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 1-8 and 19-22 are hereby under examination.
Election/Restrictions
Claims 1-8 and 19-22 are allowable. The restriction requirement between Species 1A and 1B, as set forth in the Office action mailed on 9/25/2024, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 9/25/2024 is partially withdrawn. Claims 3-4, directed to a second pressure sensor is configured to be positioned in the right atrium to sense the right atrial pressure no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
Claim 8 objected to because of the following informalities: “circuity” should be “circuitry”. Appropriate correction is required.
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.
Claims 7-8 and 19-20 are 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.
Claim 7 recites the limitation “the first sensor” and "the second sensor". There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the second sensor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19, line 14 recites “a left atrial pressure”. However, earlier in line 1, there is already “a left atrial pressure”. It is unclear if the left atrial pressures are the same or different. For the purpose of examination, it is interpreted as the same.
Claim 20 is rejected based upon its dependency on claim 19.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record is US20120265296A1 (McNamara et. al), as cited by Applicant and hereto referred as McNamara, and in view of US20150157268A1 (Winshtein et. al), hereto referred as Winshtein.
As to claim 1, McNamara-Winshtein teaches a sensor implant device comprising: a shunt structure (McNamara, [0302], “To facilitate such improvements in treatment we describe herein combining shunts, sensors, drug treatment systems, and the like”) comprising a flow path conduit (McNamara, [0117], “Arrow F in FIG. 1 shows the direction of flow”) and a plurality of arms configured to secure the shunt structure to a tissue wall (McNamara, [0117], “The body element 101 may comprise flanges 102 and 103.”); and
a first pressure sensor positioned so that it projects away from the tissue wall that the shunt structure is configured to be secured to and in or near a flow path through the flow path conduit of the shunt structure (McNamara, Fig. 68, shunt structure device 400 is placed near flow path; Fig. 63, internal sensor 420 is part of device 400 and a side of the sensor 420 projects away from the tissue wall), wherein
the first pressure sensor is configured to be positioned in the left atrium (McNamara, [0362], “The device 400, coupled with the biomarker sensor 442, may be placed in an atrial wall 407”; [0357], “left atrial chamber”) to sense the left atrial pressure (McNamara, [0309], “An internal sensor 420…[reading] a parameter indicative of blood pressure or flow”);
first control circuitry electrically coupled to the first pressure sensor and a communication facility (McNamara, [0310], “The processor 412 may route any of the stored data to the communication facility 418 to be delivered to a monitoring device.”)
a first antenna (Winshtein, [0092], “antenna 1250”)
and a first housing that houses the control circuitry (McNamara, [0314], “The device control facility 410 may be enclosed in a housing”).
However, McNamara-Winshtein does not teach a support extension extending from the flow path conduit of the shunt structure and integrally formed with the shunt structure; a first pressure sensor attached to the support extension and positioned so that it projects away from the tissue wall that the shunt structure is configured to be secured to and in or near a flow path through the flow path conduit of the shunt structure. Another close art of record is CN105193529A, cited by Applicant. CN105193529A teaches a support extension integrally formed with the shunt structure (Fig. 3, shunt 1001 is integrally formed with connecting member 2000; pg. 6, “The connecting member 2000 to 1001 along a cardiovascular circuit 1000 is connected with cardiovascular stent 1001 as a whole.”)
However, CN105193529A does not teach that a support extension extending from the flow path conduit of the shunt structure and integrally formed with the shunt structure; a first pressure sensor attached to the support extension and positioned so that it projects away from the tissue wall that the shunt structure is configured to be secured to and in or near a flow path through the flow path conduit of the shunt structure, along with other claimed steps or elements.
As such, claim 1 is allowable over McNamara-Winshtein and CN105193529A. Claims 2-6 are allowable on the virtue of dependency on the allowed independent claim.
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.”
Allowable Subject Matter
Claims 7-8 and 19-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 19 would be allowable for similar reasons as claim 1.
Conclusion
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights