DETAILED ACTION
This action is responsive to the RCE filed 1/29/26.
Claims 11-29 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 is being examined under the pre-AIA first to invent provisions.
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 11-29 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 11, 20-23, it is not clear what is meant by the term ‘grain direction’ in the context of the claims.
Regarding claims 18-29 and 28-29, it is not clear how a fastening element could be coupled between the front and back side of the heat transfer device, if the heat transfer device is recited to be located within a pouch.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Elkins et al. (US 20010039439, “Elkins”) in view of Zacoi (US 5190032).
Regarding claim 11, Elkins teaches a therapy apparatus for treatment of an animate body (Abstract, ‘A heat exchange system using pressurized air and a flowing liquid having a controlled temperature for cooling or heating a portion of a human body.’) comprising: a heat transfer device (Figs. 1a-b, splint 100) comprising a fluid bladder adapted to circulate a coolant (Figs. 1a-b and par. 27, ‘The splint 100 includes a liquid bladder 102 for containing a flow of a liquid 103 at a controlled temperature’) to transfer heat between the device and the animate body (Par. 27, ‘The liquid 103 that flows through the liquid bladder 102 picks up or gives out heat from or to the body depending upon whether the temperature of the liquid 103 is lower or greater, respectively, than the skin temperature of the body.’), and an inflatable bladder adapted to apply compressive force to the animate body (Figs. 1a-b and par. 27, ‘The pressurized in the air bladder 104 compresses the liquid bladder 102 against the body part to better conform to its shape.’), the fluid bladder formed by a first and second layer (Fig. 1b and par. 28, ‘The liquid bladder 102 is defined by a first layer 106, a second layer 108’) and the inflatable bladder formed by a third layer and sharing the second layer with the fluid bladder (Fig. 1b and par. 28, ‘The air bladder 104 is defined by the other side of the second layer 108, a third layer 116’), wherein the heat transfer device has a perimeter that defines an inwardly curved portion forming a first edge of an adjacent flap (Fig. 1a, the bottom edge of is inwardly curved and forms a first edge of a bottom corner which can be mapped to the ‘adjacent flap’); and wherein the first, and second layers are formed of a woven material (Par. 31, “The second layer 108 may be constructed in a manner that is similar using two or three plies on each side. Nylon having a woven two-hundred denier rating is suitable for the fabric of the first and second layers 106 and 108.”).
Elkins fails to teach that the third layer is formed of a woven material; a pouch adapted to reversibly receive the heat transfer device, the pouch having a perimeter corresponding to a shape of the perimeter of the heat transfer device such that the flap of the heat transfer device is reversibly received within a corresponding flap of the pouch; and a grain direction of each of the first, second and third layers is rotated relative to each other.
Regarding the woven material aspect, the examiner maintains, that it would have been obvious to POSITA at the time that the invention was made to select a woven material for the third layer, 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 the pouch aspect, Zacoi teaches a therapy apparatus for treatment of an animate body (Abstract, “An apparatus is for use with a temperature controlled fluid circulating device”) comprising: a heat transfer device (Fig. 16, circulating blanket 120) comprising a fluid bladder (Fig. 16, bladder defined by first side 124 and second side 126) adapted to circulate a coolant (Abstract, “The apparatus includes a fluid circulating blanket having connecting hoses for connection to the fluid circulating device.”) to transfer heat between the device and the animate body (Col. 6, lines 60-63, “It is also an object of the invention to provide such an apparatus which could be used to post-operatively provide cooling at the sides of a mid-line incision of the knee.”), the fluid bladder formed by a first and second layer (Fig. 16, first side 124 and second side 126 form the bladder), wherein the heat transfer device has a perimeter that defines an inwardly curved portion forming a first edge of an adjacent flap (Fig. 16, opening 140 comprises in inward curved portion which forms a first edge of elongated portion 128); a pouch adapted to reversibly receive the heat transfer device (Fig. 16 and col. 21, lines 6-8, “As also seen in FIG. 16, the improved support envelope 122 is adapted to surround the fluid circulating blanket 120.”; further, the examiner maintains that blanket 120 is at least capable of being reversibly received through access opening 176), the pouch having a perimeter corresponding to a shape of the perimeter of the heat transfer device (Fig. 16, support envelope 122 has a shape which corresponds to the perimeter of circulating blanket 120) such that the flap of the heat transfer device is reversibly received within a corresponding flap of the pouch (Col. 21, lines 22-28, “With the elongated portions 128, 130 respectively installed within the elongated envelope portions 158, 160”; further the examiner maintains that these flaps are at least capable of being reversibly received within the corresponding portions of envelope 122).
Zacoi further teaches that the support envelopes facilitate positioning and alignment of the fluid circulation blankets with the desired target area (Col. 13, lines 62-65, “Proper use of the support envelopes facilitates positioning and alignment of the fluid circulating blankets 10 and insures that they are efficiently and effectively directed to the desired area to be cooled”).
