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 .
Claim Objections
Claim 20 is objected to because of the following informalities: In claim 20, the phrase “at least one of one or more” should read “at least one of the one or more” or similar language. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins (US 2012/0116289 A1).
Regarding claim 1, Hawkins discloses (see abstract; paras. [0029]-[0044]; figs. 1-7) a catheter (fig. 3) for generating shockwaves within a blood vessel (considered to be capable of generating shockwaves within a blood vessel, as the device of Hawkins prevents blockages in smaller arteries, and the claim limitation recites intended use which does not result in a structural difference between the device of Hawkins and the claimed invention, abstract, paras. [0009], [0039] and [0043]), the catheter comprising:
an elongate shaft (shaft of 32, para. [0031]; fig. 3) extending between a proximal region and a distal region (fig. 3);
a balloon (22) coupled to the elongate shaft (fig. 3), the balloon being configured to shift between a collapsed configuration and an expanded configuration (inflatable, para. [0010]);
a first shockwave generating member (electrode pair 34) disposed on the catheter (fig. 3);
a second shockwave generating member (electrode pair 36) disposed on the catheter adjacent to the first shockwave generating member (fig. 3); and
wherein the first shockwave generating member and the second shockwave generating member are configured to generate pressure waves (each electrode pair produces a shock wave, paras. [0030]-[0031]) that constructively interfere with one another (shock waves from each electrode pair impinge upon opposite sides of leaflets to more effectively break calcium deposits, such that the shock waves are considered to move towards the leaflets and therefore towards each other, such that the waves are capable of constructively interfering to more effectively break calcium deposits, paras. [0030]-[0031]).
Regarding claim 2, Hawkins discloses the catheter of claim 1. Hawkins further discloses wherein the first shockwave generating member includes an acoustic shockwave generating member (electrode pair producing shock wave considered to be acoustic).
Regarding claim 3, Hawkins discloses the catheter of claim 1. Hawkins further discloses wherein the first shockwave generating member includes a photoacoustic shockwave generating member (UV light waves generated by arc of shockwave generators, such that electrode pair 34 is considered to encompass a photoacoustic shockwave generating member, paras. [0030] and [0036]).
Regarding claim 7, Hawkins discloses the catheter of claim 1. Hawkins further discloses wherein the first shockwave generating member is disposed along the elongate shaft at a first position underneath the balloon (depicted in fig. 3, considered to be underneath a surface of the balloon).
Regarding claim 8, Hawkins discloses the catheter of claim 7. Hawkins further discloses wherein the second shockwave generating member is disposed along the elongate shaft at a second position underneath the balloon (depicted in fig. 3, considered to be underneath a surface of the balloon).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Soltani (US 2011/0004105 A1).
Regarding claim 4, Hawkins discloses the catheter of claim 1.
However, Hawkins fails to specifically disclose wherein the pressure waves that constructively interfere with one another comprise a peak pressure of 1MPa to 25 MPa.
Soltani teaches (para. [0086]), in the same field of endeavor, a catheter for generating pressure waves (abstract), wherein the peak pressure of the pressure waves is 1MPa to 25 MPa (para. [0086]), for the purpose of generating the appropriate amount of acoustic pressure to treat tissue, creating nonlinear acoustic pressure which enhances the removal of a thrombus (para. [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hawkins such that the peak pressure produced by interfering waves is generated within the claimed range, in order to create nonlinear acoustic pressure which enhances the removal of plaque and/or tissue when desired, based on the suggestions and teachings of Soltani (para. [0088]).
Regarding claim 5, Hawkins (as modified) teaches the catheter of claim 4. Hawkins (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 25 MPa (para. [0086] of Soltani).
Regarding claim 6, Hawkins (as modified) teaches the catheter of claim 4. Hawkins (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 10 MPa (para. [0086] of Soltani).
Claim(s) 9-11 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Gustus (US 2010/0076299 A1).
Regarding claim 9, Hawkins discloses (see abstract; paras. [0029]-[0044]; figs. 1-7) a catheter (fig. 3) for generating shockwaves within a blood vessel (considered to be capable of generating shockwaves within a blood vessel, as the device of Hawkins prevents blockages in smaller arteries, and the claim limitation recites intended use which does not result in a structural difference between the device of Hawkins and the claimed invention, abstract, paras. [0009], [0039] and [0043]), the catheter comprising:
an elongate shaft (shaft of 32, para. [0031]; fig. 3) extending between a proximal region and a distal region (fig. 3);
a balloon (22) coupled to the elongate shaft (fig. 3), the balloon being configured to shift between a collapsed configuration and an expanded configuration (inflatable, para. [0010]);
a first shockwave generating member (electrode pair 34) disposed on the catheter (fig. 3);
wherein the first shockwave generating member is configured to generate a first shockwave (paras. [0030] and [0031]);
a second shockwave generating member (electrode pair 36) disposed on the catheter adjacent to the first shockwave generating member (fig. 3);
wherein the second shockwave generating member is configured to generate a second shockwave (paras. [0030] and [0031]).
