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
The amendment filed 05/21/2026 has been entered. Claim 6 has been amended. Claims 7-23 have been cancelled. Claims 32-33 are new. Claims 1-6 and 24-33 remain pending in this application.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive.
Applicant argues that Cordoba fails to disclose a plurality of disinfecting materials, and that Cordoba only discloses a single disinfecting material. However, as discussed below, Cordoba discloses gauze (¶ 0024). Cordoba further discloses positioning the gauze over the injection area such that the gauze absorbs blood (¶ 0024). Thus, under the broadest reasonable interpretation of “disinfecting material”, the gauze of Cordoba is considered to be a disinfecting material.
Regarding claim 6, applicant argues that Cordoba fails to disclose more than one container carrying the disinfecting material. However, as discussed in the arguments above, the gauze of Cordoba is considered to be a disinfecting material under the broadest reasonable interpretation. As discussed in the rejection below, Cordoba discloses the antiseptic-soaked dressing 3 is attached or fastened onto container 12 (¶ 0023) and storage compartment 4 carrying gauze is integrated into receptacle 11 (¶ 0024) (fig. 7).
Accordingly, claims 1 and 6 remain anticipated by Cordoba.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32, ln. 3 should read ---impregnated or [[/]]soaked with a disinfecting agent---
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6, 24, 26-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cordoba et al. (Pub. No.: US 2018/0264243 A1).
Regarding claim 1, Cordoba discloses (fig. 5-9) an accessory (cap assembly 1, fig. 8) configured to be attached to a medical device (autoinjector body 2, fig. 5) to disinfect a skin surface or a surface of the medical device (¶ 0017), the accessory comprising:
A plurality of disinfecting materials (anti-septic soaked dressing 3, ¶ 0023 and gauze and bandages in the storage compartment 4, ¶ 0024); and
A mounting mechanism (slip-fit fastener 141) configured to attach and detach the accessory to the medical device (¶ 0021).
Regarding claim 2, Cordoba discloses wherein the medical device comprises one of a medication delivery pen (autoinjector body 2, abstract), a syringe, a patch pump and a safety device.
Regarding claim 3, Cordoba discloses wherein the medical device comprises one of a medication delivery pen (autoinjector body 2, abstract) having a pen cap (receptacle 11) and a syringe having a syringe shield; and the mounting mechanism is attached to one of the pen cap (fig. 8) and the syringe shield.
Regarding claim 4, Cordoba discloses wherein the mounting mechanism comprises one of a universal cap, spring loaded member, press fit, adhesive, threads and a button (¶ 0021).
Regarding claim 5, Cordoba discloses a housing (removable cover 12 and receptacle 11) that carries the plurality of disinfecting material (¶ 0023-¶ 0024); wherein the mounting mechanism is connected to the housing (¶ 0025).
Regarding claim 6, Cordoba discloses a plurality of containers (receptacle 11 and removable cover 12) each one carrying one of the plurality of disinfecting materials (¶ 0023-¶ 0024); and an interlocking mechanism configured to removably connect adjacent containers to each other (cover fastener 13, ¶ 0025) and to removably connect one of the containers to the medical device (¶ 0021).
While Cordoba does not explicitly disclose “wherein after use, a selected container of the plurality of containers is removed and a subsequent container of the plurality of containers is available for use”, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The plurality of containers of Cordoba is capable of being used such that “wherein after use, a selected container of the plurality of containers is removed and a subsequent container of the plurality of containers is available for use” since Cordoba discloses that the plurality of containers are removably connected (¶ 0025), thus, a selected container (receptacle 11) is removable (¶ 0025) and once removed, a subsequent container (receptacle 12) is capable of being available for use (fig. 7), and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding claim 24, Cordoba discloses wherein the mounting mechanism comprises a mechanical clip (¶ 0028, fig. 9).
Regarding claim 26, Cordoba discloses wherein: each of the plurality of containers includes: a hollow disk (see receptacle 111 and storage compartment 4) for carrying one of the disinfecting materials (¶ 0023-¶ 0024); and an opening that exposes a central portion of the disinfecting material (fig. 7, ¶ 0024).
