DETAILED ACTION
This action is in response to amendments received on 4/9/2024. It is acknowledged that originally filed claim 1 has been canceled and new claims 2-23 added. A complete action on the merits of claims 2-23 follows below.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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 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.
Claim 22 is 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 pre-AIA the applicant regards as the invention.
Claim 22 recites the limitation “wherein controlling the temperature of the fluid within the expandable treatment elements further comprises delivering a cooling fluid to the expandable treatment element”. It is at most unclear if this step is in addition to the step of “controlling a temperature of fluid within the expandable treatment element by controlling a temperature and delivery of a heated fluid to the expandable treatment element via the energy delivery unit” of claim 18 or instead of. If it is in addition to that step, it is unclear what happens to the heated fluid already inside the balloon. Clarification and appropriate correction is required.
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.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claim 18 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Cioanta (US Pub. No. 2004/0230188).
Regarding Claim 18, Cioanta teaches a method of treating target tissue using a system comprising an energy delivery unit and an ablation device, wherein the ablation device comprises an elongate tube 25 with a proximal portion, a distal portion, and at least one lumen extending from the proximal portion to the distal portion, and wherein the ablation device further comprises an expandable treatment element 23 mounted to the elongate tube distal portion and in fluid communication with the at least one lumen (Figs. 7 and 11A), the method comprising:
ablating a first location of target tissue by delivering thermal energy from the expandable treatment element to the target tissue, wherein delivering the thermal energy from the expandable treatment element to the target tissues comprises controlling a temperature of fluid within the expandable treatment element by controlling a temperature and delivery of a heated fluid to the expandable treatment element via the energy delivery unit (“thermal treatment can include one or more of cooling, heating, or thermal ablation treatments” [0031], “the thermal ablation is carried out by causing the targeted tissue to thermocoagulate via contact with an expandable treatment balloon 23 on a catheter 20 inserted into the subject which is configured to direct circulating hot liquid heated external of the body of the subject to the targeted treatment region within the biological subject” [0061] and “heated fluid, which can be water or a water-based liquid, is heated external of the subject, directed into the catheter 20, and circulated in the enclosed fluid paths 26i, 26o in the catheter 20. The fluid is directed through the shaft 25 via the inlet path 26i to the treatment balloon 23 located proximate the desired treatment site” [0070]).
Claims 18-20 and 22-23 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Rajagopalan (US Pub. No. 2013/0345670).
Regarding Claim 18, Rajagopalan teaches a method of treating target tissue using a system comprising an energy delivery unit and an ablation device (Fig. 4), wherein the ablation device comprises an elongate tube 311/311a with a proximal portion, a distal portion, and at least one lumen extending from the proximal portion to the distal portion, and wherein the ablation device further comprises an expandable treatment element 322a/322b mounted to the elongate tube distal portion and in fluid communication with the at least one lumen ([0204]-[0206] and Figs. 4, 12), the method comprising:
ablating a first location of target tissue by delivering thermal energy from the expandable treatment element to the target tissue, wherein delivering the thermal energy from the expandable treatment element to the target tissues comprises controlling a temperature of fluid within the expandable treatment element by controlling a temperature and delivery of a heated fluid to the expandable treatment element via the energy delivery unit (“Heat energy may be delivered to treat the target tissue, such as via a hot fluid filled balloon such as a conformal balloon. The hot fluid may be a fluid selected from the group consisting of: water; saline; glycerin; steam; and combinations of these ... Energy may be delivered with a treatment element in contact with target tissue, such as when configured as a hot liquid filled balloon” [0033], also see [0076], [0088], [0146], [0182] and “a treatment includes: ablation by a hot fluid balloon” [0240]).
Regarding Claim 19, Rajagopalan teaches wherein the target tissue is duodenal mucosal tissue ([0009]-[0010], [0031]-[0033], [0088], [0116]-[0131] and [0240]).
Regarding Claim 20, Rajagopalan teaches wherein the delivery of the heated fluid comprises circulating the heated fluid through the expandable treatment element ([0033], [0076], [0088], [0146], [0182] and “a treatment includes: ablation by a hot fluid balloon” [0240]).
Regarding Claim 22, Rajagopalan teaches wherein controlling the temperature of the fluid within the expandable treatment elements further comprises delivering a cooling fluid to the expandable treatment element (“Heated and/or cooled fluids can be introduced into treatment elements 320 and/or 321 such as to create varied heating and cooling treatments for the target tissue” [0182]).
Regarding Claim 23, Rajagopalan teaches further comprising subsequently applying a negative pressure to remove the fluid from the expandable treatment element (“if energy delivery element 322b is a heated saline balloon, then controller 360 can be configured to provide and withdraw heated saline to energy delivery element 322b, such as through an energy transfer tube not shown” [0216]).
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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 21 is rejected under pre-AIA 35 U.S.C. 102 (e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Rajagopalan.
Regarding Claim 21, Rajagopalan teaches wherein the energy delivery unit comprises at least one pump constructed and arranged to deliver the heated fluid to the expandable treatment element (“if energy delivery element 322b is a heated saline balloon, then controller 360 can be configured to provide and withdraw heated saline to energy delivery element 322b, such as through an energy transfer tube not shown” [0216]). Although Rajagopalan does not necessarily show or teach the use of a pump with the controller, does teach the use of an implanted pump associated with drug delivery, it is Examiner’s position that either a pump is also used with the controller in order to pump the heated fluid to the balloon or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a pump associated with delivery of the heated fluid to the balloon since it is well known in the art to use pumps to delivery fluid.
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cioanta as applied above in view of Nguyen (US Pub. No. 2009/0306588).
