DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 11-14 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. Claim 11 does not positively recite a garment which includes a pocket. The metes and bounds of the claim are unclear. It is unclear if the claims at hand are claiming a heat pack or a garment system comprising a heat pack. For the purposes of examination, claims 11-14 will be interpreted as functional limitations and the claims being drawn to a heat pack that can be used with a garment.
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) 1-3 and 5-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Beisang et al. (US 4,596,250) in view of Strom (WO 2020/025123).
Beisang discloses a moldable cooling/heating pack comprising; a sealed silicone envelope having an outside perimeter and an inside perimeter (Fig. 2, element 8; Col. 4, line 6-8. Beisang discloses the outer layer 8 is comprised of silicone rubber and the cross section clearly defines and outer perimeter and inner perimeter of layer 8), an infill contained in the envelope (Fig. 2, 16), the infill comprising a phase change material for providing a temperature over a period of time (Col. 6, lines 25-39).
Beisang fails to disclose the heat pack silicone envelope is externally seamless and is adapted to protect against ruptures. Strom teaches that it is well known in the field of thermal therapies and specifically thermal applicators to have a seamless external surface as set forth in Pg 3, line 1-2, for providing a pleasant experience for the user (i.e. no rubbing irritation with a seam). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Beisang with modifying the heat pack silicone envelope so that it is externally seamless since such a modification would provide for a pleasant experience for the user (i.e. no rubbing irritation with a seam). Examiner notes, the claim limitation “adapted to protect against ruptures” is an attempt to define the invention by function and not be what the invention actually is. This claim limitation is being interpreted as any seamless heat pack envelope that is seamless would also protect against ruptures since a seamless design would reduce the likelihood of the heat pack envelope becoming snagged or wear on the seam itself that could cause rupture over time.
With regard to claim 2, Beisang discloses the silicone envelope comprises at least one of a reinforcing fabric or fiber (e.g. Beisang discloses additional layers of the heat pack, layers 10, 11, and 12, any of which can be considered to be a reinforcing fabric/fiber since the additional layers add material, additionally layers are also disclosed to be comprised of metal (layers 10 and 11). Lastly, layers 11 and 12 act as insulation layers which can be interpreted as reinforcing the device by reflecting radiant heat/cold from the device and to the patient. The claims do not specify what type of reinforcement is being provided for so thermal reinforcement would meet the claim as written).
With regard to claim 3, Beisang discloses the silicone envelope is seamless (see Fig. 2, outer envelope of layer 8 shows no seems, additionally Beisang discloses the pack can be shaped to any shape/size and is conformable to the body for it intended use, therefore that would inherently include seamless shapes such as spherical shapes).
With regard to claims 5-6, Beisang discloses the phase change material comprises liquid to solid phase change material and the phase change material temperature range provides heat (e.g. Beisang discloses use of paraffin wax, specifically paraffin c15-16. Col. 6, line 30).
With regard to claims 7-10, Beisang in view of Strom discloses the invention as claimed but fails to explicitly teach the phase change material being an organic wax, the organic wax being one of beeswax, soy wax, carnauba wax, and pine resin, the infill comprising an essential oil, the essential oil at least one castor oil, mint oil, vegetable oil. Beisang already discloses the phase change material can be paraffin wax but it is silent to whether paraffin wax is an organic wax. It would have been obvious to one of ordinary skill in the art to modify Beisang with using an organic wax, the organic wax being one of beeswax, soy wax, and pine resin, the infill comprising an essential oil, the essential oil being one of castor oil, mint oil or vegetable oil, since it has been held that where the general conditions of a claim are met, it is within the level of ordinary skill to select a known material on the basis of its suitability for its intended purpose (In re Leshin 277 F.2d 197, 125 USPQ 416, see MPEP 2144.07).
With regard to claims 11-14, Beisang’s disclosed heat pack would be capable of being housed within a garment pocket, it would also be capable of being housed within a pocket having a layered insulating texture, it would be capable of being housed in a garment that has a plurality of pockets, and lastly it would be capable of being housed in a garment to apply heat to a user’s abdomen and lower back. As discussed above with respect to the 112b rejections, the claims are being interpreted as not positively reciting a garment and being drawn to a heat pack, so the current claims only require the heat pack to meet the claimed functions. Additionally, it is worth noting that in this particular technology field, it is well known to integrate hot/cold packs into garment systems. CPC classification A61F2007/0233 is specifically designated for heating/cooling devices connected to the body via pockets for receiving packs or pouches.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beisang in view of Strom as applied above, further in view of Brooks (US 20160299543).