Therefore, since both Elkins and Zacoi teach different configurations for attaching the heat-transfer device to a target area of the human body, it would have been obvious to POSITA at the time that the invention was filed to substitute one known attachment configuration for the other in order to arrive at the predictable result of an attachment configuration for attaching a heat-transfer device to a target area of the human body. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the ‘grain direction’ aspect, the examiner maintains, that it would have been obvious to POSITAS at the time that the invention was made to optimize the relative orientations of the first, second and third layers, since POSITA would have recognized that the mechanical properties of the different layers are affected by its grain orientation and since 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.
Regarding claim 12-14, Elkins, as modified, further teaches wherein the first, second and third layers include a laminate coating (Par. 31, ‘The first layer 106, the second layer 108, and the third layer 116 may be constructed of a laminate having a fabric and one or more coatings of a material that can be heat welded for making a seal’), but fails to teach where a thickness of the laminate coating varies between the first, second and third layers; where a thickness of the laminate coating provided on an inner surface of the first layer is greater than a thickness of the laminate coating provided on an inner surface of the third layer; and wherein the thickness of the laminate coating on the inner surface of the first layer is greater than a thickness of the laminate coating on both a fluid bladder-facing surface of the second layer and an inflatable bladder-facing surface of the second layer.
The examiner maintains, however, that it would have been obvious to POSITA at the time that the invention was made to optimize the thicknesses of the different coating layers as desired, since POSITA would have recognized that the thicknesses of the coating layers affect the mechanical properties of the resultant heat-sealed bladders, and since 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.
Regarding claim 15, Elkins, as modified, further teaches wherein the first, second, and third layers are RF welded together (Par. 31, ‘the sealing process for the fences 120, the attachment dots 122, and the peripheral border 110 is a Radio Frequency (RF) heat sealing process’).
Regarding claim 16, Elkins, as modified, further teaches wherein the first, second, and third layers a constructed from nylon (Par. 31, ‘Nylon having a woven two-hundred denier rating is suitable for the fabric of the first and second layers 106 and 108 […] Preferably, the fabric for the third layer 116 is a stretchable nylon’) and include a laminate coating constructed from polyurethane (Par. 31, ‘Preferably, the coatings are a thermal plastic, such as an ether-based polyurethane.’) wherein the heat transfer device is movable within the pouch (Elkins has previously been modified in view of Zacoi to comprises a pouch; see Zacoi, col. 21, lines 48-50, “Specifically, the envelope width EW of the support envelope 122 exceeds the blanket width BW”; fig. 16, it is the examiner’s position that fluid circulating blanket 120 is movable within envelope 122 since the envelope width is disclosed to be larger than the blanket width) such that if a fold occurs in the heat transfer device when bending stress is applied to the apparatus, the heat transfer device will move within the pouch to maintain fluid communication within at least one of the fluid bladder or the inflatable bladder of the heat transfer device (Fig. 16, it is the examiner’s position that fluid circulation blanket is at least capable of moving within envelope 122 to prevent kinking).
Regarding claim 17, Elkins, as modified, further teaches a fluid source fluidly coupled to the fluid bladder and a gas source fluidly coupled to the inflatable bladder (Abstract, ‘The flowing liquid and the pressurized air enter and exit the splint directly into the liquid and air bladders through planar ports. The control unit includes a liquid circuit for providing the flowing fluid at a controlled temperature and an air circuit for providing the pressurized air.’).
Regarding claim 18, Elkins, as modified, further teaches a fastening element coupled between a front side and a back side of the heat transfer device (Elkins has previously been modified in view of Zacoi to comprise a pouch with fastening elements; see Zacoi, fig. 18, the back side of straps 196/198 comprises hook tabs 192 and communicate with the front side of envelope 122).
Regarding claim 19, Elkins, as modified, teaches hook and loop fastening elements included on a front side and a back side of the heat transfer element (Elkins has previously been modified in view of Zacoi to comprise a pouch with fastening elements; see Zacoi, col. 14, lines 35-37, “The outside surface 64 of each support envelope 60R, 60L may be formed of a polypropylene or other foam material with a loop material laminated thereon”; see Zacoi, fig. 16, hook tabs 192), but fails to teach wherein the front side includes a hook portion which forms the hook portion of a hook and loop fastening element, and the back side includes a loop portion which forms the loop portion of the hook and loop fastening element of the apparatus.
