DETAILED ACTION
In Applicant’s Response filed 8/22/25, Applicant has amended claims 1-5; cancelled claims 8-9; added new claims 11-13; amended the specification; and submitted replacement drawing sheets. Currently, claims 1-7 and 10-13 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 .
Drawings
The drawings were received on 8/22/25. These drawings are acceptable.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanington (US 3063555).
With respect to claim 1, Hanington discloses a protective toe covering (surgical pad element 6; figs 1-4; interpreted as being capable of covering/protecting a user’s toe because the device is disclosed as being configured for use on a corn or callous and for placement on the foot such as between toes – see col 3 lines 2-3 and col 4 lines 3-7) consisting of: a protective cover (body portion 8), comprising a front face and a rear face (the opposing faces of the body portion 8 of element 6 is shown in fig 4; for pad element 6, the rear face is the lower surface adjacent adhesive 9 and the front face is the upper surface that is adjacent to pad element 5); an adhesive placed on the rear face of the protective cover (adhesive 9 on underside – col 2 lines 64-65; fig 4), wherein the adhesive is configured to adhere to bare skin (col 3 lines 2).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hanington (US 3063555) in view of Utsugi (US 2004/0044299).
With respect to claim 2, Hanington discloses the protective toe covering as claimed (see rejection of claim 1) but does not disclose that the protective cover consists of medical grade silicone.
Utsugi, however, teaches an adhesive dressing that includes a backing made of silicone material (abstract; para [0032]; the silicone is interpreted as being “medical grade” since the adhesive dressing is specifically for medical applications). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the protective cover of Hanington from a medical grade silicone like the backing of the dressing of Utsugi since 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hanington (US 3063555) in view of Ishmael et al (US 2016/0198790).
With respect to claim 3, Hanington discloses the protective toe covering as claimed (see rejection of claim 1) but does not explicitly disclose that the adhesive is latex free.
Ishmael, however, teaches an adhesive article configured to be applied to a user’s foot wherein, specifically, the adhesive used is latex free for sensitive skin using an acrylic based, medical grade adhesive (para [0065]). Thus, 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 latex free adhesive as the adhesive on the device of Hanington, like the adhesive used on the device of Ishmael, in order to avoid irritating sensitive skin on the user’s feet.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hanington (US 3063555) in view of Cunningham (US 7329448).
With respect to claim 4, Hanington discloses the protective toe covering as claimed (see rejection of claim 1) and also discloses that the protective cover (8) is substantially circular (as shown in figs 1-4). Hanington does not, however, explicitly disclose that the protective cover has a diameter of about 5 mm.
Cunningham, however, teaches adhesive pads that are configured for providing protection to areas of a user’s feet and toes wherein the pads are formed as disk-shaped elements having a diameter of about ¼ in to about 1in (col 4 lines 28-32; approx. 6.35mm-25.4mm; 6.35mm is interpreted as being “about” 5mm). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the protective cover of Hanington having a diameter of about 5 mm like the adhesive pads in Cunningham in order to provide a structure that is appropriately sized for use on the feet.
Claims 5 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hanington (US 3063555) in view of Nakamura (JP 3635647 B1) and further in view of Yin (CN-201978268-U) and Beecher et al (US 6322363).
With respect to claim 5, Hanington discloses a protective toe covering (surgical pad element such as element 4, 5 and/or 6; figs 1-4; interpreted as being capable of covering/protecting a user’s toe because the device is disclosed as being configured for use on a corn or callous and for placement on the foot such as between toes – see col 3 lines 2-3 and col 4 lines 3-7) kit (the pad elements 4, 5 and 6 are provided on a backing member 3 within an enclosure 1 which is interpreted as being a “kit”; see col 2 lines 33-51) comprising: a case (enclosure 1) comprising a lid pivotally coupled to a base (disclosed as being a “paperboard envelope” – col 2 lines 33-35; envelopes inherently comprise a flap that is pivotally coupled to a base pocket structure – thus, the flap of the envelope is interpreted as being the pivoting lid), wherein the base includes at least one compartment (envelope structures inherently include a pocket structure – the space within the pocket is interpreted as being a compartment); at least one sheet configured to be loosely retained within a compartment (backing card/sheet 3 inside enclosure 1 – col 2 lines 38-42), each sheet retaining a plurality of protective toe coverings (sheet 3 retains surgical pad elements 4, 5 and 6 as shown in figs 1-2); wherein each of the plurality of protective toe coverings (4, 5, 6) comprises a protective cover (body portion 8), comprising a front face and a rear face (the opposing faces of the body portion 8 of each pad element 4, 5 and 5 are shown in fig 4; for pad element 6 for example, the rear face is the lower surface adjacent adhesive 9 and the front face is the upper surface that is adjacent to pad element 5); an adhesive placed on the rear face of the protective cover (adhesive 9 on underside – col 2 lines 64-65; fig 4), wherein the adhesive is configured to adhere to bare skin (col 3 lines 2);
Hanington does not, however, disclose that the base comprises a plurality of protective covering compartments and at least one pick-up tool compartment with a plurality of sheets loosely retained in one of the protective covering compartments and at least one pick-up tool configured to be loosely retained within the at least one pick-up tool compartment.
