DETAILED ACTION
Response to Amendment
This Action is in response to the Amendment filed August 18, 2025.
In view of the Amendment, the rejection of claim 10 under 35 USC 112, as set forth in the Office Action dated 04/18/2025, is withdrawn.
Claims 1, 4-7, and 11-13 are amended.
Claim 10 is canceled.
Claims 1-9 and 11-13 are pending.
Response to Arguments
Applicant’s arguments, see the Amendment, filed 08/18/2025, with respect to the rejection(s) of claim(s) 1-8 and 10-13 under 35 USC 102 or 35 USC 103 have been fully considered and are persuasive. Therefore, the rejections has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made using the prior art in the 04/14/2025 Office Action in view of US Patent Application Publication No. 2017/0095676 to Caparso et al. in order to meet the new language added to the claims.
Applicant's arguments filed 08/18/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that US Patent Application No. 2012/0041513 to Tucker fails to teach or suggest treating a patient after experiencing cerebral ischemia, the Examiner disagrees. In contrast to Applicant’s mischaracterization of Tucker’s disclosed invention, Tucker expressly discloses treatment of Dysfunction of Systemic Circulation including ischaemic organ disease and cerebro-vascular disease (e.g., paragraph [0161] of Tucker: the invention relates to methods and apparatus for preventing, reducing or alleviating pathologies and symptoms associated with dysfunction of the heart and systemic circulation). It is the Office Action’s position that cerebral ischemia is a cerebro-vascular disease; and Tucker expressly discloses treating patients who suffered from a cerebro-vascular disease.
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, independent claims 1 and 5 are rejected by Tucker in view of Caparso under 35 USC 103, and independent claim 4 is rejected by Tucker in view of Forrest and Caparso.
In response to Applicant’s arguments concerning the combination of references applied against independent claims 11-13, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
With respect to “the specific window of 1 week to 6 months”, Caparso expressly teaches that stimulation should be performed within 6 months, which is with the specific window, and thus, meets the limitation of the claim. The Examiner notes that the instant specification does not provide any criticality of the “specific window”.
As to the new feature of the patient being in the seated position while an electric stimulus is administered, Tucker expressly discloses that when a patient is in the seated position, the pumping of blood in the veins of the lower leg is significantly reduced or absent (e.g., paragraph [0019] of Tucker), and indicates that electrical stimulation of the leg muscles may occur while the patient is sitting (e.g., paragraphs [0045] and [0175] of Tucker). The Examiner further notes that the originally filed specification fails to provide support for a patient who has experienced cerebral ischemia being in a seated position while electrical stimulation is administered to a nerve of the patient (see 35 USC 112 (a) rejection below).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The closest disclosure of a subject in the seated position found in the originally-filed specification (OFS) is directed to “healthy volunteers” where “an initial resting state recording was taken for 5 minutes in the sitting position”, after which the GEKO stimulation device was applied to a nerve and recordings with stimulation were taken … in the sitting position (e.g., page 13, line 22 - page 14, line 3 of the OFS: Example 1). The Examiner did not find a passage where the electrical stimulation of the patient who experienced cerebral ischemia. Thus, the OFS does not reasonably convey to one of ordinary skill in the art that the inventors, at the time the application was filed had possession of the invention, as amended.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2012/0041513 to Tucker et al. (hereinafter referred to as “Tucker”) in view of US Patent Application Publication No. 2017/0095676 to Caparso et al. (hereinafter referred to as “Caparso”).
Referring to claim 1, Tucker is directed to a method of improving recovery of a patient from cerebral ischemia (e.g., paragraphs [0001] and [0161]: The present method may be used for management and treatment of cerebro-vascular disease; and [0011] and [0044]: calf muscle when activated increases perfusion pressure in distal tissues), the method comprising: while the patient is in a seated position, administering an electrical stimulus to a nerve of the patient innervating opposed leg muscles sufficient to cause isometric contraction of said muscles (e.g., paragraphs [0045], [0154]-[0158] and [0173]-[0175]: implies that the patient may be seated when electrical stimulation is administered; [0042]-[0043]: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically).
