CTNF 18/443,511 CTNF 96369 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Double Patenting 08-33 AIA 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 7-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 6-14 of copending Application No. 18684213 (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 skin of a patient, comprising: an applicator configured to absorb the antiseptic composition, 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; and a holding portion 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 , which reads on the applicator and gripping portion of the instant claim 1. 08-35 Claim s 1 and 9-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 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 § 112 07-30-02 AIA 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. 07-34-01 Claim 20 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. Regarding claim 20, “the one or more non-alcohol based compounds” in line 1 lacks antecedent basis. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1, 3-5, and 9-15 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by (US 20110066121 A1, provided in Applicant’s IDS of 2/20/2024) . Regarding claim 1 , Hoang teaches a skin preparation device for applying an antiseptic composition to skin of a patient (abstract: An antiseptic applicator device) , comprising: an applicator configured to absorb the antiseptic composition (Fig. 8: applicator 540 with plate 530; par. 42: The applicator 140 comprises a non-woven material or foam sponge pad that is attached to the distal end 114 via an adhesive that is compatible with the antiseptic agent 122) , 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. 8: top surface and bottom surface (not shown) of applicator 540, wherein the top surface is facing upwards and the bottom surface is facing downwards) ; 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. 8: body 810). Regarding claim 3 , Hoang teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the gripping portion is a ring-shaped structure (Fig. 9A: body 910; Fig. 9B shows that the structure is round and hollow and thus ring-shaped). Regarding claim 4 , Hoang 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. 8: body 810 has two prongs which define two opposite ends). Regarding claim 5 , Hoang 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. 8: body 810). Regarding claim 9 , Hoang 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 (par. 38: For example, in some embodiments an antimicrobial solution in accordance with the present invention includes a 50-95% alcohol solution… The alcohol is generally selected from at least one of ethyl alcohol, isopropal alcohol, n-propanol alcohol, and mixtures thereof; NOTE: the antiseptic composition is not positively recited in claim 1 and therefore, so long as the device of Hoang is capable of being used with the claimed antiseptic composition, Hoang would read on this limitation). Regarding claim 10 , Hoang 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 (par. 38: For example, in some embodiments an antimicrobial solution in accordance with the present invention includes a 50-95% alcohol solution… In some embodiments, the solution further contains dimethicone, glycerin, cationic polymer such as PVP, cellulose, docosanol, BTMS, behenyl alcohol and/or poloxamer. In a preferred embodiment, a base antimicrobial solution contains approximately 70% alcohol, 2% CHG and 28% USP purified water for skin prepping, and 0.12% CHG in alcohol for mouth disinfecting). Regarding claim 11 , Hoang 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 (par. 38: For example, in some embodiments an antimicrobial solution in accordance with the present invention includes a 50-95% alcohol solution which further includes additional antimicrobial agents such as CHG , PCMX , triclosan , octenidine , hexachlorophene , PVP-1, iodine , and/or quaterine compounds). Regarding claim 12 , Hoang 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 (par. 38: For example, in some embodiments an antimicrobial solution in accordance with the present invention includes a 50-95% alcohol solution… In some embodiments, the solution further contains dimethicone, glycerin, cationic polymer such as PVP, cellulose, docosanol, BTMS, behenyl alcohol and/or poloxamer. In a preferred embodiment, a base antimicrobial solution contains approximately 70% alcohol, 2% CHG and 28% USP purified water for skin prepping, and 0.12% CHG in alcohol for mouth disinfecting). Regarding claim 13 , Hoang teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the antiseptic composition includes CHG and an alcohol (par. 38: In a preferred embodiment, a base antimicrobial solution contains approximately 70% alcohol, 2% CHG and 28% USP purified water for skin prepping, and 0.12% CHG in alcohol for mouth disinfecting). Regarding claim 14 , Hoang teaches the skin preparation device of claim 13, as set forth above, and teaches wherein the alcohol is isopropyl alcohol (par. 38: The alcohol is generally selected from at least one of ethyl alcohol, isopropal alcohol). Regarding claim 15 , Hoang 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 Hoang is capable of being used with the claimed antiseptic composition, Hoang would read on this limitation; par. 38: The alcohol is generally selected from at least one of ethyl alcohol, isopropal alcohol… In a preferred embodiment, a base antimicrobial solution contains approximately 70% alcohol, 2% CHG and 28% USP purified water for skin prepping, and 0.12% CHG in alcohol for mouth disinfecting) . 07-15 AIA Claim s 16-17 and 19-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Lim (KR 101873172 B1) . 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). 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 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 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 2 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hoang in view of Law (US 20170165463 A1, provided in Applicant’s IDS of 2/20/2024) . Regarding claim 2 , Hoang teaches the skin preparation device of claim 1, as set forth above, but does not teach wherein the applicator and the gripping portion are made of the same material . Hoang teaches a material for the body but does not teach a material for plate 530 of the applicator (par. 9: The body is generally composed of a semi-flexible polymer material capable of being compressed or squeezed by a user). 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 body and the applicator are formed of the same material (par. 49: Polyolefin walls for the pre-loaded container body are preferred (as they are cheap), with polypropylene most preferred; par. 65: The applicator body is made from polypropylene). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plate 530 of Hoang to be formed of the same material as that of the body/gripping portion, as taught by Law, as one possible means of fulfilling the need for a material to make up the plate 530. Regarding claim 6 , Hoang modified by Law teaches the skin preparation device of claim 1, as set forth above, and teaches wherein the applicator and the gripping portion are formed from a single piece of material (since the Law modification 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). Regarding claim 7 , Hoang teaches the skin preparation device of claim 1, as set forth above, and teaches a sponge (par. 42: The applicator 140 comprises a non-woven material or foam sponge pad) but does not teach wherein the applicator is at least one of a natural sponge and a synthetic sponge . Hoang does not teach a specific material for the sponge pad. Law teaches wherein the sponge pad of an applicator is made out of polyurethane (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 sponge pad of Hoang to be made out of polyurethane, as taught by Law, in order to provide a material for the sponge pad suitable for use in a disinfectant applicator. A polyurethane sponge would read on a synthetic sponge. Regarding claim 8 , Hoang modified by Law 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 . 07-21-aia AIA 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 Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on (571) 272-1374 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /C.C./Examiner, Art Unit 1796 /KEVIN JOYNER/Primary Examiner, Art Unit 1799 Application/Control Number: 18/443,511 Page 2 Art Unit: 1796
Prosecution Insights