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 § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1,3-4,7-12,14 and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wilder-Smith et al. (US 2015/0351957) in view of DILLIGAN et al. (US 2020/0375793).
Regarding claim 1, Wilder-Smith discloses a method of treating or preventing chemotherapy induced polyneuropathy (CIPN) in a patient receiving chemotherapy treatment [0011], the method comprising: providing thermal therapy to a selected region of a body of the patient (fig.1, see also [0011]); the selected region comprising a hand or a foot [0015], wherein the thermal therapy comprises: fitting a thermal therapy device to uniformly contact a skin surface of the selected region of the body (fig.1-2, see also [0012] and [0076]); and providing a temperature control device to supply the thermal therapy device with a temperature control fluid [0075]; a temperature of the skin surface of the selected region of the body remains within a range of about 15°C to about 22°C. Wilder-Smith also discloses the temperature of, the subject's body part is reduced to between 15° C. and 25° C. Preferably, the temperature of the subject's body part is reduced to around 20° C [0048]. Wilder-Smith teaches that induced hypothermia is induced for a period, for example 30 minutes before administration of chemotherapy. Preferably induced hypothermia is maintained throughout the administration of chemotherapy. The induced hypothermia is, maintained for a period (preferably 30 minutes) after administration of chemotherapy ([0051]-[0053]).However, Wilder-Smith does not specifically disclose maintaining a temperature the temperature control fluid to be within the range between about 15 °C and 17 °C for duration of the chemotherapy treatment, such that even tempering of the skin surface is achieved.
Dilligan teaches devices, systems, and methods for providing cooling to reduce or prevent side effects from chemotherapy [0004]. The system comprising the cooling unit, which is compact and portable, may be configured to decrease a temperature of a cooling fluid and to transfer the cooled cooling fluid to cap assembly and control the temperature of the circulating fluid based on sensor [0118]. The controller is configured to adjust one or more components of the cooling unit (150) to achieve a desired result such as a lower cooling fluid temperature, a higher cooling fluid temperature, a lower scalp temperature a higher scalp temperature, a lower flow rate and/or a higher flow rate. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the system as taught by Wilder-Smith with a cooling unit that is configured to adjust the desired temperature of the fluid including a temperature between about 15 °C and 17 °C as taught by Dilligan for the purpose of achieving the desired target treatment temperature of the treatment. The combination method of Wilder-Smith/ Dilligan teaches the limitation “such that even tempering of the skin surface is achieved and reducing metabolism and blood flow in the selected region such that less chemotherapy drug reaches the blood capillaries of the selected region.” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although Wilder-Smith/ Dilligan does not discuss that reducing metabolism and blood flow in the selected region such that less chemotherapy drug reaches the blood capillaries of the selected region, this result is inherently met since the method steps are disclosed.
Regarding claim 3, Wilder-Smith/ Dilligan teaches the method according to claim 1, wherein the temperature of the skin surface during the thermal therapy is no more than 20 °C ([0049] of Wilder-Smith).
Regarding claim 4, Wilder-Smith/ Dilligan teaches the method according to claim 1, wherein the thermal therapy is provided for at least 20 minutes after starting the chemotherapy treatment ([0051] of Wilder-Smith).
Regarding claim 7-8, Wilder-Smith discloses a method of treating or preventing chemotherapy induced polyneuropathy (CIPN) in a patient receiving chemotherapy treatment [0011], the method comprising: providing thermal therapy to a selected region of a body of the patient (fig.1-2, see also [0011]), the thermal therapy being delivered using a thermal therapy device (fig.1-2, see also [0011]), the thermal therapy device comprising: a heat transfer unit provided to be brought into contact with the selected region of the body (fig.1-2), the heat transfer unit being configured to receive a temperature control fluid ([0075]- [0076]);and a temperature control device (fig.1, see also [0092]) provided to control a temperature of the temperature control fluid ([0075]- [0076]); and cooling the selected region of the body to a target skin temperature (fig.1-2), using a temperature control fluid ([0075]- [0076]). However, Wilder-Smith does not disclose a pressure device configured to generate, or to increase, a contact pressure of the heat transfer unit on the selected region of the body, to improve thermal transfer between the heat transfer unit and the selected region of the body, the temperature control fluid is no more than 7 °C cooler than the target skin temperature, such that even tempering of the skin surface is achieved; thereby reducing metabolism and blood flow in the selected region such that less chemotherapy drug reaches the blood capillaries of the selected region; and wherein the thermal therapy comprises cooling the selected region of the body to a target skin temperature, using a temperature control fluid that is no more than 5 °C cooler than the target skin temperature.
