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
The amendment filed on 02/23/2026 has been entered. Claims 1, 2, 15, 32, 33, 66, and 68 have been amended. Claim 102 is newly added. No claims are cancelled. Claims 1-3, 5, 7, 8, 15, 16, 18, 19, 22, 26, 30, 32, 33, 66-69, 71, 74, 77, 80, 81, 83, 90, and 102 are pending in the instant application. Applicant’s amendments to the claims have overcome the objections, 112(f) interpretations, and 112(b) rejection raised in the non-final rejection mailed on 08/22/2025.
Response to Arguments
Applicant’s arguments with respect to claim 1 and 66 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 7-8, 15-16, 18-19, 22, 26, 30, 32, 66-69, 71, 74, 77, 80-81, 83, 90, and 102 are rejected under 35 U.S.C. 103 as being unpatentable over US20200375793A1 to Dilligan et al. (hereinafter “Dilligan”) in view of US20160317348A1 to Banker (hereinafter “Banker”).
Regarding claim 1, Dilligan discloses a head covering for inducing vasocompression in the blood supply of a patient receiving chemotherapy (Figs. 1A and 1B cooling cap assembly 110, inflatable member 130; Paragraph 0129 discloses the cap is worn and therapy is administered as chemotherapy is being given to the patient; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient), comprising:
A shell having a front edge, a back edge, a top, a left side edge and a right side edge (Fig. 1B cover 114; See Dilligan Annotated Fig. 1 for designation of the front, back, left, and right side edges, and top);
A liner including at least an inner liner within the shell shaped to at least partially accommodate the hair of the patient (Fig. 1B liner 112 and Annotated Fig. 1B together comprise the liner; Paragraph 0054 discloses the liner is placed on the scalp; Examiner notes that positioning the liner on the scalp will naturally allow the liner to accommodate the patient’s hair);
At least one vasocompression element within the shell, (Fig. 1B inflatable member 130 is within cover 114);
A head covering retention system coupled to the shell (Fig. 7E shows a strap which is integrally connected with the rest of the shell that keeps the rest of the device secured to the user; Paragraph 0055 discloses cover 114 may comprise a fastener which releasably attaches the cooling cap assembly to the head of the patient).
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Dilligan does not explicitly disclose wherein one or more of the vasocompression element and the liner are configured to be one or more of sized, shaped or positioned relative to the head covering based on a hairstyle of the patient. However, Banker teaches a system and method for limiting chemotherapy-induced alopecia which has a liner configured to be positioned based on a hairstyle of the patient (Figs. 1-2 & 5 circulating pad 12; Paragraph 0047 discloses the circulating pad may be configured to be position at least a portion of the hair follicles of a wearer; Examiner notes that positioning the pad based on location of the hair follicles would positioning based on a hairstyle of the patient).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to position Dilligan’s liner relative to the head covering based on a hairstyle of the patient, as taught by Banker, in order to cover a portion of the body where it is desired to limit hair loss (Paragraph 0047).
Regarding claim 2, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses wherein the head covering retention system comprises a submandibular strap connected to the shell (Figs. 1B and 7E show a strap goes beneath the patient’s jaw when the system is worn).
Regarding claim 3, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses wherein the head covering retention system comprises one or more of a rear strap, a front strap or a neck strap connected to the shell (Examiner notes the strap shown in Figs. 1 and 7E is a front strap which is integrally connected with cover 114).
Regarding claim 5, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses wherein the at least one vasocompression element is an expandable bladder within the liner (Fig. 1B inflatable member 130).
Regarding claim 7, Dilligan in view of Banker discloses the head covering of claim 5, and Dilligan further discloses a pressure source in communication with the expandable bladder (Paragraph 0056 discloses the inflatable member may be connected to a pump which inflates the inflatable member).
Regarding claim 8, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses a continuous perimeter connecting the front edge, the back edge, the left side edge and the right side edge (See Dilligan Annotated Fig. 1 in the rejection of claim 1; Examiner notes all edges define a continuous perimeter).
Regarding claim 15, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses wherein the head covering retention system further comprising: a hook and loop fastener, a buckle, a quick release mechanism configured to assist in removing the head covering retention system from a head of he patient, or an adjustment feature configured to adjust a tightness of the head covering retention system on the head of the patient (Figs. 1 and 7E show the strap which goes under the patient’s jaw; Examiner notes the strap may be slipped off and thus is interpreted to be a quick release mechanism as discussed in the 112(b) rejection above).
