DETAILED ACTION
In Applicant’s Response filed 3/10/26, Applicant has amended claims 1, 11 and 12, Claims 5, 8 and 16-19 have been cancelled. Currently, claims 1-4, 6-7 and 9-15 are pending.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is no support in the specification as originally filed for reciting an absorbent segment disposed on the backing layer wherein the fold line bisects the absorbent segment and an absorbent eyepad wherein the fold line extends across the absorbent eyepad, as recited in amended claim 1 (i.e. there is no disclosure of an absorbent segment and an absorbent eyepad on the same article or of the fold line extending through or bisecting two separate absorbent elements on the same article). Additionally, the drawings do not appear to illustrate these features. Therefore, the subject matter of amended claim 1 constitutes new matter and fails to comply with the written description requirement. Claims 2-4 and 6 depend from claim 1 and, therefore, contain the same deficiencies.
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) 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over McMullen (US 2012/0192330) in view of Riedel et al (US 4793003) and further in view of Murata (JP 2006167055 A).
With respect to claim 1, McMullen discloses a system (packaged eye mask in fig 8) comprising: a package (packet 50; fig 8); and a medical article contained within the package (a folded eye mask 20 is contained within packet 50 as shown in fig 8; para [0041]) wherein the medical article (eye mask 20) is an eyepatch configured to be worn in front of only one eye (mask 20 includes an eyepatch that is configured to be worn in front of only the left eye and a separate eyepatch that is configured to be worn in front of only the right eye as shown in fig 1a; see also annotated fig 1b), wherein the medical article comprises an adhesive article (eye mask 20 includes an attachment portion 30 on interior surface 22b that is a two-sided medical grade adhesive tape 32 which has one side that is configured to be attached to the user’s face to hold the eye mask on the face – see para [0032]) comprising: a backing layer (flexible sheet 22); at least one adhesive layer disposed on the backing layer (attachment portion 30 on interior surface 22b that is a two-sided medical grade adhesive tape 32 which has one side that is configured to be attached to the user’s face to hold the eye mask on the face – see para [0032]); and wherein the adhesive article comprises at least one fold along a fold line along an axis of symmetry of the adhesive article (the eye mask 20, including adhesive attachment portion 30, is folded in the center for insertion into packet 50 as shown in fig 8 and described in para [0041]; the fold line is along a center axis of the eye mask) wherein the fold line bisects the article (as shown in fig 8).
ANNOTATED FIG 1B:
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McMullen does not, however, disclose an absorbent segment disposed on the backing layer and surrounded by the at least one adhesive layer.
Riedel, however, teaches an eye patch (10; figs 1-2) that comprises a backing layer (film 16; fig 1-2); at least one adhesive layer disposed on the backing layer (adhesive 18 on film 16; fig 1-2); and an absorbent segment (absorbent pad 12) disposed on the backing layer (attached to film 16 via adhesive 18) and surrounded by the at least one adhesive layer (part of the adhesive 18 extends around the periphery of pad 12; see fig 1-2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added an absorbent segment like pad 12 of Riedel to the backing layer of McMullen such that it is surrounded by the at least one adhesive layer, like the pad 12 in Riedel, in order to provide cushioning and protection to the eye as well as fluid absorbency (Riedel col 3 lines 51-52).
McMullen also does not disclose that the eyepatch comprises an absorbent eyepad, and wherein the fold line extends across the absorbent eyepad.
Riedel, however, teaches an eye patch (10; figs 1-2) that comprises an absorbent pad (absorbent pad 12). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added an absorbent eyepad like pad 12 of Riedel to the backing layer of McMullen in order to provide cushioning and protection to the eye as well as fluid absorbency (Riedel col 3 lines 51-52).
Reidel does not teach a fold line that extends across the absorbent eyepad.
However, Murata teaches an analogous eyepad which includes a fold line that extends across the center of the eyepad to allow the eyepad to be folded in half to provide a three dimensional structure that protrudes forward away from the eye and provides spacing between the eye and the eyepad during use to allow a user to blink while the eye is covered (para [0010;0014-0015]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have folded the absorbent eyepad of McMullen in view of Riedel so that the fold line extends across the eyepad, as taught by Murata, in order to provide a three dimensional structure with spacing between the eyepad and the eye to permit blinking for improved comfort.
With respect to claim 2, McMullen in view of Riedel and further in view of Murata discloses the system substantially as claimed (see rejection of claim 1) and McMullen also discloses that the adhesive article is a planar article (the mask portion 22 of eye mask 20 is interpreted as being planar as shown in fig 8) with a length (x axis) (interpreted as being the longitudinal dimension that extends from ear to ear on the patient during use) and a width (y axis) (interpreted as being the vertical dimension that extends from forehead to nose of the user during use) and the one fold along an axis of symmetry comprises a fold along a fold line along the y axis (as shown in fig 8).
