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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/6/20206 has been entered.
Response to Arguments
Applicant's arguments filed 7/6/2026 with respect to the 112(a) rejection have been fully considered but they are not persuasive. The applicant argues that the specification teaches that the “implant may be encapsulated in at least one layer of a biocompatible material.” This is true. However, the biocompatible material that the implant may be encapsulated in is NOT the flexible carrier. The specification makes clear that that the flexible carrier is completely separate from the biocompatible material that encapsulates the implant. The pertinent paragraph from the original specification is included below:
In some embodiments, the flexible carrier of the implant comprises a flexible, biocompatible, material and/or an insulating material. Such materials may include, for example, silicone, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), Parylene C, polyimide, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone (PEEK), Liquid Crystal Polymer (LCP), Kapton, etc. Further to the above, the implant may be encapsulated in at least one layer of a biocompatible material, and may include ceramic material, thermoplastic material such as ULTEM, or other compatible materials.
As seen above, the flexible carrier may include “silicone, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), Parylene C, polyimide, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone (PEEK), Liquid Crystal Polymer (LCP), Kapton, etc.” The same paragraph clearly states that FURTHER TO THE ABOVE, the implant may be encapsulated in a separate layer of biocompatible material, and may include “ceramic material, thermoplastic material such as ULTEM, or other compatible materials.” Clearly, there is no overlap in the materials lists of the flexible carrier and the encapsulation material. Furthermore, the encapsulation material is not described as being flexible, and it should be noted that ceramic and ULTEM are known for their stiffness and brittleness, as opposed to the material list provided for the flexible carrier. It is therefore clear to the Examiner that the original specification does not disclose that the secondary transmission unit is encapsulated in the flexible carrier, but instead, the secondary transmission unit (and the flexible carrier) may be encapsulated in a separate material, such as ceramic.
While the original specification does state that the secondary transmission unit may be “integrated with the flexible carrier” that does NOT provide support for encapsulation, specifically. A generic statement does not provide blanket support for any and all possible species of that generic statement. The 35 USC 112(a) rejection is still considered proper.
Applicant’s amendments and associated arguments filed 7/6/2026 with respect to the 102 rejections using Woods have been fully considered and are persuasive. Therefore, the 102 rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hazard et al.
Claim Interpretation
Claim 1 recites a system “for treating head and facial pain” in the preamble. When reading the preamble in the context of the entire claim, this recitation is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Furthermore, claim 1 is directed to an apparatus claim. The following principles of law govern apparatus claims:
"To anticipate a claim, a reference must disclose every element of thechallenged claim and enable one skilled in the art to make the anticipatingsubject matter." PPG Indus. Inc. v. Guardian Indus. Corp, 75 F.3d 1558,1566 (Fed. Cir. 1996).
"[T]he patentability of apparatus or composition claims depends onthe claimed structure, not on the use or purpose of that structure." CatalinaMktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir.2002).
"It is well settled that the recitation of a new intended use for an oldproduct does not make a claim to that old product patentable." In reSchreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-13, and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 1, the applicant’s original specification does not contain written description for “secondary transmission unit encapsulated within the flexible carrier.” The applicant pointed to pages 8 and 9 of the specification for support. However, these paragraphs state that the secondary transmission unit may be “mounted onto or otherwise be integrated with the flexible carrier.” This is not equivalent to the claimed “encapsulated within the flexible carrier.” The paragraph abridging pages 8 and 9 states that the “implant may be encapsulated in at least one layer of a biocompatible material” but this seems to be separate from the flexible carrier. The pertinent paragraph from the original specification is included below:
In some embodiments, the flexible carrier of the implant comprises a flexible, biocompatible, material and/or an insulating material. Such materials may include, for example, silicone, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), Parylene C, polyimide, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone (PEEK), Liquid Crystal Polymer (LCP), Kapton, etc. Further to the above, the implant may be encapsulated in at least one layer of a biocompatible material, and may include ceramic material, thermoplastic material such as ULTEM, or other compatible materials.
As seen above, the flexible carrier may include “silicone, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), Parylene C, polyimide, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone (PEEK), Liquid Crystal Polymer (LCP), Kapton, etc.” The same paragraph clearly states that FURTHER TO THE ABOVE, the implant may be encapsulated in a separate layer of biocompatible material, and may include “ceramic material, thermoplastic material such as ULTEM, or other compatible materials.” Clearly, there is no overlap in the materials lists of the flexible carrier and the encapsulation material. Furthermore, the encapsulation material is not described as being flexible, and it should be noted that ceramic and ULTEM are known for their stiffness and brittleness, as opposed to the material list provided for the flexible carrier. It is therefore clear to the Examiner that the original specification does not disclose that the secondary transmission unit is encapsulated in the flexible carrier, but instead, the secondary transmission unit (and the flexible carrier) may be encapsulated in a separate material, such as ceramic.
The dependent claim are rejected based on their association to claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 8-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Woods et al. (US 2004/0044383, hereinafter Woods) in view of Hazard et al. (US 2015/0374989, hereinafter Hazard).
Regarding claims 1, 10 and 19, Woods discloses a neurostimulation system as seen in figures 1 and 5. The system includes a BTE external unit 5 with a housing, and a processor/circuitry disposed, a rechargeable battery 30 disposed in the housing, a primary transmission unit 40 and LEDs 15/16 (par. 0004, 0031, 0041). The system includes an implant unit with a lead 28, an electrode array 27 on the lead and a secondary transmission unit (par. 0031). Figure 1 of Woods shows a flexible carrier 25 such that lead 28 is connected to the flexible carrier. Par. 0031 discloses that the secondary transmission coil (“implanted receiving coil”) is contained (“encapsulated”) within the flexible carrier. The flexible carrier 25 has the flexibility to contain various types of circuitry and be implanted in different locations. The processor circuitry establishes a coupling between the primary and secondary transmission units to transmit power and data from the power source to the implant unit via inductive coupling (par. 0005, 0032).
However, Woods is silent as to the specific material of the flexible carrier, and that the material is flexible and biocompatible, although since the flexible carrier is implantable, it is implied that the carrier is biocompatible. Attention is directed to the analogous art of Hazard, which also discloses a cochlear implant 10 with a flexible carrier 12 and a lead 18 connected to the flexible carrier, wherein a transmission unit 14 is encapsulated within the flexible carrier (fig. 1 and par. 0051). Hazard discloses that the flexible carrier is fabricated from a flexible silicone elastomer, which is also known to be biocompatible. Therefore it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the flexible carrier of Woods to be made of flexible, biocompatible silicone elastomer as taught by Hazard, as KSR indicates that the simple substitution of one known element for another would have yielded predictable results, in this case, a carrier for a cochlear implant that would not have changed the overall functionality or purpose of Woods.
Regarding claims 2 and 8, the battery is rechargeable, so there inherently must be a charging unit.
Regarding claim 3, figure 5 of US 4,532,930, incorporated by reference in par. 0004 of Woods, shows the electrodes evenly spaced on the lead.
Regarding claim 5, the housing is configured for attachment to the subject’s skin using glue, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 9, the external BTE unit of Woods is a remote control for adjustment of the neurostimulation.
Regarding claims 11 and 12, the lead of the implant unit can be placed through an incision of 0.5-3.5 cm, and the lead is implanted in the cochlea (which is a tunnel), but is also configured to be placed in a tunnel toward an inion, if so desired by a user. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 13, the lead can be located near an occipital nerve, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 18, the housing comprises flexible portion 50 and or flexible portion 10 that conforms to a location of the subject’s skin.
Regarding claim 20, any two of the electrodes 27 are considered a pair, and the delivery of stimulation from each electrode inherently creates electric fields that exists between the electrodes.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Woods and Hazard in view of Pilarski et al. (US 2010/0179561, hereinafter Pilarski)
Woods, as described and modified above, discloses the applicant’s basic invention, but is silent as to the lead having a tine. However, Pilarski also discloses a nerve stimulation device, and thus is analogous art with Woods (par. 0030). Pilarski discloses that the a lead can include a tine that can resist withdrawal/displacement of the lead (par. 0030). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Woods a tine of the lead as taught by Pilarski that can resist withdrawal/displacement of the lead.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Woods and Hazard in view of Armstrong et al. (US 2011/0288615, hereinafter Armstrong).
Woods, as described and modified above, discloses the applicant’s basic invention, but is silent as to utilizing an energy harvesting unit for deriving power from thermal or kinetic energy. However, Armstrong also discloses a nerve stimulation device, and thus is analogous art with Woods (par. 0004). Armstrong discloses that the implanted system can be powered using an energy harvesting unit external to the body that harvests energy from heat or motion (par. 0065). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Woods to include an energy harvesting unit for deriving power from thermal or kinetic energy to power the implanted device as taught by Armstrong since such energy sources never run out of power.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892, specifically US 2018/0133486 and US 2009/0216324, which both disclose a cochlear implant with a flexible carrier made of a flexible, biocompatible material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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