DETAILED ACTION
This action is responsive to the RCE filed 8/12/25.
Claims 1-3, 5-6 and 8-22 are rejected.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 21 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 claim 1, the claim has been amended to recite ‘wherein the plurality of wells are arranged in a rectangular grid comprising uniformly spaced wells extending in perpendicular directions’. It is not clear whether the phrase ‘extending in perpendicular directions’ modifies the arrangement of wells within the grid or the physical geometry of the wells themselves (e.g. wells having sidewalls extending in perpendicular directions to each other). The examiner suggests amending the claims to clarify applicant’s intended meaning.
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) 8 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foster (US 20160030238).
Regarding claim 8, Foster teaches a therapeutic device for an animal (Fig. 1, protection system 100) comprising: a flexible compress member (Fig. 7 and par. 64, ‘The trays can be made of a soft, pliable material.’) having a plurality of wells (Fig. 7, trays 762, 764, 766, 768, 770 and 772), wherein each of the plurality of wells comprises a first internal volume (Fig. 7 and par. 64, ‘Each tray includes an open top, a bottom surface, and a plurality of compartments separated by walls 790. It is contemplated that a cold pack is placed within each compartment’) and an upper end of the wells comprises an overhang (Par. 64, ‘the walls are scalloped to permit easier grasp of the coldpack within the compartment’; in this case the scalloped surface of the walls can be considered the recited overhang; or par. 69, ‘Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head.’; in this embodiment the overhang can be considered the insulating cover); a plurality of fluid-containing modules (Par. 64, ‘It is contemplated that a cold pack is placed within each compartment’; par. 73, ‘The reactive materials causing the endothermic reaction are, in particular embodiments, water and ammonium chloride. Other combinations of materials that result in an endothermic reaction include water with ammonium nitrate; water with potassium chloride; and ethanoic acid with sodium carbonate’), wherein each of the plurality of fluid-containing modules comprises a second internal volume (Fig. 2b, the ‘second internal volume’ can be considered the internal volumes of the different cold packs 221-240 which are disclosed to contain reactants in par. 69) and is operable to be repeatedly removed from and inserted into the first internal volume of a well (Fig. 7 and par. 64, ‘It is contemplated that a cold pack is placed within each compartment’; it is the examiner’s position that the disclosed cold packs are at least capable of being repeatedly removed and inserted into the different trays since the cold packs are not disclosed to be fixedly attached to the different trays) a material provided within the second internal volume (Par. 69, ‘Each cold pack contains the two different reactive materials separated by a rupturable membrane, which react endothermically when mixed’) wherein the overhang is operable to selectively receive and extend over only a portion of a fluid-containing module (Par. 64, in the case of the scalloped walls, the scalloped walls receive and extend over a side portion of the cold packs but do not extend over a top portion of the cold packs; or par. 69, in the case of the insulating cover, the insulating cover receives and extends over a top portion of the cold packs but does not extend over the side portions or bottom portion of the cold packs), and the overhang extends around an entire periphery of the upper end of each one of the plurality of wells (Par. 64, in the case of the scalloped walls, the scalloped walls surround the periphery of the different tray compartments including the upper portions of the tray compartments; Par. 69, in the case of the insulative cover, the insulative cover covers the entire upper openings of the tray compartments and therefore can be construed to surround the periphery of the upper openings of the different tray compartments) and wherein the device is operable to act as a heating or cooling agent for an animal body part (Abstract, ‘When the first reactive material and the second reactive material are mixed, an endothermic reaction occurs’).
Regarding claim 11, Foster further teaches wherein the plurality of wells are arranged in a grid (Fig. 7, the different compartments of trays 762, 764, 766, 768, 770 and 772 can be considered to be arranged in grid patterns).
Regarding claim 12, Foster further teaches wherein at least some of the fluid-containing modules comprises substantially rectangular cubes (Fig. 2b, showing cold packs 221-240 which are substantially rectangular/cubed shaped).
Regarding claim 13, Foster further teaches a cover member extending along the upper end of the wells and comprises a seal for at least some of the plurality of wells (Par. 69, ‘Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head’; or alternatively, par. 70, ‘In some other embodiments, the reactive materials can be placed within the tray compartments, and the top of the tray would be sealed with a film.’).
