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 .
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 Status
Applicant’s amendments in the response filed on 5/23/2025 has been considered by the Examiner. Currently, claims 1, 6-20 are pending, claims 2-5 are canceled, and claims 1 and 10 have been amended. A complete action on the merits of claims 1, and 6-20 follows below.
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, 6, 8-10, 12-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US 2019/0000664) in view of Angelo (5,119,812) and in further view of Sanker (2011/0208279).
Regarding claim 1, McMahon teaches an eye mask for treating an ocular condition ([0001] This invention relates to dry eye compresses; and more particularly, to a dry eye compress with a heat reflective cover), comprising:
a fabric having a first layer and a second layer opposite the first layer (Fig. 3 moisture therapy compress 100 includes two layers opposite each other since it forms a pocket to receive granules and is stitched at the top edge 101; Claim 1 flexible first shell and flexible outer shell); and
a heat diffusing fill material enclosed between the first and the second layers ([0024] conventional moisture therapy compress 100 includes zeolite granules),
wherein the first layer and the second layer are stitched together substantially along their edges ([0022] Fig. 3 body capping 101 configured to permanently seal a body aperture used to fill the zeolite granules ),
wherein the first section is elongate along a horizontal axis proximal to the top edge of said mask (see annotated Fig. 3 below. In addition, the term section is broad and is not limited to the capping portion 101 and can additionally include portions above the second and third section), and
wherein a second section is configured to be placed over a first eye (see annotated Fig. 3 below),
wherein a third section is configured to be placed over a second eye (see annotated Fig. 3 below)
wherein a fill material is substantially filled within [first and second] sections (Fig. 3)
wherein a bottom edge of the mask is arcuate and comprises an indentation to fit over the bridge of a wearer’s nose (Fig. 4 [0024] A notch 105 is provided at a bottom edge of the compress between the first and second eye portions; the notch is configured to contact and conform about a patient's nose),
wherein the fill material is configured to deliver a moist heat to an ocular surface (Claim 1 the hydrophilic zeolite fill granules are microwave compatible and substantially retain said at least one antimicrobial metal material therein upon multiple exposures to microwave irradiation, but allow repeated absorption and dissipation of moisture to and from the hydrophilic zeolite fill granules).
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While McMahon generally provides for three sections (left and right lobes, and top portion), McMahon does not teach wherein one or more rows of stitch points define three substantially distinct sections in the first layer, wherein a fill material is substantially enclosed within each of the sections and wherein a row of stitch points from said indentation segregates the second section from the third section, and wherein the first section is configured to be placed over the eyebrows and forehead.
However, Angelo teaches a device within the same field of invention wherein one or more rows of stich points define three substantially distinct sections in the first layer and second layer, and wherein the fill material is substantially enclosed within each of the sections, the sections are separated by seams, and the first section can be placed over the eyebrows and forehead (Angelo generally teaches stitches 30 define a plurality of sections that provide for thermal therapy Fig 1 and Fig. 3. While Angelo provides its device can be removably sectioned so that a user targets a desired treatment area, it also teaches its device can be integral; Col 3 line 6. As a result, Angelo provides for an eye mask whereby an area of the device is configured to be placed over the eyebrows and forehead; a portion of Col. 3 lines 57-65. Angelo provides for an area on the top portion of its mask 10 that include elongate arcuate stitched sections filled with filler material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the size of the cover in McMahon such that it is configured to be covered over the eyebrows and forehead as taught Angelo to provide therapy to desired areas on the face. Furthermore, it would have been obvious to include stitch points that define multiple sections or three substantially distinct sections whereby the sections include fill material in order to provide thermal therapy to desired areas on the face. Furthermore, it would have been obvious to have modified the first section in McMahon such that it is arcuate and filled with fill material to provide for the desired therapy across the forehead.
McMahon in view of Angelo does not teach wherein the top edge the first section is arcuate.
However, Sanker teaches a top edge of an eye mask that is arcuate (see annotated Fig. 3 below).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the shape of the top edge so that it is arcuate as a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed object was significant. MPEP 2144.04.
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Regarding claim 6, McMahon in view of Angelo and Sanker teaches the limitations of claim 1 and wherein the fill material comprises a thermally conductive material (McMahon Claim 1 wherein the hydrophilic zeolite fill granules are microwave compatible and substantially retain said at least one antimicrobial metal material therein upon multiple exposures to microwave irradiation).
