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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-25) in the reply filed on 6/22/2026 is acknowledged.
Applicant’s election without traverse of Species 1A (gel pack being a cold therapy pack) in the reply filed on 6/22/206 is acknowledged.
Applicant’s election without traverse of Species 2A (Fig. 1-2B) in the reply filed on 6/22/2026 is acknowledged.
Applicant’s election without traverse of Species 3B (silicone tape) in the reply filed on 6/22/2026 is acknowledged. Examiner notes this selection was only required for embodiments that would have dressing or silicone tape provided. With Applicant’s selection of Species 2A (Fig. 1-2B) above which uses closures 5 and not silicone tape or dressing pads for attachment, the selection here isn’t relevant. Unelected species relating to Fig. 21-29 are the embodiments having a dressing pad or silicone tape.
Claim 26 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claim 27 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 3, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claim 16 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, elected Species 2A does not use a dressing pad on the gel pack as disclosed, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claim 17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 2, the elected Species 2A being drawn to a human leg and not for application to an animal, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claim 18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, elected Species 2A does not use silicone tape sheet on the gel pack as disclosed, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claim 19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, elected Species 2A is not designed to fit into a pocket, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claims 20-25 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, elected Species 2A does not comprise medical adhesive on the gel pack, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/2026.
Claims 16-27 thus withdrawn, claims 1-15 examined.
Examiner notes that Applicant’s election of being a cold therapy pack (Species 1A) thus means where claims recite “cold or heat therapy pack” for example this will be thus only interpreted as “cold therapy pack”.
Examiner notes that Applicant’s election of Species 2A being drawn to a therapy pack for a human leg means where claims recite “animal or human” will be examined only as “human”.
Claim Objections
Claims 1, 4-5, 7 objected to because of the following informalities:
Claim 1 line 2 recites “A gel material” should be -a gel material-.
The line spacing between claims 4 and 5 contains a misplaced parenthesis (“(“).
Claim 5 line 1 “the width” should be -a width-.
Clam 5 line 2 “the length” should be -a length-.
Claim 7 line 1 “the thickness” should be -a thickness-.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 14-15 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 14 recites “the gel pack is secured to the anatomical area or body part of the human or animal user with” wherein this is positively reciting the human organism as recited as part of the structure of the invention and should be more concretely written as functional language. Examiner suggests -the gel pack is configured to be secured to the anatomical area or body part of the human or animal user with-.
Claim 15 is rejected as being dependent on claim 14.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 8-9, 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brodsky (US 5129391 A).
Regarding claim 1, Brodsky discloses a gel pack 110 (Abstract, Fig. 11) comprising:
a gel material 20 (Col. 3 lines 35-41, gel 20), and
a shell material 110 enclosing the gel material 20 (Col. 3 lines 1-12, panel 10 being a shell material containing the gel 20; Col. 7 lines 5-20, panel 110 fabricated the same as panel 10),
wherein the gel pack is a cold or heat therapy pack (Col. 1 lines 1-12, invention is a cold pack) that includes at least one void area 16/112 free of the gel material 20 (Fig. 11 and Col. 3 lines 12-36, baffle seams 16 form void areas free of gel material in the shell 10, as well as voids 112A/112B in Fig. 11),
wherein the at least one void area 16/112 provides the gel pack with flexibility that allows the gel pack to closely conform to an anatomical area or body part of a human or animal user (Fig. 1-4 and Col. 3 lines 12-36, baffle seams/voids 16/112 provide “give” in the panel/shell 10 being flexibility and would enable easy folding along such seams enabling easy conforming of the gel pack to the human user; Col. 4 lines 20-26, gel pack can conform; voids/openings 112 in Fig. 11 would enable conforming to eyes of the face of the user as well).
Regarding claim 2, Brodsky discloses the invention of claim 1 above.
Brodsky further discloses wherein the at least one void area 16/112 (Fig. 11) comprises linear voids 16 (Fig. 11).
Regarding claim 3, Brodsky discloses the invention of claim 1 above.
Brodsky further discloses wherein the at least one void area 16/112 comprises non-linear voids 112A/112B (Fig. 11).
Regarding claim 4, Brodsky discloses the invention of claim 1 above.
Brodsky further discloses wherein the at least one void area 16/112 comprises a combination of linear (16) and non-linear (112A/112B) voids (Fig. 11).
Regarding claim 8, Brodsky discloses the invention of claim 1 above.
Brodsky further discloses wherein the gel material is a gel comprising a thickening agent, water, and an anti-freezing agent (Col. 3 Lines 35-45, gel 20 is formed of a thickening agent being hydroxyethyl cellulose collosize resin; water; and an anti-freezing agent being sodium chloride).
