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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 15 Jul 2026. As directed by the amendment: claims 1, 5-6, 16, and 19 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Claim Objection
Applicant’s arguments, see Remarks, filed 15 Jul 2026, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
The 35 U.S.C. § 112(f) Interpretation
Applicant's arguments filed 15 Jul 2026 have been fully considered but they are not persuasive.
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.
The limitation “fixation element” meets the three-prong test:
(A) “Element” is a generic placeholder for performing the claimed function of “fixation”
(B) The generic placeholder “element” is modified by the functional language “fixation” and “configured to couple to the body to the target site”
(C) Claim 15 does not describe the fixation element with any specific structure
Therefore, the interpretation of “fixation element” under 35 U.S.C. 112(f) is maintained.
The 35 U.S.C. § 112(b) Rejection
Applicant’s arguments, see Remarks, filed 15 Jul 2026, with respect to the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the claim amendments. The rejections of the claims under 35 U.S.C. 112(b) have been withdrawn.
The 35 U.S.C. § 102 Rejection
Applicant’s arguments, see Remarks, filed 15 Jul 2026, with respect to the rejections of claims 1 and 16 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Becklund et al. (US 20180178023 A1), hereinafter Becklund, as explained in further detail below.
The 35 U.S.C. § 103 Rejection
No specific arguments were made regarding the previous rejections under 35 U.S.C. 103, nor the previously cited previously cited Garai, Sparks, and Serina references. See Remarks, Page 9. Therefore, dependent claims 6-9, 11-13, and 19 are rejected below.
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, 7-10, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becklund et al. (US 20180178023 A1), hereinafter Becklund.
Regarding claim 1, Becklund discloses an implantable apparatus (Fig. 1, implantable leadless cardiac pacing device 10) comprising:
a body defining a distal end region extending along a distal end region axis (Fig. 2, distal end 16 of housing 12),
wherein the body is configured to be inserted into cardiac tissue of a patient's heart at a target site (paragraph [0062], "The implantable device 10 may include a fixation mechanism 24 proximate the distal end 16 of the housing 12 configured to attach the implantable device 10 to a tissue wall of the heart H"); and
a plurality of markers located along at least a portion of an outer surface of the distal end region of the body (Fig. 6, paragraph [0074], radiopaque bands or dots 206),
wherein each of the plurality of markers defines a first configuration when located within the cardiac tissue and a second configuration when not located within the cardiac tissue, wherein the first configuration is different than the second configuration (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206").
Regarding claim 2, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that the plurality of markers are radiopaque and viewable under imaging when located within the patient's heart (paragraph [0065], "a radiopaque material...may be used to increase the radiopacity of the fixation mechanism 24"; paragraph [0087], "Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure").
Regarding claim 3, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that the body is configured to be inserted into the cardiac tissue such that only a portion of the plurality of markers are located within the cardiac tissue, wherein the portion of the plurality of markers define the first configuration and a remainder of the plurality of markers define the second configuration (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206. This may allow a physician to visually confirm adequate fixation of the implantable device 10 under fluoroscopy. Conversely, the tines 202 of a fixation mechanism 200 that is not secured or not well secured may not bend or flex (e.g., temporarily change shape) under the pulling force of the physician. As such, no change or very little change in the constellation or pattern of the radiopaque bands 206 may be observed, indicating that the implantable device 10 has not been adequately secured").
Regarding claim 4, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that the first configuration of the plurality of markers defines a first visual appearance under imaging and the second configuration of the plurality of markers defines a second visual appearance under imaging, wherein the first and second visual appearances are different (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206. This may allow a physician to visually confirm adequate fixation of the implantable device 10 under fluoroscopy. Conversely, the tines 202 of a fixation mechanism 200 that is not secured or not well secured may not bend or flex (e.g., temporarily change shape) under the pulling force of the physician. As such, no change or very little change in the constellation or pattern of the radiopaque bands 206 may be observed, indicating that the implantable device 10 has not been adequately secured").
Regarding claim 5, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that each of the plurality of markers are spaced apart along the distal end region axis by a preset distance (paragraph [0075], "radiopaque bands 206 may be positioned on the tines 202 at discrete intervals along a length of the tines 202. ... In some embodiments, the radiopaque bands 206 may be positioned at evenly spaced intervals. In other embodiments, the radiopaque bands 206 may be positioned at non-uniformly spaced intervals, as desired").
Regarding claim 7, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that the plurality of markers comprise filaments extending from the outer surface of the distal end region of the body (Fig. 6, paragraph [0073], hooks or tines 202).
Regarding claim 8, Becklund discloses the implantable apparatus of claim 7, as explained above. Becklund further discloses that the filaments are bent when in the first configuration (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206").
Regarding claim 9, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that
the plurality of markers comprise a material coating (Fig. 5, paragraphs [0068]-[0071], radiopaque coating 106),
wherein the plurality of markers define a first visual appearance when in the first configuration due to a pressure applied to the plurality of markers by the cardiac tissue (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206"),
wherein the plurality of markers define a second visual appearance when in the second configuration (paragraph [0076], "the tines 202 of a fixation mechanism 200 that is not secured or not well secured may not bend or flex (e.g., temporarily change shape) under the pulling force of the physician"),
wherein the first and second visual appearance are different (the amount that the tines bend is different depending on whether the tines are secured in the tissue).
