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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/11/2024, 10/14/2024, and 10/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 3, 4, 8-11 and 13 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.
Regarding claims 8-10 The term “Further apparatus” is an undefined term which renders the claim unclear. The term “Further apparatus” 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. Examiner therefore interprets the term “further apparatus” to mean another apparatus or a second apparatus.
Regarding claims 3-4, 8-11, and 13 the term “about” renders the scope of the claim indefinite because the phrase “about” allows for a range of values, or “close to” type of interpretation and is therefore indefinite. The term “about” is not defined in specification to give a value of how close or far the time needs to be to the stated time period. The specification fails to provide a standard for the boundaries of the term “about”. See MPEP 2173.05(d).
Claim Rejections - 35 USC § 102
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 1 is rejected under 35 U.S.C 102(a)(1) as being anticipated by Nicholson (US5494441) herein referred to as “Nicholson”.
Regarding claim 1, Nicholson teaches: A method for preventing and/or treating pain and/or inflammation of a cancer patient suffering from an oral tissue ulceration in said patient's oral cavity aggravated by anti- cancer infusion therapy, ([Abstract] a method for preventing inflammation and oral sores, which is seen as oral tissue ulceration, caused by chemotherapy, which is seen as anti-cancer infusion therapy) comprising placing an apparatus within said patient's oral cavity prior to administration of an infusion of an anti-cancer agent to said patient, ([col 2: line 1] the oral apparatus is inserted into the mouth of the patient undergoing chemotherapy to enable the patient to receive the full treatment, which is seen as being placed in the oral cavity prior to administration of the chemotherapy) said apparatus adapted to be retained within said oral cavity, ([col 2: line 7] the device conforms to the patient’s mouth to remain within the oral cavity for the duration of the treatment) said apparatus comprising a coolant for reducing temperature below an ambient temperature of the patient's oral cavity for a first predetermined period of time to permit fluid within said apparatus to cool said oral cavity and to prevent and/or to alleviate pain and/or inflammation caused by said ulceration, ([col 2: line 9-12] the cooling medium is seen as a coolant for reducing the temperature; [col 3: lines 18-20] the supply source circulating the cooling medium to reduce the temperature is seen as the first predetermined time period) maintaining placement of said apparatus during infusion of said anti-cancer agent for a second predetermined period of time, ([col 3: line 64-65] maintaining the temperature for the duration of the chemotherapy treatment is seen as having a second predetermined period of time) and continuing use of said apparatus after completion of said infusion for a third pre-determined period of time ([col 3: line 20-25] maintaining the cooling temperature throughout the chemotherapy treatment is seen as having a third predetermined period of time which equates to the end of the chemotherapy infusion).
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.
Claim 5-11, 14-20, 24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz (US20180140407A1) herein referred to as “Yoskowitz”.
Regarding claim 5, Nicholson discloses: The method of claim 1, further comprising retaining said apparatus in said oral cavity ([col 2: line 7] the device conforms to the patient’s mouth to remain within the oral cavity for the duration of the treatment), however, Nicholson does not explicitly disclose: retaining said apparatus in said oral cavity for a period of up to 2 hours after administration of said infusion.
Yoskowitz discloses: retaining said apparatus in said oral cavity for a period of up to 2 hours after administration of said infusion ([0063] the apparatus can be retained in the mouth following chemotherapy; [0122] the mouth piece can be retained inside the mouth for 30 minutes, which is seen as including a period of up to 2 hours).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the duration as disclosed in Nicholson to include retaining the apparatus for a period of up to 2 hours. The motivation being that this prevents mouth sores and oral discomfort following chemotherapy treatment by keeping the mouth environment cool. (Yoskowitz [0063]).
Regarding claim 6, Nicholson discloses: The method of claim 1, however, Nicholson does not explicitly disclose: wherein said apparatus comprises a first reservoir containing a first fluid with a freezing point below about 0 C, a second reservoir containing a second fluid having a freezing point above 0 C, and a passageway for circulating at least said first fluid in said apparatus.
Yoskowitz discloses: wherein said apparatus comprises a first reservoir containing a first fluid with a freezing point below about 0 C, a second reservoir containing a second fluid having a freezing point above 0 C, and a passageway for circulating at least said first fluid in said apparatus ([0109] the salt water which is seen as the first fluid has a freezing point below 0 C and a second fluid has a freezing temperature above the freezing point temperature of the salt water).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as disclosed in Nicholson to include a fluid with a freezing point above 0 C. The motivation being that this allows for cooling the salt water. (Yoskowitz [0109]).