The examiner maintains however, that it would have been obvious to POSITA at the time that the invention was made to switch the relative locations of the hook and loop portions between the front side of the envelope and the back side of the securing straps since such a modification amounts to a mere rearrangement of parts , and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 20, Elkins, as modified, teaches a therapy apparatus for treatment of an animate body (Abstract, ‘A heat exchange system using pressurized air and a flowing liquid having a controlled temperature for cooling or heating a portion of a human body.’) comprising: a heat transfer device (Figs. 1a-b, splint 100) comprising a fluid bladder for circulating a fluid (Figs. 1a-b and par. 27, ‘The splint 100 includes a liquid bladder 102 for containing a flow of a liquid 103 at a controlled temperature’) and an inflatable bladder for pressurization to apply a compressive force (Figs. 1a-b and par. 27, ‘The pressurized in the air bladder 104 compresses the liquid bladder 102 against the body part to better conform to its shape.’), the fluid bladder formed by a first and second layer (Fig. 1b and par. 28, ‘The liquid bladder 102 is defined by a first layer 106, a second layer 108’) and the inflatable bladder formed by a third layer and sharing the second layer with the fluid bladder (Fig. 1b and par. 28, ‘The air bladder 104 is defined by the other side of the second layer 108, a third layer 116’), where a grain direction of at least one of the first, second, and third layers are rotated relative to each other (Elkins has previously been modified to optimize the relative orientations of the different layers, see the discussion of claim 11, above); a connection port in communication with the fluid bladder and the inflatable bladder (Fig. 1a, liquid/air connector 119); and a pouch adapted to reversibly receive the heat transfer device (Elkins has previously been modified in view of Zacoi to comprise a support envelope; see Zacoi, fig. 16 and col. 21, lines 6-8, “As also seen in FIG. 16, the improved support envelope 122 is adapted to surround the fluid circulating blanket 120.”; further, the examiner maintains that blanket 120 is at least capable of being reversibly received through access opening 176), wherein the heat transfer device is movable within the pouch (See Zacoi, fig. 16 and col. 21, lines 48-50, “Specifically, the envelope width EW of the support envelope 122 exceeds the blanket width BW”; it is the examiner’s position that fluid circulating blanket 120 is movable within envelope 122 since the envelope width is disclosed to be larger than the blanket width) such that if a fold occurs in the heat transfer device when a bending stress is applied to the apparatus, the heat transfer device will move within the pouch to maintain fluid communication within the at least one of the fluid bladder or the inflatable bladder of the heat transfer device (Fig. 16, it is the examiner’s position that fluid circulation blanket is at least capable of moving within envelope 122 to prevent kinking).
Regarding claim 21, Elkins, as modified, further teaches wherein the first, second and third layers are constructed from a woven material (Par. 31, “The second layer 108 may be constructed in a manner that is similar using two or three plies on each side. Nylon having a woven two-hundred denier rating is suitable for the fabric of the first and second layers 106 and 108.”; further the material of the third layer has previously been modified to comprise a woven material; see the discussion of claim 11, above) and the grain direction of the woven materials of each of the first, second and third layers is rotated by about 10 to 30 degrees relative to each other (Elkins has previously been modified to optimize the relative grain orientations of the different layers, see the discussion of claim 11, above).
Regarding claim 22, Elkins, as modified, further teaches wherein the grain direction of the second layer is offset in a counterclockwise direction from the grain direction of the first layer, wherein the grain direction of the third layer is offset in a clockwise direction from the grain direction of the second layer (Elkins has previously been modified to optimize the relative grain orientations of the different layers, see the discussion of claim 11, above).
Regarding claim 23, Elkins, as modified, further teaches wherein the grain direction of the second layer is offset in a counterclockwise direction by about 10 to 30 degrees from the grain direction of the first layer, wherein the grain direction of the third layer is offset in a clockwise direction by about 10 to 30 degrees from the grain direction of the second layer (Elkins has previously been modified to optimize the relative grain orientations of the different layers, see the discussion of claim 11, above).
Regarding claim 24, Elkins, as modified, further teaches wherein the first, second, and third layer are composed of a woven material (Par. 31, “The second layer 108 may be constructed in a manner that is similar using two or three plies on each side. Nylon having a woven two-hundred denier rating is suitable for the fabric of the first and second layers 106 and 108.”; further the material of the third layer has previously been modified to comprise a woven material; see the discussion of claim 11, above).
Regarding claim 25, Elkins, as modified, further teaches wherein the woven material of each of the first, second and third layers is laminated with a polymer material (Par. 31, ‘The first layer 106, the second layer 108, and the third layer 116 may be constructed of a laminate having a fabric and one or more coatings of a material that can be heat welded for making a seal’).
Regarding claim 26, Elkins, as modified, further teaches wherein the woven material comprises a nylon material (Par. 31, ‘Nylon having a woven two-hundred denier rating is suitable for the fabric of the first and second layers 106 and 108 […] Preferably, the fabric for the third layer 116 is a stretchable nylon’).