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient who experienced cerebral ischemia between one week and six months previously and administering the electrical stimulation within a period between one week and six months from the patient experiencing cerebral ischemia. Consequently, one of ordinary skill in the art would have modified the method of improving recovery of a patient from a cerebral vascular disease of Tucker to include the step of selecting/identifying a patient who experienced inadequate blood flow to the brain due to a neuro-ischemic event or cerebral ischemia within the preceding six months and administering electrical stimulation to the patient within six months in order to improve a patient’s recovery in view of the teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of Tucker to select a patient who experienced cerebral ischemia between one week and six months previously and administered the electrical stimulus of Tucker within a period between one week and six months from the patient experiencing cerebral ischemia in view of the teachings of Caparso that the first six months after the neuro-ischemic event is a preferred time to perform electrical stimulation in order to improve recovery from the neuro-ischemic event, and because the combination would have yielded a predictable result.
With respect to claim 2, Tucker in view of Caparso teaches the method of claim 1, wherein the isometric contraction results in improved or increased cerebral blood flow (e.g., paragraphs [0011], [0161], and [0047] of Tucker: stimulation of a nerve enhances blood flow and would treat cerebro-vascular disease); and/or an improvement in cerebral perfusion pressure (e.g., paragraphs [0011] and [0161] of Tucker: the activated calf muscle results in increased perfusion pressure in distal tissues and increases perfusion, which would treat cerebro-vascular disease). The Examiner further notes that MPEP 2111.04 states claim language that raise a question as to the limiting effect of the language in a claims are wherein clauses and a method claim is not give patentable weight when such a clause simply expresses the intended result of a process step positively recited.
Referring to claim 5, Tucker discloses a method of improving recovery of a patient from cerebral ischemia (e.g., paragraphs [0001] and [0161]: The present method may be used for management and treatment of cerebro-vascular disease; and [0011] and [0044]: calf muscle when activated increases perfusion pressure in distal tissues), the method comprising b) while the patient is in a seated position, administering an electrical stimulus to a nerve of the patient innervating opposed leg muscles, said stimulus being sufficient to cause isometric contraction of said muscles (e.g., paragraphs [0045], [0154]-[0158] and [0173]-[0175]: implies that the patient may be seated when electrical stimulation is administered; [0042]-[0043]: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically), said isometric contraction resulting in improved or increased cerebral blood flow (e.g., paragraphs [0011], [0161], and [0047]: stimulation of a nerve enhances blood flow and would treat cerebro-vascular disease); and c) administering an electrical stimulus to a nerve of the patient innervating opposed leg muscles sufficient to cause isometric contraction of said muscles (e.g., paragraphs [0042]-[0043] and [0063] as above), said electrical stimulation being sufficient to alter electrical activity in the brain (e.g., paragraphs [0050]-[0052] and [0137]: AC wave with pulse width typically around 0.3 ms or 300 µs, a frequency less than 100 Hz, and current between 5-10mA – within the ranges disclosed for the typical electrical stimulus in Applicant’s specification (pages 7, line 30-page 8, line 1). Thus, the electrical stimulation of Tucker would inherently be sufficient to alter electrical activity in the brain).
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient who experienced cerebral ischemia between one week and six months previously and administering the electrical stimulation within a period between one week and six months from the patient experiencing cerebral ischemia. Consequently, one of ordinary skill in the art would have modified the method of improving recovery of a patient from a cerebral vascular disease of Tucker to include the step of selecting/identifying a patient who experienced inadequate blood flow to the brain due to a neuro-ischemic event or cerebral ischemia within the preceding six months and administering electrical stimulation to the patient within six months in order to improve a patient’s recovery in view of the teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of Tucker to select a patient who experienced cerebral ischemia between one week and six months previously and administered the electrical stimulus of Tucker within a period between one week and six months from the patient experiencing cerebral ischemia in view of the teachings of Caparso that the first six months after the neuro-ischemic event is a preferred time to perform electrical stimulation in order to improve recovery from the neuro-ischemic event, and because the combination would have yielded a predictable result.
