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
Acknowledgement is made of the response filed on June 24, 2026. In that response, claims 1, 5, 6, and 10 were amended and claim 55 was added. Claims 1, 3-6, 9-19, 22-24, 29, 30, 54, and 55 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Drawings
The drawings remain objected to because Figure 8 is a photograph of a line drawing with text which is difficult to read. A replacement drawing for Figure 8 was received on June 24, 2026. It has the same illegible writing and therefore is not accepted. However the line drawing in Figure 8 in the PCT counterpart application, WO 2023/0009854, has been referenced for examination at this time.
Claim Objections
Claim 1 is objected to because of the following informalities: a “to” seems appropriate after “applying”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: claim 16 depends from claims 10 and 1 which do not recite a roller or a central member. Applicant argues (Remarks, 8, June 24, 2026) that claim 6 has been amended to recite a first roller and a first central member, and therefore claim 16 finds antecedent bases. However claim 16 does not depend from or otherwise require the limitations in claim 6. In claim 16, distinguishing the “a second central member” to “an applicator central member” or the like and “a second roller” to “an applicator roller” or the like would avoid lack of antecedent bases and confusion. 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 55 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 55 depends from claim 1 and recites “performing a surgical incision into the skin”. This step raises confusion. Claim 1 is drawn to “method of preparing skin for surgery”. However performing a surgical incision into the skin is itself a step of surgery, not “preparing …for” surgery. The disclosure does not discuss in what context a surgical incision comprises a step in preparation for surgery. Furthermore claim 1 recites “applying and then removing a first adhesive member from the skin,…”. It is ambiguous when the incision step of claim 55 occurs, i.e., before or after applying and then removing the adhesive member, or after applying the antibacterial agent in claim 1.
The Specification discusses not removing an adhesive member comprising the antibacterial agent, and then cutting through that member into the skin (Specification, para.[0038]). However this disclosure does not apply to claim 55 since it does not require an adhesive member comprising the antibacterial agent or making the incision through anything but skin.
For the purposes of examination now the step of claim 55 is construed as occurring at any point in the method of claim 1.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 4, 6, 9-19, 22-24, 29, 30, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Castaldi (US 2015/0148276) in view of Gavriely (US 2021/0205838).
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. Hand or palm skin does not comprise hair follicle whereas legs and arms comprise hair follicles as in claims 17 and 18.
Regarding the antibacterial agent, Castaldi teaches, “[i]n addition to the capture of undesirable particles, the hand cleaner sheets can also incorporate antibacterial additives that will further enhance the product by killing bacteria and germs that may be on the hand” and “[a]ny suitable antibacterial agent can be used as long as it is suitable for use with the PSA” (para.0025).
Castaldi does not specifically refer to “preparing the skin for surgery” as in claim 1 or performing an incision step, 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 discusses reducing bacterial infection that are common in hospitals and clinics, by physicians and other healthcare workers (paras.0009-10, 0020; see paras.0028-29), and removing “tiny particles of dirt and detritus may remain lodged in the pores and/or crevices of the skin's surface” that “may be difficult to see, [and] carry numerous infectious bacterial agents” (para.0031). Therefore it is easily conceivable that physicians and other healthcare workers in “hospitals, clinics” (para.0028) could perform a surgical incision after using Castaldi’s cleaner sheets.
Castaldi does not specifically teach an antibacterial agent located in a separate absorbent material or an applicator that comprises an absorbent material, roller, and a central member, and the antibacterial agent located in a reservoir as in claims 1, 9-16, and 22-24.
Gavriely teaches “a liquid disinfectant applicator device” comprising ”a frame, a pair of axle portions that are movable coupled to the frame at varying angles therebetween, an absorbable roller rotatably mounted on the pair of axle portions, a sealed resilient container, at least one conduit and a perforated plate” (abstract (emphasis added); see entire document including title; paras. 0008-13, 0055-68). The axle portion is a central member. The “invention relates to applicator devices that are configured to apply a relatively thin layer of liquid (e.g., a liquid medicament) to curved skin surfaces of a patient from a sterile reservoir of the liquid” (para.0001). Gavriely teaches applying a “betadine, …, germicidal detergent, chlorhexidine, and other disinfecting fluid,…” (para.0032). Figure 12 (para.0052) is shown below.
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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 Gavriely 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 clinical settings comprising contacting the skin with antibacterial agents provided on a substrate, and Gavriely teaches that its application could “uniformly spread a liquid on a surface, whether flat or curved/arcuate, while preventing the liquid from contact with ambient air (and its contaminants and oxygen) within the liquid reservoir of the device before being applied to the surface” (para.0015). The skilled person would further recognize the convenience of Gavriely’s applicator over embodiments where an absorbent applicator is dipped into a reservoir to load a disinfectant, prior to contacting the applicator with skin.
Regarding claims 3, 4, and 6, Castaldi’s 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. Figure 4 shows an outline of a hand to remind the user to grab the adhesive which would roll around the center 5 as in instant claim 6.
Regarding claim 10 Gavriely discusses prior art device (similar to the ChloraPrepTM applicators of record) wherein the absorbent material cannot rotate (Figs. 1D-1F, paras.0009-0010). Therefore the skilled person could envision may comprise a non-rotating absorbent applicator.
Claim(s) 1, 3-6, 9-19, 22-24, 29, 30, 54, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Castaldi (US 2015/0148276) in view of Gavriely (US 2021/0205838) and 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).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-6, 9-19, 22-24, 29, 30, 54, and 55 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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
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