DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12138071 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of claim 21 are anticipated by the scope of claim 1 of U.S. Patent No. US 12138071 B2. Claim 1 of US 12138071 B2 does not include recitation of a tone intensity; however, it is clear from claim 1 that the intensity can be adjusted. The broadest reasonable interpretation of a tone intensity is an adjustable stimulation level, which is recited by the increasing and decreasing stimulation of claim 1 in US 12138071 B2.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a first implantable stimulation element to be in electrical stimulating relation…” in claim 21. The recitation of an “element” is not modified by structure in the claim to sufficiently describe what an “element” would be. Similarly, claim 28 recites, “a second implantable stimulation element…”. An “element” is a placeholder for means (nonce term). One of ordinary skill would not recognize a stimulation “element” as a specific structure. The claimed limitation is therefore given the definition provided in the instant specification. However, the instant specification does not provide a written description of an “element to be in electrical stimulating relation.” For Examination purposes, the Examiner will interpret an “implantable stimulation element” as anything that could reasonably be implanted and is involved with stimulation of a nerve.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
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 21-39 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 claims contain 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.
Claims 21, 23, 25, 28, and 32 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
Regarding claims 21, 24, 25, 28, and 29, the claims make a distinction between a “first hypoglossal” and “second hypoglossal” nerve. However, the instant specification is silent regarding this distinction between first and second hypoglossal nerves, and only mentions a singular hypoglossal nerve (see para. [0004]: “the hypoglossal nerve.”). Therefore, there is inadequate support for the claimed limitations of “a first hypoglossal nerve” and a “second hypoglossal nerve” in the instant specification.
Claims 22-39 are rejected due to their dependency from claim 21.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, the claim recites, “a first hypoglossal nerve.” It is unclear what is considered to be a first hypoglossal nerve. One of ordinary skill would recognize that there is only one hypoglossal nerve present in the human body, and that the hypoglossal nerve can have two sides. For examination purposes the claim, the claim will be interpreted as a side a hypoglossal nerve. This phrase is repeated in claims 24, 25, 28 and 29, and are rejected for the same reason.
Regarding claims 28, similarly recite “a second hypoglossal nerve.” Claim 28 is rejected for the same reason as claim 21. For examination purposes, a “second hypoglossal nerve” will be interpreted as a side opposite that of the first located on the hypoglossal nerve. This phrase is repeated in claim 29, which is rejected for the same reason, as well as for its dependency from claim 28.
Regarding claims 21 and 28, the claims recite, “applying electrical stimulation…at a tone intensity…”. One of ordinary skill would not recognize what it means to apply stimulation at a “tone intensity”. Therefore, the metes and bounds of the claims are not defined, and the claims are rendered indefinite. For examination purposes, a “tone intensity” is considered to be an intensity of stimulation that can be increased or decreased.
Claims 22-39 are rejected due to their dependency from claim 21.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
Claim(s) 21 and 22 are rejected under pre-AIA 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tehrani et al. (US 20060247729 A1, “Tehrani”).
