DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 14/079230, filed on 11/13/2013.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 or 119(e) as follows:
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(s), Application No(s). 14/530588, 14/666214 & 62/023781 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application: the listed applications fail to provide support for a 6 month follow up after ablating as recited in claim 29.
The disclosure of the prior-filed application(s), Application No(s). 14/672013, 14/666214, 14/530588, 62/023781, 14/079230 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application: the listed applications fail to provide support for a reduction in mean pulmonary artery pressure or systolic pulmonary artery pressure.
Accordingly, claims 29-36 are given the priority benefit date of 3/23/15.
Accordingly, claims 37-42 are given the priority benefit date of 1/17/18.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph to include appropriate patent numbers.
Appropriate correction is required.
Claim Objections
Claim 31 is objected to because of the following informalities: amend “6-minute” to -the 6-minute- in ll. 2-2. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: amend “cardiac output” to -the cardiac output- in ll. 2. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: amend “applies” to -is configured to apply- in ll. 1. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: amend “the ablation element” to -the expandable ablation element- in ll. 2. Appropriate correction is required.
Claim 34 is objected to because of the following informalities: amend “or third” to -or a third- in ll. 4. Appropriate correction is required.
Claim 35 is objected to because of the following informalities: amend “comprises causes” to -is configured to cause- in ll. 1-2. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: amend “reduction mean” to -reduction in mean- in ll. 10. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: amend “reduction systolic” to -reduction in systolic- in ll. 10-11. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: amend “a reduction” to -the reduction- in ll. 2. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: amend “applies” to -is configured to apply- in ll. 1. Appropriate correction is required.
Claim 41 is objected to because of the following informalities: amend “causes” to -is configured to cause- in ll. 1. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 33-34 & 40 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 33 the limitation “wherein the ablation element is positioned adjacent the target tissue” which positively recite the human body and are thus rejected under 35 USC 101.
Claims 34 & 40 recites the limitation “wherein the device is positioned at one or more of a first ablation site at a left lateral apex of the distal portion of the main pulmonary artery, a second ablation site at an anterior side of the left lateral apex of the distal portion of the main pulmonary artery, or third ablation site at a posterior side of the left lateral apex of the distal portion of the main pulmonary artery” which positively recite the human body and are thus rejected under 35 USC 101.
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 29-42 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 29 recites the limitation “a subject” and “a patient”. It is unclear if the “subject” and the “patient” are the same as or different from one another. For purposes of examination, they will be interpreted as being the same.
Claims 30-36 depend from claim 29 and are thus also rejected.
Claim 30 recites the limitation “wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device”; however, claim 29, upon which claim 30 depends, recites the limitation “wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device” which is duplicative and also fails to provide any further structure to the product claim. Thus, it is unclear how claim 30 further limits claim 29 from which it depends.
Claims 31 & 34-35 recite limitations that a further limit functional limitations and fail to provide any further structure to the product claim either implicitly or explicitly. Thus, it is unclear how claims 31 & 34-35 further limit claim 29 from which they depend.
Claim 33 recites “an expandable ablation element, comprising one or more ablation electrodes, wherein the ablation element is positioned adjacent the target tissue”; however claim 29, upon which claim 30 depends, recites the limitation “a plurality of electrodes;(i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, …. wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device”. It is unclear if the “expandable ablation element, comprising one or more ablation electrodes” is the same as or different from the “plurality of electrodes” recited in claim 29. For purposes of examination, they will be interpreted as being the same.
Claim 37 recites the limitation “a subject” and “a patient”. It is unclear if the “subject” and the “patient” are the same as or different from one another. For purposes of examination, they will be interpreted as being the same.
Claims 38-42 depend from claim 37 and are thus also rejected.
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 30 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, or for failing to include all the limitations of the claim upon which it depends.
Claim 30 recites the limitation “wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device”; however, claim 29, upon which claim 30 depends, recites the limitation “wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device” which is duplicative. Thus, claim 30 fails to further limit claim 29 from 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.
Claim Interpretation
Claims 29-31, 34-38 & 40-42 recite limitations of the intended use, and the examiner notes that limitations of 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. The Examiner notes these claims fail to recite any structure, either implicitly or explicitly, that is configured to enact the claimed functional limitations beyond “a catheter body” and “a plurality of electrodes” that are configured to contact the claimed locations since the electrodes can be connected to an appropriate power source outputting appropriate treatment parameters to achieve the functional limitations claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 29-42 is/are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Gnanashanmugam et al. (2013/0204068).
Concerning claims 29-31, as illustrated in at least Figs. 1-3, Gnanashanmugam et al. disclose a device for ablating a target tissue of a subject for treating a heart disease or worsening signs of heart failure (system 10 for decreasing activity of one or more sympathetic nerves to treat pulmonary arterial hypertension; [0078-0080]), the device comprising:
a catheter body comprising a proximal end and a terminal distal end (elongate, flexible body 12 having a distal end 14 and a proximal end 16 and a treatment member; [0080]); and
a plurality of electrodes (balloon catheter 30, having an electrode or plurality of electrodes 34 disposed about the periphery of a distal, expandable balloon 32; [0117]);
(i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery (Once elongate body 12 is advanced to a target location in the pulmonary vasculature, actuator 22 may be used to change the shape of shape-changing member 18 from a predominantly straight (or "low-profile," "delivery" or "non-contacting") configuration to an expanded, curved, looped or otherwise shape-altered configuration such that electrodes 34 contact the inner wall of the target location; [0083-0084]), and
(ii) wherein ablating the target tissue in the pulmonary artery trunk affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating by at least about 15% (when connected to an appropriate power source with appropriate treatment parameters, ablation is capable of an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating by at least 15%),
wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device (therapy may involve denervating one or more arteries supplying the lungs, such as but not limited to the pulmonary trunk, the left pulmonary artery and/or the right pulmonary artery, where the target location may be any of a number of locations in various embodiments, such as but not limited to the pulmonary trunk PT, left pulmonary artery LPA, right pulmonary artery RPA, any of the branching vessels BV, the ostia of the left or right pulmonary artery, or the like; [0078], [0081]).
Concerning claim 32, Gnanashanmugam et al. disclose wherein the device is configured to apply at least one of radiofrequency (RF) energy, microwave energy, ultrasound energy, focused ultrasound energy, ionizing energy, electroporation, a drug, a chemical agent, or cryoablation to the target tissue ([0116]).
Concerning claim 33, Gnanashanmugam et al. disclose wherein the device comprises an expandable ablation element (30), comprising one or more ablation electrodes (34), wherein the ablation element (30) is positioned adjacent the target tissue ([0082-0084], [0117-0118]; Fig. 2-4).
Concerning claim 34, Gnanashanmugam et al. disclose wherein the device is capable of being positioned at one or more of a first ablation site at a left lateral apex of the distal portion of the main pulmonary artery, a second ablation site at an anterior side of the left lateral apex of the distal portion of the main pulmonary artery, or third ablation site at a posterior side of the left lateral apex of the distal portion of the main pulmonary artery ([0117-0118]; Fig. 1B-4).
Concerning claim 35, Gnanashanmugam et al. disclose wherein ablating the target tissue comprises causes disruption of sympathetic nerves at the pulmonary artery trunk ([0078], [0081]).
Concerning claim 36, Gnanashanmugam et al. disclose the device (10) is arranged to advance into a femoral vein of the patient, upwardly into an inferior vena cava of the patient, then upwards into a right atrium of the patient, then down into a right ventricle of the patient, and then up through a pulmonary semilunar valve of the patient to the main pulmonary artery trunk ([0081]).
Concerning claims 37-38, as illustrated in at least Figs. 1-3, Gnanashanmugam et al. disclose a device for ablating a target tissue of a subject for treating a heart disease or worsening signs of heart failure (system 10 for decreasing activity of one or more sympathetic nerves to treat pulmonary arterial hypertension; [0078-0080]), the device comprising:
a catheter body comprising a proximal end and a terminal distal end (elongate, flexible body 12 having a distal end 14 and a proximal end 16 and a treatment member; [0080]); and
a plurality of electrodes (balloon catheter 30, having an electrode or plurality of electrodes 34 disposed about the periphery of a distal, expandable balloon 32; [0117]);
(i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery (Once elongate body 12 is advanced to a target location in the pulmonary vasculature, actuator 22 may be used to change the shape of shape-changing member 18 from a predominantly straight (or "low-profile," "delivery" or "non-contacting") configuration to an expanded, curved, looped or otherwise shape-altered configuration such that electrodes 34 contact the inner wall of the target location; [0083-0084]), and
(ii) wherein ablating the target tissue in the pulmonary artery affects a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure by at least about 15% (when connected to an appropriate power source with appropriate treatment parameters, ablation is capable of reducing mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure by at least about 15%; [0187]),
wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device (therapy may involve denervating one or more arteries supplying the lungs, such as but not limited to the pulmonary trunk, the left pulmonary artery and/or the right pulmonary artery, where the target location may be any of a number of locations in various embodiments, such as but not limited to the pulmonary trunk PT, left pulmonary artery LPA, right pulmonary artery RPA, any of the branching vessels BV, the ostia of the left or right pulmonary artery, or the like; [0078], [0081]).
