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 Amendment
This Office action is responsive to the amendment filed 05/05/2026. Claims 12 and 15 have been cancelled. Claims 2-11, 13-14 and 16-23 are currently pending in the application and under examination.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 05/05/2026, with respect to the objection to claims 15 have been fully considered and are persuasive. Claim 15 has been cancelled, rendering the objection moot. Therefore, the objection has been withdrawn.
Applicant’s arguments, see pg. 6, filed 05/05/2026, with respect to the rejection of claim 12 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Claim 12 has been cancelled, rendering the rejection moot. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pg. 16-26, filed 05/05/2026, with respect to the rejections of the claims under 35 U.S.C. 102(a)(1) have been fully considered but they are not persuasive.
Applicant first argues, see pg. 16-21, that Naghavi does not expressly or inherently disclose each and every element set forth in independent claims 2 and 17. Applicant further argues that the Examiner arrived at an assertion of anticipation by impermissibly "picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference."
The Examiner disagrees. It is first noted that although Naghavi discloses multiple embodiments of the inventive subject matter, this does not preclude Naghavi from anticipating the method of claims 2 and 17. “[W]hen the species is clearly named, the species claim is anticipated no matter how many other species are additionally named” (see MPEP 2131.01).
It is the Examiner’s position that Naghavi clearly discloses each and every feature set forth in claims 2 and 17 and that the rejections of the claims do not rely on a combination of disparate disclosures.
Naghavi teaches a variety of devices and methods for ischemic conditioning “to reduce damage to tissues and/or improve response to therapies” (see [0006]) and specifically states that one such therapy is chemotherapy (see [0008]). It is clear based off of Naghavi’s disclosure that any of the disclosed methods and devices for ischemic conditioning can be used to treat a patient undergoing chemotherapy. See also paragraph [0099] of Naghavi which states “neuropathy is also believed to be prevented or reduced by administering ischemic conditioning as described herein For example, chemotherapy or diabetes induced neuropathy can be anticipated and is believed to be reduced or prevented by ischemic conditioning.”
The Examiner relies on a specific embodiment of an apparatus and method disclosed by Naghavi for ischemic conditioning of the hand or foot. Naghavi discloses exerting a compressive force directly to the hand or foot. While Naghavi also discloses remote ischemic conditioning in paragraph [0015], the paragraph further states “Alternatively, the releasable compressing elements may comprise inflatable compression mittens, socks and/or gloves.” It is understood that compressing elements in the form of mittens, socks or gloves would provide compressive force directly to the hand or foot. The Examiner also cited Fig. 9A, which clearly shows the compressing elements in the form of a glove and sock, in the rejection of the claims (see pg. 4 of Non-Final Rejection mailed 04/17/2026).
Applicant further argues, see pg. 21-23, that Naghavi does not teach the application of pressure directly to the hand or foot. Similarly, as described above, it is the Examiner’s position that this is clearly disclosed by Naghavi in paragraph [0015] and Fig. 9A, both of which were cited in the Non-Final Rejection mailed 04/17/2026. Naghavi also clearly describes that local ischemia is provided to superficial skin layers of the hand and foot by the glove, mitten and sock shown in Fig. 9A (see [0079]).
Applicant further argues, see pg. 23-26, that Naghavi does not disclose “the magnitude being sufficient to simultaneously reduce exposure of the peripheral nerve endings to chemotherapeutic agents circulating in the blood and simultaneously maintain sufficient blood flow to provide oxygenation and retain dermis tissue cell life while chemotherapeutic agents are present in circulating blood of the patient.”
It is the Examiner’s position that any compressive force necessarily has a magnitude even if unspecified. The claim does not specify a numerical magnitude. The claim only requires that the magnitude be sufficient to simultaneously reduce exposure of the peripheral nerve endings to chemotherapeutic agents circulating in the blood and simultaneously maintain sufficient blood flow to provide oxygenation and retain dermis tissue cell life while chemotherapeutic agents are present in circulating blood of the patient.
