Prosecution Insights
Last updated: October 01, 2026
Application No. 18/669,332

LEADLESS PACEMAKER HAVING ATTACHMENT FEATURE

Non-Final OA §103§112
Filed
May 20, 2024
Priority
Mar 09, 2018 — provisional 62/641,129 +4 more
Examiner
POLAND, CHERIE MICHELLE
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Pacesetter Inc.
OA Round
3 (Non-Final)
60%
Grant Probability
Moderate
3-4
OA Rounds
1y 2m
Est. Remaining
93%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
358 granted / 602 resolved
-10.5% vs TC avg
Strong +33% interview lift
Without
With
+33.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
35 currently pending
Career history
641
Total Applications
across all art units

Statute-Specific Performance

§101
5.2%
-34.8% vs TC avg
§103
34.0%
-6.0% vs TC avg
§102
21.2%
-18.8% vs TC avg
§112
27.2%
-12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 602 resolved cases

Office Action

§103 §112
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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 June 2026 has been entered. Formal Matters Claims 4, 5, 12, 13, 18, and 19 are cancelled. Claims 1, 6, 9, 14, 15, and 20 are currently amended. Claims 1-3, 6-11, 14-17, and 20 are pending and under examination. Objections/Rejections Withdrawn The rejection of claims 4, 12, and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly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matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), is withdrawn in light of the cancellation of claims 4, 12, and 18. The rejection over claims 1-20 under 35 U.S.C. 103 as being unpatentable over Schmidt et al., US 20180001082 (4 January 2018) (previously cited of record) in view of Eidenschink et al., US 20160096001 (7 April 2016) (previously cited of record), and further in view of Khairkhahan et al., US 20120095539 (19 April 2012), is withdrawn in light of Applicant’s amendments and the cancellation of claims 5, 13, and 19. Response to Arguments Regarding the rejection under 35 USC 103 over Schmidt et al., US 20180001082 (4 January 2018) in view of Eidenschink et al., US 20160096001 (7 April 2016) and Khairkhahan et al., US 20120095539 (19 April 2012), Applicant argues that amendments to independent claims 1, 9, and 15 wherein “the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the implantable medical device and on the docking cap” is not taught by Schmidt. Applicant argues that the citations previously cited against now cancelled claim 5 over Schmidt did not show the docking member and covering as part of the retrieval catheter in FIG 2 of Schmidt. Applicant argues that the Office Action has not shown that the atraumatic sheath of Eidenschink applies an inwardly compressive force on a docking cap of a retrieval catheter, in addition to the leadless pacemaker, as amended in the claims. Applicant argues that the Office Action has not shown that Khairkhahan discloses “the flexible sheath includes an expandable mesh sized to apply an inwardly compressive force on the implantable medical device and on the docking cap” as in the amended claims. Applicant’s arguments have been fully considered and are persuasive. However, further search and consideration identified additional references in light of Applicant’s amendments. 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. Claims 1-3, 6-11, 14-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al., WO 2012082755 (21 June 2012) (hereinafter Khairkhahan ‘755) in view of Eidenschink (US 20160096001) (7 April 2016) (previously cited of record). Regarding currently amended independent claim 1, Khairkhahan ‘755 teaches a biostimulator transport system (**Embodiment covering FIGs 1-3B, ¶¶42, 44, 49, 52) comprising: a retrieval catheter (FIGs 1-3B; retrieval catheter 106/206/306) including a docking cap (FIGs 1-3B, 104/204/304) shaped to receive an implantable medical device (FIGs 1-3B, 102/202/302); a snare (FIGs 2A-C, snare 203) extending through the retrieval catheter (FIGs 1-3B, retrieval catheter 106/206/306) to capture the implantable medical device (FIGs 1-3B, implantable device 102/202/302); and a flexible sheath (sheath 107/207/304) extendable along the retrieval catheter (“sheath 107 can be advanced longitudinally over catheter shaft 106 and guide catheter shaft 111 to cover the pacemaker during retrieval and prevent the pacemaker from catching onto or damaging