Beisang in view of Strom discloses the invention as claimed but fails to teach the envelope inside perimeter comprises a branching pattern. Beisang discloses that the envelope can be prepared by dip or spray coating layer 8 onto the device. Brooks teaches that it is well known to select between a non-exhaustive list of methods for forming a silicone thermal management device such as compression molding, extrusion, ram extrusion, injection molding, extrusion, co-extrusion, rotational molding, blow molding, injection blow molding, thermoforming, vacuum forming, casting, solution casting, centrifugal casting, overmolding, resin transfer molding, vacuum assisted resin transfer molding, spinning, printing, etc. It would have been obvious to one having ordinary skill in the art to modify Beisang in view of Strom with selecting between any known silicone application/forming technique including the techniques taught by Brooks, since Brooks teaches that these are all known equivalents. Additionally, as to the specifically claimed branching structure, Applicant has indicated that this branching structure is a product of the injection molding process and therefor the selection of the injection molding process listed by Brooks would also necessarily result in a similar branched structure.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to select a branched structure for the interior perimeter of the envelope in order to provide the predictable results of forming a thin surface while maintaining structural integrity of the envelope for its intended use.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beisang in view of Strom as applied above, further in view of Kang (US 20130085553).
Beisang in view of Strom discloses the invention as claimed including heating the heat pack device (Beisang discloses a similar phase change heat pack and due to the heating mechanism being a phase change material the phase change material and pack would necessarily have to be pre-heated before use), the heat pack device comprising a phase change material and the heating creating a phase change of the phase change material (as discussed above the heat pack of Beisang uses a phase change material such as paraffin wax which would undergo a phase change when heated, which is the same type of phase change material claimed by applicant above).
Beisang in view of Strom fails to disclose placing the heat pack in a pocket of a garment and placing the garment on a user to position the heat pack device in contact with a user. Kang teaches that it is known to place a heating device in a pocket of a garment and placing the garment on a user to position the device in contact with a user (e.g. Fig. 2 shows heating device 120 is inserted into pocket 118 of the garment belt and the garment belt is then applied to the user to bring heating device 120 into contact with the user, see also paragraph 35).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Beisang in view of Strom with placing the heat pack in a pocket of a garment and placing the garment on a user to position the heat pack device in contact with a user since it would provide the predictable results of adapting the heat pack for use to target and treat a specific region of the body in a known manner.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beisang in view Strom and Kang as applied above, further in view of Altshuler (US 20030100936).
With regard to claim 16, Beisang in view of Strom and Kang disclose the invention as claimed but is silent to the method of heating the heat pack being at least one of; immersing the device in boiling water, microwaving the device, placing the device in an oven, heating the device with an electrical element.
Altshuler teaches that it is known to heat a phase change material for providing thermotherapy to a user prior to use, and the means for heating being heated in an oven, boiling water, or microwave (see paragraph 36). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the invention of Beisang in view of Strom and Kang with heating the device in any of an over, boiling water, or microwave since Altshuler teaches that these are all known equivalents for heating phase change materials for thermotherapy and the selection of any of these known techniques would be within the level of ordinary skill in the art.
With regard to claim 17, Beisang in view of Strom and Kang and Altshuler disclose the invention as claimed but fail to explicitly teach the steps of rolling the device into a compact size and adding boiling water to a vessel with the device to heat the heat pack. The rejection of claim 16 already sets forth that it would be obvious to heat the heat pack within boiling water. The specific steps of rolling the device into a compact size and adding/pouring over the device the boiling water would have been obvious to one of ordinary skill in the art at the time the invention was made since these steps are either inherent or plainly obvious. A user must be able to place the heat pack device within a vessel in order for it to be warmed with boiling water and the physical manipulation of bending, folding, rolling etc. would be necessary. Additionally, while it is possible to place the device in a vessel and then add water and bring it all to a boil at once, the alternative method of adding boiling water over the top of the device within the vessel is also an obvious variant for Altshulers teaching of warming the device in boiling water. In short, there exists only two possible ways to warm the device in boiling water, either boiling the water with the device or adding separately boiled water to the vessel with the device in it. One of ordinary skill in the art would certainly be able to select either of these known techniques.
Response to Arguments
Applicant’s arguments, see Remarks, filed 8/7/2025, with respect to the rejection(s) of claim(s) 1-17 under Beisang 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 Beisang in view of Strom necessitated by amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794