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 1-19 of U.S. Patent No. 10,765,871. Although the claims at issue are not identical, they are not patentably distinct from each other because 10,765,871 teaches the same invention except does not explicitly disclose wherein the pressure sensing region is entirety proximal of the midpoint. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by U.S. Patent No. 10,765,871 with the pressure sensing region is entirety proximal of the midpoint, because Applicant has not disclosed that the pressure sensing region is entirety proximal of the midpoint provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the pressure sensing region location as taught by U.S. Patent No. 10,765,871, because it provides an output signal representing the pressure of the environment outside of the housing and since it appears to be an arbitrary design consideration which fails to patentably distinguish over U.S. Patent No. 10,765,871.
Therefore, it would have been an obvious matter of design choice to modify U.S. Patent No. 10,765,871 to obtain the invention as specified in the claim(s).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,151,116. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal 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. 11,065,459. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
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.
Claim(s) 1, 9, 10, 12, 13, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al (US Publication 2009/0018599).
Referring to Claim 1, Hastings et al teaches a leadless cardiac pacemaker (LCP) for implantation in a ventricle of a heart, the LCP (e.g. Figure 1, Element 26) comprising: an elongated housing having a midpoint with a proximal region extending proximally of the midpoint to a proximal end, and a distal region extending distally of the midpoint to a distal end (e.g. Figure 1, Element 26); a first electrode exposed to the environment outside of the housing distally of the midpoint (e.g. Figure 4, Element 142); a second electrode exposed to the environment outside of the housing proximally of the midpoint (e.g. Figure 4, Element 144); a fixation member proximate the distal end of the housing for fixing the housing relative to a heart wall of the ventricle at an implant site (e.g. Figure 4, Elements 138a); a pressure sensor structured to sense a pressure in the environment outside of the housing, wherein the pressure sensor is operationally coupled with the environment outside of the housing at a pressure sensing region (e.g. Paragraph [0050]), circuitry housed by the housing and operatively coupled to the first electrode, the second electrode and the pressure sensor, the circuitry is configured to deliver a pacing therapy to the ventricle of the heart via the first electrode and the second electrode (e.g. Paragraphs [0050] and [0053]). However, Hastings et al does not explicitly disclose wherein the pressure sensing region is entirety proximal of the midpoint.
It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Hastings et al with the pressure sensing region is entirety proximal of the midpoint, because Applicant has not disclosed that the pressure sensing region is entirety proximal of the midpoint provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the pressure sensing region location as taught by Hastings et al, because it provides an output signal representing the pressure of the environment outside of the housing and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Hastings et al.
Therefore, it would have been an obvious matter of design choice to modify Hastings et al to obtain the invention as specified in the claim(s).
Referring to Claim 9, Hastings et al teaches the LCP of claim 1, further comprising communication circuitry configured to send information to a remote device that is based at least in part on the pressure sensed by the pressure sensor (e.g. Paragraphs [0050] and [0053]).
Referring to Claim 10, Hastings et al teaches the LCP of claim 1, wherein the first electrode and the second electrode are each situated along an outer surface of the housing (e.g. Figure 4).
Referring to Claim 12, Hastings et al teaches the LCP of claim 1, wherein the pressure sensing region corresponds to pressure receiving port of the housing (e.g. Paragraph [0050]).
Referring to Claim 13, Hastings et al teaches a leadless cardiac pacemaker (LCP) for implantation in a ventricle of a patient's heart, wherein the patient's heart includes an atrium that contracts to supply blood to the ventricle, the LCP (e.g. Figure 1, Element 26) comprising: an elongated housing having a midpoint with a proximal region extending proximally of the midpoint to a proximal end, and a distal region extending distally of the midpoint to a distal end (e.g. Figure 1, Element 26); a first electrode exposed to the environment outside of the housing distally of the midpoint (e.g. Figure 4, Element 142); a second electrode exposed to the environment outside of the housing proximally of the midpoint (e.g. Figure 4, Element 144); a pressure sensor configured to produce an output signal that is responsive to a change in pressure in the ventricle of the patient's heart that is indicative of a contraction of the atrium of the patient's heart, wherein the pressure sensor is operationally coupled with the environment outside of the housing at a pressure sensing region (e.g. Paragraph [0050]); circuitry housed by the housing in operative communication with the first electrode, the second electrode and the pressure sensor, wherein the circuitry is configured to detect the change in pressure in the ventricle of the patient's heart that is indicative of the contraction of the atrium of the patient's heart from the pressure sensed by the pressure sensor, the circuitry is configured to deliver an electrostimulation therapy to the patient's heart via the first electrode and the second electrode that is based, at least in part, on the detected change in pressure in the ventricle of the patient's heart that is indicative of the contraction of the atrium of the patient's heart (e.g. Paragraphs [0050] and [0053]). However, Hastings et al does not explicitly disclose wherein the pressure sensing region is entirety proximal of the midpoint.
