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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore the third electrode, fourth electrode, fifth electrode, sixth electrode, seventh electrode, the first and second electrodes including a plurality of electrodes, sensor and second controller must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because the claim recites “the ansa cervicalis” in line 3, “the sternothyroid muscle” in line 4, “the phrenic nerve” in line 5 and “the diaphragm” in line 6, each recitation which lacks proper antecedent basis and the word “the” should be replaced with “an” or “a” where appropriate.
Claim 2 recites “the sternohyoid muscle”, this language lacks antecedent basis and should be amended to recite “a sternohyoid muscle”.
Claim 3 recites “the omohyoid muscle”, this language lacks antecedent basis and should be amended to recite “an omohyoid muscle”.
Claim 4 recites “the omohyoid muscle”, this language lacks antecedent basis and should be amended to recite “an omohyoid muscle”.
Claim 5 recites “the hypoglossal nerve” and “the genioglossus muscle”, this language lacks antecedent basis and should be amended to recite “a hypoglossal nerve” and “a genioglossus muscle”.
Claim 6 recites “the glossopharyngeal nerve” this language lacks antecedent basis and should be amended to recite “a glossopharyngeal nerve”.
Claim 7 recites “the pharyngeal nerve plexus”, this language lacks proper antecedent basis and should recite “a pharyngeal nerve plexus”.
Claim 11 recites “the presence” this language lacks proper antecedent basis and should read “a presence”.
Claim 21 recites “the phrenic nerve” and “the diaphragm” in line 3, this language lacks antecedent basis and should recite “a phrenic nerve” and “ diaphragm”.
Claim 21 line 3 after the word diaphragm there is a period (.) this should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 21 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6 and 21 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Each of the following positively recite a human body part, in order to comply with 35 USC 101 each of the following should be amended to recite “a” or “an” instead of “the”.
Claim 1 “the phrenic nerve” in line 5
Claim 1 “the diaphragm” in line 6
Claim 2 “the sternohyoid muscle” in line 3
Claim 3 “the omohyoid muscle” in line 3
Claim 4 “the omohyoid muscle” in line 3
Claim 5 “the hypoglossal nerve” in line 2
Claim 5 “the genioglossus muscle” in line 3
Claim 6 “the glossopharyngeal nerve” in line 2
Claim 21 “the phrenic nerve” in lines 2-3
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 8 and 18 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.
Claim 8 recites “wherein the controller is programmed to avoid stimulating a cranial root of an accessory nerve of the patient”. Nowhere within applicants specification is there a discussion as to how applicant intends to program the controller to avoid stimulating a cranial root or an accessory nerve of the patient.
Claim 18 recites “the controller is programmed to adjust a duty cycle”. Nowhere in the specification is it discussed how applicant intends the controller to be programmed to adjust duty cycle based on sleep state.
Claim 8 and 18 are considered to be computer implemented claim limitations. In order to comply with written description the specification must provide sufficient detail regarding any program and/or algorithm which can perform these tasks. The specification fails to provide sufficient detail so that one of ordinary skill would understand how the inventors intend to make and use the invention. There is no hardware or software discussed. If the program and/or algorithm is absent then more than routine experimentation is needed. In this case more than routine experimentation is needed.
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)(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.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dieken et al. US 2020/0147376.
Regarding claim 21: Dieken discloses a therapy system 121 (figure 6) to treat sleep disordered breathing (paragraph 0064) comprising; a first electrode 12/132 (figures 2 and 6) and a second electrode 22/142 (figures 3 and 6) and a controller/pulse generator, the controller/pulse generator delivers signals to stimulate the associated nerves (paragraphs 0076-0077). The first electrode 12 (figure 1) is implanted to stimulate upper airway patency nerves and activate the upper airway patency muscles (figure 1) and the second electrode 22 (figure 2) is implanted to stimulate central sleep related nerves and patency related muscles (figure 2). The stimulation applied to the second electrode treats sleep apnea by stimulating the phrenic nerve (figure 30A) which innervates the diaphragm (paragraph 0105).
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 5, 10-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. US 2020/0147376 in view of Testerman et al. US 5,591,216.
