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 Status
A complete action on the merits of the claims 1-20 follows below.
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.
Claim 5 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 pre-AIA the applicant regards as the invention.
Claim 5 recites the limitation “opposing end walls”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the “opposing end walls" are one of or other than "the first and second side walls" recited in claim 1. Due to lack of clarity in the claims, it is the Examiner's position that the scope of the claims is indefinite. For the purposes of compact prosecution the Examiner interprets "the opposing end walls" to be the inner side of the first and second side walls recited in claim 1. In addition claim 5 recites “the length of the tissue receiving cavity.” It is unclear if the limitation is one of or in addition to “a length between opposing end walls of the conductive cup.” For the purposes of compact prosecution the Examiner interprets the length to be the length between opposing end walls of the conductive cup.
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(s) 1-3, 5, 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber (Pub. No. 20120239123).
Regarding claim 1, Weber teaches an apparatus for treating a subject’s submental tissue (Application systems, disposable interface assemblies and methods for cooling subcutaneous lipid-rich tissue [Abstract] the treatment devices 14 may be designed to treat target areas of the patient's body, such as chin [0054]), comprising:
a thermally conductive cup including a first sidewall, a second sidewall, and a bottom (vacuum cup 702 having an intermediate portion 180 on a bottom with a vacuum port 704, a first cooling unit 710a on one side of the cup 702, and a second cooling unit 710b on an opposing side of the cup 702 [0080]);
a tissue receiving cavity (cavity within vacuum cup of 702);
at least one vacuum port in fluid communication with the tissue receiving cavity to provide a vacuum for drawing the submental tissue into the tissue receiving cavity, wherein the tissue receiving cavity is sufficiently shallow to allow the subject's submental tissue to occupy substantially the entire tissue receiving cavity when the vacuum is drawn via the at least one vacuum port (vacuum port 704 which provides sufficient vacuum to keep tissue within the tissue receiving cavity of vacuum cup 702… the rim of the vacuum cup is placed against the skin of a subject and a vacuum is drawn within the cup. The vacuum pulls the tissue of the subject into the cup 702 and coapts the target area with the interface elements 150 of the corresponding first and second interface assemblies 120a-b [0081]);
a thermal device in thermal communication with the conductive cup, wherein the thermal device is configured to cool the conductive cup such that the first sidewall, the second sidewall, and the bottom together non-invasively cool subcutaneous lipid rich cells (the interface assembly 120 includes a connector 170 that couples the cryoprotectant vessel 130 to the cooling unit 110 [0079]. The embodiment of the cooling unit 110 shown on FIG. 2A can include a plate 112 that has a high thermal conductivity, one or more Thermoelectric Elements (TEEs) 114 and a coolant chamber 116. As explained above with reference to FIG. 1, a coolant can recirculate through the coolant chamber 116 via inlet and outlet lines 118a and 118b, respectively, and the TEEs 114 can selectively heat and/or cool relative to the temperature of the coolant in the coolant chamber 116 to control the temperature over relatively large areas of the cooling plate 112… the cooling unit 110 provides a heat sink that cools the interface assembly 120 [0066]) in the submental tissue an amount sufficient to be biologically effective in damaging and/or reducing the subcutaneous lipid rich cells (The treatment system 10 is suitable for cooling the subcutaneous adipose tissue of a subject 11 in a manner that reduces the volume of the adipose tissue. "Subcutaneous tissue" can include tissue lying beneath the dermis and includes subcutaneous fat, or adipose tissue that may be composed primarily of lipid-rich cells, or adipocytes. When cooling subcutaneous tissues to a temperature lower than 37.degree. C., subcutaneous lipid-rich cells can be affected selectively [0047]. Without being bound by theory, the selective effect of cooling on lipid-rich cells is believed to result in, for example, membrane disruption, cell shrinkage, disabling, destroying, removing, killing or other methods of lipid-rich cell alteration [0048]).
