DETAILED ACTION
Notice of Pre-AIA or AIA Status
This action is in response to the claims set filed 04/24/2026 following the Final Rejection of 02/24/2026. Claims 1, 7 and 10-14 were amended; claim 9 was cancelled; claim 21 is newly added. Claims 1-8 and 10-21 are currently pending.
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 Arguments
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to the specification objections and claims 10-20 rejected under 35 USC § 103 have been fully considered and are persuasive. These objections and rejections of 02/24/2026 have been withdrawn.
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to the drawing objections have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, a new ground(s) of objection is made in view of the new/replacement drawings.
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to claims rejected under 35 USC § 102 have been fully considered but they are not persuasive. The prior art still reads on to the claimed invention.
Applicant’s arguments with respect to claim(s) 6 rejected under 35 USC § 103 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.
Applicant's point on pages 12-13 of Remarks that “Anticipation requires that each element of a claim is disclosed by a single reference as arranged in the claim. As set forth above, Alpert does not disclose or suggest a disinfecting cap comprising a tapered protrusion configured to interfit with a tapered cavity of a female luer connector to seal off an intravenous (IV) catheter assembly” is not found persuasive by Examiner.
While Applicant is correct that Alpert does not explicitly state that their cap is “configured to interfit with a tapered cavity of a female luer connector to seal off an intravenous (IV) catheter assembly”, Alpert does not need to explicitly state this functional aspect to anticipate claim 1. The prior art only needs to have the structure that is needed/required to accomplish the “configured to” limitation. Currently, claim 1 is directed specifically to a disinfecting cap and the limitations related to the female luer connector are not positively recited/required by the claimed invention of a disinfecting cap. The structure of Alpert possesses the required structure to accomplish this task since the finger 58 possesses the required structure such that it is capable of interfitting with a tapered cavity of a hypothetical female luer connector to seal off a IV catheter assembly upon engagement of the cap/device 50 with the IV assembly due to the tapered form of the finger 58 in fig. 4A allowing it to interfit with a tapered cavity of a hypothetical female luer connector to form a seal. Applicant has not pointed out the particular structure that Alpert is missing/lacking which is required by the claimed invention of a disinfecting cap. For the reasons detailed above. Alpert still reads onto the claimed disinfecting cap. If Applicant would like for claim 1 and its dependents to have positively recited limitations related to the luer hub and/or female luer connector, the beginning of claim 1 could be amended to read something to the effect of: “A luer connection of an intravenous (IV) catheter assembly, the luer connection comprising: a luer hub and a disinfecting cap engageable with the luer hub”.
Regarding Applicant's point on page 16 of Remarks related to Solomon failing to disclosed a tapered protrusion formed from a rigid thermoplastic polymer. Examiner disagrees with Applicant's assertion. Applicant appears to misunderstand the limitation as recited in the claim. The claim requires that the tapered protrusion is formed of a rigid thermoplastic polymer, not that the tapered protrusion is rigid itself. Solomon discloses of particular materials that are cited directly in Applicant's instant specification. If Solomon does not disclose of a rigid thermoplastic polymer as alleged by applicant, then it raises questions as to what can be considered a rigid thermoplastic polymer and whether Applicant fully had possession of the invention at the effective filing date of invention if the specific materials listed in the instant specification would not qualify as rigid thermoplastic polymers. Solomon discloses the use of polypropylene, polyethylene, polycarbonate, and ABS which are also stated as usable materials in the instant specification.
Regarding Applicant's point on pages 18-19 of Remarks that “as shown in the magnified portion of fig. 9, Solomon does not show a double-start thread” is not found persuasive by Examiner.
In review of fig. 9 of Solomon, it is quite clear from fig. 9 that the connection interface 312 comprises a threading feature 313 which is a double-start thread where the first thread groove is visible at the top of the connection interface 312 and the clearly visible beginning of the second thread groove at the bottom of the connection interface 312 for the threading feature 313. This would be the start of a second thread groove for the threading feature 313 given its position at the threading feature 313. Applicant has not presented any rationale as to why the bottom groove clearly shown at the threading feature 313 would be an aesthetic feature or the like and not a thread groove for the threading feature 313 given its position at the threading feature 313.