Dilligan teaches devices, systems, and methods for providing cooling to reduce or prevent side effects from chemotherapy [0004]. The system comprising the cooling unit, which is compact and portable, may be configured to decrease a temperature of a cooling fluid and to transfer the cooled cooling fluid to cap assembly and control the temperature of the circulating fluid based on sensor [0118]. The system also includes an inflatable configured to transition from a deflated configuration to an inflated configuration may increase a pressure applied to the head of patient by the cooling cap assembly and the contact area between the heat exchanger and the head of the patient (the target area) [0057]. The controller is configured to adjust one or more components of the cooling unit to achieve a desired result such as a lower cooling fluid temperature, a higher cooling fluid temperature, a lower scalp temperature a higher scalp temperature, a lower flow rate and/or a higher flow rate. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the system as taught by Wilder-Smith with a cooling unit that is configured to adjust the desired temperature of the fluid including a temperature no more than 5 °C or 7 °C cooler than the target skin temperature and a pressure device configured to generate, or to increase, a contact pressure of the heat transfer unit on the selected region of the body as taught by Dilligan for the purpose of achieving the desired target treatment temperature of the treatment and increase a contact area between the cooling device and the body part.
Regarding claim 9, Wilder-Smith/ Dilligan teaches the method of claim 7, wherein the temperature control fluid is between about 15 °C and 17 °C ([0049] of Wilder-Smith).
Regarding claim 10, Wilder-Smith/ Dilligan teaches the method according to claim 7, wherein the selected region of the body comprises a hand (fig.1-2 of Wilder-Smith).
Regarding claim 11, Wilder-Smith/ Dilligan teaches the method according to claim 7, wherein the selected region of the body comprises a foot (fig.1-2 of Wilder-Smith).
Regarding claim 12, Wilder-Smith discloses a method of increasing adherence to chemotherapy treatment, the method comprising: administering chemotherapy to a patient in need thereof [0011]; and providing thermal therapy to a selected region of a body of the patient to prevent CIPN thereby increasing treatment adherence (fig.1-2, see also [0011]), wherein the thermal therapy comprises fitting a thermal therapy device to uniformly contact a skin surface of the selected region of the body, the selected region comprising a hand or a foot [0015], and providing a temperature control device to supply the thermal therapy device with a temperature control fluid [0075] and temperature of the skin surface of the selected region of the body remains within a range of about 15°C to about 22°C (fig.1-2, see also [0049]-[0050]). However, Wilder-Smith does not specifically disclose the temperature control fluid which is maintained at a temperature between about 15 °C and 17 °C for duration of the chemotherapy treatment, such that even tempering of the skin surface is achieved.
Dilligan teaches devices, systems, and methods for providing cooling to reduce or prevent side effects from chemotherapy [0004]. The system comprising the cooling unit, which is compact and portable, may be configured to decrease a temperature of a cooling fluid and to transfer the cooled cooling fluid to cap assembly and control the temperature of the circulating fluid based on sensor [0118]. The controller is configured to adjust one or more components of the cooling unit (150) to achieve a desired result such as a lower cooling fluid temperature, a higher cooling fluid temperature, a lower scalp temperature a higher scalp temperature, a lower flow rate and/or a higher flow rate. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the system as taught by Wilder-Smith with a cooling unit that is configured to adjust the desired temperature of the fluid including a temperature between about 15 °C and 17 °C as taught by Dilligan for the purpose of achieving the desired target treatment temperature of the treatment. The combination method of Wilder-Smith/ Dilligan teaches the limitation “such that even tempering of the skin surface is achieved and reducing metabolism and blood flow in the selected region such that less chemotherapy drug reaches the blood capillaries of the selected region.” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although Wilder-Smith/ Dilligan does not discuss that reducing metabolism and blood flow in the selected region such that less chemotherapy drug reaches the blood capillaries of the selected region, this result is inherently met since the method steps are disclosed.
Regarding claim 14, Wilder-Smith/ Dilligan teaches the method according to claim 12, wherein the temperature of the skin surface during the thermal therapy is no more than 20 °C ([0049] of Wilder-Smith).
Regarding claim 17, Wilder-Smith/ Dilligan teaches the method according to claim 1, wherein the temperature control fluid is water-based ([0087] of Wilder-Smith).
Regarding claim 18, Wilder-Smith/ Dilligan teaches the method according to claim 7, wherein the temperature control fluid is water-based ([0087] of Wilder-Smith).
Regarding claim 19, Wilder-Smith/ Dilligan teaches the method according to claim 12, wherein the temperature control fluid is water- based ([0087] of Wilder-Smith).
Regarding claim 20, Wilder-Smith/ Dilligan teaches the thermal therapy is carried out at the same time ([0051] of Wilder-Smith). However, Wilder-Smith/ Dilligan does not teaches wherein the chemotherapy treatment is part of a sequence of chemotherapy treatments, and the thermal therapy is carried out at the same time as each chemotherapy treatment of said sequence.
