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 .
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,446,961 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,446,961 B2 has been found to anticipate each and every element of the present invention, for instance both provide:
18/904,579 (claim 1)
US 12,446,961 B2 (claim 1)
A catheter system for disrupting calcification at a treatment site within or adjacent to a vessel wall or heart valve, the catheter system comprising:
A catheter system for disrupting calcification at a treatment site within or adjacent to a vessel wall or heart valve, the catheter system comprising:
an energy source that generates energy;
an energy source that generates energy, the energy source including one of (i) a laser and (ii) a high voltage energy source that provides pulses of high voltage;
a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon interior being configured to receive a balloon fluid;
a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon interior being configured to receive a balloon fluid;
an energy guide that is configured to receive energy from the energy source,
an energy guide that is configured to receive energy from the energy source,
the energy guide guiding the energy into the balloon interior;
the energy guide guiding the energy into the balloon interior, the energy guide including one of (iii) an optical fiber and (iv) an electrode pair having spaced apart electrodes that extend into the balloon interior;
an inflation conduit that is in fluid communication with the balloon interior,
and a tubular member that allows fluid communication between the balloon interior
the inflation conduit being configured to convey the balloon fluid into the balloon interior;
the tubular member transmitting the balloon pressure of the balloon fluid within the balloon interior directly to the pressure sensor,
and a pressure sensor assembly that is configured to sense a balloon pressure of the balloon fluid within the balloon interior,
a pressure sensor that is configured to sense a balloon pressure of the balloon fluid within the balloon interior;
the pressure sensor assembly being in fluid communication with the balloon interior and the inflation conduit.
the tubular member transmitting the balloon pressure of the balloon fluid within the balloon interior directly to the pressure sensor, the balloon fluid being directed through the tubular member to inflate the balloon.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,446,961 B2.
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.
Claims 1-2, 11-12 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeevanandam et al. (US 9,592,328 B2).
As to claim 1, Jeevanandam et al. discloses a catheter system for positioning at a treatment site within or adjacent to a vessel wall or heart valve (see Figure 2) comprising: an energy source that generates energy (external driver, depicted as 320 in Figure 3); a balloon (pump, depicted as 180 in Figures 2-3) that is positionable substantially adjacent to the treatment site (Figure 2), the balloon having a balloon wall that defines a balloon interior, the balloon interior being configured to receive a balloon fluid (col. 4, lines 37-42 and col. 5, lines 17-28); an energy guide (drive line, depicted as 310 and 170 in Figure 3) that is configured to receive energy from the energy source, the energy guide guiding the energy into the balloon interior (Figure 3); an inflation conduit (pneumatic drive line, depicted as 170 in Figure 2; cols. 3-4, lines 49-67 and 1-15, respectively) that is in fluid communication with the balloon interior, the inflation conduit being configured to convey the balloon fluid into the balloon interior(col. 5, lines 33-43); and a pressure sensor assembly that is configured to sense a balloon pressure of the balloon fluid within the balloon interior (col. 6, lines 6-11), the pressure sensor assembly being in fluid communication with the balloon interior and the inflation conduit (cols. 3-4, lines 49-67 and 1-15, respectively).
As to claim 2, Jeevanandam et al. discloses a handle assembly that is coupled to the balloon (lumen, depicted as 165 in Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively; Since the lumen 165 retains the components for delivery and usage, the examiner considers it to be a "handle"), the handle assembly being positioned spaced apart from the balloon (Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively), the handle assembly being usable by a user to operate the catheter system (Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively), the pressure sensor being positioned within the handle assembly (cols. 3-4, lines 43-67 and 1-15, respectively).
As to claim 11, Jeevanandam et al. discloses a catheter system for positioning at a treatment site within or adjacent to a vessel wall or heart valve (see Figure 2) comprising: an energy source that generates energy (external driver, depicted as 320 in Figure 3); a balloon (pump, depicted as 180 in Figures 2-3) that is positionable substantially adjacent to the treatment site (Figure 2), the balloon having a balloon wall that defines a balloon interior, the balloon interior being configured to receive a balloon fluid (col. 4, lines 37-42 and col. 5, lines 17-28); an energy guide (drive line, depicted as 310 and 170 in Figure 3) that is configured to receive energy from the energy source, the energy guide guiding the energy into the balloon interior (Figure 3); an inflation conduit (pneumatic drive line, depicted as 170 in Figure 2; cols. 3-4, lines 49-67 and 1-15, respectively) that is in fluid communication with the balloon interior, the inflation conduit being configured to convey the balloon fluid into the balloon interior(col. 5, lines 33-43); and a pressure sensor assembly that is configured to sense a balloon pressure of the balloon fluid within the balloon interior (col. 6, lines 6-11), the pressure sensor assembly being in fluid communication with the balloon interior and the inflation conduit (cols. 3-4, lines 49-67 and 1-15, respectively).
As to claim 12, Jeevanandam et al. discloses a handle assembly that is coupled to the balloon (lumen, depicted as 165 in Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively; Since the lumen 165 retains the components for delivery and usage, the examiner considers it to be a "handle"), the handle assembly being positioned spaced apart from the balloon (Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively), the handle assembly being usable by a user to operate the catheter system (Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively), the pressure sensor being positioned within the handle assembly (cols. 3-4, lines 43-67 and 1-15, respectively).
