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 .
The amendment filed on April 7, 2026 has been received and considered. By this amendment, claims 1-20 are amended and now pending in the application.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vandenburg (U.S. 2020/0171315, previously cited). Regarding claim 1, Vandenburg discloses an active medical device (AMD) assembly 100/200a/200b/300/400/500/ 600/700/800 (see Figures 2A, 3A, 4A, 5A, 6A, 7B, 8B, and 9A-D), comprising: a) an active medical device (AMD), 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, wherein at least one of the terminal blocks is connected to the control circuitry (see Figures 2G-H, with similar configurations shown in less detail in other illustrated embodiments); and 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); and b) a unitary auxiliary strain relief device 102/104/202a/202b/204a/204b/302/ 304/ 402/404/502/504/602/604/702/704/802/804 (each of these elements is a unitary element) comprising: i) a manifold portion having a proximal manifold wall spaced from a distal manifold 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 is configured to detachably mate with the strain relief member of the AMD and comprises a tapered opening portion that begins at the proximal manifold wall and extends downwardly towards and distally along the opening axis to meet an enlarged inner annular recess having a first diameter perpendicular the opening axis that is greater than a second diameter of the tapered opening portion immediately adjacent to the enlarged inner 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 distal wall of 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).
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Regarding claim 2, Vandenburg discloses that the enlarged inner annular recess 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 a unitary auxiliary strain relief device 102/ 104/202a/202b/204a/204b/302/304/ 402/404/502/504/602/604/702/704/802/804 (each of these elements is a unitary element) comprising: a) a manifold portion having a proximal manifold wall spaced from a distal manifold wall and at least one manifold opening that extends along an opening axis to the proximal and distal manifold walls, wherein a tapered opening portion of the at least one manifold opening begins at the proximal manifold wall and extends downwardly towards and distally along the opening axis to meet an enlarged inner annular recess having a first diameter perpendicular to the opening axis that is greater than a second diameter of the tapered opening portion immediately adjacent to the enlarged inner 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 distal wall of 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 enlarged inner annular recess 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]).
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.
Claims 19 and 20 are allowed.
Response to Arguments
Applicant's arguments filed April 7, 2026 have been fully considered but they are not persuasive. Regarding the rejection of the claims as being anticipated by Vandenburg, the Applicant argues that Vandenburg fails to disclose the newly-amended limitation to a unitary auxiliary strain relief device because the auxiliary strain relief device of Vandenburg includes an upper 102 and lower portion 104. It is respectfully submitted that lower strain relief 104 is considered a unitary auxiliary strain relief device and upper strain relief 102 would be considered a unitary auxiliary strain relief device. Each of these elements is unitary in design, and connects to an interacts with other elements within the invention of Vandenburg. It is respectfully submitted that this configuration remains within the scope of the invention as claimed and, as such, Vandenburg is considered to satisfy the claim limitations as currently respected and rejected above.
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 TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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