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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/72/2026 has been entered.
Response to Amendment
This office action is responsive to an amendment filed on 2/27/2026. As directed by the amendment, claims 1-20 were cancelled, no claims were amended and claim 40 was added. Thus, claims 21-40 are presently pending in this application.
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.
Claim 40 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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 limitation “further comprising: administering a result effective dose of an immunosuppressive composition to the patient; and following said administering the negative pressure therapy to the patient, reducing the result effective dose of the immunosuppressive composition and continuing administration of the immunosuppressive composition to the patient with the reduced dose” (claim 40, lines 1-7) is not supported by the original disclosure and is therefore, new matter. The specification discloses in paragraphs 24, 44, and 0058 discloses that the immunosuppressive composition is combined with negative pressure therapy, but does not disclose that the method further comprising: administering a result effective dose of an immunosuppressive composition to the patient; and following said administering the negative pressure therapy to the patient, reducing the result effective dose of the immunosuppressive composition and continuing administration of the immunosuppressive composition to the patient with the reduced dose. Therefore, the limitation contains new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 21-23 and 29-39 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (“A Review of Spasticity Treatments: Pharmacological and Interventional Approaches”) in view of Roesch (DE 10 2004 034 625) and alternatively in view of Salo Darder (2016/0022530).
Regarding claim 21, Chang discloses a method of treating or preventing spasticity in a patient, the method comprising: identifying the patient as having spasticity as a result of cerebral palsy, stroke, spinal cord injury, multiple sclerosis (see abstract and pages 2-8, Chang discloses that spasticity is a velocity-dependent increase in muscle tone and uncontrolled, repetitive, involuntary contractions of skeletal muscles, and often manifest as increased tone and spasms, and further discloses that spasticity can be a result of spinal cord injury (SCI), cerebral palsy, stroke, amyotrophic lateral sclerosis, and multiple sclerosis (MS), and further discloses a method of treating spasticity including providing treatment drugs in the form of oral agent Baclofen, Benzodiazepines, and Dantrolene Sodium, throughout the disclosure, Chang discloses what spasticity is, therefore, is a step of identifying spasticity, alternatively, by disclosing what spasticity is and ways to treat spasticity, one must have to identify a patient with spasticity to treat spasticity in patient), Chang further discloses that physical therapies can be complementary with medicine such as oral agents to treat spasticity (see “Treatments” section in page 2), but fails to disclose that the physical therapy includes negative pressure therapy and that the method comprising administering the negative pressure therapy to the patient.
Roesch teaches a method of treating or preventing spasticity in a patient, the method comprising applying a physical therapy including negative pressure therapy to the patient (see paragraphs 0007 and 0009 of the English translation, Roesch discloses that the device applies a negative pressure on an extremity of the patient, and the device treats cramping of the extremities or prevent cramping, treating or preventing cramping is treating or preventing spasticity, furthermore, cramping is an involuntary muscle contraction).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chang to be used with a method of applying negative pressure to treat or prevent spasticity as taught by Roesch for the purpose of combining a physical therapy with oral agents of Chang to treat spasticity, thereby providing comfort to the patient (see paragraphs 0007 and 0009 of Roesch and see “Treatments” section in page 2 of Chang).
Furthermore, if there is any question as to the obviousness of utilizing the negative pressure therapy of Roesch to treat the spasticity of Chang, since Roesch does not specifically disclose the term “spasticity”. Salo Darder teaches the use of negative pressure therapy to treat “spasticity” (see paragraphs 0453, 0465, 0587-0594).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and the negative pressure of the modified Chang to have the negative pressure therapy of Roesch to treat the spasticity of Chang as taught by Salo Darder for the purpose of utilizing negative pressure therapy to treat spasticity (see paragraphs 0453, 0465, 0587-0594 of Salo Darder).
Regarding claim 22, the modified Chang discloses that the administering step follows a detection of increased spasticity in the patient (after the modification with Roesch, any form of detection of spasticity in the patient would be an increased spasticity relative to zero spasticity, therefore, any form of treatment in Chang and Roesch would involve detecting any form of spasticity before applying the appropriate therapy including the negative pressure therapy of Roesch, see paragraphs 0007 and 0009 of the English translation, Roesch discloses that the device applies a negative pressure on an extremity of the patient to treat cramping). However, if there is any doubt that the modified Chang discloses that the administering step follows a detection of increased spasticity in the patient. The feature of choosing to administer the negative pressure of Roesch based on detection of increased spasticity is considered as being an obvious treatment design choice, since a doctor/physician would find it obvious to administer the negative pressure after the detection of spasticity.