Regarding claim 14, Foster, as modified, further teaches wherein the fluid-containing modules comprise sealed modules (Fig. 2b, walls of cold packs 221-240 seal the fluid within the internal volume of the cold packs).
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(s) 14-15, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foster in view of Wilson et al. (US 20060004427, “Wilson”).
Regarding claim 15, Foster teaches a therapeutic device for an animal (Fig. 1, protection system 100) comprising: a flexible member comprising at least one well (Fig. 7, trays 762, 764, 766, 768, 770, 772 each having multiple compartments and par. 64, ‘The trays can be made of a soft, pliable material.’); wherein the at least one well comprises a plurality of sidewalls, a bottom portion, and a first internal volume (Fig. 7 and par. 64, ‘Each tray includes an open top, a bottom surface, and a plurality of compartments separated by walls 790’); a fluid-containing module (Par. 64, ‘cold pack’; par. 69, ‘Each cold pack contains the two different reactive materials separated by a rupturable membrane, which react endothermically when mixed.’; par. 73, ‘The reactive materials causing the endothermic reaction are, in particular embodiments, water and ammonium chloride.’) that is operable to be repeatedly removed from and inserted into the at least one well (Fig. 7 and par. 64, ‘It is contemplated that a cold pack is placed within each compartment’; it is the examiner’s position that the disclosed cold packs are at least capable of being repeatedly removed and inserted into the different trays since the cold packs are not disclosed to be fixedly attached to the different trays); wherein the fluid-containing module comprises a substantially rectangular cube having an upper end, a lower end, a plurality of sidewalls, a second internal volume (Fig. 2b, showing cold packs 221-240 which are substantially rectangular/cubed shaped and which have multiple side walls which seal an internal volume containing reactants as disclosed in par. 73), a fluid provided within the second internal volume (Par. 73, e.g. water) and a cover operable to seal the second internal volume (The ‘cover’ can be considered the outer surfaces of the different cold packs (221-240) which enclose the reactive materials shown in fig. 2b; alternatively it can be considered the rupturable membrane which separates the different reactants within the cold packs as disclosed in par. 69); wherein the at least one well comprises at least one of a flexible and an elastic component that is operable to selectively receive and at least partially secure a portion of a fluid-containing module (Par. 64, ‘As seen here, the walls are scalloped to permit easier grasping of the cold pack in the compartment. The trays can be made of a soft, pliable material’; or par. 70, ‘and the top of the tray would be sealed with a film.’); and wherein the device is operable to act as a heating or cooling agent for an animal body part (Abstract, ‘When the first reactive material and the second reactive material are mixed, an endothermic reaction occurs’).
Foster fails to teach the second internal volume being less than the first internal volume; or that the fluid-containing module further comprises an aperture operable to serve as a fill port for filling the fluid-containing module.
Regarding the second internal volume aspect, the examiner maintains, that it would have been obvious to POSITA at the time that the invention was filed to size the internal volume of the fluid-containing module to be lower than the internal volume of the receiving wells in order to configure the fluid-containing modules to fit within the wells, as intended, and since a change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Regarding the fill port aspect, Wilson teaches a fluid-containing module (Fig. 1, thermal pack 100; par. 46, ‘A temperature-retaining fluid 108 is received into the space between the inner surface 104 and the outer surface 105.’); wherein the fluid-containing module comprises a plurality of sidewalls (Fig. 1, inner/outer surfaces 104/105), an internal volume (Par. 46, ‘the space between the inner surface 104 and the outer surface 105’), a fluid provided within the second internal volume (Par. 46, ‘A temperature-retaining fluid 108 is received into the space between the inner surface 104 and the outer surface 105’) , a cover operable to seal the second internal volume (Pars. 64-66, describing the manufacture of the fluid containing module through heat-sealing), and an aperture operable to serve as a fill port for filling the fluid-containing module (Fig. 7D and Par. 67, ‘With reference to FIG. 7D, an optional fill valve 120 is installed between the first edge 116 and the second edge 118 before the two edges are sealed together. The fill valve 120 can be a conventional valve, or can simply constitute a small tube of the flexible material through which the temperature-retaining fluid can be inserted.’).
