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 .
Reissue Applications
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Continuing Obligations
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent Nos. 8,784,312, RE48,038 and RE49,527 are or were involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Claim Rejections - 35 USC § 251 – Oath/Dec
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
Applicant’s reissue oath/declaration filed on July 9, 2026 acceptable. It properly recites at least one error as required by MPEP 1414 and 37 CFR 1.175.
Specification
The amendment to the specification filed on July 9, 2026 requires clarification. Specifically, the amended text in the specification reads “application no. 16/895,592, filed June 8, 2020, now U.S. Patent No. RE49,527, which is a reissue of U.S. Patent No. 8,784,312 and a continuation of application no. 15/217,480” (emphasis added). It appears as if the phrase “a continuation of application no. 15/217,480” should read - - a continuation reissue of application no. 15/217,480 - - for consistency and clarity.
Claim Rejections - 35 USC § 251 – Original Patent
Claims 21-33, 44 and 48 are rejected under 35 USC 251 for failing to comply with the original-patent requirement. MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention. The Examiner contends, however, that the reissue claims are not described in the original patent and enabled by the original patent specification such that 35 USC 112 first is satisfied.
New claim 21 recites a method for operating an external device with an “internal device” in the preamble of the claim.
New claim 27 recites a method for operating an external removable device with “another device attached to a recipient” in the preamble.
Claim 44 recites that the another device is “fixed inside the recipient.”
Claim 48 requires communication with the internal device which is a “medical device implant.”
Nothing in Applicant’s original filed disclosure supports that Applicant envisioned the method for an “internal device” in general, or a “device attached to a recipient” in general or a device “fixed inside the recipient” in general. Everything in Applicant’s original disclosure describes a method for an implanted internal device specifically. In the medical context, the Examiner contends that the term “implanted” refers to devices or materials that are fixed inside the body via connection to tissue often through surgical procedures. On the contrary an “internal device,” as set forth in new reissue claims 21-26, need not be fixed via connection to tissue through surgical procedures but could merely be a device resting within a cavity. Similarly, an “attached device,” as set forth in claim 27, need not be implanted or internal. A device that is “fixed inside the recipient” as set forth in claim 44 may be fixed by a means which prevents removal (i.e. an ear plug with a cap) but does not necessarily require the device is implanted. Finally, communication with “a medical device” implant as set forth in claim 48 does not require the medical device implant to be physically implanted when such communication occurs.
Claim Rejections - 35 USC § 251 - New Matter
The following is a quotation of 35 U.S.C. 251(a):
(a) IN GENERAL.—… No new matter shall be introduced into the application for reissue.
Claims 21-33, 44 and 48 are rejected under 35 U.S.C. 251 as being based upon new matter added to the patent for which reissue is sought, as discussed in detail below in the rejections under 35 U.S.C. 112(a) for lack of written description.
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 21-33, 44 and 48 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.
As set forth above, Applicant’s original filed disclosure fails to provide written description support for a method for an “internal device” in general, a “device attached to a recipient” in general, “the another device fixed inside the recipient” or “the internal device is a medical device implant.” Applicant’s original written description describes a method for an implanted internal device specifically. In the medical context, the Examiner contends that the term “implanted” refers to devices or materials that are fixed inside the body via connection to tissue often through surgical procedures. Applicant’s originally filed written description fails to provide support for a broader “internal device”, a broader “attached device”, a broader “attached device…fixed inside the recipient” or a broad method step of communication with the internal device that “is a medical device implant” without necessarily requiring the device to be implanted. These limitations added in reissue claims 21, 27, 44 and 48 would encompass embodiments beyond what is described in the originally filled application.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 21, 27-33, 44-45 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 25-26, 28-32, of U.S. Patent No. RE49,527. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending reissue claims 21 and 27-33 are merely broader than patented claims 19 and 25-26, 28-32. All of the limitations of the pending reissue claims 21, 27-33, 44-45 and 48 are encompassed within the patented claims 19 and 25-26, 28-32.
Claims 21-24, 26 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-25, of U.S. Patent No. RE48,038. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending reissue claims 21-24 and 26 are merely broader than patented claims 22-25. All of the limitations of the pending reissue claims 21-24 and 26 are encompassed within the patented claims 22-25.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. RE49,038 in view of Leysieffer (6,198,971). Claim 22 of US Patent No. RE49,038 recites all limitations of pending reissue claim 25 with the exception of the internal device being a brain stem implant. Leysieffer teaches implant system for rehabilitation of hearing with external and internal components wherein the internal component can be in the form of a brain stem implant of a cochlea implant (see column 5, lines 9-10). Using an internal device in the form of a brain stem implant in the method disclosed by the ‘038 patent would have been obvious since a brain stem implant since the location of the implant may be a surgical consideration that is preferred for a particular patient (see column 4, line 58 – column 5, line 10).
Claims 34-39, 42-43 and 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 33 of U.S. Patent No. RE49,527. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending reissue claim 33 is merely broader than patented claim 33. All of the limitations of the pending reissue claims 34 are encompassed within the patented claim 33.
Response to Amendment/Arguments
Applicant’s amendment, arguments and remarks filed on July 9, 2026 have been fully considered.
Applicant’s newly filed reissue oath and declaration, and the error statement included therein, is acceptable.
Applicant’s amendment to the specification has been reviewed, however, as noted above the Examiner requests clarification of the relationship between Application Number 16/895,592 and Application Number 15/217,480. A review of the benefit claim appears to indicate that 16/895,592 is a continuation reissue of 15/217,480.
Applicant argues that the amendment to claim 27 has overcome the USC 251 original patent rejection and the 35 USC 112(a) rejection. Claim 27 has been amended to replace the phrase “another device attached to a recipient” with the phrase - - another device that is part of a system that includes the external removable device and the another device, wherein the external device is removable from the recipient.” Nothing in the amended text requires the “another device” be an implanted device. As set forth above, Applicant’s disclosure only supports communication between an external device and an implanted device. By reciting “the another device” as broadly it is recited in claim 27, Applicant is claiming a group of devices that reaches far beyond what has written description support.
Applicant argues that the Examiner’s position does not address the fundamental fact than an implanted device is an internal device, moreover, that all implanted devices are internal devices. The Examiner agrees with Applicant that an implanted device is an internal device. The mere fact that the original disclosure supports claims to a device/method comprising an implanted device does not mean that it supports claims to a device/method comprising any internal device in general as is now being claimed in the new and amended reissue claims.
Applicant further argues that disclosure of an “implanted device” expressly, implicitly and inherently provides written description support for an “internal device” in general. The Examiner disagrees. Applicant’s specification, drawings and claims as originally filed describe an implanted device. Nothing in Applicant’s original specification, drawings or claims conveys that a PHOSITA would recognize that the invention could be performed with any internal device. A PHOSITA, when taking the disclosure as a whole, would recognize that the device/method functions with an implanted device. The fact that an implanted device is an internal device does not lead to the conclusion that the written description supports claims drawn to a broader internal device.
Applicant further argues that the written description requirement for a claimed genus may be satisfied by disclosure of a species. MPEP 2163 (II)(A)(3)(ii) specifically states “The written description requirement for a claimed genus may be satisfied through a sufficient description of a representative number of species by actual reduction to practice…, reduction to drawings, or by disclosure of relevant, identifying characteristics.” Applicant’s disclosure does not provide written description support of “a representative number of species.” Applicant’s disclosure provides written description support for a single solution which includes a device/method requiring an implanted device. There is nothing in Applicant’s disclosure to support that the implanted device is a single species within a broader genus of internal devices.
Applicant’s amendments have overcome the 112 (b) rejections set forth March 11, 2026 office action. Applicant’s comments with respect to claim 34 have been considered and are persuasive.
Conclusion
Claims 1-20 are cancelled.
Claims 21-48 are rejected.
THIS ACTION IS MADE FINAL. 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 SARAH B. MCPARTLIN whose telephone number is (571)272-6854. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eileen Lillis can be reached at 571-272-6928. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Any general questions regarding this communication can be directed to the Central Reexamination Unit at 571-272-7705.
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/SARAH B MCPARTLIN/Reexamination Specialist, Art Unit 3993
Conferees:
/MATTHEW J KASZTEJNA/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
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