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 § 102
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) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tidwell et al. US 2016/0375233A1.
With regards to claim 1, Tidwell discloses a skin preparation device for applying an antiseptic composition to a skin surface of a patient (abstract), the skin preparation device comprising:
an applicator (30 fig 11-12) configured to absorb the antiseptic composition, the applicator comprising an application surface and a holding surface, the application surface configured to apply the antiseptic composition to the skin surface of the patient ([0041]); and a holding member (12 and 16, figs 11- 12 and 15A-B and [0030] which discloses the construction of the holding member) configured to provide a portion of the skin preparation device that is gripped by a user when using the skin preparation device (fig 12 and 15a-b and [0043-44]), the holding member including a first end and an opposing second end, the holding member being operatively connected to the holding surface of the applicator, wherein the holding member is made of a material that provides flexibility to allow the first end and the second end to be pulled into contact with one another to be gripped by the user of the skin preparation device ((fig 12 and 15a-b and [0043-44]).
With regards to claim 2, Tidwell discloses, wherein the applicator and the holding member are made of different materials ([0030] discloses the holder or cover plus base sheet are form from a thermoplastic and foil and [0040] discloses the applicator can be made of foam).
With regards to claim 3, Tidwell discloses wherein the applicator is made of foam or non-woven paper ([0040] discloses the applicator can be made of foam).
With regards to claim 4, Tidwell discloses, wherein the holding member is made of a blister packaging ([0030] discloses the holder or cover plus base sheet are form from a thermoplastic and foil thereby being a blister type packaging).
With regards to claim 5, Tidwell discloses wherein the applicator has a thickness that prevents the holding member from contacting the skin surface of the patient (see figure 15B which shows the applicator having a thickness such that the holding member extends away from it).
With regards to claim 6, Tidwell discloses wherein the applicator includes a flexibility to bend as the first end and the second end of the holding member are pulled into contact with one another (see figure 15a-b and [0043-44]).
With regards to claim 7, Tidwell discloses wherein the holding surface of the applicator defines a plurality of grooves and ridges to assist the applicator in bending (see holes and groves in fig 11-12 and [42-43]).
With regards to claim 8, Tidwell discloses wherein the applicator is operatively connected to the holding member using an adhesive ([0034]).
With regards to claim 9, Tidwell discloses, wherein the applicator is rectangular, in shape (see figure 11 for shape of applicator 30).
With regards to claim 10, Tidwell discloses wherein the antiseptic composition comprises alcohol based compounds, non-alcohol based compounds, or a mixture of alcohol and non-alcohol based compounds ([0031] which disclose various compositions).
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.
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) 11- 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tidwell et al. US 2016/0375233A1 in view of Stanton US 3386793.
With regards to claim 11, Tidwell discloses a skin preparation device for applying an antiseptic composition to a skin surface of a patient (abstract), the skin preparation device comprising:
an applicator (30 fig 11-12) configured to absorb the antiseptic composition, the applicator comprising an application surface and a holding surface, the application surface configured to apply the antiseptic composition to the skin surface of the patient ([0041]); and a holding member (12 and 16, figs 11- 12 and 15A-B and [0030] which discloses the construction of the holding member) configured to provide a portion of the skin preparation device that is gripped by a user when using the skin preparation device (fig 12 and 15a-b and [0043-44]), the holding member including a first end and an opposing second end, the holding member being operatively connected to the holding surface of the applicator, wherein the holding member is made of a material that provides flexibility to allow the first end and the second end to be pulled into contact with one another to be gripped by the user of the skin preparation device ((fig 12 and 15a-b and [0043-44]).
Tidwell fails to disclose a packing web operatively connected to the holding member to seal the applicator between the packaging member and holding member
Stanton teaches an applicator pad (22) attached to a holder (20 and 21), wherein the pad is sealed between the holder and a cover (23) (fig 1 and Col 1 lines 30-60). Stanton is drawn to solve a similar problem as the instant claims in that it seals an applicator prior to use.
It would have been obvious to one of ordinary skill before the effective filing date to have added a cover sheet to cover the applicator of Tidwell prior to use to maintain sterility and cleanliness of the exposed pad.
With regards to claim 12, Tidwell discloses wherein the holding member is made of a material that provides flexibility to allow the first end and the second end to be pulled into contact with one another to be gripped by the user of the skin preparation device (see figure 15a-b and [0043-44]).
With regards to claim 13, Tidwell as modified by Stanton discloses wherein the packaging web comprises a peel tab to remove the packaging web from the holding member (Stanton 34/34a in figure 1, Col 3 lines 15-25).
With regards to claim 14, Tidwell as modified by Stanton discloses wherein the packaging web comprises at least one perforation line (or tab) to assist in removing at least a portion of the packaging web from the skin preparation device (Col 5 lines 5-7 disclose the cover is torn off from the applicator and holder combination).
With regards to claim 15, Tidwell as modified by Stanton discloses wherein the packaging web is heat sealed to a perimeter of the holding member (which discloses the cover is heat sealed to the edges- Col 3 lines 10-15).
With regards to claim 16, Tidwell as modified by Stanton discloses wherein the packaging web is made of blister packaging (the cover is made from foil, which is a component of blister packaging, fig 1, Col 3 lines 10-15).
With regards to claim 17, Tidwell discloses wherein the applicator is made of foam or non-woven paper ([0040] discloses the applicator can be made of foam).
With regards to claim 18, Tidwell discloses wherein the applicator has a thickness that prevents the holding member from contacting the skin surface of the patient (see figure 15B which shows the applicator having a thickness such that the holding member extends away from it).
With regards to claim 19, Tidwell discloses wherein the applicator includes a flexibility to bend as the first end and the second end of the holding member are pulled into contact with one another (see figure 15a-b and [0043-44]).
With regards to claim 20, Tidwell discloses wherein the holding surface of the applicator defines a plurality of grooves and ridges to assist the applicator in bending (see holes and groves in fig 11-12 and [42-43]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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