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 filed 14APR2026 have been fully considered but they are not persuasive.
Kane teaches a device which comprises all the claimed structures and a controller capable of operating as required. Additional claim language relating to the application of chemotherapeutic agents is merely intended use of the device and provides no structural or physical requirements as presented. Furthermore, the requirements relating to causing partial occlusion and retaining cell life are not defined in a clear way which allows one to distinguish the instant device from the prior art of record. Without clear limits, these requirements must be interpreted broadly. As an example, full occlusion of blood flow may occur for a short period of time and then be removed. Upon removal of pressure, blood flow would resume and dermis tissue would retain cell life therein. Therefore, any level of occlusive pressure short of complete occlusion would meet the claim requirements as written, barring teachings that said pressure causes complete cell death in the affected area. While Kane teaches a different application, the Claims are directed to a device, and not the method of using said device. The device of Kane is capable of use as claimed as it teaches the same features (applying pressure to an extremity) in an attempt to control blood flow.
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.
Claim(s) 46-65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20080132816 A1 (Kane et al.).
Regarding Claim 46, Kane teaches a compression apparatus (Figs. 1, 2A, and 2B showing the device, with Fig. 8 detailing the controller), comprising:
a pressure controller (160); and
a compression exertion device (100) operatively connected to the pressure controller;
wherein the compression exertion device includes an interior space (150) configured to receive a body part of a patient (an extremity [0129]);
wherein the pressure controller is configured to cause pressurization of a compression-inducing medium (gases and/or liquids [0055]) to exert compressive pressure on the body part within the interior space (via gas plenums (172) [0071]);
wherein the pressure controller is configured to simultaneously:
cause partial occlusion of blood flow (teaching 3-40 mmHg [0052]) within dermis tissue of the body part to limit exposure of peripheral nerve endings within the dermis tissue to chemotherapeutic agents circulating in blood of the patient; and
maintain blood flow within the dermis tissue to retain dermis tissue cell life therein (the pressure not preventing blood flow for a duration which would cause cell death); and
wherein the pressure controller is configured to maintain the compressive pressure during a treatment interval ([0122] describing treatment involving cycling the compression for various time periods) corresponding to administration of a chemotherapeutic agent, including a period in which the chemotherapeutic agent is present in the circulating blood of the patient.
“[T]o limit exposure of peripheral nerve endings within the dermis tissue to chemotherapeutic agents circulating in blood of the patient; and maintain blood flow within the dermis tissue to retain dermis tissue cell life therein” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
“[D]uring a treatment interval corresponding to administration of a chemotherapeutic agent, including a period in which the chemotherapeutic agent is present in the circulating blood of the patient” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 47, the device of Claim 46 is considered to teach the controller being configured to simultaneously cause said partial occlusion and maintain said blood flow includes the pressure controller being configured to maintain the compressive pressure at one or more magnitudes each less than that which causes complete occlusion of blood flow within the dermis tissue and sufficient to at least partially occlude blood flow within the dermis tissue while simultaneously maintaining blood flow to retain dermis tissue cell life by teaching the ability to cycle pressure in a controlled way [0122] and providing a plurality of pressures (namely 0-100 mmHg [0052]).
Regarding Claim 48, the device of Claim 46 is considered to teach the controller being configured to simultaneously cause said partial occlusion and maintain said blood flow includes the pressure controller being configured to regulate the compressive pressure to maintain one or more magnitudes such that blood flow within the dermis tissue is at least partially occluded while blood flow is simultaneously maintained within the dermis tissue to retain dermis tissue cell life by teaching the ability to cycle pressure in a controlled way [0122], and providing a plurality of pressures (namely 0-100 mmHg [0052]).
Regarding Claim 49, Kane further teaches the compression-inducing medium comprises a gaseous medium, a liquid medium, or a combination thereof [0055].
Regarding Claim 50, the body part is a hand or a foot [0017].
Regarding Claim 51, the device of Claim 46 is considered to teach the pressure controller (160) is configured to initiate application of the compressive pressure prior to administration of the chemotherapeutic agent as the user initiates both the controller and the administration of chemotherapeutic agent.
Regarding Claim 52, the controller being configured to simultaneously cause said partial occlusion and maintain said blood flow includes the pressure controller being configured to maintain the compressive pressure at one or more magnitudes during a period in which the chemotherapeutic agent is present in the circulating blood of the patient, including a period after completion of administration by teaching the ability to cycle pressure in a controlled way [0122] and that the user initiates both the controller and the administration of chemotherapeutic agent.
Regarding Claim 53, Kane further teaches the pressure controller is configured to intermittently apply the compressive pressure by cycling between a pressurized state and a reduced-pressure state (cycling pressure between a lower pressure and a higher pressure [0122]) to permit sufficient blood flow to retain dermis tissue cell life.