With respect to claim 6, Tucker in view of Caparso teaches the method of claim 5 wherein steps b) and c) are carried out using different electrical stimulation parameters (e.g., paragraphs [0053] and [0070] of Tucker: where repeated stimuli are applied, characteristics of the stimuli may vary between different stimuli) .
As to claim 7, Tucker in view of Caparso teaches the method of claim 5 wherein steps b) and c) are carried out sequentially (e.g., paragraphs [0071] of Tucker: stimuli is preferably applied sequentially).
With respect to claim 8, Tucker in view of Caparso teaches the method of claim 1, wherein said improvement in recovery is a reduction to cerebral cell death (not required, as only 1 condition needs to be satisfied); and/or an improvement in cerebral autoregulation (not required, as only 1 condition needs to be satisfied); and/or an improvement in cerebral perfusion pressure (CCP) (e.g., paragraphs [0011] and [0161] as above where treatment of cerebro-vascular disease results in increased cerebral perfusion pressure).
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker in view of Caparso as applied to claim 1 above, and further in view of US Patent Application Publication No. 2017/0197078 to Forrest et al. (hereinafter referred to as “Forrest”).
With respect to claim 3, Tucker in view of Caparso teaches the method of claim 1, but does not expressly disclose that said electrical stimulation is sufficient to alter electrical activity in the brain. However, Forrest, in a related art: neuromuscular stimulation system and method, teaches that wide pulse high frequency neuromuscular stimulation (WPHF-NMES) applied by placing electrodes on the skin of the patient engages circuits of the central nervous system that control movement (i.e., the brain) (e.g., paragraphs [0014], [0020]); and [0035] of Forrest: surface electrodes were placed over muscles or nerves of lower extremities (legs) and WPHF-NMES was applied to produce contractions by activating motor and sensory axons, the latter of which activate circuits in the central nervous system that control movement). That is, Forrest teaches that electrical stimulation of the legs of a patient activate/alter brain activity. Accordingly, one of ordinary skill in the art would have recognized the benefits of a neuromuscular stimulation system would include altering electrical activity in the brain in view of the teachings of Forrest. Consequently, one of ordinary skill in the art would have recognized that the electrical stimulation applied to opposed leg muscles of a patient of Tucker in view of Caparso could alter electrical activity in the brain in view of the teachings of Forrest; and thus, one of ordinary skill in the art would have modified the method of Tucker in view of Caparso so that the electrical stimulation alters electrical activity in the brain since such was a known result of applying electrical stimulation as taught by Forrest, and because the combination would have yielded a predictable result.
As to claim 9, Tucker in view of Caparso and Forrest teaches the method of claim 3, wherein said improvement in recovery is an increase in neuroplasticity (e.g., paragraph [0012] of Forrest: the method and system facilitate the modulation of CNS circuits by activating signals that drive plasticity of the nervous system to recover a specific function; and/or an improvement in cognitive function (not required, as only 1 condition needs to be satisfied). Accordingly, one of ordinary skill in the art would have recognized the benefits of electrically stimulating opposed leg muscles of a patient to include an increase in neuroplasticity in view of the teachings of Forrest. Consequently, one of ordinary skill in the art would have modified the method of Tucker in view of Caparso and Forrest further so that the improvement in recovery is an increased in neuroplasticity in order to recover motor function of the patient as taught by Forrest, and because the combination would have yielded a predictable result.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tucker in view of Forrest and Caparso.
