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.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, U.S. Provisional Patent Application No. 63/440,342, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AlA 35 U.S.C. 112, first paragraph for one or more claims of this application. More specifically, this application fails to disclose the specifically-claimed ‘tapered tip’ and ‘fluid lumen’ configurations.
The Examiner notes that support for the instant claims has been found in the instant application. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 10/17/2023, this being the filing date of the instant application.
Claim Objections
Claim 2 is objected to because of the following informalities: in line 2, “at” 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 11-16 and 20 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 therapeutic agent" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the central axis" in line 2. The antecedent basis for this limitation is confusing, since it’s unclear whether it’s related to the previously-recited “central longitudinal axis” or “central axis”.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/819,958 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application anticipate the claims of the instant application. Accordingly, the instant application claims are not patentably distinct from the copending claims. Here, the more specific copending claims encompass the broader instant 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) 1-10 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Wyk, U.S. 2005/0234446 (hereinafter Van Wyk).
Regarding claims 1-3, Van Wyk discloses (note figs. 1-5) a cautery probe for coupling to a radiofrequency (RF) generator comprising: a rigid shaft (note figs. 3-5, paragraph 64) having a proximal end, a smoothly tapering distal end (see angled tip in figs. 3-5), a central axis, and an electrode (‘54’ – note paragraph 85) extending through the shaft; a rounded tapered metal cutting tip (‘34’ – note figs. 3-5; note paragraph 64 and abstract) longitudinally fixed at the distal end of the shaft and coupled to the electrode, the cutting tip having an exposed length (i.e., length of exposed face of tip ‘34’) in a ‘dimension’ (i.e., direction) parallel to the central axis (note figs. 1-2), the cutting tip tapering in thickness over a tapered portion of the exposed length of the cutting tip in a direction toward a sharp distal edge (note fig. 5), and having a rounded profile transverse to the thickness (note figs. 3-4), the proximal end of the shaft adapted to be coupled to the RF generator (‘102’ – note paragraph 77) to deliver RF energy from the RF generator to the metal cutting tip. However, Van Wyk fails to explicitly disclose whether this metal cutting tip has the claimed dimensions. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the tip accordingly, 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. It should also be noted that a change in size (In re Rose, 105 USPQ 237 (CCPA 1955)) and shape (In re Dailey et al., 149 USPQ 47) is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Regarding claim 4, Van Wyk discloses (see above) a cautery probe comprising a metal tip having a rounded profile, but fails to explicitly disclose that this profile comprises a full semicircular radius along the edge. At the time the invention was filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to shape the metal tip so that its profile comprises a full semicircular radius along the edge, because applicant has not disclosed that this arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Van Wyk’s apparatus and applicant’s invention, to perform equally well with either the arrangement taught by Van Wyk or the claimed ‘full semicircular’ arrangement because both arrangements would perform the same function of delivering energy equally well considering their similarities. Therefore, it would have been prima facie obvious to further modify Van Wyk to obtain the invention as specified in claim 4 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Van Wyk. It should also be noted that a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 5, Van Wyk discloses (see above) a cautery probe further comprising: a handle (12), wherein the shaft is ‘separable’ (i.e., necessarily capable of being separated) from the handle.
Regarding claim 6, Van Wyk discloses (see above) a cautery probe further comprising: a handle (12), wherein the shaft is ‘disposable’ and the handle is ‘reusable’ (i.e., necessarily capable of being disposed of and reused, respectively).
Regarding claim 7, Van Wyk discloses (see above) a cautery probe wherein a fluid lumen (‘74’ – note paragraph 85) extends through a portion of the shaft offset from and ‘external’ (could necessarily be described in this manner) to the electrode, the fluid lumen having a proximal opening (78/80) and a distal exit (where ‘74’ reaches distal face of tip – note fig. 4), and a first fluid connector (plug at proximal end of ‘26’ – note fig. 2) is coupled to the shaft in fluid communication with the proximal opening, and the distal exit is at or adjacent the metal cutting tip.
Regarding claim 8, Van Wyk discloses (see above) a cautery probe wherein the first fluid connector is adapted to removably attach (necessarily capable of removably attaching) a syringe to the shaft of the probe, and the first fluid connector has a longitudinal axis axially offset from the central axis (note fig. 2). 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 9, Van Wyk discloses (see above) a cautery probe wherein the longitudinal axis of the first fluid connector is obliquely oriented relative to the central axis of the shaft (see angle of plug axis relative to shaft axis).
Regarding claim 10, Van Wyk discloses (see above) a cautery probe wherein the cautery probe includes a handle (12) ‘separable’ (i.e., necessarily capable of being separated) from the shaft, the handle including controls (30/32) to actuate delivery of RF energy from the RF generator to the metal cutting tip (note paragraph 84).
Regarding claim 17, Van Wyk discloses (see above) a cautery probe wherein the distal exit (lateral locations where ‘74’ reaches distal face of tip – note fig. 4) of the fluid lumen is necessarily located ‘adjacent’ a width-wise center of the metal cutting tip and proximal the tapered portion of the metal cuffing tip. It should be noted that according to Cambridge dictionary, “adjacent” has been define as “very near, next to, or touching”.
Regarding claim 18, Van Wyk discloses (see above) a cautery probe wherein the distal exit of the fluid lumen (lateral locations where ‘74’ reaches distal face of tip – note fig. 4) is located to a side of the metal cutting tip.
Regarding claim 19, Van Wyk discloses (see above) a cautery probe wherein the distal exit of the fluid lumen (lateral locations where ‘74’ reaches distal face of tip – note fig. 4) does not pass through the metal cutting tip.