Regarding Claims 12, 17 and 23, Cioanta teaches the invention as applied above, but does not teach wherein the at least one fluid pump of the energy delivery unit is configured to apply a negative pressure and/or subsequently applying a negative pressure to remove the mixed fluid/fluid from the expandable treatment element.
In the same field of invention, Nguyen teaches “After the procedure is completed, the fluid is withdrawn from the balloon and the balloon is removed” in [0004] and [0073]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to subsequently apply a negative pressure to remove the fluid from the expandable treatment element after the procedure ended in order to allow easy withdrawal of the balloon from the target area.
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 2-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,201,342. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to a method of treating target tissue using a system comprising an energy delivery unit and an ablation device, wherein the ablation device comprises an elongate tube with a proximal portion, a distal portion, and at least one lumen extending from the proximal portion to the distal portion, and wherein the ablation device further comprises an expandable treatment element mounted to the elongate tube distal portion and in fluid communication with the at least one lumen, the method comprising:
ablating a first location of target tissue by delivering thermal energy from the expandable treatment element to the target tissue, wherein delivering the thermal energy from the expandable treatment element to the target tissue comprises generating a mixed fluid within the expandable treatment element by dynamically and separately controlling delivery of (a) a heated fluid via the energy delivery unit and (b) a cooling fluid to the expandable treatment element (claim 2 of the current invention) and further comprising subsequently applying a negative pressure to remove the mixed fluid from the expandable treatment element (claim 17 of the current invention) vs. (a) delivering a first volume of a first heated fluid via the energy delivery unit to the expandable treatment element to ablate the target tissue, (b) subsequently delivering a first volume of a first cooling fluid via the energy delivery unit to the expandable treatment element to dilute the first volume of the first heated fluid, thereby generating a mixed fluid to cool the target tissue; and subsequently applying a negative pressure to remove the mixed fluid from the expandable treatment element (claim 1 of U.S. Patent No. 12,201,342).
and/or ablating a first location of target tissue by delivering thermal energy from the expandable treatment element to the target tissue, wherein delivering the thermal energy from the expandable treatment element to the target tissues comprises controlling a temperature of fluid within the expandable treatment element by controlling a temperature and delivery of a heated fluid to the expandable treatment element via the energy delivery unit (claim 18 of the current invention) and wherein controlling the temperature of the fluid within the expandable treatment elements further comprises delivering a cooling fluid to the expandable treatment element (claim 22 of the current invention) and further comprising subsequently applying a negative pressure to remove the fluid from the expandable treatment element (claim 23 of the current invention) vs. (a) delivering a first volume of a first heated fluid via the energy delivery unit to the expandable treatment element to ablate the target tissue, (b) subsequently delivering a first volume of a first cooling fluid via the energy delivery unit to the expandable treatment element to dilute the first volume of the first heated fluid, thereby generating a mixed fluid to cool the target tissue; and subsequently applying a negative pressure to remove the mixed fluid from the expandable treatment element (claim 1 of U.S. Patent No. 12,201,342).
Allowable Subject Matter
Claims 2-17 would be allowable by receiving an acceptable Terminal Disclaimer to overcome the Double Patenting rejection, set forth in this Office action.
Regarding Claim 2, Cioanta (US Pub. No. 2004/0230188) teaches a method of treating target tissue using a system comprising an energy delivery unit and an ablation device, wherein the ablation device comprises an elongate tube 25 with a proximal portion, a distal portion, and at least one lumen extending from the proximal portion to the distal portion, and wherein the ablation device further comprises an expandable treatment element 23 mounted to the elongate tube distal portion and in fluid communication with the at least one lumen (Figs. 7 and 11A), the method comprising:
ablating a first location of target tissue by delivering thermal energy from the expandable treatment element to the target tissue (“thermal treatment can include one or more of cooling, heating, or thermal ablation treatments” [0031]); however does not teach wherein delivering the thermal energy from the expandable treatment element to the target tissue comprises generating a mixed fluid within the expandable treatment element by dynamically and separately controlling delivery of (a) a heated fluid via the energy delivery unit and (b) a cooling fluid to the expandable treatment element.
Regarding Claim 2, Rajagopalan (US Pub. No. 2013/0345670) teaches a method of treating target tissue using a system comprising an energy delivery unit and an ablation device (Fig. 4), wherein the ablation device comprises an elongate tube 311/311a with a proximal portion, a distal portion, and at least one lumen extending from the proximal portion to the distal portion ([0204]), and wherein the ablation device further comprises an expandable treatment element 322a/322b mounted to the elongate tube distal portion and in fluid communication with the at least one lumen ([0204]-[0206] and Figs. 4, 12), the method comprising:
ablating a first location of target tissue by delivering thermal energy from the expandable treatment element to the target tissue (“Heat energy may be delivered to treat the target tissue, such as via a hot fluid filled balloon such as a conformal balloon. The hot fluid may be a fluid selected from the group consisting of: water; saline; glycerin; steam; and combinations of these ... Energy may be delivered with a treatment element in contact with target tissue, such as when configured as a hot liquid filled balloon” [0033], also see [0076], [0088], [0146], [0182] and “a treatment includes: ablation by a hot fluid balloon” [0240]); although Rajagopalan teaches “Heated and/or cooled fluids can be introduced into treatment elements 320 and/or 321 such as to create varied heating and cooling treatments for the target tissue” [0182], does not specifically teach the method step of wherein delivering the thermal energy from the expandable treatment element to the target tissue comprises generating a mixed fluid within the expandable treatment element by dynamically and separately controlling delivery of (a) a heated fluid via the energy delivery unit and (b) a cooling fluid to the expandable treatment element.
Claims 3-16 depend on claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
Prosecution Insights