Regarding claim 7, Nicholson discloses: The method of claim 6, however, Nicholson does not explicitly disclose: wherein said first fluid is salt water and said second fluid is fresh water.
Yoskowitz discloses: wherein said first fluid is salt water and said second fluid is fresh water ([0083] the external chamber contains a salt water chamber and a pure water chamber which is seen as fresh water).
It would have been obvious to one of ordinary skill in the art to modify the method as disclosed in Nicholson to include a first fluid of salt water and a second fluid of fresh water. The motivation being that salt water and fresh water is safe and readily available. (Yoskowitz [0084]).
Regarding claim 8, Nicholson discloses: The method of claim 6, however, Nicholson does not explicitly disclose: further comprising replacing said apparatus with a further apparatus after about 20-45 minutes after prior placement of an apparatus.
Yoskowitz discloses: further comprising replacing said apparatus with a further apparatus after prior placement of an apparatus ([0082] after a preselected time the first mouth piece is removed and replaced by a second mouth piece which is seen as a further apparatus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nicholson to include replacing the apparatus with a further apparatus after a period of time as disclosed in Yoskowitz. The motivation being that replacing the first apparatus with a second apparatus allows the mouth to regain the desired cooling effect that faded from the first mouth piece. (Yoskowitz [0082]). The secondary does not disclose for a period of 20-45 minutes. Since a preselected time period exists, making the preselected time to be about 20-45 minutes as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). There is no criticality on the range claimed, indicating that simply “Infusive therapy requires several hours, so a plurality of apparatus is provided for replacement as needed.” (Applicant specification [00158]).
Regarding claim 9, Nicholson discloses: The method of claim 6, however, Nicholson does not explicitly disclose: further comprising replacing said apparatus with a further apparatus after about 30 minutes.
Yoskowitz discloses: further comprising replacing said apparatus with a further apparatus ([0082] after a preselected time the first mouth piece is removed and replaced by a second mouth piece which is seen as a further apparatus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nicholson to include replacing the apparatus with a further apparatus after a period of time as disclosed in Yoskowitz. The motivation being that replacing the first apparatus with a second apparatus allows the mouth to regain the desired cooling effect that faded from the first mouth piece. (Yoskowitz [0082]). The secondary does not disclose for a period of 30 minutes. Since a preselected time period exists making the preselected time to be about 30 minutes as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). There is no criticality on the range claimed, indicating that simply “Infusive therapy requires several hours, so a plurality of apparatus is provided for replacement as needed.” (Applicant specification [00158]).
Regarding claim 10, Nicholson discloses: The method of claim 8, however, Nicholson does not explicitly disclose: comprising delaying replacing said apparatus with a further apparatus after a period of up to 10 minutes.
Yoskowitz discloses: comprising delaying replacing said apparatus with a further apparatus ([0082] after a preselected time the first mouth piece is removed and replaced by a second mouth piece which is seen as a further apparatus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nicholson to include replacing the apparatus with a further apparatus after a period of time as disclosed in Yoskowitz. The motivation being that replacing the first apparatus with a second apparatus allows the mouth to regain the desired cooling effect that faded from the first mouth piece. (Yoskowitz [0082]). The secondary does not disclose for a period of 10 minutes. Since a preselected time period exists making the preselected time to be about 10 minutes as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). There is no criticality on the range claimed, indicating that simply “Infusive therapy requires several hours, so a plurality of apparatus is provided for replacement as needed.” (Applicant specification [00158]).
Regarding claim 11, Nicholson discloses: The method of claim 8, however, Nicholson does not explicitly disclose: further comprising replacing said apparatus from about 30 minutes to about 45 minutes after initiation of said infusion and continuing to replace each apparatus with another apparatus during administration of said infusion as said temperature of said fluid rises above said pre-defined temperature.
Yoskowitz discloses: further comprising replacing said apparatus after initiation of said infusion and continuing to replace each apparatus with another apparatus during administration of said infusion as said temperature of said fluid rises above said pre-defined temperature ([0082] After a preselected temperature of the mouth is reached, the first mouth piece is removed and replaced by a second mouth piece, which is seen as another apparatus, during administration of the infusion).