Regarding claim 23, the modified Chang discloses that the negative pressure therapy comprises: enclosing an area of skin of the patient in an enclosure (2 and 4, fig. 1 of Roesch) such that the area of skin is sealed from external conditions; and subjecting the area of skin to a negative pressure (see figs. 1-2 of Roesch, see paragraphs 0007 and 0009-0017 of Roesch).
Regarding claims 29-32, the modified Chang discloses applying negative pressure therapy to the patient comprises a treatment having a time (see paragraphs 0007 and 0009 of Roesch), but fails to specifically discloses that the treatment is of at least 30 minutes, 40 minutes, 1 hour or that the applying negative pressure therapy includes two treatments per day. However, the feature of choosing when and how long each treatment therapy is considered as obvious treatment design choice since it is based on a doctor’s determination of what is proper and is based on the severity of the spasticity of the patient, and the feature of choosing how often to provide the treatment per day is considered as an obvious treatment design choice since it is based on the doctor’s determination, the urgency of the treatment, the severity of the disease/condition and the patient’s schedule.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment to be of at least 30 minutes, 40 minutes or 1 hour, and the applying of negative pressure therapy includes two treatments per day for the purpose of providing a therapy time and frequency that would be able to treat or prevent the spasticity, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II).
There appears to be no criticality in having a specific duration or how often the treatment is being applied as long as that specific duration or how often the treatment is being applied is adequate enough to treat or prevent spasticity which are dependent on how severe the spasticity is, see paragraph 84 of the instant application, applicant stated that the negative pressure can be applied to at least one region for at least 20 minutes, 30 minutes, 40 minutes or for at least one hour, or that the treatment can be at least one per day or at least two per day.
Regarding claim 33, the modified Chang fails to disclose that the applying step is applied prior to the patient sleeping. However, the feature of choosing to apply the negative pressure to the patient prior to sleeping is considered as an obvious treatment design choice, since it is based on the doctor’s determination on when is an appropriate time to provide treatment to the patient, furthermore, it is known that if there is not a need to immediately provide the therapy to the user while they are asleep, it is desirable to perform the therapy while the patient is awake such that the therapy would not interfere with the patient’s sleep, thereby providing health and comfort to the patient.
Regarding claim 34, the modified Chang fails to specifically disclose that the applying step is performed for at least two limbs of the patient. However, the feature of choosing how many limbs to provide negative pressure to is considered as an obvious treatment design choice, since it is based on the doctor’s determination of where the cramps/spasticity are located.
Regarding claim 35, the modified Chang discloses that the applying step comprises applying an effective amount of the negative pressure therapy to a limb of the patient, wherein the limb is a limb nearest to the region of the patient’s body where the spasticity is treated or prevented (see paragraphs 0007 and 0009 and fig. 1 of Roesch, Roesch discloses enclosing and applying negative pressure to extremities to treat cramping, therefore, if both extremities are being treated, a left limb for example is being treated with negative pressure therapy, the right limb (limb nearest to the region of the patient’s body where the spasticity is treated or prevented that has been treated by the method) would be nearest to the left limb that the administration of the negative pressure therapy is being performed on. Alternatively, Roesch discloses all of the method steps and device as claimed, therefore, would be capable of treating or preventing spasticity that is nearest to the limb where the administration of the negative pressure therapy is being performed on in the same manner as the applicant’s claimed invention.
Regarding claim 36, the modified Chang discloses a pressure therapy device (entire device shown in figs. 1-2 and the negative pressure source, see paragraphs 0015-0017) comprising a pressure chamber (chamber of 2 where arm is located, see paragraph 0017 of the English translation) arranged for enclosing a portion of a body therein (figs. 1-2), the pressure therapy device arranged for performing the method according to claim 21 (see rejection to claim 21).
