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 with traverse of Group I (Claims 1-11) in the reply filed on August 3rd, 2026 is acknowledged. The traversal is on the ground(s) that “all of the claims are directed to a common invention that includes a sensor and frames, where one of the frames includes a recessed portion as defined in the claims”. This is not found persuasive because although Groups I-VIII have similar limitations regarding the sensor and frames, the claim limitations are indeed different.
Even if they were the same, the shared technical feature being addressed by the prior art means the restriction is proper. The special technical feature has been identified as the shared claim language, which was shown to be taught by the prior art. If the prior art did not address the shared technical feature, then the restriction would be improper and that is how the groups would be delineated. Applicant may amend the withdrawn claims concurrently during prosecution and would likely be able to rejoin them if any found allowable subject matter is inputted into those claims. The requirement is still deemed proper and is therefore made FINAL.
Claims 12-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups II-VIII, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 3rd, 2026.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract currently does not meet the required range of 50 to 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1 recites “assembly for placement” in line 1, but should read “assembly configured for placement”
Claim 7 recites “and further wherein” in line 3, but should read “and wherein”
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 1-11 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 1 recites the limitation "the atrial septum" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “at least one of” in line 2. Further in line 2, Claim 3 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or whether both limitations are required. For examination purposes, the Examiner will interpret it as an alternative limitation.
Claim 6 recites “wherein the inner profile of the engagement section is defined by a membrane material” in lines 1-2. It is unclear as to how a section is “defined by” a membrane material, as it is unclear as to whether the “membrane material” is a part of the engagement section or not. Furthermore, it is unclear as to what type of material can be considered as a “membrane material”.
Claim 8 recites the limitation "the inner circumference" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
The term “complementary” in claim 11 is a relative term which renders the claim indefinite. The term “complementary” 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
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 1-5, 7, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eigler et al (U.S. Publication No. 2005/288596; cited by Applicant).
Regarding Claim 1, Eigler discloses a sensor assembly for placement across the atrial septum of a patient (Implantable pressure transducer system optimized for reduced thrombosis effect; Abstract), the sensor assembly comprising:
a sensor (sensor 120) having one or more recessed portions (annular grooves 170,172) in an outer surface of the sensor (the sensor 120 is a pressure transducer having a substantially cylindrical body 160; [0200]);
an anchor comprising:
a first frame component (distal anchor 110; [0201]); and
a second frame component spaced from the first frame component (proximal anchor 112; [0201]; Figure 3),
wherein the anchor is engaged with the one or more recessed portions in the outer surface of the sensor in a mating relationship such that the first frame component and the second frame component are rotationally fixed relative to the sensor (the distal anchor 110 is secured to the sensor 120 by struts or locking tabs 130 on the anchor, which engage an angled annular groove 170 which circumscribes a distal portion of the sensor 120. The locking tabs 130 extending distally from the distal anchor 110 (as shown in FIGS. 1 and 2) are preferably bent slightly radially inwards such that they will engage the distal annular groove 170 in the sensor as shown in the detail view of FIG. 9. Similarly, a proximal annular groove 172 is provided to be engaged by the locking tabs 150 of the proximal anchor 112 (shown in FIG. 3). The anchor-to-sensor attachment system illustrated in FIGS. 7-9 allows the anchors 110 and 112 to rotate about the sensor 120…Alternatively, in place of an annular groove, the sensor could comprise angled notches for receiving the locking tabs in a single rotational orientation on the sensor 120; [0201]).
Regarding Claim 2, Eigler discloses wherein the anchor is engaged with the one or more recessed portions such that the first and second frame components are maintained at a selected spacing relative to one another (the sensor could comprise angled notches for receiving the locking tabs in a single rotational orientation on the sensor 120; [0201]; Examiner’s Note: The implementation of the “angled notches” would result in a selected spacing relative to one another).
Regarding Claim 3, Eigler discloses wherein the anchor further comprises an engagement section coupled to at least one of the first frame component and the second frame component, the engagement section having an inner profile that is engaged with the one or more recessed portions in the outer surface of the sensor (the distal anchor 110 is secured to the sensor 120 by struts or locking tabs 130 on the anchor, which engage an angled annular groove 170 which circumscribes a distal portion of the sensor 120. The locking tabs 130 extending distally from the distal anchor 110 (as shown in FIGS. 1 and 2) are preferably bent slightly radially inwards such that they will engage the distal annular groove 170 in the sensor as shown in the detail view of FIG. 9. Similarly, a proximal annular groove 172 is provided to be engaged by the locking tabs 150 of the proximal anchor 112 (shown in FIG. 3); [0201]).
