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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29APR2026 has been entered.
Response to Arguments
Applicant’s arguments and associated amendments, see p. 10, filed 29APR2026, with respect to Claims 41, 57, 60, and 65 have been fully considered and are persuasive. While Naghavi teaches that postconditioning continues after the ischemic event, the reference fails to explicitly teach exertion of compression after administration of chemotherapeutic agents.
Applicant's arguments filed 29APR2026 have been fully considered but they are not persuasive.
Regarding preconditioning and postconditioning as taught by Naghavi, Applicant’s arguments are partially persuasive. Naghavi is understood to teach that conditioning involves application of pressure through the teachings of [0002-0008]. [0003] describes that brief periods of ischemia prior to treatment are considered preconditioning. As Naghavi teaches compression as the means to cause ischemia, it is considered reasonable to interpret preconditioning as involving compression. Even assuming arguendo that the teachings of preconditioning did not involve “exerting compressive pressure”, [0071] clearly details exertion prior to administration, in previously cited [0071], Naghavi teaches “applying superficial pressure during chemotherapy can be preceded by ischemic conditioning treatments before chemotherapy” which is considered to fulfill the claim requirement. Applicant’s arguments relating to preconditioning are not considered relevant as cited [0071] clearly states that pressure is applied both during treatment and prior to treatment.
Regarding postconditioning, Applicant’s arguments are persuasive. See Reasons for Allowance.
Regarding Claim 38, Applicant’s arguments are not persuasive. The requirement to exert pressure continuously during said administration is considered to be taught as previously cited. Applicant’s arguments appear to desire exertion for the duration of the administration, which is not claimed.
Regarding Claim 45, the claim offers optional conditions including “prior to said administering and during said administering” which is considered to be taught, as previously discussed.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 38-40, 45, 55, and 61-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140066786 A1 (Naghavi et al.) in view of US 20090177184 A1 (Christensen et al.).
Regarding Claim 38, Naghavi teaches a method for mitigating peripheral nerve neuropathy associated with chemotherapy treatment [0055], comprising:
administering a chemotherapeutic agent to a patient [0071]; and
in conjunction with said administering, exerting compressive pressure on a body part of the patient positioned within a first interior space (where the limb is placed) of a compression exertion device during said administering [0071] and at least one of prior to said administering [0071], wherein said exerting is controlled by a controller-managed pressurization system (controlling device 20 operating the occluding device 10 [0056]), wherein said exerting is performed for causing at least one of a magnitude of said compressive pressure (the controller necessarily causing a magnitude of compressive pressure) and a duration of time [0013] for said compressive pressure being exerted to at least partially reduce capillary blood flow in a skin layer of the body part comprising nerve endings [0071]
Naghavi fails to teach wherein said exerting includes the controller-managed pressurization system pressurizing a compression-inducing medium within a second interior space of the compression exertion device, wherein said exerting includes exerting said compressive pressure on the body part continuously during said administering by a portion of the compression exertion device at least partially defining the second interior space, wherein said exerting includes pressurizing a compression-inducing medium within a second interior space of the compression exertion device to compress the skin layer of the body part, wherein said exerting includes exerting said compressive pressure directly onto the body part, wherein the body part includes one of a hand and a foot, and wherein said pressurizing includes maintaining the compression-inducing medium at a pressure compressive pressure is greater than 0 mm Hg and does not exceeding 50 mm Hg.
Christensen teaches a compression exertion device (1400) (Fig. 12C) capable of treating neurological disorders (peripheral neuropathy being a neurological disorder) wherein exerting pressure includes the controller-managed (controller 160) pressurization system pressurizing a compression-inducing medium within a second interior space (1414) of the compression exertion device, wherein said exerting includes exerting said compressive pressure on the body part (1431) continuously during said administering by a portion of the compression exertion device at least partially defining the second interior space (by 1410B, where [0124] describes pressure application and the thermal exchange units are optionally included [0056, 0120]), wherein said exerting includes pressurizing a compression-inducing medium within a second interior space of the compression exertion device to compress the skin layer of the body part (the device applying pressure to the skin as previously cited), wherein said exerting includes exerting said compressive pressure directly onto the body part (1410B making contact with the skin as seen in Fig. 12C), wherein the body part includes one of a hand and a foot (1400 being cited for other areas, but other embodiments being used on hands and feet [0058]), and wherein said pressurizing includes maintaining the compression-inducing medium at a pressure compressive pressure is greater than 0 mm Hg and does not exceeding 50 mm Hg (namely 5-20 mmHg [0059]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Naghavi to use the alternate compression exertion device of Christensen as a simple substitution of one compression exertion device for another to treat neuropathy MPEP 2143 I.
Regarding Claim 39, the device of Claim 38 is considered to teach the compressive pressure is less than 25 mm Hg by teaching a pressure of 5-20 mmHg [0059] as previously cited.
Naghavi in view of Christensen fails to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
Christensen further teaches thermal conditioning units (at least 1420) are maintained at 10°C (50°F) [0145] and through contact with the compression-inducing medium and skin is considered to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claim 38 to control temperature to control blood flow [Christensen 0059].
Regarding Claim 40, Naghavi further teaches preconditioning [0038] and is considered to teach exertion during administration as the effects of treatment are monitored and adjusted during treatment [0061]. Naghavi is therefore considered to teach said exerting is performed prior to said administering and during said administering.
Regarding Claim 45, Naghavi further teaches preconditioning [0038] and is considered to teach exertion during administration as the effects of treatment are monitored and adjusted during treatment [0061]. Naghavi is therefore considered to teach said exerting is performed prior to said administering, during said administering, and after said administering.
