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 .
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 9 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 added material which is not supported by the original disclosure is as follows: as to claim 9, “the at least one primary bladder is configured to have a plurality of sockets to accommodate fingers of a hand or toes of a foot of the subject or wherein the at least one primary bladder is configured to be a single socket that accommodates a whole hand or a whole foot of the subject”; claim 1 recites “…the at least one primary bladder is inflated, minimizing blood perfusion to prevent chemotherapy delivery to the skin or surface tissue of the scalp of the subject”; it is unclear to the Office how can the same at least one primary bladder when inflated, minimizing blood perfusion to prevent chemotherapy delivery to the skin or surface tissue of the scalp of the subject as well as the fingers of a hand or toes of a foot of the subject and the whole hand or a whole foot of the subject at the same time. The original filed disclosure does not provide evidence that Applicant possessed these limitations at the time the Application was filed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 9, the limitation, “the at least one primary bladder is configured to have a plurality of sockets to accommodate fingers of a hand or toes of a foot of the subject or wherein the at least one primary bladder is configured to be a single socket that accommodates a whole hand or a whole foot of the subject” renders the claim vague and indefinite, because, claim 1 to which claim 9 depend recite, “…the at least one primary bladder is inflated, minimizing blood perfusion to prevent chemotherapy delivery to the skin or surface tissue of the scalp of the subject”; it is unclear to the Office how can the same at least one primary bladder when inflated, minimizing blood perfusion to prevent chemotherapy delivery to the skin or surface tissue of the scalp of the subject as well as the fingers of a hand or toes of a foot of the subject and the whole hand or a whole foot of the subject at the same time. As best understood from the drawings, both claims are drawn to separate embodiments as evident by (figs.1-9).
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) 1, 4-8, 11 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quisenberry et al. U.S. Patent No. (10,512,587 B2).
With respect to claim 1, Quisenberry et al. discloses a pneumatic compression device for use in preventing or treating chemotherapy-induced alopecia or chemotherapy-induced peripheral neuropathy (CIPN) in a subject receiving chemotherapy treatment ([Col.1], lines 30-40), the device comprising:
an attachment member (100, fig.1B), a first layer (153, fig.1C) connected to the attachment member adapted to fit the device to a scalp of the subject ([Col.4], lines 45-50),
at least one primary bladder (151, fig.1C); and
a fluid inlet (134, 136) and ([Col.5], lines 15-20 and 26-33),
wherein the at least one primary bladder (151) is configured to inflate with a fluid at ambient temperature ([Col.5], lines 26-33), and which exerts a compressive pressure to skin or surface tissue of the scalp of the subject when the at least one primary bladder is inflated, minimizing blood perfusion to prevent chemotherapy delivery to the skin or surface tissue of the scalp of the subject ([Col.5], lines 26-33).
With respect to claim 4, Quisenberry et al. discloses secondary bladder (150, fig.1C), wherein the secondary bladder (150) is configured to attach to the attachment member (153) such that the secondary bladder comes in contact with the skin or surface tissue of the subject ([Col4], lines 45-67) and ([Col.5], lines 1-5).
With respect to claim 5, Quisenberry et al. discloses a first fastening system (708, fig.7A).
With respect to claim 6, Quisenberry et al. discloses a first fastening system and a second fastening system adapted to tighten the attachment member to the subject (as shown in the reproduced image of fig.7A below).
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With respect to claim 7, Quisenberry et al. discloses the at least one primary bladder is attached along its perimeter surface to the first layer and along its lower edge surface to the attachment member (as shown in fig.1C).
With respect to claim 8, Quisenberry et al. discloses at least one adjustable strap to secure the device under, around or over a chin of the subject (as shown in fig.7A).
With respect to claim 11, Quisenberry et al. discloses a first securing member to secure the device in place (as shown in fig.7A and the reproduced image of fig.7A above).
With respect to claim 20, Quisenberry et al. discloses a control element (4) and ([Col.3], lines 4-11).
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.
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry et al. as applied to claim 1 above, and further in view of Belson et al. U.S. Publication No. (20203/0248606 A1, provisional filed June 24,2020).
With respect to claim 21, Quisenberry et al. substantially discloses a control element (4), the control element comprising a pump ([Col.3], lines 4-11) except and a pressure sensor.
Belson et al. however, teaches various devices and methods useful for providing vasocompression to a patient who is undergoing chemotherapy treatment (abstract) comprising a head covering having one or more pressure sensors within an interior portion of the head covering. The one or more pressure sensors can provide an indication of pressure to the control system. The one or more pressure sensors can be adapted to indicate an amount of pressure applied to a patient undergoing chemotherapy when the patient is wearing the head covering; the head covering can further include a control system for adjusting the flow of gas from the gas source to maintain a desired pressure within the head covering [0009].
