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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
The applicant's amendments and arguments/remarks have been fully considered but are moot in view of the new grounds of rejections presented herein. Specifically, the examiner has provided the Gafni reference to teach the limitations presented in the newly amended claims.
Response to Amendment
Information Disclosure Statement
The information disclosure statements filed 08/02/2023 and 07/10/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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:
-‘an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe’ in claim 16. The claim recites a function ‘electrical stimulation signal…delivered…using’ and a generic placeholder ‘probe’. No further structure is given in the claim. For examination purposes it will be treated as a conductive material/sensor as per Page 2, Line 26-Page 3, Line 2 and Page 7, Lines 14-16 of the specification.
-‘applying, from a stimulation head of a sensitized muscle identification system, a stimulation signal’ in claim 29. The claim recites a function ‘applying…a stimulation signal’ and a generic placeholder the head and system. No further structure is given in the claim. For examination purposes it will be treated as a conductive material/sensor as per Page 2, Line 26-Page 3, Line 2 and Page 7, Lines 14-16 of the specification.
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 § 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.
Claim(s) 16, 24-29, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stellar et al. (US 2006/0224210) in view of Hoffman (US Patent No. 5273033) and Gafni et al. (US 2007/0010860).
Regarding claim 16, Stellar teaches a sensitized muscle identification system (Abstract) comprising:
a stimulation probe (10; ‘electron-neuron stimulator’) comprising a handle (12) and a stimulation head (18/22; ‘first electrode 18 includes a circular-shaped head’) at an end of the handle (Figures 1-2; Paragraph 0023);
a reference electrode (80; ‘ground electrode’); and
a control system (Paragraph 0028; printed circuit board including potentiometers) in communication with the stimulation probe and the reference electrode (Paragraph 0028), the control system comprising: (i) a processor configured to execute instructions stored in memory of the control system; and (ii) a signal generator (DSP; digital signal processor functions as both the processor and signal generator; Paragraphs 0013 and 0055).
Stellar is silent on the stimulation inducing an activation potential in a plurality of nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces a contractile response in the stimulated muscle.
Hoffman teaches configured to generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle (Column 2, Lines 23-52; either the sensor level stimulation or the noxious level stimulation without muscle contraction; noxious stimulation specifically activates nociceptors).
It would have been obvious to one of ordinary skill in the art to have modified Stellar with Hoffman because Stellar teaches being able to adjust the stimulation as desired (Paragraphs 0036-0037 of Stellar) and Hoffman teaches these types of stimulations as being known in the art (Column 2, Lines 23-26) thus one of ordinary skill in the art could combine the teachings through routine experimentation with reasonable expectation of predictable results.
Examiner notes that the language of “when” makes the limitation conditional such that is it not required but merely the system must be capable of performing this. As Stellar and Hoffman are capable of generating various stimulation levels, they would be fully capable of providing the stimulation level as stated in the claim.
Should this be found not explicit enough, Gafni teaches generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle (Paragraph 0096; being able to stimulate and differentiate between high threshold nociceptor and low threshold nociceptor would allow for the claimed functionality; the high threshold nociceptor being equivalent to the non-sensitized nociceptor and the low threshold nociceptor being equivalent to the sensitized nociceptor).
It would have been obvious to one of ordinary skill in the art to have modified Stellar in view of Hoffman with Gafni because it aids in diagnosing pathological effects of various maladies, and selective assessment of peripheral nerve system functioning and of sensor loss (Paragraph 0095 of Gafni).
Regarding claim 24, Stellar teaches wherein the electrical stimulation signal comprises a carrier wave and a modulation wave (Paragraph 0037).
Regarding claim 25, Stellar teaches wherein the carrier wave and the modulation wave each have a respective frequency parameter and a respective amplitude parameter (Paragraph 0037).
