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 .
Benefit
The application is a Continuation of 18/593,803 (1 March 2024) issued as 12,279,782 (22 April 2025), which is a Continuation of 17/827,169 (27 May 2022), issued as 12,329,400 (17 June 2025), which claims benefit as a Continuation-In-Part (CIP) of PCT/US2022/014785 (1 February 2022), which claims benefit to US Provisional 63/274,832 (2 November 2021), US Provisional 63/241,295 (7 September 2021), and US Provisional 63/145,641 (4 February 2021).
Formal Matters
Claims 1-125 are cancelled. Claims 126-145 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 19 March 2025, 26 June 2025, 30 July 2025, 27 August 2025, 9 September 2025, 16 December 2025, 13 February 2026, have been considered. Signed copies are attached.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Non-Statutory Type Double Patenting Rejections
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 126, 131, and 144 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,636,025 in view of in view of Takamiya et al., US 4,832,005 (23 May 1989).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain the same subject matter in overlapping claims. The claims of the ‘025 patent anticipate the claims of the application. A table is provided below to show a claim-by-claim comparison.
The ’025 patent does not teach wherein the proximal and distal chambers are shaped differently.
Takamiya teaches a balloon catheter assembly (FIG 1) comprising: (a) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(b) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(c) a proximal connector present at the proximal end of the catheter (FIGs 1, 2, isolator 20), wherein the proximal connector comprises:
(i) a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
(ii) a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
(iii) a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),wherein the proximal and distal chambers are shaped differently (FIG 2).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the ’025 patent and Takamiya, given that the prior art included each element claimed, although not necessarily in a single reference. The ’025 patent and Takamiya teach in the same field of endeavor, balloon catheter assemblies.
Although, the ’025 patent discloses the claimed base balloon catheter assembly (pulse generator, proximal connector comprising a proximal chamber and a distal chamber separated by a membrane, wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange, where the proximal flange comprises a proximal port), the ’025 patent does not expressly disclose that the proximal and distal chambers are shaped differently.
Takamiya specifically addresses the differential shape of the proximal and distal chambers in FIG 2 and also explains that limiting member 28 may modify the proximal chamber (col 4, lines 24-33). Because the ’025 patent includes the comprising a proximal chamber and a distal chamber separated by a membrane, wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange, a person of ordinary skill in the art, seeking to control the rise of pressure (Takamiya, col 2, lines 21-23) in the ’025 patent’s architecture would reasonably consult Takamiya’s differential shape solution. Takamiya’s differential shape of the proximal and distal chambers can be incorporated alongside the ’025 patent’s proximal connector comprising a proximal chamber and a distal chamber separated by a membrane (same general location and interaction) using known assembly methods without redesigning the ’025 patent’s core architecture.
Because the references address the same engineering problem (optimizing balloon catheter systems to configured to output energy to fracture calcified lesions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (differentially shaping the proximal and distal chambers or adding a deflector to the existing chamber to modify the shape as an optimizable parameter or results-effective variable), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
A terminal disclaimer, as set forth above, is required in order to overcome this rejection.
Application 19/084,192
US Patent 12,636,025
126. A balloon catheter assembly comprising:
(a) a catheter comprising proximal and distal ends;
(b) a balloon present at the distal end of the catheter; and
(c) a proximal connector present at the proximal end of the catheter, wherein the proximal connector comprises:
(i) a proximal chamber defined by a proximal flange;
(ii) a distal chamber defined by a distal flange; and
(iii) a membrane separating the proximal and distal chambers,
Wherein the proximal and distal chambers are shaped differently. [TAUGHT BY TAKAMIYA]
1. A pulsatile balloon catheter system, the system comprising: (a) a pulse generator configured to output energy to fracture calcified lesions, the pulse generator comprising:(i) a controller configured to control one or more of frequency, duty cycle and amplitude of the outputted energy from the pulse generator; (ii) an electrical connector electrically for connecting the controller to an electrical assembly of a balloon catheter assembly, wherein the electrical connector can be releasably coupled to an electrical connector of the balloon catheter assembly; (iii) a pneumatic connector configured to transmit energy from the pulse generator to a proximal port of the balloon catheter assembly, wherein the pneumatic connector can be releasably coupled to the proximal port of the balloon catheter assembly; and (iv) a release button configured to release the pulse generator from the balloon catheter assembly such that the electrical connector and the pneumatic connector can be disconnected from the balloon catheter assembly; (b) a balloon catheter assembly removably coupled to the pulse generator, the balloon catheter assembly comprising:
(i) a proximal connector operably connected to the pulse generator, wherein the proximal connector comprises a proximal chamber and a distal chamber separated by a membrane
and a proximal port configured to receive the outputted energy from the pulse generator, wherein the pulse generator is directly coupled to the proximal chamber through the proximal port, and the proximal port is releasably coupled to the pneumatic connector of the pulse generator;
(ii) a catheter operably connected to the proximal connector and comprising a distal balloon;
and (iii) an electrical assembly attached to the proximal connector and comprising memory, wherein the electrical assembly comprises a flexible printed circuit board disposed along an outer region of the proximal connector; the electrical assembly further comprises an electrical connector releasably coupled to the electrical connector of the pulse generator and electrically connecting the electrical assembly to the controller of the pulse generator; and the memory comprises configuration data for the catheter and the distal balloon.
2. The pulsatile balloon catheter system according to claim 1, wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange.