Regarding claim 2, Weber teaches the limitations of claim 1 as previously rejected above. Weber teaches wherein each of the first sidewall, the second sidewall, and the bottom is positioned to absorb heat from the submental tissue to damage or reduce the lipid rich cells which are in a subcutaneous layer of adipose tissue , in number or size to an extent ([0047][0048][0066]) while non-lipid rich cells deeper than the subcutaneous layer of adipose tissue are not reduced in number and/or size to the extend (Because non-lipid-rich cells usually can withstand colder temperatures better than lipid-rich cells, the subcutaneous lipid-rich cells can be affected selectively without affecting the non-lipid-rich cells in the dermis, epidermis and other surrounding tissue [0047]).
Regarding claim 3, Weber teaches the limitations of claim 1 as previously rejected above. Weber teaches a pressurization device in fluid communication with the tissue receiving cavity via the vacuum portion (the interface element 150 and the epidermis of the target site are coapted under pressure provided by a vacuum that forces the skin of the subject against the interface element 150 [0071]); and a controller with instructions for causing the apparatus to hold the submental tissue in the tissue receiving cavity using suction provided by the pressurization device while the conductive cup conductively cools the subject's tissue (the cooling unit includes a plurality of individually controlled thermal segments that create a custom spatial cooling profile and/or a time-varying cooling profile. Each custom treatment profile can include one or more segments, and each segment can include a specified duration, a target temperature, and control parameters for features such as vibration, massage, vacuum and other treatment modes [0056] A processing unit 24 may be connected to the treatment device, cooling unit, and interface assembly. The processing unit 24 may be a processor, programmable logic controller, distributed control system and so on [0059]).
Regarding claim 5, Weber teaches the limitations of claim 1 as previously rejected above. Weber teaches the tissue receiving cavity has a length between opposing end walls of the conductive cup (the distance between a first cooling unit 710a on one side of the cup 702, and a second cooling unit 710b on an opposing side of the cup 702), a width between first and second sidewalls (the thickness between the cooling units; z-direction), and a depth between an opening of the tissue recieivng cavity and the bottom of the conductive cup (depth of cup 702) wherein the depth is substantially uniform along most of the length of the tissue receiving cavity (the depth of cup 702 is substantially uniform along most of the length or distance between first and second cooling units 710a, b).
Regarding claim 14, Weber teaches a method of non-invasively cooling a submental region of a subject (Application systems, disposable interface assemblies and methods for cooling subcutaneous lipid-rich tissue [Abstract] the treatment devices 14 may be designed to treat target areas of the patient's body, such as chin [0054]), comprising:
placing a submentum applicator on the subject, wherein the submentum applicator includes a vacuum cup and a tissue receiving cavity (vacuum cup 702 having an intermediate portion 180 on a bottom with a vacuum port 704, a first cooling unit 710a on one side of the cup 702, and a second cooling unit 710b on an opposing side of the cup 702 [0080].. cavity within vacuum cup of 702);
drawing submental tissue through the tissue receiving cavity and into thermal contact with a section of the vacuum cup located at a bottom of the tissue receiving cavity (vacuum port 704 which provides sufficient vacuum to keep tissue within the tissue receiving cavity of vacuum cup 702… the rim of the vacuum cup is placed against the skin of a subject and a vacuum is drawn within the cup. The vacuum pulls the tissue of the subject into the cup 702 and coapts the target area with the interface elements 150 of the corresponding first and second interface assemblies 120a-b [0081]); and
conductively extracting heat from the submental tissue to the submentum applicator so as to cool the submental tissue (the interface assembly 120 includes a connector 170 that couples the cryoprotectant vessel 130 to the cooling unit 110 [0079]. The embodiment of the cooling unit 110 shown on FIG. 2A can include a plate 112 that has a high thermal conductivity, one or more Thermoelectric Elements (TEEs) 114 and a coolant chamber 116. As explained above with reference to FIG. 1, a coolant can recirculate through the coolant chamber 116 via inlet and outlet lines 118a and 118b, respectively, and the TEEs 114 can selectively heat and/or cool relative to the temperature of the coolant in the coolant chamber 116 to control the temperature over relatively large areas of the cooling plate 112… the cooling unit 110 provides a heat sink that cools the interface assembly 120 [0066]) an amount sufficient to be biologically effective in damaging and/or reducing the subcutaneous lipid rich cells (The treatment system 10 is suitable for cooling the subcutaneous adipose tissue of a subject 11 in a manner that reduces the volume of the adipose tissue. "Subcutaneous tissue" can include tissue lying beneath the dermis and includes subcutaneous fat, or adipose tissue that may be composed primarily of lipid-rich cells, or adipocytes. When cooling subcutaneous tissues to a temperature lower than 37.degree. C., subcutaneous lipid-rich cells can be affected selectively [0047]. Without being bound by theory, the selective effect of cooling on lipid-rich cells is believed to result in, for example, membrane disruption, cell shrinkage, disabling, destroying, removing, killing or other methods of lipid-rich cell alteration [0048]).