Drawings
The new drawings of 04/24/2026 are address the prior drawing objections established in the Final Rejection of 02/24/2026 but also present new drawing objections.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “Meanwhile, while the first thread groove 54a engages the single-start thread 52, the second thread groove 54b of the threaded outer surface 28 of luer hub 22 remains open, with no thread mating therewith. The open second thread groove 54b on threaded outer surface 28 of luer hub 22 may, as explained in further detail below, serve as a fluid channel through which disinfecting solution may flow when the disinfecting cap 30 is coupled to the luer hub 22” as stated in pr. 49 of the specification (as well as discussed in claims 10 and 13). One manner of addressing this objection is to amend fig. 9 by swap the first thread groove “54a” and the second thread groove “54b” as this would show the second thread groove 54b as open with no thread mating therewith. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13, “wherein the single-start thread engages a first thread groove of the double start thread, and wherein a second thread groove of the double start thread remains open” should likely read “wherein the single-start thread engages [[a]] the first thread groove of the double-start thread, and wherein [[a]] the second thread groove of the double-start thread remains open”. This is because claim 10, from which claim 13 depends upon, has already introduced a first thread groove and a second thread groove of the double-start thread.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 14, the limitation “wherein the threaded inner surface of the sidewall comprises a double-start thread” leads to the claim failing the written description requirement. Claim 10, from which claim 14 depends upon, states that “the threaded outer surface comprising a double- start thread defining a first thread groove and a second thread groove” and “the second thread groove forming a fluid channel through which the disinfecting solution can flow upon engagement of the disinfecting cap”. The instant disclosure has only stated that the second thread groove can only form a fluid channel through which the disinfecting solution can flow when the threaded inner surface of the side wall comprises a single-start thread as this allows for the second thread groove to be open to function as a fluid channel. This is not the case when the threaded inner surface of the sidewall comprises a double-start thread, as required by claim 14, as that wouldn’t provide for an open second thread groove, which functions as a fluid channel, for the double-start thread of the threaded outer surface of the female luer connector. As such, this limitation of claim 14 leads to the claim failing the written description requirement and is considered new matter.
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.
Claim 14 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 14, the limitation “wherein the threaded inner surface of the sidewall comprises a double-start thread” renders the claim indefinite. Claim 10, from which claim 14 depends upon, states that “the threaded outer surface comprising a double-start thread defining a first thread groove and a second thread groove” and “the second thread groove forming a fluid channel through which the disinfecting solution can flow upon engagement of the disinfecting cap”. It is unclear how the second thread groove can form a fluid channel through which disinfecting solution can flow in the case where both the threaded inner surface and the threaded outer surface comprise double-start threads since there would no longer be an open thread groove which would form a fluid channel as both thread grooves would be occupied.
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.
(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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0022469, herein referenced as Alpert.