131. The balloon catheter assembly according to claim 126, wherein the proximal flange comprises a proximal port.
3. The pulsatile balloon catheter system according to claim 2, wherein the proximal flange comprises the proximal port.
144. A pulsatile balloon catheter system, the system comprising:
(a) a pulse generator; and
(b) a balloon catheter assembly operably connected to the pulse generator, the balloon catheter assembly comprising:
(i) a catheter comprising proximal and distal ends;
(ii) a balloon present at the distal end of the catheter; and
(iii) a proximal connector present at the proximal end of the catheter, wherein the proximal connector comprises:
a proximal chamber defined by a proximal flange;
a distal chamber defined by a distal flange; and
a membrane separating the proximal and distal chambers,
Wherein the proximal and distal chambers are shaped differently. [TAUGHT BY TAKAMIYA]
1. A pulsatile balloon catheter system, the system comprising: (a) a pulse generator configured to output energy to fracture calcified lesions, the pulse generator comprising:(i) a controller configured to control one or more of frequency, duty cycle and amplitude of the outputted energy from the pulse generator; (ii) an electrical connector electrically for connecting the controller to an electrical assembly of a balloon catheter assembly, wherein the electrical connector can be releasably coupled to an electrical connector of the balloon catheter assembly; (iii) a pneumatic connector configured to transmit energy from the pulse generator to a proximal port of the balloon catheter assembly, wherein the pneumatic connector can be releasably coupled to the proximal port of the balloon catheter assembly; and (iv) a release button configured to release the pulse generator from the balloon catheter assembly such that the electrical connector and the pneumatic connector can be disconnected from the balloon catheter assembly; (b) a balloon catheter assembly removably coupled to the pulse generator, the balloon catheter assembly comprising:
(i) a proximal connector operably connected to the pulse generator, wherein the proximal connector comprises a proximal chamber and a distal chamber separated by a membrane
and a proximal port configured to receive the outputted energy from the pulse generator, wherein the pulse generator is directly coupled to the proximal chamber through the proximal port, and the proximal port is releasably coupled to the pneumatic connector of the pulse generator;
(ii) a catheter operably connected to the proximal connector and comprising a distal balloon;
and (iii) an electrical assembly attached to the proximal connector and comprising memory, wherein the electrical assembly comprises a flexible printed circuit board disposed along an outer region of the proximal connector; the electrical assembly further comprises an electrical connector releasably coupled to the electrical connector of the pulse generator and electrically connecting the electrical assembly to the controller of the pulse generator; and the memory comprises configuration data for the catheter and the distal balloon.
2. The pulsatile balloon catheter system according to claim 1, wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange.
Claims 126 and 144 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,279,782 in view of Takamiya et al., US 4,832,005 (23 May 1989).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain the same subject matter in overlapping claims. The claims of the ‘782 patent anticipate the claims of the application. A table is provided below to show a claim-by-claim comparison.
The ’782 patent does not teach a proximal chamber defined by a proximal flange, a distal chamber defined by a distal flange, or wherein the proximal and distal chambers are shaped differently.
Takamiya teaches a balloon catheter assembly (FIG 1) comprising: (a) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(b) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(c) a proximal connector present at the proximal end of the catheter (FIGs 1, 2, isolator 20), wherein the proximal connector comprises:
(i) a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
(ii) a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
(iii) a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),wherein the proximal and distal chambers are shaped differently (FIG 2).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the ‘782 patent and Takamiya, given that the prior art included each element claimed, although not necessarily in a single reference. The ‘782 patent and Takamiya teach in the same field of endeavor, balloon catheter assemblies.
Although, the ‘782 patent discloses the claimed base balloon catheter assembly (pulse generator, proximal connector comprising a proximal chamber and a distal chamber separated by a membrane, where the proximal flange comprises a proximal port), the ‘782 patent does not expressly disclose a proximal chamber defined by a proximal flange, a distal chamber defined by a distal flange, or wherein the proximal and distal chambers are shaped differently.
Takamiya specifically addresses the differential shape of the proximal and distal chambers in FIG 2 and also explains that limiting member 28 may modify the proximal chamber (col 4, lines 24-33). Takamiya also specifically addresses a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21) and a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22). Because the ‘782 patent includes the comprising a proximal chamber and a distal chamber separated by a membrane, a person of ordinary skill in the art, seeking to control the rise of pressure (Takamiya, col 2, lines 21-23) in the architecture of the proximal connector would reasonably consult Takamiya’s defining proximal and distal housings (flanges) and differential shape solution. Takamiya’s differential shape of the proximal and distal chambers with their respective housings (flanges) can be incorporated alongside the ‘782 patent’s proximal connector comprising a proximal chamber and a distal chamber separated by a membrane (same general location and interaction) using known assembly methods without redesigning the ‘782 patent’s core architecture.
Because the references address the same engineering problem (optimizing balloon catheter systems to configured to output energy to fracture calcified lesions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (differentially shaping the proximal and distal chambers or adding a deflector to the existing chamber to modify the shape as an optimizable parameter or results-effective variable), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
A terminal disclaimer, as set forth above, is required in order to overcome this rejection.