Regarding claim 4, Tucker discloses a method of improving recovery of a patient from cerebral ischemia (e.g., paragraphs [0001] and [0161]: The present method may be used for management and treatment of cerebro-vascular disease; and [0011] and [0044]: calf muscle when activated increases perfusion pressure in distal tissues), the method comprising: while the patient is in the seated position, administering an electrical stimulus to a nerve of the patient innervating opposed leg muscles, said stimulus being sufficient to cause isometric contraction of said muscles (e.g., paragraphs [0045], [0154]-[0158] and [0173]-[0175]: reasonably implies that the patient may be seated when electrical stimulation is administered; [0042]-[0043]: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically), said isometric contraction resulting in improved or increased cerebral blood flow (e.g., paragraphs [0042]-[0043]: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically). Tucker differs from the claimed invention in that it does not expressly disclose said electrical stimulation being sufficient to alter electrical activity in the brain and the newly added features of selecting a patient and administering electrical stimulus within a certain period.
However, Forrest, in a related art: neuromuscular stimulation system and method, teaches that wide pulse high frequency neuromuscular stimulation (WPHF-NMES) applied by placing electrodes on the skin of the patient engages circuits of the central nervous system that control movement (i.e., the brain) (e.g., paragraphs [0014], [0020]); and [0035] of Forrest: surface electrodes were placed over muscles or nerves of lower extremities (legs) and WPHF-NMES was applied to produce contractions by activating motor and sensory axons, the latter of which activate circuits in the central nervous system that control movement). That is, Forrest teaches that electrical stimulation of the legs of a patient activate/alter brain activity. Accordingly, one of ordinary skill in the art would have recognized the benefits of a neuromuscular stimulation system would include altering electrical activity in the brain in view of the teachings of Forrest. Consequently, one of ordinary skill in the art would have recognized that the electrical stimulation applied to opposed leg muscles of a patient of Tucker could alter electrical activity in the brain in view of the teachings of Forrest; and thus, one of ordinary skill in the art would have modified the method of Tucker so that the electrical stimulation alters electrical activity in the brain since such was a known result of applying electrical stimulation as taught by Forrest, and because the combination would have yielded a predictable result.
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient who experienced cerebral ischemia between one week and six months previously and administering the electrical stimulation within a period between one week and six months from the patient experiencing cerebral ischemia. Consequently, one of ordinary skill in the art would have modified the method of improving recovery of a patient from a cerebral vascular disease of Tucker in view of Forrest to include the step of selecting/identifying a patient who experienced inadequate blood flow to the brain due to a neuro-ischemic event or cerebral ischemia within the preceding six months and administering electrical stimulation to the patient within six months in order to improve a patient’s recovery in view of the teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of Tucker to select a patient who experienced cerebral ischemia between one week and six months previously and administered the electrical stimulus of Tucker in view of Forrest within a period between one week and six months from the patient experiencing cerebral ischemia in view of the teachings of Caparso that the first six months after the neuro-ischemic event is a preferred time to perform electrical stimulation in order to improve recovery from the neuro-ischemic event, and because the combination would have yielded a predictable result.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2020/0139118 to John et al. (hereinafter referred to as “John”) in view of US Patent Application Publication No. 2017/0095676 to Caparso et al. (hereinafter referred to as “Caparso”) and Tucker.
Referring to claim 11, John discloses a method for selecting a patient for therapy to aid recovery from a disorder (e.g., paragraph [0240]: enhanced transcutaneous nerve stimulation screening method), the method comprising: identifying a patient who might benefit from various types or modes of neuromodulation therapy (e.g., paragraph [0242]); administering an electrical stimulus to a nerve of the patient (e.g., Fig. 22b, step 212 and paragraph [0242]: provide at least one stimulation signal to the patient from a stimulator according to a screening protocol); monitoring patient response prior to and during and/or after said administration of electrical stimulus (e.g., Fig. 22b, step 214 and paragraph [0242]: assessing patient response to the stimulation signal can be calculated from a comparison of data before, during, and/or after the stimulation takes place); and selecting the patient for continued therapy in the event that positive results are obtained during and/or after said administration (e.g., Fig. 22b, 216 and paragraph [0242]: positive results are obtained when screening results are compared and result in a fully implantable device for continued therapy).
