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 .
Response to Amendment/Arguments
The Amendment filed 6/19/2026 has been entered. Claims 1-5 and 7-20 remain pending on the application. Applicant’s amendments to the Specification and the Claims have overcome each and every 112(b) rejection to the Claims previously set forth in the Non-Final Office Action mailed 3/25/2026.
Applicant argues:
The Office Action acknowledges that Hoang fails to disclose or suggest an applicator and a gripping portion that are formed from a single piece of material. Additionally, Hoang also fails to disclose or suggest an applicator and a gripping portion that are integrally formed. Instead, the applicators in Hoang are formed separately of a non-woven material or foam sponge pad (see paragraph [0042] of Hoang) and the bodies of the devices in Hoang are a semi- flexible polymer. See paragraph [0057] of Hoang. Moreover, Hoang discloses that the mounting plate 530 provides a generally planar surface "which is attached an applicator 540." As such, Hoang fails to disclose or suggest an applicator and a gripping portion that are integrally formed, and that are formed from a single piece of material.
Additionally, Law fails to remedy the deficiencies of Hoang.
First, the Office Action asserts that Law discloses an applicator and a gripping portion that are formed from a single piece of material, because "Law makes the applicator and gripping portion the same material, then they would be capable of being formed from a single piece of material that may be separated into different parts." Specifically, the Office Action points to "polyolefin walls for the pre-loaded container body" in paragraph [0049] and "applicator body" in paragraph [0065] of Law as an applicator and a gripping portion. However, neither of these components would be reasonably considered as "an applicator" as is disclosed in Hoang and therefore would provide no motivation to modify the applicator 540 of Hoang such as to form the applicator 540 as an integral part and from a single piece of material with the rest of the body of the antiseptic applicator devices 800 in Hoang. Here, the "polyolefin walls for the pre-loaded container body" are the walls of pre-loaded container 11 which is configured to contain component liquids. See paragraphs [0016] and [0049] of Law. The "applicator body" is applicator body 10 which "extends outwardly and upwardly from the applicator pad" and which receives the pre- loaded container. See paragraphs [0013]-[0014] and [0065]-[0066] of Law. In contrast, the applicator 540 in Hoang is an applicator pad that is configured to absorb and apply an antiseptic solution to a desired surface. See paragraph [0009] of Hoang. In this regard, neither the pre-loaded container 11 nor the applicator body 10 of Law can be reasonably equated to the applicator 540 in Hoang, such that Law provides no disclosure or suggest to provide the applicator 540 as being formed of a single piece of material with the rest of the body of the antiseptic applicator devices 800 of Hoang. It is noted that in the rejection of claim 2, the Office Action discusses modifying "the plate 530 of Hoang." However, amended independent claim 1 recites that the applicator includes a bottom surface that is "configured to apply the antiseptic composition to the skin of the patient," and since plate 530 does not include such a bottom surface, any such modification must also include motivation to modify applicator 540 of Hoang, which Applicant maintains is not present.
Additionally, Law also fails to render obvious an applicator and a gripping portion that are integrally formed. Specifically, as discussed above, neither the pre-loaded container 11 nor the applicator body 10 can be reasonably equated to applicator 540 of Hoang. Moreover, the pre-loaded container of Law is disclosed as being received within the applicator body and that pre- loaded container is capable of movement relative to the applicator body. See paragraph [0014] of Law. In this regard, it cannot be reasonably asserted that the pre-loaded container and the applicator body are integrally formed. Still further, the remaining portion of the devices of Law, a deformable liquid permeable applicator pad, is disclosed as being "attached at an edge to the applicator body," and therefore is not integrally formed with the pre-loaded container or the applicator body. See paragraphs [0015] and [0035] of Law.
As such, amended independent claim 1 is novel and not obvious over Hoang and Law at least because Hoang and Law fail to disclose or suggest an applicator and a gripping portion that are integrally formed, and further, which are formed from a single piece of material.