Regarding claim 21, Tehrani teaches a method of treating obstructive sleep apnea (abstract; para. [0012]: "Accordingly, it would be desirable to provide an improved device and method for treating OSA") comprising: placing a first implantable stimulation element (para. [0069]: "Electrode 51 may stimulate (as well as sense) at the upper airway muscles or hypoglossal nerve.") to be in electrical stimulating relation to a first hypoglossal nerve (para. [0069]); and applying electrical stimulation, via the first implantable stimulation element (Fig. 2; electrode 51), to the first hypoglossal nerve (para. [0069]) continuously at a tone intensity (para. [0133]: "The stimulation described or shown herein may be comprised of several stimulation parameters...Low level pulses or continuous stimulation may comprise stimulation at about 8 mA or less or may be determined on a case-by-case basis. However, other amplitudes and frequencies may be used as desired.") during a sleep treatment period (para. [0133]: "The frequencies may vary or may be varied depending upon a desired result." frequency of stimulation means there is a period of stimulation.; para. [0140]: "Alternatively, a continuous hypoglossal nerve stimulation may be provided for a predetermined time.") according to: a multi-site parameter (para. [0071]: "The electrodes assemblies 21, 22 are coupled via leads 23, 24 to input/output terminals 101, 102 of a control unit 100."; Fig. 1A/B show multiple sites for obtaining sensed parameters that are sent to the control unit 100) to electrically stimulate at least one of different multiple sites of the first hypoglossal nerve (para. [0072]: "The control unit 100 is implanted subcutaneously within the patient, for example in the chest region on top of the pectoral muscle. The control unit may be implanted in other locations within the body as well. The control unit 100 is configured to receive sensed nerve electrical activity from the sensors or electrode assemblies 21, 22, (31, 32, 41, 42, 51, 57, 58, 59) corresponding to respiratory effort or other respiration related parameters of a patient. The control unit 100 is also configured to receive information corresponding to other physiological parameters as sensed by other sensors. The control unit 100 delivers stimulation to the nerves 15, 16 or diaphragm as desired in accordance with the invention. The control unit 100 also delivers stimulation to the hypoglossal nerve 19."; para. [0069]: "Electrode 51 may stimulate (as well as sense) at the upper airway muscles or hypoglossal nerve."; This demonstrates that the electrode stimulates multiple sites of the hypoglossal nerve, such as muscles associated with the nerve; para. [0071]: "Electrode(s) 51, may be placed at or near the hypoglossal nerve in accordance with a variation of the invention where stimulation of the diaphragm is coordinated with activation of upper airway muscles to open the airway passage just prior to stimulating the diaphragm muscles. Electrode(s) 51 is (are) coupled through lead(s) 52 to electronics in control unit 100."); and a multi-fascicle parameter to electrically stimulate at least one of different multiple fascicles within the first hypoglossal nerve. (para. [0069]: "Electrode 51 may stimulate (as well as sense) at the upper airway muscles or hypoglossal nerve."; para. [0070]: "The control unit 100 is configured to receive and process signals corresponding to sensed physiological parameters, e.g., pressure, flow, nerve activity, diaphragm or intercostal muscle movement."; para. [0071]: "Electrode(s) 51, may be placed at or near the hypoglossal nerve in accordance with a variation of the invention where stimulation of the diaphragm is coordinated with activation of upper airway muscles to open the airway passage just prior to stimulating the diaphragm muscles. Electrode(s) 51 is (are) coupled through lead(s) 52 to electronics in control unit 100.").
Regarding claim 22, Tehrani teaches the method of claim 21 (see above), wherein applying the stimulation via the multi-site parameter includes stimulating multiple muscle groups associated with promoting upper airway patency. (para. [0072]: "The control unit 100 may determine when to stimulate the chest wall or abdominal muscles, as well as specific stimulation parameters, e.g., based on sensed information."; para. [0101]: " In some variations of the invention, stimulation during intrinsic breathing is configured to stiffen the upper airway, thereby increasing upper airway patency.").
Claim(s) 21-29 are rejected under pre-AIA 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bolea et al. (US 20080103545 A1, “Bolea”).
Regarding claim 21, Bolea teaches a method of treating obstructive sleep apnea (para. [0002]: "More particularly, the inventions described herein relate to devices, systems and methods for treating obstructive sleep apnea.") comprising: placing a first implantable stimulation element (para. [0076]: "nerve cuff (not shown)" to be in electrical stimulating relation to a first hypoglossal nerve (para. [0076]: "The nerve cuff electrode (not shown) may be attached to a nerve by surgical dissection at a surgical access site 110 proximate the targeted stimulation site. In the illustrated example, the target nerve is the right hypoglossal nerve and the surgical access site is in the submandibular region."); and applying electrical stimulation, via the first implantable stimulation element, to the first hypoglossal nerve (para. [0077]: " With reference to FIGS. 11A and 11B, a surgical dissection 110 to the hypoglossal nerve is shown schematically. A unilateral dissection is shown, but a bilateral approach for bilateral stimulation may also be employed.") continuously at a tone intensity during a sleep treatment period according to (para. [0073]: " In addition, sensing the impedance of lead 60 may facilitate periodic, automated adjustment of stimulation pulse amplitude so as to maintain constant current, energy, and/or charge delivery using a simpler voltage mode delivery circuit."; para. [0341]: "The electrical field shape for an implanted system can be changed by adjusting the polarity, amplitude and other stimulation intensity parameters for each of the electrodes within the nerve stimulating cuff.";): a multi-site parameter to electrically stimulate at least one of different multiple sites of the first hypoglossal nerve (Fig. 12; para. [0089]: " Co-activating sites A+C+D involves implanting a first electrode on a hypoglossal nerve proximal of a branch innervating the genioglossus muscle and distal of a branch innervating the geniohyoid muscle; implanting a second electrode on the hypoglossal nerve proximal of a branch innervating the geniohyoid muscle and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a third electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the sternohyoid."); and a multi-fascicle parameter to electrically stimulate at least one of different multiple fascicles within the first hypoglossal nerve (Fig. 12; para. [0090-0092] describe electrodes placed on muscles of the first hypoglossial nerve; Additionally, para. [0195] shows that the system operates as a closed system and stimulation is applied as a function of sensed feedback parameters).