Regarding claim 15, Weber teaches the limitations of claim 14 as previously rejected above. Weber teaches wherein conductively extracting heat from the submental tissue causes damage to an or reduction of a sufficient amount of the submental subcutaneous lipid rich cells to visibly reduce chin of the subject (methods for cooling subcutaneous lipid-rich tissue [Abstract] the treatment devices 14 may be designed to treat target areas of the patient's body, such as chin [0054]). While Weber does not specifically mention reducing a double chin of the subject it would have been obvious to one of ordinary skill in the art to treat the double chin of the subject since Weber already provides that the treatment device is configured to cool subcutaneous lipid rich tissue such as the chin area [0054] and cooling of subcutaneous lipid rich tissue the selective effect of cooling on lipid-rich cells is believed to result in cell shrinkage [0048].
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 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber (Pub. No. 20120239123).
Regarding claim 4, Weber teaches the limitations of claim 1 as previously rejected above. Weber teaches wherein the conductive cup includes a metal surface that faces the tissue receiving cavity (suitable materials for a rigid contact member 152 include titanium, aluminum, stainless steel ; [0067]). Weber is silent about specifically teaching the metal surface has an area equal to or less than about 40 cm2. However, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the area of the metal surface to be the claimed range since Weber teaches the treatment device can have various, configurations, shapes and sizes suitable for different body parts such that heat can be removed from any subcutaneous lipid-rich target area of the subject [0054] and 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.
Claims 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber (Pub. No. 20120239123), in view of Levinson (Pub. No. 20080077211), Mercuro (Pub. No. 2008/0161892), Lurie (Pub. No. 20030062040) and in further view of Koby (Patent No. 6,151,735).
Regarding claim 6, Weber teaches the limitations of claim 1 as previously rejected above. Weber is silent about specifically teaching a restraint apparatus. However, Levinson teaches a device to cool subcutaneous tissue that is within the same field of invention wherein the device comprises a restraint that holds the device in thermal contact with the subject's target region (receiving a band or elastomeric strap to retain the cooling device 104 in place on a subject 101 during treatment [0042]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device in Weber in order to provide for at least one restraint for the purposes of holding the cooling device in place on a subject during thermal treatment as taught by Levinson. Furthermore, Levinson does not specifically teach the at least one restraint holds the tissue cooling apparatus in thermal contact with the subject's submental region; however, Mercuro teaches the restraint holds a thermal apparatus against a chin or submental area (Fig. 7) and it would be obvious to utilize a restraint to hold a tissue cooling apparatus in thermal contact with the submental region of a patient for the purposes of applying therapy to the chin area [0009].
Weber in view of Levinson does not teach a pillow including a head cradle portion and the at least one restrain coupleable to the pillow. However, Lurie teaches a medical system including a pillow (neck pillow or head rest 72, Fig. 9B) and at least one restrain coupleable to the pillow (head strap 80...the head strap may be configured to attach to the headrest to hold the headrest in the proper position while also securing the facial mask /applicator to the patient's face [0009]. Therefore, it would have been obvious to one of ordinary skill in the art to further include a pillow and modify Levinson’s restraint which holds the cooling device on a subject such that it is coupleable to the pillow since the head rest or pillow may provide support to the head of the patient, elevate and tilt the patient's head while supporting an applicator on a patient via the restraint's.