With respect to claim 3, McMullen in view of Riedel and further in view of Murata discloses the system substantially as claimed (see rejection of claim 1) and McMullen also discloses that the adhesive article is a planar article (the mask portion 22 of eye mask 20 is interpreted as being planar as shown in fig 8) with a length (x axis) (interpreted as being the vertical dimension that extends along the length of the user’s face from forehead to nose of the user during use) and a width (y axis) (interpreted as being the longitudinal dimension that extends across the width of the user’s face from ear to ear on the patient during use) and the one fold along an axis of symmetry comprises a fold along a fold line along the y axis (as shown in fig 8).
With respect to claim 4, McMullen in view of Riedel and further in view of Murata discloses the system substantially as claimed (see rejection of claim 1) and McMullen also discloses that the at least one adhesive layer is covered with a release liner (eye mask 20 includes an attachment portion 30 on interior surface 22b that is a two-sided medical grade adhesive tape 32 which has one side that is configured to be attached to the user’s face to hold the eye mask on the face but is covered by a release layer 34 prior to use – see para [0032]).
With respect to claim 6, McMullen in view of Riedel and further in view of Murata discloses the system substantially as claimed (see rejection of claim 1) and McMullen also discloses that the fold line further comprises a gap or division that does not pass through the entire article (the eye mask 20 can further comprise a nose bridge portion 36 that is added to the center as shown in fig 3 where the mask is folded as shown in fig 8; thus, the nose bridge portion 36 is on the fold line).
Claim(s) 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over McMullen (US 2012/0192330) in view of Riedel et al (US 4793003).
With respect to claim 7, McMullen discloses a system (packaged eye mask in fig 8) comprising: a package (packet 50; fig 8); and a medical article contained within the package (a folded eye mask 20 is contained within packet 50 as shown in fig 8; para [0041]) wherein the medical article (eye mask 20) comprises an adhesive article (eye mask 20 includes an attachment portion 30 on interior surface 22b that is a two-sided medical grade adhesive tape 32 which has one side that is configured to attached to the user’s face to hold the eye mask on the face – see para [0032]) comprising: a backing layer (flexible sheet 22); a first segment comprising a first adhesive layer (left side of eye mask which includes adhesive tape 32 as shown in fig 1B) disposed on the backing layer (attachment portion 30 on interior surface 22b that is a two-sided medical grade adhesive tape 32 which has one side that is configured to be attached to the user’s face to hold the eye mask on the face – see para [0032]); a second segment, adjacent to the first segment (nose bridge portion 36 at the center of the eye mask which is adjacent to the left side of the mask; can be added to eye mask 20 at the center as shown in fig 3); and a third segment (right side of the eye mask), adjacent to the second segment (the right side of the eye mask is adjacent to the nose bridge portion 36 at the center) and comprising a second adhesive layer disposed on the backing layer (adhesive tape 32 on the right side of the eye mask; attachment portion 30 on interior surface 22b that is a two-sided medical grade adhesive tape 32 which has one side that is configured to be attached to the user’s face to hold the eye mask on the face – see para [0032]); one fold along a fold line along an axis of symmetry of the adhesive article (the eye mask 20, including adhesive attachment portion 30, is folded in the center for insertion into packet 50 as shown in fig 8 and described in para [0041]; the fold line is along a center axis of the eye mask) and located in the second segment (nose bridge portion 36 is added to the center as shown in fig 3 where the mask is folded as shown in fig 8; thus, the nose bridge portion 36 is on the fold line), wherein the fold line bisects the article (as shown in fig 8); and a double-sided release liner (release layer 34 – see para [0032]) with a first release surface and an opposing second release surface (left and right side of release layer 34; the left side is located on the side that is opposite to the right side), wherein the first release surface is in contact with the first adhesive layer of the first segment (left side of layer 34 covers the adhesive tape 32 on the left side of the eye mask as shown in fig 1B), and the second release surface is in contact with the second adhesive layer of the third segment (right side of layer 34 covers the adhesive tape 32 on the right side of layer 34 as shown in fig 1B); and wherein part of the release liner is in contact with the second segment (as shown in fig 1B, part of layer 34 covers a part of the center portion of the eye mask).
McMullen does not, however, disclose that the second segment comprises an absorbent pad disposed on the backing layer.
Riedel, however, teaches an eye patch (10; figs 1-2) that comprises a backing layer (film 16; fig 1-2); at least one adhesive layer disposed on the backing layer (adhesive 18 on film 16; fig 1-2); and an absorbent pad (absorbent pad 12) disposed on the backing layer (attached to film 16 via adhesive 18). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added an absorbent pad like pad 12 of Riedel to the backing layer of McMullen, like the pad 12 in Riedel, in order to provide cushioning and protection to the eye as well as fluid absorbency (Riedel col 3 lines 51-52).
With respect to claim 9, McMullen in view of Riedel discloses the system substantially as claimed (see rejection of claim 7) but does not explicitly disclose that the first adhesive layer and the second adhesive layer independently comprise a pressure sensitive adhesive layer or a gel adhesive.