It is the Examiner’s position that magnitude of pressure applied through the methods disclosed by Naghavi is sufficient to reduce exposure of the peripheral nerve endings to chemotherapeutic agents circulating in the blood since that is clearly disclosed by Naghavi and is the problem with which the inventors of the devices and methods of Naghavi were concerned (see Naghavi paragraph [0081] which states “applying superficial pressure to reduce blood flow can reduce delivery of chemotherapy toxins to selected tissues”). Naghavi further teaches the applied pressure maintains sufficient blood flow to provide oxygenation and retain dermis tissue cell life since Naghavi discloses partial occlusion of blood flow (see [0065]) and the Examiner maintains that it is understood that partial occlusion of blood flow as disclosed by Naghavi rather than total occlusion of blood flow would retain dermis tissue cell life.
It is noted that Applicant’s own disclosure supports this claim that partial occlusion of blood flow is sufficient for retaining cell life (see paragraph [0041] of the instant application).
The rejections of the claims under 35 U.S.C. 102(a)(1) are maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-11,13-14, and 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naghavi et al. (US 2010/0105993).
Regarding claims 2, 4, 6, 7, 10, 16-17 and 23, Naghavi discloses a method for mitigating peripheral nerve neuropathy in a patient undergoing chemotherapy (the disclosed methods can be used to prevent or reduce neuropathy from chemotherapy, see [0065]), comprising: administering a chemotherapeutic agent to the patient during a chemotherapy treatment session; and during the chemotherapy treatment session in which the chemotherapeutic agent is administered to the patient, exerting a distributed compressive force on a body part of the patient to at least partially occlude blood flow to dermis tissue comprising peripheral nerve endings while retaining dermis tissue cell life (Naghavi discloses the application of a distributed compressive force to a body part to reduce blood flow during a chemotherapy treatment session by way of an inflatable cuff, which would partially displace blood within dermis tissue necessarily containing nerve endings and it is understood that partial displacement of blood rather than total occlusion would retain dermis tissue cell life, see [0081] and Fig. 1), wherein the body part is a hand or a foot (the treated body part can be a hand and/or foot, see [0015] and Fig. 9A), and wherein the distributed compressive force is maintained at a magnitude for at least a portion of the chemotherapy treatment session (the force can applied during a chemotherapy treatment session, see [0081]), the magnitude being sufficient to simultaneously reduce exposure of the peripheral nerve endings to chemotherapeutic agents circulating in the blood and simultaneously maintain sufficient blood flow to provide oxygenation and retain dermis tissue cell life while chemotherapeutic agents are present in circulating blood of the patient (the applied pressure reduces exposure to chemotherapeutic agents circulating in the blood by reducing blood flow to the target tissue and it is understood that partial occlusion of blood flow as disclosed by Naghavi rather than total occlusion of blood flow would retain dermis tissue cell life, see [0081]).
Regarding claims 3 and 18, Naghavi discloses the methods of claims 2 and 17, wherein exerting the compressive force is initiated prior to administration of the chemotherapeutic agent and maintained during at least a portion of the chemotherapy treatment session (the application of pressure during the chemotherapy treatment session can be preceded by the application of pressure before the treatment session, see [0081]).
Regarding claim 5, Naghavi discloses the method of claim 2, wherein the compressive force is applied during a period in which chemotherapeutic agents are present in circulating blood of the patient, including a period after administration of the chemotherapeutic agent (the pressure can be applied after administration of the chemotherapeutic agent, see [0008]).
Regarding claim 8, Naghavi discloses the method of claim 2, wherein exerting the compressive force causes displacement of blood containing chemotherapeutic agents from dermis tissue during the chemotherapy treatment session (when pressure is applied to the dermis tissue to partially occlude and reduce blood flow during a chemotherapy treatment session, as disclosed by Naghavi, this method would necessarily result in the displacement of blood containing chemotherapeutic agents, see [0081]).
Regarding claim 9, Naghavi discloses the method of claim 2, wherein exerting the compressive force reduces exposure of peripheral nerve endings located within epidermis and dermis skin layers to chemotherapeutic agents circulating in the blood (reduction in the flow of blood containing chemotherapeutic agents to a target tissue, as disclosed by Naghavi, see [0081], would reduce exposure of peripheral nerve ending in dermis tissue to the agents).
