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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 03/07/2024, has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “steering wires for steering the probe tip” (as recited in claim 3) and the “withdrawal device mountable on the elongate probe” (as recited in claim 4), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7-9, 11, and 14, 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 7] The claim recites the limitation of “the insulating cap” in the 1st line of the claim. There is a lack of antecedent basis for this limitation in the claim. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim is intended to depend from claim 1 or claim 2 (reciting an insulating cap). For purposes of examination, it is interpreted that claim 7 depends from claim 2.
[Claim 7] The claim recites the limitation of “the flow path” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claim. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim is intended to depend from claim 1 or claim 2 (reciting a flow path). For purposes of examination, it is interpreted that claim 7 depends from claim 2.
[Claim 8] The claim is rejected based upon its dependency from claim 7.
[Claim 9] The claim recites the limitation of “the plurality of openings” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claim. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim is intended to depend from claim 4 or claim 7 (reciting a plurality of openings). For purposes of examination, it is interpreted that claim 9 depends from claim 7.
[Claim 11] The claim recites the limitation of “the outlet” in the 4th and 5th lines of the claim. There is a lack of antecedent basis for this limitation in the claim. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim is intended to depend from claim 1 or claim 2 (reciting an outlet). For purposes of examination, it is interpreted that claim 11 depends from claim 2.
[Claim 14] The claim recites the limitation of “the insulating cap” in the 1st line of the claim. There is a lack of antecedent basis for this limitation in the claim. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim is intended to depend from claim 1 or claim 2 (reciting an insulating cap). For purposes of examination, it is interpreted that claim 14 depends from claim 2.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hancock et al. (PGPub 2016/0113700), in view of Krasik et al. (PGPub 2017/0354453).
[Claim 1] Hancock teaches a urinary tract infection treatment apparatus (figure 12a, item 500; paragraph [0052]) comprising:
an elongate probe (figure 12a, items 502/514) comprising a coaxial cable (figure 12a, item 502) for conveying radiofrequency (RF) electromagnetic (EM) energy or microwave EM energy (paragraph [0010]),
a probe tip (figure 12a, items 510/512/518/520) connected at the distal end of the coaxial cable (figure 12a, item 502) for receiving the RF or microwave EM energy (paragraph [0124]), and
a gas conduit (figure 12a, item 516) for conveying gas to the probe tip (figure 12a, items 510/512/518/520) (paragraph [0123]);
wherein the coaxial cable (figure 12a, item 502) comprises an inner conductor (figure 12a, item 504), an outer conductor (figure 12a, item 506) and a dielectric material (figure 12a, item 508) separating the inner conductor (figure 12a, item 504) from the outer conductor (figure 12a, item 506) (paragraph [0122]),
wherein the probe tip (figure 12a, items 510/512/518/520) comprises a first electrode (figure 12a, item 512) connected to the inner conductor (figure 12a, item 504) of the coaxial cable (figure 12a, item 502), and a second electrode (figure 12a, item 518/520) connected to the outer conductor (figure 12a, item 506) of the coaxial cable (figure 12a, item 502) (paragraphs [0124], [0125]), and
wherein the first electrode (figure 12a, item 512) and second electrode (figure 12a, item 518/520) are arranged to produce an electric field from the received RF or microwave EM energy across a flow path of gas received from the gas conduit (figure 12a, item 516) to produce a non-thermal plasma that is emitted from the probe tip (figure 12a, items 510/512/518/520) (paragraphs [0010], [0032], [0124]).
Hancock does not specifically disclose the probe tip comprises a temperature sensor.
However, Krasik teaches a treatment apparatus (figure 1a, item 10) comprising an elongate probe (figure 4b, item 26) with a distal probe tip (figure 4a, items 26b/28); wherein the probe tip (figure 4a, items 26b/28) comprises a temperature sensor (figure 4b, items 72/74) (paragraphs [0089], [0132], [0133]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the probe tip taught by Hancock, with the use of a temperature sensor, as taught by Krasik, in order to provide increased functionality and safety, by allowing for a means by which plasma temperature might be monitored and provided as feedback (Krasik; paragraph [0132], [0133]).
