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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21 - 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims recite details of a system, method, and non-transitory computer-readable medium including program code that contains the instructions, which are all within a statutory category of invention, for “determining a pressure-derived coronary flow reserve based on the aortic pressure and the distal coronary pressure…” and “detecting, based on the pressure-derived coronary flow reserve, a hemodynamic disorder…”, which falls into the category of a mental process. This judicial exception is not integrated into a practical application because with regard to Revised step 2A, prong 1, an exception is present as noted above and with regard to Revised step 2A, prong 2, the claim does not recite additional elements that integrate the judicial exception into a practical application. Further, with regard to Revised step 2B, the claim does not recite additional elements that integrate the judicial exception into practical application. In particular, “receiving, from one or more sensors…, a blood pressure” is directed towards a generalized data gathering step with no specific structure required to collect the data as the one or more sensors are not positively claimed as a part of the system and no step of measuring a blood pressure using one or more sensors are positively claimed. Additionally, the “data processor” and “memory storing instructions” are directed towards general structures that do not impose meaningful limitation onto the claim scope, as the limitations do not constitute use of the exception in the context of “a particular machine”. The step of “generating … an alert,” is directed towards generalize signal processing and is not sufficient to integrate the judicial exception into practical application. Claims 23 – 26, 28, 31, 33 – 36, and 38, are directed towards details of data processing and are not sufficient to integrate the judicial exception into practical application. Claims 27 and 37 are directed towards details of the one or more sensors, but Examiner notes that the one or more sensors are not positively claimed as a part of the system and thus do not further integrate the judicial exception into practical application. Claims 29 and 30 are further directed towards receiving data, which would be considered a generalized data gathering step without sufficient structure to integrate the judicial exception into practical application.
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 21 – 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 17 of U.S. Patent No. 12171531 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because independent claim 21 and dependent claims 22 – 24 of APP: 18/951,229 are broader in scope than independent claim 1 of U.S. Patent No. 12171531 B2. As such, any invention meeting the limitations of the patent claims would necessarily meet those of the application as well. Independent claim 21 of APP: 18/951,229 is directed towards a system comprising at least one data processor and at least one memory storing instructions which when executed by the processor result in operations comprising:
Receiving, from one or more sensors positioned within a cardiovascular structure of a patient, a blood pressure over a plurality of heartbeats, the blood pressure comprising an aortic pressure and a distal coronary pressure;
determining a pressure-derived coronary flow reserve based on the aortic pressure and the distal coronary pressure for each heartbeat of the plurality of heartbeats;
detecting, based on the pressure-derived coronary flow reserve, a hemodynamic disorder within the cardiovascular structure of the patient; and
generating, based on the detection of the hemodynamic disorder, an alert.
Claims 22 – 24 are further directed towards the system of claim 21 where the operations further comprise:
determining a complement of a ratio of the distal coronary pressure to the aortic pressure for each heartbeat of the plurality of heartbeats (claim 22)
determining, based on the complement of the ratio, a maximum complement of the ratio and a minimum complement of the ratio (claim 23)
determining, based on the maximum complement and the minimum complement, the pressure-derived coronary flow reserve, the pressure-derived coronary flow reserve comprising a ratio of the maximum complement to the minimum complement (claim 24)
Claim 1 of U.S. Patent No. 12171531 B2 is directed towards a system comprising at least one data processor and at least one memory storing instructions which when executed by the processor result in operations comprising:
receiving, from one or more sensors positioned within a cardiovascular structure of a patient, a blood pressure over a plurality of heartbeats, the blood pressure comprising an aortic pressure and a distal coronary pressure;
determining a complement of a ratio of the distal coronary pressure to the aortic pressure for each heartbeat of the plurality of heartbeats;
determining, based on the complement of the ratio, a maximum complement of the ratio and a minimum complement of the ratio;
determining, based on the maximum complement and the minimum complement, a pressure-derived coronary flow reserve, the pressure-derived coronary flow reserve comprising a ratio of the maximum complement to the minimum complement
detecting, based on the complement of the ratio of the distal coronary pressure to the aortic pressure, a hemodynamic disorder within the cardiovascular structure of the patient; and
generating, based on the detection of the hemodynamic disorder, an alert.
