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 of Group I, encompassing claims 1-7 and 10-11 in the reply filed on 05/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Response to Amendment
An amendment was filed on 05/22/2026. Claims 1, 3-6, 8, and 10-11 have been amended. Currently, claims 1-11 are pending, with claims 8-9 have been withdrawn from consideration, and claims 1-7 and 10-11 are pending and are being examined on the merits.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Follman (US 20180333566) in view of Miller (US 5791801), and further in view of Flores (US 20100226706).
Regarding claim 1, Follman discloses a liquid applicator for applying a liquid to a surface (abstract), the liquid applicator comprising:
a hollow body (fig. 3B, handle 300 handle for holding swabs) comprising a wall defining an internal chamber having a closed end and an open end (fig. 3B, closes end in opposite direction from element 308, open end at element 308);
a polyurethane foam coupled to the open end of the hollow body (fig. 2, foam applicator 600 at the open end of handle 300. Paragraph 0041 describes the use of polyurethane foam and felted and non-felted foams); and
an alcohol-based antiseptic solution dispersed within the felted polyurethane foam (paragraph 0041, “the foam applicator 600 can function as a liquid reservoir and can store antiseptic drug product”, paragraph 0045, “the antiseptic solution can comprise at least 3.15% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol )
but is silent to wherein the polyurethane foam is a felted polyurethane foam, wherein the felted polyurethane foam has a flatwise tensile strength of at least 1.0 lbf*in/(in2 of foam)
However, Follman already teaches a polyurethane foam (paragraph 0041), and suggests that felted and non-felted foams are equivalent structures for the sake of the invention (paragraph 0041). Further, Miller teaches a liquid applicator (abstract) that uses a felted polyurethane foam (col. 4, lines 10-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Follman such that the polyurethane foam is a felted polyurethane foam, as taught and suggested by Fredric, since it has been held that substituting one equivalent structure for another would have been obvious to one of ordinary skill in the art.
Follman, as modified by Miller is silent to wherein the flatwise tensile strength is at least 1.0 lbf*in/(in2 of foam).
However, wherein the claimed and prior art products are identical or substantially identical in structure or composition [in this instance, a felted polyurethan foam], a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01.
If this is not clearly envisioned by the applicant, Flores teaches an applicator pad with a generic tensile strength of 10 PSI (paragraph 0023).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Follman such that the flatwise tensile strength is at least 1.0 lbf*in/(in2 of foam), as taught by Florence, for the purpose of providing a suitable tensile strength for a more durable product.
Regarding claim 2, Follman discloses wherein the polyurethane foam is a polyether polyurethane foam (paragraph 0041)
Regarding claim 3, Follman discloses an example foam wherein a porosity of the polyurethane foam is between 10-150 pores per linear inch (paragraph 0041), but is silent to wherein the porosity of the felted polyurethane foam, prior to felting, is between 10 pores per linear inch and 150 pores per linear inch.
However, because Follman teaches that aspects such as the material, dimensions, density, and pore size can be selected such that it stores a desired amount of liquid antiseptic (paragraph 0042), it appears that an aspect of the material such as the porosity would be considered a result effective variable that can be changed depending on how much antiseptic is desired to be held.
Regarding claim 4, Follman discloses wherein the alcohol-based antiseptic solution is selected as a chlorhexidine salt (paragraph 0045, wherein chlorhexidine gluconate is considered a chlorohexidine salt).
Regarding claim 5, Follman discloses wherein the alcohol-based antiseptic solution is selected as a chlorohexidine salt (paragraph 0045, wherein chlorhexidine gluconate is considered a chlorohexidine salt).
Claims 6-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Follman in view of Miller and Flores, and further in view of Dombrowski (US 20150094640).
Regarding claim 6, Follman discloses a method of preparing a site on skin of a patient, the method comprising:
providing a liquid applicator, comprising;
a hollow body (fig. 3B, handle 300 handle for holding swabs) comprising a wall defining an internal chamber having a closed end and an open end (fig. 3B, closes end in opposite direction from element 308, open end at element 308);
a polyurethane foam coupled to the open end of the hollow body (fig. 2, foam applicator 600 at the open end of handle 300. Paragraph 0041 describes the use of polyurethane foam and felted and non-felted foams); and
an alcohol-based antiseptic solution dispersed within the felted polyurethane foam (paragraph 0041, “the foam applicator 600 can function as a liquid reservoir and can store antiseptic drug product”, paragraph 0045, “the antiseptic solution can comprise at least 3.15% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol ), and is silent to the method comprising scrubbing the site with the felted polyurethane foam for a period of at least one minute.
but is silent to wherein the polyurethane foam is a felted polyurethane foam, wherein the felted polyurethane foam has a flatwise tensile strength of at least 1.0 lbf*in/(in2 of foam), and the method comprising scrubbing the site with the felted polyurethane foam for a period of at least one minute.
However, Follman already teaches a polyurethane foam (paragraph 0041), and suggests that felted and non-felted foams are equivalent structures for the sake of the invention (paragraph 0041). Further, Miller teaches a liquid applicator (abstract) that uses a felted polyurethane foam (col. 4, lines 10-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Follman such that the polyurethane foam is a felted polyurethane foam, as taught and suggested by Fredric, since it has been held that substituting one equivalent structure for another would have been obvious to one of ordinary skill in the art.
Follman, as modified by Miller is silent to wherein the flatwise tensile strength is at least 1.0 lbf*in/(in2 of foam), and wherein the method comprises scrubbing the site with the felted polyurethane foam for a period of at least one minute..
However, wherein the claimed and prior art products are identical or substantially identical in structure or composition [in this instance, a felted polyurethan foam], a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01.
If this is not clearly envisioned by the applicant, Flores teaches an applicator pad with a generic tensile strength of 10 PSI (paragraph 0023).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Follman such that the flatwise tensile strength is at least 1.0 lbf*in/(in2 of foam), as taught by Florence, for the purpose of providing a suitable tensile strength for a more durable product.
Follman is silent to the method comprising scrubbing the site with the felted polyurethane foam for a period of at least one minute.
However Dombrowski teaches that antiseptic preparation conventionally includes a 3-10 minute scrubbing of the affected area with an antiseptic soap solution (paragraph 0014).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Follman such that it involves scrubbing the site with the felted polyurethane foam for a period of at least one minute, as taught by Dombrowski, for the purpose of providing a suitable method that allows proper time for the antiseptic solution to work.
Regarding claim 7, Follman discloses wherein the site on the skin of the patient comprises a surgical site (paragraph 003, “It is common practice to prepare a patient for surgery by applying a fluid, such as an antiseptic solution, to a target body portion”)
Regarding claim 10, Follman discloses the method further comprising:
coupling the felted polyurethane foam to a handle (paragraph 007 describes the foam applicator coupled to the bottom surface of the plate to couple to the handle)
introducing the alcohol-based antiseptic solution into the felted polyurethane foam (paragraph 0043 describes the foam applicator )
Regarding claim 11, Follman discloses wherein the alcohol-based antiseptic solution is a chlorohexidine salt (paragraph 0045 describes the use of chlorhexidine gluconate, which is a chlorhexidine salt).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cybulski (US 20060072962) discloses a surgical prop solution applicator
Froimson (US 20130202482) discloses an applicator for dispensing a surgical prep solution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
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