Regarding claim 22, Bolea teaches the method of claim 21 (see above), wherein applying the stimulation via the multi-site parameter includes stimulating multiple muscle groups associated with promoting upper airway patency (para. [0048]: “Generally, electrical stimulus is delivered by the INS 50 via the stimulation lead 60 to a nerve innervating a muscle controlling upper airway patency to mitigate obstruction thereof.”; para. [0049]: “[0049] Stimulus may be delivered to one or more of a variety of nerve sites to activate one muscle or muscle groups controlling patency of the upper airway. For example, stimulation of the genioglossus muscle via the hypoglossal nerve”).
Regarding claim 23, Bolea teaches the method of claim 22 (see above), wherein the stimulating of multiple muscle groups comprises activating, via two or more different electrode elements of the first stimulation element spaced apart along at least one nerve innervating tongue-protruder muscles and/or tongue-retruder muscles. (para. [0089]: "Co-activating sites A+C+D involves implanting a first electrode on a hypoglossal nerve proximal of a branch innervating the genioglossus muscle.").
Regarding claim 24, Bolea teaches the method of claim 21 (see above), wherein the application of electrical stimulation via the multi-site parameter comprises electrically stimulating the at least one of different multiple sites along a length of the first hypoglossal nerve. (para. [0088]: "Co-activating sites A+C involves implanting a first electrode on a hypoglossal nerve proximal of a branch innervating the genioglossus muscle and distal of a branch innervating the geniohyoid muscle, and implanting a second electrode on the hypoglossal nerve proximal of a branch innervating the geniohyoid muscle and distal of branches innervating the hyoglossus muscle and the styloglossus muscle.").
Regarding claim 25, Bolea teaches the method of claim 21 (see above), wherein placing the first implantable stimulation element comprises implanting: at least one first cuff electrode coupled to the first hypoglossal nerve in a neck region (para. [0342]: "The proportion of stimulation intensity of two electrode cuffs used to stimulate a nerve can be modulated while the system is providing therapy based on feedback indicating the presence (or lack) of apneas/hypopneas. For example, one nerve stimulating electrode cuff may be place on the more proximal section of the hypoglossal nerve, while a second is placed more distally."); a lead (Fig. 2; para. [0047]: "stimulation lead body 62") supporting, and extending proximally from, the at least one first cuff electrode (Fig. 2; para. [0047]: "the stimulation lead body 62 disposed in a subcutaneous tunnel, the nerve cuff electrode 64 disposed on a nerve…") to extend into a pectoral region (Fig. 37; see "Distal current carrying electrode" placed in pectoral region); and an implantable pulse generator in the pectoral region and which is connectable to the lead (Fig. 37; see "pulse generator location"; para. [0046]: "The implanted components of the system 10 may generally include an implanted neurostimulator (INS) 50 (a.k.a., implanted pulse generator (IPG)), an implanted stimulation lead (or leads) 60"; This shows that the IPG is connected to the lead.).
Regarding claim 26, Bolea teaches the method of claim 25 (see above), wherein the at least one first cuff electrode (Fig. 6; nerve cuff electrode 64; para. [0066]) comprises multiple electrodes spaced longitudinally along a length of a body of the cuff electrode. (Fig. 6; para. [0067]: "anode electrodes 90A and 90B; Fig. 6 shows the electrodes spaced apart along the cuff body 80).
Regarding claim 27, Bolea teaches the method of claim 26 (see above), wherein applying the simulation comprises selectively applying via the multiple electrodes (para. [0088-89]; “first” and “second” electrodes), stimulation via the multi-site parameter and/or the multi- fascicle parameter (para. [0088-0089]; Fig. 12; para. [0195]: “the neurostimulation system described herein may operate in a closed-loop process 400 wherein stimulation of the targeted nerve may be delivered as a function of a sensed feedback parameter (e.g., respiration). For example, stimulation of the hypoglossal nerve may be triggered to occur during the inspiratory phase of respiration.”).
Regarding claim 28, Bolea teaches the method of claim 21 (see above), wherein the first hypoglossal nerve is on a first side of the body, and comprising: arranging a second implantable stimulation element (para. [0059]: " One or more electrodes") to be in electrical stimulating relation to a second hypoglossal nerve on an opposite second side of the body (para. [0075]: " With reference to FIG. 10, surgical access sites are schematically shown for implanting the internal neurostimulator components 20 shown in FIG. 1. The internal neurostimulator components 20 may be surgically implanted in a patient on the right or left side."); and applying electrical stimulation, via the second implantable stimulation element, to the second hypoglossal nerve (para. [0077]: " With reference to FIGS. 11A and 11B, a surgical dissection 110 to the hypoglossal nerve is shown schematically. A unilateral dissection is shown, but a bilateral approach for bilateral stimulation may also be employed.") continuously at a tone intensity during the sleep treatment period according to (para. [0073]: " In addition, sensing the impedance of lead 60 may facilitate periodic, automated adjustment of stimulation pulse amplitude so as to maintain constant current, energy, and/or charge delivery using a simpler voltage mode delivery circuit."; para. [0341]: "The electrical field shape for an implanted system can be changed by adjusting the polarity, amplitude and other stimulation intensity parameters for each of the electrodes within the nerve stimulating cuff."): the multi-site parameter to electrically stimulate at least one of different multiple sites of the second hypoglossal nerve (Fig. 12; para. [0089]: " Co-activating sites A+C+D involves implanting a first electrode on a hypoglossal nerve proximal of a branch innervating the genioglossus muscle and distal of a branch innervating the geniohyoid muscle; implanting a second electrode on the hypoglossal nerve proximal of a branch innervating the geniohyoid muscle and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a third electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the sternohyoid."); and the multi-fascicle parameter to electrically stimulate at least one of different multiple fascicles within the second hypoglossal nerve. (Fig. 12; para. [0090-0092] describe electrodes placed on muscles of the first hypoglossial nerve; Additionally, para. [0195] shows that the system operates as a closed system and stimulation is applied as a function of sensed feedback parameters) (para. [0019]: "[0019] FIG. 10 schematically illustrates surgical access and tunneling sites for implanting the system illustrated in FIG. 2; The bilaterial electrode configuration is a duplication of the electrode from claim 21.; para. [0059]: " one or more electrodes may be used for attachment to one or more portions of nerves on both sides (bilateral) of the body. Variations in lead body 62 and electrode 64 design as well as variations in the target stimulation site or sites will be described in more detail hereinafter."; para. [0077]: "a surgical dissection 110 to the hypoglossal nerve is shown schematically. A unilateral dissection is shown, but a bilateral approach for bilateral stimulation may also be employed."; Although not shown in the drawings, Bolea teaches replicating the electrode configuration of claim 21 for a contralateral side in a bilateral configuration.).
Regarding claim 29, Bolea teaches The method of claim 28 (see above), comprising: implementing the application of electrical stimulation to the first hypoglossal nerve and the second hypoglossal nerve according to a bilateral parameter via which one or both of the respective first and second hypoglossal nerves may be stimulated (para. [0059]: " the stimulation lead 60 may comprise a variety of different design embodiments and may be positioned at different anatomical sites…The nerve electrode 64 may be attached to a specific branch of a nerve innervating the desired muscle(s), or may be attached to a proximal trunk of the nerve in which a specific fascicle innervating the desired muscle(s) is targeted by steering the stimulus with multiple electrodes…or one or more electrodes may be used for attachment to one or more portions of nerves on both sides (bilateral) of the body."; para. [0073]: "In addition, sensing the impedance of lead 60 may facilitate periodic, automated adjustment of stimulation pulse amplitude so as to maintain constant current, energy, and/or charge delivery using a simpler voltage mode delivery circuit."; The paragraphs show that bilateral stimulation may be used, and that a parameter (bioimpedance) may be measured to control the delivery of the stimulation.).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 30-33 and 34-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bolea et al. (US 20080103545 A1, "Bolea") in view of Erikson (US 5549655 A).
Regarding claim 30, Bolea teaches the method of claim 29 (see 102 rejection above). However, Bolea does not expressly teach implementing the via at least the bilateral parameter, the multi-site parameter, and the multi-fascicle parameter to selectively: incrementally increase the intensity of the stimulation.
Erikson, in the same field of endeavor of treating obstructive sleep apnea, discloses a method of stimulating the upper airways and hypoglossal nerve. Erikson discloses implementing a via at least a bilateral parameter, the multi-site parameter, and the multi-fascicle parameter to selectively: incrementally increase the intensity of the stimulation (para. (20): "These values can then be stored in memory and compared with the same parameters in each respiratory cycle to identify the increased inspiratory effort above a predetermined threshold value that is characteristic of an apnea event. The threshold value can be programmed into the device according to the requirements of the particular patient. Upon detection of the onset of the apnea event, stimulation can then be enabled to restore the airway to patency or the stimulation intensity can be increased if the intensity of stimulation being given has been inadequate to produce patency.") upon sensing sleep disordered breathing behavior exceeding a programmable threshold (para. (20): "The threshold value can be programmed into the device according to the requirements of the particular patient. Upon detection of the onset of the apnea event, stimulation can then be enabled to restore the airway to patency or the stimulation intensity can be increased if the intensity of stimulation being given has been inadequate to produce patency."); and decrementally decrease the intensity of the stimulation upon sensing sleep disordered breathing behavior below the programmable threshold (para. (10): "The shape of the stimulus burst is indicated as a stimulus window 175 which includes a peak amplitude 177 which is specifically set by the physician at a level required by the patient, a ramp 179 gradually increasing the stimulus during a rise time and a ramp 181 gradually decreasing stimulus during a fall time.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bolea to further include incrementally increasing and decreasing the stimulation intensity upon crossing a threshold, as disclosed by Erikson. One of ordinary skill would recognize that combining the methods of Erikson would improve Bolea’s method by providing practical and reliable detection of the inspiration portion of the respiratory cycle, which would improve the treatment of obstructive sleep apnea (see Erikson para. (6)). Therefore, it would have been obvious to combine the method of Bolea with the method of Erikson.
Regarding claim 32, Bolea teaches the method of claim 21 (see 102 rejection above). However, Bolea does not expressly teach implementing the application of the electrical stimulation to increase upper airway patency at least until a number of obstructive sleep apnea events changes from a first level to a second level as assessed via a pulse generator in communication with the first stimulation element.
Erikson discloses implementing the application of the electrical stimulation to increase upper airway patency at least until a number of obstructive sleep apnea events changes from a first level to a second level as assessed via a pulse generator in communication with the first stimulation element (para. (20): "These values can then be stored in memory and compared with the same parameters in each respiratory cycle to identify the increased inspiratory effort above a predetermined threshold value that is characteristic of an apnea event. The threshold value can be programmed into the device according to the requirements of the particular patient. Upon detection of the onset of the apnea event, stimulation can then be enabled to restore the airway to patency or the stimulation intensity can be increased if the intensity of stimulation being given has been inadequate to produce patency.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bolea to further include modulating stimulation based on the detected changes in sleep apnea events, as disclosed by Erikson. One of ordinary skill would recognize that combining the methods of Erikson would improve Bolea’s method by providing practical and reliable detection of the inspiration portion of the respiratory cycle, which would improve the treatment of obstructive sleep apnea (see Erikson para. (6)). Therefore, it would have been obvious to combine the method of Bolea with the method of Erikson.
Regarding claim 33, Bolea, in combination with Erikson, discloses the method of claim 32 (see above). Bolea further discloses assessing an effectiveness of the electrical stimulation as the number of obstructive sleep apnea events during the sleep period while applying the electrical stimulation signal. (para. [0073]: “In addition, sensing the impedance of lead 60 may facilitate periodic, automated adjustment of stimulation pulse amplitude so as to maintain constant current, energy, and/or charge delivery using a simpler voltage mode delivery circuit. Such automated adjustment may facilitate ensuring safety and effectiveness by consistently delivering the prescribed current, energy, or charge in the presence of tissue/electrode impedance variations. By consistently controlling the delivery of only the minimally required energy necessary for stimulation of the nerve, the stimulation amplitude may be programmed closer to the actual stimulation threshold rather than programming a wide margin to ensure continued effectiveness.”).
Regarding claim 34, Bolea, in combination with Erikson, discloses the method of claim 33 (see above). Bolea further discloses wherein the assessing during the sleep period comprises on- going monitoring of sensed physiologic conditions (para. [0072]: “System 10 may also include a plurality of diagnostic mechanisms (e.g., circuitry and/or programming) for monitoring and/or determining the functionality of certain components… While those having ordinary skill in the art will readily recognize that any suitable impedance sensing method may be utilized to monitor and/or determine the functionality of lead 60…”; Additionally, para. [0180] discloses monitoring respiration signals: “By way of example, not limitation, the following bio-Z vectors may be effective for monitoring respiration and/or for measuring artifacts for subsequent removal of the artifact from the respiration signal.”).
Regarding claim 35, Bolea, in combination with Erikson, discloses the method of claim 34 (see above). Bolea further discloses wherein the sensed physiologic conditions include a duration of the respective obstructive sleep apnea events and/or an intensity of the respective obstructive sleep apnea events. (para. [0214]: "Generally, if the CV is greater than 0.20 over a one minute period then person is awake. Also generally, if the CV is less than 0.20 over a one-minute period then person is asleep. These events may be flagged for the step of fiducial extraction 378 wherein data (e.g., event duration, CV, PP range, PPmin, PPmax, etc.) may be time stamped and stored with an event identifier.").
Claims 31 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani (US 20060247729 A1, “Tehrani”) in view of Bolea et al. (US 20080103545 A1, "Bolea").
Regarding claim 31, Tehrani teaches the method of claim 21 (see 102 rejection above). However, Tehrani does not expressly teach implementing the via at least the multi-site parameter and the multi-fascicle parameter to selectively: incrementally increase the intensity of the stimulation upon sensing sleep disordered breathing behavior exceeding a programmable threshold; or decrementally decrease the intensity of the stimulation upon sensing sleep disordered breathing behavior below the programmable threshold.
Bolea, in the same field of endeavor of treating obstructive sleep apnea, discloses a device and method for providing therapeutic nerve stimulation for treatment of obstructive sleep apnea. Bolea discloses implementing the via at least the multi-site parameter and the multi-fascicle parameter (para. [0069]: "Electrode 51 may stimulate (as well as sense) at the upper airway muscles or hypoglossal nerve."; para. [0070]: "The control unit 100 is configured to receive and process signals corresponding to sensed physiological parameters, e.g., pressure, flow, nerve activity, diaphragm or intercostal muscle movement."; para. [0071]: "Electrode(s) 51, may be placed at or near the hypoglossal nerve in accordance with a variation of the invention where stimulation of the diaphragm is coordinated with activation of upper airway muscles to open the airway passage just prior to stimulating the diaphragm muscles. Electrode(s) 51 is (are) coupled through lead(s) 52 to electronics in control unit 100.") to selectively: incrementally increase the intensity of the stimulation upon sensing sleep disordered breathing behavior exceeding a programmable threshold (Fig. 4A and 4C; threshold 450; para. [0110]: "For purposes of detecting a threshold volume on a breath-by-breath basis or in real time, a programmed threshold may be set. The threshold value may be determined when initializing the device as the value at or below which preventative or mitigating treatment is required or is otherwise optimal."); and decrementally decrease the intensity of the stimulation upon sensing sleep disordered breathing behavior below the programmable threshold. (Fig. 4A and 4C; threshold 450; para. [0112]: "An obstructive respiratory event may be detected by monitoring a decrease in tidal volume, for example as a predetermined percentage of normal or intrinsic tidal volume. The threshold 450 below which treatment is to be provided by the device is shown in FIGS. 4A-4D. FIG. 4D illustrates a stimulation protocol corresponding to the resulting tidal volume waveforms of FIG. 4C."; Referring to FIG. 11A, the tidal volume from intrinsic breathing gradually decreases (1111, 1112) until it falls below a threshold level 1150 (1113-1115) and then resumes normal tidal volume (1116-1117) after treatment. After breath 1113 is detected below threshold level 1150, a stimulation pulse 1160 is provided during and in synchronization with the subsequent breath 1114, 1115 to thereby provide the resulting breath.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tehrani to further include a threshold for increasing and decreasing stimulation when the threshold is crossed, as disclosed by Bolea. One of ordinary skill would recognize that incremental changes would improve the delivery of the stimulation by adjusting the level of stimulation in accordance with the number of apnea events. One of ordinary skill would also recognize that combining the methods of Bolea would improve Tehrani’s method by providing a treatment method that is a non-invasive option with effective results for treating obstructive sleep apnea (see Bolea para. [0004-0005]). Therefore, it would have been obvious to combine the methods of Bolea with methods of Tehrani.
Claims 32, 36, and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani (US 20060247729 A1, “Tehrani”) in view of Erikson (US 5549655 A).
Regarding claim 32, Tehrani teaches the method of claim 21 (see 102 rejection above). However, Tehrani does not expressly teach implementing the application of the electrical stimulation to increase upper airway patency at least until a number of obstructive sleep apnea events changes from a first level to a second level as assessed via a pulse generator in communication with the first stimulation element.
Erikson, in the same field of endeavor of treating obstructive sleep apnea, discloses a method of stimulating the upper airways and hypoglossal nerve. Erikson discloses implementing a via at least a bilateral parameter, the multi-site parameter, and the multi-fascicle parameter to selectively: incrementally increase the intensity of the stimulation (para. (20): "These values can then be stored in memory and compared with the same parameters in each respiratory cycle to identify the increased inspiratory effort above a predetermined threshold value that is characteristic of an apnea event. The threshold value can be programmed into the device according to the requirements of the particular patient. Upon detection of the onset of the apnea event, stimulation can then be enabled to restore the airway to patency or the stimulation intensity can be increased if the intensity of stimulation being given has been inadequate to produce patency.") upon sensing sleep disordered breathing behavior exceeding a programmable threshold (para. (20): "The threshold value can be programmed into the device according to the requirements of the particular patient. Upon detection of the onset of the apnea event, stimulation can then be enabled to restore the airway to patency or the stimulation intensity can be increased if the intensity of stimulation being given has been inadequate to produce patency."); and decrementally decrease the intensity of the stimulation upon sensing sleep disordered breathing behavior below the programmable threshold (para. (10): "The shape of the stimulus burst is indicated as a stimulus window 175 which includes a peak amplitude 177 which is specifically set by the physician at a level required by the patient, a ramp 179 gradually increasing the stimulus during a rise time and a ramp 181 gradually decreasing stimulus during a fall time.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tehrani to further include incrementally increasing and decreasing the stimulation intensity upon crossing a threshold, as disclosed by Erikson. One of ordinary skill would recognize that combining the methods of Erikson would improve Tehrani’s method by providing practical and reliable detection of the inspiration portion of the respiratory cycle, which would improve the treatment of obstructive sleep apnea (see Erikson para. (6)). Therefore, it would have been obvious to combine the method of Tehrani with the method of Erikson.
Regarding claim 36, Tehrani, in combination with Erikson, discloses the method of claim 32 (see above). Tehrani further discloses wherein the second level is less than the first level, and the method comprises: decreasing application of the electrical stimulation during the sleep period while the number of obstructive sleep apnea events is maintained at or below the second level. ("para. [0131]: "When control of respiratory rate is achieved (and possibly entrainment), if a slowing of the breathing rate is desired, the pacing rate can be decreased gradually as shown schematically in the Figure by stimuli delivered at a cycle length of T2+x, followed by T2+2x, inducing paced breaths 1426 and 1427.").
Regarding claim 37, Tehrani, in combination with Erikson, discloses the method of claim 36 (see above). Tehrani further discloses wherein decreasing application of the electrical stimulation signal during the sleep period comprises decreasing at least one of: a duration of the applied electrical stimulation; a frequency of the applied electrical stimulation; and an amplitude of the applied electrical stimulation. (para. [0082]: "The first RAM memory 119 may be programmed to provide certain stimulation parameters such as pulse or burst morphology; frequency, pulse width, pulse amplitude, duration and a threshold or trigger to determine when to stimulate.").
Claim 38 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani (US 20060247729 A1, “Tehrani ‘729”), Erikson (US 5549655 A), and Tehrani (US 20050085866 A1, “Tehrani ‘866”).
Regarding claim 38, Tehrani 729’, in combination with Erikson, discloses the method of claim 36 (see 103 rejection above). However, neither reference expressly discloses wherein decreasing the application during the sleep period comprises: terminating application of the electrical stimulation signal when the number of obstructive sleep apnea events is at or below the second level.
Tehrani ‘866, in the same field of endeavor of treating breathing disorders, discloses a therapy delivery device and methods for treatment. Tehrani ‘866 discloses wherein decreasing the application during the sleep period comprises: terminating application of the electrical stimulation signal when the number of obstructive sleep apnea events is at or below the second level. (para. [0033]: "Other information may also be sensed and used to determine if to stimulate, and when to stop or modify stimulation. Also, the processor may determine when to cease stimulation by determining when the body resumes normal respiratory function, when respiration has been captured or is being controlled by the stimulation, or when the breathing disorder has been prevented or treated.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tehrani ‘729 to further include terminating stimulation upon crossing an apnea threshold, as disclosed by Tehrani ‘866. One of ordinary skill would recognize that combining the methods of Tehrani ‘866 would improve Tehrani ‘729’s method by providing preventing and predicting a breathing disorder (see Tehrani ‘866 para. [0016]). Therefore, it would have been obvious to combine the method of Tehrani ‘729 with the method of Tehrani ‘866.
Claim 39 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tehrani (US 20060247729 A1, “Tehrani ‘729”), Erikson (US 5549655 A), and Stahmann et al. (US 20050115561 A1, “Stahmann”)
Regarding claim 39, Tehrani, in combination with Erikson, discloses the method of claim 32 (see 103 rejection above). However, neither reference expressly discloses wherein the first level is greater than the second level, and comprising: increasing application of the electrical stimulation signal during the sleep period to cause the number of obstructive sleep apnea events to decrease from the first level to the second level.
Stahmann, in the same field of endeavor of monitoring for sleep apnea, discloses a system, methods and devices for monitoring and treating respiratory disorders. Stahmann discloses wherein the first level is greater than the second level, and comprising: increasing application of the electrical stimulation signal during the sleep period to cause the number of obstructive sleep apnea events to decrease from the first level to the second level. (para. [0300]: "In one embodiment, episodes of disordered breathing may be detected by monitoring the respiratory waveform output of a transthoracic impedance sensor. When the tidal volume (TV) of the patient's respiration, as indicated by the transthoracic impedance signal, falls below a hypopnea threshold, then a hypopnea event is declared. For example, a hypopnea event may be declared if the patient's tidal volume falls below about 50% of a recent average tidal volume or other baseline tidal volume value. If the patient's tidal volume falls further to an apnea threshold, e.g., about 10% of the recent average tidal volume or other baseline value, an apnea event is declared."; para. [0309]: "If the transthoracic impedance does not exceed 960 the inspiration threshold within a first predetermined interval 965, denoted the sleep apnea interval, then a condition of sleep apnea is detected 970. Severe sleep apnea is detected 980 if the non-breathing period extends beyond a second predetermined interval 975, denoted the severe sleep apnea interval."; para. [0281]: "In one scenario, one or more episodes of disordered breathing are detected and the cardiac electrical therapy is initiated or increased to treat the detected episodes.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tehrani to further include increasing stimulation until and effective amount is applied to reduce apnea, as disclosed by Stahmann. One of ordinary skill would recognize that combining the methods of Stahmann would improve Tehrani’s method by effectively monitoring the complex interactions between cardiovascular and pulmonary system to better identify and treat apnea disorders (see Stahmann [0004-0011]). Therefore, it would have been an obvious improvement to combine the method of Stahmann with the method of Tehrani.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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