Nakamura, however, teaches a medical kit comprising a storage unit in figure 1A which includes a plurality of compartments (as shown in fig 1A) including compartments configured for storing bandages and tweezers therein (translation pg 2/9; the compartments are interpreted as being capable of storing multiple bandages wherein the bandages are not disclosed as being rigidly retained or secured within a compartment – thus the storage unit is interpreted as comprising a compartment with a plurality of sheets loosely retained therein; the tweezers are not disclosed as being rigidly retained or secured within a compartment – thus the storage unit is interpreted as comprising a compartment with a tweezer pick up tool loosely retained therein). 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 base of the case of Hanington to comprise a plurality of protective covering compartments and at least one pick-up tool compartment with a plurality of sheets loosely retained in one of the protective covering compartments and at least one pick-up tool configured to be loosely retained within the at least one pick-up tool compartment, like the storage unit in the medical kit of Nakamura, in order to provide the tools and supplies necessary for treatment all in one location thereby improving convenience, economy, and functionality of the kit (see Nakamura translation pg 2/9, paragraph 8).
Hanington in view of Nakamura does not, however, explicitly teach that the pick-up tool comprises two pincer levers coupled together at a fixed end and each of the two pincer levers having first and second pincer portions arranged to form an angle relative to one another and each having a free end wherein the free end of each of the two pincer levers comprises an elliptical tooth.
Yin, however, teaches tweezers which include two pincer levers, each comprising a first lever portion 2 and a second lever portion 3 which are angled relative to each other as shown in the figure on page 4, the two levers coupled together at a fixed end 1 and each of the two pincer levers having a free end 4. Yin further teaches that the free end 4 of each of the two pincer levers comprises an elliptical tooth (element 4 has an elliptical shape as shown in the figure on page 4) that is integrally connected to the two pincer levers 2 via a first pincer portion and a second pincer portion (elements 3 which are each attached between elements 2 and 4).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used tweezers as disclosed in Yin in the kit of Hanington in view of Nakamura in order to permit easier and more secure grasping of protective toe coverings for application to a patient (in the same manner as Yin describes how the tweezers improve grasping of cotton balls in para [0010]).
Yin does not, however, teach that the first and second pincer portions are arranged to form an acute angle relative to one another.
Beecher, however, teaches tweezer-like pliers 10 which include two pincer levers (handles 11, 12) each comprising first and second pincer portions (base 13 and tips 15) which are arranged to form an acute angle relative to one another (Beaks or tips 15 at second ends of the handles are angled about 70-degrees downwardly – col 2 lines 65-66). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have repositioned the first/second pincer portions to thereby modify the angle between the first and second pincer portions of the two pincer levers of the tool of Yin to be an acute angle as taught by Beecher since rearranging parts of an invention involves only routine skill in the art.
With respect to claims 10-11, the claim is rejected under 35 USC 103 as being unpatentable over Hanington in view of Nakamura and further in view of Yin and Beecher because with respect to the method steps claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP 2112.01(I). In the present case, the kit and device (protective toe covering) recited in method claims 10-11 are identical to the kit and device recited in claim 5, which is unpatentable over Hanington in view of Nakamura and further in view of Yin and Beecher (see claim rejection above). Since the prior art device/kit is the same as the device/kit for carrying out the claimed method, it is obvious that the device/kit will perform the claimed process and, therefore, the method claimed is considered to be obvious in view of the prior art.
With respect to claims 12-13, Hanington in view of Nakamura and further in view of Yin and Beecher discloses the kit and method substantially as claimed (see rejections of claims 5 and 11) and Beecher further teaches that the second pincer portion includes a curvature that forms an obtuse angle in an opposite direction relative to said acute angle formed between the first pincer portion and second pincer portion (as shown in fig 4, the resulting angle in the area opposite to the acute angle formed between portions 12a and 15a is expected to be approximately 110 degrees (180-70; since the acute angle is disclosed as being approximately 70 degrees). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have repositioned the first/second pincer portions to thereby modify the angle between the first and second pincer portions of the two pincer levers of the tool of Yin to define a curvature that forms an obtuse angle in an opposite direction relative to an acute angle formed between the first pincer portion and second pincer portion,
as taught by Beecher, since rearranging parts of an invention involves only routine skill in the art.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hanington (US 3063555) in view of Nakamura (JP 3635647 B1), Yin (CN-201978268-U) and Beecher et al (US 6322363) and further in view of Utsugi (US 2004/0044299).
With respect to claim 6, Hanington in view of Nakamura and further in view of Yin and Beecher discloses the protective toe covering kit substantially as claimed (see rejection of claim 5) and Hanington also discloses that each sheet comprises a release liner coupled to a sheet in which the plurality of protective toe coverings are formed (the backing member 3 can be a laminated paper and plastic film structure and protects the adhesive prior to use wherein the pad elements are removed from the structure for use – col 2 lines 38-47).
Hanington in view of Nakamura does not, however, disclose that the sheet that the release liner is coupled to is a silicone sheet.
Utsugi, however, teaches an adhesive dressing that includes a backing made of silicone material (abstract; para [0032]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the sheet that the release liner is coupled to in the device of Hanington in view of Nakamura and further in view of Yin and Beecher from silicone like the backing of the dressing of Utsugi since 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 7, Hanington in view of Nakamura, Yin and Beecher and further in view of Utsugi discloses the protective toe covering kit substantially as claimed (see rejection of claim 6) and Hanington also discloses that the adhesive of each of the plurality of protective toe coverings releasably adheres to the release liner and the adhesive remains only on a respective one of the plurality of protective toe coverings when the respective one of the plurality of toe coverings is removed from the release liner (col 2 lines 38-47).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 8/22/25 have been fully considered as follows:
Regarding the objections to the drawings, Applicant’s replacement drawing sheets have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the objections to the specification, Applicant’s amendments have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 102 and 35 USC 103, Applicant’s arguments on pages 7-9 have been fully considered but are rendered moot in view of the modified and/or new rejections 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