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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-17 in the reply filed on June 5, 2026 is acknowledged.
Claims 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 5, 2026.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claim 1: “An implantable medical device configured to be implanted within a heart that reduces or eliminates a likelihood of signal transmission interference” should read instead as “An implantable medical device configured to reduce or eliminate a likelihood of signal transmission interference and further configured to be implanted within a heart.” This change is to make clear that it is not “a heart” which “reduces or eliminates a likelihood of signal transmission interference."
Claim 9: “An anchoring device configured to be implanted within a heart that reduces or eliminates a likelihood of signal transmission interference” should instead as “An anchoring device that reduces or eliminates a likelihood of signal transmission interference and further configured to be implanted within a heart,” similarly to the recommendation of amending claim 1.
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.
Claim 2 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.
Re. Claim 2: Claim 2 possesses multiple issues of indefiniteness:
As claimed, the sensor itself does not have an antenna; rather, the sensor is coupled to a housing comprising an antenna. Since the housing is a distinct element from the sensor, the components of the housing cannot be interpreted as components of the sensor.
Claim 2 further recites the term “about” when describing where the discontinuous loop is arranged. The term “about” in claim 2 is a relative term which renders the claim indefinite since a definition for the term “about” may be interpreted as “in the vicinity” (https://www.merriam-webster.com/dictionary/about). The term “about” 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.
Claim Rejections - 35 USC § 102
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, 2, 6-9, 13, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Bak-Boychuk et al. (US 20210361238 A1) (hereinafter – BB).
Re. Claims 1, 9, and 15: BB teaches an implantable medical device configured to be implanted within a heart (Paragraph 0055: the device is directed to implantable cardiac pressure sensors)
that reduces or eliminates a likelihood of signal transmission interference (intended result),
the implantable medical device comprising:
a sensor configured to sense physiological parameters of the heart (Paragraph 0069: “In some implementations, a sensor-integrated implant device may be configured to detect physiological parameters or conditions indicative or predictive of heart failure or other condition(s) one or more weeks prior to manifestation of symptoms related therewith, such as dyspnea”);
a housing comprising a transmitter and an antenna (Fig. 4: sensor housing 410 comprising control circuitry 414 and antenna 418; Paragraph 0080: “The control circuitry 414 may utilize data storage for storing sensed data collected over a period of time, wherein the stored data can be transmitted periodically to an external monitor or other external subsystem;” Paragraph 0083: “In certain embodiments, an external reader/monitor comprises a coil antenna that is matched and/or tuned to be inductively paired with the antenna 418 of the internal implant device 410;” Examiner notes that transmitting stored data teaches an implicit transmitter),
wherein the sensor is coupled to the housing (Fig. 4: the sensor 410 is comprised of sensor housing 416), and
wherein the transmitter and the antenna are configured to transmit the sensed physiological parameters of the heart (Paragraph 0055: “For example, embodiments of the present disclosure allow for cardiac pressure monitoring of a patient post-operatively, wherein the pressure monitoring may involve tracking and/or notification of pressure trends (or trends relating to one or more other physiological parameters monitored in accordance with the present disclosure) that may result in or be associated with adverse effects or events;” Paragraphs 0079-0083: transmission of data to external device);
and an anchoring device formed by one or more wires comprising:
an engagement component arranged around at least a portion of the housing (Fig. 6: see portion of anchor 520 surrounding central portion of sensor 510; Figs. 15, 16: intermediate smaller-diameter helical portion 223; Fig. 20: sleeve/cuff 2039 holding sensor device 2010 also possessing what can be interpreted as wires in arms 2020 and 2022);
a first frame component configured to engage a first wall defining a first chamber of the heart (Fig. 6: arms 521; Figs. 15, 16: portion of large-diameter helical portions 224 engaging a first wall (e.g., the right side of Fig. 15); Fig. 20: arms 2022);
a second frame component configured to engage a second wall defining a second chamber of the heart (Fig. 6: arms 522; Figs. 15, 16: portion of large-diameter helical portions 224 engaging a second wall (e.g., the left side of Fig. 15); Fig. 20: arms 2020); and
wherein the first frame component, the second frame component, or the first frame component and the second frame component comprise a first end separated from a second end to form a discontinuous loop (see prior citations of frame components; Examiner notes that the term “loop” is provided with the following definition from Merriam-Webster: “a ring or curved piece used to form a fastening, handle, or catch” (https://www.merriam-webster.com/dictionary/loop); any curved portion may be considered a loop, whereby a discontinuity in a loop may be considered wherever the curve ends)
and are formed from a conductive material (Paragraph 0091: “In some embodiments, the anchor 520 comprises a memory metal frame, such as Nitinol or the like;” Paragraph 0114: “In some embodiments, the wire form anchor 220 comprises memory metal wire preformed into the desired coil shape, as illustrated”).
Claim 9 substantively differs from claim 1 in that a sensor housing is not claimed; therefore, citations of claim 1 teach each requirement of claim 9.
Claim 15 recites limitations of claim 1 mutatis mutandis as a method claim, and differs by not requiring an anchoring device formed of one or more wires; therefore, citations of claim 1 teach each requirement of claim 15.
Re. Claim 2: BB teaches the invention according to claim 1. BB further teaches the invention wherein the discontinuous loop is arranged about the sensor at a position where an antenna of the sensor is located (see figures cited in rejection of claim 1 – curved anchor components are arranged “about” a sensor device containing an antenna as shown in Fig. 4).
