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 .
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.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities: These claims recite “at least one subset of the tabs” and should recite --at least one subset of the one or more tabs--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 7-11, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0155341 A1 to Voorhees et al. (Voorhees) in view of US 2014/0222121 A1 to Spence et al. (Spence).
Regarding claim 1, Voorhees teaches a medical pad (medical pad 10) for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient (abstract which states in part “An improved medical pad for contact thermal exchange with a patient includes a fluid circulation layer for containing a thermal exchange fluid circulatable therethrough…”), the pad comprising a fluid containing layer ([0032] which states in part “the pad 10 may include a flexible base member 14 and a flexible film layer 15 that are interconnected to define the fluid circulation layer of the pad 10.”), comprising a channel structure ([0035] which states in part “the fluid circulation layer may comprise one or a plurality of fluid channels to direct fluid flow between the inlet port 12a and outlet port 12b.”), and a film (flexible film layer 15) disposed across an underside of the channel structure (Fig. 2), the film sealably coupled with the channel structure to form a flow path for the TTM fluid ([0035] which states in part “the base member 14 may include one or a plurality of rib members 14a that project from a base portion 14d and are interconnected to the film layer 15. The fluid channels may extend between adjacent rib members 14a and/or between sealed edges of the pad 10 and/or between rib members 14a and sealed edges of the pad 10.”), a hydrogel layer (flexible hydrogel layer 16) disposed across the underside of the film (Fig. 2), the hydrogel layer defining a thermal coupling ([0032] which states in part “the hydrogel layer 16 provides for thermal conduction between the circulated thermal exchange fluid and a patient…”), and an adhesive ([0032] which states in part “the hydrogel layer 16 provides….and further presents an adhesive surface 16a to establish and maintain intimate contact with a skin region of a patient so as to optimize thermal exchange.”) for adhering the fluid containing layer to the patient’s skin.
However, Voorhees does not teach a plurality of openings extending between a topside of the channel structure and an underside of the film or wherein the pad is configured to increase in length in at least one direction so that, in use, the pad increases in length together with an increase in length of the patient’s skin.
Spence teaches an analogous device (title “Athletic Cooling and Heating Systems, Devices and Methods”) to that of Voorhees as well as a plurality of openings (see for example Fig. 8B) extending between a topside of the structure and an underside of the structure ([0087] which states that “The opening 156 in the pad 150 allows for expansion and contraction of the pad 150 in three dimensions so that the pad can adapt to different sizes of individual users.” and [0088] which states in part “thermal pad 160 showing how additional openings 162a, 162b, 162c, e.g., slits, in the pad 160 may be useful for creating a more precise fluid flow pattern. This can additionally ensure good flow and cooling and/or heating to all areas of the pad 160, as well as additional freedom for expansion and conformity to different shapes and sizes of individual users.”). The openings of Spence will stretch and compress to adapt to different sizes of individuals ([0087-0088]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Voorhees to include the plurality of openings as taught by Spence to allow for adapting to different sizes of individuals as taught by Spence ([0087-0088]).
Regarding claim 2, the combination teaches the pad of claim 1 as well as Voorhees teaching wherein the hydrogel layer comprises an ultraviolet light-cured composition ([0039] which states in part “The hydrogel layer 16 may comprise an ultraviolet light-cured composition…”) that includes a cross-linking copolymer in an amount between about 15% to 30% by weight of the composition ([0039]), water in an amount of between about 15% to 40% by weight of the composition ([0039]), and glycerol in an amount of between about 25% to 35% by weight of the composition ([0039]).
Regarding claim 7, the combination teaches the pad of claim 1 as well as an inlet port (inlet port 12a) in fluid communication with a first end of the flow path ([0032]), and an outlet port (outlet port 12b) in fluid communication with a second end of the flow path ([0032]).
Regarding claim 8, the combination teaches the pad of claim 1 as well as Spence teaching wherein the expansion of the pad includes an increase of at least one dimension of one or more openings ([0087-0088]).
Regarding claim 9, the combination teaches the pad of claim 8 as well as Spence teaching wherein the openings include fissures (Fig. 8B) extending inward from a perimeter edge of the pad, and across a portion of the pad (Fig. 8B).
Regarding claim 10, the combination teaches the pad of claim 9 as well as Spence teaching wherein the openings include a first subset of fissures (Fig. 8B) extending inward from a first perimeter edge of the pad and a second subset of fissures (Fig. 8) extending inward from a second perimeter edge of the pad, the second perimeter being opposite the first perimeter (Fig. 8).
Regarding claim 11, the combination teaches the pad of claim 10 as well as Spence teaching wherein the first subset of fissures and second subset of fissures are disposed in an alternating arrangement (Fig. 8B).
Regarding claim 17, the combination teaches the pad of claim 1, as well as Spence teaching a jacket or shirt (18) configuration, but not wherein the pad defines a vest configured to extend around a torso. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the pad of whatever form or shape was desired or expedient. A change in size of shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Regarding claim 18, Voorhees teaches a targeted temperature management system (title “Medical Pad and System for Thermotherapy”) comprising a system module (100) configured for preparation and delivery of the TTM fluid )[0047-0050]) and a medical pad (pad 10) fluidly coupled with the system module (Fig. 5), but not specifically the medical pad of claim 1. Claim 1 is addressed above with respect to Voorhees as modified by Spence and as set forth above it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Voorhees to include the plurality of openings as taught by Spence to allow for adapting to different sizes of individuals as taught by Spence ([0087-0088]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Voorhees to include the medical pad of claim 1 to allow for adapting to different sizes of individuals as taught by Spence.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees and Spence as applied to claim 1 above, and further in view of US 2016/0165972 A1 to Michalak (Michalak).