It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Hastings et al with the pressure sensing region is entirety proximal of the midpoint, because Applicant has not disclosed that the pressure sensing region is entirety proximal of the midpoint provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the pressure sensing region location as taught by Hastings et al, because it provides an output signal representing the pressure of the environment outside of the housing and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Hastings et al.
Therefore, it would have been an obvious matter of design choice to modify Hastings et al to obtain the invention as specified in the claim(s).
Referring to Claim 15, Hastings et al teaches the LCP of claim 13, wherein the pressure sensing region corresponds to pressure receiving port of the housing (e.g. Paragraph [0050]).
Referring to Claim 18, Hastings et al teaches the LCP of claim 13, further comprising communication circuitry configured to send information to a remote device that is based at least in part on the pressure sensed by the pressure sensor (e.g. Paragraphs [0050] and [0053]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al (US Publication 2009/0018599) as applied above, and further in view of Morris et al (US Publication 2018/0168463).
Referring to Claim 3, Hastings et al teaches the LCP of claim 1, except wherein the circuitry is configured to obtain a plurality of pressure measurements from the pressure sensor at a sample rate that is greater than 100 Hertz (Hz).
Morris et al teaches that it is known to use obtaining a plurality of pressure measurements from the pressure sensor at a sample rate that is greater than 100 Hertz as set forth in Paragraph [0153] and [0162] to provide sufficient sampling as to obtain an accurate representation of the waveform such as obtaining signatures of valve opening and closings. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with obtain a plurality of pressure measurements from the pressure sensor at a sample rate that is greater than 100 Hertz as taught by Morris et al, since such a modification would provide the predictable results of sufficient sampling as to obtain an accurate representation of the waveform such as obtaining signatures of valve opening and closings.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al (US Publication 2009/0018599) in view of Morris et al (US Publication 2018/0168463) as applied above, and further in view of Gilkerson et al (US Patent 7,580,746).
Referring to Claim 4, Hastings et al in view of Morris et al teaches the LCP of claim 3, except wherein the circuitry is configured to determine a change in pressure per time (dP/dT) parameter based at least in part on two or more of the plurality of pressure measurements.
Gilkerson et al teaches that it is known to use determining a change in pressure per time (dP/dT) parameter based at least in part on two or more of the plurality of pressure measurements as set forth in Figure 3A-3F] to provide monitoring of the heart and optimization of therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with determining a change in pressure per time (dP/dT) parameter based at least in part on two or more of the plurality of pressure measurements as taught by Gilkerson et al, since such a modification would provide the predictable results of monitoring of the heart and optimization of therapy.
Referring to Claim 5, Hastings et al in view of Morris et al teaches the LCP of claim 3, except wherein the circuitry is configured to determine a peak to peak change in pressure parameter based at least in part on two or more of the plurality of pressure measurements. Gilkerson et al teaches that it is known to use determining a peak to peak change in pressure parameter based at least in part on two or more of the plurality of pressure measurements as set forth in Figure 3A-3F to provide monitoring of the heart and optimization of therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with determining a peak to peak change in pressure parameter based at least in part on two or more of the plurality of pressure measurements as taught by Gilkerson et al, since such a modification would provide the predictable results of monitoring of the heart and optimization of therapy.
Referring to Claim 6, Hastings et al in view of Morris et al teaches the LCP of claim 3, except wherein the circuitry is configured to determine a pressure-volume loop for one or more cardiac cycles based at least in part on two or more of the plurality of pressure measurements. Gilkerson et al teaches that it is known to use determining a pressure-volume loop for one or more cardiac cycles based at least in part on two or more of the plurality of pressure measurements as set forth in Figure 3A-3F to provide monitoring of the heart and optimization of therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with determining a pressure-volume loop for one or more cardiac cycles based at least in part on two or more of the plurality of pressure measurements as taught by Gilkerson et al, since such a modification would provide the predictable results of monitoring of the heart and optimization of therapy.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al (US Publication 2009/0018599) in view of Morris et al (US Publication 2018/0168463) as applied above, and further in view of Park et al (US Patent 7,212,861).