Therefore, in view of Wilson, it would have been obvious to POSITA at the time that the invention was filed to provide the fluid-containing module with a fill valve in order to facilitate the filling of the fluid-containing module with fluid, as taught by Wilson.
Regarding claim 18, Foster, as modified, further teaches wherein the plurality of wells are arranged in a grid (Fig. 7, the different compartments of trays 762, 764, 766, 768, 770 and 772 can be considered to be arranged in grid patterns).
Regarding claim 19, Foster, as modified, further teaches wherein an upper end of the well comprises at least one of an overhang and a constriction operable to at least partially secure a fluid-containing module (Par. 64, ‘the walls are scalloped to permit easier grasp of the coldpack within the compartment’; in this case the scalloped surface of the walls can be considered the recited overhang/constriction; or par. 69, ‘Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head.’; in this embodiment the constriction/overhang can be considered the insulating cover).
Regarding claim 14 and 20, Foster, as modified, further teaches wherein the fluid-containing module(s) comprise(s) a sealed module(s) (Fig. 2b, walls of cold packs 221-240 seal the cold packs).
Alternatively, Wilson teaches using heat sealing techniques to construct fluid-containing modules from heat-sealable films (Pars. 64-66).
Therefore, in view of Wilson it would have been obvious to POSITA to utilize heat sealing techniques in order to construct the fluid-containing modules using heat-sealable films, as taught by Wilson.
Claim(s) 1-3, 5-6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foster or in the alternative over Foster in view of Wilson, as applied to claims 14-15 and 18-20, above, and further in view of Desiderio et al. (US 20110106227, “Desiderio”) and Dyrek (US 5409500).
Regarding claim 1, Foster teaches a therapeutic device for an animal (Fig. 1, protection system 100) comprising: a flexible compress member (Fig. 7 and par. 64, ‘The trays can be made of a soft, pliable material.’) having a plurality of wells (Fig. 7, trays 762, 764, 766, 768, 770 and 772 each having multiple compartments); wherein each of the plurality of wells comprises a first internal volume and an upper end of the wells comprises at least one of a constriction and an overhang (Par. 64, ‘the walls are scalloped to permit easier grasp of the coldpack within the compartment’; in this case the scalloped surface of the walls can be considered the recited overhang; or par. 69, ‘Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head.’; in this embodiment the constriction/overhang can be considered the insulating cover); a plurality of fluid-containing modules (Par. 64, ‘It is contemplated that a cold pack is placed within each compartment’; par. 73, ‘The reactive materials causing the endothermic reaction are, in particular embodiments, water and ammonium chloride. Other combinations of materials that result in an endothermic reaction include water with ammonium nitrate; water with potassium chloride; and ethanoic acid with sodium carbonate’), wherein each of the plurality of fluid-containing modules is operable to be provided within the first internal volume of a well (Par. 64, ‘It is contemplated that a cold pack is placed within each compartment’) wherein each of the plurality of fluid-containing modules comprises a substantially rectangular sealed cube with a plurality of sidewalls (Fig. 2b, showing cold packs 221-240 which are substantially rectangular/cubed shaped and which have multiple side walls which seal an internal volume containing reactants as disclosed in par. 73; alternatively see Wilson, pars. 64-66, which teaches the manufacture of fluid-containing modules using heat-sealing techniques) and each of the plurality of fluid-containing modules comprises a fluid (Par. 73, ‘The reactive materials causing the endothermic reaction are, in particular embodiments, water and ammonium chloride.’); wherein each of the fluid-containing modules comprises a second internal volume, (Par. 69, ‘Each cold pack contains the two different reactive materials separated by a rupturable membrane, which react endothermically when mixed.’; the fact that the cold packs are disclosed to contain reactive materials implies an internal volume; see Williams, fig. 1a, showing an internal volume between walls 15), the second internal volume being less than the first internal volume (Foster has previously been modified to modify the sizes of the cold packs to fit within tray compartments, which is mapped to the first internal volume; see the discussion of claim 15, above); the fluid provided within the second internal volume (Par. 73, e.g. water); wherein the at least one of a constriction and an overhang comprises a flexible component that is operable to selectively receive and at least partially secure a portion of a fluid-containing module (Par. 64, ‘As seen here, the walls are scalloped to permit easier grasping of the cold pack in the compartment. The trays can be made of a soft, pliable material.’; or par. 69, ‘Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head.’); and wherein the device is operable to act as a heating or cooling agent for an animal body part (Abstract, ‘When the first reactive material and the second reactive material are mixed, an endothermic reaction occurs’).