tissue”; ¶44), wherein the flexible sheath (sheath 107/207/307; ¶44, ¶52) covers the implantable medical device and the docking cap (FIG 3A, “FIG 3A illustrates protective sheath positioned slightly proximally to the docking cap 304 along the catheter shaft of the retrieval system”, ¶49; FIG 3B, “the protective sheath can be advanced over the pacemaker, and the pacemaker can then be removed from the patient”, ¶52). **Khairkhahan ‘755 show four continuous actions over a series of four figures (FIGs 1, 2, 3A, and 3B) with related, but subsequent element numbers “illustrating one embodiment of a method of retrieving a medical device or leadless cardiac pacemaker from a patient” (¶52). This is expressly explained in Khairkhahan ‘755 at ¶52. Khairkhahan ‘755 does not expressly teach that the expandable sheath comprises mesh or that the sheath applies an inwardly compressive force. Eidenschink teaches atraumatic pacemaker sheath 104 that may have a braided or woven construction or mesh rolled or folded back on itself (¶¶12, 18) that is sufficiently flexible to allow atraumatic pacemaker sheath 104 to encompass leadless pacemaker 103 (¶51). Eidenschink teaches that sheath 104 “self-biases into a reduced diameter” (¶51). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Khairkhahan ‘755 and Eidenschink, given that the prior art included each element claimed, although not necessarily in a single reference. Khairkhahan ‘755 and Eidenschink teach in the same field of endeavor, catheters for implantable medical devices. Although, Khairkhahan ‘755 discloses the claimed biostimulator transport catheter system (retrieval catheter including a docking cap, a snare, and a sheath), Khairkhahan ‘755 does not expressly teach that the expandable sheath comprises mesh or that the sheath applies an inwardly compressive force. Eidenschink specifically addresses the self-biasing flexibility of an implant catheter sheath that has braided or woven (broadly interpreted as mesh) construction that is expressly taught as being sufficiently flexible to expand to encompass a leadless pacemaker and that is self-biasing into a reduced diameter. This self-biasing to a reduced diameter is broadly interpreted as providing an inwardly compressive force. Because Khairkhahan ‘755 includes a retrieval catheter comprising a sheath that extends over the snare, over the docking cap, and over the pacemaker (implantable device), a person of ordinary skill in the art, seeing to control the self-biasing or reduced diameter of the sheath over the device being retrieved would look for established sheath designs to avoid creating a novel interface and would reasonably consult Eidenschink’s self-biasing, reduced diameter solution in the same field of implantation/retrieval catheters. This is also motivated by the teachings of Khairkhahan ‘755 which emphasize that “the capture sheath and pacemaker can be withdrawn together from an introducer/trocar inserted in the patient. The capture sheath allows the pacemaker to cross a hemostatic seal provided by the introducer without damaging itself or the seal of the introducer” ¶53. A person of ordinary skill in the art, seeking to control the snugness of the sheath in Khairkhahan ‘755’s architecture to reduce the retrieval “footprint” through the hemostatic seal as much as possible would reasonably consult Eidenschink’s flexible, self-biasing mesh sheath solution. Eidenschink’s flexible, self-biasing mesh sheath solution can be incorporated alongside Khairkhahan‘755’s retrieval catheter system and sheath extending over the retrieval catheter, docking cap, and pacemaker, (same general location and interaction with the implantable device being retrieved) using known assembly methods without redesigning Khairkhahan ‘755’s core device. Because the references address the same engineering problem (sheaths that surround implantable devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting sheaths to provide an improvement on an existing retrieval catheter sheath), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 2, Khairkhahan ‘755 modified by Eidenschink teach the biostimulator transport system of claim 1, as set forth above, for the reasons set forth above. Eidenschink teaches wherein the expandable mesh includes a double-walled construction (¶¶12, 18). Regarding claim 3, Khairkhahan ‘755 modified by Eidenschink teach