Application 19/084,192
US Patent 12,279,782
126. A balloon catheter assembly comprising:
(a) a catheter comprising proximal and distal ends;
(b) a balloon present at the distal end of the catheter; and
(c) a proximal connector present at the proximal end of the catheter, wherein the proximal connector comprises:
(i) a proximal chamber defined by a proximal flange; [TAUGHT BY TAKAMIYA]
(ii) a distal chamber defined by a distal flange; and[TAUGHT BY TAKAMIYA]
(iii) a membrane separating the proximal and distal chambers,
Wherein the proximal and distal chambers are shaped differently. [TAUGHT BY TAKAMIYA]
1. A pulsatile balloon catheter system, the system comprising: (a) a pulse generator; and (b) a balloon catheter assembly operably connected to the pulse generator, the balloon catheter assembly comprising:
(i) a proximal connector operably connecting the balloon catheter assembly to the pulse generator,
wherein the proximal connector comprises: a proximal chamber and a distal chamber separated by a membrane,
a pressure sensor operably coupled to the distal chamber, and a membrane positional sensor that directly measures changes in spatial position of the membrane;
(ii) a distal balloon; and (iii) a catheter component comprising a fluidic passage operably positioned between the proximal connector and the distal balloon;
wherein the system is configured to assess vessel compliance based on changes in pressure detected by the pressure sensor and changes in volume based on changes in position of the membrane detected by the membrane positional sensor.
144. A pulsatile balloon catheter system, the system comprising:
(a) a pulse generator; and
(b) a balloon catheter assembly operably connected to the pulse generator, the balloon catheter assembly comprising:
(i) a catheter comprising proximal and distal ends;
(ii) a balloon present at the distal end of the catheter; and
(iii) a proximal connector present at the proximal end of the catheter, wherein the proximal connector comprises:
a proximal chamber defined by a proximal flange; [TAUGHT BY TAKAMIYA]
a distal chamber defined by a distal flange; and [TAUGHT BY TAKAMIYA]
a membrane separating the proximal and distal chambers,
Wherein the proximal and distal chambers are shaped differently. [TAUGHT BY TAKAMIYA]
1. A pulsatile balloon catheter system, the system comprising:
(a) a pulse generator;
and (b) a balloon catheter assembly operably connected to the pulse generator, the balloon catheter assembly comprising:
(i) a proximal connector operably connecting the balloon catheter assembly to the pulse generator,
wherein the proximal connector comprises: a proximal chamber and a distal chamber separated by a membrane,
a pressure sensor operably coupled to the distal chamber, and a membrane positional sensor that directly measures changes in spatial position of the membrane;
(ii) a distal balloon; and
(iii) a catheter component comprising a fluidic passage operably positioned between the proximal connector and the distal balloon;
wherein the system is configured to assess vessel compliance based on changes in pressure detected by the pressure sensor and changes in volume based on changes in position of the membrane detected by the membrane positional sensor.
Claim 145 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,329,400 in view of Takamiya et al., US 4,832,005 (23 May 1989).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain the same subject matter in overlapping claims. The claims of the ‘400 patent anticipate the claims of the application. A table is provided below to show a claim-by-claim comparison.
The ’400 patent does not teach wherein the proximal connector comprises: a proximal chamber defined by a proximal flange; a distal chamber defined by a distal flange; and a membrane separating the proximal and distal chambers, wherein the proximal and distal chambers are shaped differently.
Takamiya teaches a balloon catheter assembly (FIG 1) comprising: (a) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(b) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(c) a proximal connector present at the proximal end of the catheter (FIGs 1, 2, isolator 20), wherein the proximal connector comprises:
(i) a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
(ii) a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
(iii) a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),wherein the proximal and distal chambers are shaped differently (FIG 2).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the ‘400 patent and Takamiya, given that the prior art included each element claimed, although not necessarily in a single reference. The ‘400 patent and Takamiya teach in the same field of endeavor, balloon catheter assemblies.
Although, the ‘400 patent discloses the claimed base balloon catheter assembly (pulse generator, proximal connector comprising a proximal chamber and a distal chamber separated by a membrane, where the proximal flange comprises a proximal port), the ‘400 patent does not expressly disclose wherein the proximal connector comprises: a proximal chamber defined by a proximal flange; a distal chamber defined by a distal flange; and a membrane separating the proximal and distal chambers, wherein the proximal and distal chambers are shaped differently.
Takamiya specifically addresses that proximal connector comprises: proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21); a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22), and a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23), wherein the proximal and distal chambers are shaped differently (FIG 2) and also explains that limiting member 28 may modify the proximal chamber (col 4, lines 24-33). Because the ‘400 patent includes the comprising a proximal chamber and a distal chamber separated by a membrane, a person of ordinary skill in the art, seeking to control the rise of pressure (Takamiya, col 2, lines 21-23) in the architecture of the proximal connector would reasonably consult Takamiya’s defining proximal and distal housings (flanges) and differential shape solution. Takamiya’s differential shape of the proximal and distal chambers with their respective housings (flanges) can be incorporated alongside the ‘400 patent’s proximal connector (same general location and interaction) using known assembly methods without redesigning the ‘400 patent’s core architecture.
Because the references address the same engineering problem (optimizing balloon catheter systems to configured to output energy to fracture calcified lesions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (differentially shaping the proximal and distal chambers or adding a deflector to the existing chamber to modify the shape as an optimizable parameter or results-effective variable), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
A terminal disclaimer, as set forth above, is required in order to overcome this rejection.