Regarding claim 27, Cordoba discloses wherein each of the plurality of containers comprises a two piece assembly that is configured to be opened to remove the disinfecting material for disinfection (first container comprises storage receptacle 11 and removable cover 12, second container comprises removable cover 12 and cover lid 5, ¶ 0024, fig. 8).
Regarding claim 28, Cordoba discloses a medical device assembly (fig. 7) comprising: the accessory of claim 1 (see claim 1 above); and the medical device comprises one of a medication delivery pen (autoinjector body 2, abstract), a syringe, a patch pump and a safety device.
Regarding claim 29, Cordoba discloses a universal fitting that provides engagement between the medical device and the accessory (the receptacle 11 can be attached to a variety of different autoinjectors, ¶ 0021, thus the autoinjector body 2 comprises a universal fitting).
Regarding claim 30, Cordoba discloses wherein the universal fitting includes one of a ring (see autoinjector body 2, fig. 7), rotating sleeve, ribs, pleats, scales and a spring loaded member.
Regarding claim 31, Cordoba discloses wherein the universal fitting communicates with a microcontroller to vary commands for operating the accessory (¶ 0027).
Claim Rejections - 35 USC § 103
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) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cordoba, as applied to claim 5 above, and further in view of Mast, Jr. (US Pat. No.: 4,053,242), hereinafter Mast.
Regarding claim 25, Cordoba fails to disclose wherein the housing includes a spring that moves the plurality of disinfecting material toward a distal end of the accessory.
Mast teaches (fig. 1-6) an accessory (package 12) to application to a skin surface (col. 1, ln. 19-21) and thus in the same field of endeavor, the accessory comprising: a plurality of disinfecting materials (applicators 1); and a housing (tubular wall 13, col. 4, ln. 61-64), wherein the housing includes a spring (18) that moves the plurality of disinfecting material toward a distal end of the accessory (see bottom 15) (col. 5, ln. 8-13), the spring configured to dispense the disinfecting material (abstract).
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 housing of Cordoba such that it includes a spring that moves the plurality of disinfecting material toward a distal end of the accessory, as taught by Mast, in order to dispense the disinfecting material (Mast, abstract).
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cordoba, as applied to claim 1 above, and further in view of Solomon et al. (Pub. No.: US 2011/0044850 A1).
Regarding claim 32, Cordoba discloses wherein the plurality of disinfecting materials includes a plurality of discrete disinfecting units (antiseptic soaked dressing 3, ¶ 0023 and gauze, ¶ 0024). Cordoba fails to disclose each disinfecting unit comprises a disinfecting material impregnated or soaked with a disinfecting agent and configured to disinfect the skin surface or the surface of the medical device.
Solomon teaches (fig. 10) an accessory (assembly 100) configured to be attached to a medical device (¶ 0116) to disinfect a skin surface or a surface of the medical device (¶ 0125, ¶ 0131) and thus in the same field of endeavor, the accessory comprising a plurality of disinfecting materials including a plurality of discrete disinfecting units (pad 1032, pad 1070), each disinfecting unit comprises a disinfecting material impregnated or soaked with a disinfecting agent (antiseptic 1033) and configured to disinfect the skin surface or the surface of the medical device (¶ 0125, ¶ 0131), such plurality of disinfecting materials impregnated or soaked with disinfecting agent configured to disinfect medical connectors (¶ 0092).
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 plurality of discrete disinfecting units of Cordoba such that they each comprise a disinfecting material impregnated or soaked with a disinfecting agent and configured to disinfect the skin surface or the surface of the medical device, as taught by Solomon, in order to configure the accessory to disinfect medical connectors (Solomon ¶ 0092).
Regarding claim 33, Cordoba discloses wherein the plurality of disinfecting materials includes at least two of the plurality of discrete disinfecting units are successively usable (¶ 0023-¶ 0024).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Harding et al. (Pub. No.: US 2021/0138221 A1) discloses an accessory comprising a plurality of disinfecting materials. Burkholz (Pub. No.: US 2020/0222682 A1) discloses a plurality of disinfecting materials.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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