Regarding claim 16, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses a gas source in communication with the liner or the at least one vasocompression element for inflation of a portion of the liner or a portion of the at least one vasocompression element (Paragraph 0056 discloses the inflatable member 130 may be connected to a pump which inflates the inflatable member).
Regarding claim 18, Dilligan in view of Banker discloses the head covering of claim 16, and Dilligan further discloses wherein the gas source is a manual pump mechanism, a bulb, an electric pump, or pressurized tank, cartridge or reservoir (Paragraph 0087 discloses the pump may be a manual pump fluidly connected to the chambers of the inflatable member).
Regarding claim 19, Dilligan in view of Banker discloses the head covering of claim 16, and Dilligan further discloses a control system for adjusting the flow of gas from the gas source to maintain a desired pressure within the head covering (Paragraph 0058 discloses controller 140 may be configured to adjust the fluid pressure of inflatable member 130 using the pump).
Regarding claim 22, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses one or more pressure sensors within an interior portion of the head covering, wherein the one or more pressure sensors are adapted to indicate an amount of pressure applied to a patient undergoing chemotherapy when the patient is wearing the head covering (Fig. 1B sensors 132; Paragraph 0088 discloses the system’s controller may dynamically (using sensor data) control an inflation pressure of the inflatable member; Paragraph 0109 discloses the sensors may be pressure sensors; Examiner notes Fig. 1B shows the sensors are in an interior portion of cooling cap assembly 110).
Regarding claim 26, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses a continuous structure from the occiput area to the eyebrows or to the forehead (See structure of cover 114 in Fig. 1B and 7 which extends from the occiput area to the patient’s forehead).
Regarding claim 30, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses wherein the liner is a rigid or semi-elastic layer configured for an exact fit for the patient to fit exactly the shape of the patient's head and hair (Paragraph 0105 discloses the liner may be a flexible/elastic such as a knit polyamide or a knit nylon to hold the patient’s hair in a desired configuration).
Regarding claim 32, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan further discloses further comprising one or more selective pressure points positioned to compress one or more vessels of the cranial circulatory system of a patient (Fig. 1B inflatable member 130; Examiner notes that there are multiple inflation chambers which, when inflated, would provide pressure points to the user’s head).
Regarding claim 66, Dilligan discloses a method of inducing vasocompression in a cranial circulatory system of a patient receiving chemotherapy (Figs. 1A and 1B cooling cap assembly 110, inflatable member 130; Paragraph 0129 discloses the cap is worn and therapy is administered as chemotherapy is being given to the patient; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient), comprising:
Placing a head covering about the head of the patient (Figs. 1B and 7 show the cooling cap assembly 110 is placed on the head of a patient);
At least partially inducing vasocompression in a portion of the cranial circulatory system of the patient using a vasocompression element of the head covering (Fig. 1B inflatable member 130; Paragraph 0052 discloses inflatable member 130 is part of compression assembly 145; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient);
wherein the induced vasocompression includes configuring a liner including at least an inner liner (Fig. 1B liner 112 and Annotated Fig. 1B together comprise the liner; Paragraph 0054 discloses the liner is placed on the scalp);
Initiating a chemotherapy session with the patient (Paragraph 0129 discloses a patient may use the system while the chemotherapy session is completed);
Concluding the chemotherapy session with the patient (Paragraph 0129 discloses the patient may finish the chemotherapy session); and
Ceasing the step of at least partially inducing vasocompression in a portion of the cranial circulatory system of the patient when a period of time has elapsed after the step of concluding the chemotherapy session sufficient to partially mitigate an effect of chemotherapy induced alopecia in the patient (Paragraph 0129 discloses the patient may transport the system home after the chemotherapy session and use the system again; Paragraph 0099 discloses inflating the inflatable member(s) allows for uniform cooling of the patient’s head; Paragraph 0004 discloses the disclosed systems and methods are provided to mitigate alopecia associated with chemotherapy).
Dilligan does not explicitly disclose wherein the induced vasocompression includes configuring a liner including at least an inner liner to fit a shape of the hair of the patient; further wherein the inner liner and the vasocompression element are configured to be one or more of sized, shaped or positioned relative to the head covering based on a hairstyle of the patient. However, Banker teaches a system and method for limiting chemotherapy-induced alopecia which has a liner configured to be positioned based on a hairstyle of the patient (Figs. 1-2 & 5 circulating pad 12; Paragraph 0047 discloses the circulating pad may be configured to be position at least a portion of the hair follicles of a wearer; Examiner notes that positioning the pad based on location of the hair follicles would positioning based on a hairstyle of the patient).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to position Dilligan’s liner relative to the head covering based on a hairstyle of the patient, as taught by Banker, in order to cover a portion of the body where it is desired to limit hair loss (Paragraph 0047).