Regarding claim 37, Chang discloses a method of treating or preventing spasticity in a patient, the method comprising: identifying the patient as having spasticity as a result of cerebral palsy, stroke, spinal cord injury, multiple sclerosis (see abstract and pages 2-8, Chang discloses that spasticity is a velocity-dependent increase in muscle tone and uncontrolled, repetitive, involuntary contractions of skeletal muscles, and often manifest as increased tone and spasms, and further discloses that spasticity can be a result of spinal cord injury (SCI), cerebral palsy, stroke, amyotrophic lateral sclerosis, and multiple sclerosis (MS), and further discloses a method of treating spasticity including providing treatment drugs in the form of oral agent Baclofen, Benzodiazepines, and Dantrolene Sodium, throughout the disclosure, Chang discloses what spasticity is, therefore, is a step of identifying spasticity, alternatively, by disclosing what spasticity is and ways to treat spasticity, one must have to identify a patient with spasticity to treat spasticity in patient), Chang further discloses that physical therapies can be complementary with medicine such as oral agents to treat spasticity (see “Treatments” section in page 2), administering a result effective dose an anti-spasmodic composition to the patient (see “Treatments” section in pages 2-4, an anti-spasmodic composition includes Baclofen or Dantrolene Sodium or Benzodiazepines), but fails to disclose that the physical therapy includes negative pressure therapy and that the method comprising administering the negative pressure therapy to the patient.
Roesch teaches a method of treating or preventing spasticity in a patient, the method comprising applying a physical therapy including negative pressure therapy to the patient (see paragraphs 0007 and 0009 of the English translation, Roesch discloses that the device applies a negative pressure on an extremity of the patient, and the device treats cramping of the extremities or prevent cramping, treating or preventing cramping is treating or preventing spasticity, furthermore, cramping is an involuntary muscle contraction).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chang to be used with a method of applying negative pressure to treat or prevent spasticity as taught by Roesch for the purpose of combining a physical therapy with oral agents of Chang to treat spasticity, thereby providing comfort to the patient (see paragraphs 0007 and 0009 of Roesch and see “Treatments” section in page 2 of Chang).
Furthermore, if there is any question as to the obviousness of utilizing the negative pressure therapy of Roesch to treat the spasticity of Chang, since Roesch does not specifically disclose the term “spasticity”. Salo Darder teaches the use of negative pressure therapy to treat “spasticity” (see paragraphs 0453, 0465, 0587-0594).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and the negative pressure of the modified Chang to have the negative pressure therapy of Roesch to treat the spasticity of Chang as taught by Salo Darder for the purpose of utilizing negative pressure therapy to treat spasticity (see paragraphs 0453, 0465, 0587-0594 of Salo Darder).
Regarding claim 38, the modified Chang discloses administering the anti-spasmodic composition and said administering the negative pressure therapy are performed concurrently (see “Treatments” section in page 2 of Chang, Chang discloses that the physical therapy are complementary to the oral agent, which would mean that they are concurrent, therefore, after the modification, the negative pressure therapy (physical therapy) are also complementary to the oral agent). However, if there is any doubt that the modified Chang discloses administering the anti-spasmodic composition and said administering the negative pressure therapy are performed concurrently. The feature of choosing to administering the anti-spasmodic composition and said administering the negative pressure therapy are performed concurrently would be an obvious treatment design choice, since it is based on a doctor’s determination as to how to apply the two form of treatment based on the patient’s condition and patient’s needs.
Regarding claim 39, Chang discloses a method of treating or preventing spasticity in a patient, the method comprising: identifying the patient as having spasticity as a result of cerebral palsy, stroke, spinal cord injury, multiple sclerosis (see abstract and pages 2-8, Chang discloses that spasticity is a velocity-dependent increase in muscle tone and uncontrolled, repetitive, involuntary contractions of skeletal muscles, and often manifest as increased tone and spasms, and further discloses that spasticity can be a result of spinal cord injury (SCI), cerebral palsy, stroke, amyotrophic lateral sclerosis, and multiple sclerosis (MS), and further discloses a method of treating spasticity including providing treatment drugs in the form of oral agent Baclofen, Benzodiazepines, and Dantrolene Sodium, throughout the disclosure, Chang discloses what spasticity is, therefore, is a step of identifying spasticity, alternatively, by disclosing what spasticity is and ways to treat spasticity, one must have to identify a patient with spasticity to treat spasticity in patient), Chang further discloses that physical therapies can be complementary with medicine such as oral agents to treat spasticity (see “Treatments” section in page 2), administering a result effective dose an anti-spasmodic composition to the patient (see “Treatments” section in pages 2-4, an anti-spasmodic composition includes Baclofen or Dantrolene Sodium or Benzodiazepines), but fails to disclose that the physical therapy includes negative pressure therapy and that the method comprising administering the negative pressure therapy to the patient.