Claims 2-5 and 7-15 depend from amended independent claim 1 and are believed to be patentable for at least the same reasons as amended independent claim 1.
Additionally, Applicant respectfully submits that claim 2 is novel and not obvious for at least the same reasons as amended independent claim 1 as well as for the following reasons. The Office Action asserts that Law provides motivation to modify "the plate 530" of Hoang to be formed of the same material as a gripping portion. However, claim 2 recites, including recitations from its dependency on amended independent claim 1, an applicator including a bottom surface configured to apply an antiseptic composition to the skin of a patient, and that the applicator is made of the same material as a gripping portion. Here, "the plate 530" of Hoang does not include a bottom surface configured to apply an antiseptic composition to the skin of a patient and, therefore, Law would be require to modify a material of applicator 540 to arrive at an applicator with the claimed bottom surface which is also formed of the same material as a gripping portion. In this regard, Applicant respectfully submits that Law provides no motivation to modify a material of the applicator 540 of Hoang. For example, for the reasons discussed above, the pre-loaded container 11 and the applicator body 10 of Law cannot be reasonably equated to the applicator 540 of Hoang, such that Law provides no motivation to modify the applicator 540 to include the same material as the rest of the devices in Hoang. Moreover, the applicator pad of Law is deformable and liquid-permeable and therefore appears to not suggest being formed of the same material as the remainder of the devices in Law. As such, claim 2 is novel and not obvious over Hoang and Law.
Reconsideration and withdrawal of the prior art rejections over Hoang are respectfully requested.
Applicant’s amendments have further specified claim 1 such that the entire portion of the applicator has to be the same material as the rest of the body and has to be integrally formed with the rest of the body. As such, the rejections to claim 1 and its dependent claims have been updated to rely on Lim instead and Applicant’s arguments regarding the deficiencies of Hoang and Law are now moot.
Independent claim 16 has been amended to recite, in relevant part, that "opposing ends of the skin preparation device are bonded together to form the clasping portion." Applicant respectfully submits that amended independent claim 16 is novel and not obvious for at least the following reasons.
Lim is directed to a finger application device including a body that includes a coating part 100 for applying a material, and a supply part 200 for supplying a material to the coating part. See Abstract of Lim translation. The device further includes a fixing part for fixing the device to a finger. Id. The fixing part 400 includes a finger coupling ring 430. See page 4 of Lim translation. Lim discloses that the upper end of application unit 100 (i.e., coating part 100) is contracted by elasticity when pressure is applied by the user's scraping motion. See page 3 of Lim translation. In this regard, it is the surface of coating part 100 that applies a liquid to the patient.
However, Lim fails to disclose or suggest a skin preparation device that includes opposing ends that are bonded together to form the clasping portion. Instead, Lim simply provides a finger coupling ring 430 which forms a semi ring structure for inserting a finger, but does not reasonably disclose or suggest opposing ends of a device that are bonded together to form a clasping portion.
Additionally, Lim fails to disclose or suggest an applicator and a clasping portion that form a ring-like structure that has a passageway defined therethrough, in which a user can insert a finger to use the skin preparation device. Specifically, the Office Action equates the finger coupling ring 430 of Lim to a clasping portion, and the entire remainder of the finger application device of Lim as an applicator, and that the finger coupling ring 430 discloses a ring-like structure as recited in independent claim 16. However, Lim does not disclose or suggest a ring-like structure that is formed from both an applicator and a clasping portion, but instead, only discloses the finger coupling ring 430 that forms the alleged ring-like structure. As such, Lim fails to disclose or suggest an applicator and a clasping portion, where this applicator and clasping portion form a ring-like structure.
As such, amended independent claim 16 is novel and not obvious over Lim at least because Lim fails to disclose or suggest opposing ends of a skin preparation device that are bonded together to form a clasping portion, and further, fails to disclose or suggest an applicator and a clasping portion that form a ring-like structure.
