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 .
Status of Claims
Claims 1-12 and 16-23 are pending and currently under consideration for patentability.
Applicant has herein cancelled claims 13-15 and amended.
Claims 1, 4-5, 8-12, and 16-20 are newly amended.
Claims 21-23 are new.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/15/2026 and 09/01/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) Claims 1-12 and 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (WO 2020123338 A1) in view of Najafi (US 20130144379 A1).
Regarding Claim 1, Rowe teaches a sensor implant system (par. 121-122, figs. 16A-C) comprising:
a shunt implant (1620) comprising a central flow portion configured to maintain an opening through a tissue wall(fig. 16A); and
a sensor implant device (#1627 fig. 16A, see par. 121: "the sensor 1610 comprises or is associated with one or more projections 1627 configured or designed to hold or secure the sensor 1610 to the shunt structure 1620") comprising: a shunt body configured to fit at least partially within the central flow portion (structures #1627 of D1 fit within the central flow, see par. 122:" ... showing the sensor 1610 disposed in the flow path 1603 of the shunt structure")
Rowe fails to explicitly teach the sensor anchor coupled to the sensor, the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant. Najafi teaches an implantable wireless sensor system wherein the sensor anchor (18) coupled to the sensor (10) (paragraph [0027][0055]), the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant (fig. 1) to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant (paragraph [0027][0055]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor implant of Rowe, wherein the sensor anchor coupled to the sensor, the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant, so that the sensor stays locked into one part of the body while measuring data.
Regarding Claim 2, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor is configured to extend at least partially over the opening through the tissue wall (figs. 14B, 15, 16A).
Regarding Claim 3, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor is configured to extend at least partially over the tissue wall (figs. 14B, 15, 16A).
Regarding Claim 4, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor is coupled to the sensor anchor via an arm extending from the sensor anchor (arm #1527 fig. 15).
Regarding Claim 5, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor anchor comprises a wire loop (1621) having a proximal portion configured to assume a first width within the central flow portion of the shunt implant and having a distal portion configured to expand to a second width beyond the central flow portion of the shunt implant, and wherein the second width is greater than the first width (figure 16c).
Regarding Claim 6, Rowe in view of Najafi teaches the sensor implant system of claim 5. Rowe further teaches wherein the wire loop is configured to expand to the second width beyond a first side of the tissue wall (figure 17), and wherein the sensor (1610) is configured to extend beyond a second side of the tissue wall (figure 16B and 17).
Regarding Claim 7, Rowe in view of Najafi teaches the sensor implant system of claim 5. Rowe further teaches wherein the proximal portion of the wire loop is configured to be situated at least partially within the central flow portion of the shunt implant (figure 16B and 17).
Regarding Claim 8, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor anchor comprises a coil (paragraph [0117 and 0140]) having a proximal portion configured to form a first width within the central flow portion of the shunt implant and having a distal portion configured to form a second width beyond the central flow portion of the shunt implant, and wherein the second width is greater than the first width (figure 16c).
Regarding Claim 9, Rowe in view of Najafi teaches the sensor implant system of claim 8. Rowe further teaches wherein the sensor anchor is configured to form the second width beyond a first side of the tissue wall(figure 17), and wherein the sensor (1610) is configured to extend beyond a second side of the tissue wall (figure 16B and 17).
Regarding Claim 10, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor anchor has an hourglass shape in which a midsection of the sensor anchor has a first diameter and the sensor anchor expands to a second diameter at a first end of the sensor anchor and at a second end of the sensor anchor, wherein the second diameter is greater than the first diameter (figure 16B).
Regarding Claim 11, Rowe in view of Najafi teaches the sensor implant system of claim 10. Rowe further teaches wherein the sensor anchor comprises a sensor dock (1625) at the first end, and wherein the sensor is configured to couple to the sensor anchor at the sensor dock (figure 16B).
Regarding Claim 12, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor anchor has a partial cylindrical form (1622) with a gap separating a first end of the shunt body from a second end of the sensor anchor (fig. 16B).
Regarding Claim 16, Rowe in view of Najafi teaches the sensor implant system of claim 1. Rowe further teaches, a coupling arm (1522) interconnecting the sensor and the shunt body, wherein the coupling arm comprise a network of struts forming diamond shaped cells (figure 15).