McMullen does, however, teach that many other eye patches that are known in the art are affixed to a patient’s face using pressure-sensitive, latex free, hypoallergenic adhesive (para [0005]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a pressure sensitive adhesive for the first and second adhesive layers on the device of McMullen since such an adhesive is well known in the art for use in attaching eye patches to a user’s skin and it is 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.
With respect to claim 10, McMullen in view of Riedel discloses the system substantially as claimed (see rejection of claim 7) and McMullen also discloses that the first release surface of the double- sided release liner is the same as the second release surface (both the left and right sides of layer 34 are made from the same material – para [0033]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over McMullen (US 2012/0192330) Riedel et al (US 4793003) and further in view of Michel et al (US 2009/0186183).
With respect to claim 11, McMullen in view of Riedel discloses the system substantially as claimed (see rejection of claim 7) but McMullen does not, however, explicitly disclose that the first release surface has a first release coating and the second release surface has a second release coating, where the first and second release coatings are different.
Michel, however, teaches release liners which, specifically, comprise release coatings on both sides wherein the coatings have different release forces with respect to a layer of adhesive (see para [0015;0027]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the release liner of McMullen in view of Riedel so that the first release surface has a first release coating and the second release surface has a second release coating, where the first and second release coatings are different, like the liner taught in Michel, in order to provide different attachment strengths between the liner and adhesive at different areas on the article.
Claim(s) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over McMullen (US 2012/0192330) in view of Michel et al (US 2009/0186183) and further in view of Patsiatzis (WO-2011035393-A1).
With respect to claim 12, McMullen discloses a system (packaged eye mask in fig 8) comprising: a package (packet 50; fig 8); and a medical article contained within the package (a folded eye mask 20 is contained within packet 50 as shown in fig 8; para [0041]) wherein the medical article (eye mask 20) comprises a double-sided release liner (release layer 34 – see para [0032]) with a first release surface and opposing second release surface (left and right side of release layer 34; the left side is located on the side that is opposite to the right side), a first adhesive article attached to the first release surface of the double-sided release liner (left side of layer 34 covers the adhesive tape 32 on the left side of the eye mask as shown in fig 1B – thus, the left eye portion of mask 20 is attached to the left side of layer 34); and a second adhesive article attached to the second release surface of the double-sided release liner (right side of layer 34 covers the adhesive tape 32 on the right side of layer 34 as shown in fig 1B - thus, the right eye portion of mask 20 is attached to the right side of layer 34).
McMullen does not, however, explicitly disclose that the first release surface has a first release coating and the second release surface has a second release coating, where the first and second release coatings are different.
Michel, however, teaches release liners which, specifically, comprise release coatings on both sides wherein the coatings have different release forces with respect to a layer of adhesive (see para [0015;0027]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the release liner of McMullen so that the first release surface has a first release coating and the second release surface has a second release coating, where the first and second release coatings are different, like the liner taught in Michel, in order to provide different attachment strengths between the liner and adhesive at different areas on the article.
McMullen also does not explicitly disclose that the second adhesive article is independent from the first adhesive article.
Patsiatzis, however, teaches protectors that may be incorporated into eye masks (pg 4 lines 14-17) and which comprise a blocking portion that includes adhesive that may be continuous or discontinuous over all or part of the blocking portion (pg 3 lines 26-29) wherein the adhesive engages with the skin when the blocking surface is pressed against the skin during securing the of the device (pg 4 line 36-pg 5 line 2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the first and second adhesive articles of McMullen in view of Michel so that the adhesive is a discontinuous layer, as taught by Patsiatzis, thereby rendering the first adhesive article independent from the second, since constructing a formerly integral structure in various elements involves only routine skill in the art.
With respect to claim 13, McMullen in view of Michel and further in view of Patsiatzis discloses the system substantially as claimed (see rejection of claim 12) and McMullen also discloses that the first adhesive article and the second adhesive are the same (the left and right sides of eye mask 20 are both configured as eye covering portions and thus are interpreted as being the same).
With respect to claim 14, McMullen in view of Michel and further in view of Patsiatzis discloses the system substantially as claimed (see rejection of claim 13) and McMullen also discloses that the first and second adhesive articles comprise eye patches (mask 20 is an “eye mask” and the left and right sides of the mask are specifically configured as eye covering portions as shown i.e. in figure 1A; the eye covering portions include adhesive tape 32 about the outer peripheral edge as shown in fig 1B for attachment to the users face – para [0032] and thus are interpreted as being eye patches).
With respect to claim 15, McMullen in view of Michel and further in view of Patsiatzis discloses the system substantially as claimed (see rejection of claim 12) and McMullen also discloses that the first adhesive article and the second adhesive article are different (the left eye covering portion is specifically configured for covering the left eye and would not be capable of use to cover the right eye while the right eye covering portion is specifically configured for covering the right eye and would not be capable of use to cover the left eye; thus, each of the eye covering portions are configured for covering a different eye and thus are interpreted as being different).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 3/10/26 have been fully considered as follows:
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 6-10 of the Response have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786