Regarding claim 27, Elkins, as modified, further teaches a fluid source fluidly coupled to the fluid bladder and a gas source fluidly coupled to the inflatable bladder (Abstract, ‘The flowing liquid and the pressurized air enter and exit the splint directly into the liquid and air bladders through planar ports. The control unit includes a liquid circuit for providing the flowing fluid at a controlled temperature and an air circuit for providing the pressurized air.’).
Regarding claim 28, Elkins, as modified, further teaches a fastening element coupled between a front side and a back side of the heat transfer device (Elkins has previously been modified in view of Zacoi to comprise a pouch with fastening elements; see Zacoi, fig. 18, the back side of straps 196/198 comprises hook tabs 192 and communicate with the front side of envelope 122).
Regarding claim 29, Elkins, as modified, further teaches wherein the front side having a hook portion which forms the hook portion of a hook and loop fastening element, and the back side having a loop portion which forms the loop portion of the hook and loop fastening element of the apparatus (Elkins has previously been modified in view of Zacoi to comprise a pouch with fastening elements; see Zacoi, col. 14, lines 35-37, “The outside surface 64 of each support envelope 60R, 60L may be formed of a polypropylene or other foam material with a loop material laminated thereon”; see Zacoi, fig. 16, hook tabs 192; further the relative locations of the loop and hook materials have previously been modified; see the discussion of claim 19, above).
Terminal Disclaimer
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,013,635 in view of Zacoi. Although the claims at issue are not identical, they are not patentably distinct from each other, as illustrated by the comparison below.
Application claim 11
Patent Claim 1 (Note the patent claim limitations are reorder to align with the application claims)
11. A therapy apparatus for treatment of an animate body comprising:
a heat transfer device comprising a fluid bladder adapted to circulate a coolant to transfer heat between the device and the animate body, and
an inflatable bladder adapted to apply compressive force to the animate body,
the fluid bladder formed by a first and second layer and the inflatable bladder formed by a third layer and sharing the second layer with the fluid bladder,
wherein the heat transfer device has perimeter that defines an inwardly curved portion forming a first edge of an adjacent flap; and
a pouch adapted to reversibly receive the heat transfer device, the pouch having a second perimeter corresponding to a shape of the perimeter of the heat transfer device such that the flap of the heat transfer device is reversibly received within a
corresponding flap of the pouch,
wherein the first, second, and third layers are formed of a woven material and a grain direction of each of the first, second and third layers is rotated relative to each other.
1. A system for treatment of differently sized animate body parts, comprising:
a heat transfer device comprising a fluid bladder for circulating a fluid and
an inflatable bladder for pressurization to apply a compressive force,
the fluid bladder formed by a first and second layer and the inflatable bladder formed by a third layer and sharing the second layer with the fluid bladder,
‘a first modular member forming an internal pouch adapted to receive the heat transfer device within the first modular member, the pouch of the first modular member having a perimeter, a back side of the first modular member including a pouch opening extending between a top edge and a bottom edge of the first modular member for accessing the pouch and a fastener for releasably closing the opening, the bottom edge including a port opening, where the pouch opening extends from a lateral end of the port opening such that when the heat transfer device is received within the internal pouch of the first modular member at least a portion of the connection port extends through the port opening;’
‘where the first, second, and third layer are composed of a woven material and a grain direction of each of the first, second, and third layers is rotated relative to each other’
a connection port in communication with the fluid bladder and the inflatable bladder;
and
a second modular member forming an internal pouch adapted to receive the heat transfer device within the second modular member, the pouch of the second modular member having a perimeter,
wherein the second modular member pouch has the same configuration and size as the first modular member pouch,
wherein the heat transfer device is slidably movable within the pouches of the first modular member and second modular member when the pouches are closed such that the position of the heat transfer device relative to the perimeter of the pouches of the first modular member and second modular member is capable of slidably changing while providing access to the connection port when the fluid bladder of the heat transfer device is filled with a heat transfer fluid or when the inflatable bladder of the heat transfer device is pressurized,
wherein the pouches of the first modular member and second modular member are oversized relative to the heat transfer device by an amount sufficient to allow the position of the fluid bladder and the inflatable bladder of the heat transfer device to slidably change to maintain fluid circulation in the fluid bladder and pressurization in the inflatable bladder, and
wherein the first and second modular member are configured for wrapping to differently sized body parts, an overall perimeter of the second modular member is greater than an overall perimeter of the first modular member.
As can be seen from the comparison, above, the only application claim feature not explicitly taught by the patent claim is related to the inwardly curved portion of the heat transfer device forming the first edge of a flap which is reversibly received by a corresponding portion of the pouch. However, as discussed, above these features are seen to be obvious over Zacoi.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 12/11/25, with respect to the rejection(s) of claim(s) 11-29 under 35 USC 112(a) 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 under 35 U.S.C. 103(a) based on the combination of Elkins in view of Zacoi, as discussed above.
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
Prosecution Insights