Examiner has further clarified how Lim reads on this structure in the rejection to claim 16. The two prongs of the ring 430 are interpreted to be opposing ends of the device. In addition, the two prongs are interpreted to be melded to the neck/spine that connects with the rest of the body and is interpreted to be part of the applicator, such that the middle of the ring is formed by that neck/spine, which comprises part of the ring-like structure. That is, the ring is interpreted in terms of three parts: the neck/spine in the middle, and the two curved parts connected to it.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18853958 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application teaches
A skin preparation device for applying an antiseptic composition to a skin surface of a patient, the skin preparation device comprising:
an applicator 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; and
a holding member configured to provide a portion of the skin preparation device that is gripped by a user when using the skin preparation device, 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, which reads on the applicator and gripping portion of the instant claim.
Claims 1 and 9-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, and 15 of copending Application No. 18071093 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application teaches
A device for aseptic skin treatment and disinfection of medical connectors comprising:a pad and a handle comprising a single piece of material, the pad soaked with a disinfectant material configured to be released from the pad when pressed against a skin surface of a patient, the pad having a distal face and a proximal face;the handle associated with the proximal face of the pad, the handle configured to be grasped to remove the device from a sterile package and to be manipulated by a user and to press and scrub the distal face of the pad against a surface of the skin while preventing unintended touch contamination of the distal face of the pad; andan opening extending through a portion of the distal face of the pad and at least partially into a body of the pad, the opening configured to receive at least an end portion of a medical connector therein such that a portion of the pad comes into contact with the medical connector for disinfecting the medical connector. The pad reads on the applicator and the handle reads on the gripping portion of the instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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.
Claims 1, 3-5, 9-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim (KR 101873172 B1).
Regarding claim 1, Lim teaches a skin preparation device for applying an antiseptic composition to skin of a patient (abstract: The present invention relates to a finger application device fixed to a finger), comprising:
an applicator configured to absorb the antiseptic composition (Fig. 2: entire portion attached to ring 430, including a portion of the ring itself where the portion is attached; pg. 3 par. 6: A plurality of circular or hexagonal polygonal protrusions formed on the lower end of the material storage part 210 in contact with the material storage part 210 may be formed by a liquid material, a gel, or a semi-solid material from the material storage part 210 into a plurality of material receiving grooves 110, To be absorbed or adsorbed easily… Protrusions protruding at a predetermined height from the upper end of the application unit 100 are contracted by elasticity when pressure is applied by the user's scraping motion after the finger applicator of the present invention is worn and the material passes through the transmissive portion), the applicator comprising a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of the patient (Fig. 9: transmission portion is the bottom surface; Fig. 4: inside surface of the cap is the top surface); and
a gripping portion configured to provide a portion of the skin preparation device that is gripped by a user when using the skin preparation device (Fig. 2: finger combination ring 430);
wherein the applicator and the gripping portion are integrally formed; and
wherein the applicator and the gripping portion are formed from a single piece of material (Fig. 1-3; pg. 3 par. 5: The finger applicator 10 of the present invention is formed of any one or more materials).
Regarding claim 2, Hoang teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the applicator and the gripping portion are made of the same material (Fig. 1-3; pg. 3 par. 5: The finger applicator 10 of the present invention is formed of any one or more materials).
Regarding claim 3, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the gripping portion is a ring-shaped structure (Fig. 2: finger combination ring 430).
Regarding claim 4, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the gripping portion is formed from opposing ends of the skin preparation device (Fig. 2: each prong of the ring is interpreted to be an opposing end of the device; alternatively, the user may grip the device in a place where the portion is formed from opposing ends of the device).
Regarding claim 5, Lim teaches the skin preparation device of claim 4, as set forth above, and teaches wherein the opposing ends of the skin preparation device are bent away from the applicator (Fig. 2: the applicator as defined by the honeycombed portion is angled/bent away from the ring 430).