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 Nicholson to include replacing the apparatus after a pre-defined temperature and with a further apparatus after a period of time. The motivation being that this allows for a constant supply of cooled mouth pieces for the patient to use during chemotherapy and replacing the first apparatus with a second apparatus allows the mouth to regain the desired cooling effect that faded from the first mouth piece. (Yoskowitz [0082]). The secondary does not disclose for a period from about 30 minutes to about 4 5minutes. Since a preselected time period exists making the preselected time to be about 30 minutes to about 45 minutes as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). There is no criticality on the range claimed, indicating that simply “Infusive therapy requires several hours, so a plurality of apparatus is provided for replacement as needed.” (Applicant specification [00158]).
Regarding claim 14, Nicholson discloses: The method of claim 1, wherein said step of placing an apparatus within said patient's oral cavity prior to administration of an infusion of an anti-cancer agent to said patient comprises placing, into the patient's mouth, said apparatus which includes: a. an external chamber having proximal and distal ends for storing a cooling medium ([col 4: lines 20-23] contains an outer chamber which is seen as an external chamber; See FIG 2 where the outer chamber has a proximal and distal end for storing the cooling medium) comprised of a first solution having a freezing temperature below 0 degrees Celsius, ([col 3: line 44] the first solution is approximately 0 degrees) the proximal end having a malleable top element configured to rest adjacent at least major surfaces of the upper gums and teeth of a patient's mouth in a close-fitting relationship ([col 1: lines 57-61] the material is pliable and forms an impression of the patient’s mouth which is seen as being in a close-fitting relationship; [col 4: lines 60-64] the top of the device contacts the patient’s gums and teeth) and a malleable bottom element configured to rest adjacent at least major surfaces of the lower gums and teeth of a patient's mouth in a close-fitting relationship, ([col 4: lines 60-64] the lower gums and teeth of the patient’s mouth is also in contact with the device) wherein the top element is integral with or connected to the bottom element to permit emplacement in the mouth as a one-piece unit; (See FIG 2 where the top and bottom elements are integrated and can be placed as one unit together in the mouth) and b. a bladder ([col 3: line 67] the device comprises a bladder) however, Nicholson does not explicitly disclose: the bladder positioned inside the external chamber for storing a second solution having a freezing temperature above the freezing point temperature of the first solution to assist in cooling the first solution, wherein the first solution flows throughout the top element and the bottom element for retaining a cooling environment within the mouth sufficient to reduce capillary blood flow to the patient's mouth.
Yoskowitz explicitly discloses: the bladder positioned inside the external chamber for storing a second solution having a freezing temperature above the freezing point temperature of the first solution to assist in cooling the first solution, ([0015] the bladder is positioned inside the external chamber for storing a second solution having a freezing temperature above the freezing temperature of the first solution) wherein the first solution flows throughout the top element and the bottom element for retaining a cooling environment within the mouth sufficient to reduce capillary blood flow to the patient's mouth ([0015] the first solution flows through the top element and the bottom element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder as disclosed in Nicholson to include the position to be inside the external chamber. The motivation being that this allows the temperature to be sufficient for cooling the environment of the mouth. (Yoskowitz [0015])
Regarding claim 15, Nicholson discloses: The method of claim 14, however, Nicholson does not explicitly disclose: wherein said apparatus further comprises: c. at least one breathing tube extending within the external chamber and having a proximate opening formed at the proximal end and a distal opening formed at the distal end of the external chamber to permit a patient to breathe through the mouth when the mouthpiece is emplaced within the mouth in said operative close-fitting relationship.
Yoskowitz discloses: wherein said apparatus further comprises: c. at least one breathing tube extending within the external chamber and having a proximate opening formed at the proximal end and a distal opening formed at the distal end of the external chamber to permit a patient to breathe through the mouth when the mouthpiece is emplaced within the mouth in said operative close-fitting relationship ([0056] a flexible tube, which is seen as a breathing tube as it assists the patient in inhaling air from outside, can be attached to the aperture 70, which is located within the external chamber. A tube is seen to have a proximal opening at the proximal end and a distal opening at the distal opening).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as disclosed in Nicholson to include the breathing tube as disclosed in Yoskowitz. The motivation being that this allows the patient to breathe comfortably while using the device. (Yoskowitz [0056]).
Regarding claim 16, Nicholson disclose: The method of claim 15, however, Nicholson does not explicitly disclose: wherein at least one breathing tube is attached to the bladder.