Additionally, the claim 25 of APP: 18/951,229 generally commensurate in scope to that of claim 3 of U.S. Patent No. 12171531 B2; claim 26 of APP: 18/951,229 is generally commensurate in scope to that of claim 4 of U.S. Patent No. 12171531 B2; claim 27 of APP: 18/951,229 is generally commensurate in scope to that of claim 5 of U.S. Patent No. 12171531 B2; claim 28 of APP: 18/951,229 is generally commensurate in scope to that of claim 6 of U.S. Patent No. 12171531 B2; claim 29 of APP: 18/951,229 is generally commensurate in scope to that of claim 7 of U.S. Patent No. 12171531 B2; claim 30 of APP: 18/951,229 is generally commensurate in scope to that of claim 8 of U.S. Patent No. 12171531 B2; claim 31 of APP: 18/951,229 is generally commensurate in scope to that of claim 10 of U.S. Patent No. 12171531 B2.
Similarly, method claims 32 – 35 of APP: 18/951,229 are generally commensurate in scope in scope to claim 11 of U.S. Patent No. 12171531 B2; claim 36 of APP: 18/951,229 is generally commensurate in scope to that of claim 13 of U.S. Patent No. 12171531 B2; claim 37 of APP: 18/951,229 is is generally commensurate in scope to that of claim 15 of U.S. Patent No. 12171531 B2; claim 38 of APP: 18/951,229 is generally commensurate in scope to that of claim 16 of U.S. Patent No. 12171531 B2.
Additionally, the claims 39 – 40, directed towards a non-transitory computer readable storage medium, of APP: 18/951,229 are generally commensurate in scope to claim 17 of U.S. Patent No. 12171531 B2.
Claim Rejections - 35 USC § 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 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 21, 26 – 32, & 37 - 39 are rejected under 35 U.S.C. 103 as being unpatentable Kanz (US 20080269572 A1 – Cited by Applicant) and further in view of Shalman (US 6471656 B1).
In regard to claims 21, 32, and 39, Kanz discloses a system (FIG. 1, component 100), method, and non-transitory computer medium (paragraph [0038]) comprising a processor (FIG. 1, component 112; paragraph [0033]) and memory (FIG. 1, component 114; paragraph [0038]) storing instructions that, when executed by the processor, results in operations comprising receiving, from one or more sensors (FIG. 1, component 102; paragraph [0035]) positioned within a cardiovascular structure of a patient (paragraph [0005]), a blood pressure over a plurality of heartbeats comprising an aortic pressure and distal coronary pressure (paragraph [0005]) which is used to determine a coronary flow reserve or fractional flow reserve (FFR) based on the ratio of distal coronary pressure (Pd) to aortic pressure (Pa; paragraph [0005]; FIG. 10, see “Pd/Pa”, “Pa”, and “Pd”). The system (FIG. 1, component 100) additionally processes input signals from multiple pressure transducers (FIG. 1, component 102; paragraph [0032]) and outputs an alert with measured parameters and other generalized measures of a physiological status including diagnostic information such as severity of a blockage and if the user needs treatment based upon the input parameter values (paragraph [0032]). Kanz additionally discusses the use of FFR to determine stenosis severity where FFR values are considered within a normal range when FFR is approximately 1 and values less than 0.75 are deemed significant and require treatment, such as angioplasty and stenting (paragraph [0006]).
While Kanz discloses processing diagnostic measurement data over time, Kanz does not specify that the coronary flow reserve is calculated for each heartbeat over a plurality of heartbeats.
However, Shalman teaches a method and system for pressure-based measurements of coronary flow reserve (Abstract) where pressure derived coronary flow reserve (CFR) or fractional flow reserve (FFR) are calculated for each heartbeat in a plurality of heartbeats (FIG. 26, see “Pulse NO.”; Column 21, lines 24 – 41) based on a proximal and distal pressure (Column 7, line 66 – Column 8, line 3).
It would have been obvious to one of ordinary skill in the prior to the effective filing date of the claimed invention to have modified the system, method, and non-transitory medium disclosed by Kanz with the teachings of Shalman that includes processing pressure data to determine coronary flow reserve for each heartbeat in a plurality of heartbeats because doing so allows the processing system to assess the measurement and discard undesirable signals such as measurements during the administration of a drug or medication (Shalman, column 8, lines 46 – 57).