Weber in view of Levinson and in further view of Lurie does not teach an adjustable pillow and being operable to controllably adjust tilt of the subject’s head supported by the head cradle portion. However, Koby teaches an adjustable pillow including a head cradle portion and being operable to controllably adjust tilt of the subject’s head supported by the head cradle portion (An inflatable pillow bladder component 1 supporting the head of the user in a resting position . The pillow includes separate inflatable chambers comprised of neck support chamber 3 and head support chamber 4. The neck support chamber 3 is inflated to a shape that will cradle the user's neck, gently restrain movement from side to side and provide a firm but gentle variable upward traction by urging the user's head upward and extending the neck. Such controlled traction force is beneficial not only in therapeutic application to a traumatic condition, but is also healthfully stimulating to the normal musculature; Col. 2, lines 3-50). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the combination of Weber, in view of Levinson, Mercuro and Lurie to provide for a pillow that is adjustable for the purposes of optimizing comfort, stabilizing support and restraining movement of the head and neck of the subject ; Col. 1 lines 51-65).
Regarding claim 16, Weber teaches the limitations of claim 14 as previously rejected above. Weber is silent about specifically teaching further holding the submentum applicator in thermal contact with the submental region using at least one restrain. However, Levinson teaches a device to cool subcutaneous tissue that is within the same field of invention wherein the device comprises a restraint that holds the device in thermal contact with the subject's target region (receiving a band or elastomeric strap to retain the cooling device 104 in place on a subject 101 during treatment [0042]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device in Weber in order to provide for at least one restraint for the purposes of holding the cooling device in place on a subject during thermal treatment as taught by Levinson. Furthermore, Levinson does not specifically teach the at least one restraint holds the tissue cooling apparatus in thermal contact with the subject's submental region; however, Mercuro teaches the restraint holds a thermal apparatus against a chin or submental area (Fig. 7) and it would be obvious to utilize a restraint to hold a tissue cooling apparatus in thermal contact with the submental region of a patient for the purposes of applying therapy to the chin area [0009].
Weber in view of Levinson does not teach a pillow including a head cradle portion and the at least one restrain coupleable to the pillow. However, Lurie teaches a medical system including a pillow (neck pillow or head rest 72, Fig. 9B) and at least one restrains coupleable to the pillow (head strap 80...the head strap may be configured to attach to the headrest to hold the headrest in the proper position while also securing the facial mask /applicator to the patient's face [0009]. Therefore, it would have been obvious to one of ordinary skill in the art to further include a pillow and modify Levinson’s restraint which holds the cooling device on a subject such that it is coupleable to the pillow since the head rest or pillow may provide support to the head of the patient, elevate and tilt the patient's head while supporting an applicator on a patient via the restraint's.
Weber in view of Levinson and in further view of Lurie does not teach an adjustable pillow including a deployable head cradle portion and is capable of controllably adjusting the forward tilt of a subject’s head supported by the head cradle portion. However, Koby teaches an adjustable pillow including a deployable head cradle portion and being operable to controllably adjust tilt of the subject’s head supported by the head cradle portion (An inflatable pillow bladder component 1 supporting the head of the user in a resting position . The pillow includes separately inflatable chambers comprised of neck support chamber 3 and head support chamber 4. The neck support chamber 3 is inflated to a shape that will cradle the user's neck, gently restrain movement from side to side and provide a firm but gentle variable upward traction by urging the user's head upward and extending the neck. Such controlled traction force is beneficial not only in therapeutic application to a traumatic condition, but is also healthfully stimulating to the normal musculature; Col. 2, lines 3-50). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the combination of Weber, in view of Levinson and Lurie to provide for a pillow that is adjustable for the purposes of optimizing comfort, stabilizing support and restraining movement of the head and neck of the subject ; Col. 1 lines 51-65).
Claims 7, 8, 9, 11, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber (Pub. No. 20120239123) in view of Deem (Pub. No. 2008/0269851).