Yoskowitz discloses: wherein at least one breathing tube is attached to the bladder (See FIG 13 where the aperture, 70, [0056] which can contain a flexible tube, which is seen as a breathing tube, is attached to the bladder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder as disclosed in Nicholson to include a breathing tube as disclosed in Yoskowitz. The motivation being that this allows the patient to comfortably breathe while using the apparatus. (Yoskowitz [0056]).
Regarding claim 18, Nicholson discloses: The method according to claim 14, wherein the bladder includes a proximal end, a central portion, and a distal end, (See FIG 2 piece 14 contains a proximal end, central portion and a distal end) and wherein the bladder is dimensioned and configured such that the proximal end is positioned at least partly between the top element and the bottom element (See FIG 2 where the bladder, 14, can be between the top element and bottom element), however, Nicholson does not explicitly disclose: a bladder with the at least one breathing tube.
Yoskowitz discloses: a bladder with the at least one breathing tube ([0056] a flexible tube, which is seen as a breathing tube as it assists the patient in inhaling air from outside, can be attached to the aperture 70, which is between the top element and the bottom element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as disclosed in Nicholson to include the breathing tube as disclosed in Yoskowitz. The motivation being that this allows the patient to breathe comfortably while using the device. (Yoskowitz [0056]).
Regarding claim 19, Nicholson discloses: The method according to claim 17, however, Nicholson does not explicitly disclose: in which the proximal end of the bladder has a rectangular cross-section profile and the first and second breathing tubes are attached along opposing exterior lateral side walls of the rectangular proximal end of the bladder.
Yoskowitz discloses: in which the proximal end of the bladder has a rectangular cross-section profile and the first and second breathing tubes are attached along opposing exterior lateral side walls of the rectangular proximal end of the bladder ([0113] the proximal end of the water bladder can be rectangular in cross section; The proximal ends are dimensioned to fit between the outer walls).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder as disclosed in Nicholson to include a rectangular cross-section profile as disclosed in Yoskowitz. The motivation being that it allows for maximizing the cooling effect and maintains a uniform temperature inside the mouth (Yoskowitz [0113]).
Regarding claim 20, Nicholson discloses: The method according to claim 17, however, Nicholson does not explicitly disclose: in which the central portion has a circular cross-section profile and the first and second breathing tubes are attached along opposing interior lateral sides of the circular central portion of the bladder.
Yoskowitz discloses: in which the central portion has a circular cross-section profile (See FIG 27, the central portion, 914, has a circular cross-section) and the first and second breathing tubes are attached along opposing interior lateral sides of the circular central portion of the bladder (([0056] a flexible tube, which is seen as a breathing tube as it assists the patient in inhaling air from outside; [0113] The proximal ends are dimensioned to fit between the outer walls).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as disclosed in Nicholson to include the circular-cross section profile as disclosed in Yoskowitz. The motivation being that the outer portion formed from the central portion has to correspond to the inner surface and permit emplacement in a nest arrangement to prevent leakage. (Yoskowitz [0117]).
Regarding claim 24, Nicholson discloses: The method according to claim 14, however, Nicholson does not explicitly disclose: wherein the distal end of the external chamber comprises an end cap configured and dimensioned to seal the external chamber closed.
Yoskowitz discloses: wherein the distal end of the external chamber comprises an end cap configured and dimensioned to seal the external chamber closed ([0116] a cap, 940, which is seen as an end cap is used to seal the external chamber; See also FIG 27 where cap 940 is located at the distal end).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber as disclosed in Nicholson to include an end cap as disclosed in Yoskowitz. The motivation being that having an end cap allows for providing a water tight seal that can prevent leakage. (Yoskowitz [0118]).
Regarding claim 26, Nicholson discloses: The method according to claim 1, wherein said coolant is at or below a temperature of 0 C ([col 3: lines 40-45] the coolant is maintained at a temperature of 0 C).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz in further view of Sorensen et al (“Chemotherapy-induced Oral Mucositis with Nonblinded Randomized Comparison to Oral Cooling ((Cryotherapy) in Gastrointestinal Malignancies”) herein referred to as “Sorensen”.
Regarding claim 3, Nicholson in view of Yoskowitz discloses: The method of claim 1, comprising placing said apparatus in said oral cavity, however, Nicholson in view of Yoskowitz does not explicitly disclose: the time from about 30 minutes to about 10 minutes prior to administration of said infusion.
