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 .
Response to Amendment
Applicant’s amendments filed on 07/06/2026 have been fully considered. Claims 1-6 and 8-15 are pending in this application. Claims 1, 4-6, 8-10, and 13-14 are amended.
Response to Arguments
Applicant’s arguments with respect to amended independent claim 1 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.
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 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1).
Regarding claim 1, Gibbs teaches a fluid applicator (applicator device 100; Paragraph 0026-0027; Figures 1-2) comprising:
a housing having an open proximal end (housing 110 has an open proximal end; Figures 1-2; Paragraphs 0026-0027), a distal base (distal base applicator 140; Figures 1-2; Paragraph 0026-0027) and a cavity configured to receive a pumping device (cavity of housing 110 receives reservoir 120 with plunger 130; Figures 1-2; Paragraph 0026), the distal base having a fluid applicator sponge extending distally from the distal base (accessory 150 can be a sponge that extends distally from base 140; Figure 1; Paragraph 0026);
the pumping device having a barrel (reservoir 120; Paragraph 0026; Figures 1-2) and a plunger at least partially disposed within the barrel (plunger 130 within reservoir 120; Figures 1-2; Paragraph 0026), the barrel having a distal end (reservoir 120 has a distal end; Figures 1-2) and an elongate tip extending from the distal end of the barrel (hose 202 extends from distal end of reservoir 120; Paragraph 0031; Figure 2), the elongate tip positioned a distance from the distal base of the housing (hose 202 is positioned a distance from the distal base of the housing 140; Figure 2), the barrel at least partially disposed within the cavity of the housing (reservoir 120 is within cavity of housing 110; Figures 1-2);
fluid disposed between the barrel and the plunger of the pumping device (fluid 122 is disposed between reservoir 120 and plunger 130; Figures 1-2; Paragraphs 0027-0028). Gibbs does not teach wherein one or more longitudinal ribs extend from an inside surface of the housing to create an interference fit with the barrel. Gibbs further teaches that the housing 110 and the reservoir 120 are separate and apart from each other (Paragraph 0027).
Gibbs and Gueret are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs incorporate the teachings of Gueret to have the threading on the inner surface of the housing of Gibbs and the external threading on the barrel of Gibbs, as taught by Gueret. This allows for the user to access the fluid within the container by opening/closing the connection between the two components (Gueret; Paragraph 0064). Furthermore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention was made to switch the location of the threading that was on the outer surface of the housing to be in the inner surface of the housing and the threading on the inner surface of the barrel to be on the outer surface of the barrel, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Regarding claim 2, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs in view of Gueret does not teach further comprising a flow distribution sponge disposed adjacent and proximal to the distal base.
Since the applicant has not disclosed that placing a second sponge adjacent to the distal base does anything more than produce predictable results (i.e. provide fluid distribution out from the distal base for delivering fluid onto the skin), the mere duplication of the fluid applicator sponge of Gibbs in view of Gueret is not considered to have patentable significance. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention was made, to modify Gibbs in view of Gueret to include a second sponge adjacent and proximal to the distal base, in order to predictably have an additional fluid distribution from the device towards the skin of the person. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
Regarding claim 3, Gibbs in view of Gueret teaches the fluid applicator of claim 2. The modified Gibbs in view of Gueret further teaches wherein the flow distribution sponge is configured to uniformly distribute fluid from the elongate tip of the pumping device (second fluid distribution sponge is fully capable of uniformly distribute fluid from the elongate tip of the pumping device; see rejection of claim 2 above).
Regarding claim 8, Gibbs in view of Gueret teaches the fluid applicator of claim 1. The combination of Gibbs in view of Gueret further teaches wherein the one or more longitudinal ribs are tabs (Gueret; threading 104 in the inner surface of structure 100 are tabs/projections to have interference fit with container 10 thread 12; Paragraph 0058; Figure 1 and 2A-2B). Regarding claim 9, Gibbs in view of Gueret teaches the fluid applicator of claim 1. The combination of Gibbs in view of Gueret further teaches wherein the one or more longitudinal ribs are an inner flange (Gueret; threading 104 in the inner surface of structure 100 are inner flanges to have interference fit with container 10 thread 12; Paragraph 0058; Figure 1 and 2A-2B).