Regarding claim 1: Dieken discloses a therapy system 121 (figure 6) to treat sleep disordered breathing (paragraph 0064) comprising; a first electrode 12/132 (figures 2 and 6) and a second electrode 22/142 (figures 3 and 6) and a controller/pulse generator, the controller/pulse generator delivers signals to stimulate the associated nerves (paragraphs 0076-0077). The first electrode 12 (figure 1) is implanted to stimulate upper airway patency nerves and activate the upper airway patency muscles (figure 1) and the second electrode 22 (figure 2) is implanted to stimulate central sleep related nerves and patency related muscles (figure 2). The stimulation applied to the second electrode treats central sleep apnea by stimulating nerves that innervate the diaphragm (paragraph 0106), the associated nerve is disclosed as the (paragraph 0091). Dieken further discloses that the hypoglossal nerve is stimulated to target the upper airway patency (paragraphs 0104, 0142) which causes contraction of upper airway patency muscles (paragraph 0150). Therefore, Dieken discloses the claimed invention however, Dieken does not disclose that the first electrode stimulates the ansa cervicalis to activate the sternothyroid muscle. Testerman however teaches of a sleep apnea treatment via electrical stimulation (title) in which the ansa cervicalis is taught as innervating the sternothyroid muscle, which is a muscle of the upper airway (column 5, lines 22-39). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken to include stimulation of the ansa cervicalis to activate the sternothyroid muscle, according to the teachings of Testerman in order to stimulate the sternothyroid muscle.
Regarding claim 2: Dieken discloses that the electrodes 132/142 (figure 6) can be an array of electrodes with a grid configuration of 2x2 or 3x3. The 3x3 grid of electrodes would include a total of 9 electrodes, thus Dieken is disclosing up to 9 electrodes which would include a third electrode (paragraphs 0106, 0168). However, Dieken does not disclose stimulation of the ansa cervicalis to activate the sternohyoid muscle. Testerman however teaches of a sleep apnea treatment via electrical stimulation (title) in which the ansa cervicalis is taught as innervating the sternohyoid muscle, which is a muscle of the upper airway (column 5, lines 22-39). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken to include stimulation of the ansa cervicalis to activate the sternohyoid muscle, according to the teachings of Testerman in order to stimulate the sternohyoid muscle.
Regarding claim 5: Dieken discloses that the electrodes 132/142 (figure 6) can be an array of electrodes with a grid configuration of 2x2 or 3x3. The 3x3 grid of electrodes would include a total of 9 electrodes, thus Dieken is disclosing up to 9 electrodes which would include a fifth electrode (paragraphs 0106, 0168). Dieken further discloses stimulation of the hypoglossal nerve to stimulation upper airway muscles (paragraphs 0104, 0142 and 0150). However Dieken does not disclose that the genioglossus muscle is stimulated based on the stimulation to the hypoglossal nerve. Testerman however teaches that the hypoglossal nerve can be stimulated to cause the genioglossus muscle to be activated (column 3, lines 27-25). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken to include stimulation of the hypoglossal nerve to cause the genioglossus muscle to be activated, as taught by Testerman in order to improve airway patency.
Regarding claim 10: Dieken discloses an array of electrodes considered to be a plurality (paragraph 0168).
Regarding claim 11: Dieken discloses closed loop stimulation which is based on sensory feedback, with the sensory information including respiration cycles (paragraph 0087) as well as determining the severity of sleep apnea behavior (paragraph 0089).
Regarding claim 12: Dicken discloses that stimulation is based on sensory feedback regarding parameters of the stimulation, this would include activating the electrodes based on the sensed signals (paragraphs 0088, 0157).
Regarding claim 13: Dieken discloses closed loop stimulation which is based on sensory feedback, with the sensory information including respiration cycles (paragraph 0087) which is considered to be a respiratory state.
Regarding claim 14: Dieken discloses that the stimulation is synchronized with the inspiratory phase of the respiration cycle (paragraph 0091).
Regarding claim 15: Dieken discloses that the stimulation causes inspiration or expiration (paragraph 0092) which is considered to be the respiratory state. The stimulation is not delivered during expiration (paragraph 0094).
Regarding claim 16: Dieken disclose that the physiological parameter associated with stimulation is based on when the patent is asleep and/or awake (paragraph 0079).
Regarding claim 17: Dieken discloses that the stimulation delivered to the electrodes is synchronized with respiration (paragraphs 0089, 0101, 0114-0115 and 0117).
Regarding claim 19: Dieken discloses a pulse generator 1510 (figure 30E) which signals both the hypoglossal and phrenic nerve stimulation (figure 30E). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken figure 30E to include two separate pulse generators in that this is a simple duplication of parts. A mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F .2d 699, 124 USPQ 378 (CCPA 1960). MPEP 2144.04 VI. B.
Regarding claim 20: Dieken discloses an external patient and physician controller (paragraph 0288) and the therapy system is at least partially controlled by the external controllers (paragraph 0289).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. US 2020/0147376 in view of Testerman et al. US 5,591,216 herein Testerman ‘216 and further in view of Testerman et al. US 7,890,178 herein Testerman ‘178.