Regarding claim 26, Stellar teaches wherein the frequency parameter of the carrier wave is between 0.1 kHz and 10 kHz (Paragraph 0037; ‘For example, the carrier frequency can be a sinusoidal waveform falling within a frequency range of about 1500 Hz to about 5000 Hz)
Regarding claim 27, Stellar teaches wherein the frequency parameter of the modulation wave is between 0.01 kHz and 1 kHz (Paragraph 0037; ‘amplitude modulated with a sinusoidal waveform which produces a beat frequency in the range of about 1 Hz to about 200 Hz.’)
Regarding claim 28, Stellar is silent on the stimulation as claimed. Hoffman teaches wherein the sensation of pressure or discomfort is produced within the stimulated muscle from an origin of the stimulated muscle to an insertion of the stimulated muscle (Column 2, Lines 23-52; either the sensor level stimulation or the noxious level stimulation without muscle contraction).
It would have been obvious to one of ordinary skill in the art to have modified Stellar with Hoffman because Stellar teaches being able to adjust the stimulation as desired (Paragraphs 0036-0037 of Stellar) and Hoffman teaches these types of stimulations as being known in the art (Column 2, Lines 23-26) thus one of ordinary skill in the art could combine the teachings through routine experimentation with reasonable expectation of predictable results.
Regarding claim 29, Stellar teaches a method (Abstract), comprising:
applying, from a stimulation head (18/22; ‘first electrode 18 includes a circular-shaped head’) of a sensitized muscle identification system (10), a stimulation signal to a patient's skin surface that is proximate to an individual muscle (Figures 1-2; Paragraph 0023);
Stellar is silent on the stimulation inducing an activation potential in a plurality of nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle.
Hoffman teaches to induce an activation potential in a plurality of sensitized nociceptors present in the individual muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle, wherein the activation potential in the plurality of sensitized nociceptors induces a sensation of discomfort in the individual muscle that is experienced by the patient (Column 2, Lines 23-52; either the sensor level stimulation or the noxious level stimulation without muscle contraction; noxious stimulation specifically activates nociceptors).
It would have been obvious to one of ordinary skill in the art to have modified Stellar with Hoffman because Stellar teaches being able to adjust the stimulation as desired (Paragraphs 0036-0037 of Stellar) and Hoffman teaches these types of stimulations as being known in the art (Column 2, Lines 23-26) thus one of ordinary skill in the art could combine the teachings through routine experimentation with reasonable expectation of predictable results.
Should this be found not explicit enough, Gafni teaches applying a stimulation signal, to induce an activation potential in a plurality of sensitized nociceptors present in the individual muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle (Paragraph 0096; being able to stimulate and differentiate between high threshold nociceptor and low threshold nociceptor would allow for the claimed functionality; the high threshold nociceptor being equivalent to the non-sensitized nociceptor and the low threshold nociceptor being equivalent to the sensitized nociceptor).
It would have been obvious to one of ordinary skill in the art to have modified Stellar in view of Hoffman with Gafni because it aids in diagnosing pathological effects of various maladies, and selective assessment of peripheral nerve system functioning and of sensor loss (Paragraph 0095 of Gafni).
Regarding claim 35, Stellar is silent on the stimulation as claimed. Hoffman teaches wherein the sensation of discomfort is produced within the individual muscle from an origin of the individual muscle to an insertion of the individual muscle (Column 2, Lines 23-52; either the sensor level stimulation or the noxious level stimulation without muscle contraction).
It would have been obvious to one of ordinary skill in the art to have modified Stellar with Hoffman because Stellar teaches being able to adjust the stimulation as desired (Paragraphs 0036-0037 of Stellar) and Hoffman teaches these types of stimulations as being known in the art (Column 2, Lines 23-26) thus one of ordinary skill in the art could combine the teachings through routine experimentation with reasonable expectation of predictable results.
Claim(s) 17-19 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stellar et al. (US 2006/0224210) in view of Hoffman (US Patent No. 5273033) and Gafni et al. (US 2007/0010860) and in further view of Rondoni et al. (US 2013/0204097).
