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 .
Claims 1-2, 5-9, 11-12, 14 and 38-46 are hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 45 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “desirable” in claim 45 is a relative term which renders the claim indefinite. The term “desirable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the degree of tension is rendered indefinite.
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, 9, 11-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20120265296A1 (McNamara et. al), cited by Applicant and hereto referred as McNamara.
As to claims 1, 9, 11-12 and 14, McNamara teaches a first pressure sensor device configured to be positioned at least partially in a left atrium to sense a left atrial pressure in the left atrium (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication.”; [0341], “The pressure monitor may be integrated with the pressure regulating device 400”), wherein the first pressure sensor device includes:
a first sensor configured to be positioned in the left atrium to sense the left atrial pressure (McNamara, [0382], “For example, one or more of the sensors may sense 475 a heart condition of the patient, such as one or more pressures in regions of the heart, as a higher pressure in the left atrium and a lower pressure in the right atrium.”);
a first antenna (McNamara, [0304], “communication facility 418”);
first control circuitry electrically coupled to the first sensor and the first antenna (McNamara, [0304], “A device control facility 410 may comprise a processor 412”); and
a first housing that houses the first control circuitry (McNamara, [0314], “The device control facility 410 may be enclosed in a housing”);
a stent structure integrated with or attached to the first pressure sensor device (McNamara, [0100], “FIG. 67 depicts a diagram of an intra-atrial shunt with integrated sensor and drug administration facilities.”); wherein
the first housing of the pressure sensor device is configured to extend through a tissue wall (McNamara, [0362], “The device 400, coupled with the biomarker sensor 442, may be placed in an atrial wall 407 of a patient's body.”; [0357], “In embodiments, the sensor 402 may include a pressure transducer (not shown) that may be adapted to measure pressure in a chamber such as a left atrial chamber or vessel such as a pulmonary artery.”).
As to claim 11, McNamara teaches the first housing of the first pressure sensor device is configured to extend through the tissue wall (McNamara, Fig. 68), and wherein
the first pressure sensor device includes tissue wall anchor features configured to anchor the first pressure sensor device to the tissue wall (McNamara, [0121], “In other embodiments, the surface finish is textured to induce tissue response and tissue in growth for improved stabilization.”).
As to claim 12, McNamara teaches the tissue wall anchor features extend outward from the first housing of the first pressure sensor device (McNamara, Fig. 67, the stent of device 400 expands outward from the pressure sensor device) and are configured to provide compressive force on the tissue wall (McNamara, Fig. 57, the expansion of the stent structure provides compressive force to the tissue wall).
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.
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 2, 5, 39-42, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara as applied to claim 1 above, and further in view US20160045165A1 (Braido et. al), cited by Applicant and hereto referred as Braido.
Claim 1 is taught as above.
As to claims 2 and 5, McNamara teaches the first pressure sensor device further comprises: a second sensor configured to be positioned in a right atrium to sense a right atrial pressure or in a coronary sinus to sense a coronary sinus pressure simultaneously with the left atrial pressure (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication.”; Fig. 57, stent 40; [0386], “The same types of sensors may be used near the coronary sinus to sense blood conditions, e.g., blood chemistry, and physical conditions, e.g., blood pressure”; [0382], “For example, one or more of the sensors may sense 475 a heart condition of the patient, such as one or more pressures in regions of the heart, as a higher pressure in the left atrium and a lower pressure in the right atrium.”),
wherein the first control circuity is electrically coupled to the second sensor (McNamara, [03019], “The processor 412 may be programmed to evaluate one or more pressure and flow readings taken by one or more internal sensors 420”).
McNamara strongly hints, but does not explicitly state a first pressure sensor device comprising a first and second sensor. Braido teaches similar art of implantable sensor (Braido, abstract). Braido teaches first pressure sensor device comprising a first and second sensor (Braido, Fig. 19D, inflow sensor 4400 and outflow sensor 4100). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNamara in view of Braido to include a first and second sensor because McNamara already strongly suggests that multiple pressure sensor may be used to detect left atrium and coronary sinus/right atrium pressure, and Braido explicitly states that there are two pressure sensors in a pressure sensor device.
As to claim 38, McNamara-Braido teaches a sensor implant device comprising: a first pressure sensor device configured to be positioned in a left atrium to sense a left atrial pressure in the left atrium, wherein the first pressure sensor device includes (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication.”; [0341], “The pressure monitor may be integrated with the pressure regulating device 400”):
a first sensor configured to be positioned in the left atrium to sense the left atrial pressure (McNamara, [0357], “In embodiments, the sensor 402 may include a pressure transducer (not shown) that may be adapted to measure pressure in a chamber such as a left atrial chamber”); a first antenna; first control circuitry electrically coupled to the first sensor and the first antenna; and a first housing that houses the first control circuitry (McNamara, Fig. 63, communication facility 418; processor 412; housing is interpreted to be the box 410); and
a second pressure sensor device configured to be positioned in a right atrium or a coronary sinus to sense a right atrial pressure in the right atrium or a coronary sinus pressure in the coronary sinus, wherein the second pressure sensor device includes: a second sensor configured to be positioned in the right atrium to sense the right atrial pressure or the coronary sinus to sense the coronary sinus pressure; a second antenna; second control circuitry electrically coupled to the first sensor and the second antenna; and a second housing that houses the second control circuitry (McNamara, [0386], “The same types of sensors may be used near the coronary sinus to sense blood conditions”; Braido, Fig. 19, two sensors 4400 and 4100); wherein
the first pressure sensor device is configured to be positioned on a first side of a tissue wall and the second pressure sensor device is configured to be positioned on a second side of the tissue wall (McNamara, [0357], “In embodiments, the sensor 402 may include a pressure transducer (not shown) that may be adapted to measure pressure in a chamber such as a left atrial chamber”; [0386], “The same types of sensors may be used near the coronary sinus to sense blood conditions”; Braido, Fig. 19, two sensors 4400 and 4100); and wherein
the first pressure sensor device and the second pressure sensor device are secured to one another by an attachment member (McNamara, Fig. 59, stent 56; Braido, Fig. 19, two sensors 4400 and 4100, the two sensors are held to one another by arms 4070).