Regarding Claim 17, Rowe teaches a method comprising:
delivering a shunt implant (1620) to an opening in a tissue wall, the shunt implant comprising a central flow portion configured to maintain the opening (paragraph [0070 and 0089]);
delivering a sensor implant device to the opening in the tissue wall (paragraph [0070 and 0089]);
the sensor implant device comprising:
Rowe teaches a sensor implant system (par. 121-122, figs. 16A-C) comprising:
a shunt implant (1620) comprising a central flow portion configured to maintain an opening through a tissue wall(fig. 16A); and
a sensor implant device (#1627 fig. 16A, see par. 121: "the sensor 1610 comprises or is associated with one or more projections 1627 configured or designed to hold or secure the sensor 1610 to the shunt structure 1620") comprising: a shunt body configured to fit at least partially within the central flow portion (structures #1627 of D1 fit within the central flow, see par. 122:" ... showing the sensor 1610 disposed in the flow path 1603 of the shunt structure")
Rowe fails to explicitly teach the sensor anchor coupled to the sensor, the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant. Najafi teaches an implantable wireless sensor system wherein the sensor anchor (18) coupled to the sensor (10) (paragraph [0027][0055]), the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant (fig. 1) to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant (paragraph [0027][0055]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor implant of Rowe, wherein the sensor anchor coupled to the sensor, the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant, so that the sensor stays locked into one part of the body while measuring data.
Regarding Claim 18, Rowe in view of Najafi teaches the method of claim 17. Rowe further teaches wherein the shunt body comprises a wire loop (1621) having a proximal portion configured to assume a first width within the central flow portion of the shunt implant and having a distal portion configured to expand to a second width beyond the central flow portion of the shunt implant, and wherein the second width is greater than the first width (figure 16c).
Regarding Claim 19, Rowe teaches a sensor implant device comprising: A sensor implant system device comprising:a shunt implant comprising a central flow portion configured to maintain an opening through a tissue wall, wherein the shunt implant is configured to anchor to the tissue wall; and a sensor implant device that is disconnected from the shunt implant, the sensor implant device comprising: a sensor anchor shunt body configured to fit at least partially within a central flow portion of a shunt implant; anda sensor coupled to the sensor anchor shunt body, Rowe teaches a sensor implant system (par. 121-122, figs. 16A-C) comprising:
a shunt implant (1620) comprising a central flow portion configured to maintain an opening through a tissue wall(fig. 16A); and
a sensor implant device (#1627 fig. 16A, see par. 121: "the sensor 1610 comprises or is associated with one or more projections 1627 configured or designed to hold or secure the sensor 1610 to the shunt structure 1620") comprising: a shunt body configured to fit at least partially within the central flow portion (structures #1627 of D1 fit within the central flow, see par. 122:" ... showing the sensor 1610 disposed in the flow path 1603 of the shunt structure")
Rowe fails to explicitly teach the sensor anchor coupled to the sensor, the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant. Najafi teaches an implantable wireless sensor system wherein the sensor anchor (18) coupled to the sensor (10) (paragraph [0027][0055]), the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant (fig. 1) to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant (paragraph [0027][0055]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor implant of Rowe, wherein the sensor anchor coupled to the sensor, the sensor anchor being disconnected from the shunt implant and configured to anchor to the tissue wall independently of the shunt implant to position the sensor near the shunt implant and collect measurements related to blood flow through the shunt implant, so that the sensor stays locked into one part of the body while measuring data.
Regarding Claim 20, Rowe in view of Najafi teaches the sensor implant system of claim 19. Rowe further teaches wherein the sensor anchor has an hourglass shape in which a midsection of the sensor anchor has a first diameter and the sensor anchor expands to a second diameter at a first end of the sensor anchor and at a second end of the sensor anchor, wherein the second diameter is greater than the first diameter (figure 16B).
Regarding Claim 21, Rowe in view of Najafi teaches the method of claim 17. The combination further teaches wherein the sensor is configured to extend at least partially over the opening through the tissue wall (Najafi, paragraph [0027][0055]).
Regarding Claim 22, Rowe in view of Najafi teaches the sensor implant system of claim 19. The combination further teaches wherein the sensor is configured to extend at least partially over the opening through the tissue wall (Najafi, paragraph [0027][0055]).
Regarding Claim 23, Rowe in view of Najafi teaches the sensor implant system of claim 19. The combination further teaches wherein the sensor is configured to extend at least partially beyond the opening and over the tissue wall (Najafi, paragraph [0027][0055]).
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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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.
/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights