DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments have been fully considered but they are found persuasive in part and non persuasive. Regarding the rejection of claims 35-55, applicant’s arguments are found persuasive; accordingly, the rejection is withdrawn and the claims are allowed. Regarding the rejection of claim 56, new grounds of rejection are presented below. With respect to the rejection under 112 – ¶¶ 87 of the disclosure describes a specific embodiment where the electrode is implanted at the base of the tongue and further shows a figure where the array is not wrapped around the Hypoglossal nerve in any manner. Accordingly, the rejection is maintained.
.Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 12/581,907, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
In claim 56, the phrase “array of electrodes disposed on a flexible carrier configured to wrap around a hypoglossal nerve of a patient….the third electrode extend along a longitudinal axis of the hypoglossal nerve…” in combination with the other elements and language present in the claim language, fails to be supported by the disclosure of the prior-filed application, Application No. 12/581,907. The specification describes an embodiment related to the Hypoglossal nerve in Fig. 3D; however, there is no disclosure of a configuration wrapping around the hypoglossal nerve – just being “able to stimulate the Genioglossus horizontal compartment”.
Accordingly, the claim 56 does not benefit from the priority claim and is awarded a priority date of 16 September 2020.
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 56 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 56 recites the phrase “array of electrodes disposed on a flexible carrier configured to wrap around a hypoglossal nerve of a patient….the third electrode extend along a longitudinal axis of the hypoglossal nerve…” in combination with the other elements and language present in the claim language, fails to be supported by the disclosure of the prior-filed application, Application No. 12/581,907. The disclosure briefly mentions the ability of the array to wrap around a nerve and describes an embodiment related to the Hypoglossal nerve in Fig. 3D; however, the examiner was unable to find any discussion of an orientation with wrapping where the electrodes extend along an axis of the hypoglossal nerve as claimed – just being “able to stimulate the Genioglossus horizontal compartment”. It is required that applicant indicate where support lies for this claim language or amend the claims to fall within the scope of the disclosure as originally filed.
Claim Rejections - 35 USC § 102
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
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 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.
Claims 56 is rejected under 35 U.S.C. 102(b) as being anticipated by Bolea et al. (US 2008/0103545). Bolea discloses a system, comprising: an array of electrodes disposed on a flexible carrier configured to wrap around a hypoglossal nerve of a patient, the array of electrodes including a first electrode, a second electrode, and a third electrode arranged on the flexible carrier such that the first electrode, the second electrode, and the third electrode extend along an axis of the hypoglossal nerve when the flexible carrier is wrapped around the hypoglossal nerve (e.g. Fig. 19A, #190); an implantable stimulator electrically connected to the array of electrodes by at least one flexible wire (e.g. Fig. 19A, #62), the implantable stimulation including: a housing (e.g. ¶¶ 38 – “INS 50”), at least one sensor configured to sense a physiological parameter of a respiratory system of the patient (e.g. ¶¶ 55), and a controller disposed within the housing and in signal communication with the at least one sensor (e.g. ¶¶ 45 – circuitry inside INS 50), the controller configured to: receive a communication from an external device for selecting at least one of the first electrode, the second electrode, and the third electrode that will participate in stimulating the hypoglossal nerve of the patient, receive at least one signal from the at least one sensor, the at least one signal indicative of the physiological parameter of the respiratory system of the patient that is sensed and generate a stimulation signal for use by the array of electrodes for stimulating the hypoglossal nerve to treat obstructive sleep apnea (e.g. ¶¶ 158-173).
Allowable Subject Matter
Claims 35-55 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
Prosecution Insights