In view of the teachings of Belson et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control element of Quisenberry et al. by incorporating a pressure sensor in order to maintain a desired pressure within the head covering.
With respect to claim 22, the combination of Quisenberry et al./Belson et al. substantially discloses the invention as claimed. Belson et al. further teaches a control element comprising a pump and a pressure sensor, wherein the pressure sensor is in communication with the at least one primary bladder [0009].
Claim(s) 23, 29 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry et al. as applied to claim 1 above, and further in view of Everett et al. U.S. Publication No. (2020/0163679 A1).
With respect to claim 23, Quisenberry et al. substantially discloses the invention as claimed except the at least one primary bladder further comprises a plurality of bladder compartments, each bladder compartment of the plurality of bladder compartments either operating independently of each other or in fluid communication with a juxtaposed bladder compartment.
Everett et al., however, teaches a compression device (as shown in fig.9) comprising least two expansion cavities for providing two separate pressure-inducing medium [0070], Everett further teaches in [0070, a first pressure inducing medium within the first expansion cavity 632 and a second pressure inducing medium within the oxygen-carrying medium cavity 637 (i.e., a second expansion cavity). The compression exertion device 602 can further include a third first expansion cavity connector 641 and a fourth expansion cavity connector 642. The outer enclosure 620 and the cavity partition 635 jointly define the expansion cavity 632].
In view of the teachings of Everett et al. it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one primary bladder of Quisenberry et al. by incorporating a plurality of bladder compartments, each bladder compartment of the plurality of bladder compartments either operating independently of each other or in fluid communication with a juxtaposed bladder compartment such that different pressure-inducing mediums and associated delivery pressures can be used for exerting blood supply occluding compression on the appendage 1 and for delivering oxygen (e.g., bio-available dissolved oxygen or nano oxygen bubble water solution) to the appendage via its epidermal skin layer [0070] of Everett et al.
With respect to claim 29, the combination of Quisenberry et al./Everett et al. substantially discloses the invention as claimed. Everett et al. further teaches the compressive pressure is applied incrementally, and wherein the compressive pressure is applied uniformly and/or non-uniformly [0073, the pressures can be cycled from a minimal pressure state and then increased to the high-pressure state with the use of programmable precision controlled medical pumps, provided by numerous medical device manufacture].
With respect to claim 33, the combination of Quisenberry et al./Everett et al. substantially discloses the invention as claimed. Everett et al. further teaches the at least one primary bladder (324) is inflated to a pre-determined pressure level below a target therapeutic pressure level prior to a user using the device [0050] and [0071].
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry et al. as applied to claim 1 above, and further in view of Everett et al. U.S. Publication No. (2020/0163679 A1) and Taheri U.S. Patent No. (4,624,244).
With respect to claim 25, Quisenberry et al. substantially discloses the invention as claimed except the at least one primary bladder further comprises a plurality of bladder compartments, each bladder compartment of the plurality of bladder compartments either operating independently of each other, or in fluid communication with a juxtaposed bladder compartment, and wherein the at least one primary bladder or the plurality of bladder compartments are connected to a pump, the pump having a two-way valve system to control an inflow and outflow of the fluid.
Everett et al., however, teaches a compression device (as shown in fig.9) comprising least two expansion cavities for providing two separate pressure-inducing medium [0070], Everett further teaches in [0070, a first pressure inducing medium within the first expansion cavity 632 and a second pressure inducing medium within the oxygen-carrying medium cavity 637 (i.e., a second expansion cavity). The compression exertion device 602 can further include a third first expansion cavity connector 641 and a fourth expansion cavity connector 642. The outer enclosure 620 and the cavity partition 635 jointly define the expansion cavity 632].
In view of the teachings of Everett et al. it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one primary bladder of Quisenberry et al. by incorporating a plurality of bladder compartments, each bladder compartment of the plurality of bladder compartments either operating independently of each other or in fluid communication with a juxtaposed bladder compartment such that different pressure-inducing mediums and associated delivery pressures can be used for exerting blood supply occluding compression on the appendage 1 and for delivering oxygen (e.g., bio-available dissolved oxygen or nano oxygen bubble water solution) to the appendage via its epidermal skin layer [0070] of Everett et al.
The combination of Quisenberry et al./Everett et al. substantially discloses the invention as claimed except the at least one primary bladder or the plurality of bladder compartments are connected to a pump, the pump having a two-way valve system to control an inflow and outflow of the fluid.