Regarding claim 17, Stellar is silent on the user interface. Rondoni teaches further comprising:
a user interface comprising a graphical interface and controls for adjusting parameters of the electrical stimulation signal generated by the signal generator (Figures 1 and 3), wherein the memory of the control system comprises information identifying major muscle groups of the patient and a plurality of individual muscles within each of the major muscle groups (Paragraph 0083), the user interface configured to:
(i) display, via the graphical interface, depictions of the major muscle groups and the plurality of individual muscles within each of the major muscle groups (Figures 1, 3, 6B, and 12 and associated disclosure),
(ii) receive user selections of one or more individual muscles of the plurality of individual muscles (Paragraphs 0097-0102), and
(iii) receive patient input that indicates the sensation experienced in the stimulated muscle of the patient in response to applying the electrical stimulation signal to the skin surface of the patient overlying the stimulated muscle (Paragraphs 0097-0102; response can qualify as a patient input).
It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for quantitative evaluation of the muscle stimulation information that easily differentiates between target muscles and non-target muscles thus simplifying the role of the operation by providing real-time representations of the effect of a particular stimulation (Paragraph 0019 of Rondoni).
Regarding claim 18, Stellar is silent on the user interface. Rondoni teaches wherein the control system is further configured to store information relevant to locations of the plurality of individual muscles within each of the major muscle groups, and to control the user interface to display the information relevant to the locations of the plurality of individual muscles in response to the user selections of the one or more individual muscles of the plurality of individual muscles (Paragraph 0097; ‘2) highlighting, upon activation via the stimulation signal, at least one of the respective muscle groups listed in the index,’; ‘the nerve-muscle index aids in displaying or identifying to the user, which muscle group has been activated in the event that the graphical display of the activated muscle in image 40 is difficult to see.’). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for determining and visually representing of a location of a stimulation element relative to the body in real time while also simultaneously allowing for quantitative evaluation of the stimulation (Paragraph 0018 of Rondoni). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for quantitative evaluation of the muscle stimulation information that easily differentiates between target muscles and non-target muscles thus simplifying the role of the operation by providing real-time representations of the effect of a particular stimulation (Paragraph 0019 of Rondoni).
Regarding claim 19, Stellar is silent on the user interface. Rondoni teaches wherein the information relevant to locations of the plurality of individual muscles includes one or more of:an origin point location, an insertion point location, a frequently identified muscle corresponding to pain described by the patient, a muscle name, a muscle identification landmark, a biological feature corresponding to each of the plurality of individual muscles, a nerve, a vascular hazard, a stimulation signal parameter (Paragraphs 0097-0102; Figures 1, 3, 6B, and 12 and associated disclosure). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for quantitative evaluation of the muscle stimulation information that easily differentiates between target muscles and non-target muscles thus simplifying the role of the operation by providing real-time representations of the effect of a particular stimulation (Paragraph 0019 of Rondoni).
Regarding claim 30, Stellar is silent on the user interface. Rondoni teaches comprising displaying, by a user interface and in response to a first user selection, a major muscle group comprising a plurality of individual muscles, the plurality of individual muscles comprising the individual muscle being stimulated, receiving, by the user interface, a second user selection of the individual muscle being stimulated (Paragraph 0097; ‘2) highlighting, upon activation via the stimulation signal, at least one of the respective muscle groups listed in the index,’; ‘the nerve-muscle index aids in displaying or identifying to the user, which muscle group has been activated in the event that the graphical display of the activated muscle in image 40 is difficult to see.’; Further see Paragraphs 0098-0102; Figures 1, 3, 6B, and 12 and associated disclosure). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for quantitative evaluation of the muscle stimulation information that easily differentiates between target muscles and non-target muscles thus simplifying the role of the operation by providing real-time representations of the effect of a particular stimulation (Paragraph 0019 of Rondoni).
Regarding claim 31, Stellar is silent on the user interface. Rondoni teaches further comprising displaying, by the user interface and responsive to the second user selection, information relevant to locating the individual muscle (Paragraph 0097; ‘2) highlighting, upon activation via the stimulation signal, at least one of the respective muscle groups listed in the index,’; ‘the nerve-muscle index aids in displaying or identifying to the user, which muscle group has been activated in the event that the graphical display of the activated muscle in image 40 is difficult to see.’; Further see Paragraphs 0098-0102; Figures 1, 3, 6B, and 12 and associated disclosure). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for quantitative evaluation of the muscle stimulation information that easily differentiates between target muscles and non-target muscles thus simplifying the role of the operation by providing real-time representations of the effect of a particular stimulation (Paragraph 0019 of Rondoni).
Regarding claim 32, Stellar is silent on the user interface. Rondoni teaches wherein the displaying the information relevant to locating the individual muscle includes: displaying one or more of an origin point location, an insertion point location, a frequently identified muscle corresponding to pain described by the patient, a muscle name, a muscle identification landmark, a biological feature corresponding to individual muscles, a nerve, a vascular hazard, a stimulation signal parameter, or a referred pain muscle associated with the individual muscle being stimulated (Paragraphs 0097-0102; Figures 1, 3, 6B, and 12 and associated disclosure). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Rondoni because it allows for quantitative evaluation of the muscle stimulation information that easily differentiates between target muscles and non-target muscles thus simplifying the role of the operation by providing real-time representations of the effect of a particular stimulation (Paragraph 0019 of Rondoni).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stellar et al. (US 2006/0224210) in view of Hoffman (US Patent No. 5273033) and Gafni et al. (US 2007/0010860) and Rondoni et al. (US 2013/0204097) and in further view Giuffrida et al. (US Patent No. 9314190).
Regarding claim 20, Stellar is silent on the storing of treatment information. Giuffrida teaches wherein the control system is further configured to store a description of one or more supplementary treatments for each of the plurality of individual muscles and display at least one supplementary treatment of the stimulated muscle responsive to the patient input that indicates the sensation experienced in the stimulated muscle (Column 3, Lines 66-Column 4, Line 32). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Giuffrida because it allows for a more patient customized and adaptive recovering and treatment (Column 4, Lines 1-32 of Giuffrida).
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stellar et al. (US 2006/0224210) in view of Hoffman (US Patent No. 5273033) and Gafni et al. (US 2007/0010860) and Rondoni et al. (US 2013/0204097) and Giuffrida et al. (US Patent No. 9314190) and in further view Pundyk et al. (US 2019/0000711).
Regarding claim 21, Stellar is silent on the storing of treatment information. Pundyk wherein the one or more supplementary treatments comprises dry needling, trigger point injections, muscle tendon injections, injections of various medications, massage, electrical nerve stimulation, acupressure, acupuncture, photo-bio-modulation, or stretching (Paragraph 0001). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Pundyk because these are conventional treatment options (Paragraph 0001 of Pundyk) such that having them as treatments would be routine to one of ordinary skill in the art and using such conventional treatments would yield predictable results.
Regarding claim 22, Stellar is silent on the storing of treatment information. Giuffrida teaches wherein the control system is further configured to store historical treatment information related to a plurality of historical treatments for each of the plurality of individual muscles, and to control the user interface to display the historical treatment information on the graphical interface (Column 3, Lines 66-Column 4, Line 32). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Giuffrida because it allows for a more patient customized and adaptive recovering and treatment (Column 4, Lines 1-32 of Giuffrida).
Regarding claim 23, Stellar is silent on the storing of treatment information. Giuffrida teaches wherein the historical treatment information comprises a historical treatment date, an indication of historical treatment, or a type of historical treatment (Column 3, Lines 66-Column 4, Line 32). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Giuffrida because it allows for a more patient customized and adaptive recovering and treatment (Column 4, Lines 1-32 of Giuffrida).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stellar et al. (US 2006/0224210) in view of Hoffman (US Patent No. 5273033) and Gafni et al. (US 2007/0010860) and in further view of Giuffrida et al. (US Patent No. 9314190).
Regarding claim 33, Stellar is silent on the storing of treatment information. Giuffrida teaches further comprising displaying, by a user interface and responsive to receiving the second user selection, at least one supplementary treatment of the individual muscle being stimulated (Column 3, Lines 66-Column 4, Line 32). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Giuffrida because it allows for a more patient customized and adaptive recovering and treatment (Column 4, Lines 1-32 of Giuffrida).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stellar et al. (US 2006/0224210) in view of Hoffman (US Patent No. 5273033) and Gafni et al. (US 2007/0010860) and Giuffrida et al. (US Patent No. 9314190) and in further view of Pundyk et al. (US 2019/0000711)
Regarding claim 34, Stellar is silent on the storing of treatment information. Pundyk teaches wherein the at least one supplementary treatment comprises dry needling, trigger point injections, muscle tendon injections, injections of various medications, massage, electrical nerve stimulation, acupressure, acupuncture, photo-bio- modulation, or stretching (Paragraph 0001). It would have been obvious to one of ordinary skill in the art to have modified Stellar with Pundyk because these are conventional treatment options (Paragraph 0001 of Pundyk) such that having them as treatments would be routine to one of ordinary skill in the art and using such conventional treatments would yield predictable results.
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 29-35 are rejected on the ground of nonstatutory double patenting as being unpatentable being unpatentable over claims 1-9 of U.S. Patent No. 11484257 in view of Gafni et al. (US 2007/0010860). Although the claims at issue are not identical, they are not patentably distinct from each other because see the overlapping subject matter identified in the chart below. The Conflicting Patent does not disclose the newly added claim limitation towards the sensitized nociceptors vs non-sensitized nociceptors.
Gafni teaches generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle (Paragraph 0096; being able to stimulate and differentiate between high threshold nociceptor and low threshold nociceptor would allow for the claimed functionality; the high threshold nociceptor being equivalent to the non-sensitized nociceptor and the low threshold nociceptor being equivalent to the sensitized nociceptor). It would have been obvious to one of ordinary skill in the art to have modified the conflicting patent with Gafni because it aids in diagnosing pathological effects of various maladies, and selective assessment of peripheral nerve system functioning and of sensor loss (Paragraph 0095 of Gafni).
Instant Application 18/331,587
Conflicting US Patent No. 11484257
29. (New) A method, comprising: applying, from a stimulation head of a sensitized muscle identification system, a stimulation signal to a patient's skin surface that is proximate to an individual muscle to induce an activation potential in a plurality of sensitized nociceptors present in the individual muscle while remaining below a threshold that induces an activation potential in non-sensitized nocicpetors within the stimulated muscle, wherein the activation potential in the plurality of sensitized nociceptors induces a sensation of discomfort in the individual muscle that is experienced by the patient.
1. A sensitized muscle identification method comprising:
inputting an identifier of a muscle group into a sensitized muscle identification system;
receiving, from the sensitized muscle identification system, a compilation of muscles within the muscle group;
receiving from a patient a muscle group producing a pain sensation; inputting the muscle group into the sensitized muscle identification system;
receiving from the sensitized muscle identification system a table of muscles within the muscle group; selecting a first muscle to be tested from within the muscle group;
placing a sensor head of an electrical stimulation probe of the sensitized muscle identification system in contact with a first skin surface of the patient, the first skin surface being proximate to the first muscle; and
applying a stimulation signal to the first skin surface using the sensor head to induce an activation potential in a plurality of sensitized nociceptors present in the first muscle while remaining below a threshold that induces a contractile response in the first muscle, wherein the activation potential in the plurality of sensitized nociceptors induces a sensation of discomfort in the first muscle that is experienced by the patient.
Claims 16-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11484257 in view of Stellar et al. (US 2006/0224210) and Gafni et al. (US 2007/0010860).
The Conflicting Patent does not disclose the stimulation probe handle, reference electrode, and control system with a processor and signal generator or the newly added claim limitation towards the sensitized nociceptors vs non-sensitized nociceptors. Stellar discloses each of these elements as noted in the 103 rejection above. It would have been obvious to one of ordinary skill in the art to have modified the Conflicting Patent with Stellar since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the stimulation system of the Conflicting Patent with that of Stellar. Gafni teaches generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle (Paragraph 0096; being able to stimulate and differentiate between high threshold nociceptor and low threshold nociceptor would allow for the claimed functionality; the high threshold nociceptor being equivalent to the non-sensitized nociceptor and the low threshold nociceptor being equivalent to the sensitized nociceptor). It would have been obvious to one of ordinary skill in the art to have modified the conflicting patent with Gafni because it aids in diagnosing pathological effects of various maladies, and selective assessment of peripheral nerve system functioning and of sensor loss (Paragraph 0095 of Gafni).
Further the patent is the method version essentially of using the system of the instant application. The functions performed by the system of the instant application are all recited as method steps in the Conflicting Patent.
Instant Application 18/331,587
Conflicting US Patent No. 11484257
16. (New) A sensitized muscle identification system comprising:
a stimulation probe comprising a handle and a stimulation head at an end of the handle;
a reference electrode; and
a control system in communication with the stimulation probe and the reference electrode, the control system comprising: (i) a processor configured to execute instructions stored in memory of the control system; and (ii) a signal generator configured to generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle.
1. A sensitized muscle identification method comprising:
inputting an identifier of a muscle group into a sensitized muscle identification system;
receiving, from the sensitized muscle identification system, a compilation of muscles within the muscle group;
receiving from a patient a muscle group producing a pain sensation;
inputting the muscle group into the sensitized muscle identification system;
receiving from the sensitized muscle identification system a table of muscles within the muscle group;
selecting a first muscle to be tested from within the muscle group;
placing a sensor head of an electrical stimulation probe of the sensitized muscle identification system in contact with a first skin surface of the patient, the first skin surface being proximate to the first muscle; and
applying a stimulation signal to the first skin surface using the sensor head to induce an activation potential in a plurality of sensitized nociceptors present in the first muscle while remaining below a threshold that induces a contractile response in the first muscle, wherein the activation potential in the plurality of sensitized nociceptors induces a sensation of discomfort in the first muscle that is experienced by the patient.
Claims 16-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11707222 in view of Gafni et al. (US 2007/0010860). Although the claims at issue are not identical, they are not patentably distinct from each other because see the overlapping subject matter identified in the chart below. The Conflicting Patent does not disclose the newly added claim limitation towards the sensitized nociceptors vs non-sensitized nociceptors.
Gafni teaches generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle (Paragraph 0096; being able to stimulate and differentiate between high threshold nociceptor and low threshold nociceptor would allow for the claimed functionality; the high threshold nociceptor being equivalent to the non-sensitized nociceptor and the low threshold nociceptor being equivalent to the sensitized nociceptor). It would have been obvious to one of ordinary skill in the art to have modified the conflicting patent with Gafni because it aids in diagnosing pathological effects of various maladies, and selective assessment of peripheral nerve system functioning and of sensor loss (Paragraph 0095 of Gafni).
Instant Application 18/331,587
Conflicting US Patent No. 11707222
16. (New) A sensitized muscle identification system comprising:
a stimulation probe comprising a handle and a stimulation head at an end of the handle;
a reference electrode; and
a control system in communication with the stimulation probe and the reference electrode, the control system comprising: (i) a processor configured to execute instructions stored in memory of the control system; and (ii) a signal generator configured to generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle.
1. A sensitized muscle identification system comprising:
a stimulation probe comprising a handle and a stimulation head at an end of the handle;
a reference electrode; and
a control system in communication with the stimulation probe and the reference electrode, the control system comprising: a processor configured to execute instructions stored in memory of the control system; a signal generator configured to generate an electrical stimulation signal to be delivered to a skin surface of a patient via the stimulation head,
wherein a voltage amplitude of the electrical stimulation signal is controlled by the signal generator;
a muscle identification system comprising information identifying major muscle groups of the patient and a plurality of individual muscles within each of the major muscle groups; and
a user interface comprising a graphical interface and controls for adjusting parameters of the electrical stimulation signal generated by the signal generator, the user interface configured to: (i) display, via the graphical interface, depictions of the major muscle groups and the plurality of individual muscles within each of the major muscle groups, (ii) receive user selections of one or more individual muscles of the plurality of individual muscles, and (iii) receive patient input that indicates a sensation experienced in a stimulated muscle of the patient in response to applying the electrical stimulation signal to the skin surface of the patient overlying the stimulated muscle,
wherein the electrical stimulation signal, when delivered to the skin surface of the patient using the stimulation probe, induces an activation potential in a plurality of nociceptors within the stimulated muscle, the activation potential sufficient to produce the sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces a contractile response in the stimulated muscle.
16. (New) A sensitized muscle identification system comprising:
a stimulation probe comprising a handle and a stimulation head at an end of the handle;
a reference electrode; and
a control system in communication with the stimulation probe and the reference electrode, the control system comprising: (i) a processor configured to execute instructions stored in memory of the control system; and (ii) a signal generator configured to generate an electrical stimulation signal which, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of sensitized nociceptors within a stimulated muscle that is sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle.
13. A sensitized muscle identification system comprising:
a stimulation probe comprising a handle and a stimulation head at an end of the handle; a
reference electrode; and
a control system in communication with the stimulation probe and the reference electrode, the control system comprising: a processor configured to execute instructions stored in memory of the control system; and a signal generator configured to generate an electrical stimulation signal to be delivered to a skin surface of a patient via the stimulation head,
wherein a voltage amplitude of the electrical stimulation signal is controlled by the signal generator to be exclusively between 0.1 and 10 Volts,
wherein the electrical stimulation signal, when delivered to a skin surface of a patient using the stimulation probe, induces an activation potential in a plurality of nociceptors within a stimulated muscle, the activation potential sufficient to produce a sensation of pressure or discomfort within the stimulated muscle while remaining below a threshold that induces a contractile response in the stimulated muscle.
29. (New) A method, comprising:
applying, from a stimulation head of a sensitized muscle identification system, a stimulation signal to a patient's skin surface that is proximate to an individual muscle to induce an activation potential in a plurality of sensitized nociceptors present in the individual muscle while remaining below a threshold that induces an activation potential in non-sensitized nociceptors within the stimulated muscle, wherein the activation potential in the plurality of sensitized nociceptors induces a sensation of discomfort in the individual muscle that is experienced by the patient.
14. A method, comprising:
displaying, by a user interface of a sensitized muscle identification system, depictions of a plurality of major muscle groups;
receiving, by the user interface, a first user selection of a major muscle group of the plurality of major muscle groups;
displaying, by the user interface and in response to the first user selection, a plurality of individual muscles within the major muscle group,
receiving, by the user interface, a second user selection of an individual muscle of the major muscle group;
applying, from a stimulation head of the sensitized muscle identification system, a stimulation signal to a skin surface of a patient, the skin surface being proximate to the individual muscle, to induce an activation potential in a plurality of sensitized nociceptors present in the individual muscle while remaining below a threshold that induces a contractile response in the individual muscle, wherein the activation potential in the plurality of sensitized nociceptors induces a sensation of discomfort in the individual muscle that is experienced by the patient; and
receiving, by the user interface, patient input that indicates a sensation experienced in the individual muscle in response to applying the stimulation signal.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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