the biostimulator transport system of claim 1, as set forth above, for the reasons set forth above. Eidenschink teaches wherein a distal end of the expandable mesh is rounded (¶9 atraumatic; FIG 3K atraumatic end distal region 304). Atraumatic is broadly interpreted as being rounded, consistent with the definition in the Specification at ¶306. Regarding currently amended claim 6, Khairkhahan ‘755 modified by Eidenschink teaches the biostimulator transport system of claim 1, as set forth above, for the reasons set forth above. Neither Khairkhahan ‘755 nor Eidenschink expressly teach that the docking cap includes a sharp distal edge. Eidenschink teaches that helix 203 has sharp edges (¶53) and expressly teaches that “atraumatic pacemaker sheath 204 is used to cover the catheter shaft 206, pacemaker 202, and helix 203 to protect patient tissue from the sharp edges of helix 203” (¶53). Eidenschink specifically addresses the need to protect patient tissue from sharp edges (¶53). This patient protection requirement is fundamental for all medical devices, not just docking caps. Because Eidenschink expressly provides an example of a sharp edged portion of a device used in vivo and the need to protect patients from sharp-edged injuries is universal, a person of ordinary skill in the art seeking to reduce patient injury from sharp edges on devices used in vivo would reasonably look to Eidenschink’s atraumatic sheath solution to protect against sharp edges on any device surfaces. Eidenschink’s atraumatic flexible sheath solution is modular and can be adapted to the device of Khairkhahan to enable patient protection against sharp-edged device components without undue experimentation. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings given the success of the atraumatic sheath being protective against the sharp edges of Eidenschink’s helix 203. Regarding claim 7, Schmidt modified by Eidenschink and Khairkhahan, teaches the biostimulator transport system of claim 1, as set forth above, for the reasons set forth above. Eidenschink teaches the system further comprising a rigid sheath (FIGs 2C-D, ¶53, guide catheter sheath 211) extendable along the flexible sheath (atraumatic pacemaker sheath 204) to press the flexible sheath against the implantable medical device (¶¶52, 53). Regarding claim 8, Khairkhahan ‘755 modified by Eidenschink teach the biostimulator transport system of claim 1, as set forth above, for the reasons set forth above. Eidenschink teaches the system further comprising a protective sheath disposable about the rigid sheath and the flexible sheath (FIGs 2C-D; ¶53, guide catheter sheath 211 is extended distally to cause atraumatic pacemaker sheath 204 to cover catheter shaft 206). Regarding currently amended independent claim 9, Khairkhahan ‘755 teaches a retrieval system (**Embodiment covering FIGs 1-3B, ¶¶42, 44, 49, 52) comprising: a retrieval catheter (FIGs 1-3B; retrieval catheter 106/206/306) including a docking cap (FIGs 1-3B, 104/204/304) shaped to receive an implantable medical device (FIGs 1-3B, 102/202/302); a snare (FIGs 2A-C, snare 203) extending through the retrieval catheter (FIGs 1-3B, retrieval catheter 106/206/306) to capture the implantable medical device (FIGs 1-3B, implantable device 102/202/302); and a flexible sheath (sheath 107/207/304) extendable along the retrieval catheter (“sheath 107 can be advanced longitudinally over catheter shaft 106 and guide catheter shaft 111 to cover the pacemaker during retrieval and prevent the pacemaker from catching onto or damaging tissue”; ¶44), wherein the flexible sheath (sheath 107/207/307; ¶44, ¶52) covers the implantable medical device and the docking cap (FIG 3A, “FIG 3A illustrates protective sheath positioned slightly proximally to the docking cap 304 along the catheter shaft of the retrieval system”, ¶49; FIG 3B, “the protective sheath can be advanced over the pacemaker, and the pacemaker can then be removed from the patient”, ¶52). **Khairkhahan ‘755 show four continuous actions over a series of four figures (FIGs 1, 2, 3A, and 3B) with related, but subsequent element numbers “illustrating one embodiment of a method of retrieving a medical device or leadless cardiac pacemaker from a patient” (¶52). This is expressly explained in Khairkhahan ‘755 at ¶52. Khairkhahan ‘755 does not expressly teach that the expandable sheath comprises mesh or that the sheath applies an inwardly compressive force. Eidenschink teaches atraumatic pacemaker sheath 104 that may have a braided or woven construction or mesh rolled or folded back on itself (¶¶12, 18) that is sufficiently flexible to allow atraumatic pacemaker sheath 104 to encompass leadless pacemaker 103 (¶51). Eidenschink teaches that sheath 104 “self-biases into a reduced diameter” (¶51). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Khairkhahan ‘755 and Eidenschink, given that the prior art included each element claimed, although not necessarily in a single reference. Khairkhahan ‘755 and Eidenschink teach in the same field of endeavor, catheters for implantable medical devices. Although, Khairkhahan ‘755 discloses the claimed retrieval catheter system (retrieval catheter including a docking cap, a snare, and a sheath), Khairkhahan ‘755 does not expressly teach that the expandable sheath comprises mesh or that the sheath applies an inwardly compressive force. Eidenschink specifically addresses the self-biasing flexibility of an implant catheter sheath that has braided or woven (broadly interpreted as mesh) construction that is expressly taught as being sufficiently flexible to expand to encompass a leadless pacemaker and that is self-biasing into a reduced diameter. This self-biasing to a reduced diameter is broadly interpreted as providing an inwardly compressive force. Because Khairkhahan ‘755 includes a retrieval catheter comprising a sheath that extends over the snare, over the docking cap, and over the pacemaker (implantable device), a person of ordinary skill in the art, seeing to control the self-biasing or reduced diameter of the sheath over the device being retrieved would look for established sheath designs to avoid creating a novel interface and would reasonably consult Eidenschink’s self-biasing, reduced diameter solution in the same field of implantation/retrieval catheters. This is also motivated by the teachings of Khairkhahan ‘755 which emphasize that “the capture sheath and pacemaker can be withdrawn together from an introducer/trocar inserted in the patient. The capture sheath allows the pacemaker to cross a hemostatic seal provided by the introducer without damaging itself or the seal of the introducer” ¶53. A person of ordinary skill in the art, seeking to control the snugness of the sheath in Khairkhahan ‘755’s architecture to reduce the retrieval “footprint” through the hemostatic seal as much as possible would reasonably consult Eidenschink’s flexible, self-biasing mesh sheath solution. Eidenschink’s flexible, self-biasing mesh sheath solution can be incorporated alongside Khairkhahan‘755’s retrieval catheter system and sheath extending over the retrieval catheter, docking cap, and pacemaker, (same general location and interaction with the implantable device being retrieved) using known assembly methods without redesigning Khairkhahan ‘755’s core device. Because the references address the same engineering problem (sheaths that surround implantable devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting sheaths to provide an improvement on an existing retrieval catheter sheath), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 10, Khairkhahan ‘755 modified by Eidenschink, teaches the retrieval system of claim 9, as set forth above, for the reasons set forth above. Eidenschink teaches wherein the expandable mesh includes a double-walled construction (¶¶12, 18). Regarding claim 11, Khairkhahan ‘755 modified by Eidenschink, teaches the retrieval system of claim 9, as set forth above, for the reasons set forth above. Eidenschink teaches wherein a distal end of the expandable mesh is rounded (¶9 atraumatic; FIG 3K atraumatic end distal region 304). Atraumatic is broadly interpreted as being rounded, consistent with the definition in the instant Specification at ¶306. Regarding currently amended claim 14, Khairkhahan ‘755 modified by Eidenschink teaches the retrieval system of claim 9, as set forth above, for the reasons set forth above. Neither Khairkhahan ‘755 nor Eidenschink expressly teach that the docking cap includes a sharp distal edge. Eidenschink teaches that helix 203 has sharp edges (¶53) and expressly teaches that “atraumatic pacemaker sheath 204 is used to cover the catheter shaft 206, pacemaker 202, and helix 203 to protect patient tissue from the sharp edges