DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/16/26 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 7/7/26, with respect to the rejection(s) of claim(s) 2-18 and 20-21 under Hoey in view of Hoey II have been fully considered and are not persuasive. The Applicant argues that Hoey II fails to teach a coil that is connected to power and is wrapped around the heating element. The Examiner respectfully disagrees. Hoey II clearly discloses that the electrical source (e.g. 440) provide the energy for the inductive heating (e.g. ¶115) and that the coil (e.g. 450) provides the inductive heating (e.g. ¶¶117-118). Further the flow channel (e.g. 410) provide a means for the fluid to flow and be heated when the tubes receive the inductive energy (e.g. ¶118). Therefore, the rejections stand.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 8 recites that the flow channel within the heating structure has a diameter ranging from 0.01” to 0.10”. The specification and originally filed claims are silent as to the flow channel having a diameter ranging from 0.01” to 0.10”.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 recites that the flow channel within the heating structure has a length ranging from 10-500cm. The specification and originally filed claims are silent as to the flow channel being 10-500cm in length within or in total. Further the specification states that the sleeve of the heater (which is shown in figure 10 as the entire length of the heater) is only 1.5” in length in paragraph 115. Therefore, it is further unclear how a flow channel within the heater can be 10-500cm in length when the full length of the heater is disclosed as 3.81cm (1.5 inches).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2-18 and 20-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoey et al. (U.S. Pub. 2009/0149846 hereinafter “Hoey”) in view of Hoey et al. (U.S. Pub. 2010/0204688 hereinafter “Hoey II”).
Regarding claim 2, Hoey discloses a method for treating adipose tissue in a human subject with a vapor delivery probe (e.g. ¶136), comprising: providing a probe (e.g. 102) having a handle (e.g. 104) coupled to an elongate shaft (e.g. 105) with a working end (e.g. 110); positioning the working end at a targeted site proximate at least one of intestinal walls, a lung tumor, a lung nodule, sinus tissue, hemorrhoids, soft palate tissue, or tongue tissue (e.g. ¶¶75, 87, 100, 134 and 136); providing a flow of liquid media at a selected fluid flow rate and converting the liquid media to vapor media in a handle of the probe (e.g. ¶74); and delivering the vapor media through the shaft and working end to the targeted site for a selected time interval thereby delivering ablative energy to the targeted site (e.g. ¶¶19, 74). Hoey discloses the claimed invention except for the heating element being in the handle. Hoey II teaches a similar device and further teaches that it is known to put the heating element (e.g. 455) within in the handle along with a coil (e.g. 450) wrapped around the heating element as set forth in Paragraph 113, 115 and 117-118 and Figure 10 to provide inductive heating in the probe handle for directing vapor generated by inductive heater to either flow channel portion or the recirculation channel portion for easy use. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Hoey, with heating element within the handle as taught by Hoey II, since such a modification would provide the predictable results of provide inductive heating in the probe handle for directing vapor generated by inductive heater to either flow channel portion or the recirculation channel portion for easy use.
Regarding claim 3, meeting the limitations of claim 2 above, Hoey further discloses wherein the selected fluid flow rate is between 0.01 ml/min to 50 ml/min (e.g. ¶74).
Regarding claim 4, meeting the limitations of claim 2 above, Hoey further discloses wherein a corresponding vapor flow rate is between 1 ml/min to 1500 ml/min (e.g. ¶74).
Regarding claim 5, meeting the limitations of claim 2 above, Hoey further discloses wherein the energy applied for converting the liquid media to vapor media is between 1 W and 3000 W (e.g. ¶74).
Regarding claim 6, meeting the limitations of claim 2 above, Hoey further discloses wherein the selected time interval is between 1 second and 1 minute (e.g. ¶74).
Regarding claim 7, meeting the limitations of claim 2 above, Hoey II further discloses wherein converting includes actuating an electrical source (e.g. 440) configured to heat a helical structure (e.g. 450) in the handle having a flow channel that carries the flow of liquid media (e.g. 455; ¶118).