Regarding claim 7, Weber teaches an apparatus for treating a subject's tissue (Application systems, disposable interface assemblies and methods for cooling subcutaneous lipid-rich tissue [Abstract] the treatment devices 14 may be designed to treat target areas of the patient's body, such as chin [0054]), comprising:
a submental vacuum applicator including (vacuum cup 702 having an intermediate portion 180 on a bottom with a vacuum port 704, a first cooling unit 710a on one side of the cup 702, and a second cooling unit 710b on an opposing side of the cup 702 [0080])
a tissue receiving cavity (cavity within vacuum cup of 702),
a lip defining a mouth of the tissue receiving cavity, wherein the lip is configured to engage a submental area of the subject such that mostly submental tissue of the subject extends through the mouth and fills substantially all of the tissue receiving cavity while the submental vacuum applicator draws a vacuum and the lip portions surround at least a portion of the subject’s body (the rim of the vacuum cup is placed against the skin of a subject and a vacuum is drawn within the cup. The vacuum pulls the tissue of the subject into the cup 702 and coapts the target area with the interface elements 150 of the corresponding first and second interface assemblies 120a-b [0081]), and;
a thermal device positioned to be in thermal contact with the submental tissue in the tissue receiving cavity such that the thermal device is operable to non-invasively cool subcutaneous lipid rich cells in the submental tissue (the interface assembly 120 includes a connector 170 that couples the cryoprotectant vessel 130 to the cooling unit 110 [0079]. The embodiment of the cooling unit 110 shown on FIG. 2A can include a plate 112 that has a high thermal conductivity, one or more Thermoelectric Elements (TEEs) 114 and a coolant chamber 116. As explained above with reference to FIG. 1, a coolant can recirculate through the coolant chamber 116 via inlet and outlet lines 118a and 118b, respectively, and the TEEs 114 can selectively heat and/or cool relative to the temperature of the coolant in the coolant chamber 116 to control the temperature over relatively large areas of the cooling plate 112… the cooling unit 110 provides a heat sink that cools the interface assembly 120 [0066]) an amount sufficient to be biologically effective in damaging and/or reducing the subcutaneous lipid rich cells (The treatment system 10 is suitable for cooling the subcutaneous adipose tissue of a subject 11 in a manner that reduces the volume of the adipose tissue. "Subcutaneous tissue" can include tissue lying beneath the dermis and includes subcutaneous fat, or adipose tissue that may be composed primarily of lipid-rich cells, or adipocytes. When cooling subcutaneous tissues to a temperature lower than 37.degree. C., subcutaneous lipid-rich cells can be affected selectively [0047]. Without being bound by theory, the selective effect of cooling on lipid-rich cells is believed to result in, for example, membrane disruption, cell shrinkage, disabling, destroying, removing, killing or other methods of lipid-rich cell alteration [0048]).
Weber is silent about specifically teaching that the lip is a contoured lip including a first arcuate lip portion and a second arcuate lip portion configured to engage a submental area of the subject. However Deem specifically teaches a device for treating a subject’s tissue comprising a contoured lip defining a mouth of the tissue receiving cavity and including a first arcuate lip portion and a second arcuate lip portion, wherein the contoured lip is configured to engage a submental area of the subject (cross sectional view in Fig. 8, the vacuum chamber may have a race track shape comprising a first side and a second side, the first and second sides parallel to each other, and a first end and a second end, the first and second ends having arcuate shapes [0022] arcuate ends are formed by chamber angle z [0072], Fig. 19… vacuum pressure is used to elevate the dermis and hypodermis 1307 and the cooling plate 340 removes heat from the tissue [0061][0081][0082]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the mouth of the tissue receiving cavity in Weber, to provide for a first and second arcuate lip portion since it facilitates the acquisition of tissue as taught by Deem [0072].