Foster fails to teach wherein the plurality of wells are arranged in a rectangular grid comprising uniformly spaced wells extending in perpendicular directions; that each of the plurality of fluid containing modules comprises a silicone cube.
Regarding the rectangular grid aspect, Dyrek teaches an analogous cooling device for treatment of the lumbar region of the back (Fig. 6) comprising a flexible compress (Fig. 1, cold pack 20) member having a plurality of wells (Fig. 1, compartments 22), wherein the plurality of wells are arranged in a rectangular grid comprising uniformly spaced wells extending in perpendicular directions (Fig. 1, compartments 22 are arranged in a rectangular grid where compartments 22 are uniformly spaced and extend in perpendicular directions).
Therefore, in view of Dyrek it would have been obvious to POSITA at the time that the invention was filed to arrange the plurality of wells in a grid of uniformly spaced wells extending in perpendicular directions, in order to configure the device to treat the lumbar region of the back, as taught by Dyrek
Regarding the silicone cube aspect, Desiderio teaches an analogous cold pack (Abstract, ‘A bracelet and wrap having therapeutic properties is worn on a child's injured or sensitive wrist to facilitate healing and/or provide cold/warm treatment.’; figs. 1-3, treatment pack 20/220/320), which comprises a substantially rectangular (Figs. 1-3, thermal pack 20/220/320 is substantially rectangular) silicone cube with a plurality of sidewalls and which contains a fluid (Par. 12, ‘In this case, preferably the treatment pack (and visa vie the central portion wherein the treatment pack is integrated within the central portion rather than removable therefrom) and/or the central portion is composed of a transparent rubber (preferably), silicone or polymeric material preferably having a movable fluid therein’).
Therefore, since both Foster and Desiderio teach different outer casing materials for holding heat transfer fluid in the context of cooling packs, it would have been obvious to POSITA at the time that the invention was filed to substitute one known outer casing material for the other in order to arrive at the predictable result of an outer casing material for holding heat transfer fluid in the context of a cooling pack. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Additionally, the examiner maintains that it would have been obvious to POSITA at the time that the invention was filed to manufacture the outer casing of the fluid containing modules of silicone rubber, as desired, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 2, Foster, as modified, fails to explicitly teach wherein the flexible compress comprises silicone rubber.
The examiner maintains, however, that it would have been obvious to POSITA at the time the invention was filed to construct the tray component of silicone rubber, as desired, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 3, Foster, as modified, further teaches wherein the contained fluid comprises water (Par. 73, ‘The reactive materials causing the endothermic reaction are, in particular embodiments, water and ammonium chloride.’; see Desiderio, par. 12, ‘silicone or polymeric material preferably having a movable fluid therein, such as water, non-toxic water mixtures, or a visco-elastic gel to provide flexibility and heat transfer.’).
Regarding claim 5, Foster, as modified, further teaches a cover member (Par. 69, ‘the trays can be fastened to the insulating cover, so that the cold packs directly contact the patient's head. Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head’).
Regarding claim 6, Foster, as modified, further teaches wherein the cover member extends along the upper end of the wells and comprises a seal for at least some of the plurality of wells (Par. 69, ‘Alternatively, the trays can be fastened to the insulating cover such that the cold packs are trapped between the bottom of the tray and the insulating cover, and the tray bottom directly contacts the patient's head’).