[Claim 2] Hancock and Krasik teach the limitations of claim 1, upon which claim 2 depends. Hancock further discloses the second electrode (figure 12a, item 518/520) encloses an internal volume (see annotated figure below) of the probe tip (figure 12a, items 510/512/518/520), wherein the first electrode (figure 12a, item 512) extends longitudinally within the internal volume (see annotated figure below),
wherein the probe tip (figure 12a, items 510/512/518/520) further comprises an insulating cap (figure 12a, item 510) mounted at a distal end of the coaxial cable (figure 12a, item 502) to isolate the coaxial cable (figure 12a, item 502) from the internal volume (paragraph [0122]),
wherein the gas conduit (figure 12a, item 516) is in fluid communication with the internal volume via a flow path (via conduit 516) formed between the insulating cap (figure 12a, item 510) and the second electrode (figure 12a, item 518/520) (paragraphs [0123], [0126]),
wherein the first electrode (figure 12a, item 512) and second electrode (figure 12a, item 518/520) are configured to receive the RF or microwave energy from the coaxial cable (figure 12a, item 502) to set up an electric field in the internal volume for striking a plasma therein (paragraph [0124]), and
wherein the probe tip (figure 12a, items 510/512/518/520) includes an outlet (see annotated figure below) for releasing plasma from the internal volume (figure 12a).
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[Claim 3] Hancock and Krasik teach the limitations of claim 1, upon which claim 3 depends. The embodiment relied upon to teach the limitations of claim 1 (as shown in figure 12a) does not specifically disclose the elongate probe further comprises steering wires for steering the probe tip.
However, Hancock teaches an alternative embodiment (figure 3a) which utilizes steering wires (“pull wire”) for maneuvering the probe (paragraphs [0090], [0091]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the embodiment of figure 12a taught by Hancock, with the use of steering wires, as taught by the embodiment of figure 3a of Hancock, in order to provide increased functionality and versatility, by allowing for a commonly known means of positioning the apparatus.
[Claim 4] Hancock and Krasik teach the limitations of claim 1, upon which claim 4 depends. Hancock also discloses a withdrawal device (“scope”) mountable on the elongate probe (figure 12a, items 502/514) and configured to retract the elongate probe (figure 12a, items 502/514) therethrough (paragraph [0034]).
[Claims 5 and 6] Hancock and Krasik teach the limitations of claim 1, upon which claims 5 and 6 depend. Hancock also teaches a flexible surgical scoping device (“scoping device”) for introducing the elongate probe (figure 12a, items 502/514) to a urinary tract (paragraphs [0022], [0034], [0122]).
[Claims 7 and 8] Hancock and Krasik teach the limitations of claim 2 (see 112(b) interpretation above), upon which claims 7 and 8 depend. In addition, Hancock discloses the insulating cap (figure 12a, item 510) is mounted within the second electrode (figure 12a, item 518/520), and wherein the flow path (via conduit 516) comprises a plurality of openings (spaces provided between radially projecting bumps 520) in the second electrode (figure 12a, item 518/520) that permit gas flow around the insulating cap (figure 12a, item 510) (figure 12a; paragraph [0125]); wherein the second electrode (figure 12a, item 518/520) is a cylinder (figure 12a), and the plurality of openings (spaces provided between radially projecting bumps 520) each comprise a longitudinal notch in the cylinder (spaces provided between radially projecting bumps 520) (figure 12a; paragraph [0125]).
[Claim 9] Hancock and Krasik teach the limitations of claim 7 (see 112(b) interpretation above), upon which claim 9 depends. Hancock further discloses a proximal end (near item 520) of the second electrode (figure 12a, item 518/520) is castellated to provide the plurality of openings (spaces provided between radially projecting bumps 520) (paragraph [0125]).
[Claim 10] Hancock and Krasik teach the limitations of claim 1, upon which claim 10 depends. Hancock also teaches the elongate probe (figure 12a, items 502/514) comprises a protective sleeve (figure 12a, item 514) that defines a lumen through which the coaxial cable (figure 12a, item 502) extends (figure 12a), and wherein the gas conduit (figure 12a, item 516) is a passageway formed between an outer surface of the coaxial cable (figure 12a, item 502) and an inner surface of the protective sleeve (figure 12a, item 514) (figure 12a; paragraph [0123]).
[Claim 12] Hancock and Krasik teach the limitations of claim 1, upon which claim 12 depends. Hancock further discloses the first electrode (figure 12a, item 512) is helical (“first electrode may be a radiating microwave monopole antenna structure”) (“a radiating monopole antenna, which may take the form of a cylinder, a ball, a stiff wire or a helix”) (paragraphs [0005], [0019]).
