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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 24, 2025 has been entered.
It is noted that the applicant indicates that claims 29-39 are pending, while simultaneously stating that no claims have been cancelled (see page 5 of the Remarks dated October 24, 2025). Prior to submission under 37 CFR 1.114, however, claims 29-46 and 48 were pending. No formal amendment has been submitted canceling claims 40-46 and 48. Lacking any formal amendment, the examiner will consider claims 29-46 and 48 to remain pending for examination. If the applicant wishes to cancel claims 40-46 and 48, a formal amendment must be submitted in response to this Office Action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 29-46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9,227,076 in view of Sjostedt et al. (Pat. No. 8,437,855) and Honeck et al. (Honeck: WO 2004/247910).
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are merely broader in scope than the patented claims. The patented claims recite a pre-molded header with first, second and third openings for multiple components (i.e., a header comprising a continuous region of a molded material encasing multiple components therein). Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Regarding the material concerning multiple contact assemblies and multiple parallel conductors each extending linearly between the can and a corresponding contact assembly, such arrangements are old and well-known in the medical device art. Sjostedt, for example, discloses such structure (see elements 26 (cylindrical ring contacts), elements 36 (parallel conductors) and Figs. 1, 3, 4) in use in a standard implantable device. The applicant gives no criticality whatsoever to such features, and in fact, does not even discuss the parallel nature of the wires other than what can be gleaned from the drawings. Given that such arrangements are standard in the art and lacking any criticality, the use of parallel conductors would have been considered a matter of obvious design expediency by artisans of ordinary skill in the art. One would expect any arrangement allowing proper connection of the output terminals with the contact assemblies to have been reasonably successful.
Regarding the set screw block having first and second funnel-shaped, tapered openings as recited, note the application of Sjostedt and Honeck for identical limitations in the art rejection below.
Regarding claim 31, rounded rectangular shapes are old and well known in the implantable medical device art as they allow one to optimize packaging of components, while reducing sharp angles that may cause tissue irritation and discomfort to the patient. Official Notice was taken in the previous Office Action and, lacking traversal, this feature is now considered admitted prior art (attention is also invited to the Meadows reference cited below).
Regarding method claim 42, the use of a liquid mold material would have been considered obvious to those of ordinary skill in the art because of the known, art-recognized properties of a liquid (e.g., suitability for injection into a mold and ability to completely fill voids). Official Notice was taken in the previous Office Action that it was old and well known to use liquid materials when manufacturing molded products. Lacking traversal, this feature is now considered admitted prior art.
Claims 29-46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,065,044 in view of Sjostedt et al. (Pat. No. 8,437,855) and Honeck et al. (Honeck: WO 2004/047910).
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are merely broader in scope than the patented claims. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Note further the comments made above which apply here as well for similar limitations.
Regarding limitations pertaining to the funnel-shaped or tapered sidewalls, note the application of Honeck as elaborated below.
Claims 42-46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,946,204 in view of Sjostedt et al. (Pat. No. 8,437,855) and Honeck et al. (Honeck: WO 2004/047910).
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are merely broader in scope than the patented claims. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Note further the comments made above in the application of Sjostedt and Honeck which apply here as well for similar limitations.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 29-32 and 34-41 is/are rejected under 35 U.S.C. 103 as obvious over Meadows et al. (Pub. No. 2011/0112601) in view of Sjostedt et al. (Sjostedt: Pat. No. 8,437,855) and Honeck et al. (Honeck: WO 2004/047910).
Regarding claim 29, Meadows discloses a signal generator (pulse circuitry of the IPG), comprising: a header (silicone header; as shown for example Figs. 13 and 16) coupleable to a can (hermetic, titanium enclosure; see Fig. 13) and comprising a material (silicone or epoxy; par. 0121) at least partially encasing multiple components therein (see par. 0121), the components including: a charging coil (inductive charging coil); and a communication antenna (MICS telemetry coil) to receive control signals (commands; par. 0129).