Roesch teaches a method of treating or preventing spasticity in a patient, the method comprising applying a physical therapy including negative pressure therapy to the patient (see paragraphs 0007 and 0009 of the English translation, Roesch discloses that the device applies a negative pressure on an extremity of the patient, and the device treats cramping of the extremities or prevent cramping, treating or preventing cramping is treating or preventing spasticity, furthermore, cramping is an involuntary muscle contraction).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chang to be used with a method of applying negative pressure to treat or prevent spasticity as taught by Roesch for the purpose of combining a physical therapy with oral agents of Chang to treat spasticity, thereby providing comfort to the patient (see paragraphs 0007 and 0009 of Roesch and see “Treatments” section in page 2 of Chang).
Furthermore, if there is any question as to the obviousness of utilizing the negative pressure therapy of Roesch to treat the spasticity of Chang, since Roesch does not specifically disclose the term “spasticity”. Salo Darder teaches the use of negative pressure therapy to treat “spasticity” (see paragraphs 0453, 0465, 0587-0594).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and the negative pressure of the modified Chang to have the negative pressure therapy of Roesch to treat the spasticity of Chang as taught by Salo Darder for the purpose of utilizing negative pressure therapy to treat spasticity (see paragraphs 0453, 0465, 0587-0594 of Salo Darder).
The modified Chang fails to specifically disclose that following the administering of the negative pressure therapy to the patient, reducing the result effective dose of the anti-spasmodic composition and continuing administration of the anti-spasmodic composition to the patient with the reduced dose. However, the feature of choosing to reducing the result effective dose of the anti-spasmodic composition and continuing administration of the anti-spasmodic composition to the patient with the reduced dose following the administering of the negative pressure therapy to the patient would be an obvious treatment design choice, since it is based on a doctor’s determination when to reduce the result effective dose of the anti-spasmodic composition based on the patient’s condition and patient’s needs.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (“A Review of Spasticity Treatments: Pharmacological and Interventional Approaches”) in view of Roesch (DE 10 2004 034 625) and alternatively in view of Salo Darder (2016/0022530) as applied to claim 23 above, and further in view of Atkinson (2006/0287621).
Regarding claim 24, the modified Chang discloses a negative pressure, but fails to disclose that the negative pressure is within the range of -20 mmHg and -80 mmHg.
However, Atkinson teaches a method of preventing spasticity by applying negative pressure therapy to the patient, the negative pressure is between -20 mmHg and -80 mmHg (see paragraph 0003, Atkinson discloses that Varicose veins causes night cramps, and further discloses in paragraph 0006 that the device of the invention is used to treat or prevent varicose veins, and further discloses providing sub-atmospheric compression, and Atkinson further discloses in paragraphs 0017 and claim 7 that the vacuum pressure is 10-30 mmHg).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the modified Chang to have the negative pressure be between -20 mmHg and -80 mmHg as taught by Atkinson for the purpose of providing a negative pressure setting that would be able to treat or prevent spasticity (see paragraphs 0003, 0006, 0017 and claim 7 of Atkinson).
Furthermore, if there is any doubt that it would be obvious to modify with Atkinson. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the negative pressure to be within the range of -20 mmHg and -80 mmHg for the purpose of providing a pressure that would be capable of treating spasticity, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II).
Regarding claim 25, the modified Chang discloses a negative pressure, but fails to disclose that the negative pressure is a pulsating pressure.
However, Atkinson teaches a method of preventing spasticity by applying negative pressure therapy to the patient, the negative pressure is between -20 mmHg and -80 mmHg (see paragraph 0003, Atkinson discloses that Varicose veins causes night cramps, and further discloses in paragraph 0006 that the device of the invention is used to treat or prevent varicose veins, and further discloses providing sub-atmospheric compression, and Atkinson further discloses in paragraphs 0017 and claim 7 that the vacuum pressure is 10-30 mmHg) and that the pressure is a pulsating negative pressure (see paragraph 0018, Atkinson discloses that the vacuum source 20 may vent to atmospheric pressure to provide intermittent compression).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the modified Chang to have the negative pressure and that the negative pressure is a pulsating pressure as taught by Atkinson for the purpose of providing a negative pressure setting that would be able to treat or prevent spasticity (see paragraphs 0003, 0006, 0017 and claim 7 of Atkinson).