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Regarding claim 67, Dilligan in view of Banker discloses the method of claim 66, and DIlligan further discloses engaging a head covering retention system to immobilize the head covering relative to the head of the patient (Fig. 7E shows a strap which is integrally connected with the rest of the shell that keeps the rest of the device secured to the user; Paragraph 0055 discloses cover 114 may comprise a fastener which releasably attaches the cooling cap assembly to the head of the patient).
Regarding claim 68, Dilligan in view of Banker discloses the method of claim 66, but does not disclose wherein the period of time that has elapsed after the step of concluding the chemotherapy session is up to 24 hours. However, Banker teaches a system and method for limiting chemotherapy-induced alopecia where providing compression may continue after administration of chemotherapy for a period of up to 24 hours (Paragraph 0030 discloses scalp cooling and compression may be continued for “a period of time after treatment (e.g., for about 120 to 180 minutes) after administration of the chemotherapeutic agent has ended; Paragraph 0032 discloses scalp compression and cooling may begin again after chemotherapy in concert with phototherapy. The duration of the wait between the chemotherapy and phototherapy and restarting of scalp cooling/compression is based upon the half-life of the chemotherapy agents “e.g., when the activity of the chemo agent(s) has been reduced to at least 50%”; Examiner notes the half-lives of chemotherapy drugs may be several hours (i.e. methotrexate has a half-life of 8-15 hours (“Methotrexate” by M. Hanoodi, National Institute of Health, 2023)))).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Dilligan to provide time period of up to 24 hours ceasing chemotherapy treatment and beginning compression again, as taught by Banker, in order to continue therapeutic treatment for the patient at home (Paragraphs 0034 and 0039).
Regarding claim 69, Dilligan in view of Banker discloses the method of claim 66, but Dilligan does not disclose wherein the period of time that has elapsed after the step of concluding the chemotherapy session is at least one hour. However, Banker teaches a system and method for limiting chemotherapy-induced alopecia where providing compression may continue after administration of chemotherapy for a period of at least one hour (Paragraph 0030 discloses scalp cooling and compression may be continued for “a period of time after treatment (e.g., for about 120 to 180 minutes) after administration of the chemotherapeutic agent has ended; Paragraph 0032 discloses scalp compression and cooling may begin again after chemotherapy in concert with phototherapy. The duration of the wait between the chemotherapy and phototherapy and restarting of scalp cooling/compression is based upon the half-life of the chemotherapy agents “e.g., when the activity of the chemo agent(s) has been reduced to at least 50%”; Examiner notes the half-lives of chemotherapy drugs may be several hours (i.e. methotrexate has a half-life of 8-27 hours (“Methotrexate” by M. Hanoodi, National Institute of Health, 2023))).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Dilligan to provide time period of up to 24 hours ceasing chemotherapy treatment and beginning compression again, as taught by Banker, in order to continue therapeutic treatment for the patient at home (Paragraphs 0034 and 0039).
Regarding claim 71, Dilligan in view of Banker discloses the method of claim 66, and Dilligan further discloses wherein the vasocompression element of the head covering is a liner wherein a step of expanding the liner or a step of contracting the liner is performed during the step of at least partially inducing vasocompression in a portion of the cranial circulatory system of the patient (Fig. 1B inflatable chamber 130; Examiner notes that the inflatable chambers are connected together forming a liner (See Annotated Fig. 1B for designation of the liner); Examiner notes the liner naturally expands and contracts when the chambers are inflated and deflated; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient).
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Regarding claim 74, Dilligan in view of Banker discloses the method of claim 66, and Dilligan further discloses wherein the vasocompression element of the head covering is a liner having one or more features wherein a step of expanding the liner or a step of contracting the liner is performed during the step of at least partially inducing vasocompression in a portion of the cranial circulatory system of the patient ((Fig. 1B inflatable chamber 130; Examiner notes that the inflatable chambers are connected together forming a liner (See Annotated Fig. 1B for designation of the liner); Examiner notes the liner naturally expands and contracts when the chambers are inflated and deflated; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient).
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Regarding claim 77, Dilligan in view of Banker discloses the method of claim 66, and Dilligan further discloses wherein the vasocompression element of the head covering is an inflatable bladder wherein the degree of vasocompression during the step of at least partially inducing vasocompression in a portion of the cranial circulatory system of the patient corresponds at least in part to the amount of pressure within the inflatable bladder (Fig. 1B inflatable chamber 130; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient).