Claim 39 is rejected upon the same rationale as applied to claim 32.
Claim 40 is rejected upon the same rationale as applied to claim 34.
Claim 41 is rejected upon the same rationale as applied to claim 35.
Claim 42 is rejected upon the same rationale as applied to claim 36.
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 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,820,800. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device. The Examiner notes the ablation device disclosed in the claim comprises at least two electrodes that are capable of being connected to an appropriate power source outputting appropriate treatment parameters and is thus capable of the functional limitations of the claim.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,827,036. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device. The Examiner notes the ablation device disclosed in the claim comprises at least two electrodes that are capable of being connected to an appropriate power source outputting appropriate treatment parameters and is thus capable of the functional limitations of the claim.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,872,720. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device. The Examiner notes the ablation device disclosed in the claim comprises at least two electrodes that are capable of being connected to an appropriate power source outputting appropriate treatment parameters and is thus capable of the functional limitations of the claim.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,918,776. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device. The Examiner notes the ablation device disclosed in the claim comprises at least two electrodes that are capable of being connected to an appropriate power source outputting appropriate treatment parameters and is thus capable of the functional limitations of the claim.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,458,427 and/or in view of Alexander (2014/0179993). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device. The Examiner notes the ablation device disclosed in the claim comprises at least two electrodes that are capable of being connected to an appropriate power source outputting appropriate treatment parameters and is thus capable of the functional limitations of the claim. Further, Alexander et al. disclose a treating heart disease to affect a reduction in mean pulmonary artery pressure to treat heart disease is also effective to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output from about at least 6 months after the ablating to about 2 years after the ablating ([0343], [0407], Table 2). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the ablating is configured to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output from about at least 6 months after the ablating since Alexander et al. teach that conditions effective to affect the reduction in mean pulmonary artery pressure to treat heart disease also are effective to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output from about at least 6 months after the ablating and one of ordinary skill in the art would recognize the claimed results to be predictable.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,241,267. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,082,868 and/or in view of Alexander (2014/0179993). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device. The Examiner notes the ablation device disclosed in the claim comprises at least two electrodes that are capable of being connected to an appropriate power source outputting appropriate treatment parameters and is thus capable of the functional limitations of the claim. Further, Alexander et al. disclose a treating heart disease to affect a reduction in mean pulmonary artery pressure to treat heart disease is also effective to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output from about at least 6 months after the ablating to about 2 years after the ablating ([0343], [0407], Table 2). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the ablating is configured to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output from about at least 6 months after the ablating since Alexander et al. teach that conditions effective to affect the reduction in mean pulmonary artery pressure to treat heart disease also are effective to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output from about at least 6 months after the ablating and one of ordinary skill in the art would recognize the claimed results to be predictable.
Claims 37-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,082,868. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device.
Claims 29-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,458,427. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a device for ablating tissue for treating heart disease or worsening signs of heart failure comprising: a catheter body and a plurality of electrodes (i) wherein the plurality of electrodes is arranged to contact a pulmonary artery trunk of a patient, the pulmonary artery trunk including a distal portion of a main pulmonary artery, a proximal portion of a left pulmonary artery, and a proximal portion of a right pulmonary artery, and (ii) wherein ablating the target tissue in the pulmonary artery trunk to affect an increase in one or more of 6-minute walk distance (6MWD) or cardiac output at least 6 months after the ablating or to affect a reduction mean pulmonary artery pressure and a reduction systolic pulmonary artery pressure, wherein the target tissue comprises at least one of the distal portion of the main pulmonary artery, the proximal portion of the left pulmonary artery, or the proximal portion of the right pulmonary artery with the ablation device.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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