Regarding Claim 4, Eigler discloses wherein the inner profile of the engagement section has a polygonal shape defining a plurality of engagement features for mating engagement with the one or more recessed portions in the outer surface of the sensor (Examiner’s Note: Figure 7 shows a triangular shape, which is considered a polygonal shape).
Regarding Claim 5, Eigler discloses wherein the inner profile of the engagement section has a circular shape (Examiner’s Note: Although Figure 7 shows an overall triangular shape, there is also a circular shape shown in the center).
Regarding Claim 7, Eigler discloses wherein the engagement section is a first engagement section associated with the first frame component, and further wherein the anchor further comprises a second engagement section associated with the second frame component (the distal anchor 110 is secured to the sensor 120 by struts or locking tabs 130 on the anchor, which engage an angled annular groove 170 which circumscribes a distal portion of the sensor 120. The locking tabs 130 extending distally from the distal anchor 110 (as shown in FIGS. 1 and 2) are preferably bent slightly radially inwards such that they will engage the distal annular groove 170 in the sensor as shown in the detail view of FIG. 9. Similarly, a proximal annular groove 172 is provided to be engaged by the locking tabs 150 of the proximal anchor 112 (shown in FIG. 3); [0201]).
Regarding Claim 9, Eigler discloses wherein the one or more recessed portions of the sensor include a first set of recessed portions and a second set of recessed portions, and the first frame component is coupled to the first set of recessed portions and the second frame component is coupled to the second set of recessed portions (the distal anchor 110 is secured to the sensor 120 by struts or locking tabs 130 on the anchor, which engage an angled annular groove 170 which circumscribes a distal portion of the sensor 120. The locking tabs 130 extending distally from the distal anchor 110 (as shown in FIGS. 1 and 2) are preferably bent slightly radially inwards such that they will engage the distal annular groove 170 in the sensor as shown in the detail view of FIG. 9. Similarly, a proximal annular groove 172 is provided to be engaged by the locking tabs 150 of the proximal anchor 112 (shown in FIG. 3). The anchor-to-sensor attachment system illustrated in FIGS. 7-9 allows the anchors 110 and 112 to rotate about the sensor 120…Alternatively, in place of an annular groove, the sensor could comprise angled notches for receiving the locking tabs in a single rotational orientation on the sensor 120; [0201]).
Regarding Claim 10, Eigler discloses wherein the first frame component comprises a first plurality of engagement features defining a first engagement section of the anchor, and the second frame component comprises a second plurality of engagement features defining a second engagement section of the anchor, and further wherein the first plurality of engagement features engages the first set of recessed portions in a mating relationship and the second plurality of engagement features engages the second set of recessed portions in a mating relationship (the distal anchor 110 is secured to the sensor 120 by struts or locking tabs 130 on the anchor, which engage an angled annular groove 170 which circumscribes a distal portion of the sensor 120. The locking tabs 130 extending distally from the distal anchor 110 (as shown in FIGS. 1 and 2) are preferably bent slightly radially inwards such that they will engage the distal annular groove 170 in the sensor as shown in the detail view of FIG. 9. Similarly, a proximal annular groove 172 is provided to be engaged by the locking tabs 150 of the proximal anchor 112 (shown in FIG. 3). The anchor-to-sensor attachment system illustrated in FIGS. 7-9 allows the anchors 110 and 112 to rotate about the sensor 120…Alternatively, in place of an annular groove, the sensor could comprise angled notches for receiving the locking tabs in a single rotational orientation on the sensor 120; [0201]).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Eigler et al in view of Mooney (U.S. Publication No. 2016/0045199; cited by Applicant).
Regarding Claim 8, Eigler fails to teach wherein the anchor further comprises one or more wires forming the engagement section, the inner circumference of the engagement section being defined by at least one turn of the one or more wires.
In a similar technical field, Mooney teaches an implantable medical device (Abstract), wherein the anchor further comprises one or more wires forming the engagement section (the elongate member 110 comprises a single continuous wire. As will be described further below in reference to FIGS. 6A and 6B, the single continuous wire can be bent using a mandrel to form the frame 100; [0023]), the inner circumference of the engagement section being defined by at least one turn of the one or more wires (wire loops 122 and 142; [0032-0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wire loop teachings of Mooney into those of Eigler in order to ensure that each of the one or more elongate wire loops is configured to bear a load associated with the tissue surface without imparting a substantial force to any other one or more elongate wire loop (Claim 14 of Mooney).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