of helix 203” (¶53). Eidenschink specifically addresses the need to protect patient tissue from sharp edges (¶53). This patient protection requirement is fundamental for all medical devices, not just docking caps. Because Eidenschink expressly provides an example of a sharp edged portion of a device used in vivo and the need to protect patients from sharp-edged injuries is universal, a person of ordinary skill in the art seeking to reduce patient injury from sharp edges on devices used in vivo would reasonably look to Eidenschink’s atraumatic sheath solution to protect against sharp edges on any device surfaces. Eidenschink’s atraumatic flexible sheath solution is modular and can be adapted to the device of Khairkhahan to enable patient protection against sharp-edged device components without undue experimentation. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings given the success of the atraumatic sheath being protective against the sharp edges of Eidenschink’s helix 203. Regarding currently amended independent claim 15, Khairkhahan ‘755 teaches a delivery system (**Embodiment covering FIGs 1-3B, ¶¶42, 44, 49, 52) comprising: a retrieval catheter (FIGs 1-3B; retrieval catheter 106/206/306) including a docking cap (FIGs 1-3B, 104/204/304) shaped to receive an implantable medical device (FIGs 1-3B, 102/202/302); a snare (FIGs 2A-C, snare 203) extending through the retrieval catheter (FIGs 1-3B, retrieval catheter 106/206/306) to capture the implantable medical device (FIGs 1-3B, implantable device 102/202/302); and a flexible sheath (sheath 107/207/304) extendable along the retrieval catheter (“sheath 107 can be advanced longitudinally over catheter shaft 106 and guide catheter shaft 111 to cover the pacemaker during retrieval and prevent the pacemaker from catching onto or damaging tissue”; ¶44), wherein the flexible sheath (sheath 107/207/307; ¶44, ¶52) covers the implantable medical device and the docking cap (FIG 3A, “FIG 3A illustrates protective sheath positioned slightly proximally to the docking cap 304 along the catheter shaft of the retrieval system”, ¶49; FIG 3B, “the protective sheath can be advanced over the pacemaker, and the pacemaker can then be removed from the patient”, ¶52). **Khairkhahan ‘755 show four continuous actions over a series of four figures (FIGs 1, 2, 3A, and 3B) with related, but subsequent element numbers “illustrating one embodiment of a method of retrieving a medical device or leadless cardiac pacemaker from a patient” (¶52). This is expressly explained in Khairkhahan ‘755 at ¶52. Khairkhahan ‘755 does not expressly teach that the expandable sheath comprises mesh or that the sheath applies an inwardly compressive force. Eidenschink teaches atraumatic pacemaker sheath 104 that may have a braided or woven construction or mesh rolled or folded back on itself (¶¶12, 18) that is sufficiently flexible to allow atraumatic pacemaker sheath 104 to encompass leadless pacemaker 103 (¶51). Eidenschink teaches that sheath 104 “self-biases into a reduced diameter” (¶51). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Khairkhahan ‘755 and Eidenschink, given that the prior art included each element claimed, although not necessarily in a single reference. Khairkhahan ‘755 and Eidenschink teach in the same field of endeavor, catheters for implantable medical devices. Although, Khairkhahan ‘755 discloses the claimed retrieval catheter system (retrieval catheter including a docking cap, a snare, and a sheath), Khairkhahan ‘755 does not expressly teach that the expandable sheath comprises mesh or that the sheath applies an inwardly compressive force. Eidenschink specifically addresses the self-biasing flexibility of an implant catheter sheath that has braided or woven (broadly interpreted as mesh) construction that is expressly taught as being sufficiently flexible to expand to encompass a leadless pacemaker and that is self-biasing into a reduced diameter. This self-biasing to a reduced diameter is broadly interpreted as providing an inwardly compressive force. Because Khairkhahan ‘755 includes a retrieval catheter comprising a sheath that extends over the snare, over the docking cap, and over the pacemaker (implantable device), a person of ordinary skill in the art, seeing to control the self-biasing or reduced diameter of the sheath over the device being retrieved would look for