Regarding claim 10, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that
the plurality of markers comprise a material coating (Fig. 5, paragraphs [0068]-[0071], radiopaque coating 106),
wherein the plurality of markers define a first visual appearance when in the first configuration due to an interaction between the cardiac tissue and the material coating (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206"),
wherein the plurality of markers define a second visual appearance when in the second configuration (paragraph [0076], "the tines 202 of a fixation mechanism 200 that is not secured or not well secured may not bend or flex (e.g., temporarily change shape) under the pulling force of the physician"),
wherein the first and second visual appearance are different (the amount that the tines bend is different depending on whether the tines are secured in the tissue).
Regarding claim 14, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that the body comprises a pacing lead (Fig. 2, paragraph [0060], electrode 20).
Regarding claim 15, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses a fixation element extending from the distal end region of the body and configured to couple the body to the target site (Fig. 2, paragraph [0062], fixation mechanism 24).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Becklund et al. (US 20180178023 A1), hereinafter Becklund, in view of Garai et al. (US 20120323253 A1, previously cited), hereinafter Garai.
Regarding claim 6, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund further discloses that the target site comprises a chamber of a heart such as a right ventricle (paragraph [0060]), but does not explicitly disclose that the target site comprises the interventricular septum.
However, Garai teaches a device for positioning an electrode in tissue (Abstract) wherein the target site comprises an interventricular septum (Fig. 2, paragraph [0021]; Figs. 29A-F, paragraphs [0056]-[0057]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Becklund with the teachings of Garai so that the target site comprises an interventricular septum, because doing so allows electrical stimulation to help regulate heart rate (Garai, paragraph [0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the apparatus to be located at an interventricular septum, since Becklund discloses that the apparatus can be implanted in a chamber of a heart (paragraphs [0060], [0062]), and since such a modification would have involved a mere change in the form or shape of the implant components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, it is noted that there are no limitations in the apparatus that structurally limits the body to be implanted in this particular region. The location of implantation of the body is considered to be intended use. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Becklund et al. (US 20180178023 A1), hereinafter Becklund, in view of Sparks et al. (US 20180126156 A1, previously cited), hereinafter Sparks.
Regarding claim 11, Becklund discloses the implantable apparatus of claim 1, as explained above. Becklund does not explicitly disclose that the plurality of markers comprise inflatable balloons extending from the outer surface of the distal end region of the body.
However, Sparks teaches devices and methods for positioning an electrode in tissue (paragraph [0006]) wherein the plurality of markers comprise inflatable balloons extending from the outer surface of the distal end region of the body (Fig. 22c, paragraph [0238], expandable displacement member 320 with marker 328).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Becklund with the teachings of Sparks so that the plurality of markers comprise inflatable balloons extending from the outer surface of the distal end region of the body, because doing so allows the apparatus to initiate contact and exert force on a wall of a body cavity, thus displacing the lead body in a different (e.g., the opposite) direction, towards the tissue targeted for contact for affixation to the tissue (Sparks, paragraph [0224]).
Regarding claim 12, the implantable apparatus of claim 11 is obvious over Becklund and Sparks, as explained above. Becklund does not explicitly disclose that the balloons are inflated when in the second configuration and compressed when in the first configuration.
However, Sparks further teaches that the balloons are inflated when in the second configuration (paragraph [0224], "expansion of the expandable displacement member 320 can initiate contact and exert force on a wall of a body cavity") and compressed when in the first configuration (paragraph [0224], "upon deflation the inflatable displacement member may re-fold and retract back to its original un-deployed configuration").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Becklund with the teachings of Sparks so that the balloons are inflated when in the second configuration and compressed when in the first configuration, because doing so allows the apparatus to initiate contact and exert force on a wall of a body cavity, thus displacing the lead body in a different (e.g., the opposite) direction, towards the tissue targeted for contact for affixation to the tissue (Sparks, paragraph [0224]).
Regarding claim 13, the implantable apparatus of claim 11 is obvious over Sampson and Sparks, as explained above. Becklund does not explicitly disclose that the balloons comprise a visible material that is viewable under imaging.
However, Sparks further teaches that the balloons comprise a visible material that is viewable under imaging (Fig. 22c, paragraph [0239], marker 328).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Becklund with the teachings of Sparks so that the balloons comprise a visible material that is viewable under imaging, because doing so can help the user better orient the distal lead segment under fluoroscopic guidance (Sparks, paragraph [0239]).
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Becklund et al. (US 20180178023 A1), hereinafter Becklund, in view of Sampson et al. (US 20160256149 A1, previously cited), hereinafter Sampson.