Regarding claim 8, Weber in view of Deem teaches the limitations of claim 7 as previously rejected above. Weber teaches a controller with instructions for causing the thermal device to cool a conductive cup of the submental vacuum applicator such that the submental vacuum applicator non-invasively cools the subcutaneous lipid rich cells to a temperature less than about 0˚C (the treatment system 100 can apply cooling temperatures to the skin of the subject 11 in a range of about -20.degree. C. to about 20.degree. C. In other embodiments, the cooling temperatures can be from about -20.degree. C. to about 10.degree. C., approximately 0.degree. C. to approximately 20.degree. C., about -15.degree. C. to about 5.degree. C., approximately -5.degree. C. to approximately 15.degree. C., or about -10.degree. C. to about 0.degree. C. [0047][0064]).
Regarding claim 9, Weber in view of Deem teaches the limitations of claim 7 as previously rejected above. Weber teaches wherein the tissue receiving cavity includes a first end, a second end, and a central section extending between the first and second ends and wherein the central section has a curved longitudinal axis and a substantially uniform maximum depth along most of the curved longitudinal axis (see annotated figure 7 below where the first end or the bottom of the vacuum cup is curved and the central section comprises a curved axis wherein a maximum depth is substantially uniform along the curved longitudinal axis).
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Regarding claim 11, Weber in view of Deem teaches the limitations of claim 7 as previously rejected above. Weber teaches wherein the tissue receiving cavity has a substantially uniform maximum depth along most of a longitudinal length of the tissue receiving cavity (Fig. 7 substantially uniform cavity depth along most of a longitudinal length of vacuum cup 702). Likewise, Deem also teaches substantially uniform cavity depth (depth Y, Fig. 8 [0702]).
Regarding claim 12, Weber in view of Deem teaches the limitations of claim 7 as previously rejected above. Weber teaches a vacuum source fluidically coupled to the tissue receiving cavity and configured to provide sufficient vacuum to draw the submental tissue to a bottom of the tissue receiving cavity to bring the submental tissue into thermal contact with a concave metal heat exchanging surface of the submental vacuum applicator (vacuum port 704 which provides sufficient vacuum to keep tissue within the tissue receiving cavity of vacuum cup 702… the rim of the vacuum cup is placed against the skin of a subject and a vacuum is drawn within the cup. The vacuum pulls the tissue of the subject into the cup 702 and coapts the target area with the interface elements 150 of the corresponding heat exchange first and second interface assemblies 120a-b [0081]).
Regarding claim 13, Weber in view of Deem teaches the limitations of claim 7 as previously rejected above. Weber teaches wherein the submental vacuum applicator includes an applicator unit and a liner assembly removably attached to the applicator unit (interface assembly 120 is removably attached to applicator or vacuum cup 702...interface assembly 120 can be disposed [Abstract][0079][0081]).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber (Pub. No. 20120239123) in view of Deem (Pub. No. 2008/0269851) and in further view of Lau (Pub. No. 2005/0010197).
Regarding claim 10 Weber in view of Deem teaches the limitations of claim 7 as previously rejected above. While Weber provides for the curved longitudinal axis and Deem provides for the first and second arcuate lip portions, it is silent about specifically teaching a curved longitudinal axis having the same curvature as a curvature of at least one of the first and second arcuate lip portions. However, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify Weber in view of Deem as further evidenced by Lau since it teaches a tissue grasping cavity comprising curvature 25f and internal vacuum space 25e and the curvature improves the ability of the suction member to engage with tissue and the cavity comprising a curved longitudinal axis creates a large volume to engage tissue which creates a strong engagement or hold on the tissue while distributing the holding forces over a substantial area of the tissue so as not to damage it [0193]. Likewise, Deem provides that the arcuate lip portions facilitate the acquisition of tissue [0072].
Claims 17, 18, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable Levinson (Pub. No. 20080077211), as further evidenced by Mercuro (Pub. No. 2008/0161892), in view of Lurie (Pub. No. 20030062040) and in further view of Koby (Patent No. 6,151,735).
Regarding claim 17, Levinson teaches a system for treating a subject (A cooling device for removing heat from subcutaneous lipid-rich cells of a subject having skin is provided; [Abstract]), comprising:
at least one restraint holds a tissue cooling apparatus in thermal contact with the subject (receiving a band or elastomeric strap to retain the cooling device 104 in place on a subject 101 during treatment [0042]). Levinson does not specifically teach the at least one restraint holds the tissue cooling apparatus in thermal contact with the subject's submental region; however, Mercuro teaches the restraint holds a thermal apparatus against a chin or submental area (Fig. 7) and it would be obvious to utilize a restraint to hold a tissue cooling apparatus in thermal contact with the submental region of a patient for the purposes of applying therapy to the chin area [0009].