John differs from the claimed invention in that the method is not expressly disclose for selecting a patient who has experienced a cerebral ischaemia. However, Caparso, in the medical art, teaches methods of improving patients recovery after a neuro-ischemic event where the first step of the method is to identify a patient who has suffered a neuro-ischemic event (e.g., Fig. 1, 102 and paragraph [0036] of Caparso: patient identified at step 102 may have suffered a neuro-ischemic event that results in inadequate blood flow to a neural structure, such as the brain, of the patient [or cerebral ischaemia as evidenced by the article in Neurobiology of Aging, introduction), and then, stimulating a parasympathetic structure of the patient, before, during, and/or after the patient undergoes a task-oriented therapy (e.g., Fig. 1, 104 and paragraphs [0017] and [0035] of Caparso: patient is electrically stimulated to apply a therapy signal to the parasympathetic structure of the patient). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient for therapy to aid recovery from cerebral ischaemia to first identify a patient that has suffered/experienced cerebral ischemia/ischaemia before applying stimulation in view of the teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of John so that the disorder the patient is being selected for treatment/recovery is cerebral ischemia and to modify the initial step of identifying to a person that has experienced cerebral ischemia in view of the teachings of Caparso that such a protocol was well-known in the medical arts, and because the combination would have yielded a predictable result.
John in view of Caparso differs from the claimed invention in that the administered stimulation is not expressly taught to innervate opposed leg muscles sufficient to cause isometric contraction of said muscles, and that the monitoring is not expressly taught to look at cerebral blood flow. However, Tucker, in a related art: a method of improving recovery of a patient from cerebral ischemia (e.g., paragraphs [0001] and [0161] of Tucker: The present method may be used for management and treatment of cerebro-vascular disease; and [0011] and [0044] of Tucker: calf muscle when activated increases perfusion pressure in distal tissues), teaches that to treat a cerebro-vascular disease, while the patient is in a seated position, administration of an electrical stimulus to a nerve of a patient innervating opposed leg muscles sufficient to cause isometric contraction of the muscles can be used (e.g., paragraphs [0045], [0154]-[0158] and [0173]-[0175]: reasonably implies that the patient may be seated when electrical stimulation is administered; [0042]-[0043] of Tucker: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically); and to monitor blood pressure and/or circulation (e.g., paragraphs [0056]-[0057] of Tucker). Accordingly, one of ordinary skill in the art would have recognized the benefits of the applied electrical stimulus innervating opposed leg muscles sufficient to cause isometric contraction of the muscles being innervated and the need to monitor cerebral blood flow (when the method is for the treatment of a cerebro-vascular disease) in view of the teachings of Tucker. Consequently, one of ordinary skill in the art would have modified the administering and monitoring steps of John in view of Caparso to innervate opposed leg muscles sufficient to cause isometric contraction of the muscles being innervated and the need to monitor cerebral blood flow in view of the teachings of Tucker that such were well-known protocol for treating a cerebro-vascular disease, and because the combination would have yielded a predictable result. With respect to the selecting step, it would have been further obvious to select a patient when treating a reduced blood flow disease where the monitored cerebral blood flow increases for further or continued therapy as that treatment would be a successful result.
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient who experienced cerebral ischemia between one week and six months previously and administering the electrical stimulation within a period between one week and six months from the patient experiencing cerebral ischemia. Consequently, one of ordinary skill in the art would have modified the method of improving recovery of a patient from a cerebral vascular disease of John in view of Caparso to include the step of selecting/identifying a patient who experienced inadequate blood flow to the brain due to a neuro-ischemic event or cerebral ischemia within the preceding six months and administering electrical stimulation to the patient within six months in order to improve a patient’s recovery in view of the further teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of John in view of Caparso and Tucker to select a patient who experienced cerebral ischemia between one week and six months previously and administered the electrical stimulus of Tucker within a period between one week and six months from the patient experiencing cerebral ischemia in view of the teachings of Caparso that the first six months after the neuro-ischemic event is a preferred time to perform electrical stimulation in order to improve recovery from the neuro-ischemic event, and because the combination would have yielded a predictable result.