Regarding claim 9, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the antiseptic composition includes one or more alcohols, comprising ethyl alcohol, propyl alcohol, isopropyl alcohol, n-propanol, and/or mixtures thereof (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents)
Regarding claim 10, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the antiseptic composition includes one or more non-alcohol based compounds (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
Regarding claim 11, Lim teaches the skin preparation device of claim 10, as set forth above, and teaches wherein the one or more non-alcohol based compounds comprise at least one of iodine, para-chloro-meta-xylenol, bis-biguanides, chlorhexidine gluconate (CHG), chlorhexidine diacetate, a quaterium class compound, benzethonium chloride, benzalkonium chloride, chloroxylenol, triclosan, hexachlorophene, octenidine, diazolidinyl urea, methyl chloro isothiazoline, methyl isothiazoline, triclosan, and/or mixtures thereof (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
Regarding claim 12, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the antiseptic composition includes a mixture of alcohol and non-alcohol based compounds (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
Regarding claim 13, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the antiseptic composition includes CHG and an alcohol (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
Regarding claim 14, Lim teaches the skin preparation device of claim 13, as set forth above, and teaches wherein the alcohol is isopropyl alcohol (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
Regarding claim 15, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the antiseptic composition includes about 2% (w/v) CHG and about 70% (v/v) isopropyl alcohol (NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
Regarding claim 16, Lim teaches a skin preparation device for applying an antiseptic composition to skin of a patient (abstract: The present invention relates to a finger application device fixed to a finger), comprising:
an applicator configured to absorb the antiseptic composition (Fig. 2: entire portion attached to ring 430, including a portion of the ring itself where the portion is attached; pg. 3 par. 6: A plurality of circular or hexagonal polygonal protrusions formed on the lower end of the material storage part 210 in contact with the material storage part 210 may be formed by a liquid material, a gel, or a semi-solid material from the material storage part 210 into a plurality of material receiving grooves 110, To be absorbed or adsorbed easily… Protrusions protruding at a predetermined height from the upper end of the application unit 100 are contracted by elasticity when pressure is applied by the user's scraping motion after the finger applicator of the present invention is worn and the material passes through the transmissive portion), the applicator comprising a top surface and a bottom surface, the bottom surface configured to apply the antiseptic composition to the skin of the patient (Fig. 9: transmission portion is the bottom surface; Fig. 4: inside surface of the cap is the top surface); and
a clasping portion, connected with the applicator, wherein the applicator and the clasping portion form a ring-like structure that has a passageway defined therethrough, in which a user can insert a finger to use the skin preparation device (Fig. 2: finger combination ring 430, wherein the two prongs are interpreted to be the clasping portion, but the neck/spine that the prongs are attached to are interpreted to be part of the applicator);
wherein opposing ends of the skin preparation device are bonded together to form the clasping portion (Fig. 2: each prong of the ring is interpreted to be an opposing end of the device).
Regarding claim 17, Lim teaches the skin preparation device of claim 16, as set forth above, and teaches wherein the applicator and the clasping portion are formed as a monolithic structure (Fig. 1-3).
Regarding claim 19, Lim teaches the skin preparation device of claim 16, as set forth above, and teaches wherein the antiseptic composition includes one or more alcohols, comprising ethyl alcohol, propyl alcohol, isopropyl alcohol, n-propanol, and/or mixtures thereof (NOTE: the antiseptic composition is not positively recited in claim 16 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid; abstract: a body comprising a coating part applying one of materials selected from liquid).