Regarding claim 21, Wilder-Smith/ Dilligan teaches the method of claim 1, wherein the thermal therapy is commenced at least 30 minutes before a start of the chemotherapy treatment ([0051] of Wilder-Smith).
Regarding claim 22, Wilder-Smith/ Dilligan teaches the method of claim 1, wherein the thermal therapy is maintained throughout the entire administration of the chemotherapeutic agent ([0051] of Wilder-Smith).
Response to Arguments
Applicant's arguments filed on 03/02/2026 have been fully considered but they are not persuasive. One of the arguments is Dilligan is Non-Analogous Art / Improper Combination. Dilligan is non-analogous art, making the combination improper. More specifically, the combination is improper because Dilligan is directed to an entirely different problem in an entirely different body part.
Different problems:
- Applicant's invention: Preventing CIPN (nerve damage) by reducing blood flow and metabolism in peripheral nerves in hands and feet.
- Dilligan: Preventing alopecia (hair loss) by cooling hair follicles in the scalp
Diferent body parts with different technical challenges:
- Scalp (Dilligan): Relatively smooth, rounded surface; large continuous area; patient's head is stationary during treatment.
- Hands and feet (Applicant's invention): Highly irregular surfaces with fingers, toes, knuckles, joints creating complex 3D geometry; thin skin over bony prominences, thicker skin on palms/soles; air pockets readily form in spaces between fingers/toes, over knuckles, along arch of foot. One of ordinary skill in the art would not look to a scalp cooling device when designing a hand/foot cooling device for an entirely different clinical condition. Hence, the rejection should be withdrawn for at least this reason.
This argument is not persuasive.
First, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Second, as discussed on the interview. Wilder-Smith explicitly teaches that the device is used to cool the limb coverings to induce local cooling. Wilder-Smith is the primary reference that is used to teach most of the structure and the method step of the claimed invention. The teaching reference, Dilligan, is only used to teach the controller is configured to adjust one or more components of the cooling unit (150) to achieve a desired result such as a lower cooling fluid temperature, a higher cooling fluid temperature. Dilligan explicitly teaches the controller is configured to adjust the temperature of fluid to the desired level for the desired treatment. This modification allows the method of maintaining a temperature of the temperature control fluid to be at the desired range including within the range of between about 15° C and 17°C for the duration of the chemotherapy treatment. It has been held that a prior art reference must either be in the field of the inventor' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Dilligan is in the field of the inventor' s endeavor since it is about cooling a body part in order to prevent from adverse effect of chemotherapy and also is reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. Dilligan teaches about the importance of a controller that is configured do adjust and maintaining the desired temperature range for the treatment.
The Applicant further agued regarding the teaching references about solving different problems. As clearly stated above, the primary reference Wilder-Smith discloses inducing and regulating controlled hypothermia in a subject to prevent or treat peripheral nerve neuropathy before, during and after chemotherapy. The examiner did not rely on Dilligan to teach the limitation of Neurotoxic mechanism. Dilligan does teach a system that is configured to o alter (e.g., increase or decrease) or maintain the measured temperatures, measured flow rate, and/or delta T [0118].
The Applicant argued Dilligan Teaches Adjusting Pressure, Not Coolant Temperature. Dilligan does teach a “For example, the controller may adjust the temperature of the circulating cooling fluid by adjusting the power of the compressor of the cooling unit and/or may adjust the flow rate of the cooling fluid by adjusting the power of the cooling fluid pump in the cooling unit until the temperature reaches the target, surpasses a threshold value, is below a maximum value, or is within a target range” [0170]. See also “The controller may be configured to compare the temperature measurements, the calculated delta T, and/or the flow rate measurements to target measurements (e.g., target temperature, target delta T, target flow rate) and/or a target range of measurements, and may adjust one or more components of the cooling unit (150) to achieve a desired result (e.g., a lower cooling fluid temperature, a higher cooling fluid temperature, a lower scalp temperature (as measured by sensors in the cooling cap assembly), a higher scalp temperature, a lower flow rate, a higher flow rate). For example, the controller may adjust the power delivered to the compressor (152) and/or the pump (158) to alter (e.g., increase or decrease) or maintain the measured temperatures, measured flow rate, and/or delta T” [0118].
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Dilligan's approach of dynamically adjusting pressure in different chambers will create hot spots - areas of higher and lower contact pressure across the scalp) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant invention does not explain how the temperature is being adjusted or maintained. All the limitation needed in the claim is maintaining a temperature of the temperature control fluid to be within the range of between about 15° C and 17° C for the duration of the chemotherapy treatment.
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 TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794