Sorensen discloses: the time from about 30 minutes to about 10 minutes prior to administration of said infusion ([page 2: paragraph 2] oral cooling which is seen as placing the apparatus in said oral cavity, can be done for 30 to 45 minutes before chemotherapy, which is seen as prior to administration of the infusion. 30 to 45 minutes falls within the time period from about 30 minutes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nicholson in view of Yoskowitz to include the time for placing the apparatus prior to administration as disclosed in Sorensen. The motivation being oral cooling for this time period prior to chemotherapy may reduce the frequency of oral mucositis. (Sorensen [page 2: paragraph 2]).
Regarding claim 4, Nicholson in view of Yoskowitz discloses: The method of claim 3, comprising placing said apparatus in said oral cavity, however, Nicholson in view of Yoskowitz does not explicitly disclose: the time from about 15 to about 10 minutes prior to administration of said infusion.
Sorensen discloses: a time from about 15 to about 10 minutes prior to administration of said infusion ([page 2: paragraph 2] oral cooling for 30 to 45 minutes before chemotherapy encompasses about 15 to about 10 minutes prior to administration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nicholson in view of Yoskowitz to include the time for placing the apparatus prior to administration as disclosed in Sorensen. The motivation being oral cooling for this time period prior to chemotherapy may reduce the frequency of oral mucositis. (Sorensen [page 2: paragraph 2]).
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz in further view of Fox (US20020138121A1) herein referred to as “Fox”.
Regarding claim 12, Nicholson in view of Yoskowitz discloses: The method of claim 1, however, Nicholson in view of Yoskowitz does not explicitly disclose: further comprising repeating said method after said infusion therapy terminates, for a period of from 1 day to about 2 weeks.
Fox discloses: further comprising repeating said method after said infusion therapy terminates, for a period of from 1 day to about 2 weeks ([0121] hypothalamic cooling can be repeated 4 days later which is included in the period of 1 day to about 2 weeks).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Nicholson in view of Yoskowitz to include repeating the method for a period as disclosed in Fox. The motivation being that the repeating the cooling for a period of time after allows the infusion to be more effective. (Fox [0121]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz in further view of Walladbegi et al (“Efficacy of a novel device for cryoprevention of oral mucositis: a randomized, blinded, multicenter, parallel group phase 3 trial”) herein referred to as “Walladbegi”.
Regarding claim 13, Nicholson in view of Yoskowitz discloses: The method of claim 11, however, Nicholson in view of Yoskowitz does not explicitly disclose: repeating said method from about 1 time to about 5 times per day.
Walladbegi discloses: repeating said method from about 1 time to about 5 times per day ([page 192: under “interventions”] the cooling session which is seen as the method, was repeated for 2 cooling sessions per day, which is seen as about 1 time to about 5 times per day).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Nicholson in view of Yoskowitz to include repeating the method as disclosed in Walladbegi. The motivation being that longer more frequent cooling sessions offer better results. (Walladbegi [page 196: paragraph 3]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz in further view of Yoskowitz (US20200069459A1) herein referred to as “Yoskowitz ‘459”.
Regarding claim 17, Nicholson discloses: The method according to claim 15, however, Nicholson does not explicitly disclose: wherein the at least one breathing tube comprises first and second breathing tubes extending within the external chamber.
Yoskowitz ‘459 discloses: wherein the at least one breathing tube comprises first and second breathing tubes extending within the external chamber ([0152] the external chamber comprises two breathing tubes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as disclosed in Nicholson in view of Yoskowitz to include a second breathing tube as disclosed in Yoskowitz ‘459. The motivation being that this allows the patient to breathe comfortably while using the device. (Yoskowitz ‘459 [0152]).
Claims 21-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz in further view of Sheikh (US20150016755A1) herein referred to as “Sheikh”.
Regarding claim 21, Nicholson in view of Yoskowitz discloses: The method according to claim 14, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein the distal end of the external chamber includes a flange extending radially inward and forming an opening configured and dimensioned to receive the bladder.
Sheikh discloses: wherein the distal end of the external chamber includes a flange extending radially inward and forming an opening configured and dimensioned to receive the bladder ([0069] the bladder includes a flange and includes an opening; See FIG 2 and 3 where the flange extends radially outward).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber as disclosed in Nicholson in view of Yoskowitz to include a flange as disclosed in Sheikh. The motivation being that a flange allows for the chamber to be sealed. (Sheikh [0032]).