Application 19/084,192
US Patent 12,329,400
145. A method comprising: deploying a system so that a balloon of the system is adjacent to internal luminal tissue, the system comprising:
(a) a pulse generator; and
(b) a balloon catheter assembly operably connected to the pulse generator, the balloon catheter assembly comprising:
(i) a catheter comprising proximal and distal ends;
(ii) the balloon present at the distal end of the catheter; and
(iii) a proximal connector present at the proximal end of the catheter,
wherein the proximal connector comprises: [TAUGHT BY TAKAMIYA]
a proximal chamber defined by a proximal flange; [TAUGHT BY TAKAMIYA]
a distal chamber defined by a distal flange; and[TAUGHT BY TAKAMIYA]
a membrane separating the proximal and distal chambers, [TAUGHT BY TAKAMIYA]
wherein the proximal and distal chambers are shaped differently; [TAUGHT BY TAKAMIYA]
and actuating the system to impart pulsatile energy to the internal luminal tissue.
17. A method comprising: deploying a system so that a distal balloon of the system is adjacent to an internal luminal tissue location, the system comprising:
(a) first and second pulse generating assemblies, wherein each pulse-generating assembly comprises:
(i) a pulse generator; and (ii) a proximal connector operably connected to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy;
(b) a catheter component comprising a fluidic passage, wherein the fluidic passage is operably positioned between the proximal connectors and a distal balloon and configured to propagate each second pulse energy from each proximal connector along the fluidic passage to the distal balloon; and
(c) a controller configured to independently control each of the first and second pulse generating assemblies;
and actuating the system to impart pulsatile energy to the internal luminal tissue location.
Claim Objections
Claim 138 objected to because of the following informalities: the recitation in line 2 of “attenuation at the balloon of input pulse energy applied to the proximal connector is 5% or less” is awkward. The phrase should be reworded or punctuation added so that it is clear that “the input pulse energy applied to the proximal connector results in attenuation of 5% or less at the balloon.” Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 126-145 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Takamiya et al., US 4,832,005 (23 May 1989) (cited on Applicant’s IDS filed 9/9/2025).
Regarding claim 126, Takamiya teaches a balloon catheter assembly (FIG 1) comprising:
(a) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(b) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(c) a proximal connector present at the proximal end of the catheter (FIGs 1, 2, isolator 20), wherein the proximal connector comprises:
(i) a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
(ii) a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
(iii) a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),wherein the proximal and distal chambers are shaped differently (FIG 2).
Takamiya does not textually recite the word “catheter”.
However, Takamiya teaches a “pipe line” (col 9, lines 13 and 26-32) between components of FIG 1. FIG 1 also shows an exemplary catheter structure and col 1, lines 11-12 expressly state that the apparatus is “for driving an intraaorta balloon pump”. The balloon pump assembly and affiliated structures are shown in FIG 1. (FIG 1, “pipe line” col 9, lines 13 and 26-32
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya as including a catheter as a structure with a lumen sufficient to expand a balloon as shown by the exemplary balloon pump assembly of FIG 1 and the express teaching of the apparatus for driving an intraaorta balloon pump at column 1, lines 11-12. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33, requiring a hollow tube, sheath, or catheter to be connected (claim 1, col 9, line 56) between the balloon pump assembly and the balloon in order to effect the expansion and contraction. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the apparatus for driving an intraaorta balloon pump included a catheter based on these teachings.
Regarding claim 127, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal flange comprises a frustoconical shape (FIG 2).
Regarding claim 128, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the distal flange comprises a campanulate shape (FIG 2).
Regarding claim 129, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal chamber comprises a volume between 0.1 mL and 100 mL (FIG 2, input chamber 24).
Takamiya does not expressly textually teach the volume of the proximal chamber with any specificity.
However, FIG 2 of Takamiya shows an exemplary structure of the proximal chamber (input chamber 24). Takamiya also teaches that the purpose of the apparatus is for driving an intraaorta balloon pump (col 1, lines 11-12; claim 11).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya where the proximal input chamber 24 is part of the apparatus (FIG 1) for driving an intraaorta balloon pump (col 1, lines 11-12; claim 11) that the volume of the chamber is sufficient to accommodate the volume change required to fill balloon 33. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the input chamber 24 (FIG 2) of Takamiya is volumetrically sized sufficiently to accommodate the volume change required to fill a balloon for driving an intraaorta balloon pump based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume of proximal chamber (FIG 2, input chamber 24), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the volume the proximal chamber (24) of FIG 2 of Takamiya falls within the claimed range and that a device having the claimed relative dimensions (volume of the proximal chamber) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 130, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the distal chamber comprises a volume between 0.1 mL and 100 mL (FIG 2, output chamber 25).
Takamiya does not expressly textually teach the volume of the distal chamber with any specificity.
However, FIG 2 of Takamiya shows an exemplary structure of the proximal chamber (output chamber 25). Takamiya also teaches that the purpose of the apparatus is for driving an intraaorta balloon pump (col 1, lines 11-12; claim 11).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya where the distal output chamber 25 is part of the apparatus (FIG 1) for driving an intraaorta balloon pump (col 1, lines 11-12; claim 11) that the volume of the chamber is sufficient to accommodate the volume change required to fill balloon 33. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the output chamber 25 (FIG 2) of Takamiya is volumetrically sized sufficiently to accommodate the volume change required to fill a balloon for driving an intraaorta balloon pump based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume of distal chamber (FIG 2, output chamber 25), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the volume the distal chamber (25) of FIG 2 of Takamiya falls within the claimed range and that a device having the claimed relative dimensions (volume of the distal chamber) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 131, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal flange (FIG 2, housing 21) comprises a proximal port (FIG 1, port proximal to proximal input chamber 24).