Taheri however, teaches a device for aiding cardiocepital venous flow from the foot and leg of a patient including a first flexible fabric cuff for encircling the arch and instep of a patient's foot, a first bladder in the first cuff for placement in contiguous relationship to the arch, a second cuff for encircling the leg of the patient, a plurality of sequentially ascending second bladders in the second cuff for placement in contiguous relationship to the calf of the leg of the patient, a first conduit in communication with the first bladder, and second conduits in communication with the second bladders (abstract) and (figs.1-4); comprising a compressor (66) in communication with a relief valve (69, a relief valve is a two-way valve) and ([Col.3], lines 30-33).
In view of the teachings of Taheri, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one primary bladder compartments of Quisenberry et al./Everett et al.by incorporating a pump having a two-way valve system to control an inflow and outflow of the fluid in order to regulate the amount of air going in and out of the plurality of bladder compartments.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry et al. as applied to claim 1 above, and further in view of Segal U.S. Patent No. (11,064,753 B2).
With respect to claim 35, Quisenberry et al. substantially discloses the invention as clamed except the attachment member further comprising at least one status indicator light.
Segal however, teaches a helmet comprising status indicators, such as lights indicating whether the airbag helmet 20 is in an activation mode, a deactivation mode, or when the batteries are running low ([Col.2], lines 57-63).
In view of the teachings of Segal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the attachment member of Quisenberry et al. by incorporating at least one status indicator light for indicating whether the compression device is in an activation mode, a deactivation mode.
Claim(s) 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. U.S. Publication No. (2020/0163679 A1).
With respect to claim 36, Everett et al. substantially discloses a method of controlling drug delivery via blood vessels to a target site on a body, the method comprising: mechanically compressing skin or surface tissue at a target tissue site at a compressive pressure to occlude upstream blood vessels; maintaining the compressive pressure for a predetermined period; and releasing the compressive pressure applied to the surface tissue at the target site [Abstract, the present invention are directed to devices, systems and methods adapted for implementing intermittent displacement of blood to mitigate peripheral nerve neuropathy such as that induced by chemotherapeutic agents (i.e., chemotherapy-induced neuropathy (CIN)) that are administered to a patient] and [0084].
Everett et al. substantially discloses the invention as claimed except a predetermined compressive pressure and at a predetermined rate and in a pre-determined geometric pattern.
Everett et al. however, teaches in [0084, the system is provided having a programmable controlled pressure source adapted to introduce a compression inducing medium (fluid or gas) in to an expansion cavity of a compression exertion device for achieving controlled intermittent inflation of the expansion cavity when the compression inducing medium is introduced and pressurized within the expansion cavity from the programmable controlled pressure source]. Since, a programmable controlled pressure source has been taught/suggested by Everett et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to determined predetermined compressive pressure and at a predetermined rate and in a pre-determined geometric pattern based on a treatment regimen.
With respect to claim 37, Everett et al. substantially discloses the invention as claimed. Everett et al. further teaches the predetermined compressive pressure [0084] is applied to the target tissue site [dermis skin layer, 0084] upstream of an intended effect site [0041].
With respect to claim 38, Everett et al. substantially discloses the invention as claimed. Everett et al. further teaches the predetermined compressive pressure [0084] is applied to the skin or surface tissue at the target site at about 10 mmHg to about 100 mmHg [0017].
Claim(s) 46 is rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry et al. as applied to claim 1 above, and further in view of Oppenheimer U.S. Publication No. (2020/0000679 A1).
With respect to claim 46, Quisenberry et al. substantially discloses the invention as claimed except a tissue perfusion sensor.
Oppenheimer however, teaches a compression system (Abstract) comprising a tissue perfusion sensor [0010, the system further includes a tissue perfusion sensor operable to sense an amount of tissue perfusion of the patient, in which the tissue perfusion sensor is couplable to the first computing device].
In view of the teachings of Oppenheimer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the compression device of Quisenberry et al. by incorporating a tissue perfusion sensor to sense an amount of tissue perfusion of the patient [0010] of Oppenheimer.
Allowable Subject Matter
Claims 44 is allowed.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to Quisenberry et al. fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in independent claim 44 which recite features not taught or suggested by the prior art drawn to Quisenberry et al. The Office maintain the teaching references to cure the deficiencies of Quisenberry et al.
Response to Arguments
Applicant’s arguments, see pages 1-5, filed 03/23/2026, with respect to the rejection(s) of claim(s) 1, 5-7, 11, 20-22, 29, 33, 36-38 and 44 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Quisenberry et al.
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 OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786
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