire, but fails to explicitly disclose that this wire comprises a distal anchor. Davies further teaches (see above) a similar system comprising a flexible wire with a distal ‘anchor’ (see distal loop), which minimizes unwanted movement thereof and increases safety. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Asirvatham to comprise a flexible wire with a distal anchor, in order to minimize unwanted movement and increase safety.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham in view of Davies and Garibotto as applied to claims 12-17, 19, 20, and 23 above, and further in view of MacDonald, U.S. 2020/0397472 (hereinafter MacDonald).
Regarding claim 18, Asirvatham discloses (see above) a system comprising a flexible wire and dilator, but fails to explicitly disclose that these components contain visualization markers thereon. Davies further teaches (see above) a similar system comprising a flexible wire with visualization markers thereon (note paragraph 144), and MacDonald teaches a similar system comprising a dilator with visualization markers thereon (note paragraph 102), which both facilitate visualization and increase safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Asirvatham to comprise a flexible wire and dilator with visualization markers thereon, in order to facilitate visualization and increase safety and efficiency.
Allowable Subject Matter
Claims 1-7, 11, 21, and 22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they do not apply to the current rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Passman, U.S. 2020/0391016 (note fig. 5).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794