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 .
Response to Arguments
Applicant’s arguments and associated amendments, see p. 14, filed 30DEC2025, with respect to Claims 38-46 have been fully considered and are persuasive. The 35 U.S.C. § 112(a), 112(b) rejection of Claims 38-46 has been withdrawn.
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) 38-46 and 55-66 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 (teaching preconditioning [0003]) and after said administering (teaching postconditioning [0005]), 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 postconditioning [0039] 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 41, Naghavi further teaches preconditioning [0038] and postconditioning [0039] 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 during said administering and after said administering.
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 42, Naghavi further teaches four cycles of 5 minute treatments [0049], and is therefore considered to teach said exerting being performed after said administering includes one of said exerting being performed for 3 minutes to 10 minutes after said administering; said exerting being performed for 10 minutes to 30 minutes after said administering; said exerting being performed for 3 minutes to 30 minutes after said administering; said exerting being performed for 30 minutes to 60 minutes after said administering; said exerting being performed for 60 minutes to 90 minutes after said administering; said exerting being performed for 30 minutes to 90 minutes after said administering; and said exerting being performed for at least 90 minutes after said administering.
Regarding Claim 43, Naghavi further teaches preconditioning [0038] and postconditioning [0039] 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.
Regarding Claim 44, Naghavi further teaches four cycles of 5 minute treatments [0049], and is therefore considered to teach said exerting being performed after said administering includes one of said exerting being performed for 3 minutes to 10 minutes after said administering; said exerting being performed for 10 minutes to 30 minutes after said administering; said exerting being performed for 3 minutes to 30 minutes after said administering; said exerting being performed for 30 minutes to 60 minutes after said administering; said exerting being performed for 60 minutes to 90 minutes after said administering; said exerting being performed for 30 minutes to 90 minutes after said administering; and said exerting being performed for at least 90 minutes after said administering.
Regarding Claim 45, Naghavi further teaches preconditioning [0038] and postconditioning [0039] 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 46, Naghavi further teaches four cycles of 5 minute treatments [0049], and is therefore considered to teach said exerting being performed after said administering includes one of said exerting being performed for 3 minutes to 10 minutes after said administering; said exerting being performed for 10 minutes to 30 minutes after said administering; said exerting being performed for 3 minutes to 30 minutes after said administering; said exerting being performed for 30 minutes to 60 minutes after said administering; said exerting being performed for 60 minutes to 90 minutes after said administering; said exerting being performed for 30 minutes to 90 minutes after said administering; and said exerting being performed for at least 90 minutes after said administering.
Naghavi fails to teach cyclical compressive pressure.
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 Claims 55 and 56, 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 57, Naghavi teaches preconditioning [0038] and postconditioning [0039] 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 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.
Regarding Claim 58, 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 59, 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 60, Naghavi teaches preconditioning [0038] and postconditioning [0039] 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 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.
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 (teaching preconditioning [0003]) and after said administering (teaching postconditioning [0005]),
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].
Regarding Claim 65, 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].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HANS KALIHER/ Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781