Regarding claim 26, the modified Chang discloses a negative pressure, but fails to disclose that the negative pressure is a pulsating pressure comprises generating a negative pressure against the area of skin for a first predetermined time interval and releasing the negative pressure for a second predetermined time interval.
However, Atkinson teaches a method of preventing spasticity by applying negative pressure therapy to the patient, the negative pressure is between -20 mmHg and -80 mmHg (see paragraph 0003, Atkinson discloses that Varicose veins causes night cramps, and further discloses in paragraph 0006 that the device of the invention is used to treat or prevent varicose veins, and further discloses providing sub-atmospheric compression, and Atkinson further discloses in paragraphs 0017 and claim 7 that the vacuum pressure is 10-30 mmHg) and that the pressure is a pulsating negative pressure (see paragraph 0018, Atkinson discloses that the vacuum source 20 may vent to atmospheric pressure to provide intermittent compression), wherein the pulsating pressure comprises a negative pressure against the area of skin for a first predetermined time interval and releasing the negative pressure for a second predetermined time interval (see paragraph 0018, the negative pressure being applied below the release would have a first predetermined time interval, and when the pressured is released to provide an intermittent compression, there would be a second predetermined time interval).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the modified Chang to have the negative pressure and that the negative pressure is a pulsating pressure as taught by Atkinson for the purpose of providing a negative pressure setting that would be able to treat or prevent spasticity (see paragraphs 0003, 0006, 0017 and claim 7 of Atkinson).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (“A Review of Spasticity Treatments: Pharmacological and Interventional Approaches”) in view of Roesch (DE 10 2004 034 625) and alternatively in view of Salo Darder (2016/0022530) and Atkinson (2006/0287621) as applied to claim 26 above, and further in view of Atkinson (2006/0287621) and Filtvedt (2005/0027218).
Regarding claim 27, the modified Chang fails to disclose that the first predetermined time interval is different than the second predetermined time interval.
However, Filtvedt teaches a method of applying negative pressure, wherein the negative pressure is a pulsating pressure comprising generating a negative pressure against the area of skin for a first predetermined time interval and releasing the negative pressure for a second predetermined time interval, wherein the first predetermined time interval is different than the second predetermined time interval (see paragraph 0080, Filtvedt discloses that the pressure is pulsed between -40 mmHg and +15 mmHg, wherein the +15 mmHg is 5 seconds and -40 mmHg is 7 seconds).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the modified Chang to have the negative pressure comprising a first predetermined time interval that is different than the second predetermined time interval as taught by Filtvedt for the purpose of providing a pulsatile negative pressure that would be able to provide therapeutics benefits and providing a pulsatile negative pressure that would be capable of treating or preventing spasticity (see paragraph 0008 of Filtvedt).
Regarding claim 28, the modified Chang fails to disclose that the first predetermined time interval is different than the second predetermined time interval.
However, Filtvedt teaches a method of applying negative pressure, wherein the negative pressure is a pulsating pressure comprising generating a negative pressure against the area of skin for a first predetermined time interval and releasing the negative pressure for a second predetermined time interval, wherein the first predetermined time interval is different than the second predetermined time interval (see paragraph 0080, Filtvedt discloses that the pressure is pulsed between -40 mmHg and +15 mmHg, wherein the +15 mmHg is over 5 seconds and -40 mmHg is 7 seconds).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the modified Chang to have the negative pressure comprising a first predetermined time interval that is different than the second predetermined time interval as taught by Filtvedt for the purpose of providing a pulsatile negative pressure that would be able to provide therapeutics benefits and providing a pulsatile negative pressure that would be capable of treating or preventing spasticity (see paragraph 0008 of Filtvedt).
After the modification, the first predetermined time interval (7 seconds, see paragraph 0080 of Filtvedt) and the second predetermined time interval (5 seconds, see paragraph 0080 of Filtvedt) each have a duration greater than a heartbeat of the patient (5 seconds and 7 seconds each are greater than a duration of a heartbeat of a patient, it is well known in the art that a typical heart beat at 60-100 beats per minute, which equates to an average beat of 1 second or less).