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Figure 4A of Alpert
Regarding Claim 1, Alpert discloses a disinfecting cap (device 50 fig. 4A) engageable with a luer hub (female leur connector 40 fig. 4A) of an intravenous (IV) catheter assembly (IV infusion system 12 fig. 1), the disinfecting cap comprising:
a housing (52 fig. 4A) defining an inner cavity (chamber 53 fig. 4A), the housing comprising:
a top wall (proximal wall 57 fig. 4A);
a sidewall (circumferential sidewall 55 fig. 4A) extending down from the top wall (57 fig. 4A), the sidewall comprising a threaded inner surface (threads 54 fig. 4A) configured to engage with a female luer connector of the luer hub (the threads 52 possess the required structure for a disinfecting cap such that it is capable of engaging with a hypothetical female luer connector of a luer hub, the threads 52 engaging with the outer threads 42 of connector 40 fig. 4A supports the conclusion stated by Examiner);
an open bottom end (shown in fig. fig. 4A) formed by the sidewall and defining an opening (see opening at bottom of chamber 53 defined by the circumferential sidewall 55 in fig. 4A) configured to receive the luer hub (shown in fig. 4B); and
a tapered protrusion (see tapered finger 58 in fig. 4A) extending a length downward from the top wall (57 fig. 4A) and being integrally formed with the top wall and sidewall (finger 58, circumferential sidewall 55 and proximal wall 57 are all shown to be integrally formed in fig. 4A) from a rigid thermoplastic polymer (“housing 52 may be molded in a single piece from a plastic, such as polypropylene or styrene, or other suitable material” pr. 39; polypropylene being one of the material listed for a thermoplastic polymer material in pr. 45 of the instant specification), the protrusion having a single taper angle along the length (the finger 58 shown to have only a single taper angle present along its length in fig. 4A; finger 58 shown in said figure to have a single taper angle and then a rounded end); and
an annular-shaped absorbent disinfecting member (matrix 56 fig. 4A; matrix would be annularly shaped since it would be provided around the finger 58 as shown in fig. 4A; “matrix 56 can be any fluid-absorbing material” pr. 34) disposed within the inner cavity (chamber 53 fig. 4A) adjacent an inner surface of the top wall (proximal wall 57 fig. 4A) and positioned about the tapered protrusion (matrix 56 shown to be positioned about finger 58 in fig. 4A), the absorbent disinfecting member including a disinfecting solution (“a matrix 56 that is configured to retain a quantity of a disinfectant fluid such as, for example and without limitation, isopropyl alcohol or chlorhexidine” pr. 34) and being configured to disinfect portions of the luer hub (40 fig. 4B; “Contact with or compression of matrix 56 may release a portion of the liquid disinfectant to wet the surface 48 as well as the portions of the body 41 adjacent to surface 48” pr. 35);
wherein the tapered protrusion is configured to interfit with a tapered cavity of the female luer connector to seal off the IV catheter assembly upon engagement of the disinfecting cap with the IV catheter assembly (the finger 58 possesses the required structure for a disinfecting cap such that it is capable of interfitting with a tapered cavity of a hypothetical female luer connector to seal off the IV catheter assembly upon engagement of the cap/device 50 with the IV assembly; the tapered form of the finger 58 in fig. 4A can interfit with a tapered cavity of a hypothetical female luer connector to form a seal).
Regarding Claim 2, Alpert discloses the disinfecting cap of claim 1, wherein the absorbent disinfecting member comprises a compressible sponge or open cell foam (“matrix 56 can be any fluid-absorbing material such as, for example and without limitation, polyester, polyvinyl acetate, polyurethane, or cotton, and may be formed into a woven or nonwoven pad or a foam” pr. 34), and wherein the sponge or open cell foam is compressed to release at least some of the disinfecting solution (“Contact with or compression of matrix 56 may release a portion of the liquid disinfectant to wet the surface 48 as well as the portions of the body 41 adjacent to surface 48” pr. 35) not before the tapered protrusion is interfit with the luer hub to seal off the IV catheter assembly (the device 50 and matrix 56 in fig. 4A possess the required structure for a disinfecting cap such that they are capable of releasing some of the disinfecting solution not before the finger 58 is interfit with a possible luer hub to seal off the IV catheter assembly).
Regarding Claim 3, Alpert discloses the disinfecting cap of claim 1, wherein the length is less than a length of the sidewall (the length the finger 58 extends from the proximal wall 57 is shown to be less than the length the circumferential wall 55 does in fig. 4A).
Regarding Claim 4, Alpert discloses the disinfecting cap of claim 1, further comprising a peel-off protective cover (lid 70 fig. 6) positioned over the open bottom end of the housing (lid 70 shown to cover the open bottom end of the chamber 53 in fig. 6).
Regarding Claim 5, Alpert discloses the disinfecting cap of claim 1, wherein the tapered protrusion comprises a solid protrusion (finger 58 is shown to be formed as a solid protrusion in fig. 4A).
Claim(s) 1 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0008393, herein referenced as Howlett.
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Examiner Figure 1 – annotated version of claim 18 of Howlett
Regarding Claim 1, Howlett discloses a disinfecting cap (see cap 302 figs. 18-20) engageable with a luer hub (see medical connector 340 fig. 19) of an intravenous (IV) catheter assembly (“Commonly, protective tip caps are applied to luer connectors of tubing, IV access devices, stopcocks and syringes” pr. 9), the disinfecting cap comprising:
a housing defining an inner cavity (see housing of cap 302 which defines the interior portion 304 in fig. 18), the housing comprising:
a top wall (see top wall in Examiner Figure 1);
a sidewall extending down from the top wall (see side wall in Examiner Figure 1), the sidewall comprising a threaded inner surface (see threads 306 on inner surface of side wall in Examiner Figure 1) configured to engage with a female luer connector (see medical connector 304 fig. 18; “Similar to post 280, post 308 is sized and shaped to be received within and sealingly engage a conduit of connector 340 when cap 302 is secured on connector 340 to prevent fluid within a fluid pathway from leaking out of the connection between connector 340 and cap 302” pr. 86; post 280 of cap 275 (similar to cap 302) is shown to be engaged with a female luer connector 132 fig. 16) of the luer hub (see fig. 18);
an open bottom end (see opening at bottom end of interior portion 304 of cap 302 on right in fig. 18) formed by the sidewall and defining an opening configured to receive the luer hub (see opening of cap 302 which receives the medical connector 340 fig. 18); and
a tapered protrusion (see tapered post 308 fig. 18) extending a length downward from the top wall (post 308 shown to extend a length from top wall in Examiner Figure 1) and being integrally formed with the top wall and sidewall from a rigid thermoplastic polymer (post 308 shown to be integrally formed with the top wall and side wall in Examiner Figure 1; “Caps 102 and 104 may be injection molded using polypropylene or other material that can be sterilized” pr. 63, polypropylene being listed as one of the rigid thermoplastic polymers that the instant invention can be made of), the protrusion having a single taper angle along the length (shown in fig. 18; “a frustoconical cone shaped post 308” pr. 86); and
an annular-shaped absorbent disinfecting member disposed within the inner cavity adjacent an inner surface of the top wall and positioned about the tapered protrusion (see pad 160 within interior 304 and adjacent the inner wall of the top wall in Examiner Figure 1; “disposed within interior portion 304 and about post 308 is a pad 160, which can be saturated or impregnated with an antiseptic agent” pr. 87), the absorbent disinfecting member including a disinfecting solution and being configured to disinfect portions of the luer hub (“pad 160, which can be saturated or impregnated with an antiseptic agent, as discussed herein. With either connector 340 or a male type cap, such as cap 104, connected to cap 302, pad 160 is disposed to contact at least threadable segment 344 of connector 340 or circular edge 148 of cap 104 (FIG. 5) to cleanse at least threadable segment 344” pr. 87);
wherein the tapered protrusion is configured to interfit with a tapered cavity of the female luer connector to seal off the IV catheter assembly upon engagement of the disinfecting cap with the IV catheter assembly (the frustoconical cone shaped post 308 in fig. 18 can be interfit with a tapered cavity of a female luer connector due to its frustoconical cone shape; “Similar to post 280, post 308 is sized and shaped to be received within and sealingly engage a conduit of connector 340 when cap 302 is secured on connector 340 to prevent fluid within a fluid pathway from leaking out of the connection between connector 340 and cap 302” pr. 86).
Regarding Claim 6, Howlett discloses the disinfecting cap of claim 1, wherein the tapered protrusion comprises a hollow protrusion (the orifice 310 of post 308 establishes the post 380 as a hollow protrusion/post as shown in fig. 18).
Regarding Claim 7, Howlett discloses the disinfecting cap of claim 1, wherein the female luer connector comprises a threaded outer surface engageable with the threaded inner surface of the sidewall (see threadable segment 344 of medical connector 340 which is engageable with the threads 306 in the interior portion 304 of cap 302 in fig. 18; “Threads 306 are of a size and pitch to complimentarily engage threads of another cap, such as cap 104, or a medical connector, such as connector 340, to facilitate coupling thereto as discussed herein” pr. 86).