While Meadows appears to suggest multiple contact assemblies capable of interacting with and providing electrical power to corresponding contacts (electrical connectors) at the proximal end of the lead (signal delivery device) as shown in Fig. 7, and shows multiple parallel conductors extending from the can in the form of feedthroughs which would necessarily need to be connected to corresponding contact assemblies in order to conduct stimulation pulses to the distal portion of the lead (see Figs. 15 and 16), Meadows does not explicitly refer to the use of multiple parallel conductors each extending linearly between the can and a corresponding contact assembly. Sjostedt, however, without speculation, explicitly discloses the use of such structure (see elements 26 (cylindrical ring contacts), elements 36 (parallel conductors) and Figs. 1, 3, 4 showing the relative arrangement between the two structures) in use in a related standard implantable device. The applicant gives no criticality whatsoever to such features, and in fact, does not even discuss the parallel nature of the wires other than what can be gleaned from the drawings. Given that such arrangements are standard in the art and lacking any criticality, the use of parallel conductors would have been considered a matter of obvious design expediency by artisans of ordinary skill in the art. One would expect any arrangement allowing proper connection of the output terminals with the contact assemblies, while maintaining electrical separation between conductors, to have been reasonably successful, with parallel conductors providing a simple solution by allowing the most direct attachment and enabling electrical isolation.
Further, while Meadows does not explicitly state that the silicone/epoxy header is molded, such a limitation is considered to represent a product-by-process limitation. In such a case, the determination of patentability must be based on the product itself and not its method of production (see MPEP 2113). In the instant case, the silicone or epoxy header of Meadows would be indistinguishable --or in the very least—obvious, from a silicone or polymer header (note par. 0024 of the present disclosure indicating the suitability of silicone/polymer) produced by molding. Both headers would serve to suitably seal the components therein from fluid intrusion and would have substantially identical material characteristics. It is further old and well-known that headers may be manufactured by molding silicone, as such a process allows one to easily form the silicone into any desired complex shape, thus simplifying the manufacturing process.
Regarding the use of a header with a continuous region of a molded material encasing multiple components therein, Meadows discloses in Fig. 16 the use of a molded outer header element that is continuous and that encases multiple components therein once placed over the components during final assembly.
Regarding limitations pertaining to the set screw block, Sjostedt discloses as shown in Figs. 1-4, a set screw block (generally comprising holding ring 30 and set screw 52) that defines a receiving passage (see Figs. 1 and 2; passage that receives the proximal end 13 of the lead 12). As is old and well-known in the implantable device art, Sjostedt teaches that an alternative embodiment may position the set screw block at the distal end of the connector assembly for providing the locking function on the lead cable (see par. Abridging cols. 7 and 8). Such a location would inherently require having a first opening positioned to direct the electrical connector into the receiving passage, and a second opening opposite the first opening and positioned to direct the electrical connector into contact with the multiple contact assemblies of the output terminal, in order to allow the lead to be fully inserted and secured within the header so as to establish contact with the more proximally located contact assemblies. As stated in MPEP 2144.04, VI., C, the rearrangement of parts without affecting the operation of the device is considered legal precedence sufficient to support a rejection under §103 in the absence of any expressed criticality. The applicant gives no criticality to the position of the set screw block or to the use of the recited first and second openings. One would expect any known set screw block location allowing the lead to be securely connected to the header to be suitable to the invention.
Specifically addressing the most recently added limitation regarding the first and second openings both being tapered (or funnel-shaped as in claim 32), Honeck discloses a related implantable signal generator including a funnel shaped (or tapered) sidewall (see Figs. 13, 14D and 15, element 6014). The funnel/tapered shape is taught to provide strain relief for the lead where it exits the header (p. 25, lines 14-24). Use of a similar arrangement in the Meadows device as modified by Sjostedt to provide strain relief, would have been considered an obvious mechanical expediency by those of ordinary skill in the art concerned with aiding ease of insertion and preventing lead damage.
It is noted that the applicant gives no criticality to having both openings tapered. The specification, in fact, merely states that the funnel-shaped, tapered sidewall’s purpose is to receive an electrical connector or plug in order to facilitate insertion and alignment (pars. 0036 and 0037). Once a connector or plug is received and aligned within the receiving passage 502 (Fig. 5B), it is unclear what function the tapered shape of the second opening serves. As stated in MPEP 2144.04, a person of ordinary skill in the art would have found a change in shape to be obvious absent persuasive evidence that the particular configuration was significant. Any changes in shape to the second opening would have been considered an obvious matter of design and/or an obvious matter of manufacturing expediency (e.g., manufacturing a symmetrical component for ease of assembly) by those of ordinary skill in the art.
The limitations of claims 30, 31, 34 and 35 are clearly disclosed by Meadows.
Regarding claim 32, note the comments made above relating to the funnel-shaped feature. The purpose of such a feature is irrelevant in the absence of any structural distinction restricting use of the passage in such a manner.