Allowable Subject Matter
Claim 40 is allowed over the prior art.
Response to Arguments
Applicant's arguments filed on 2/27/2026 have been fully considered but they are not persuasive.
The applicant on pages 8-13 of the remarks argues that it is asserted that “there is no evidence that the spasm of Chang is different enough from the spasms being disclosed by Roesch and Salo Darder such that one having ordinary skill in the art would be unmotivated to utilize the negative pressure of Roesch and/or Salo Darder to treat, the source of the spasm might be different but the spasm of Chang are being disclosed as spasm, while the spasm of Roesch and/or Salo Darder are being disclosed as cramps or spasticity, respectively, which are all muscle spasm within the art. However, it is respectfully submitted that this assertion is incorrect, as the source of the spasm is in fact the basis for the described treatments and one skilled in the art would not disregard the source of a condition when determining treatment. For example, Roesch relates to a method “for treating lymphedema and cramping conditions”, where lymphedema is described as “the chronic swelling of one or more extremities due to the accumulation of protein-rich tissue fluid in the intercellular space” (paragraphs 0001-2). Roesch indicates that the tissue is “decongested” to treat lymphedema and associated cramps, meaning that absent such congestion or swelling as occurs in lymphedema there would be no reason from Roesch for one skilled in the art to “decongest” the tissue. Chang characterizes spasticity as a “velocity-dependent increase in tonic stretch reflexes with exaggerated movements due to the hyperexcitability of such stretch reflexes being subdivided into spinal or cerebral spasticity, spinal spasticity resulting from the removal or destruction of supraspinal control and leading to increased excitability of motor neurons, while cerebral spasticity stems from a loss of descending inhibition. Chang indicates that the location of spasticity depends on the lesion in the central nervous system. As there is no indication in Chang that any tissue congestion is present and instead the spasticity is attributed to lesions in the central nervous system, one skilled in the art would not expect the “decongestion” treatment of Roesch to have any effect on the spasticity of Chang. Salo Darder is directed to a method of diagnosing and treating lesions in a “myofascial chain” (paragraph 0010). According to Salo Darder, when one of the links (at any point of the chain) comes under tension, a tensional chain is initiated, and the provoked tension along a myofascial chain leads to incorrect biomechanical compensations in the body and tension in the antagonistic muscles of the affected tensional chain (paragraphs 0009-10 and 0072-73). A “lesions” according to Salo Darder is accordingly described as “an alteration of a myofascial unit whereby said myofascial unit presents one or more of the following characteristics a) abnormal muscular tension, b) limitation of the myofascial mobility and c) limitation of the mobility of the superficial fascias” resulting from muscle tension along a myofascial chain in Salo Darder involves the application of suction for “the movement and stretching of the tissue” in a “relaxed position/stretch treatment” (paragraphs 0419 and 0447). The applicant further cited paragraph 0526 and stated that the biomechanical and muscle tension chain source of the asserted “spasticity” in Salo Darder differs from the spasticity of Chang which is caused by lesions in the central nervous system. The otherwise near-universal applicability of the myofascial treatment alleged in Salo Darder would additionally lead one skilled in the art away from believing the treatment could possibly be effective for every indication listed, let alone those that are not. Accordingly, one skilled in the art would find no reason to expect “movement and stretching of the tissue” by suction according to Salo Darder to address the spasticity caused by lesions in the central nervous system as described in Chang. Further, the drugs from Chang referenced in the office action are only used for spasticity indications resulting from neurological deficits and the cramps or spasticity of the references like Roesch and Salo Darder would not be treated with these drugs due to their having a different underlying cause. Such an underlying cause may include: electrolyte imbalances; atherosclerosis etc. The suggestions that it would be obvious to use the drugs of Chang in all of these conditions just because they are associated with cramping is clearly erroneous, but the rejection relies on just such an assumption that they “are all muscle spasm within the art”. This conclusion is further inconsistent with the teachings of the Chang reference, which explains with reference to table 1 that spasticity may include increased muscle tone, spasms and clonus, such that it cannot be reduced to simply any involuntary muscle contraction. As such, the proposed combination of Chang, Roesch and/or Salo Darder detailed in the office action is unreasonable and would not lead one skilled in the art to the method of the current claims. According to the new and unexpected results of the current application described in at least paragraph 20 that the present disclosure comprises the discovery that a patient suffering from spasticity related to diseases of and injuries to the central nervous system can be treated using negative pressure therapy.
