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 .
Status of Claims
In the response dated July 1st, 2026, Applicant amended claims 1, 5-6, 10, 15-16, and 19. Claims 3-4, 13-14, and 20 are canceled. Claims 1, 2, 5-12, and 15-19 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 9th, 2025 and February 10th, 2026 is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for priority. The current application claims benefit of provisional application 63/534,786, filed on August 25th, 2023. Examiner acknowledges the applicant’s claim for priority.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding page 6, Applicant’s arguments have been considered and are persuasive. Applicant argues that the fixation mechanism does not encompass a socket. Under broadest reasonable interpretation, Examiner interprets the fixation mechanism to be a pacing electrode, as depicted in [0009] and claim 19 where “a fixation helix of the fixation mechanism” encompasses the helix of an electrode.
Regarding page 6, Applicant’s arguments have been considered and are persuasive. Applicant argued that attachment feature is not intended to mean a button. MPEP 2111 discusses the words of a claim must be given their “plain meaning” unless such meaning is inconsistent with the specification. Examiner interprets an attachment feature to comprise electrode tines and all equivalent structures. Applicant is recommended to clarify the record for any alternative interpretation.
Regarding page 7, Applicant’s arguments have been considered but are unpersuasive as they are solely directed to newly added limitations by amendment. A new ground of rejection which recites additional prior art is set forth for the amended claims.
Regarding page 8, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that Bonnor does not teach a fixation mechanism freely rotating for claims 3, 13, and 20. MPEP 2111 discusses the words of a claim must be given their “plain meaning” unless such meaning is inconsistent with the specification. Under broadest reasonable interpretation, Bonner depicts a highly adjustable electrode that turns freely during implantation into a patient. It would have been prima facie obvious to have modified Drake with the teachings of Bonner with a reasonable expectation of success by allowing Drake's helix electrode leads to freely rotate, reducing the torsional strain of the electrode leads. Bonner described that “the lead is free to rotate” which, under broadest reasonable interpretation, encompasses the dependent claim’s limitation. However, a new ground of rejection is set forth in regards to the new claim language and in view of the canceled dependent claims.
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.
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 provided below.
“fixation mechanism” in claims 1, 7-9, 10, and 17-20
“drive mechanism” in claims 1, 10, 19, and all dependent claims thereof
“release and retrieval mechanisms” in claim 9
“biostimulator transport system” in claim 10, 17, and 18
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“fixation mechanism”: pacing electrode in [0009] and any equivalents thereof
“drive mechanism”: torque drive in [0032] and any equivalents thereof
“release and retrieval mechanisms”: hook in [0059] and any equivalents thereof
“biostimulator transport system”: structure(s) described in [0049] and [0052] and any equivalents thereof
If applicant does not intend to have this/these limitation(s) 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 it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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.
Claims 1, 2, 5-12, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Drake et al. (Pat. 10159834) in view of Whittington et al. (WO2022152587). Citations are made to Drake’s publication (US20170209690), an equivalent document to Pat. 10159834, which shares a common specification.
Drake’s figures 5 and 12 below will be used, in part, for reference on the following claims.
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Regarding claim 1, Drake teaches a biostimulator, comprising: ([61] “intra-cardiac pacing device”) a housing having an electronics compartment containing pacing circuitry; ([62] “LPD (10), hermetically sealed in housing (14)”) an electrical extension having an elongated electrical conductor, ([64] “Leadlet 20 comprises a body 23” where the body is an electrical extension and the leadlet is an electrical conductor) wherein the electrical extension extends from a proximal extension end at the housing to a distal extension end ([Figure 12] leadlet (20) extends proximally from leadless pacing device (10) to distal end of t-leadlet (76)); and a pacing extension body mounted on the distal extension end of the electrical extension, ([Figure 12] distal t-leaflet (74)) wherein the pacing extension body includes: a pacing electrode electrically coupled to the pacing circuitry through the elongated electrical conductor ([65] “elongated conductor 19 of leadlet 20, which extends through… helix 21”), a fixation mechanism ([Fig. 12] helix (21)), and a drive mechanism to transmit torque to the fixation mechanism (Fig. 12] leadlet mover (60) twists helix) and a drive port [i.e., an eyelet tether] providing access for insertion of a drive tool [i.e., tether] to engage and apply a torque to the drive mechanism of the pacing body to cause the fixation mechanism to rotate relative to the pacing extension body. ([Figure 5] eyelet tether (52) allows for insertion of a tether for torquing the helix)
Regarding claim 1, Drake does not explicitly teach, as taught by Whittington, a fixation mechanism freely rotating within the pacing extension body ([Fig. 1] and [page 7, lines 20-22] “the anchoring device 1 is able to rotate freely (or can be brought into such a state) within an end portion 4a of a housing 4 rather than being in a permanent fixed rotational position with respect to the housing 4”)
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Drake to incorporate a freely rotating fixing mechanism, as taught by Whittington. This would allow the medical implant to be attached and removed “without damaging the heart (utilizing the rotational freedom of the anchoring device 1 with respect to the housing)” [page 7]. Drake and Whittington are both from the same field of invention and would have come across one another while seeking improvements that improve an implant’s retention.
