DETAILED ACTION
1. This office action is in response to the communicated dated 19 May 2026 concerning application number 17/813,281 effectively filed on 18 July 2022.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of Claims
3. Claims 1-29 are pending, of which claims 1, 12, and 24 have been amended; claim 30 has been cancelled; and claims 1-29 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 19 May 2026, referred to herein as “the Arguments”, have been fully considered and are persuasive. Therefore, the Examiner has withdrawn the rejections of claims 1-29 under 35 U.S.C. 103. However, claim 7 is now rejected under 35 U.S.C. 112(d) in response to the amended limitations of claim 1. Furthermore, claim 11 has been rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112
5. 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.
6. Claim 11 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.
Claim 11 recites the limitation "the septum" in line 2. There is insufficient antecedent basis for this limitation in the claim.
7. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claim 7 recites “wherein the one or more electrodes are configured to extend parallel to the longitudinal axis.” The Examiner respectfully submits that claim 7 depends upon claim 1 which recites “one or more electrodes that extend directly from the header parallel to the longitudinal axis”. In this case, claim 1 recites the one or more electrodes to extend parallel to the longitudinal axis. Thus, the dependent claim 7 fails to further limit the subject matter of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
9. Claims 1-6, 8-10, and 12-29 contain allowable subject matter. However, claim 7 has been rejected under 35 U.S.C. 112(d) and claim 11 has been rejected under 35 U.S.C. 112(b). Thus, all of the claims (claims 1-29) not in condition for allowance.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that demonstrates how the prior art of record fails to suggest the corresponding claims.
Regarding claim 1, Liu teaches an implantable medical device (IMD) (the pacing device 20 is implanted within the patient’s heart 10 [0056, FIG. 1]) comprising:
a housing defining a longitudinal axis (the pacing device 20 includes a housing 22 which defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]);
a header at a distal end of the housing (the header 22b is disposed at the distal end of the housing 22 [0080, FIG. 2]), the header defining a header plane (the header 22b of the housing 22 defines a plane or axis [0080, FIG. 2]), the header plane disposed at an angle relative to a reference plane (the annotated figure below indicates the reference plane [see the annotated figure below]. Furthermore, the header 22b may be configured to extend at an angle that is oblique to the central longitudinal axis "A" and the reference plane [0080, see the annotated figure below]. The Examiner respectfully submits that the oblique angle of the header 22b would affect the plane or axis of the header 22b [0080]), where the reference plane is perpendicular to the longitudinal axis ([see the annotated figure below]);
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wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A [0056, 0080, FIG. 2]. Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097, FIG. 2]. In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 [0080, 0096]);
a fixation mechanism extending from the header (the header 22b comprises a distal extension 24 which includes anchors (e.g., tines) that are configured to engage the tissue [0068, 0082, FIG. 2]), the fixation mechanism configured to be advanced into tissue of a heart of a patient to fix at least a portion of the IMD to the heart ([0068]);
one or more electrodes that extend directly from the header (the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. This configuration would allow the one or more electrodes to extend directly from the header, as the one or more electrodes will span or cover the entire length of the distal extension 24 which is directly attached to the header 22b [0060, 0067, 0070]. Alternatively, the one or more electrodes may cover or span a portion (e.g., partial length) of the distal extension 24 that is attached is attached directly to the header 22b [0060, 0067, 0070]) and are configured to engage with heart tissue ([0064, 0070-0071]); and
circuitry within the housing (the housing 22 of the pacing device 20 comprises an electronics module or circuit which includes a pulse generating module 62 [0053, 0099, 0105]), wherein the circuitry is configured to deliver cardiac pacing to the heart via the one or more electrodes (the electronics module or circuit includes a pulse generating module 62 that provides the stimulation pulses to the electrodes 30, 32, 34, and 36 [0099, 0105]. Specifically, the electrodes 30, 32, 34, and 36 are configured to provide cardiac pacing [0060, 0064, 0074]).