Referring to Claim 7, Hastings et al in view of Morris et al teaches the LCP of claim 3, except wherein the circuitry is configured to determine a pressure-impedance loop for one or more cardiac cycles based at least in part on two or more of the plurality of pressure measurements. Park et al teaches that it is known to use a pressure-impedance loop for one or more cardiac cycles based at least in part on two or more of the plurality of pressure measurements as set forth in Column 2 lines 53-62 and Figure 7 to provide monitoring of the heart and optimization of therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hasting et al, with a pressure-impedance loop for one or more cardiac cycles based at least in part on two or more of the plurality of pressure measurements as taught by Park et al, since such a modification would provide the predictable results of monitoring of the heart and optimization of therapy.
Claim(s) 8, 11, 14, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al (US Publication 2009/0018599) as applied above, and further in view of Maile et al (US Publication 2010/0317978).
Referring to Claim 8, Hastings et al teaches the LCP of claim 1, except wherein the pressure sensor comprises a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor produces an electrical output signal that is dependent on the amount of movement of the diaphragm ().
Maile et al teaches that it is known to use a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor produces an electrical output signal that is dependent on the amount of movement of the diaphragm as set forth in Paragraphs [0086] and [0088]-[0091] to provide substitution of one known pressure sensing mechanism for another to provide precise and reliable readings. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor produces an electrical output signal that is dependent on the amount of movement of the diaphragm as taught by Maile et al, since such a modification would provide the predictable results of substitution of one known pressure sensing mechanism for another to provide precise and reliable readings.
Referring to Claim 11, Hastings et al teaches the LCP of claim 1, except wherein the pressure sensing region corresponds to a thinned region of the housing.
Maile et al teaches that it is known to use wherein the pressure sensing region corresponds to a thinned region of the housing as set forth in Paragraphs [0086] and [0088]-[0091] to provide substitution of one known pressure sensing mechanism for another to provide precise and reliable readings. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with wherein the pressure sensing region corresponds to a thinned region of the housing as taught by Maile et al, since such a modification would provide the predictable results of substitution of one known pressure sensing mechanism for another to provide precise and reliable readings.
Referring to Claim 14, Hastings et al teaches the LCP of claim 13, except wherein the pressure sensing region corresponds to a thinned region of the housing.
Maile et al teaches that it is known to use wherein the pressure sensing region corresponds to a thinned region of the housing as set forth in Paragraphs [0086] and [0088]-[0091] to provide substitution of one known pressure sensing mechanism for another to provide precise and reliable readings. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with wherein the pressure sensing region corresponds to a thinned region of the housing as taught by Maile et al, since such a modification would provide the predictable results of substitution of one known pressure sensing mechanism for another to provide precise and reliable readings.
Referring to Claim 16, Hastings et al teaches the LCP of claim 13, except wherein the pressure sensor comprises a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor produces an electrical output signal that is dependent on the amount of movement of the diaphragm.
Maile et al teaches that it is known to use the pressure sensor comprises a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor produces an electrical output signal that is dependent on the amount of movement of the diaphragm as set forth in Paragraphs [0086] and [0088]-[0091] to provide substitution of one known pressure sensing mechanism for another to provide precise and reliable readings. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor comprises a diaphragm that is configured to move by an amount that is dependent on an applied input pressure, and wherein the pressure sensor produces an electrical output signal that is dependent on the amount of movement of the diaphragm as taught by Maile et al, since such a modification would provide the predictable results of substitution of one known pressure sensing mechanism for another to provide precise and reliable readings.
Referring to Claim 17, Hastings et al teaches the LCP of claim 13, except wherein the circuitry is configured to determine one or more arrhythmias based at least in part on the pressure sensed by the pressure sensor. Maile et al teaches that it is known to use the pressure sensor comprises circuitry configured to determine one or more arrhythmias based at least in part on the pressure sensed by the pressure sensor as set forth in Paragraphs [0051] to provide determination of heart conditions that would require delivery of energy to improve/optimize cardiac output. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hastings et al, with circuitry configured to determine one or more arrhythmias based at least in part on the pressure sensed by the pressure sensor as taught by Maile et al, since such a modification would provide the predictable results of determination of heart conditions that would require delivery of energy to improve/optimize cardiac output.
Allowable Subject Matter
The examiner notes the following claims are rejected under nonstatutory double patenting as identified above. No prior art was found to read on the limitations of claims 2, 19, and 20.
The following is a statement of reasons for the indication of allowable subject matter: No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically the circuitry is configured to identify an atrial contraction of the heart based at least in part on the electrical A-wave output signal from the pressure sensor; the circuitry is configured to adapt a timing of delivery of at least part of the pacing therapy delivered to the ventricle of the heart based at least in part on the identified atrial contraction of the heart, in combination with the recited structural limitations of the claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/William J Levicky/Primary Examiner, Art Unit 3796
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