Regarding claim 16, Becklund discloses a method comprising:
positioning a body of an implantable apparatus proximate a target site comprising cardiac tissue of a patient's heart (paragraph [0060], "implantable leadless cardiac pacing device 10 (e.g., a leadless pacemaker) implanted in a chamber of a heart H"),
wherein the body defines a distal end region extending along a distal end region axis (Fig. 2, distal end 16 of housing 12),
wherein the implantable apparatus further comprises a plurality of markers located along at least a portion of an outer surface of the distal end region of the body (Fig. 6, paragraph [0074], radiopaque bands or dots 206);
inserting at least a portion of the distal end region of the body into the cardiac tissue of the patient's heart at the target site such that a first portion of the plurality of markers are located within the cardiac tissue and a second portion of the plurality of markers are located outside of the cardiac tissue, wherein the first portion of the plurality of markers is configured differently than the second portion of the plurality of markers when the first portion is within the cardiac tissue (paragraph [0076], "For example, once the fixation mechanism 200 has been deployed into the heart wall, the physician may exert a pulling force on the implantable device 10 to verify the fixation mechanism 200 has been engaged with the heart wall. If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206. This may allow a physician to visually confirm adequate fixation of the implantable device 10 under fluoroscopy. Conversely, the tines 202 of a fixation mechanism 200 that is not secured or not well secured may not bend or flex (e.g., temporarily change shape) under the pulling force of the physician. As such, no change or very little change in the constellation or pattern of the radiopaque bands 206 may be observed, indicating that the implantable device 10 has not been adequately secured").
Becklund does not explicitly disclose determining a depth of the body within the cardiac tissue based on a length of the first portion of the plurality of markers.
However, Sampson teaches devices and methods for assessing the surface of a target cardiac tissue and for delivering a tissue anchor to cardiac tissue at a preselected depth within the myocardium (Abstract) comprising determining a depth of the body within the cardiac tissue based on a length of the first portion of the plurality of markers (paragraph [0036], "This discontinuity 71 and the straight distal portion 72 of the indicator wire 70 may provide a clear visual signal that the desired depth of penetration below endocardium 12 has been achieved").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Becklund with the teachings of Sampson so that the method comprises determining a depth of the body within the cardiac tissue based on a length of the first portion of the plurality of markers, because doing so provides a visual indication to the practitioner that the distal tip of the delivery catheter has penetrated the tissue at a certain depth (Sampson, paragraph [0030]).
Regarding claim 17, the method of claim 16 is obvious over Becklund and Sampson, as explained above. Becklund further discloses that the first configuration of the plurality of markers defines a first visual appearance under imaging and the second configuration of the plurality of markers defines a second visual appearance under imaging, wherein the first and second visual appearances are different (paragraph [0076], "If the fixation mechanism 200 has be secured to the heart wall, the tines 202 may bend or flex (e.g., temporarily change shape) under the pulling force of the physician resulting in a temporary change in the shape of the constellation or pattern of the radiopaque bands 206. This may allow a physician to visually confirm adequate fixation of the implantable device 10 under fluoroscopy. Conversely, the tines 202 of a fixation mechanism 200 that is not secured or not well secured may not bend or flex (e.g., temporarily change shape) under the pulling force of the physician. As such, no change or very little change in the constellation or pattern of the radiopaque bands 206 may be observed, indicating that the implantable device 10 has not been adequately secured").
Regarding claim 18, the method of claim 16 is obvious over Becklund and Sampson, as explained above. Becklund further discloses that each of the plurality of markers are spaced apart along the distal end region axis by a preset distance (paragraph [0075], "radiopaque bands 206 may be positioned on the tines 202 at discrete intervals along a length of the tines 202. ... In some embodiments, the radiopaque bands 206 may be positioned at evenly spaced intervals. In other embodiments, the radiopaque bands 206 may be positioned at non-uniformly spaced intervals, as desired").
Regarding claim 20, the method of claim 16 is obvious over Becklund and Sampson, as explained above. Becklund further discloses that the plurality of markers comprise filaments extending from the outer surface of the distal end region of the body (Fig. 6, paragraph [0073], hooks or tines 202).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Becklund et al. (US 20180178023 A1), hereinafter Becklund, in view of Sampson et al. (US 20160256149 A1, previously cited), hereinafter Sampson, and further in view of Garai et al. (US 20120323253 A1, previously cited), hereinafter Garai.
Regarding claim 19, the method of claim 16 is obvious over Becklund and Sampson, as explained above. Becklund further discloses that the target site comprises a chamber of a heart such as a right ventricle (paragraph [0060]), but does not explicitly disclose that the target site comprises the interventricular septum.
However, Garai teaches a device for positioning an electrode in tissue (Abstract) wherein the target site comprises an interventricular septum (Fig. 2, paragraph [0021]; Figs. 29A-F, paragraphs [0056]-[0057]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Becklund with the teachings of Garai so that the target site comprises an interventricular septum, because doing so allows electrical stimulation to help regulate heart rate (Garai, paragraph [0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the apparatus to be located at an interventricular septum, since Sampson discloses any of multiple suitable cardiac structures (paragraph [0009]), since such a modification would have involved a mere change in the form or shape of the implant components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, it is noted that there are no limitations in the apparatus that structurally limits the body to be implanted in this particular region. The location of implantation of the body is considered to be intended use. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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