Although Liu teaches the electrodes to extend directly from the header (see the explanation above), Liu does not explicitly teach the electrodes to extend parallel to the longitudinal axis. The Examiner respectfully submits that the annotated figure illustrates the electrodes (e.g., electrodes 30-36) being positioned on the distal extension 24 which extends from the header 22b at an oblique angle to the longitudinal axis “A” of the housing 22 ([see the annotated figure above], paragraphs [0067, 0070, 0080, 0096] and [claim 1]). The Examiner respectfully submits the oblique angle (e.g., 10 to 50 degrees) is critical to mitigate or eliminate a bend in the guidewire lumen ([0096]). Thus, it would not be obvious to a person having ordinary skill in the art to modify the electrodes to extend directly from the header parallel to the longitudinal axis. Specifically, such modification would alter the principle of operation of the Liu’s device.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 2-6 and 8-11 are considered to contain allowable subject matter, as claims 2-6 and 8-11 depend upon clam 1.
Regarding claim 12, Liu teaches a medical device system ([abstract]) comprising:
an implantable medical device (IMD) (the pacing device 20 is implanted within the patient’s heart 10 [0056, FIG. 1]) comprising:
a housing defining a longitudinal axis (the pacing device 20 includes a housing 22 which defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]);
a header at a distal end of the housing (the header 22b is disposed at the distal end of the housing 22 [0080, FIG. 2]), the header defining a header plane (the header 22b of the housing 22 defines a plane or axis [0080, FIG. 2]), the header plane disposed at an angle relative to a reference plane (the annotated figure above indicates the reference plane [see the annotated figure above]. Furthermore, the header 22b may be configured to extend at an angle that is oblique to the central longitudinal axis "A" and the reference plane [0080, see the annotated figure above]. The Examiner respectfully submits that the oblique angle of the header 22b would affect the plane or axis of the header 22b [0080]), where the reference plane is perpendicular to the longitudinal axis ([see the annotated figure above]);
wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A [0056, 0080, FIG. 2]. Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097, FIG. 2]. In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 [0080, 0096]);
a fixation mechanism extending from the header (the header 22b comprises a distal extension 24 which includes anchors (e.g., tines) that are configured to engage the tissue [0068, 0082, FIG. 2]), the fixation mechanism configured to be advanced into tissue of a heart of a patient to fix at least a portion of the IMD to the heart ([0068]);
one or more electrodes that extend directly from the header (the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. This configuration would allow the one or more electrodes to extend directly from the header, as the one or more electrodes will span or cover the entire length of the distal extension 24 which is directly attached to the header 22b [0060, 0067, 0070]. Alternatively, the one or more electrodes may cover or span a portion (e.g., partial length) of the distal extension 24 that is attached is attached directly to the header 22b [0060, 0067, 0070]) and are configured to engage with heart tissue ([0064, 0070-0071]);
circuitry within the housing (the housing 22 of the pacing device 20 comprises an electronics module or circuit which includes a pulse generating module 62 [0053, 0099, 0105]), wherein the circuitry is configured to deliver cardiac pacing to the heart via the one or more electrodes (the electronics module or circuit includes a pulse generating module 62 that provides the stimulation pulses to the electrodes 30, 32, 34, and 36 [0099, 0105]. Specifically, the electrodes 30, 32, 34, and 36 are configured to provide cardiac pacing [0060, 0064, 0074]); and
a catheter extending to a distal end (the pacing device 20 may be positioned within the delivery / retrieval catheter 88 [0160, FIG. 28]. Specifically, figure 28 illustrates the delivery / retrieval catheter 88 extending from a proximal to a distal end [0160, FIG. 28]), the catheter having a cup at the distal end of the catheter (figure 28 illustrates the delivery / retrieval catheter 88 having a cup or receptacle which contains the pacing device 20 [0160, FIG. 28]), the cup having a distal cup end (figure 28 illustrates the receptacle of the delivery / retrieval catheter 88 having a distal end [0160, FIG. 28]), the distal cup end defined by a cup end plane and a cup longitudinal axis (the Examiner respectfully submits that the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), and wherein the IMD is configured to be disposed within the cup (the pacing device 20 may be positioned within the receptacle of the delivery / retrieval catheter 88 [0160, FIG. 28]).