Regarding claim 8, McMahon in view of Angelo and Sanker teaches the limitations of claim 1 and wherein the eye mask is configured to treat dry eyes (McMahon [0015] The system for moisture therapy can be used to treat dry eye syndrome (DES), meibomian gland dysfunction (MGD), temporomandibular joint disorders (TMJ), sinus pressure, tension, stress, conjunctivitis, sty, and other similar discomforts).
Regarding claim 9, McMahon in view of Angelo teaches the limitations of claim 1 and further comprising an adjustable strap component, wherein the strap component comprises:
a first strap member interposed between the first layer and the second layer along a first side of the mask (strap 102 between the layers of compress 100); and
a second strap member interposed between the first layer and the second layer along a second side of the mask (strap 103 between the layers of compress 100).
McMahon does not teach wherein each strap member includes one or more fastening elements.
However, Sanker teaches a device within the same field of invention (eye thermal therapy) wherein each strap member includes a fastening element (elastic straps 11, and 12 includes left and right Velcro attachment respectively [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a fastening element for each strap since Velcro attachments are well known and widely used fasteners in the art and provide for strap adjustment.
Regarding claim 10, McMahon teaches an eye mask for treating an ocular condition ([0001] This invention relates to dry eye compresses; and more particularly, to a dry eye compress with a heat reflective cover), comprising:
(A) a cover (200), the cover having a fabric comprising:
a first layer;
a second layer, wherein the first layer and the second layer are stitched together substantially along their edges (first and second layers are stitched along the edges, Fig. 1); and
a pocket formed between the first layer and the second layer (the cover includes an opening that is configured to receive a compress); and
(B) an insert, wherein the insert is configured for placement within the pocket (100),
wherein the first section is elongate along a horizontal axis proximal to the top edge of said mask (see annotated Fig. 3 above ), and
wherein a second section is configured to be placed over a first eye (see annotated Fig. 3 above),
wherein a third section is configured to be placed over a second eye (see annotated Fig. 3 above)
wherein a fill material is substantially filled within [first and second] sections (Fig. 3)
wherein a bottom edge of the mask is arcuate and comprises an indentation to fit over the bridge of a wearer’s nose (Fig. 4 [0024] A notch 105 is provided at a bottom edge of the compress between the first and second eye portions; the notch is configured to contact and conform about a patient's nose),
wherein the inset comprises a heat diffusing fill material ([0024] conventional moisture therapy compress 100 which includes zeolite granules is configured to be received by opening 201), and
wherein the fill material is configured to deliver a moist heat to an ocular surface (Claim 1 the hydrophilic zeolite fill granules are microwave compatible and substantially retain said at least one antimicrobial metal material therein upon multiple exposures to microwave irradiation, but allow repeated absorption and dissipation of moisture to and from the hydrophilic zeolite fill granules).
While McMahon generally provides for three sections (left and right lobes, and top portion), McMahon does not teach wherein one or more rows of stitch points define three substantially distinct sections in the first layer, wherein a fill material is substantially enclosed within each of the sections and wherein a row of stitch points from said indentation segregates the second section from the third section.
However, Angelo teaches a device within the same field of invention wherein one or more rows of stich points define three substantially distinct sections in the first layer and second layer, and wherein the fill material is substantially enclosed within each of the sections, the sections are separated by seams, and the first section can be placed over the eyebrows and forehead (Angelo generally teaches stitches 30 define a plurality of sections that provide for thermal therapy Fig 1 and Fig. 3. While Angelo provides its device can be removably sectioned so that a user targets a desired treatment area, it also teaches its device can be integral; Col 3 line 6. As a result, Angelo provides for an eye mask whereby an area of the device is configured to be placed over the eyebrows and forehead; a portion of Col. 3 lines 57-65. Angelo provides for an area on the top portion of its mask 10 that include elongate arcuate stitched sections filled with filler material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the size of the cover in McMahon such that it is configured to be covered over the eyebrows and forehead as taught Angelo to provide therapy to desired areas on the face. Furthermore, it would have been obvious to include stitch points that define multiple sections or three substantially distinct sections whereby the sections include fill material in order to provide thermal therapy to desired areas on the face. Furthermore, it would have been obvious to have modified the first section in McMahon such that it is arcuate and filled with fill material to provide for the desired therapy across the forehead.
McMahon in view of Angelo does not teach wherein the top edge the first section is arcuate.
However, Sanker teaches a top edge of an eye mask that is arcuate (see annotated Fig. 3 below).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the shape of the top edge so that it is arcuate as a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed object was significant. MPEP 2144.04.