However, Hawkins fails to explicitly disclose wherein the first shockwave and the second shockwave are configured to constructively interfere with one another to form a higher peak pressure shockwave.
Gustus teaches (para. [0071]; fig. 5), in the same field of endeavor, a catheter (12, para. [0057]; fig. 1) creating pressure waves in tissue (60), wherein the waves are configured to constructively interfere with one another to form a higher peak pressure wave (over-lapping wave patterns depict constructive interference in which waves combine, considered to form a higher peak pressure wave, para. [0071]), for the purpose of modulating wavelengths to focus on different depths of plaque, allowing the system to be disease-area/location-specific (para. [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hawkins to produce shockwaves that constructively interfere with one another to form a higher peak pressure shockwave, in order to focus on different depths of the leaflets, providing the capability of focusing higher pressure shockwaves on specific locations of tissue, based on the teachings of Gustus (para. [0071]).
Regarding claim 10, Hawkins (as modified) teaches the catheter of claim 9. Hawkins further discloses wherein the first shockwave generating member includes an acoustic shockwave generating member (electrode pair producing shock wave considered to be acoustic).
Regarding claim 11, Hawkins (as modified) teaches the catheter of claim 9. Hawkins further discloses wherein the first shockwave generating member includes a photoacoustic shockwave generating member (UV light waves generated by arc of shockwave generators, such that electrode pair 34 is considered to encompass a photoacoustic shockwave generating member, paras. [0030] and [0036]).
Regarding claim 15, Hawkins (as modified) teaches the catheter of claim 9. Hawkins further discloses wherein the first shockwave generating member is disposed along the elongate shaft at a first position underneath the balloon (depicted in fig. 3, considered to be underneath a surface of the balloon).
Regarding claim 16, Hawkins (as modified) teaches the catheter of claim 15. Hawkins further discloses wherein the second shockwave generating member is disposed along the elongate shaft at a second position underneath the balloon (depicted in fig. 3, considered to be underneath a surface of the balloon).
Regarding claim 17, Hawkins discloses (see abstract; paras. [0029]-[0044]; figs. 1-7) a catheter (fig. 3) for generating shockwaves (abstract), the catheter comprising:
a catheter shaft (shaft of 32, para. [0031]; fig. 3) having a distal end region (fig. 3);
an expandable balloon (22) coupled to the distal end region (fig. 3);
a first shockwave generating member (electrode pair 34) disposed along the catheter shaft at a first position underneath the expandable balloon (depicted in fig. 3);
wherein the first shockwave generating member is configured to generate a first shockwave (paras. [0030]-[0031]);
a second shockwave generating member (electrode pair 36) disposed along the catheter shaft at a second position underneath the expandable balloon (depicted in fig. 3);
wherein the second shockwave generating member is configured to generate a second shockwave (paras. [0030]-[0031]).
However, Hawkins fails to disclose wherein the first shockwave and the second shockwave are configured to constructively interfere with one another to form one or more higher peak pressure shockwaves with a higher peak pressure than both the first shockwave and the second shockwave.
Gustus teaches (para. [0071]; fig. 5), in the same field of endeavor, a catheter (12, para. [0057]; fig. 1) creating pressure waves in tissue (60), wherein the waves are configured to constructively interfere with one another to form a higher peak pressure wave with a higher peak pressure than both the first and second wave (over-lapping wave patterns depict constructive interference in which waves combine, considered to form a higher peak pressure wave relative to the original waves, para. [0071]), for the purpose of modulating wavelengths to focus on different depths of plaque, allowing the system to be disease-area/location-specific (para. [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hawkins to produce shockwaves that constructively interfere with one another to form a higher peak pressure shockwave with a higher peak pressure than both the first and second shockwave, in order to focus on different depths of the leaflets, providing the capability of focusing higher pressure shockwaves on specific locations of tissue, based on the teachings of Gustus (para. [0071]).