As to claim 20, Jeevanandam et al. discloses a catheter system for positioning at a treatment site within or adjacent to a vessel wall or heart valve (see Figure 2) comprising: an energy source that generates energy (external driver, depicted as 320 in Figure 3); a balloon (pump, depicted as 180 in Figures 2-3) that is positionable substantially adjacent to the treatment site (Figure 2), the balloon having a balloon wall that defines a balloon interior, the balloon interior being configured to receive a balloon fluid (col. 4, lines 37-42 and col. 5, lines 17-28); an energy guide (drive line, depicted as 310 and 170 in Figure 3) that is configured to receive energy from the energy source, the energy guide guiding the energy into the balloon interior (Figure 3); and a handle assembly that is coupled to the balloon (lumen, depicted as 165 in Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively; Since the lumen 165 retains the components for delivery and usage, the examiner considers it to be a "handle"), the handle assembly being positioned spaced apart from the balloon (Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively), the handle assembly being usable by a user to operate the catheter system (Figure 1A; cols. 3-4, lines 43-67 and 1-15, respectively), an inflation conduit (pneumatic drive line, depicted as 170 in Figure 2; cols. 3-4, lines 49-67 and 1-15, respectively) that is in fluid communication with the balloon interior, the inflation conduit being configured to convey the balloon fluid into the balloon interior(col. 5, lines 33-43); and a pressure sensor that is configured to sense a balloon pressure of the balloon fluid within the balloon interior (col. 6, lines 6-11); the pressure sensor assembly being in fluid communication with the balloon interior and the inflation conduit (cols. 3-4, lines 49-67 and 1-15, respectively), the pressure sensor being positioned within the handle assembly (cols. 3-4, lines 43-67 and 1-15, respectively).
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.
Claims 3-10 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jeevanandam et al. (US 9,592,328 B2) in view of Jeevanandam et al. (US 8,066,628 B2) {hereafter “Jeevanandam et al. (‘628)”}.
As to claims 3 and 13, Jeevanandam et al. discloses the invention substantially as claimed but does not explicitly disclose “a manifold assembly that is coupled to the handle assembly” wherein “ the manifold assembly being in fluid communication with (i) the balloon fluid within the balloon interior, (ii) the pressure sensor assembly, and (iii) the inflation conduit”. Jeevanandam et al. (‘628) discloses “a ventricular assist device can include an external drive unit with any one of, or any combination of, a variety of features. The drive unit can be a small box designed to be worn externally by a patient. The drive unit can include a rechargeable battery, a transformer, a custom circuit board, custom software, and one or more valve manifolds” (col. 10, lines 14-28). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the drive unit of Jeevanandam et al. with a valve manifold as disclosed by Jeevanandam et al. (‘628) in order to provide the predictable results of optimizing performance and function of the device to optimize treatment to meets specific patient needs and requirements. Furthermore, components such as a manifold, are well-known electrical components used to optimize performance and function.
Claims 4 and 14, the modified Jeevanandam et al. discloses the drive unit is operated in closed pumping mode (Figures 10 and 14). Therefore, the inflation fluid of the modified Jeevanandam et al. is configured to flow first through the inflation conduit and subsequently through the manifold assembly before entering the balloon interior.
As to claims 5 and 15, the modified Jeevanandam et al. discloses the inclusion of a manifold assembly but does not explicitly disclose the manifold assembly includes a manifold retainer that is configured to receive and retain the balloon fluid. However, since the modified Jeevanandam et al. discloses a manifold, there would necessarily if not obviously, be coordinating structure to engage with and retain the manifold. As such, the examiner considers under the broadest reasonable interpretation, that modified Jeevanandam et al. would disclose coordinating structure that would function as a “manifold retainer”.
As to claims 6 and 16, the modified Jeevanandam et al. as applied to claims 5 and 15 above, discloses the pressure sensor assembly includes a pressure sensor that contacts the manifold retainer so that it can sense the balloon pressure of the balloon fluid based on the balloon fluid retained within the manifold retainer (col. 6, lines 6-11).
As to claims 7 and 17, the modified Jeevanandam et al. discloses the pressure sensor assembly includes a pressure sensor, the pressure sensor including a printed circuit board (Jeevanandam et al. (‘628), col. 10, lines 14-28).
As to claims 8 and 18, the modified Jeevanandam et al. discloses the manifold assembly includes a manifold body, the pressure sensory assembly being coupled to the manifold body so that the pressure sensor extends within the manifold body (col. 6, lines 6-11).
As to claims 9 and 19, the modified Jeevanandam et al. discloses a pressure sensor assembly, but does not explicitly disclose the inclusion of a pressure sensor sealer that forms a seal between the pressure sensor and the manifold body. It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a “pressure sensor sealer” in order to provide the predictable results of ensuring connectivity and performance of the device to meet specific patient therapeutic needs and requirements.
As to claim 10, the modified Jeevanandam et al. discloses the manifold body and a pressure sensor, but does not explicitly disclose the manifold body includes a pressure sensor aperture that is configured to receive the pressure sensor. However, since the modified Jeevanandam et al. discloses a pressure sensor, there would necessarily if not obviously, be coordinating structure to connect with the sensor to receive the sensor data. As such, the examiner considers under the broadest reasonable interpretation, that modified Jeevanandam et al. would disclose coordinating structure that would connect with the sensor and thus function as a “sensor aperture”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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