Regarding claim 3: Dieken discloses that the electrodes 132/142 (figure 6) can be an array of electrodes with a grid configuration of 2x2 or 3x3. The 3x3 grid of electrodes would include a total of 9 electrodes, thus Dieken is disclosing up to 9 electrodes which would include a fourth electrode (paragraphs 0106, 0168). Dieken/Testerman ‘216 discloses the claimed invention however Dieken/Testerman ‘216 does not discloses stimulation of the ansa cervicalis to activate an omohyoid muscle. Testerman ‘178 however teaches of the ansa cervicalis nerve is a fascicle of the hypoglossal nerve which innervates/activates the omohyoid muscle (column 8, lines 28-40). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken/Testerman ‘216 to include stimulation of the ansa cervicalis to activate the omohyoid muscle, as taught by Testerman ‘178, in order to treat sleep apnea.
Regarding claim 4: Dieken discloses that the electrodes 132/142 (figure 6) can be an array of electrodes with a grid configuration of 2x2 or 3x3. The 3x3 grid of electrodes would include a total of 9 electrodes, thus Dieken is disclosing up to 9 electrodes which would include a fourth electrode (paragraphs 0106, 0168). Dieken/Testerman ‘216 discloses the claimed invention however Dieken/Testerman ‘216 does not discloses stimulation of the ansa cervicalis to activate an omohyoid muscle. Testerman ‘178 however teaches of the ansa cervicalis nerve is a fascicle of the hypoglossal nerve which innervates/activates the omohyoid muscle (column 8, lines 28-40). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken/Testerman ‘216 to include stimulation of the ansa cervicalis to activate the omohyoid muscle, as taught by Testerman ‘178, in order to treat sleep apnea.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. US 2020/0147376 in view of Testerman et al. US 5,591,216 and further in view of Bolea et al US 2008/0103545.
Regarding claim 6: Dieken/Testerman discloses the claimed invention. Dieken discloses that the electrodes 132/142 (figure 6) can be an array of electrodes with a grid configuration of 2x2 or 3x3. The 3x3 grid of electrodes would include a total of 9 electrodes, thus Dieken is disclosing up to 9 electrodes which would include a sixth electrode (paragraphs 0106, 0168). However, Dieken/Testerman does not disclose stimulation of the glossopharyngeal nerve to activate the stylopharyngeus muscle. Bolea however teaches that the glossopharyngeal nerve innervates the stylopharyngeus muscle. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken/Testerman to include stimulation of the glossopharyngeal nerve innervates the stylopharyngeus muscle, as taught by Bolea, in order to treat sleep apnea.
Regarding claim 7: the language found in claim 7, as well as claim 6, which is directed towards an efferent fiber and the nerve plexus is considered to be intended use and/or functional claim language. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since 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. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises electrodes and a controller to stimulate associated nerves to cause muscle activation.
Regarding claim 8: the language found in claim 8 which is directed to how the controller is programmed is considered to be intended use and/or functional claim language. There is no disclosure as to how the controller is specifically programmed. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since 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. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises electrodes and a controller to stimulate associated nerves to cause muscle activation.
Regarding claim 9: Dieken/Testerman discloses the claimed invention. Dieken discloses that the electrodes 132/142 (figure 6) can be an array of electrodes with a grid configuration of 2x2 or 3x3. The 3x3 grid of electrodes would include a total of 9 electrodes, thus Dieken is disclosing up to 9 electrodes which would include a sixth electrode (paragraphs 0106, 0168). However Dieken/Testerman does not disclose stimulation of pharyngeal nerve and activation of the palatoglossal muscle. Bolea however teaches of stimulation of the pharyngeal nerve (paragraph 0081) and activation of the palatoglossal muscle (paragraph 0093). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken/Testerman to include stimulation of the pharyngeal nerve and activation of the palatoglossal muscle, as taught by Bolea, in order to treat sleep apnea.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dieken et al. US 2020/0147376 in view of Testerman et al. US 5,591,216 and further in view of Bolea US 2015/0224307.
Regarding claim 18: Dieken/Testerman discloses the claimed invention however Dieken/Testerman does not disclose adjusting the duty cycle. Bolea however teaches of a sleep apnea device in which the duty cycle can be adjusted to optimize therapy (paragraph 0055). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Dieken/Testerman to include adjusting the duty cycle, as taught by Bolea, in order to optimize therapy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796