Regarding claim 132, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 131, as set forth above, for the reasons set forth above, wherein a junction (FIGs 1 and 2) between the proximal chamber (input chamber 24) and the proximal port (FIG 1, port proximal to proximal input chamber 24) comprises a diffuser (FIG 2).
The specification discloses that a diffuser is an opening (p. 20) that “may be formed geometrically by the proximal flange” and “may act to increase or decrease velocity of the flow at the expense of fluid pressure” (p. 17).
The examiner broadly interprets “a diffuser” in light of the specification as an opening “shaped to increase or decrease fluid velocity”. The examiner interprets this as any opening of any shape that acts as an application of Bernoulli’s Principle such that in a flowing fluid, an increase in the fluid’s speed occurs simultaneously with a decrease in pressure or potential energy. The relationship between pressure, velocity, and height of a fluid in motion is a physical principle of fluid mechanics derived from the conservation of energy. Accordingly, the requirement of the claim limitation is broadly interpreted as merely an application of an innate physical principle of fluid mechanics such that the shape of the junction between the proximal port and the proximal chamber creates “a diffuser” that acts according to Bernoulli’s Principle.
Additionally, because the Patent Office does not have the facilities to determine whether variations in the system taught by Takamiya has the requisite shape of the junction meets the physical application of Bernoulli’s Principle beyond what is shown in FIGs 1, 2, and 8 of Takamiya, the burden is on the applicant to show a novel and unobvious difference between the claimed assembly and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Regarding claim 133, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 132, as set forth above, for the reasons set forth above, wherein the proximal flange (FIGs 1, 2, housing 21) comprises the diffuser (FIG 2).
The specification discloses that a diffuser is an opening (p. 20) that “may be formed geometrically by the proximal flange” and “may act to increase or decrease velocity of the flow at the expense of fluid pressure” (p. 17).
The examiner broadly interprets “a diffuser” in light of the specification as an opening “shaped to increase or decrease fluid velocity”. The examiner interprets this as any opening of any shape that acts as an application of Bernoulli’s Principle such that in a flowing fluid, an increase in the fluid’s speed occurs simultaneously with a decrease in pressure or potential energy. The relationship between pressure, velocity, and height of a fluid in motion is a physical principle of fluid mechanics derived from the conservation of energy. Accordingly, the requirement of the claim limitation is broadly interpreted as merely an application of an innate physical principle of fluid mechanics such that the shape of the junction between the proximal port and the proximal chamber creates “a diffuser” that acts according to Bernoulli’s Principle.
Additionally, because the Patent Office does not have the facilities to determine whether variations in the system taught by Takamiya has the requisite shape of the junction meets the physical application of Bernoulli’s Principle beyond what is shown in FIGs 1, 2, and 8 of Takamiya, the burden is on the applicant to show a novel and unobvious difference between the claimed assembly and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Regarding claim 134, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 133, as set forth above, for the reasons set forth above, wherein the diffuser (FIG 2) comprises a convergent-divergent nozzle (FIG 2, limiting member 28; col 4, lines 24-33).
The specification discloses that a diffuser is an opening (p. 20) that “may be formed geometrically by the proximal flange” and “may act to increase or decrease velocity of the flow at the expense of fluid pressure” (p. 17). The specification discloses that a “convergent-divergent nozzle may be used to optimize flow velocity” (p. 18).
The examiner broadly interprets “a diffuser” in light of the specification as an opening “shaped to increase or decrease fluid velocity”. The examiner interprets this as any opening of any shape that acts as an application of Bernoulli’s Principle such that in a flowing fluid, an increase in the fluid’s speed occurs simultaneously with a decrease in pressure or potential energy. The relationship between pressure, velocity, and height of a fluid in motion is a physical principle of fluid mechanics derived from the conservation of energy. Accordingly, the requirement of the claim limitation is broadly interpreted as merely an application of an innate physical principle of fluid mechanics such that the shape of the junction between the proximal port and the proximal chamber creates “a diffuser” that acts according to Bernoulli’s Principle.
Additionally, because the Patent Office does not have the facilities to determine whether variations in the system taught by Takamiya has the requisite shape of the junction meets the physical application of Bernoulli’s Principle beyond what is shown in FIGs 1, 2, and 8 of Takamiya, the burden is on the applicant to show a novel and unobvious difference between the claimed assembly and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Regarding claim 135, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal chamber (FIG 2, input chamber 24) is shaped to modify ramp-up time or smoothness of the second pulse energy (FIG 8; col 2, lines 20-23).