Regarding claim 9, Brodsky discloses the invention of claim 8 above.
Brodsky further discloses wherein the thickening agent is selected from the group consisting of carboxymethyl cellulose, hydroxyethyl cellulose, sodium polyacrylate silica gel, and combinations thereof (Col. 3 Lines 35-45, gel 20 is formed of a thickening agent being hydroxyethyl cellulose collosize resin).
Regarding claim 14, Brodsky discloses the invention of claim 1 above.
Brodsky further discloses wherein the gel pack 110 is secured to the anatomical area or body part of the human or animal user with at least one set of closures 120A/120B (Fig. 11 Col. 7 lines 5-20, fasteners 120 are a set of closures to attach to the human body).
Regarding claim 15, Brodsky discloses the invention of claim 14 above.
Brodsky further discloses wherein the at least one set of closures 120A/120B (Fig. 11) are selected from the group consisting of hook and loop closures, buckle closures, strap closures, adhesive closures, and combinations thereof (Col. 7 lines 5-40, closures 120A/120B are hook and loop closures on strap closures, Fig. 11).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodsky (US 5129391 A).
Regarding claim 5, Brodsky discloses the invention of claim 1 above.
Brodsky does teach the at least one void area 16 has a length that is greater than its width (Figure 1 shows that the seams 16 are elongated with a small width).
Brodsky does not disclose wherein the width of the at least one void area will range from 1-5 mm and the length of the at least one void area will range from 2-10 cm.
However, the present application fails to provide any criticality towards these specific measurements providing unexpected results or significant function for the void areas that would be different in resulting function from the void areas 16 of Brodsky (instant app [0064-0065]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to produce a void area with a width ranging from 1-5 mm and a length ranging from 2-10 cm as changes in shape and size have been held to be a matter of design choice absent persuasive evidence that the particular configuration of the claimed shape was significant. See MPEP 2144(IV)(B) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); and “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
The motivation for doing so would have been to provide a void a length and width that would allow the gel pack to bend but to still provide a majority of the surface area of the pack with cooling medium. Additionally, the motivation would have been to provide the voids in a shape and size that would allow the gel pack to contour around a particular body area, for example, to provide elongated voids that would allow the pack to curve around the arm or leg of a user
Regarding claim 6, Brodsky discloses the invention of claim 1 above.
Brodsky does not disclose wherein the shell material has a thickness of 1-2 mm without the gel material.
However, the present application fails to provide any criticality towards these specific measurements of the shell material providing unexpected results or significance for the shell that would be different in resulting function from the shell 10/110 of Brodsky (instant app [0064-0065]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to produce a shell material has a thickness of 1-2 mm without the gel material as changes in shape and size have been held to be a matter of design choice absent persuasive evidence that the particular configuration of the claimed shape was significant. See MPEP 2144(IV)(B) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); and “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
The motivation for doing so would have been to select a thickness for the shell material that would be sufficient to prevent leaks and cracks over time while still allowing the gel pack to bend and flex around a user's body.
Regarding claim 7, Brodsky discloses the invention of claim 1 above.
Brodsky does not disclose wherein the thickness of the cold or heat therapy pack when filled with the gel material is 5-10 mm.
However, the present application fails to provide any criticality towards these specific measurements of the thickness of the gel pack providing unexpected results or significance for the gel pack that would be different in resulting function from the gel pack thickness of Brodsky (instant app [0064-0065]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to produce a thickness of the cold or heat therapy pack when filled with the gel material is 5-10 mm as changes in shape and size have been held to be a matter of design choice absent persuasive evidence that the particular configuration of the claimed shape was significant. See MPEP 2144(IV)(B) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); and “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
The motivation for doing so would have been to select a thickness for the gel pack that would provide a sufficient amount of gel to cool the area while still allowing the gel pack to bend and flex to fit a user's body.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodsky (US 5129391 A) in view of Liu (US 20100028965 A1).
Regarding claim 10, Brodsky discloses the invention of claim 8 above.
Brodsky does not disclose wherein the anti-freezing agent is selected from the group consisting of tri-methylene glycol, diethylene glycol, ethylene glycol, propylene glycol, butanediol, glycerol, and combinations thereof.
However, Liu teaches 1,3-propanediol (which is tri-methylene glycol) is a known anti-freeze agent (see [0008]), which can be obtained from organic materials such as vegetable oils and animal fat (Fig. 1 and [0016] Liu provides a method of obtaining from glycerol).
Examiner further notes that there is no specific criticality to the choice of anti-freeze being used in the gel pack outside of mere recitation of being an anti-freeze material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have chosen the anti-freeze agent of sodium chloride of Brodsky to be 1,3-propanediol (which is tri-methylene glycol) as taught by Liu as an alternative known anti-freeze which is obtainable from organic materials in increasing amounts for thus being a cheap anti-freeze material (Fig. 1 and [0007-0008, 0016]).