Regarding claim 10, Gibbs in view of Gueret teaches the fluid applicator of claim 1. The combination of Gibbs in view of Gueret further teaches wherein the one or more longitudinal ribs are positioned a distance within the housing such that the distal end of the barrel of the pumping device abuts the one or more longitudinal ribs (threading 104 of Gueret on the inner surface of the housing of Gibbs is positioned a distance to engage with the thread 12 of Gueret on of the barrel of Gibbs; see rejection of claim 7 above).
Regarding claim 11, Gibbs in view of Gueret teaches the fluid applicator of claim 1. The combination of Gibbs in view of Gueret further teaches wherein the distal base is at an angle relative to the housing (distal base 140 is at an angle from housing 110; Figures 1-2).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1), as applied to claim 1 above, and further in view of Bergey et al. (Patent No. US 6,902,335 B2).
Regarding claim 4, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs in view of Gueret does not teach further comprising a frangible seal disposed over the elongate tip configured to break upon advancement of the plunger into the barrel of the pumping device.
However, Bergey teaches further comprising a frangible seal disposed over the elongate tip configured to break upon advancement of the plunger into the barrel of the pumping device (frangible seal 210 at the dispensing end of the device when pressure is applied to rupture the seal open for dispensing; Figure 2).
Gibbs in view of Gueret and Bergey are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Bergey to have the frangible seal of Bergey on the elongate tip of Gibbs in view of Gueret. This allows a controlled rupture of the seal by the user when the use of the applicator is desired (Bergey; Column 5, lines 57 to Column 6, line 3).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1), as applied to claim 1 above, and further in view of Thorne, JR. et al. (Publication No. US 2012/0265171 A1).
Regarding claim 5, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs in view of Gueret does not teach further comprising a friction tip cap disposed over the elongate tip configured to eject upon advancement of the plunger into the barrel of the pumping device.
However, Thorne, JR. teaches further comprising a friction tip cap disposed over the elongate tip configured to eject upon advancement of the plunger into the barrel of the pumping device (stopper 180 in pathway 164; Paragraph 0120; Figure 6-7).
Gibbs in view of Gueret and Thorne, JR. are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Thorne, JR. to have the friction tip cap of Thorne, JR. on the elongate tip of Gibbs in view of Gueret. This allows for a seal that is ejected when desired for dispensing by the user (Thorne, JR.; Paragraph 0120 and 0122-0123).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1), as applied to claim 1 above, and further in view of Montanari et al. (Publication No. US 2008/0115796 A1).
Regarding claim 6, Gibbs in view of Gueret teaches the fluid applicator of claim 1. The combination of Gibbs in view of Gueret does not teach wherein the barrel further comprises a flange surrounding a open proximal end of the barrel, the flange configured as a hard stop for limiting insertion of the pumping device into the housing.
However, Montanari teaches wherein the barrel further comprises a flange surrounding a open proximal end of the barrel (barrel 1 has flange 6 surrounding the open proximal end of the barrel; Figure 1 and 2; Paragraph 0043), the flange configured as a hard stop for limiting insertion of the pumping device into the housing (flange 6 of barrel 1 and flange 12 of plunger 8 prevents further insertion of plunger 8 through syringe and impact connection of part 14; Figure 1-2; Paragraph 0043 and 0053).
Gibbs in view of Gueret and Montanari are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Montenari to have the barrel of Gibbs in view of Gueret to be shaped with the flange and the open proximal end, as taught by Montenari. This allows for the barrel to not surpass the housing (Montenari; Paragraph 0053) and to allow for filling of device through open end of barrel (Montenari; Paragraph 0035-0037).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1), as applied to claim 1 above, and further in view of Quaglia (Publication No. US 2016/0106964 A1).
Regarding claim 12, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs in view of Gueret does not teach wherein the distal base is perpendicular to the housing.
However, Quaglia teaches wherein the distal base is perpendicular to the housing (flanged base 15 is perpendicular to the main body 2; Paragraph 0083-0085; Figure 2B).
Gibbs in view of Gueret and Quaglia are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Quaglia to have the housing of Gibbs in view of Gueret be attached with the distal base of Quaglia. This allows for the device to apply fluids parallel to the skin of the user (Quaglia; Paragraph 0085).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1), as applied to claim 1 above, and further in view of Hoang et al. (Publication No. US 2004/0240927 A1).