Regarding claim 22, Nicholson in view of Yoskowitz discloses: The method according to claim 21, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein the distal end of the bladder includes a flange extending radially outward and includes an opening configured and dimensioned to receive the second solution, wherein a circumference of the opening of the radially inward flange of the external chamber is configured and dimensioned to receive and secure the radially inward flange of the bladder.
Sheikh discloses: wherein the distal end of the bladder includes a flange extending radially outward ([0069] the bladder includes a flange; See FIG 2 and 3 where the flange extends radially outward) and includes an opening configured and dimensioned to receive the second solution, ([0064] the bladder can receive a fluid which is seen as receiving a second solution) wherein a circumference of the opening of the radially inward flange of the external chamber is configured and dimensioned to receive and secure the radially inward flange of the bladder ([0066] the bladder contains a receiver which receives and secures the flange).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber as disclosed in Nicholson in view of Yoskowitz to include a flange as disclosed in Sheikh. The motivation being that a flange allows for the chamber to be sealed. (Sheikh [0032]).
Regarding claim 23, Nicholson in view of Yoskowitz discloses: The method according to claim 22, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein the circumference of the opening of the radially inward flange of the external chamber and the radially outward flange of the bladder are in a keyed arrangement.
Sheikh discloses: wherein the circumference of the opening of the radially inward flange of the external chamber and the radially outward flange of the bladder are in a keyed arrangement (See FIG 14 where the inward flange 152, is in keyed arrangement with the outward flange 158).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber as disclosed in Nicholson in view of Yoskowitz to include a keyed arrangement as disclosed in Sheikh. The motivation being this arrangement allows for the components to be sealed. (Sheikh [0015]).
Regarding claim 25, Nicholson in view of Yoskowitz discloses: The method according to claim 23, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein the end cap includes a shoulder configured and dimensioned to seal the bladder closed.
Sheikh discloses: wherein the end cap includes a shoulder configured and dimensioned to seal the bladder closed ([0100] See FIG 25 where the cap 20H contains piece 280 which is seen as the shoulder; [0100] the shoulder 280 is threaded which is seen as being configured to receive the bladder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap as disclosed in Nicholson in view of Yoskowitz to include a shoulder as disclosed in Sheikh. The motivation being that a shoulder allows for the components to be sealed. (Sheikh [0015]).
Claims 2, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of Yoskowitz in further view of Enam et al (US20220378608A1) herein referred to as “Enam.”
Regarding claim 2, Nicholson in view of Yoskowitz discloses: The method of claim 1, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein said subject suffers from a cancer characterized by solid and/or liquid tumors.
Enam discloses: wherein said subject suffers from a cancer characterized by solid and/or liquid tumors ([0062] solid tumors and liquid tumors can be treated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Nicholson in view of Yoskowitz to specify the form of cancer as disclosed in Enam. The motivation being that this includes specifying type of cancer that can be treated through a cooling device. (Enam [0062]).
Regarding claim 27, Nicholson in view of Yoskowitz discloses: The method of claim 2, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein said cancer is characterized by solid tumors, and is selected from the group consisting of breast, lung, and colorectal cancer.
Enam discloses: wherein said cancer is characterized by solid tumors, and is selected from the group consisting of breast, lung, and colorectal cancer ([0062] solid tumors include breast, lung, and colon cancer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Nicholson in view of Yoskowitz to specify the form of cancer as disclosed in Enam. The motivation being that this specifies the exact forms of solid cancers that can be treated through a cooling device. (Enam [0062]).
Regarding claim 28, Nicholson in view of Yoskowitz discloses: The method of claim 2, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein said cancer is characterized by liquid tumors and is a blood cancer.
Enam discloses: wherein said cancer is characterized by liquid tumors and is a blood cancer ([0062] liquid tumors include blood cancer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Nicholson in view of Yoskowitz to specify the form of cancer as disclosed in Enam. The motivation being that this specifies the type of liquid cancers that can be treated through a cooling device. (Enam [0062]).
Regarding claim 29, Nicholson in view of Yoskowitz discloses: The method of claim 27, however, Nicholson in view of Yoskowitz does not explicitly disclose: wherein said blood cancer is leukemia or lymphoma.
Enam discloses: wherein said blood cancer is leukemia or lymphoma ([0062] blood cancer includes leukemias and lymphomas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed in Nicholson in view of Yoskowitz to specify the form of cancer as disclosed in Enam. The motivation being that this specifies the types of blood cancers that can be treated through a cooling device. (Enam [0062]).
Conclusion
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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