Claim(s) 11, 13-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Wyk in view of Christopherson, U.S. 2005/0245923 (hereinafter Christopherson).
Regarding claim 11, Van Wyk discloses (note figs. 1-5) a cautery probe system for coupling to a radiofrequency (RF) generator comprising: a) a cautery probe, including, a rigid shaft (note figs. 3-5, paragraph 64) having a proximal end, a smoothly tapering distal end (see angled tip in figs. 3-5), a central longitudinal axis extending between the proximal and distal ends, an electrode (‘54’ – note paragraph 85) extending through the shaft parallel to the longitudinal axis, and a fluid lumen (‘74’ – note paragraph 85) extending through a portion of the shaft axially offset from the electrode, the fluid lumen having a proximal opening and a distal exit (lateral locations where ‘74’ reaches distal face of tip – note fig. 4) at the distal end of the rigid shaft, a first fluid connector (i.e., plug at proximal end of ‘26’) coupled to the shaft and in fluid communication with the proximal opening, the first fluid connector having a central axis axially offset from the longitudinal axis (see angle of plug axis relative to shaft axis), a metal tip (‘34’ – note paragraph 64) longitudinally fixed at the distal end of the shaft and coupled to the electrode, the distal exit of the fluid lumen opening adjacent and to a side of the metal tip (note fig. 4); and b) a conductive irrigant source (104) adapted to be coupled to the first fluid connector, the proximal end of the shaft adapted to be coupled to the RF generator (‘102’ – note paragraph 77) to deliver RF energy from the RF generator to the metal tip, and the irrigant source is configured to deliver the conductive fluid out of the distal exit of the fluid lumen. However, Van Wyk fails to explicitly disclose that the irrigant source comprises a syringe including a barrel and a plunger, the barrel provided with at least one of a numbing/desensitization agent and an anti-inflammatory agent, wherein the plunger can be moved relative to the barrel to deliver the therapeutic agent. Christopherson teaches a similar system (note abstract) with a conductive irrigant source comprising a syringe including (necessarily) a barrel and a plunger (note paragraph 28), the barrel provided with at least one of a numbing/desensitization agent and an anti-inflammatory agent (note paragraph 56), wherein the plunger can be moved relative to the barrel to deliver the therapeutic agent. This design, which uses an agent that is both conductive and anti-inflammatory, has been utilized in order to increase safety (note paragraph 56). Furthermore, it is well known in the art that these different fluid source configurations (i.e., a bag vs a syringe) are widely considered to be interchangeable. 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 irrigant source of Van Wyk to comprise an agent that is both conductive and anti-inflammatory in order to increase safety. 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 irrigant source of Van Wyk to comprise a syringe including a barrel and a plunger, wherein the plunger can be moved relative to the barrel to deliver the therapeutic agent. This is because this modification would have merely comprised a simple substitution of interchangeable fluid source configurations in order to produce a similar/predictable result (see MPEP 2143).
Regarding claim 13, Van Wyk discloses (see above) a cautery probe system wherein the central axis of the first fluid connector (i.e., plug at proximal end of ‘26’) is obliquely oriented relative to the longitudinal axis of the shaft (see angle of plug axis relative to shaft axis).
Regarding claim 14, Van Wyk discloses (see above) a cautery probe system wherein the distal end of the shaft is necessarily capable of forming a fluid tight seal within a Luer connector.
Regarding claim 15, Van Wyk discloses (see above) a cautery probe system wherein the distal end of the shaft is tapered and necessarily capable of forming a friction fit within a Luer connector.
Regarding claim 16, Van Wyk discloses (see above) a cautery probe system wherein the cautery probe includes a handle (12) ‘separable’ (i.e., necessarily capable of being separated) from the shaft, the handle including controls (30/32) to actuate delivery of RF energy from the RF generator to the metal tip (note paragraph 84).
Regarding claim 20, Van Wyk discloses (see above) a cautery probe system wherein the metal tip has an exposed length (i.e., length of exposed face of tip ‘34’) in a ‘dimension’ (i.e., direction) parallel to the central axis (note figs. 1-2), the tip tapering in thickness over a tapered portion of the exposed length of the tip in a direction toward a sharp distal edge. However, Van Wyk fails to explicitly disclose whether this metal tip has the claimed dimensions. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified the tip accordingly, 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. It should also be noted that a change in size (In re Rose, 105 USPQ 237 (CCPA 1955)) and shape (In re Dailey et al., 149 USPQ 47) is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Wyk in view of Christopherson as applied to claims 11, 13-16, and 20 above, and further in view of McClurken, U.S. 2009/0264879 (hereinafter McClurken).
Regarding claim 12, Van Wyk discloses (see above) a cautery probe comprising a first fluid connector, but fails to explicitly disclose that this fluid connector comprises a Luer connector. McClurken teaches a similar system comprising a cautery probe with a fluid connector, wherein this fluid connector comprises a Luer connector (note paragraph 240). It is well known in the art that these different fluid connector configurations are widely considered to be interchangeable. 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 fluid connector of Van Wyk to comprise a Luer connector. This is because this modification would have merely comprised a simple substitution of interchangeable fluid connector configurations in order to produce a similar result (see MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are either addressed below or rendered moot because they do not apply to the current rejections. Regarding Applicant’s arguments concerning the ‘distal exit of the fluid lumen’ in Van Wyk, Examiner respectfully disagrees. More specifically, Examiner maintains that this limitation has been met by Van Wyk, as can be seen in the updated rejection above. Therefore, Examiner asserts that the claims have been properly rejected by the cited references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2022/0160419 (note figs. 1U-W).
U.S. 2005/0283151.
U.S. 7,611,509.
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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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794