[Claim 13] Hancock and Krasik teach the limitations of claim 1, upon which claim 13 depends. Hancock also teaches the first electrode (figure 12a, item 512) is formed from a portion of the inner conductor (figure 12a, item 504) of the coaxial cable (figure 12a, item 502) that extends beyond a distal end of the outer conductor (figure 12a, item 506) (figure 12a).
[Claim 14] Hancock and Krasik teach the limitations of claim 2 (see 112(b) interpretation above), upon which claim 14 depends. In addition, Hancock teaches the insulating cap (figure 12a, item 510) has a chamfered distal edge (figure 12a).
[Claim 15] Hancock and Krasik teach the limitations of claim 1, upon which claim 15 depends. Hancock further discloses the apparatus (figure 12a, item 500) is part of a robotically assisted surgical system (paragraphs [0017], [0027]-[0029]).
[Claim 16] Hancock and Krasik teach the limitations of claim 1, upon which claim 16 depends. In addition, Krasik discloses a controller (“feedback loop of the system”) configured to control plasma generation parameters of the plasma based on a signal from the temperature sensor (figure 4b, items 72/74) (paragraph [0133]).
Claims 1, 11, and 16, are rejected under 35 U.S.C. 103 as being unpatentable over Penny et al. (PGPub 2005/0149012), in view of Krasik et al. (PGPub 2017/0354453).
[Claim 1] Penny teaches a urinary tract infection treatment apparatus (figures 2 and 14, item 16) comprising:
an elongate probe (figure 14, items 30/40) comprising a coaxial cable (figure 14, item 40) for conveying radiofrequency (RF) electromagnetic (EM) energy or microwave EM energy (paragraph [0093]),
a probe tip (figure 14, items 92/94) connected at the distal end of the coaxial cable (figure 14, item 40) for receiving the RF or microwave EM energy (paragraph [0093]), and
a gas conduit (figure 2, items 34/36) for conveying gas to the probe tip (figure 14, items 92/94) (paragraph [0089]);
wherein the coaxial cable (figure 14, item 40) comprises an inner conductor (figure 2, item 42), an outer conductor (figure 2, item 44) and a dielectric material (figure 2, item 46) separating the inner conductor (figure 2, item 42) from the outer conductor (figure 2, item 44),
wherein the probe tip (figure 14, items 92/94) comprises a first electrode (figure 14, items 54/160) connected to the inner conductor (figure 2, item 42) of the coaxial cable (figure 14, item 40), and a second electrode (figure 14, item 70) connected to the outer conductor (figure 2, item 44) of the coaxial cable (figure 14, item 40), and
wherein the first electrode (figure 14, items 54/160) and second electrode (figure 14, item 70) are arranged to produce an electric field from the received RF or microwave EM energy across a flow path of gas received from the gas conduit (figure 2, items 34/36) to produce a non-thermal plasma that is emitted from the probe tip (figure 14, items 92/94) (paragraph [0142]).
Penny does not specifically disclose the probe tip comprises a temperature sensor.
However, Krasik teaches a treatment apparatus (figure 1a, item 10) comprising an elongate probe (figure 4b, item 26) with a distal probe tip (figure 4a, items 26b/28); wherein the probe tip (figure 4a, items 26b/28) comprises a temperature sensor (figure 4b, items 72/74) (paragraphs [0089], [0132], [0133]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the probe tip taught by Penny, with the use of a temperature sensor, as taught by Krasik, in order to provide increased functionality and safety, by allowing for a means by which plasma temperature might be monitored and provided as feedback (Krasik; paragraph [0132], [0133]).
[Claim 11] Penny and Krasik teach the limitations of claim 2 (see 112(b) interpretation above), upon which claim 11 depends. In addition, Penny discloses the probe tip (figure 14, items 92/94) comprises a conductive cap (figure 14, item 160) mounted on the first electrode (figure 14, items 54/160) at a distal end of the internal volume (figure 14), the conductive cap (figure 14, item 160) being spaced from a distal end of the second electrode (figure 14, item 70) to define the outlet (figure 14) (figure 14; paragraph [0142]).
[Claim 16] Penny and Krasik teach the limitations of claim 1, upon which claim 16 depends. In addition, Krasik discloses a controller (“feedback loop of the system”) configured to control plasma generation parameters of the plasma based on a signal from the temperature sensor (figure 4b, items 72/74) (paragraph [0133]).
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 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 15 of U.S. Patent No. 11,950,825. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 14 of the patent. The difference between claim 1 of the instant application and claim 14 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 14 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 14 of the patent, it is not patentably distinct from claim 14 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 05/12/2026
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