Regarding claim 12, McMahon in view of Angelo and Sanker teaches the limitations of claim 10 and wherein the fill material comprises a thermally conductive material (McMahon Claim 1 wherein the hydrophilic zeolite fill granules are microwave compatible and substantially retain said at least one antimicrobial metal material therein upon multiple exposures to microwave irradiation).
Regarding claim 13, McMahon in view of Angelo and Sanker teaches the limitations of claim 1 and wherein the insert is removable (Fig. 2), and further wherein the insert is configured to be heated in a microwave (Claim 1).
Regarding claim 14, McMahon in view of Angelo and Sanker teaches the limitations of claim 10 and wherein the cover is configured to be hand- or machine-washed ([Abstract] The therapeutically adaptive cover communicates hot or cold moisture therapy while isolating the compress from the treatment site, allowing for re-use of the compress by way of replacing the cover, or washing the cover prior to subsequent use for maintaining optimum sterility and cleanliness.
Regarding claim 19, McMahon teaches a method for treating dry eyes ([0015]), comprising:
(a) providing an eye mask according to Claim 1(McMahon in view of Angelo and Sanker; see claim rejection 1);
(b) heating the mask in a microwave oven for a predetermined time period (Claim 1 repeated microwave heating);
(c) placing the heated mask over a user’s eyes ([0005]).
Regarding claim 20, McMahon teaches a method for treating dry eyes ([0015]), comprising:
(a) providing an eye mask according to Claim 10 (McMahon in view of Angelo and Sanker ; see claim rejection 10);
(b) heating the insert in a microwave oven for a predetermined time period (100, Claim 1 repeated microwave heating);
(c) placing the heated insert within the pocket (cover 200 receives 100, Fig. 2); and
(d) placing the cover with the heated inserted over a user’s eyes ([0005]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US 2019/0000664) in view of Angelo (5,119,812), Sanker (2011/0208279), and in further view of Bruder (2014/0330222).
Regarding claim 7, McMahon in view of Angelo teaches the limitations of claim 1 as previously rejected above. McMahon does not teach wherein the fill material comprises a plurality of silica beads. However, Bruder teaches a device within the same field of invention ([Abstract] An article for therapy and treatment of at least one eye. [0002] The present invention relates in general to moist-heat therapy wound dressings and compresses). Bruder teaches a plurality of silica beads ([0039] Example anti-microbial metal(s) include adsorbent technologies employing beads of activated alumina, silica gel, bentonite and molecular sieves, with or without metals).
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the fill material in McMahon since Bruder provides silica beads also provide for treatment of dry-eye or other eye conditions [0026].
Claim(s) 11 are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US 2019/0000664) in view of Angelo (5,119,812), Sanker (2011/0208279), and in further view of Bamberg (US 2016/0000607).
Regarding claim 11, McMahon in view of Angelo teaches the limitations of claim 10. McMahon does not teach wherein the fill material is arranged in a cross-hatch pattern. However, Bamber teaches the claimed limitation ([0046] each cell 50 preferably includes an upper side 52 opposite a lower side 54 which are of similar size and shape and are formed by portions of the sleeve 40. This shape is preferably approximately hexagonal in form with two of the sides of the hexagon formed by divider seams 58 dividing the adjacent cells 50 from each other…[0048] these edge seams 55 are preferably not straight, but rather follow a contour which causes the cells 50 to have the hexagonal shape described above).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to provide a cross hatch pattern for the fill material to provide therapy uniformly across the device.
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US 2019/0000664) in view Angelo (5,119,812), Sanker (2011/0208279), and Bruder (2017/0252210)
Regarding claim 15, McMahon teaches a kit for providing heat therapy for the eyes (dry eye compress) comprising:
(a) an eye mask according to Claim 1 (McMahon in view of Angelo and Sanker see claim rejection 1).
McMahon does not teach (b) one or more eyelid wipes, wherein the eyelid wipe is impregnated with an eyelid cleanser.
However, Bruder ‘210 teaches a device within the same field of invention (thermal therapy to help treat dry eye [0006] comprising removable/microwavable inserts/pods ) wherein the eyelid wide is impregnated with an eyelid cleanser (Fig. 13 includes pod 450 and pad 452 [0051] The pad or disc 452 can be impregnated with medication and can be effective in either a moist or dry condition. The antibacterial medication can include, for example, liposomes and/or microspheres).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for one or more eyelid wipes impregnated with eyelid cleanser since it would provide for antibacterial properties [0051].