Regarding claim 11, Naghavi discloses the method of claim 2, wherein: exerting the compressive force comprises applying the compressive force to the body part either directly or indirectly (the compressive force is applied to the body part directly by the inflatable cuff, see Fig. 9A, and alternatively, it can also be said that pressure is applied indirectly to the body by the inflation fluid since the cuff is intermediate the body and the fluid, which is consistent with how Applicant construes indirect application of pressure, see [0051] of the Specification of the instant application); and the compressive force is exerted onto dermis tissue comprising peripheral nerve endings to at least partially displace blood while maintaining dermis tissue cell life (the compressive force is applied to dermis tissue which necessarily includes nerve endings and it is understood that partial occlusion of blood flow as disclosed by Naghavi rather than total occlusion of blood flow would retain dermis tissue cell life, see [0081]).
Regarding claims 13, 14 and 19, Naghavi discloses the methods of claims 2 and 17, wherein exerting the compressive force is intermittently relieved and reapplied on the body part while chemotherapeutic agents are present in circulating blood of the patient (the application of pressure can be intermittently applied, see [0054]).
Regarding claims 20, 21 and 22, Naghavi discloses the method of claim 17, wherein: exerting the distributed compressive force is performed in a continuous manner during at least a portion of the chemotherapy treatment session during which chemotherapeutic agents are present in circulating blood of the patient (although Naghavi discloses intermittent application of pressure, the periods during which the pressure is applied can be considered continuous pressure application), and the compressive force is exerted at a magnitude that is less than that which causes complete occlusion of blood flow through blood vessels within dermis tissue and not less than that which causes at least partial occlusion of blood flow through the blood vessels within the dermis tissue, while retaining dermis tissue cell life (Naghavi discloses application of pressure to reduce blood flow, which is considered partial occlusion, see [0081]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 4, 6, 7, 8, 9, 10, 11, 16-17 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,251,114. Although the claims at issue are not identical, they are not patentably distinct from each other.
While Claim 17 of ‘114 does not expressly claim the compressive force is applied to “maintain sufficient blood flow to provide oxygenation and retain dermis tissue cell life while chemotherapeutic agents are present in circulating blood of the patient,” as required by claims 2 and 17 of the instant application, it is understood that this would be the result of the claimed method since applying compressive pressure to a body part during administration of a chemotherapeutic agent to partially occlude blood flow in a skin layer of the body as claimed in claim 17 of ‘114 , would provide oxygenation and retain dermis tissue cell life.
Claims 3, 5, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,251,114 in view of Naghavi.
Regarding claims 3 and 18, claim 17 of U.S. Patent No. 12,251,114 substantially claims the method of claims 2 and 17, but fails to expressly claim the exerting the compressive force is initiated prior to administration of the chemotherapeutic agent and maintained during at least a portion of the chemotherapy treatment session.
Naghavi, in the same field of art, teaches a related method where a compressive force is initiated prior to and/or during a chemotherapy treatment session to reduce or prevent negative outcomes associated with exposure to chemotherapeutic agents (see [0081] and [0065]).
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 claim 17 of ‘114 to include the step of initiating the compressive force prior to administration of the chemotherapeutic agent since doing so would have reduced or prevented negative outcomes associated with exposure to chemotherapeutic agents.
Regarding claim 5, claim 17 of U.S. Patent No. 12,251,114 substantially claims the method of claim 2 but fails to expressly claim the compressive force is applied during a period a period after administration of the chemotherapeutic agent.
Naghavi teaches where a compressive force is applied after a chemotherapy treatment session to reduce the negative effects associated with the exposure to chemotherapeutic agents (the pressure can be applied after administration of the chemotherapeutic agent, see [0008]).
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 claim 17 of ‘114 to include the step of applying the compressing force during a period including after administration of the chemotherapeutic agent since doing so would have reduced negative outcomes associated with exposure to chemotherapeutic agents.
Conclusion
THIS ACTION IS MADE FINAL. 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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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