Regarding claim 2, Drake teaches all of claim 1. Drake also teaches wherein the fixation mechanism comprises a fixation helix. ([90] “attach helix 21 to atrial appendage”)
Regarding claim 5, Drake teaches all of claim 2. Drake also teaches wherein the pacing electrode comprises an electrode ring disposed on the pacing extension body proximal to the fixation helix. ([Figure 12] anode ring (180) proximal to helical electrode (21))
Regarding claim 6, Drake teaches all of claim 2. Drake also teaches wherein the drive tool is integrated in the pacing extension body. ([Figure 5] eyelet tether (52) integrated into the pacing body)
Regarding claim 7, Drake teaches all of claim 1. Drake also teaches wherein the housing comprises an attachment feature disposed on an end of the housing opposite the electrical extension. ([Figure 12] tines (12) on leadless pacing device (10))
Regarding claim 8, Drake teaches all of claim 1. Drake also teaches wherein the electrical extension comprises: a first semi-flexible portion extending from the housing ([65] “flexible leadlet body 20”); and a second portion coupled to the first semi-flexible portion ([Fig. 5] short bar (76)) at an obtuse angle with respect to the first semi-flexible portion at an attachment point between the first semi-flexible portion and the second portion. ([Figure 12] Obtuse angle between helix (86) and leadlet (20))
Regarding claim 9, Drake teaches all of claim 1. Drake also teaches wherein the pacing extension body further comprises a release and retrieval mechanism. ([Fig. 12] delivery device (26); see also [69] “Leadlet retrieval generally involves reversing the steps relative to FIGS. 11-12”)
Regarding claim 10, Drake teaches a biostimulator system ([61] “intra-cardiac pacing device”) comprising: a biostimulator transport system ([Fig. 4a, 4b] delivery device (26); and a biostimulator mounted on the biostimulator transport system ([Fig. 4a, 4b] leadless pacing device (10)), wherein the biostimulator comprises: a housing having an electronics compartment containing pacing circuitry ([62] “LPD (10), hermetically sealed in housing (14)”); and an electrical extension having an elongated electrical conductor, wherein the electrical extension extends from a proximal extension end at the housing to a distal extension end ([Figure 12] leadlet (20) extends proximally from leadless pacing device (10) to distal end of t-leadlet (76)); and a pacing extension body mounted on the distal extension end of the electrical extension ([Figure 12] distal t-leaflet (74)), wherein the pacing extension body includes: a pacing electrode electrically coupled to the pacing circuitry through the elongated electrical conductor ([65] “elongated conductor 19 of leadlet 20, which extends through… helix 21”), a fixation mechanism ([Fig. 12] helix (21)) and a drive mechanism to transmit torque to the fixation mechanism. (Fig. 12] leadlet mover (60) twists helix), and a drive port [i.e., an eyelet tether] providing access for insertion of a drive tool [i.e., tether] to engage and apply a torque to the drive mechanism of the pacing body to cause the fixation mechanism to rotate relative to the pacing extension body. ([Figure 5] eyelet tether (52) allows for insertion of a tether for torquing the helix)
Regarding claim 10, Drake does not explicitly teach, as taught by Whittington, a fixation mechanism freely rotating within the pacing extension body ([Fig. 1] and [page 7, lines 20-22] “the anchoring device 1 is able to rotate freely (or can be brought into such a state) within an end portion 4a of a housing 4 rather than being in a permanent fixed rotational position with respect to the housing 4”)
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Drake to incorporate a freely rotating fixing mechanism, as taught by Whittington. This would allow the medical implant to be attached and removed “without damaging the heart (utilizing the rotational freedom of the anchoring device 1 with respect to the housing)” [page 7]. Drake and Whittington are both from the same field of invention and would have come across one another while seeking improvements that improve an implant’s retention.