Although Liu teaches the IMD being disposed within the cup (the pacing device 20 may be positioned within the receptacle of the delivery / retrieval catheter 88 [0160, FIG. 28]), Liu does not explicitly teach the IMD to be disposed within the cup while the IMD is delivered to a septum within the patient.
Although Liu teaches the electrodes to extend directly from the header (see the explanation above), Liu does not explicitly teach the electrodes to extend parallel to the longitudinal axis.
The prior art by Yang is analogous to Liu, as they both teach an implantable device that is configured to provide cardiac pacing ([abstract, 0035]).
Yang teaches the IMD to be disposed within the cup while the IMD is delivered to a septum within the patient (the pacemaker 10 is disposed within the cup or receptacle 108 of an outer catheter 102 [0063, 0067, FIG. 6]. Specifically, pacemaker 10 is retained within the receptacle 108 while being delivered to the implant or pacing site (e.g., ventricular septum or atrial septum) [0035, 0063]).
However, Liu and Yang do not explicitly teach the electrodes to extend parallel to the longitudinal axis.
The Examiner respectfully submits that the annotated figure illustrates Liu’s electrodes (e.g., electrodes 30-36) being positioned on the distal extension 24 which extends from the header 22b at an oblique angle to the longitudinal axis “A” of the housing 22 ([see the annotated figure above], paragraphs [0067, 0070, 0080, 0096] and [claim 1]). The Examiner respectfully submits the oblique angle (e.g., 10 to 50 degrees) is critical to mitigate or eliminate a bend in the guidewire lumen ([0096]). Thus, it would not be obvious to a person having ordinary skill in the art to modify the electrodes to extend directly from the header parallel to the longitudinal axis. Specifically, such modification would alter the principle of operation of the Liu’s device.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 13-23 are considered to contain allowable subject matter, as claims 13-23 depend upon claim 12.
Regarding claim 24, Liu teaches a method ([0002]) comprising:
advancing a medical device system within a patient ([0066]), the medical device system comprising a catheter extending to a distal end (the pacing device 20 may be positioned within the delivery / retrieval catheter 88 [0066, 0160, FIG. 28]. Specifically, figure 28 illustrates the delivery / retrieval catheter 88 extending from a proximal to a distal end [0160, FIG. 28]), the catheter having a cup at the distal end of the catheter (figure 28 illustrates the delivery / retrieval catheter 88 having a cup or receptacle which contains the pacing device 20 [0160, FIG. 28]), the cup having a distal cup end (figure 28 illustrates the receptacle of the delivery / retrieval catheter 88 having a distal end [0160, FIG. 28]), the distal cup end defined by a cup end plane and a cup longitudinal axis (the Examiner respectfully submits that the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), and an implantable medical device (IMD) disposed within the cup (the pacing device 20 may be positioned within the receptacle of the delivery / retrieval catheter 88 [0160, FIG. 28]), the IMD comprising a housing having a header (the pacing device 20 comprises a housing 22 having a header 22b [0080, FIG. 2]), the header having one or more electrodes that extend directly from the header (the one or more electrodes (e.g., electrodes 30-36) may be configured to span a length (e.g., an entire length or a partial length) of the distal extension 24 which extends from the header 22b of the housing 22 [0067, 0070]. This configuration would allow the one or more electrodes to extend directly from the header, as the one or more electrodes will span or cover the entire length of the distal extension 24 which is directly attached to the header 22b [0060, 0067, 0070]. Alternatively, the one or more electrodes may cover or span a portion (e.g., partial length) of the distal extension 24 that is attached is attached directly to the header 22b [0060, 0067, 0070]), the housing defined in part by a longitudinal axis (the pacing device 20 includes a housing 22 which defines a central longitudinal axis [0020, 0057, 0080, FIG. 2]), the header defining a header plane (the header 22b of the housing 22 defines a plane or axis [0080, FIG. 2]), the header plane disposed at an angle relative to a reference plane (the annotated figure above indicates the reference plane [see the annotated figure above]. Furthermore, the header 22b may be configured to extend at an angle that is oblique to the central longitudinal axis "A" and the reference plane [0080, see the annotated figure above]. The Examiner respectfully submits that the oblique angle of the header 22b would affect the plane or axis of the header 22b [0080]), where the reference plane is perpendicular to the longitudinal axis ([see the annotated figure above]); wherein the IMD extends along the longitudinal axis from a proximal end of the IMD to a distal end of the IMD (the IMD or pacing device 20 comprising a housing 22 consisting of a first portion 22a (e.g., proximal portion) and a header 22b that extends along a central longitudinal axis parallel to line A [0056, 0080, FIG. 2]. Furthermore, the distal extension 24 is flexible component that is configured to extend from the housing 22 at any suitable angle relative to the central longitudinal axis [0080, 0096-0097, FIG. 2]. In this case, the Examiner respectfully submits that the distal extension 24 may be configured to extend at an angle that aligns with the central longitudinal axis of the housing 22 [0080, 0096]);
delivering the IMD to an implant site with the catheter and placing the cup end plane on the heart tissue within a chamber of a heart of the patient (the cup or receptacle of the delivery / retrieval catheter 88 includes a distal end that is placed into contact with the heart tissue wall [0163]. Specifically, this allows the pacing device 20 to be delivered through the receptacle of the delivery / retrieval catheter 88 and into the heart tissue wall [0066, 0163]);
advancing the IMD from the cup (the pacing device 20 is delivered through the receptacle of the delivery / retrieval catheter 88 and into the tissue wall [0066, 0163]); and
advancing the one or more electrodes in the heart tissue (the header 22b comprises a distal extension 24 having a plurality of electrodes 30, 32, 34, and 36 that are advanced into a heart tissue [0060, 0064, 0070-0071, 0082, FIG. 2]), wherein the one or more electrodes are configured to deliver cardiac pacing to the heart tissue (the electrodes 30, 32, 34, and 36 are configured to provide cardiac pacing [0060, 0064, 0074]).
Liu do not explicitly teach wherein the cup end plane is disposed at a cup angle relative to the cup longitudinal axis, and wherein the cup longitudinal axis is non-orthogonal relative to a tissue plane
The Examiner respectfully submits, as Liu teaches the use of a cup end plane and cup longitudinal axis (the receptacle of the delivery / retrieval catheter 88 includes a distal end which is inherently defined by a plane and longitudinal axis [FIG. 28]), configuring the cup plane to be disposed at a cup angle relative to the cup longitudinal axis and the cup longitudinal axis to be non-orthogonal relative to a tissue plane would be a matter of changing the shape and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Although Liu teaches the electrodes to extend directly from the header (see the explanation above), Liu does not explicitly teach the electrodes to extend parallel to the longitudinal axis. The Examiner respectfully submits that the annotated figure illustrates the electrodes (e.g., electrodes 30-36) being positioned on the distal extension 24 which extends from the header 22b at an oblique angle to the longitudinal axis “A” of the housing 22 ([see the annotated figure above], paragraphs [0067, 0070, 0080, 0096] and [claim 1]). The Examiner respectfully submits the oblique angle (e.g., 10 to 50 degrees) is critical to mitigate or eliminate a bend in the guidewire lumen ([0096]). Thus, it would not be obvious to a person having ordinary skill in the art to modify the electrodes to extend directly from the header parallel to the longitudinal axis. Specifically, such modification would alter the principle of operation of the Liu’s device.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 25-29 are considered to contain allowable subject matter, as claims 25-29 depend upon claim 24.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art by Dahlberg (US 2014/0018892 A1) is pertinent to Applicant’s disclosure, as Dahlberg teaches an implantable medical device comprising a header, an electrode, and a fixation element ([0053]).
11. 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 JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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