Prosecution Insights
Last updated: April 19, 2026
Application No. 18/382,716

Auxiliary Strain Relief Member For The Lead Of An Active Implantable Medical Device

Non-Final OA §102
Filed
Oct 23, 2023
Examiner
MARLEN, TAMMIE K
Art Unit
3796
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Greatbatch Ltd.
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
3y 11m
To Grant
96%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
601 granted / 801 resolved
+5.0% vs TC avg
Strong +21% interview lift
Without
With
+21.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
52 currently pending
Career history
853
Total Applications
across all art units

Statute-Specific Performance

§101
5.3%
-34.7% vs TC avg
§103
26.9%
-13.1% vs TC avg
§102
33.7%
-6.3% vs TC avg
§112
28.0%
-12.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 801 resolved cases

Office Action

§102
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. Drawings The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification. 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, 9-14, and 18-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Vandenburg et al. (U.S. 2020/0171315), herein Vandenburg . Regarding claim 1, Vandenburg discloses a n active implantable medical device (AIMD) assembly 100/200a/200b/300/400/500/ 600/700/800 (see Figures 2A, 3A, 4A, 5A, 6A, 7B, 8B, and 9A-D) , the AIMD assembly comprising: a) a medical device, comprising: i ) a device housing containing an electrical power source connected to control circuitry (“ the neurostimulator includes a component, also referred to herein as a can, box or housing, that is placed in the ferrule that is situated in the craniectomy hole formed in the cranium. The can includes electronic components, such as a battery and a pulse generator ”, paragraph [0006]) ; ii) a header assembly 106/206a/206b/306/406/508/608/ 708/808 connected to the device housing, wherein the header assembly comprises a header supporting a plurality of co-axially aligned terminal blocks (each of the tubular inserts 138 are considered co-axially aligned terminal blocks) that are in open communication with a header opening leading into the header (see Figures 2G-H , with similar configurations shown in less detail in other illustrated embodiments ) ; iii) a strain relief member connected to the header at the header opening, wherein the strain relief member has a strain relief opening that is in open communication with the header opening and the plurality of aligned terminal blocks (see annotated Figure 5C below to show the strain relief member , with the same element shown in the drawings for each of the other embodiments ) ; b) an auxiliary strain relief device 102/104/ 202a/202b/204a/204b/302/304/ 402/404/502/504 /602/604/702/704/802/804 comprising: i ) a manifold portion having a proximal wall spaced from a distal wall and at least one manifold opening that extends along an opening axis to the proximal and distal manifold walls, wherein the at least one manifold opening that is configured to detachably mate with the strain relief member of the medical device and comprises a tapered opening portion that begins at the proximal wall and extends downwardly towards and distally along the opening axis to an enlarged inner annular recess having a first diameter about the opening axis that is greater than a second diameter of the tapered portion immediately adjacent to the annular recess (“ The channels 326 include a reduced width section or overhanging features 332 that retain the leads in place. ”, paragraph [0108]) ; and ii) a platform portion that extends distally from the manifold portion, wherein the platform portion is provided with at least one open channel aligned with the at least one manifold opening (see annotated Figure 5D below, with similar elements shown in the drawings for each of the other embodiments) . Regarding claim 2, Vandenburg discloses that the tapered opening portion of the at least one manifold opening is in open communication with a cylindrically-shaped open portion of the manifold opening that leads to the distal wall of the manifold portion (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions) . Regarding claim 3, Vandenburg discloses that the platform portion has a planar floor (see Figure 5E showing the planar floor, which would also be present in the other embodiments in similar configurations) that is provided with the at least one open channel aligned with the at least one manifold opening (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions) . Regarding claim 4, Vandenburg discloses that the at least one open channel extends to a distal end of the planar floor at a distal end of the platform portion (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions) . Regarding claim 5, Vandenburg discloses that the at least one open channel extends along the planar floor to an upstanding wall at a distal end of the platform portion, and wherein the upstanding wall is provided with at least one open groove that is aligned with the at least one open channel (see Figure 5E, which