Regarding claim 11, Drake teaches all of claim 10. Drake also teaches wherein the biostimulator transport system comprises a catheter ([Fig. 4A] outer member tube (34) of the delivery device (26)), wherein the electrical extension is configured to transition from a delivery state when the elongated extension component is stored in the catheter to a deployed state when the elongated extension component is exposed from the catheter ([Fig. 4a] contains the t- leaflet in the compact device; [71] “the compact device is deployed out through a distal opening 36 of a delivery device 26)”), and wherein an angle between the electrical extension and the pacing extension body is greater in the deployed state than in the delivery state. ([Fig. 4a] where the angle between the electrical extension and the pacing extension body are at an acute angle in the delivery state)
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Regarding claim 12, Drake teaches all of claim 10. Drake also teaches wherein the fixation mechanism comprises a fixation helix. ([90] “attach helix 21 to atrial appendage”)
Regarding claim 15, Drake teaches all of the claims of claim 12. Drake also teaches wherein the pacing electrode comprises an electrode ring disposed on the pacing extension body proximal to the fixation helix. ([Figure 12] anode ring (180) proximal to helical electrode (21))
Regarding claim 16, Drake teaches all of claim 12. Drake also teaches wherein the drive tool is integrated in the pacing extension body. ([Figure 5] eyelet tether (52) integrated into the pacing body)
Regarding claim 17, Drake teaches all of claim 12. Drake also teaches wherein the housing comprises an attachment feature disposed on an end of the housing opposite the electrical extension. ([Figure 12] tines (12) on leadless pacing device (10))
Regarding claim 18, Drake teaches all of claim 10. Drake also teaches wherein the extension component comprises: a first semi-flexible portion extending from the housing ([65] “flexible leadlet body 20”); and a second portion coupled to the first semi-flexible portion ([Fig. 5] short bar (76)) at an obtuse angle with respect to the first semi-flexible portion at an attachment point between the first semi-flexible portion and the second portion. ([Figure 12] Obtuse angle between helix (86) and leadlet (20))
Regarding claim 19, Drake teaches a method of deploying a biostimulator comprising: ([55] “method for deploying a compact dual chamber intra-cardiac pacing device”) affixing a housing of the biostimulator at or near a ventricular apex ([61] “intra-cardiac pacing device 8 comprises a first implanted portion 88 in a right ventricle (RV) of a heart, in proximity to an apex”); positioning a pacing extension body ([55] “delivery device is then positioned in close proximity to ventricular tissue”) comprising a pacing electrode and a fixation mechanism [i.e., helix], coupled to the housing of the biostimulator by an electrical extension, ([Fig. 4a, 4b] and [65] “elongated conductor 19 of leadlet 20, which extends through… helix 21”) at an interventricular septum ([101] “leadlet 20 can be placed in various locations in the heart such as the LV, RV, or LA” where the left ventricle (LV) and right ventricle (RV) comprises the interventricular septum); inserting a drive tool [i.e., a tether] through a drive port ([i.e., an eyelet tether) of the pacing extension body to engage a drive mechanism; ([Figure 5] eyelet tether (52) allows for insertion of a tether for torquing the helix; see also [0085] “A loop can be formed from tether 50, as is shown in FIG. 7 in order to attach to eyelet 52 to pull leadlet 20. The tether 50, shown in FIG. 4, extends through a lumen or opening between the forks”) and applying, via the drive tool, a torque to the drive mechanism to a fixation helix of the fixation mechanism disposed at a distal end of pacing extension body ([Fig. 12] leadlet mover (60) twists helix (21) to cardiac tissue at the distal end of the t-leadlet (76)) to rotate relative to the pacing extension body and to affix the pacing electrode of the pacing extension body within the interventricular septum ([101] “leadlet 20 can be placed in various locations in the heart such as the LV, RV, or LA” where the left ventricle (LV) and right ventricle (RV) comprises the interventricular septum).
Regarding claim 19, Drake does not explicitly teach, as taught by Whittington, a fixation mechanism freely rotating within the pacing extension body ([Fig. 1] and [page 7, lines 20-22] “the anchoring device 1 is able to rotate freely (or can be brought into such a state) within an end portion 4a of a housing 4 rather than being in a permanent fixed rotational position with respect to the housing 4”)
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Drake to incorporate a freely rotating fixing mechanism, as taught by Whittington. This would allow the medical implant to be attached and removed “without damaging the heart (utilizing the rotational freedom of the anchoring device 1 with respect to the housing)” [page 7]. Drake and Whittington are both from the same field of invention and would have come across one another while seeking improvements that improve an implant’s retention.
Conclusion
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
THIS ACTION IS MADE FINAL. 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.
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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