established sheath designs to avoid creating a novel interface and would reasonably consult Eidenschink’s self-biasing, reduced diameter solution in the same field of implantation/retrieval catheters. This is also motivated by the teachings of Khairkhahan ‘755 which emphasize that “the capture sheath and pacemaker can be withdrawn together from an introducer/trocar inserted in the patient. The capture sheath allows the pacemaker to cross a hemostatic seal provided by the introducer without damaging itself or the seal of the introducer” ¶53. A person of ordinary skill in the art, seeking to control the snugness of the sheath in Khairkhahan ‘755’s architecture to reduce the retrieval “footprint” through the hemostatic seal as much as possible would reasonably consult Eidenschink’s flexible, self-biasing mesh sheath solution. Eidenschink’s flexible, self-biasing mesh sheath solution can be incorporated alongside Khairkhahan‘755’s retrieval catheter system and sheath extending over the retrieval catheter, docking cap, and pacemaker, (same general location and interaction with the implantable device being retrieved) using known assembly methods without redesigning Khairkhahan ‘755’s core device. Because the references address the same engineering problem (sheaths that surround implantable devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting sheaths to provide an improvement on an existing retrieval catheter sheath), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 16, Khairkhahan ‘755 modified by Eidenschink teaches the delivery system of claim 15, as set forth above, for the reasons set forth above. Eidenschink teaches wherein the expandable mesh includes a double-walled construction (¶¶12, 18). Regarding claim 17, Khairkhahan ‘755 modified by Eidenschink, teaches the delivery system of claim 15, as set forth above, for the reasons set forth above. Eidenschink teaches wherein a distal end of the expandable mesh is rounded (¶9 atraumatic; FIG 3K atraumatic end distal region 304). Atraumatic is broadly interpreted as being rounded, consistent with the definition in the Specification at ¶306. Regarding currently amended claim 20, Khairkhahan ‘755 modified by Eidenschink, teaches the delivery system of claim 15, as set forth above, for the reasons set forth above. Neither Khairkhahan ‘755 nor Eidenschink expressly teach that the docking cap includes a sharp distal edge. Eidenschink teaches that helix 203 has sharp edges (¶53) and expressly teaches that “atraumatic pacemaker sheath 204 is used to cover the catheter shaft 206, pacemaker 202, and helix 203 to protect patient tissue from the sharp edges of helix 203” (¶53). Eidenschink specifically addresses the need to protect patient tissue from sharp edges (¶53). This patient protection requirement is fundamental for all medical devices, not just docking caps. Because Eidenschink expressly provides an example of a sharp edged portion of a device used in vivo and the need to protect patients from sharp-edged injuries is universal, a person of ordinary skill in the art seeking to reduce patient injury from sharp edges on devices used in vivo would reasonably look to Eidenschink’s atraumatic sheath solution to protect against sharp edges on any device surfaces. Eidenschink’s atraumatic flexible sheath solution is modular and can be adapted to the device of Khairkhahan to enable patient protection against sharp-edged device components without undue experimentation. A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings given the success of the atraumatic sheath being protective against the sharp edges of Eidenschink’s helix 203. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHERIE M POLAND/Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

May 20, 2024
Application Filed
Sep 24, 2025
Non-Final Rejection mailed — §103, §112
Dec 19, 2025
Response Filed
Apr 01, 2026
Final Rejection mailed — §103, §112
May 21, 2026
Response after Non-Final Action
Jun 30, 2026
Request for Continued Examination
Jul 10, 2026
Response after Non-Final Action
Jul 15, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
60%
Grant Probability
93%
With Interview (+33.3%)
3y 7m (~1y 2m remaining)
Median Time to Grant
High
PTA Risk
Based on 602 resolved cases by this examiner. Grant probability derived from career allowance rate.

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