The specification discusses the shape of a balloon at pp. 3 and 34, but does not textually discuss the shape of the proximal chamber nor does it visually or textually disclose any specific shape to modify ramp-up time or smoothness of the second pulse energy. At p. 17, the specification discusses that a nozzle or diffuse may be formed geometrically by the proximal flange in some cases. However, nothing further is disclosed with regard to any specific shape or geometry of the proximal chamber or flange. The drawings of the application showing shapes in FIGs 9A/B are also noted.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya wherein the proximal chamber (FIG 2, input chamber 24) is shaped to modify ramp-up time or smoothness of the second pulse energy with the application of Bernoulli’s Principle being demonstrated in FIG 8 and also as taught by Takamiya at col 2, lines 20-23. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that input chamber 24 (FIG 2) of Takamiya is shaped to modify ramp-up time or smoothness of the second pulse energy based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume related to the proximal chamber (FIG 2, input chamber 24), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the proximal chamber of Takamiya is shaped to modify ramp-up time or smoothness of the second pulse energy and that a device having the claimed relative dimensions (shape) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 136, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal chamber (FIG 2, input chamber 24) is shaped to induce sonic or supersonic fluid flow (FIG 8; col 2, lines 20-23).
The specification discusses the shape of a balloon at pp. 3 and 34, but does not textually discuss the shape of the proximal chamber nor does it visually or textually disclose any specific shape to induce sonic or supersonic fluid flow. At p. 17, the specification discusses that a nozzle or diffuse may be formed geometrically by the proximal flange in some cases. However, nothing further is disclosed with regard to any specific shape or geometry of the proximal chamber or flange. The drawings of the application showing shapes in FIGs 9A/B are also noted.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya wherein the proximal chamber (FIG 2, input chamber 24) is shaped to induce sonic or supersonic fluid flow with the application of Bernoulli’s Principle being demonstrated in FIG 8 and also as taught by Takamiya at col 2, lines 20-23. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that input chamber 24 (FIG 2) of Takamiya is shaped to induce sonic or supersonic fluid flow based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume related to the proximal chamber (FIG 2, input chamber 24), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the proximal chamber of Takamiya is shaped to induce sonic or supersonic fluid flow and that a device having the claimed relative dimensions (shape) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 137, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the balloon catheter assembly (FIG 1) is configured such that output pulse energy at the balloon is substantially the same as input pulse energy applied to the proximal connector (FIG 8).
The claimed “configured such that output pulse energy at the balloon is substantially the same as input pulse energy applied to the proximal connector” is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that configuring an output pulse energy at the balloon to be substantially the same as input pulse energy applied to the proximal connector can be optimized depending on the end effect desired for the use case. See FIG 8 of Takamiya. One of ordinary skill in the art would have had a reasonable expectation of success to optimize parameters including inputs, controls, and valves using the settings in FIGs 3-7 of Takamiya, given the outputs shown in FIG 8. Outputs can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential needs for the intended use case and the anatomical structures for which the devices are designed to service. As such, adjusting the components of the system to achieve an output pulse energy at the balloon that is substantially the same as input pulse energy applied to the proximal connector would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Additionally, because the Patent Office does not have the facilities to determine whether variations in the system taught by Takamiya, other than those shown in FIG 8, have the requisite output pulse energy at the balloon that is substantially the same as input pulse energy applied to the proximal connector, the burden is on the applicant to show a novel and unobvious difference between the claimed assembly and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Regarding claim 138, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the balloon catheter assembly (FIG 1) is configured such that attenuation at the balloon of input pulse energy applied to the proximal connector is 5% or less in terms of frequency, duty cycle and/or amplitude (FIG 8).
The claimed “attenuation at the balloon of input pulse energy applied to the proximal connector is 5% or less in terms of frequency, duty cycle and/or amplitude” is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that attenuation of frequency, duty cycle, and/or amplitude can be optimized depending on the end effect desired for the use case. See FIG 8 of Takamiya. One of ordinary skill in the art would have had a reasonable expectation of success to optimize parameters including frequency, duty cycle, and/or amplitude using the settings in FIGs 3-7 of Takamiya, given the output shown in FIG 8. Attenuation of any signal can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential energy needs for the intended use case and the anatomical structures for which the devices are designed to service. As such, adjusting the components of the system to achieve an optimized frequency, duty cycle, or amplitude consistent with the end-signal desired would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Additionally, because the Patent Office does not have the facilities to determine whether variations in the system taught by Takamiya has the requisite 5% or less attenuation in terms of frequency, duty cycle, and/or amplitude, the burden is on the applicant to show a novel and unobvious difference between the claimed assembly and that of the prior art. See In re Brown, 59 CCPA 1036, 459 F.2d. 531, 173 USPQ 685 (CCPA 1972) (holding at 1041, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith”) and Ex parte Gray, 10 USPQ 2d 1922, 1924-25 (PTO Bd. Pat. App. & Int.).
Regarding claim 139, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the balloon catheter assembly (FIG 1) is configured such that the balloon (balloon 33) periodically returns to a depressurized state during oscillations (FIG 8).
Regarding claim 140, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal chamber forms a minimum volume chamber (FIG 2, input chamber 24).
Takamiya does not expressly textually teach the volume of the proximal chamber.
However, FIG 2 of Takamiya shows an exemplary structure of the proximal chamber (input chamber 24).
There are only two mentions of “minimum volume chamber” in the specification of the application. Both are on page 16. Neither mention defines the term with any degree of specificity. The specification discloses that “the proximal chamber forms a minimum volume chamber while still being large enough to accommodate the volume change required to fill a balloon” (p. 16). The specification discloses that the “time to fill the minimum volume chamber to a certain pressure is minimized which allows the frequency of the procedure to be increased” (p. 16). Given the limited guidance in the specification and the context of the limitation in the claim, the examiner broadly interprets a “minimum volume chamber” to be a proximal chamber of variable size with relative dimensions sufficient to affect a volume change required to fill a balloon.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya where the proximal chamber forms a minimum volume chamber as shown in FIGs 1 and 2. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the input chamber 24 (FIG 2) of Takamiya is sufficient to accommodate the volume change required to fill a balloon for driving an intraaorta balloon pump (claim 11) based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume between the proximal chamber defined by the proximal flange (FIG 2, input chamber 24), the distal chamber defined by a distal flange (FIG 2, output chamber 25) and the membrane separating the proximal and distal chambers (FIG 2, diaphragm 23), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the proximal chamber of Takamiya forms a minimal volume chamber and that a device having the claimed relative dimensions (where the proximal chamber is a minimum volume chamber) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 141, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the proximal chamber is shaped to increase or decrease fluid velocity within the proximal chamber (FIGs 2, 8).
Takamiya does not expressly textually teach that the proximal chamber is shaped to increase or decrease fluid velocity within the proximal chamber.
However, FIG 2 of Takamiya shows an exemplary structure of the proximal chamber (input chamber 24) and FIG 8 of Takamiya shows the increase and decreases in pressure in input chamber 24 as correlated with pressure in balloon 33 as well as the expansion and contraction of balloon 33.
The examiner also broadly interprets the claim limitation “shaped to increase or decrease fluid velocity” as an application of Bernoulli’s Principle such that in a flowing fluid, an increase in the fluid’s speed occurs simultaneously with a decrease in pressure or potential energy. The relationship between pressure, velocity, and height of a fluid in motion is a physical principle of fluid mechanics derived from the conservation of energy. Accordingly, the requirement of the claim limitation is broadly interpreted as merely an application of an innate physical principle of fluid mechanics.
The specification discusses the shape of a balloon at pp. 3 and 34, but does not textually discuss the shape of the proximal chamber. At p. 17, the specification discusses that a nozzle or diffuse may be formed geometrically by the proximal flange in some cases. However, nothing further is disclosed with regard to any specific shape or geometry of the proximal chamber or flange. The drawings of the application showing shapes in FIGs 9A/B are also noted.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya wherein the proximal chamber (FIG 2, input chamber 24) is shaped to increase or decrease fluid velocity within the proximal chamber (FIG 8) with the application of Bernoulli’s Principle being demonstrated in FIG 8. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that input chamber 24 (FIG 2) of Takamiya is shaped to increase or decrease fluid velocity within the proximal chamber based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume between the proximal chamber (FIG 2, input chamber 24), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the proximal chamber of Takamiya is shaped to increase or decrease fluid velocity within the proximal chamber and that a device having the claimed relative dimensions (shape) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 142, Takamiya teaches the balloon catheter assembly (FIG 1) according to claim 126, as set forth above, for the reasons set forth above, wherein the system (FIG 1; claim 1) is configured to apply pressure oscillations (col 2, lines 25-29) with a generalized waveform (FIG 8) .
Regarding claim 143, Takamiya teaches a balloon catheter assembly (FIG 1) comprising (FIG 1; claim 1):
(a) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(b) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(c) a proximal connector present at the proximal end of the catheter (FIGs 1, 2, isolator 20), wherein the proximal connector comprises:
(i) a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
(ii) a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
(iii) a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),wherein the proximal and distal chambers are shaped differently (FIG 2), wherein the proximal and distal chambers have different volumes (FIG 2).
Takamiya does not textually recite the word “catheter”.
However, Takamiya teaches a “pipe line” (col 9, lines 13 and 26-32) between components of FIG 1. FIG 1 also shows an exemplary catheter structure and col 1, lines 11-12 expressly state that the apparatus is “for driving an intraaorta balloon pump”. The balloon pump assembly and affiliated structures are shown in FIG 1.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya as including a catheter as a structure with a lumen sufficient to expand a balloon as shown by the exemplary balloon pump assembly of FIG 1 and the express teaching of the apparatus for driving an intraaorta balloon pump at column 1, lines 11-12. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33, requiring a hollow tube, sheath, or catheter to be connected (claim 1, col 9, line 56) between the balloon pump assembly and the balloon in order to effect the expansion and contraction. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the apparatus for driving an intraaorta balloon pump included a catheter based on these teachings.
Applicant is also advised that although FIG 2 of Takamiya shows distinct structures, shapes, and available volume between the proximal chamber defined by the proximal flange (FIG 2, input chamber 24), the distal chamber defined by a distal flange (FIG 2, output chamber 25) and the membrane separating the proximal and distal chambers (FIG 2, diaphragm 23), the case law holding of Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) also applies. In Gardner, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04. Accordingly, it is the examiner’s position that the volume the proximal and distal chambers of FIG 2 of Takamiya are different from one another and that a device having the claimed relative dimensions (volume of the proximal and distal chambers) would not perform differently than the prior art device the device of Takamiya.
Regarding claim 144,Takamiya teaches a pulsatile balloon catheter system (FIGs 1, 8; claim 1), the system comprising:
(a) a pulse generator (FIGs 1, 8; claim 1); and
(b) a balloon catheter assembly (FIG 1, balloon 33) operably connected (claim 1, col 9, line 56) to the pulse generator (FIG 1), the balloon catheter assembly comprising:
(i) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(ii) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(iii) a proximal connector present at the proximal end of the catheter (FIGs 1, 2, isolator 20), wherein the proximal connector comprises:
a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),
wherein the proximal and distal chambers are shaped differently (FIG 2).
Takamiya does not textually recite the word “catheter”.
However, Takamiya teaches a “pipe line” (col 9, lines 13 and 26-32) between components of FIG 1. FIG 1 also shows an exemplary catheter structure and col 1, lines 11-12 expressly state that the apparatus is “for driving an intraaorta balloon pump”. The balloon pump assembly and affiliated structures are shown in FIG 1.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya as including a catheter as a structure with a lumen sufficient to expand a balloon as shown by the exemplary balloon pump assembly of FIG 1 and the express teaching of the apparatus for driving an intraaorta balloon pump at column 1, lines 11-12. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33, requiring a hollow tube, sheath, or catheter to be connected (claim 1, col 9, line 56) between the balloon pump assembly and the balloon in order to effect the expansion and contraction. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the apparatus for driving an intraaorta balloon pump included a catheter based on these teachings.
Regarding claim 145, Takamiya teaches a method (col 1, lines 6-12) comprising: deploying a system (FIG 1; claim 1) so that a balloon (balloon 33) of the system is adjacent to internal luminal tissue (intraaorta, col 1, lines 11-12), the system comprising:
(a) a pulse generator (FIGs 1, 8; claim 1); and
(b) a balloon catheter assembly (FIG 1, balloon 33) operably connected (claim 1, col 9, line 56) to the pulse generator (FIG 1), the balloon catheter assembly comprising (FIG 1):
(i) a catheter comprising proximal and distal ends (FIG 1, “pipe line” col 9, lines 13 and 26-32);
(ii) a balloon present at the distal end of the catheter (FIG 1, balloon 33); and
(iii) a proximal connector present at the proximal end of the catheter, wherein the proximal connector comprises (FIGs 1, 2, isolator 20):
a proximal chamber (FIG 2, input chamber 24) defined by a proximal flange (FIG 2, housing 21);
a distal chamber (FIG 2, output chamber 25) defined by a distal flange (FIG 2, housing 22); and
a membrane separating the proximal and distal chambers (FIG 2, diaphragm 23),
wherein the proximal and distal chambers are shaped differently (FIG 2); and
actuating the system to impart pulsatile energy (FIG 8 showing pressure and expansion and contraction of balloon 33) to the internal luminal tissue (intraaorta, col 1, lines 11-12; claim 1).
Takamiya does not textually recite the word “catheter”.
However, Takamiya teaches a “pipe line” (col 9, lines 13 and 26-32) between components of FIG 1. FIG 1 also shows an exemplary catheter structure and col 1, lines 11-12 expressly state that the apparatus is “for driving an intraaorta balloon pump”. The balloon pump assembly and affiliated structures are shown in FIG 1.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya as including a catheter as a structure with a lumen sufficient to expand a balloon as shown by the exemplary balloon pump assembly of FIG 1 and the express teaching of the apparatus for driving an intraaorta balloon pump at column 1, lines 11-12. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33, requiring a hollow tube, sheath, or catheter to be connected (claim 1, col 9, line 56) between the balloon pump assembly and the balloon in order to effect the expansion and contraction. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the apparatus for driving an intraaorta balloon pump included a catheter based on these teachings.
Takamiya does not provide any examples of actuating the system to impart pulsatile energy to the internal luminal tissue.
However, Takamiya teaches the purpose of the invention as “a medical appliance driving apparatus designed to expand and contract a medical appliance such as an artificial heart pump or an intraaorta balloon pump by alternately supplying positive and negative pressures thereto. More particularly, the present invention pertains to an apparatus for driving an intraaorta balloon pump” and teaches that the apparatus is capable of actuating the system to impart pulsatile energy (FIG 8 showing pressure and expansion and contraction of balloon 33) to the internal luminal tissue (intraaorta, col 1, lines 11-12; claim 1).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to broadly interpret the teachings of Takamiya for its intended purpose as an intraaorta balloon pump where the apparatus including a catheter as a structure with a lumen sufficient to expand a balloon as shown by the exemplary balloon pump assembly of FIG 1 and the express teaching of the apparatus alternately supplies positive and negative pressures to internal luminal tissue (“intraaorta”). Takamiya expressly teaches that the apparatus is capable of actuating the system to impart pulsatile for driving an intraaorta balloon pump at column 1, lines 6-12. Additionally, FIG 8 demonstrates the expansion and contraction of balloon 33, (claim 1; col 9, line 56) requiring a hollow tube, sheath, or catheter to be connected (FIG 1) between the balloon pump assembly (FIG 1) and the balloon (33) in order to actuate the expansion and contraction of balloon 33. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in understanding that the apparatus for driving an intraaorta balloon pump included a catheter based on these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Gurm et al., WO 2019200201 A1 (17 October 2019) teaches systems for effecting and controlling oscillatory pressure within balloon catheters for fatigue fracture of calculi (cited on Applicant’s IDS filed 3/19/2025).
Robinson et al., US 3,769,960 (6 November 1979), teach an intra-aortic balloon system (cited on Applicant’s IDS 3/19/2025).
Chisena et al., US 20200046949 (13 February 2020, benefit to 12 April 2018) teaches a system for effecting and controlling oscillatory pressure within balloon catheters for fatigue fracture of calculi (cited on Applicant’s IDS 3/19/2025).
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/CHERIE M POLAND/Examiner, Art Unit 3771
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