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 .
Status of the Claims
Claims 1-14 are pending in the application and under consideration.
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.
Claim 10 is 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 pre-AIA the applicant regards as the invention.
Claim 10 is indefinite as lacking antecedent basis, where claim 10 depends upon itself. See MPEP § 2173.05(e). Appropriate correction is required, e.g., making claim 10 dependent upon claim 9, where the claims will be so construed.
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 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)(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.
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Claims 1-2 and 4-6 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Miller (US 5775826 A).
As to claim 1, Miller teaches a skin preparation device 10 (Fig.1-3; Col.4 to Col.6) for applying an antiseptic composition to skin of a patient (Col.4,ll.8-10), comprising:
an applicator 16/14 configured to absorb the antiseptic composition (perforate material 16, ampules 14 with antiseptic Col.4,ll.7-9; Fig.1-3; Col.3,ll.66 to Col.4,ll.16), the applicator comprising a top surface (upper surface of 16 adjacent 18; Fig.1-3; Col.4,ll.7-16) and a bottom surface (bottom surface of 16; Fig.1-3; Col.4,ll.7-16),
the bottom surface configured to apply the antiseptic composition to the skin of the patient (application of antiseptic composition to skin of patient; Fig.1-3; Col.1,ll.4-13); and a holding portion 12 (housing 12) that receives the applicator to provide a portion of the skin preparation device that is gripped by a user when using the skin preparation device (12; Fig.1-3; Col.3,ll.66 to Col.4,ll.6).
As to claim 2, Miller teaches the skin preparation device of claim 1, wherein the applicator and the holding portion are made of a different material (applicator 16 as porous sponge material, holding portion12 as strip material formed by blow molding; Fig.1-3; Col.5,ll.5-8, Col.6,ll.30-45).
As to claim 4, Miller teaches the skin preparation of claim 1, wherein the holding portion includes at least one reinforcing member 22,24 to provide support to the applicator (22, 24; Fig.1-3; Col.4,ll.7-16).
As to claim 5, Miller teaches the skin preparation device of claim 1, wherein the holding portion defines a cavity 20 that receives at least a portion of the applicator (20 receiving instances of 14; Fig.1-3; Col.4,ll.7-16).
As to claim 6, Miller teaches the skin preparation device of claim 1, wherein the applicator is at least one of a natural sponge and a synthetic sponge (sponge-like material; Col.5,ll.5-8).
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Claims 1, 3, and 8-13 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Chiang (US 2014/0371695 A1).
As to claim 1, Chiang teaches a skin preparation device (100; Fig.1-2;2 [0050]) for applying an antiseptic composition to skin of a patient ([0051]; [0050]-[0067]), comprising:
an applicator 112 (applicator head 112; Fig.1-2;[0067]) configured to absorb the antiseptic composition (112; Fig.1-2; [0067]), the applicator comprising a top surface (surface of 112 adjacent 102; Fig.1-2; [0067]) and a bottom surface (surface of 112
opposite 102; Fig.1-2), the bottom surface configured to apply the antiseptic composition to the skin of the patient ([0067]); and
a holding portion 102 that receives the applicator to provide a portion of the skin preparation device that is gripped by a user when using the skin preparation device (102; Fig.1-2; [0050]).
As to claim 3, Chiang teaches the skin preparation device of claim 1, wherein the applicator is made of a sponge material ([0067]) and the holding portion 102 is made of a plastic material (plastic body 102; [0067]).
As to claim 8, Chiang teaches the skin preparation device of claim 1, wherein the antiseptic composition includes one or more alcohols, comprising ethyl alcohol, propyl alcohol, isopropyl alcohol ([0068]), n-propanol, and/or mixtures thereof [0068],ll.13-15.
As to claim 9, Chiang teaches the skin preparation device of claim 1, wherein the antiseptic composition includes one or more non-alcohol based compounds (chlorhexidine gluconate; [0068]).
As to claim 10, Chiang teaches the skin preparation device of claim 9 (see 112b rejection above), wherein the one or more nonalcohol based compounds comprise at least one of iodine ([0068],ll.11-12), and chlorhexidine gluconate (CHG) ([0068],ll.11,8-13).
As to claim 11, Chiang teaches the skin preparation device of claim 1, wherein the antiseptic composition includes a mixture of alcohol and non-alcohol based compounds (isopropyl alcohol and chlorhexidine gluconate; [0068]).
As to claim 12, Chiang teaches the skin preparation device of claim 1, wherein the antiseptic composition includes CHG and an alcohol (isopropyl alcohol and chlorhexidine gluconate; [0068]).
As to claim 13, Chiang teaches the skin preparation device of claim 12, wherein the alcohol is isopropyl alcohol ([0068],ll.14).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Tuman (US 2010/0257685 A1).
As to claim 7, Miller teaches the skin preparation device of claim 6, but does not teach wherein the synthetic sponge comprises at least one of a polyurethane, a polyester, and/or a vegetal cellulose.
However, Tuman teaches a cleaning sponge (100; Fig.1; [0012]), comprising: wherein the synthetic sponge comprises at least one of a polyurethane, a polyester, and/or a vegetal cellulose ([0014]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to have employed the sponge material of Tuman upon the device of Miller, and one of skill would have been motivated to do so, in order to effectively retain antiseptic material for transfer to a patient's skin.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Perez (EP 2499914 B1)
As to claim 14, Chiang teaches the skin preparation device of claim 13, but does not teach wherein the antiseptic composition includes about 2% (w/v) CHG and about 70% (v/v) isopropyl alcohol.
However, Perez teaches an antiseptic composition ([0015]), comprising: about 2% (w/v) CHG ([0015]) and about 70% (v/v) isopropyl alcohol ([0015]).
It would have been obvious to a person having ordinary skill in the art to have employed the composition relative amounts of Perez with the device of Chiang, and one of skill would have been motivated to do so, in order to effectively clean a patient site and prevent infection, and where such amounts could be determined using routine experimentation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NICHOLAS WEISS, can be reached on 571-270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781