Naghavi in view of Christensen fails to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
Christensen further teaches thermal conditioning units (at least 1420) are maintained at 10°C (50°F) [0145] and through contact with the compression-inducing medium and skin is considered to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claim 38 to control temperature to control blood flow [Christensen 0059].
Regarding Claim 55, Naghavi in view of Christensen fails to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
Christensen further teaches thermal conditioning units (at least 1420) are maintained at 10°C (50°F) [0145] and through contact with the compression-inducing medium and skin is considered to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claim 38 to control temperature to control blood flow [Christensen 0059].
Regarding Claim 61, Naghavi teaches a method for mitigating peripheral nerve neuropathy associated with chemotherapy treatment [0055], comprising:
administering a chemotherapeutic agent to a patient [0071]; and
in conjunction with said administering, exerting compressive pressure on a body part of the patient positioned within a first interior space (where the limb is placed) of a compression exertion device during said administering [0071] and at least one of prior to said administering [0071],
wherein said exerting is controlled by a controller-managed pressurization system (controlling device 20 operating the occluding device 10 [0056]), wherein said exerting is performed for causing at least one of a magnitude of said compressive pressure (the controller necessarily causing a magnitude of compressive pressure) and a duration of time [0013] for said compressive pressure being exerted to at least partially reduce capillary blood flow in a skin layer of the body part comprising nerve endings [0071];
Naghavi further teaches four cycles of 5-minute treatments [0049], and is therefore considered to teach said exerting being performed for at least 3 minutes after said administering and not than 90 minutes after said administering.
Naghavi fails to teach wherein said exerting includes the controller-managed pressurization system pressurizing a compression-inducing medium within a second interior space of the compression exertion device, wherein said exerting includes exerting said compressive pressure on the body part continuously during said administering by a portion of the compression exertion device at least partially defining the second interior space, wherein said exerting includes pressurizing a compression-inducing medium within a second interior space of the compression exertion device to compress the skin layer of the body part, wherein said exerting includes exerting said compressive pressure directly onto the body part, wherein the body part includes one of a hand and a foot, and wherein said pressurizing includes maintaining the compression-inducing medium at a pressure compressive pressure is greater than 0 mm Hg and does not exceeding 50 mm Hg.
Christensen teaches a compression exertion device (1400) (Fig. 12C) capable of treating neurological disorders (peripheral neuropathy being a neurological disorder) wherein exerting pressure includes the controller-managed (controller 160) pressurization system pressurizing a compression-inducing medium within a second interior space (1414) of the compression exertion device, wherein said exerting includes exerting said compressive pressure on the body part (1431) continuously during said administering by a portion of the compression exertion device at least partially defining the second interior space (by 1410B, where [0124] describes pressure application and the thermal exchange units are optionally included [0056, 0120]), wherein said exerting includes pressurizing a compression-inducing medium within a second interior space of the compression exertion device to compress the skin layer of the body part (the device applying pressure to the skin as previously cited), wherein said exerting includes exerting said compressive pressure directly onto the body part (1410B making contact with the skin as seen in Fig. 12C), wherein the body part includes one of a hand and a foot (1400 being cited for other areas, but other embodiments being used on hands and feet [0058]), and wherein said pressurizing includes maintaining the compression-inducing medium at a pressure compressive pressure is greater than 0 mm Hg and does not exceeding 50 mm Hg (namely 5-20 mmHg [0059]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Naghavi to use the alternate compression exertion device of Christensen as a simple substitution of one compression exertion device for another to treat neuropathy MPEP 2143 I.
Regarding Claim 62, Naghavi in view of Christensen fails to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
Christensen further teaches thermal conditioning units (at least 1420) are maintained at 10°C (50°F) [0145] and through contact with the compression-inducing medium and skin is considered to teach the compression-inducing medium is thermally-conditioned to a temperature between 25 degrees F and 77 degrees F.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claim 38 to control temperature to control blood flow [Christensen 0059].
Regarding Claim 63, Naghavi fails to teach cyclical compressive pressure between an upper pressure limit less than 25 mm Hg and a lower pressure limit greater than 0 mm Hg.
Christensen further teaches cyclically varying pressure between a higher pressure and lower pressure [0143] and is therefore considered to teach said exerting includes adjusting the said compressive pressure in a cyclical manner between an upper pressure limit less than 25 mm Hg and a lower pressure limit greater than 0 mm Hg.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure exertion of Naghavi in view of Christensen with the cyclical pressure of Christensen to control venous refilling [Christensen 0143].
Regarding Claim 64, Naghavi fails to teach cyclical compressive pressure between an upper pressure limit less than 25 mm Hg and a lower pressure limit greater than 0 mm Hg.
Christensen further teaches cyclically varying pressure between a higher pressure and lower pressure [0143] and is therefore considered to teach said exerting includes adjusting the said compressive pressure in a cyclical manner between an upper pressure limit less than 25 mm Hg and a lower pressure limit greater than 0 mm Hg.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure exertion of Naghavi in view of Christensen with the cyclical pressure of Christensen to control venous refilling [Christensen 0143].
REASONS FOR ALLOWANCE
Claims 41-44, 46, 56-60, and 65-66 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
While Naghavi teaches treatment over extended periods of time, the reference fails to explicitly teach exertion of compression after administration of chemotherapeutic agents. While there are teachings of treatments of 5-10 times a day [0054], it is recognized that treatments will be tailored to the condition being treated and Naghavi solely provides teachings of treatment prior to administration of chemotherapy.
Conclusion
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/HANS KALIHER/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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