Regarding claim 80, Dilligan in view of Banker discloses the method of claim 66, and Dilligan further discloses wherein the vasocompression element of the head covering is one or more features arranged on an interior surface of the head covering which correspond to an arrangement of the patient's hair, wherein the one of more features act on the arrangement of the patient's hair to further the performance of the step of least partially inducing vasocompression in a portion of the cranial circulatory system of the patient (Fig. 1B inflatable chamber 130; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient, and will compress the liner 112 as it is arranged below inflatable chambers 130; Fig. 1B liner 112; Paragraph 0054 discloses the liner is placed on the scalp; Examiner notes that positioning the liner on the scalp will naturally allow the liner to accommodate the patient’s hair).
Regarding claim 81, Dilligan in view of Banker discloses the method of claim 66, and Dilligan further discloses wherein during the at least partially inducing vasocompression step the vasocompression element of the head covering compresses a portion of the scalp containing a plurality of hair follicles against a portion of the cranium to at least partially vasocompress the blood supply to the plurality of hair follicles, wherein the portion of the cranium is one or more of a superior temporal line, an inferior temporal line, a parietal bone, a squamous suture, a temporal bone, a lambdoid suture, an occipital bone, a mastoid process, a sphenoid, a portion in proximity to the supraorbital foramen, a frontal bone, a coronal suture (Fig. 1B inflatable chamber 130; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient, and the parietal bone among others is the portion of the cranium which is affected; Examiner further notes the patient’s hair will naturally be compressed due to inflation of the inflatable chamber).
Regarding claim 83, Dilligan in view of Banker discloses the method of claim 66, and Dilligan further discloses wherein during the at least partially inducing vasocompression step the vasocompression element of the head covering is positioned to at least partially vasocompress an artery or a vein of the cranial circulatory system of the patient by compressing the artery or the vein against a portion of the cranium, or wherein the artery or the vein of the cranial circulatory system is a branch of an external carotid artery or a branch of the internal carotid artery, or wherein the artery or the vein of the cranial circulatory system is an ophthalmic artery, or wherein the artery or the vein of the cranial circulatory system is a superficial temporal artery, or wherein the artery or the vein of the cranial circulatory system is a posterior auricular artery, or wherein the artery or the vein of the cranial circulatory system is an occipital artery, or wherein the artery or the vein of the cranial circulatory system is a supraorbital artery or a supratrochlear artery (Fig. 1B inflatable chamber 130; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient, and temporal and occipital arteries will be compressed due to the area covered by the inflatable chambers).
Regarding claim 90, Dilligan in view of Banker discloses the method of claim 83, and Dilligan further discloses wherein the portion of the cranium is one or more of a superior temporal line, an inferior temporal line, a parietal bone, a squamous suture, a temporal bone, a lambdoid suture, an occipital bone, a mastoid process, a sphenoid, a portion in proximity to the supraorbital foramen, a frontal bone, a coronal suture (Fig. 1B inflatable chamber 130; Paragraph 0057 discloses the inflatable member increases pressure to the head of the patient; Examiner notes the inflatable member naturally induces vasocompression via compressing the head of the patient, and the parietal bone among others is the portion of the cranium which is affected).
Regarding claim 102, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan as modified by Banker further discloses wherein one or more of the liner and the at least one vasocompressive element may be used to accommodate cranial topography and shape of the patient (Banker Paragraph 0046 discloses the pad is urged against the patient’s scalp via compressive forces; Examiner notes that the pad would naturally conform to the patient’s shape as the pad is flexible and being pressed against the patient’s body).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Dilligan in view of Banker as applied to claim 1 above, and further in view of US20190262223A1 to Mitchell (hereinafter “Mitchell”).
Regarding claim 33, Dilligan in view of Banker discloses the head covering of claim 1, and Dilligan but does not disclose a vibrating element coupled to the liner or the at least one vasocompression element. However, Mitchell teaches a therapeutic vibration device for a user’s head which has vibration elements coupled to a liner (Figs. 1 & 2 body 102, vibration elements 104, 106).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the liner of Dilligan to further include a vibrational element, as taught by Mitchell, in order to provide production of beneficial hormones and pathways such as neurogenesis (Paragraph 0040).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20200085671-A1 to Fonseca; and US-20110036358-A1 to Mattalino.
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 TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-3525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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