Claim(s) 10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodsky (US 5129391 A) in view of Fan (US 20190269548 A1).
Regarding claim 10, Brodsky discloses the invention of claim 8 above.
Brodsky does not disclose wherein the anti-freezing agent is selected from the group consisting of tri-methylene glycol, diethylene glycol, ethylene glycol, propylene glycol, butanediol, glycerol, and combinations thereof.
Examiner further notes that there is no specific criticality to the choice of anti-freeze being used in the gel pack outside of mere recitation of being an anti-freeze material.
However, Fan teaches an analogous gel thermal pack (Abstract) having anti-freeze agent which may be propylene glycol or glycerin (see [0096]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have chosen the anti-freeze agent of sodium chloride of Brodsky to be propylene glycol or glycerin as known anti-freeze materials to use as taught by Fan for enabling the pack to not freeze and increase comfort in use (Fan [0096]).
Regarding claim 12, Brodsky discloses the invention of claim 1 above.
Brodsky does not disclose wherein the shell material is selected from the group consisting of polypropylene, polyvinyl chloride, polyethylene, polycarbonate, polytetrafluoroethylene, nylon, acrylonitrile butadiene styrene, and combinations thereof.
However, Fan teaches an analogous gel thermal pack (Abstract) having an analogous pack shell 3 ([0044] and Fig. 1), wherein the shell material is selected to be polyvinyl chloride (see [0044]).
Examiner further notes that there is no specific criticality to the choice of shell material used in the gel pack outside of mere recitation of being the material chosen.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have chosen the shell material of Brodsky to be polyvinyl chloride as taught by Fan as a known thermal pack shell material that would provide improved flexibility, durability, and transparent properties (Fan [0044]).
Regarding claim 13, Brodsky discloses the invention of claim 1 above.
Brodsky does not disclose wherein the shell material is polyvinyl chloride.
However, Fan teaches an analogous gel thermal pack (Abstract) having an analogous pack shell 3 ([0044] and Fig. 1), wherein the shell material is selected to be polyvinyl chloride (see [0044]).
Examiner further notes that there is no specific criticality to the choice of shell material used in the gel pack outside of mere recitation of being the material chosen.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have chosen the shell material of Brodsky to be polyvinyl chloride as taught by Fan as a known thermal pack shell material that would provide improved flexibility, durability, and transparent properties (Fan [0044]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodsky (US 5129391 A) in view of Liu (US 20100028965 A1) and Fan (US 20190269548 A1).
Regarding claim 11, Brodsky discloses the invention of claim 8 above.
Brodsky does not disclose wherein the thickening agent is carboxymethyl cellulose and the anti-freezing agent is tri-methylene glycol.
However, Liu teaches 1,3-propanediol (which is tri-methylene glycol) is a known anti-freeze agent (see [0008]), which can be obtained from organic materials such as vegetable oils and animal fat (Fig. 1 and [0016] Liu provides a method of obtaining from glycerol).
Examiner further notes that there is no specific criticality to the choice of anti-freeze being used in the gel pack outside of mere recitation of being an anti-freeze material.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have chosen the anti-freeze agent of sodium chloride of Brodsky to be 1,3-propanediol (which is tri-methylene glycol) as taught by Liu as an alternative known anti-freeze which is obtainable from organic materials in increasing amounts for thus being a cheap anti-freeze material (Fig. 1 and [0007-0008, 0016]).
Brodsky/Liu does not disclose wherein the thickening agent is carboxymethyl cellulose.
Brodsky does disclose the gel 20 contains hydroxyethyl cellulose (Col. 3 Lines 35-45, gel 20 is formed of a thickening agent being hydroxyethyl cellulose collosize resin).
Furthermore, Fan teaches an analogous gel thermal pack (Abstract) having a gel pack having analogous cellulose derivatives contained within ([0019]) wherein carboxymethyl cellulose is a known alternative cellulose derivative used in thermal packs, and also provides hydroxyethyl cellulose as chosen material analogous to Brodsky for analogous thickening agent function (see [0023]).
Examiner further notes that there is no specific criticality to the choice of thickening agent of carboxymethyl cellulose compared to the hydroxyethyl cellulose being used in the gel pack outside of mere recitation of the material itself.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the hydroxyethyl cellulose of Brodsky to be carboxymethyl cellulose as taught by Fan as a known alternative cellulose used in the formation of a thermal pack gel for thickening agent (Fan [0019, 0023]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20090088825 A1
US 20150080827 A1
US 5119812 A
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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