Regarding claim 12, John discloses a method for selecting a patient for therapy to aid recovery from a disorder (e.g., paragraph [0240]: enhanced transcutaneous nerve stimulation screening method), the method comprising: identifying a patient who might benefit from various types or modes of neuromodulation therapy (e.g., paragraph [0242]); administering an electrical stimulus to a nerve of the patient (e.g., Fig. 22b, step 212 and paragraph [0242]: provide at least one stimulation signal to the patient from a stimulator according to a screening protocol); monitoring brain electrical activity prior to and during and/or after said administration of electrical stimulus (e.g., paragraph [0252]: regardless of the screening test which is performed, the test results that can be computed or upon evaluation of measured data, such as electrical brain activity implies that brain activity is monitored during step 214 of Fig. 22b and paragraph [0242]: assessing patient response to the stimulation signal can be calculated from a comparison of data before, during, and/or after the stimulation takes place); and selecting the patient for continued therapy in the event that brain electrical activity alters during and/or after said administration (e.g., paragraph [0252]: When test results including brain activity are computed upon measured data, the data is collected and assessed in step 216 of Fig. 22b; and paragraph [0242]: positive results are obtained when screening results are compared and result in a fully implantable device for continued therapy -when brain activity is an important criteria).
John differs from the claimed invention in that the method is not expressly disclose for selecting a patient who has experienced a cerebral ischaemia. However, Caparso, in the medical art, teaches methods of improving patients recovery after a neuro-ischemic event where the first step of the method is to identify a patient who has suffered a neuro-ischemic event (e.g., Fig. 1, 102 and paragraph [0036] of Caparso: patient identified at step 102 may have suffered a neuro-ischemic event that results in inadequate blood flow to a neural structure, such as the brain, of the patient [or cerebral ischaemia as evidenced by the article in Neurobiology of Aging, introduction), and then, stimulating a parasympathetic structure of the patient, before, during, and/or after the patient undergoes a task-oriented therapy (e.g., Fig. 1, 104 and paragraphs [0017] and [0035] of Caparso: patient is electrically stimulated to apply a therapy signal to the parasympathetic structure of the patient). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient for therapy to aid recovery from cerebral ischaemia to first identify a patient that has suffered/experienced cerebral ischemia/ischaemia before applying stimulation in view of the teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of John so that the disorder the patient is being selected for treatment/recovery is cerebral ischemia and to modify the initial step of identifying to a person that has experienced cerebral ischemia in view of the teachings of Caparso that such a protocol was well-known in the medical arts, and because the combination would have yielded a predictable result.
John in view of Caparso differs from the claimed invention in that the administered stimulation is not expressly taught to innervate opposed leg muscles sufficient to cause isometric contraction of said muscles, and that the monitoring is not expressly taught to look at cerebral blood flow. However, Tucker, in a related art: a method of improving recovery of a patient from cerebral ischemia (e.g., paragraphs [0001] and [0161] of Tucker: The present method may be used for management and treatment of cerebro-vascular disease; and [0011] and [0044] of Tucker: calf muscle when activated increases perfusion pressure in distal tissues), teaches that to treat a cerebro-vascular disease, administration of an electrical stimulus to a nerve of a patient innervating opposed leg muscles sufficient to cause isometric contraction of the muscles can be used (e.g., paragraphs [0042]-[0043] of Tucker: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically); and to monitor blood pressure and/or circulation (e.g., paragraphs [0056]-[0057] of Tucker). Accordingly, one of ordinary skill in the art would have recognized the benefits of the applied electrical stimulus innervating opposed leg muscles sufficient to cause isometric contraction of the muscles being innervated and the need to monitor cerebral blood flow (when the method is for the treatment of a cerebro-vascular disease) in view of the teachings of Tucker. Consequently, one of ordinary skill in the art would have modified the administering and monitoring steps of John in view of Caparso to innervate opposed leg muscles sufficient to cause isometric contraction of the muscles being innervated and the need to monitor cerebral blood flow in view of the teachings of Tucker that such were well-known protocol for treating a cerebro-vascular disease, and because the combination would have yielded a predictable result. With respect to the selecting step, it would have been further obvious to select a patient when treating a reduced blood flow disease where the monitored cerebral blood flow increases for further or continued therapy as that treatment would be a successful result.