Regarding claim 20, Lim teaches the skin preparation device of claim 16, as set forth above, and teaches wherein the antiseptic composition comprises one or more non-alcohol based compounds, wherein the one or more non-alcohol based compounds comprise at least one of iodine, para-chloro-meta-xylenol, bis-biguanides, chlorhexidine gluconate (CHG), chlorhexidine diacetate, a quaterium class compound, benzethonium chloride, benzalkonium chloride, chloroxylenol, triclosan, hexachlorophene, octenidine, diazolidinyl urea, methyl chloro isothiazoline, methyl isothiazoline, triclosan, and/or mixtures thereof (NOTE: the antiseptic composition is not positively recited in claim 16 and therefore, so long as the device of Lim is capable of being used with the claimed antiseptic composition, Lim would read on this limitation, which Lim is capable of since Lim teaches wherein the material applied is a liquid, gel, solid, semi-solid medicine, or other reagents; pg. 3 par. 4: the present invention relates to a finger applicator 10 fixed to a finger, which is selected from materials such as liquid, gel, solid, semi-solid medicine and cosmetics, reagents).
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, 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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Law (US 20170165463 A1, provided in Applicant’s IDS of 2/20/2024) and Pharris (US 3819779 A).
Regarding claim 7, Lim teaches the skin preparation device of claim 1, as set forth above, and teaches an applicator capable of absorbing various substances (pg. 3 last par.: The material storage unit 210 may be configured to store a material selected from a liquid, a gel, a semi-solid medicine, and a material such as a cosmetic, a reagent, a glue; pg. 3 par. 6: A plurality of circular or hexagonal polygonal protrusions formed on the lower end of the material storage part 210 in contact with the material storage part 210 may be formed by a liquid material, a gel, or a semi-solid material from the material storage part 210 into a plurality of material receiving grooves 110, To be absorbed or adsorbed easily) but does not teach wherein the applicator is at least one of a natural sponge and a synthetic sponge. Lim does not teach a specific material for its applicator.
Law also teaches a liquid applicator (abstract: A surgical preparation applicator device has a pre-loaded container of surgical preparation liquid). Law teaches wherein the applicator is made out of a polyurethane sponge pad (par. 65: The pad is a polyurethane sponge).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator of Lim to be made out of polyurethane, as taught by Law, in order to provide a material for the suitable for use in a disinfectant applicator.
A polyurethane sponge would read on a synthetic sponge.
Pharris discloses that a handle can be made out of polyurethane (abstract: A plastic molded paint brush handle… The handle is preferably formed of a foamed polyurethane), which means that an applicator device can have both its applicator and handle made out of polyurethane. Pharris teaches wherein the foam polyurethane handle has better grip (C1L39-49: As a result, numerous attempts have been made to fabricate paint brush handles using substitute materials, as for example, plastics. Most such handles are made by injection molding processes employing polyethylene plastics. However, such handles are undesirable in that they are extremely slick and difficult to grasp in any event and more so if paint drips on the handle. Furthermore, they do not possess the weight or texture characteristics of wood and therefore do not provide the "feel" of a wooden paint brush handle which is often desired by a professional painter).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rest of the body portion of Lim to be made out of hard polyurethane foam, as taught by Pharris, in order to provide a material that has good grip for the application of a liquid.
Regarding claim 8, Lim modified by Law and Pharris teaches the skin preparation device of claim 7, as set forth above, and teaches wherein the synthetic sponge comprises at least one of a polyurethane (see Law modification in claim 7 rejection), a polyester, and/or a vegetal cellulose.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lim.
Regarding claim 18, Lim teaches the skin preparation device of claim 16, as set forth above, but does not teach wherein the applicator and the clasping portion are formed separately and operatively connected to one another.
However, the separation of one part into discreet parts holds no patentable distinction, absent a showing of significant or unexpected results, and is prima facie obviousness. According to MPEP 2144.05.C:
In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.").
Moreover, Lim already teaches wherein the material container is detachable and operatively connectable to the rest of the device (abstract: The material supply part comprises a detachable material storage part). Making parts separate and detachable would also make it easier to replace individual parts of the device.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lim to have its ring 430 detachable and operatively connectable to the applicator portion, as taught by Lim, in order to make it easier to replace individual parts of the device.
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.
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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