Specifically regarding claim 36, note the comments made above in the rejection of substantially similar limitations in claims 29 and 32. Regarding the header’s rounded upper surface, note Figs. 13 and 16. Regarding the recited receiving element, see the comments above pertaining to cylindrical ring contact assemblies.
Regarding claims 37-41, note the rejection of substantially similar limitations above.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meadows, Sjostedt and Honeck as applied to claims 29-32 and 34-41, and further in view of Tucci (Pat. No. 4, 479,489).
Regarding claim 33, seal 33 is considered to be an access seal as one can gain access to the set screw via the seal. In any event, the Tucci reference is applied to explicitly show a seal that provides access to the set screw through a resealable slit 30 (see Figs. 1, 2 and 4) as is old and well-known in the implantable medical device art. Such a feature allows the surgeon to conveniently selectively tighten or loosen the set screw, while still retaining the seal in its proper place. To allow a similar operation in the Meadows device would have therefore been considered a matter of obvious design to those of ordinary skill in the art.
Claim(s) 42-46 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meadows, Sjostedt, Honeck and Anderson et al. (Anderson: Pat. No. 4,072,154).
Regarding method claim 42, note the application of Meadows, Sjostedt and Honeck to substantially identical limitations already covered above. Meadows does not disclose how the silicone or epoxy header is formed. Anderson, however, discloses a related implantable signal generator including an epoxy header formed from thermosetting epoxy resins. As is old and well known in the material sciences, such a process involves placing a liquid resin/polymer within a mold and curing to provide the desired shape. Such a process simplifies manufacture of complex shapes and allows components to be embedded within a protective housing. Artisans of ordinary skill in the art tasked with creating the silicone or epoxy header of Meadows would have therefore considered such a process to be an obvious manufacturing expediency. It is further noted that removing the header from the mold would be common sense to anyone of ordinary skill and blatantly obvious in order to allow assembly of the device.
The limitations of claims 43-45 and 48 are clearly disclosed by Meadows.
The application of Honeck to claim 46 is identical to that already elaborated on above in the rejection of claim 32.
Response to Arguments
Applicant's arguments filed October 24, 2025 have been fully considered but they are not persuasive.
Lacking effective amendment or an acceptable terminal disclaimer, the rejection of claims under obviousness-type double patenting has been maintained.
Regarding the rejection of claim 29 under §103 (with substantially similar comments applying to claim 36), the applicant argues that criticality for the requirement that both the first opening and the second opening are tapered is given in par. 0037 of the specification. It is asserted that even though the example given only references the first opening, the same benefits and criticality can be said for the second opening. It is further stated that the examiner reasons that this single example is inclusive of all reasons why an opening of the set screw block might have a funnel-shaped sidewall.
The examiner responds that par. 0037 only gives a single reason for having one opening tapered (i.e., to facilitate insertion of plugs or conductor assemblies). The reason for this should be readily apparent, as only one opening is capable of receiving a plug or conductor assembly given that the other opening would be inaccessible due to the fact that it would be enclosed within the header (i.e., once assembled, a practitioner can only insert a plug or conductor assembly into the screw block from one direction). Once the practitioner inserts the plug into the receiving passage (e.g., through the first opening or insertion point), the funnel shaped sidewall engages the plug and guides the plug to the center of the receiving passage (par. 0037). It is unclear what function is served by having the other opening also tapered since the plug has already been appropriately aligned and guided to the center of the passage. Lacking any criticality for having both openings tapered, those of ordinary skill would have considered such a feature to be obvious for all of the reason elaborated in the rejection above.
The applicant then argues that even if the examiner is correct in that the specification does not provide criticality for both tapered openings, the rejection should be withdrawn because Honeck fails to teach or suggest a first tapered opening. It is asserted that Honeck teaches to provide a tapered opening where the lead exits the header in contrast to the present invention which provides a tapered first opening where the practitioner inserts the plug. It is stated that, if anything, Honeck teaches a tapered second opening (i.e. an exit opening) rather than a tapered first opening (i.e., receiving opening).
This argument is not persuasive. While Honeck states that the funnel/tapered shape provides strain relief for a lead where it exits the header, those of ordinary skill in the art would understand that the point at which the lead exits the header also serves as the insertion point of the lead, and thus this opening would represent a tapered first opening, or receiving opening.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached the 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached on 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
February 21, 2026