Regarding claim 21, Foster, as modified, further teaches wherein the at least one of a constriction and an overhang extends around an entire periphery of the upper end of the wells (Par. 64, the at least one constriction/overhang can be mapped to the scalloped walls of the different compartments which inherently extend about the entire periphery of the upper end of the compartment; or alternatively par. 69, the at least constriction/overhang can be mapped to the insulative cover which covers the peripheries of the openings of the different tray compartments).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foster, as applied to claims 8 and 11-14, above, and further in view of Desiderio et al. (US 20110106227, “Desiderio”).
*** Note that the combination Foster in view of Desiderio has previously been discussed with respect to claim 1, above, and therefore will not be reiterated.
Regarding claims 9-10, Foster, as modified, further teaches wherein the device comprises silicone rubber; and wherein the plurality of fluid-containing modules comprises silicone rubber (Foster has previously been modified to construct the outer casing of the different cold packs from silicone rubber; see Desiderio, par. 12, ‘In this case, preferably the treatment pack (and visa vie the central portion wherein the treatment pack is integrated within the central portion rather than removable therefrom) and/or the central portion is composed of a transparent rubber (preferably), silicone or polymeric material preferably having a movable fluid therein’).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foster in view of Wilson, as applied to claims 15 and 18-20, above, and further in view of Desiderio et al. (US 20110106227, “Desiderio”).
*** Note that the combination Foster in view of Desiderio has previously been discussed with respect to claim 1, above, and therefore will not be reiterated.
Regarding claims 16-17, Foster, as modified, further teaches wherein the device comprises silicone rubber; and wherein the plurality of fluid-containing module comprises silicone rubber (Foster has previously been modified to construct the outer casing of the different cold packs from silicone rubber; see Desiderio, par. 12, ‘In this case, preferably the treatment pack (and visa vie the central portion wherein the treatment pack is integrated within the central portion rather than removable therefrom) and/or the central portion is composed of a transparent rubber (preferably), silicone or polymeric material preferably having a movable fluid therein’).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foster in view of Desiderio and Dyrek, as applied to claims 1-3, 5-6 and 21, above, and further in view of Wilson.
*** Note that the combination Foster in view of Wilson has previously been discussed with respect to claim 15, above, and therefore will not be reiterated.
Regarding claim 22, Foster, as modified, further teaches wherein each of the fluid-containing modules comprises an aperture operable to serve as a fill port for filling the fluid-containing module (Foster has previously been modified in view of Wilson to provide fill ports for filling fluid-containing modules with fluid; See Wilson, Fig. 7D and Par. 67, ‘With reference to FIG. 7D, an optional fill valve 120 is installed between the first edge 116 and the second edge 118 before the two edges are sealed together. The fill valve 120 can be a conventional valve, or can simply constitute a small tube of the flexible material through which the temperature-retaining fluid can be inserted.’).
Response to Arguments
Applicant's arguments filed 7/9/25 with respect to the rejection of claims 8 and 11-13 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues:
The Examiner asserts that the film taught in Foster is equivalent to the overhang in the present invention. Applicant respectfully disagrees. The film, as taught in Foster, is configured to seal the top of the tray. See Foster, at paragraph [0070]. In other words, the film fully covers the top of the tray; therefore, the film also fully covers the cold pack contained in the compartment of the tray. In contrast, the overhang in the present invention only extends around the periphery of the wells and covers a portion of a fluid containing module.
The examiner disagrees with applicant’s assertion that the film disclosed by Foster cannot be used to teach ‘wherein the overhang is operable to selectively receive and extend over only a portion of a fluid containing module’. For instance, even if the film disclosed by Foster extends over the entire top surface of the cooling elements of Foster, it does not ‘receive and extend over’ the side portions and bottom portions of the cooling elements. Therefore, it still can be construed to ‘receive and extend over only a portion’ of the different cooling elements. Therefore, the examiner maintains that Foster can be construed to anticipate the claim language according to its broadest reasonable interpretation.
Applicant’s arguments, see “Remarks”, filed 7/9/25, with respect to the rejection(s) of claim(s) 1-3, 5-6, 21 and claim(s) 15, 18-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dyrek and Wilson.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794