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 .
Election/Restrictions
Applicant’s election without traverse of the following species in the reply filed on January 27, 2026 is acknowledged: 1) The first adhesive member having a circular cross-section; 2) The antibacterial agent located in an absorbent material; 3) The absorbent material has a rectangular, square, or oval cross-section; and 4) The skin is located at the shoulder or covers a clavicle bone, a scapula bone, an upper half of a humerus bone, or a combination thereof.
Claims 2, 7, 8, 31, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 27, 2026.
Drawings
The drawings are objected to because Figure 8 is a photograph of a line drawing with text which is difficult to read, but it could be replaced with the line drawing in Figure 8 in the PCT counterpart application, WO 2023/0009854. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 objected to because of the following informalities: absence of a period ending the claim. Appropriate correction is required.
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 16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the applicator is a second roller that further comprises a second central member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. All of “the applicator”, “a second roller, and ”a second central member” are without antecedent bases because the claims from which claim 16 depends recites none of an applicator, a first roller, and a first central member.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 4, 6, 17-19, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Castaldi (US 2015/0148276).
Castaldi teaches “a method of avoiding unnecessary contamination and/or infections by using a flexible waterless adhesive sheet for extracting detritus and dirt particles from skin surfaces, including hands” (para.0002; see entire document including title; abstract). The method involves a user who “would grasp a hand cleaner sheet and make a tightly closed fist[sic] to force the gum on the sheet into the pores and crevices of the hand. ..sheet 1 is then peeled off along with any bacteria carrying debris on any surface of the body” (para.0036). “[P]eeled off along with any bacteria carrying debris …“ indicates exposing bacteria present in skin pores. A single sheet or multiple sheets in a stack or a roll as shown in Figures 1 through 3 both comprise “a first adhesive member”.
Castaldi does not limit the target skin surface to hands (para.0002), and expressly teaches other body parts such as legs and arms (para.0041). The arm comprises skin over parts of the shoulder and the humerus bone. Furthermore “[i]n addition to the capture of undesirable particles, the hand cleaner sheets can also incorporate antibacterial additives that will further enhance the product” (para.0025).
Castaldi does not specifically refer to “preparing the skin for surgery” as in claim 1, to reduce a risk of bacterial infection. However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to use Castaldi’s method to disinfect, i.e., prepare, skin for surgery because Castaldi teaches reducing bacterial infection that are common in hospitals and clinics, by physicians and other healthcare workers (paras.0009-10, 0020; see paras.0028-29).
Regarding claims 3, 4, and 6, Figure 3 shows a roll 4 of the cleaner sheets which roll has a circular cross-section and a convex shape. It is noted that in Applicant’s disclosure discussions of “convex shape” relates to a non-straight cylinder such as shown in Figure 2 (Specification paras.[0030], [0032], [0036]). None of instant claim 4, or claims 3 and 1 from which it depends, requires a cylinder. Therefore “convex shape” is given a plain meaning interpretation as having an outline or surface curved like the exterior of a circle or sphere.
Claim(s) 1, 3-6, 17-19, 29, 30, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Castaldi (US 2015/0148276) in view of Slone (US 2017/0319046).
Castaldi does not specifically teach a first adhesive member having a curved surface of a cylinder with a rounded end as in claims 5 and 54.
Slone teaches adhesive roller assemblies having a roller that is “non-cylindrical”, i.e., having “a concave, convex, undulating, dimpled or bumpy surface” (abstract; see entire document including title; Figs.5, 15, 16). Figures 5 and 16 show a cylindrical roller with an undulating curved surface wherein both ends are rounded (paras.0026, 0036, 0053). The adhesive roller can be used to remove “hair, dust, dirt and other loose foreign matter”, including on a person’s body (paras.0020, 0037, 0056-57; Fig. 16).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Castaldi and Slone and devise using cleaning sheets on a roller as in Castaldi’s Figure 3, with one or two rounded end(s) as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to using an adhesive on a roller to remove “hair, dust, dirt and other loose foreign matter” on a person’s body, and Slone teaches that a roller having multiple protuberances or depressions such as at the ends would be “particularly useful in collecting unwanted particulates from soft materials such as… excess hair from a person's beard” (para.0056; see para.0057).
Claim(s) 1, 3, 4, 6, 9-15, 17-19, 22-24, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Castaldi (US 2015/0148276) in view of Ghobrial (Ghobrial, G.M., et al., Preoperative skin antisepsis with chlorhexidine gluconate versus povidone-iodine: a prospective analysis of 6959 consecutive spinal surgery patients, J Neurosurg Spine 28:209–214, 2018) as evidenced by BD ChloraPrep™ Patient Preoperative Skin Preparation (available at https://www.bd.com/en-us/products-and-solutions/products/product-brands/chloraprep#applicators accessed on Feb. 20, 2026).
Castaldi does not specifically teach an antibacterial agent located in an absorbent material or an applicator that comprises an absorbent material and the antibacterial agent located in a reservoir as in claims 9-15 or the agents in claims 22-24.
Ghobrial discusses preoperative skin antisepsis, specifically by applying either betadine with a winged povidone-iodine scrub sponge and then with a sterile sponge stick, or ChloraPrepTM (2% chlorhexidine gluconate and 70% isopropyl alcohol) in a 26 mL applicator (title; abstract; p.210 right col. “Skin Disinfectant Protocol”). The winged povidone-iodine scrub sponge comprises the agents in the sponge which is an absorbent material. The ChloraPrepTM applicator has a handle, a reservoir containing the antiseptic, and an absorbent skin-contacting surface into which the antiseptic soaks into upon activation (see images in BD ChloraPrep™ Patient Preoperative Skin Preparation, available at https://www.bd.com/en-us/products-and-solutions/products/product-brands/chloraprep#applicators accessed on Feb. 20, 2026; the three left applicators are 26mL; see also p.12 & Figure 6, Pala, A., et al., BME 400: Biomedical Engineering Design (Fall 2010) Project: Skin Applicator Final Report, December 8, 2010). As evidenced by the web-page the absorbent skin-contacting surface could have a rectangular, square, or circular cross-section or shaped as a right cylinder or have a convex shape depending on the antiseptic dose in the reservoir.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Castaldi and Ghobrial and use the ChloraPrepTM applicator for preoperative antisepsis as recited in the instant claim(s). The skilled person would have been motivated to do so because both references are drawn to skin disinfection in hospitals comprising application of antibacterial agents, and Ghobrial teaches successful preoperative antisepsis using the ChloraPrepTM applicators. The skilled person would also recognize the convenience of using the pre-loaded applicators. Regarding claim 23 official notice is taken that topical antibiotics such as mupirocin was common at the time of effective filing.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614