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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/08/2026 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 1, 4-8, 20-23, 25, 29, 33, 35 and 46 are 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.
The term “rigid” in claim 1 is a relative term which renders the claim indefinite. The term “rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 4-8, 20-23, 25, 29, 33, 35 and 46 are 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 since they depend directly or indirectly on rejected base claim 1 and therefore, contain the same deficiencies.
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) 1, 4-8, 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Quisenberry et al. U.S. Patent No. (10,512,587 B2) and evidenced by De Taboada U.S. Publication No. (20100204762 A1).
With respect to claim 1, Quisenberry et al. substantially 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:
a rigid attachment member (100, fig.1B), adapted to fit the device to the scalp of the subject ([Col.4], lines 45-50); Note: Quisenberry et al. discloses the use of several materials for forming the attachment member in ([Col.4], lines 45-49, one of which is polyvinyl chloride]; polyvinyl chloride (PVC) is a rigid material as evidenced by De Taboada discloses in [0221 a cover for a scalp having a body 510 formed of a rigid or substantially rigid material in order to prevent movement during irradiation, such as polyvinyl chloride], furthermore the attachment member of Quisenberry et al. imparts some degree of rigidity since the attachment member is being donned to the head of the user; a first layer (153, fig.1C) connected to the attachment member (100),
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).
Quisenberry et al. substantially discloses the invention as claimed except the bladder exerts a compressive pressure, in a range of 20mmHg to 100mmHg. The prior art drawn to Quisenberry et al. and Applicant’s invention are considered analogous art, as Quisenberry et al. discloses in ([Col.1], lines 30-40, the loss of bodily hair, a condition commonly known as “alopecia.” Alopecia has been known, in many cases, to have a dramatic effect on a patient's comfort and self-esteem. Consequently, efforts have been undertaken to ameliorate the alopecia-inducing effects of treatments including chemotherapy and radiation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize bladder of Quisenberry et al. to exert a compressive pressure, in a range of 20mmHg to 100mmHgn in order to treat alopecia caused by chemotherapy, as applicant appears to have placed no criticality on the claimed range, (see page 9, 7th paragraph, in one aspect, when activated, the device (1,100,200) applies a compressive pressure of between about 30 mmHg to about 350 mmHg, or to about 200 mmHg, to the scalp of the subject. Preferably, the compression pressure is between about 30 mmHg to about 150 mmHg or between about 20 mmHg and 100 mmHg; ideally between about 25 mmHg to about 75 mmHg; and in one aspect, between about 40 mmHg to about 60 mmHg)], since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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(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) 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 36-38 and 44 are 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 claims 36-38 and 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 1-6, filed 09/08/2026, with respect to the rejection(s) of claim(s) 1, 4-8, 11 and 20 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 35 U.S.C. 103 is made in view of Quisenberry et al.
Applicant's arguments filed 09/08/2026 have been fully considered but they are not persuasive. In view of applicant’s arguments that Quisenberry et al. discloses a first layer that is formed of a flexible material such as, for example, nylon, urethane, or polyvinyl chloride (PVC) and the materials to which the attachment member is not rigid as set forth in amended claim 1; since the attachment is being donned to the head of the user, it does impart some degree of rigidity. Furthermore, as evidenced by De Taboada discloses in [0221 a cover for a scalp having a body 510 formed of a rigid or substantially rigid material in order to prevent movement during irradiation, such as polyvinyl chloride].
Applicant further argues the prior art drawn to Quisenberry et al. does not disclose the bladder exerts a compressive pressure, in a range of 20mmHg to 100mmHg. The prior art drawn to Quisenberry et al. and Applicant’s invention are considered analogous art, as Quisenberry et al. discloses in ([Col.1], lines 30-40, the loss of bodily hair, a condition commonly known as “alopecia.” Alopecia has been known, in many cases, to have a dramatic effect on a patient's comfort and self esteem. Consequently, efforts have been undertaken to ameliorate the alopecia-inducing effects of treatments including chemotherapy and radiation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize bladder of Quisenberry et al. to exert a compressive pressure, in a range of 20mmHg to 100mmHgn in order to treat alopecia caused by chemotherapy, as applicant appears to have placed no criticality on the claimed range, (see page 9, 7th paragraph, in one aspect, when activated, the device (1,100,200) applies a compressive pressure of between about 30 mmHg to about 350 mmHg, or to about 200 mmHg, to the scalp of the subject. Preferably, the compression pressure is between about 30 mmHg to about 150 mmHg or between about 20 mmHg and 100 mmHg; ideally between about 25 mmHg to about 75 mmHg; and in one aspect, between about 40 mmHg to about 60 mmHg)], since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
The Office maintains the secondary references to cure the deficiencies of Quisenberry et al.
The amendment to claim 9 (cancelling claim 9) overcomes the rejection of claim 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, therefore, the rejection has been withdrawn.
Conclusion
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