Regarding claim 8, meeting the limitations of claim 2 above, Hoey II further discloses wherein the flow channel within the structure has a diameter ranging from 0.01″ to 0.10″ (e.g. ¶118; “wherein the bore of the ceramic liner with which the flow channel is created has a diameter of 0.1 inches”).
Regarding claim 9, meeting the limitations of claim 2 above, Hoey further discloses wherein the flow channel within the structure has a length ranging from 10 cm and 500 cm (e.g. ¶132).
Regarding claim 10, meeting the limitations of claim 2 above, Hoey further discloses wherein the selected fluid flow rate is maintained at a constant rate over the selected time interval (e.g. ¶91).
Regarding claim 11, meeting the limitations of claim 2 above, Hoey further discloses selecting an energy application rate on a controller interface (e.g. ¶¶70, 74).
Regarding claim 12, meeting the limitations of claim 2 above, Hoey further discloses selecting the time interval on a controller interface (e.g. ¶¶70, 74).
Regarding claim 13, meeting the limitations of claim 2 above, Hoey further discloses selecting a total calories applied to tissue on a controller interface (e.g. ¶¶8-9, 112, 130).
Regarding claim 14, meeting the limitations of claim 2 above, Hoey further discloses wherein a flow controller is programmable to maintain the fluid flow rate at a constant over the selected time interval (e.g. ¶91).
Regarding claim 15, meeting the limitations of claim 2 above, Hoey further discloses wherein the energy delivered to the targeted site corresponds to a controlled energy application of between 1 cal/sec to 500 cal/sec (e.g. ¶¶8-9, 112, 130).
Regarding claim 16, meeting the limitations of claim 2 above, Hoey further discloses wherein delivering the flow of the vapor media is provided through a needle extended from the working end and comprises pulsing the flow of vapor media (e.g. ¶¶41-43, 82, 89 and 93).
Regarding claim 17, meeting the limitations of claim 2 above, Hoey further discloses wherein the targeted site is benign, malignant, hyperplastic or hypertrophic tissue (e.g. ¶89).
Regarding claim 18, meeting the limitations of claim 2 above, Hoey further discloses wherein the working end comprises one or more radiopaque markings (e.g. ¶115).
Regarding claim 20, meeting the limitations of claim 2 above, Hoey II further discloses modulating the energy applied to the heating element within a selected range when converting the flow of liquid media to the flow of vapor media (e.g. ¶¶91, 98).
Regarding claim 21, meeting the limitations of claim 2 above, Hoey II further discloses wherein the medical system includes a temperature sensor proximate to the helical structure (e.g. ¶¶109; [temp sensors spaced out within flow channel]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoey in view of Hoey II as applied to claims 2-18 and 20-21 above, and further in view of Penny et al. (U.S. Pat. 6,629,974 hereinafter “Penny”).
Regarding claim 19, Hoey in view of Hoey II discloses the claimed invention including a controller that adjust settings but fails to explicitly state that the controller has a user interface that is configured for adjusting settings. However, Penny teaches that it is known to use a user interface as set forth in Figure 1, Column 14, lines 30-35 and Column 22, line 41 to Column 22, line 25 to provide a user interface for selecting the settings to allow for increase in energy or flow. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Hoey in view of Hoey II, with a user interface as taught by Penny, since such a modification would provide the predictable results of providing a user interface for selecting the settings to allow for increase in energy or flow.
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 2-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,114,909. Although the claims at issue are not identical, they are not patentably distinct from each other because while being directed toward different tissue the method and parameters are exactly the same and one of ordinary skill in the art would use the same parameters to treat various tissue. Further the specification clearly teaches that the system can be used to treat both lung, sinus, hemorrhoids, soft palate, tongue and adipose tissue.
Claim 2 of the current claim set teaches the same probe, handle, flow of liquid media and vapor delivery as claim 1 of the ‘909 patent.
Further claims 3-15 are substantially duplicate to claims 2-14 of the ‘909 patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hoey et al. (U.S. Pub. 2011/0077628) – discloses a vapor delivery probe.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