Regarding claim 13, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs in view of Gueret does not teach wherein the hollow barrel of the pumping device is made from a high barrier injection molded resin or glass configured to resist ethylene oxide (EtO) Gas.
However, Hoang teaches wherein the hollow barrel of the pumping device is made from a high barrier injection molded resin or glass configured to resist ethylene oxide (EtO) Gas (ampoule is made of glass which is a barrier to EtO gas; Paragraph 0081).
Gibbs in view of Gueret and Hoang are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Hoang to have the barrel of Gibbs in view of Gueret to be made of glass, as taught by Hoang. This allows the applicator to be protected from EtO gas during the sterilization process (Hoang; Paragraph 0081).
Regarding claim 14, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs in view of Gueret does not teach wherein the pumping device is resistant to EtO Gas.
However, Hoang teaches wherein the pumping device is resistant to EtO Gas (Paragraph 0081).
Gibbs in view of Gueret and Hoang are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Hoang to have the barrel of Gibbs in view of Gueret to be made of glass, as taught by Hoang. This allows the applicator to be protected from EtO gas during the sterilization process (Hoang; Paragraph 0081).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbs (Publication No. US 2021/0186182 A1) in view of Gueret (Publication No. US 2003/0075200 A1), as applied to claim 1 above, and further in view of Bergey et al. (Patent No. US 6,902,335 B2), Hoang et al. (Publication No. US 2004/0240927 A1), and Ruiz, SR. et al. (Publication No. US 2015/0266049 A1).
Regarding claim 15, Gibbs in view of Gueret teaches the fluid applicator of claim 1. Gibbs further teaches a method of assembling and sterilizing the fluid applicator of claim 1 (Paragraph 0030) comprising the steps of:
pre-filling the pumping device with products for cleansing the skin (Paragraph 0030),
advancing the hollow barrel of the pumping device into the cavity of the housing (Paragraph 0031). Gibbs in view of Gueret does not teach sealing the elongate tip of the pumping device with a frangible seal.
However, Bergey teaches sealing the elongate tip of the pumping device with a frangible seal (frangible seal 210 at the dispensing end of the device when pressure is applied to rupture the seal open for dispensing; Figure 2).
Gibbs in view of Gueret and Bergey are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret incorporate the teachings of Bergey to have the frangible seal of Bergey on the elongate tip of Gibbs in view of Gueret with the method of sealing of the elongated tip, as taught by Bergey. This allows a controlled rupture of the seal by the user when the use of the applicator is desired (Bergey; Column 5, lines 57 to Column 6, line 3).
The combination of Gibbs in view of Gueret and Bergey does not teach pre-filling the pumping device with disinfectant, sterilizing the pumping device with EtO sterilization.
Hoang teaches pre-filling the pumping device with disinfectant (cleansing fluid is antimicrobial; Abstract; Paragraph 0053 and 0054), sterilizing the pumping device with EtO sterilization (Paragraph 0081).
Gibbs in view of Gueret and Bergey and Hoang are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Gibbs in view of Gueret and Bergey incorporate the teachings of Hoang to have the pre-filled fluid of Gibbs in view of Gueret and Bergey to be the antimicrobial disinfectant, as taught by Hoang, with the method of the sterilization of the device using EtO sterilization, as taught by Hoang. This allows the applicator to be protected from EtO gas during the sterilization process (Hoang; Paragraph 0081) and for the device to sterilize the skin of the patient before medical procedures (Hoang; Paragraph 0002).
The combination of Gibbs in view of Gueret, Bergey, and Hoang does not teach packaging and sterilizing the fluid applicator with a non-hazardous sterilization.
However, Ruiz, SR. teaches packaging and sterilizing the fluid applicator with a non-hazardous sterilization (overpack can be used to protect applicators and go through heat sterilization; Paragraph 0125).
Gibbs in view of Gueret, Bergey, Hoang and Ruiz, SR. are considered to be analogous to the claimed invention because they are in the same field of fluid dispensers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the method of assembling and sterilizing the device of Gibbs in view of Gueret, Bergey, and Hoang incorporate the teachings of Ruiz, SR. to have the device of Gibbs in view of Gueret, Bergey, and Hoang to be placed in the overpack and go through a non-hazardous sterilization, as taught by Ruiz, SR. This allows for additional protection of the device from microbials (Ruiz, SR.; Paragraph 0125-0126).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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