As to claims 39-40, McNamara-Braido-Fitzgerald teaches the second sensor is configured to be positioned in the right atrium to sense the right atrial pressure, wherein a differential pressure between the left atrium and the right atrium is determined using the left atrial pressure sensed by the first sensor and the right atrial pressure sensed by the second sensor. (McNamara, [0373], “For example, the nano sensors may be implanted close to the right atrium for detecting any change in blood pressure.”).
As to claims 41-42, McNamara-Braido-Fitzgerald teaches the second sensor is configured to be positioned in the coronary sinus to sense the coronary sinus pressure (McNamara, [0386], “The same types of sensors may be used near the coronary sinus to sense blood conditions”), wherein a differential pressure between the left atrium and the coronary sinus is determined using the left atrial pressure sensed by the first sensor and the coronary sinus pressure sensed by the second sensor (McNamara, [0295], “if for some reason the pressure in the coronary sinus exceeds the pressure in the left atrium”).
As to claims 45-46, McNamara-Braido-Fitzgerald teaches the attachment member is configured to be tightened to a desirable tension to secure and hold the first pressure sensor device and the second pressure sensor device against the tissue wall, wherein wherein the second pressure sensor device includes a stent structure integrated with or attached to the second pressure sensor device (McNamara, Fig. 59, stent 56; Braido, Fig. 19, two sensors 4400 and 4100, the two sensors are held to one another by arms 4070; McNamara, Fig. 68, sensor 442 is held against the tissue wall).
Claims 6-8 and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara-Braido as applied to claims 5 and 41 above, and further in view of US20090187131A1 (Fitzgerald et. al), hereto referred as Fitzgerald.
Claims 5 and 41 are taught as above.
As to claim 6, McNamara-Braido teaches a differential pressure between the left atrium and the coronary sinus is determined using the left atrial pressure sensed by the first sensor and the coronary sinus pressure sensed by the second sensor (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication”; [0341], “The pressure monitor may be integrated with the pressure regulating device 400”).
As to claim 7, McNamara-Braido teaches coronary sinus pressure sensed by the second sensor (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication”; [0341], “The pressure monitor may be integrated with the pressure regulating device 400”). However, McNamara-Braido does not explicitly teach the right atrial pressure of the right atrium is determined using the coronary sinus pressure sensed by the second sensor. Fitzgerald teaches a solution to a relevant problem of relating intercardiac parameters. Fitzgerald teaches right atrium and coronary sinus are connected (Fitzgerald, [0082], “Flow rates may also be determined through pressure measurement in directly or indirectly connected compartments (in fluid communication with the target compartment); e.g. any pressure sensor in the right atrium (RA) or one of the cava veins (IVC and SVC) can be employed to provide accurate information about the endovascular pressure (and thus flow rates if cross-sectional area is known) in the terminal portions of the coronary sinus (CS), since all (RA, IVC, SVC, and CS) are connected to the same fluid system”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McNamara-Braido in view of Fitzgerald to include the right atrial pressure of the right atrium is determined using the coronary sinus pressure sensed by the second sensor because Fitzgerald teaches that coronary sinus (CS), since all (RA, IVC, SVC, and CS) are connected to the same fluid system, and McNamara-Braido teaches measuring pressure in the coronary sinus.
As to claim 8, McNamara-Braido-Fitzgerald teaches a differential pressure between the left atrium and the right atrium determined using the left atrial pressure sensed by the first sensor and the right atrial pressure determined using the coronary sinus pressure sensed by the second sensor (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication”; [0341], “The pressure monitor may be integrated with the pressure regulating device 400”; Fitzgerald, [0082], “Flow rates may also be determined through pressure measurement in directly or indirectly connected compartments (in fluid communication with the target compartment); e.g. any pressure sensor in the right atrium (RA) or one of the cava veins (IVC and SVC) can be employed to provide accurate information about the endovascular pressure (and thus flow rates if cross-sectional area is known) in the terminal portions of the coronary sinus (CS), since all (RA, IVC, SVC, and CS) are connected to the same fluid system”).
As to claims 43-44, McNamara-Braido-Fitzgerald teaches the right atrial pressure of the right atrium is determined using the coronary sinus pressure sensed by the second sensor (Fitzgerald, [0082], “Flow rates may also be determined through pressure measurement in directly or indirectly connected compartments (in fluid communication with the target compartment); e.g. any pressure sensor in the right atrium (RA) or one of the cava veins (IVC and SVC) can be employed to provide accurate information about the endovascular pressure (and thus flow rates if cross-sectional area is known) in the terminal portions of the coronary sinus (CS), since all (RA, IVC, SVC, and CS) are connected to the same fluid system”), wherein a differential pressure between the left atrium and the right atrium is determined using the left atrial pressure sensed by the first sensor and the right atrial pressure determined using the coronary sinus pressure sensed by the second sensor (McNamara, [0116], “For instance, a device such as that described in this disclosure could be placed between the coronary sinus and the left atrium for the same indication”; [0341], “The pressure monitor may be integrated with the pressure regulating device 400”).
Response to Arguments
Applicant’s arguments, see pgs. 8-17, filed 4/30/2025, with respect to 112b and art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McNamara and Braido, necessitated by the amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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