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient who experienced cerebral ischemia between one week and six months previously and administering the electrical stimulation within a period between one week and six months from the patient experiencing cerebral ischemia. Consequently, one of ordinary skill in the art would have modified the method of improving recovery of a patient from a cerebral vascular disease of John in view of Caparso and Tucker to include the step of selecting/identifying a patient who experienced inadequate blood flow to the brain due to a neuro-ischemic event or cerebral ischemia within the preceding six months and administering electrical stimulation to the patient within six months in order to improve a patient’s recovery in view of the further teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of John in view of Caparso and Tucker to select a patient who experienced cerebral ischemia between one week and six months previously and administered the electrical stimulus of Tucker within a period between one week and six months from the patient experiencing cerebral ischemia in view of the teachings of Caparso that the first six months after the neuro-ischemic event is a preferred time to perform electrical stimulation in order to improve recovery from the neuro-ischemic event, and because the combination would have yielded a predictable result.
Referring to claim 13, John discloses a method for selecting a patient for therapy to aid recovery from a disorder (e.g., paragraph [0240]: enhanced transcutaneous nerve stimulation screening method), the method comprising: identifying a patient who might benefit from various types or modes of neuromodulation therapy (e.g., paragraph [0242]); administering an electrical stimulus to a nerve of the patient (e.g., Fig. 22b, step 212 and paragraph [0242]: provide at least one stimulation signal to the patient from a stimulator according to a screening protocol); monitoring patient response including brain activity prior to and during and/or after said administration of electrical stimulus (e.g., Fig. 22b, step 214 and paragraphs [0242]: assessing patient response to the stimulation signal can be calculated from a comparison of data before, during, and/or after the stimulation takes place; and [0252]: regardless of the screening test which is performed, the test results that can be computed or upon evaluation of measured data, such as electrical brain activity implies that brain activity is monitored during step 214 of Fig. 22b); and selecting the patient for continued therapy in the event that positive results including those from brain activity are obtained during and/or after said administration (e.g., paragraph [0252]: When test results including brain activity are computed upon measured data, the data is collected and assessed in step 216 of Fig. 22b; and paragraph [0242]: positive results are obtained when screening results are compared and result in continued therapy -when brain activity is an important criteria).
John differs from the claimed invention in that the method is not expressly disclose for selecting a patient who has experienced a cerebral ischaemia. However, Caparso, in the medical art, teaches methods of improving patients recovery after a neuro-ischemic event where the first step of the method is to identify a patient who has suffered a neuro-ischemic event (e.g., Fig. 1, 102 and paragraph [0036] of Caparso: patient identified at step 102 may have suffered a neuro-ischemic event that results in inadequate blood flow to a neural structure, such as the brain, of the patient [or cerebral ischaemia as evidenced by the article in Neurobiology of Aging, introduction), and then, stimulating a parasympathetic structure of the patient, before, during, and/or after the patient undergoes a task-oriented therapy (e.g., Fig. 1, 104 and paragraphs [0017] and [0035] of Caparso: patient is electrically stimulated to apply a therapy signal to the parasympathetic structure of the patient). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient for therapy to aid recovery from cerebral ischaemia to first identify a patient that has suffered/experienced cerebral ischemia/ischaemia before applying stimulation in view of the teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of John so that the disorder the patient is being selected for treatment/recovery is cerebral ischemia and to modify the initial step of identifying to a person that has experienced cerebral ischemia in view of the teachings of Caparso that such a protocol was well-known in the medical arts, and because the combination would have yielded a predictable result.