Levinson does not teach a pillow including a head cradle portion and the at least one restraint coupleable to the pillow. However, Lurie teaches a medical system including a pillow (neck pillow or head rest 72, Fig. 9B) and at least one restraint coupleable to the pillow (head strap 80...the head strap may be configured to attach to the headrest to hold the headrest in the proper position while also securing the facial mask /applicator to the patient's face [0009]. Therefore, it would have been obvious to one of ordinary skill in the art to further include a pillow and modify Levinson’s restraint which holds the cooling device on a subject such that it is coupleable to the pillow since the head rest or pillow may provide support to the head of the patient, elevate and tilt the patient's head while supporting an applicator on a patient via the restraint's.
Weber in view of Levinson and in further view of Lurie does not teach an adjustable pillow and being operable to controllably adjust tilt of the subject’s head supported by the head cradle portion. However, Koby teaches an adjustable pillow including a head cradle portion and being operable to controllably adjust tilt of the subject’s head supported by the head cradle portion (An inflatable pillow bladder component 1 supporting the head of the user in a resting position . The pillow includes separately inflatable chambers comprised of neck support chamber 3 and head support chamber 4. The neck support chamber 3 is inflated to a shape that will cradle the user's neck, gently restrain movement from side to side and provide a firm but gentle variable upward traction by urging the user's head upward and extending the neck. Such controlled traction force is beneficial not only in therapeutic application to a traumatic condition, but is also healthfully stimulating to the normal musculature; Col. 2, lines 3-50). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the combination of Levinson in view of Mercuro and Lurie to provide for a pillow that is adjustable for the purposes of optimizing comfort, stabilizing support and restraining movement of the head and neck of the subject; Col. 1 lines 51-65).
Regarding claim 18, Levinson in view of Mercuro, Lurie, and Koby teaches the limitations of claim 17 as previously rejected above. The combination teaches further comprising the tissue cooling apparatus, wherein the at least one restraint and the adjustable pillow are configured to cooperate to inhibit movement of the tissue cooling apparatus (see claim rejection 17) while the tissue cooling apparatus non-invasively cools subcutaneous lipid rich cells an amount sufficient to be biologically effective in reducing subcutaneous lipid rich cells (One expected advantage of using the cooling device 104 is that subcutaneous lipid-rich cells can be reduced generally without collateral damage to non-lipid-rich cells in the same region; [0079]).
Regarding claims 19 and 20, Levinson in view of Mercuro, Lurie, and Koby teaches the limitations of claim 17 as previously rejected above. Koby teaches a head adjuster device or cradle adjuster device operable to reconfigure the head cradle portion to achieve the desired tilt of the subject's head and a neck adjuster device independently operable to reconfigure a neck support portion of the adjustable pillow to achieve desired neck tilt of the subject (The pillow includes separately inflatable chambers comprised of neck support chamber 3 and head support chamber 4. The neck support chamber 3 is inflated to a shape that will cradle the user's neck, gently restrain movement from side to side and provide a firm but gentle variable upward traction by urging the user's head upward and extending the neck; Col. 2, lines 3-50…. The exact shape of the forms of the head support chamber in use will be defined by the inflation pressure applied by pump 14a and the position and weight of the user's head. The user may adjust the supporting shape of this chamber by pressing the pump 14a for small increments of increased inflation pressure or by deflating the chamber in increments by depressing the associated relief valve. In the same way the user can adjust the shape of the separate inner neck traction chamber 11 with its associated pump and relief valve to provide the comfort or required traction sought by raising the volume of the neck support chamber which will tilt the head back and extend the neck; Col. 4 lines 6-10).
Conclusion
This is a continuation of applicant's earlier Application No. 14/705,868. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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