Regarding claims 3 and 4, Voorhees in view of Spence teaches the pad of claim 1, but not one or more tabs coupled with the fluid containing layer, the tabs extending outwardly from one or more perimeter edges of the pad or wherein each tab is coupled with the fluid containing layer so that a lifting force applied to the tab causes a separation of a proximate portion of the pad from the patient. Michalak teaches an analogous pad (pad 10) to that of Voorhees including a tab (60) coupled to an adhesive pad (10) that is free from adhesive and designed to facilitate the removal of the pad from the user ([0021]). Michalak teaches that the user simply pulls the tab (60) out and away from the user, providing for the pad (10) to be peeled off the face of the user quickly and easily. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Voorhees to include the tab (60) of Michalak to allow for simple removal of an adhesive pad quickly and easily as taught by Michalak ([0021]).
Regarding claim 5, the combination teaches the pad of claim 3 as well as Michalak teaching wherein at least a subset of the one or more tabs are formed of a resilient material (Michalak teaches a material that is pull and therefore resilience of that material is inherent. Additionally, it is noted that all materials have some inherent resiliency.) and include a portion extending inward from a perimeter edge (Fig. 1).
Regarding claim 6, the combination teaches the pad of claim 3, but not specifically wherein at least a subset of the one or more tabs are formed of an outward extension of the channel structure. It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have located the tabs since it has been held that rearranging parts of an invention involves only routine skill in the art.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees and Spence as applied to claim 9 above, and further in view of US 8,460,352 B2 to DeMore et al. (DeMore).
Regarding claim 12, Voorhees in view of Spence teaches the pad of claim 9, but not an extendable material disposed within each fissure, wherein the extendable material is coupled across the fissure from a first side to a second side opposite the first side and is configured to allow a widening of the fissure in accordance with the expansion of the pad. DeMore teaches an analogous device (title “Site-Specific Pad with Notch”) to that of Voorhees and Spence including a slot (15) that allows the therapy pad (10) to fit various body types ([0039] which states in part “Therapeutic slot 15 provides a distinct advantage to therapy pad 10….in that it allows therapy pad 10 to fit various body types….If a user is a larger person, first section 60 and second section 70 may be kept apparat by applying therapy pad 10 with therapeutic slot 15 in a substantially open position. Alternatively, a smaller person may wear therapy pad 10 with therapeutic slot 15 in a substantially closed position…”). The slot (15) of DeMore comprises an extendable material (flexible member 20) disposed within the slot (Fig. 1), wherein the extendable material is coupled across the slot from a first side to a second opposite side (Fig. 1) and is configured to allow widening of the slot in accordance with the expansion of the pad ([0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the extendable material (flexible member 20) of DeMore in the pad of Voorhees as modified by Spence, to allow the pad to be held in an open position when under tension but help the pad contract after the tension is released as taught by DeMore ([0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the extendable material of DeMore in the pad pf Voorhees as modified by Spence to allow expansion under tension and contraction when tension is released allowing the device to return to a smaller size as taught by DeMore.
Regarding claim 13, the combination teaches the pad of claim 12 as well as DeMore teaching wherein the extendable material (flexible member 20) may be formed of stretchable fabric, flexible plastic or elastic, but not specifically wherein the extendable material includes a rubber, a woven elasticated material, or a neoprene. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used a rubber, a woven elasticated material, or a neoprene, 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.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees and Spence as applied to claim 14 above, and further in view of US 2023/0310206 A1 to Dabrowiak (Dabrowiak).
Regarding claim 14, Voorhees in view Spence teaches the pad of claim 1, but not wherein the channel structure includes a series of interconnected channel segments forming a lattice arrangement. Dabrowiak teaches an analogous pad (title “Systems, Devices and Garments for Surface temperature Therapy of a Patient”) to that of Voorhees and Spence where the pad includes a channel structure includes a series of interconnected channel segments forming a lattice arrangement (Fig. 1A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Voorhees as modified by Spence to have the knit pattern of a plurality of tubes to allow for enhanced conformability and stretchability in a first dimension and a second dimension as taught by Dabrowiak ([0030]).
Regarding claim 15, the combination teaches the pad of claim 14, but not wherein the openings include apertures, each aperture having a circumferential perimeter defined by three or more channel segments. Dabrowiak teaches an analogous pad (title “Systems, Devices and Garments for Surface temperature Therapy of a Patient”) to that of Voorhees and Spence where the pad includes aperture (Fig. 1A) having a circumferential perimeter defined by three or more channel segments (Fig. 1A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Voorhees as modified by Spence to have the knit pattern of a plurality of tubes to allow for enhanced conformability and stretchability in a first dimension and a second dimension as taught by Dabrowiak ([0030]).
Regarding claim 16, the combination teaches the pad of claim 15, but not specifically wherein one or more apertures define one of a rhomboid, square, rectangular, hexagonal, or polygonal shape. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the aperture of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794