Re. Claims 6 and 13: BB teaches the invention according to claims 1 and 9. BB further teaches the invention wherein the sensed physiological parameters comprise pressure measurements from at least one chamber of the heart (Title; Abstract; Paragraph 0004; e.g., Paragraphs 0055, 0068-0070).
Re. Claim 7: BB teaches the invention according to claim 1. BB further teaches the invention wherein the engagement component includes a ring (Figs. 5, 6: see central portion of anchors surrounding sensor device 500; Figs. 14-16: see central spiral structures forming a ring in the longitudinal cross-section of the device; Fig. 20: sleeves/cuffs 2039 surround sensor 2010 in ring-like fashion)
and the sensor defines a groove in cross-section (Paragraph 0085: “… the sensor 510 includes or is associated with one or more projection features 517, which may comprise knobs, projections, extensions, teeth, grooves, posts, or the like, and may be used to secure the sensor 510 to one or more components of a delivery system (not shown) or to one or more features of the anchor 520”).
Re. Claim 8: BB teaches the invention according to claim 1. BB further teaches the invention wherein the one or more wires of the conductive material form one or more contact features in each of the first frame component and the second frame component (the broadest reasonable interpretation of the term “contact feature” is any feature which may be contacted – that is, each of the cited figures of the rejection of claim 1 also discloses contactable features; in the narrower interpretation that the contact features are used to engage an anatomical feature of the heart – such an aspect is already disclosed in the citations as well).
Re. Claim 17: BB teaches the invention according to claim 1. BB further teaches the invention wherein the anchoring device is formed of one or more wires (Fig. 6: anchor 520 possesses wire arms 521, 522; Figs. 15, 16: the entirety of anchor 220 is formed from a wire, as described in Paragraph 0111; Fig. 20: frame holding sensor device 2010 possessing what can be interpreted as wires in arms 2020 and 2022).
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.
Claims 3-5, 10-12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over:
Bak-Boychuk et al. (US 20210361238 A1) (hereinafter – BB)
Griswold et al. (US 20120291788 A1) (hereinafter – Griswold).
Re. Claims 3 and 10: BB teaches the invention according to claims 1 and 9, but does not teach the invention wherein at least a portion of the conductive material is covered in a non-conductive material.
Griswold teaches analogous art in the technology of implantable sensor devices (Abstract). Griswold further teaches the invention wherein at least a portion of the conductive material is covered in a non-conductive material (Paragraph 0032: “The housing 34 as well as some portions of the anchor 30 may be encapsulated in a biologically inert dielectric barrier material such as a film of silicone or polyp-xylylene) polymer sold under the trademark PARYLENE”).
It would have been obvious to one having skill in the art before the effective filing date to have modified BB to include a non-conductive barrier material as taught by Griswold, the motivation being that doing so allows the housing and anchors to be biologically inert (Paragraph 0032), reducing the risk of immune rejection and inflammation due to foreign body response, and further reduces the possible risk of material toxicity and corrosion of components of the implant.
Re. Claims 4 and 11: BB as modified by teaches the invention according to claims 1 and 9, but does not teach the invention wherein the first end, the second end, or the first end and the second end are laminated in a non-conductive material.
Such an aspect is taught by Griswold. See rejection of claims 3 and 10; motivation to modify BB is identical. Examiner notes that the term “laminate” is provided with the following definition from Merriam-Webster: “to make (something, such as a windshield) by uniting superposed layers of one or more materials” (https://www.merriam-webster.com/dictionary/laminate); see citation of the rejection of claim 3 – a thin film of polymer as taught by Griswold, when applied to the engagement components of BB, can be considered to be providing a laminated structure.
Re. Claims 5, 12, and 16: BB teaches the invention according to claims 3, 10, and 15. Griswold, in teaching further details of the modification, further teaches the invention wherein the non-conductive material is a membrane (see citation of the rejection of claim 3 – a thin film of polymer as taught by Griswold can be considered a membrane).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over:
Bak-Boychuk et al. (US 20210361238 A1) (hereinafter – BB)
Najafi (US 20180116516 A1) (disclosed by Applicant) (hereinafter – Najafi).
Re. Claim 14: BB teaches the invention according to claim 9. BB also teaches engagement components which have a reduced cross section (Figs. 5, 6, 14,15, 20: see central portions surrounding sensor devices). However, BB does not recite that a groove in a sensor device housing is used to engage such reduced cross sections of engagement components in the cited embodiments. Thus, BB does not teach wherein the engagement component has a reduced cross section that mates a groove in the sensor.
The concept of utilizing a groove to engage an anchor is known from Najafi (Figs. 21, 22; Paragraph 0034: coupling means located on sensor housing portion 20 allows interfacing with anchor 50; similarly recited in claims 2 and 10).
It would have been obvious to one having skill in the art before the effective filing date to have modified BB with the coupling means of Najafi, the motivation being that a groove located on the sensor housing securely fixes the anchoring means to the sensor device housing and reduce axial movement when the anchor means is engaged with the sensor housing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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, Alexander Valvis can be reached at (571) 272-4233. 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.
/JUSTIN XU/Primary Examiner, Art Unit 3791
Prosecution Insights