Regarding claim 18, Hawkins (as modified) teaches the catheter of claim 17. Hawkins further discloses wherein the first shockwave generating member includes an acoustic shockwave generating member (electrode pair producing shock wave considered to be acoustic).
Regarding claim 19, Hawkins (as modified) teaches the catheter of claim 17. Hawkins further discloses wherein the first shockwave generating member includes a photoacoustic shockwave generating member (UV light waves generated by arc of shockwave generators, such that electrode pair 34 is considered to encompass a photoacoustic shockwave generating member, paras. [0030] and [0036]).
Claim(s) 12-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Gustus as applied to claims 9 and 17 above, and further in view of Soltani.
Regarding claim 12, Hawkins (as modified) teaches the catheter of claim 9.
However, Hawkins (as modified) fails to specifically teach wherein the higher peak pressure shockwave comprises a peak pressure of 1MPa to 25 MPa.
Soltani teaches (para. [0086]), in the same field of endeavor, a catheter for generating pressure waves (abstract), wherein the peak pressure of the pressure waves is 1MPa to 25 MPa (para. [0086]), for the purpose of generating the appropriate amount of acoustic pressure to treat tissue, creating nonlinear acoustic pressure which enhances the removal of a thrombus (para. [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hawkins (as modified) such that the peak pressure produced by interfering waves is generated within the claimed range, in order to create nonlinear acoustic pressure which enhances the removal of plaque and/or tissue when desired, based on the suggestions and teachings of Soltani (para. [0088]).
Regarding claim 13, Hawkins (as modified) teaches the catheter of claim 12. Hawkins (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 25 MPa (para. [0086] of Soltani).
Regarding claim 14, Hawkins (as modified) teaches the catheter of claim 12. Hawkins (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 10 MPa (para. [0086] of Soltani).
Regarding claim 20, Hawkins (as modified) teaches the catheter of claim 17.
However, Hawkins (as modified) fails to teach wherein at least one of one or more higher peak pressure shockwaves comprises a peak pressure of 1 MPa to 25 MPa.
Soltani teaches (para. [0086]), in the same field of endeavor, a catheter for generating pressure waves (abstract), wherein the peak pressure of the pressure waves is 1MPa to 25 MPa (para. [0086]), for the purpose of generating the appropriate amount of acoustic pressure to treat tissue, creating nonlinear acoustic pressure which enhances the removal of a thrombus (para. [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hawkins (as modified) such that the peak pressure produced by interfering waves is generated within the claimed range, in order to create nonlinear acoustic pressure which enhances the removal of plaque and/or tissue when desired, based on the suggestions and teachings of Soltani (para. [0088]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4 and 19 of copending Application No. 18/514,506 to McGowan in view of Hawkins.
Regarding claim 1, McGown claims the catheter of claim 1 (claims 1 and 19), but fails to claim the first and second generating members being shockwave generating members.
Hawkins teaches (para. [0031]), in the same field of endeavor, a catheter comprising first and second pressure wave generating members (electrode pairs 34 and 36), wherein the pressure wave is a shockwave (para. [0031]), for the purpose of more effectively breaking calcium deposits in the valve leaflets (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the first and second generating members being shockwave generating members, in order to provide a pressure wave generating member that more effectively breaks up calcium deposits within tissue, based on the teachings of Hawkins (para. [0031]).
Regarding claim 2, McGowan (as modified) claims the catheter of claim 2 (claim 1).
Regarding claim 3, McGowan (as modified) claims the catheter of claim 3 (claim 1).
Regarding claim 4, McGowan (as modified) claims the catheter of claim 4 (claim 1).
Regarding claim 5, McGowan (as modified) claims the catheter of claim 5 (claim 3).
Regarding claim 6, McGowan (as modified) claims the catheter of claim 6 (claim 4).
Regarding claim 7, McGowan (as modified) claims the catheter of claim 7 (claim 1), but fails to claim wherein the first shockwave generating member is disposed along the elongate shaft at a first position underneath the balloon.
Hawkins teaches (fig. 3), in the same field of endeavor, a first shockwave generating member (electrode pair 34) disposed along an elongate shaft (disposed along 32) at a first position underneath a balloon (fig. 3, considered to be underneath a surface of the balloon), for the purpose of creating a shock wave within the fluid of the balloon (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the first shockwave generating member is disposed along the elongate shaft at a first position underneath the balloon, in order to locate the first shockwave generating member appropriately to react with the fluid in the balloon to create a shockwave, based on the teachings of Hawkins (para. [0031]).
Regarding claim 8, McGown (as modified) claims the catheter of claim 8 (claim 1), but fails to claim wherein the second shockwave generating member is disposed along the elongate shaft at a second position underneath the balloon.
Hawkins teaches (fig. 3), in the same field of endeavor, a second shockwave generating member (electrode pair 36) disposed along an elongate shaft (disposed along 32) at a second position underneath the balloon (fig. 3, considered to be underneath a surface of the balloon), for the purpose of creating a shock wave within the fluid of the balloon (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the second shockwave generating member is disposed along the elongate shaft at a second position underneath the balloon, in order to locate the second shockwave generating member appropriately to react with the fluid in the balloon to create a shockwave, based on the teachings of Hawkins (para. [0031]).
Regarding claim 9, McGowan claims the catheter of claim 9 (claims 1 and 19), but fails to claim the first and second generating members being shockwave generating members, wherein the first shockwave generating member is configured to generate a first shockwave, and wherein the second shockwave generating member is configured to generate a second shockwave.
Hawkins teaches (para. [0031]), in the same field of endeavor, a catheter comprising first and second pressure wave generating members (electrode pairs 34 and 36), wherein the pressure wave is a shockwave (para. [0031]), for the purpose of more effectively breaking calcium deposits in the valve leaflets (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the first and second generating members being shockwave generating members configured to generate first and second shockwaves, in order to provide a pressure wave generating member that more effectively breaks up calcium deposits within tissue, based on the teachings of Hawkins (para. [0031]).
Regarding claim 10, McGowan (as modified) claims the catheter of claim 10 (claim 1).
Regarding claim 11, McGowan (as modified) claims the catheter of claim 11 (claim 1).
Regarding claim 12, McGowan (as modified) claims the catheter of claim 12 (claim 1).
Regarding claim 13, McGowan (as modified) claims the catheter of claim 13 (claim 3).
Regarding claim 14, McGowan (as modified) claims the catheter of claim 14 (claim 4).
Regarding claim 15, McGowan (as modified) claims the catheter of claim 15 (claim 1), but fails to claim wherein the first shockwave generating member is disposed along the elongate shaft at a first position underneath the balloon.
Hawkins teaches (fig. 3), in the same field of endeavor, a first shockwave generating member (electrode pair 34) disposed along an elongate shaft (disposed along 32) at a first position underneath a balloon (fig. 3, considered to be underneath a surface of the balloon), for the purpose of creating a shock wave within the fluid of the balloon (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the first shockwave generating member is disposed along the elongate shaft at a first position underneath the balloon, in order to locate the first shockwave generating member appropriately to react with the fluid in the balloon to create a shockwave, based on the teachings of Hawkins (para. [0031]).
Regarding claim 16, McGown (as modified) claims the catheter of claim 16 (claim 1), but fails to claim wherein the second shockwave generating member is disposed along the elongate shaft at a second position underneath the balloon.
Hawkins teaches (fig. 3), in the same field of endeavor, a second shockwave generating member (electrode pair 36) disposed along an elongate shaft (disposed along 32) at a second position underneath the balloon (fig. 3, considered to be underneath a surface of the balloon), for the purpose of creating a shock wave within the fluid of the balloon (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the second shockwave generating member is disposed along the elongate shaft at a second position underneath the balloon, in order to locate the second shockwave generating member appropriately to react with the fluid in the balloon to create a shockwave, based on the teachings of Hawkins (para. [0031]).
Regarding claim 17, McGowan claims the catheter of claim 17 (claims 1 and 19), but fails to claim the first and second generating members being shockwave generating members, wherein the first shockwave generating member is configured to generate a first shockwave, and wherein the second shockwave generating member is configured to generate a second shockwave.
Hawkins teaches (para. [0031]), in the same field of endeavor, a catheter comprising first and second pressure wave generating members (electrode pairs 34 and 36), wherein the pressure wave is a shockwave (para. [0031]), for the purpose of more effectively breaking calcium deposits in the valve leaflets (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the first and second generating members being shockwave generating members configured to generate first and second shockwaves, in order to provide a pressure wave generating member that more effectively breaks up calcium deposits within tissue, based on the teachings of Hawkins (para. [0031]).
Regarding claim 18, McGowan (as modified) claims the catheter of claim 18 (claim 1).
Regarding claim 19, McGowan (as modified) claims the catheter of claim 19 (claim 1).
Regarding claim 20, McGowan (as modified) claims the catheter of claim 20 (claim 1).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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