Regarding claim 17, McMahon teaches a kit for providing heat therapy for the eyes (dry eye compress) comprising:
(a) an eye mask according to Claim 10 (McMahon in view of Angelo and Sanker ; see claim rejection 10).
McMahon does not teach (b) one or more eyelid wipes, wherein the eyelid wipe is impregnated with an eyelid cleanser.
However, Bruder ‘210 teaches a device within the same field of invention (thermal therapy to help treat dry eye [0006] comprising removable/microwavable inserts/pods ) wherein the eyelid wide is impregnated with an eyelid cleanser (Fig. 13 includes pod 450 and pad 452 [0051] The pad or disc 452 can be impregnated with medication and can be effective in either a moist or dry condition. The antibacterial medication can include, for example, liposomes and/or microspheres).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for one or more eyelid wipes impregnated with eyelid cleanser since it would provide for antibacterial properties [0051].
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US 2019/0000664) in view of Angelo (5,119,812), Sanker (2011/0208279), Bruder (2017/0252210), and in further view of Adkins (8,202,853).
Regarding claim 16, McMahon in view of Angelo, Sanker, and Bruder’210 teaches the limitations of claim 15 as previously rejected. McMahon does not teach wherein the eyelid cleanser includes a composition having polyhexamethylene biguanide.
However, Adkins teaches a device within the same field of invention (eyelid treatment kit) wherein the eyelid cleanser includes polyhexamethylene biguanide (claim 21 the anti-bacterial eyelid preparation comprising polyhexamethylene biguanide).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for the claimed cleanser composition to provide anti-bacterial properties, and proper cleansing of the eyelids to prevent recurring infections [Abstract].
Claim 18 recites the same limitations of claim 16 as previously rejected above.
Response to Arguments
Applicant’s remarks in the response filed on 5/23/2025 has been considered by the Examiner, however, they are not persuasive.
Applicant on pages 7-8 recites, “McMahon clearly teaches that the body capping is a structural feature used to seal the body containing the fill material. The body capping is not described as a portion, section, or any other element having a volume in which fill material is enclosed, nor is it configured to apply heat to a user's face. Thus, McMahon discloses only one unsegmented section, not three distinct sections containing fill material.”
While the Examiner acknowledges McMahon teaches one stitched section, the Examiner disagrees that McMahon does not teach three sections. The Examiner has previously recited “the term section is broad and is not limited to the capping portion 101 and can additionally include portions above the second and third section.” The term “portion” does not include clearly defined boundaries. Therefore, the Examiner interprets three sections on the device in McMahon to read on the claimed three sections. The first section, “elongate along a horizontal axis proximal to the top edge of said mask,” would cover an area starting from McMahons body capping portion to a section above second and third portion as indicated in annotated Fig. 3 of McMahon. The first, second, and third sections indicated in annotated Fig. 3 would include hydrophilic zeolite fill granules since McMahon provides its envelope is filled with the zeolite granules. The Examiner applies the Angelo reference two teach stitch points that define three substantially distinct sections in the first layer and the second layer
With respect to Angelo, Applicant recites “Importantly, the plurality of spaced vertical and horizontal seams facilitates shaping the mask to conform to facial features. These seams serve as fold lines and are preferably spaced apart approximately one-half inch to one inch, since closer spacing tends to restrict the effectiveness of the thermal storage material (Column 3, lines 28-35). However, Angelo does not disclose or suggest a configuration of three substantially distinct sections containing fill material. The sections taught by Angelo are solely in relation to spacing requirements and flexibility, not as distinct functional sections.”
The Examiner respectfully disagrees. While Angelo discloses it is preferred that seams 30 and 32 be spaced apart approximately one-half inch to one inch, it does disclose “the spacing of the seams 30 and 32 may be varied substantially as desired.” Col. 3 lines 30-31. Therefore, applying Angelo’s stitched portions to modify the device of McMahon to teach three distinct stitched portions would not destroy the flexibility of the device.
With respect to Sanker, Applicant recites “No disclosure is provided by Sanker of a mask comprising three distinct sections containing fill material, or any structural element that would lead a person of ordinary skill in the art to segment the fill material in this configuration. The design of Sanker relies on adjustability and the repositioning of the heating packet.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is the position of the Examiner that Sanker teaches a thermal therapy device for the eyes whereby the top edge of the eye mask can be shaped to have an arcuate portion. Therefore, applying Sanker to modify the shape of the eye mask in McMahon would not teach away.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794