“[T]o permit sufficient blood flow to retain dermis tissue cell life” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 54, Kane is considered to teach the pressure controller is configured to maintain the compressive pressure prior to administration of the chemotherapeutic agent, during administration of the chemotherapeutic agent, and for a period after completion of administration of the chemotherapeutic agent while the chemotherapeutic agent is present in the circulating blood of the patient by teaching the ability to cycle pressure in a controlled way [0122] and that the user may operate both the controller and the administration of chemotherapeutic agent.
Regarding Claim 55, Kane further teaches the compression exertion device (100) is configured to apply substantially uniform compression over irregular surface features of at least a portion of an epidermal skin layer of the body part ([0055] teaching a pliant material which conforms to the shape of the extremity and securely surrounding said extremity).
Regarding Claim 56, Kane teaches a compression apparatus (Figs. 1, 2A, and 2B showing the device, with Fig. 8 detailing the controller), comprising:
a pressure controller (160); and
a compression exertion device (100) operatively connected to the pressure controller;
wherein the compression exertion device includes an interior space (150) configured to receive a body part of a patient (an extremity [0129]);
wherein the pressure controller is configured to cause pressurization of a compression-inducing medium (gases and/or liquids [0055]) to exert compressive pressure on the body part within the interior space (via gas plenums (172) [0071]);
wherein the pressure controller is configured to simultaneously:
cause partial occlusion of blood flow (teaching 3-40 mmHg [0052]) within dermis tissue of the body part to limit exposure of peripheral nerve endings within the dermis tissue to chemotherapeutic agents circulating in blood of the patient; and
maintain blood flow within the dermis tissue to retain dermis tissue cell life therein (the pressure not preventing blood flow for a duration which would cause cell death); and
“[T]o limit exposure of peripheral nerve endings within the dermis tissue to chemotherapeutic agents circulating in blood of the patient; and maintain blood flow within the dermis tissue to retain dermis tissue cell life therein” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 57, the device of Claim 46 is considered to teach the controller being configured to simultaneously cause said partial occlusion and maintain said blood flow includes the pressure controller being configured to maintain the compressive pressure at one or more magnitudes each less than that which causes complete occlusion of blood flow within the dermis tissue and sufficient to at least partially occlude blood flow within the dermis tissue while simultaneously maintaining blood flow to retain dermis tissue cell life by teaching the ability to cycle pressure in a controlled way [0122] and providing a plurality of pressures (namely 0-100 mmHg [0052]).
Regarding Claim 58, the device of Claim 46 is considered to teach the controller being configured to simultaneously cause said partial occlusion and maintain said blood flow includes the pressure controller being configured to regulate the compressive pressure to maintain one or more magnitudes such that blood flow within the dermis tissue is at least partially occluded while blood flow is simultaneously maintained within the dermis tissue to retain dermis tissue cell life by teaching the ability to cycle pressure in a controlled way [0122], and providing a plurality of pressures (namely 0-100 mmHg [0052]).
Regarding Claim 59, Kane further teaches the compression-inducing medium comprises a gaseous medium, a liquid medium, or a combination thereof [0055].
Regarding Claim 60, the body part is a hand or a foot [0017].
Regarding Claim 61, the device of Claim 46 is considered to teach the pressure controller (160) is configured to initiate application of the compressive pressure prior to administration of the chemotherapeutic agent as the user initiates both the controller and the administration of chemotherapeutic agent.
Regarding Claim 62, the controller being configured to simultaneously cause said partial occlusion and maintain said blood flow includes the pressure controller being configured to maintain the compressive pressure at one or more magnitudes during a period in which the chemotherapeutic agent is present in the circulating blood of the patient, including a period after completion of administration by teaching the ability to cycle pressure in a controlled way [0122] and that the user initiates both the controller and the administration of chemotherapeutic agent.
Regarding Claim 63, Kane further teaches the pressure controller is configured to intermittently apply the compressive pressure by cycling between a pressurized state and a reduced-pressure state (cycling pressure between a lower pressure and a higher pressure [0122]) to permit sufficient blood flow to retain dermis tissue cell life.
“[T]o permit sufficient blood flow to retain dermis tissue cell life” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claim 64, Kane is considered to teach the pressure controller is configured to maintain the compressive pressure prior to administration of the chemotherapeutic agent, during administration of the chemotherapeutic agent, and for a period after completion of administration of the chemotherapeutic agent while the chemotherapeutic agent is present in the circulating blood of the patient by teaching the ability to cycle pressure in a controlled way [0122] and that the user may operate both the controller and the administration of chemotherapeutic agent.
Regarding Claim 65, Kane further teaches the compression exertion device (100) is configured to apply substantially uniform compression over irregular surface features of at least a portion of an epidermal skin layer of the body part ([0055] teaching a pliant material which conforms to the shape of the extremity and securely surrounding said extremity).
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
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
Prosecution Insights