However, the argument is not persuasive because Roesch discloses that the negative pressure therapy improves blood flow and improved oxygen transport, which is useful for treating or preventing cramps (spasm/spasticity), see paragraph 0007 of Roesch, it is noted that Roesch does not state that the cramps are cramps that are associated solely from lymphedema. It is unclear how the applicant came to the conclusion that the cramp of Roesch is an associated cramps of lymphedema. Furthermore, Salo Darder discloses the use of negative pressure therapy to treat “spasticity” (see paragraphs 0453, 0465, 0587-0594). Therefore, upon seeing both the references Chang and Roesch/Salo Darder, one having ordinary skilled in the art would be motivated to treat the spasticity of Chang with the negative pressure therapy, the applicant argues about the source of the spasticity being different, however, it is unclear how that would make it non-obvious for one having ordinary skilled in the art to utilize a negative pressure therapy that is able to improve blood flow and oxygen transport to treat/prevent uncontrolled muscle contractions (cramps of Roesch) of Roesch and/or the negative pressure therapy of treating uncontrolled muscle contractions (spasticity of Salo Darder) of Salo Darder to treat/prevent uncontrolled muscle contractions of Chang (spasticity of Chang). Roesch, Salo Darder or Chang does not teach away from utilizing the negative pressure therapy of Roesch on the spasticity/cramps of Chang. Roesch and Salo Darder both disclose that negative pressure can be used to treat spasm/cramps/spasticity, while Chang discloses in the abstract and pages 2-8 that spasticity is a velocity-dependent increase in muscle tone and uncontrolled, repetitive, involuntary contractions of skeletal muscles, and often manifest as increased tone and spasms, and further discloses that spasticity can be a result of spinal cord injury (SCI), cerebral palsy, stroke, amyotrophic lateral sclerosis, and multiple sclerosis (MS), and further discloses a method of treating spasticity including providing treatment drugs in the form of oral agent Baclofen, Benzodiazepines, and Dantrolene Sodium, throughout the disclosure, Chang further discloses that physical therapies can be complementary with medicine such as oral agents to treat spasticity (see “Treatments” section in page 2), therefore, upon seeing the references Roesch/Salo Darder, one having ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to modify Chang with Roesch and/or Salo Darder to utilize negative pressure of Roesch and/or Salo Darder to treat spasm/cramp/spasticity of Chang. Furthermore, there is no evidence that the spasm of Chang is different enough from the spasm being disclosed by Roesch and Salo Darder such that one having ordinary skill in the art would be unmotivated to utilize the negative pressure of Roesch and/or Salo Darder to treat. There is no evidence to show that the negative pressure of Roesch or Salo Darder are incapable of treating the spasm of Chang. The applicant provided arguments regarding how the uncontrolled muscle contractions came from different source or root cause, however, none of the references stated that the negative pressure therapy of Roesch or Salo Darder should not be used on the uncontrolled muscle contractions of Chang because the uncontrolled muscle contractions came from a different source. Regarding the applicant’s argument that the root cause (source) of the uncontrolled muscle contractions of Roesch, Salo Darder and Chang are different, therefore, it would not have been obvious for one having ordinary skill in the art would not combine the negative pressure therapy of both Roesch and Salo Darder to treat the spasticity of Chang, one having ordinary skill in the art can see that the uncontrolled muscle contractions of Roesch, Salo Darder and Chang are from the same immediate source in that the source of the Roesch, Salo Darder and Chang are all uncontrolled muscle contractions. Furthermore, regarding the argument that the instant invention contains new and unexpected results because the present disclosure comprises the discovery that a patient suffering from spasticity related to diseases of and injuries to the central nervous system can be treated using negative pressure therapy. This argument is not persuasive because as shown by both Roesch and Salo Darder, negative pressure is known to be effective against cramp/spasticity (spasm). Therefore, the rejection still stands.
Conclusion
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/TU A VO/Primary Examiner, Art Unit 3785