DETAILED ACTION
Note: 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 1-7 in the reply filed on September 12, 2025 is acknowledged. Claims 8-24 were cancelled.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed application (PRO 62/963686 filed on January 21, 2020) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 October 2022, 16 March 2023, 22 May 2023, 15 September 2023, 11 April 2024, and 4 August 2025 have been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“an anchoring element configured to be secured to tissue” in claims 1 and 3-5;
“a connecting element coupling the pressure sensor to the anchoring element” in claims 1 and 6;
“an actuation mechanism configured to adjust a geometry of the lumen” in claim 7.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
[0036] …The anchoring element 406 can be a stent, basket, cage, hook, barb, or any other structure that can be fastened to a portion of the patient's heart. For example, in the illustrated embodiment, the anchoring element 406 is configured as a stent positioned at least partially within a pulmonary vein PV.
[0037] … The connecting element 408 can be a post, rod, strut, or any other structure having an elongated shape extending away from the inner surface(s) of the heart chamber. As a result, the pressure sensor 402 can be positioned away from the heart tissue when coupled to the connecting element 408. The length of the connecting element 408 can be sufficiently long to reduce or prevent tissue overgrowth onto the pressure sensor 402. For example, the connecting element 408 can have a length of at least 1-2 mm. Optionally, the connecting element 408 can be made of and/or coated with a material that reduces or prevents tissue overgrowth.
Examiner note: there does not appear to be corresponding structure for an actuation mechanism configured to adjust a geometry of the lumen. As such, 35 USC 112B rejection is provided below.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Interpretation
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 7 recites “actuation mechanism configured to adjust a geometry of the lumen”, which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US PG Pub. No. 2017/0105635 A1) (hereinafter “Cho”).
With respect to claim 1, Cho teaches a system for monitoring intracardiac pressure of a patient (see title “Intracardiac medical device with pressure sensing”), the system comprising: a pressure sensor configured to measure a pressure within a heart chamber of the patient (pressure sensor 18 measures pressure within a heart chamber as depicted in Fig. 1); an anchoring element configured to be secured to tissue at and/or proximate the heart chamber (fixation member 32 anchors the implantable unit to tissue; par.0035 “fixation member 32 becomes fixedly engaged with tissue, anchoring housing distal end 42 to the implant site”; see Figs. 1-7); and a connecting element coupling the pressure sensor to the anchoring element (proximal sensor extension 16 couples pressure sensor 18 to the anchoring element 32; see par.0025 “Sensor extension 16 is an electrical extension that couples sensor 18 to electronic circuitry including in IMD housing 14”; see also Figs. 1-7), wherein the connecting element is configured to space the pressure sensor apart from the tissue when the anchoring element is secured to the tissue (pressure sensor 18 is spaced apart from anchoring element 32 as depicted in Figs. 1-7; see also par.0039 “Pressure sensor 18 extends to the pressure monitoring site within a volume of circulating blood without fixation of the pressure sensor 18 to tissue at the pressure monitoring site, which is spaced apart from the housing 14 and from the fixation site”).
Although Cho does not explicitly teach reduce tissue overgrowth on the pressure sensor, such a modification would have been obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for several reasons. First, Cho explicitly teaches placement of a pressure sensor 18 such that is not directly fixed to tissue (par.0039; see also Figs. 1-7). Cho also teaches implanting the sensor for a considerable period of time (par.0053 “weeks or months”). As such, Examiner argues that such long-term placement of the implantable pressure sensor, as suggested by Cho, would impliedly prevent tissue overgrowth on the pressure sensor, moreover since the pressure sensor 18 does not directly touch the surrounding tissue. Therefore, PHOSITA would have had predictable success modifying Cho when the invention was filed such that the pressure sensor 18 is oriented in a manner to reduce tissue overgrowth on the pressure sensor in order to allow for long-term use of the implantable unit.
With respect to claim 2, Cho teaches the pressure sensor is configured to be implanted within a left atrium or a right atrium of the patient (see Figs. 1-7)
With respect to claim 3, Cho teaches the anchoring element comprises a stent (par.0032 “Fixation member 32 may include multiple fixation tines 41 projecting from distal housing end 42 to stably maintain distal housing end 42 at an implant site by actively engaging with tissue at the implant site”).
With respect to claim 4, Cho teaches the anchoring element is configured to be positioned in a pulmonary vein (par.0024).
With respect to claim 5, Cho teaches the anchoring element is configured to be positioned in a septal wall (see Fig. 1).
With respect to claim 6, Cho teaches the connecting element is configured to extend at least partially into a left atrium of the patient, and wherein, when implanted, the pressure sensor is suspended within the left atrium and out of contact with heart tissue (see Figs. 1-7). Moreover, further modifying the placement of connecting element 16 in the manner recited would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Rottenberg et al. (US PG Pub. No. 2005/0148925 A1) (hereinafter “Rottenberg”).
Rottenberg was cited in applicant’s IDS filed on October 22, 2022.
With respect to claim 7, Cho teaches a system for monitoring intracardiac pressure of a patient, as established above.
However, Cho does not explicitly teach the limitations further recited in claim 7.
Regarding claim 7, Rottenberg teaches a shunting element having a lumen extending therethrough (Fig. 13D shows a shunting element 1300 having a lumen), wherein the lumen is configured to fluidly couple a left atrium and a right atrium of the patient when the shunting element is implanted in the patient (par.0033 “differential pressure regulation device… including a shunt… to connect a left atrium of a heart with a right atrium of the heart”); and an actuation mechanism configured to adjust a geometry of the lumen in response to the measured pressure (1380 and 1377 in Fig. 13D; par.0033 “DPRD may include an adjustment mechanism or a regulation mechanism, able to adjust, modify or otherwise regulate, for example the cross-sectional area of the orifice, for example, in relation to a change in pressure difference between the first and second lumens, for example, such as to increase and/or decrease the flow-rate of blood between the two lumens”), wherein the pressure sensor is operably coupled to the shunting element (par.0048 “may include a shunt 122, and one or more flexible or spring based lid, membrane or leaflets 150, optionally connected to shunt 122 by a spring or other suitable pressure sensitive mechanism 155”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Cho to further incorporate a shunting element and actuation mechanism in the manner recited in order to enable and regulate fluids to flow between the lumens, as evidence by Rottenberg (abstract).
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791