Regarding Claim 8, Howlett discloses the disinfecting cap of claim 7, wherein the disinfecting member being configured to clean and/or disinfect the threaded outer surface of the female luer connector (see pad 160 which cleanses the threaded segment 344 of medical connector 340 fig. 18; “pad 160 is disposed to contact at least threadable segment 344 of connector 340 or circular edge 148 of cap 104 (FIG. 5) to cleanse at least threadable segment 344” pr. 87).
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howlett as applied to claim 1 above, and further in view of US 8197749, herein referenced as Mercer.
Regarding Claim 21, Howlett discloses the disinfecting cap of claim 1, but fails to explicitly anticipate wherein the absorbent disinfecting member has an abrasive texture configured to scrub a surface of the luer hub.
Howlett and Mercer are analogous art since they both relate to the field of endeavor of disinfecting caps.
Mercer teaches wherein the absorbent disinfecting member has an abrasive texture configured to scrub a surface of the luer hub (see pad 262 fig. 14; “Pad 262 can also be formed of an abrasive material that can break up hardened materials that have collected on a medical connector. Additionally, pad 262 can be formed of a material that can be impregnated or saturated with an antiseptic agent, such as alcohol or -chlorhexidine gluconate” col. 11 lines 29-34, the pad 262 formed of an abrasive material such that it can break up hardened materials would mean that it would also have an abrasive texture).
Therefore, it would have been obvious before the effective filing date of invention to one of ordinary skill in the art to have modified the pad 160 fig. 18 of Howlett such that it is formed of an abrasive material, as disclosed by Mercer, to obtain the benefit of ‘being able to break up hardened materials that have collected on a medical connector’ as taught by Mercer.
Allowable Subject Matter
Claims 10-12 and 15-20 are allowed.
Claims 13-14 would be allowable if rewritten or amended to overcome the claim objection and/or rejection(s) under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 10, no prior art was found which anticipated or rendered obvious the invention of claim 10. Particularly, “the luer hub comprising a female luer connector comprising a threaded outer surface, the threaded outer surface comprising a double-start thread defining a first thread groove and a second thread groove; a disinfecting cap configured to mate with the luer hub, the disinfecting cap comprising: a housing defining an inner cavity, the housing comprising a top wall, a sidewall extending down from the top wall and having a threaded inner surface, an open bottom end formed by the sidewall configured to receive the luer hub, and a tapered protrusion extending a length downward from the top wall and being integrally formed with the top wall and sidewall from a rigid thermoplastic polymer, the protrusion having a single taper angle along the length; and an annular shaped absorbent disinfecting member disposed within the inner cavity adjacent an inner surface of the top wall and positioned about the tapered protrusion, the absorbent disinfecting member including a disinfecting solution and being configured to disinfect portions of the luer hub; wherein the threaded inner surface of the sidewall is configured to engage the threaded outer surface of the female luer connector, the second thread groove forming a fluid channel through which the disinfecting solution can flow upon engagement of the disinfecting cap with the IV catheter assembly; and the tapered protrusion is configured to interfit with the luer hub to seal off the IV catheter assembly upon engagement of the disinfecting cap with the IV catheter assembly” in context of the other limitations recited in the claim.
The closest prior art found to claim 10 was US 2022/0211993 which states that provides for a disinfecting cap with an annular shaped absorbent disinfecting sponge disposed within an inner cavity of the disinfecting cap, the inner surface of the sidewall of the disinfecting cap is threaded and corresponds with external threading on the exterior surface of a female luer lock. Threading the cap fully onto the female luer lock compresses the sponge, thereby releasing disinfectant to bathe and disinfect the exterior surfaces of the female luer lock (shown to include threads in figs. 8-10). However, this reference does not have a tapered protrusion and fails to disclose “the second thread groove [of the dual of the double-start thread of the threaded outer surface of the female luer connector] forming a fluid channel through which the disinfecting solution [of the disinfecting member] can flow upon engagement of the disinfecting cap with the IV catheter assembly” as required by the claim. While it is clear that the disinfectant bathing the exterior surface of the female luer lock would interact and contact the threads of the female luer lock, it is not stated that at least one thread groove of the threads of the female luer lock would form a fluid channel (Merriam Webster defining channel as “a usually tubular enclosed passage: conduit”) through which the disinfectant can flow. No rationale was found which would make it obvious to modify this reference such that a thread groove would form a fluid channel as claimed. It is also considered that modifying the prior art such that the thread groove forms a channel (i.e. enclosed passage) may restrict the ability of the disinfectant to sufficiently bathe the exterior surface of the female luer lock due to the nature of modifying the thread groove to form an enclosed passage. This aspect is also not merely a design choice by Applicant this allows for the apparatus to “guide disinfecting fluid through an open channel groove of the luer hub 22, to direct the disinfecting solution along a desired path” as stated in pr. 58 of the instant specification.
US 8961475 discusses an antiseptic being permitted to flow to all open portions of a disinfection chamber and defined within a cap, hereby bathing an exterior surface of a female luer connector. US 10828483 discusses a cap for a female luer, where a liquid disinfectant housed/sealed within the cap is allowed to flow over the exterior surface of the female luer once the cap is fully screwed onto the female luer. However, these references similarly fail to disclose “the second thread groove [of the dual of the double-start thread of the threaded outer surface of the female luer connector] forming a fluid channel through which the disinfecting solution [of the disinfecting member] can flow upon engagement of the disinfecting cap with the IV catheter assembly” as required by the claim. While it is clear that the disinfectant would contact the exterior surface and threads of the female luer, it is not disclosed that at a thread groove of the threads of the female luer lock would form a fluid channel (i.e. an enclosed passage) through which the disinfectant can flow. It similarly not appearing to be obvious to modify a thread groove of the female luer of the prior art to from a channel (i.e. enclosed passage) as it may restrict the ability of the disinfectant to sufficiently bathe the exterior surface of the female luer lock due to the nature of modifying the thread groove to form an enclosed passage for the disinfectant.
US 9114915 discloses a cap for a male luer connector, the cap including a pad saturated with disinfectant, grooves/slits are provided along an inner wall of the cap to allow for routing of the disinfectant toward desired areas/regions. However, these grooves/slits are formed independent from any thread structure and the general structure being geared towards a cap for a male luer connector means it would fail to teach or render obvious the claimed invention.
For the reasons listed above, claim 10 and its respective dependents are deemed to contain allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8177761 – US patent grant of prior art cited above.
US 10525250 – discloses a connection comprised of a male connector and a female connector, an antimicrobial fluid flows into the channel/reservoir at an interior most portion of the male connector where the antimicrobial fluid contacts the end of the female connector and its externally threaded surface.
US 8622995 – discloses a cap for a female connector; in one embodiment, the cap can have a coating of an antimicrobial agent which would be dissolved by a lock solution which can be displaced from the female connector into a void between the threaded interface between the cap and the female connector during insertion of the cap; in an alternative embodiment, a thread seal made of an absorbent material can be provided between the threaded interface of the cap and the female connector, the thread seal can be have an incorporated antimicrobial composition and is capable of absorbing/retaining a lock solution originating from the female connector which would be pushed into the void at the threaded connection during insertion of the cap.
US 10391295 – discloses a cap for an IV needleless connector, the cap including a disinfection sponge, the threading interface between the cap and the connector being designed to ensure venting of the disinfection sponge whereby venting occurs essentially around the outside of the threads of the needleless connector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Wesley Fisher whose telephone number is (469)295-9146. The examiner can normally be reached 10:00AM to 5:30PM, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Court Heinle can be reached at (571) 270-3508. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.L.F./Examiner, Art Unit 3745
/COURTNEY D HEINLE/Supervisory Patent Examiner, Art Unit 3745
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