shows the upstanding wall at the distal end with grooves 326) . Regarding claim 9, Vandenburg discloses that the auxiliary strain relief device comprises a compliant implantable silicone (“ The lower strain relief 304 may be made of silicone. ”, paragraph [0108]) . Regarding claim 10, Vandenburg discloses an auxiliary strain relief device 102/104/ 202a/202b/204a/204b/302/304/ 402/404/502/504/602/604/702/704/802/804 comprising: a ) a manifold portion having a proximal wall spaced from a distal wall and at least one manifold opening that extends along an opening axis to the proximal and distal manifold walls, wherein the at least one manifold opening comprises a tapered opening portion that begins at the proximal wall and extends downwardly towards and distally along the opening axis to an enlarged inner annular recess having a first diameter about the opening axis that is greater than a second diameter of the tapered portion immediately adjacent to the annular recess (“ The channels 326 include a reduced width section or overhanging features 332 that retain the leads in place. ”, paragraph [0108]); and b) a platform portion that extends distally from the manifold portion, wherein the platform portion is provided with at least one open channel aligned with the at least one manifold opening (see annotated Figure 5D above, with similar elements shown in the drawings for each of the other embodiments) . Regarding claim 11, Vandenburg discloses that the tapered opening portion of the at least one manifold opening is in open communication with a cylindrically-shaped open portion of the manifold opening that leads to the distal wall of the manifold portion (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions). Regarding claim 12, Vandenburg discloses that the platform portion has a planar floor (see Figure 5E showing the planar floor, which would also be present in the other embodiments in similar configurations) that is provided with the at least one open channel aligned with the at least one manifold opening (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions). Regarding claim 13, Vandenburg discloses that the at least one open channel extends to a distal end of the planar floor at a distal end of the platform portion (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions). Regarding claim 14, Vandenburg discloses that the at least one open channel extends along the planar floor to an upstanding wall at a distal end of the platform portion, and wherein the upstanding wall is provided with at least one open groove that is aligned with the at least one open channel (see Figure 5E, which shows the upstanding wall at the distal end with grooves 326). Regarding claim 18, Vandenburg discloses that the auxiliary strain relief device comprises a compliant implantable silicone (“ The lower strain relief 304 may be made of silicone. ”, paragraph [0108]). Regarding claim 19, Vandenburg discloses an auxiliary strain relief device 102/104/ 202a/202b/204a/204b/302/304/402/404/502/504/602/604/702/704/802/804 comprising: a manifold portion having a proximal wall spaced from a distal wall and at least one manifold opening that extends along an opening axis to the proximal and distal manifold walls, wherein the at least one manifold opening comprises a tapered opening portion that begins at the proximal wall and extends downwardly towards and distally along the opening axis to an enlarged inner annular recess having a first diameter about the opening axis that is greater than a second diameter of the tapered portion immediately adjacent to the annular recess (“ The channels 326 include a reduced width section or overhanging features 332 that retain the leads in place. ”, paragraph [0108]) . Regarding claim 20, Vandenburg discloses that the tapered opening portion of the at least one manifold opening is in open communication with a cylindrically-shaped open portion of the manifold opening that leads to the distal wall of the manifold portion (as can be seen in the annotated figures above, and other figures within Vandenburg, the channels are continuous between the manifold and platform portions) . Allowable Subject Matter Claims 6-8 and 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TAMMIE K MARLEN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1986 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday through Friday from 8 am until 4 pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Carl Layno can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-4949 . 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. /TAMMIE K MARLEN/ Primary Examiner, Art Unit 3796
Read full office action

Prosecution Timeline

Oct 23, 2023
Application Filed
Mar 16, 2026
Non-Final Rejection — §102
Apr 07, 2026
Response Filed

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
75%
Grant Probability
96%
With Interview (+21.3%)
3y 11m
Median Time to Grant
Low
PTA Risk
Based on 801 resolved cases by this examiner. Grant probability derived from career allow rate.

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