John in view of Caparso differs from the claimed invention in that the administered stimulation is not expressly taught to innervate opposed leg muscles sufficient to cause isometric contraction of said muscles, and that the monitoring is not expressly taught to look at cerebral blood flow. However, Tucker, in a related art: a method of improving recovery of a patient from cerebral ischemia (e.g., paragraphs [0001] and [0161] of Tucker: The present method may be used for management and treatment of cerebro-vascular disease; and [0011] and [0044] of Tucker: calf muscle when activated increases perfusion pressure in distal tissues), teaches that to treat a cerebro-vascular disease, while the patient is in a seated position, administration of an electrical stimulus to a nerve of a patient innervating opposed leg muscles sufficient to cause isometric contraction of the muscles can be used (e.g., paragraphs [0045], [0154]-[0158] and [0173]-[0175]: implies that the patient may be seated when electrical stimulation is administered; [0042]-[0043] of Tucker: administering electric stimuli to a plurality of leg muscles sufficient to cause isometric contraction of the muscles where the stimuli is applied indirectly via stimulation of a suitable nerve and [0063]: blood circulation is improved by administering an electric stimulus to opposed leg muscles of a patient and indirectly applying a stimulus via a nerve to cause the muscles to contract isometrically); and to monitor blood pressure and/or circulation (e.g., paragraphs [0056]-[0057] of Tucker). Accordingly, one of ordinary skill in the art would have recognized the benefits of the applied electrical stimulus innervating opposed leg muscles sufficient to cause isometric contraction of the muscles being innervated and the need to monitor cerebral blood flow (when the method is for the treatment of a cerebro-vascular disease) in view of the teachings of Tucker. Consequently, one of ordinary skill in the art would have modified the administering and monitoring steps of John in view of Caparso to innervate opposed leg muscles sufficient to cause isometric contraction of the muscles being innervated and the need to monitor cerebral blood flow in view of the teachings of Tucker that such were well-known protocol for treating a cerebro-vascular disease, and because the combination would have yielded a predictable result. With respect to the selecting step, it would have been further obvious to select a patient when treating a reduced blood flow disease where the monitored cerebral blood flow increases for further or continued therapy as that treatment would be a successful result.
With respect to the new features of Applicant’s invention: 1) selecting a patient who experienced cerebral ischemia between one week and six months previously, and 2) the electrical stimulus is administered within a period between one week and six months from the patient experiencing cerebral ischemia, Caparso et al. expressly teaches identifying a patient who “suffered any one or combination of neuro-ischemic events that result in inadequate blood flow to … the brain of the patient” or a cerebro-vascular event (e.g., paragraph [0036] of Caparso) and that its methods including stimulating a parasympathetic structure of the patient should occur within six months after the neuro-ischemic event (e.g., paragraph [0046] of Caparso). Accordingly, one of ordinary skill in the art would have recognized the benefits of selecting a patient who experienced cerebral ischemia between one week and six months previously and administering the electrical stimulation within a period between one week and six months from the patient experiencing cerebral ischemia. Consequently, one of ordinary skill in the art would have modified the method of improving recovery of a patient from a cerebral vascular disease of John in view of Caparso and Tucker to include the step of selecting/identifying a patient who experienced inadequate blood flow to the brain due to a neuro-ischemic event or cerebral ischemia within the preceding six months and administering electrical stimulation to the patient within six months in order to improve a patient’s recovery in view of the further teachings of Caparso. Consequently, one of ordinary skill in the art would have modified the method of John in view of Caparso and Tucker to select a patient who experienced cerebral ischemia between one week and six months previously and administered the electrical stimulus of Tucker w