In regard to claim 26, Kanz as modified discloses the invention of claim 21. Kanz further discloses comparing the pressure derived coronary flow reserve or FFR to a threshold value, where a lower value is indicative of a significant stenosis and an alert is issued if FFR is less than 0.75 (paragraphs [0006] and [0032]).
In regard to claims 27 and 37, Kanz as modified discloses the invention of claim 21 and 32. Kanz further teaches that the one or more sensors comprises a first sensor coupled to a first insertion tool that measures an aortic pressure (paragraph [0012]) and a second pressure sensor mounted to a guide wire that measures a distal pressure such as distal coronary pressure (paragraph [0012]).
In regard to claim 28 and 38, Kanz as modified discloses the invention of claims 27 and 37. Kanz further teaches that the operations comprise equalizing or normalizing the aortic pressure and distal coronary pressure when the sensors are positioned at the same location where the distal pressure wire is normalized or equalized to the aortic pressure (paragraphs [0048] & [0064]; FIG. 10, component 208).
In regard to claim 29, Kanz as modified discloses the invention of claim 27. Kanz further teaches that the receiving further comprises receiving the aortic pressure from the first sensor (paragraphs [0005] & [0012]) and the distal coronary pressure from the second sensor where the second sensor is positioned downstream of an anatomical restriction such as a blockage or stenosis (paragraph [0004]; paragraph [0012]; paragraphs [0031] – [0032]).
In regard to claim 30, Kanz as modified discloses the invention of claim 21. Kanz further teaches receiving the aortic and distal coronary pressure after the introduction of a medication causing the cardiovascular structure to dilate (paragraph [0005]).
In regard to claim 31, Kanz as modified discloses the invention of claim 21. While Kanz discloses outputting an alert with measured parameters and other generalized measures of a physiological status including diagnostic information such as severity of a blockage and if the user needs treatment based upon the input parameter values (paragraph [0032] discusses the use of FFR to determine stenosis severity where FFR values are considered within a normal range when FFR is approximately 1 and values less than 0.75 are deemed significant and require treatment, such as angioplasty and stenting (paragraph [0006]). One of ordinary skill in the art would recognize that the alert comprising a severity of the stenosis indicates that the pressure-derived coronary flow reserve is greater than the indicated FFR threshold of 0.75 when the severity of the stenosis is indicated to be non-significant.
Claims 22 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Kanz (US 20080269572 A1 – Cited by Applicant) and further in view of Shalman (US 6471656 B1) as applied to claims 21 and 32 above, and further in view of Oi (Oi, M., et al. Utility of nicorandil for the measurement of coronary fractional flow reserve. Cardiovasc Interv and Ther 29, 24–30 (2014)).
In regard to claims 22 and 33, Kanz as modified discloses the invention of claims 21 and 32. While Kanz and Shalman both discuss processing pressure data, with Kanz discussing the calculation of a ratio of the distal coronary pressure to the aortic pressure and Shalman specifically teaching performing calculations for each heartbeat of the plurality of heartbeats, neither Kanz nor Shalman specify that the operations further comprise determining a complement of a ratio of the distal coronary pressure to the aortic pressure.
However, Oi teaches a system and method for measuring coronary flow reserve that includes determining a complement of a ratio of the distal coronary pressure to the aortic pressure, defined as (1 – Pd/Pa) by applicant in paragraph [0062] of the specification, on a beat-to-beat basis (Section: Methods, “FFR measurement”, paragraph 3).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the system and method disclosed by Kanz as modified with the teachings of Oi, which includes determining a complement of a ratio of the distal coronary pressure to the aortic pressure for each heartbeat of a plurality of heartbeats, because doing so allows for the further assessment of hyperaemic efficacy (Oi, Section: Methods, “FFR measurement”, paragraph 3) and would further be considered combining prior art elements according to known methods to yield the predictable result of processing pressure information to assess a coronary flow reserve.
Conclusion
In regard to claims 23 – 25, 34 - 36, and 40 Kanz as modified by Shalman, and Oi disclose the invention of claims 22 and 33, where Oi teaches the determination of a complement of a ratio of the distal coronary pressure and aortic pressure, and Kanz as modified by Shalman disclose the invention of claim 40, no combination of the cited art discloses or suggests the determination of a maximum complement and a minimum complement of the ratio or the use of the maximum and minimum complements of the ratio to further determine pressure-derived coronary flow reserve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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