DETAILED ACTION
Notice of Pre-AIA or AIA Status
This action is in response to the claims set filed 11/18/2025 following the Non-Final Rejection of 08/26/2025. Claims 1-3, 5, 7-10, 12-13, 15 and 18 were amended. Claims 1-20 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 filed 11/18/2025, with respect to the drawing objections have been fully considered but they are not persuasive. The drawing objections are maintained.
The drawings still do not present the claimed subject matter of “the female luer connector comprises a double-start thread defining two thread grooves” from claim 12 nor “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, with the second thread groove forming a fluid channel through which the disinfecting solution can flow” from claim 13. Applicant's amendments do not address the previously presented drawing objections and also lead to other issues.
Applicant’s arguments, see Remarks, filed 11/18/2025, with respect to the claim objections, and claims rejected under 35 USC § 112(b) have been fully considered and are persuasive. These objections and/or rejections of 08/26/2025 have been withdrawn.
Applicant’s arguments, see Remarks, filed 11/18/2025, with respect to the rejection(s) of claim(s) rejected under 35 USC § 102 and/or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of amendments made to the claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “threaded outer surface of the female luer connector comprises a double-start thread defining two thread grooves” of claim 12 and “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, with the second thread groove forming a fluid channel through which the disinfecting solution can flow” of claim 13 must be shown or the feature(s) canceled from the claim(s). Thread grooves being understood in the art to mean the groove formed between threads/ridges. Currently, none of the figures show thread grooves present on the threaded outer surface of the female luer connector and none of the figures show a thread groove forming a fluid channel along which the disinfecting solution can flow. No new matter should be entered.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “54” has been used to designate both “a double or multi-start thread 54”, “a first thread groove 54” as well as “a second thread groove 54” for the luer hub 22 in pr. 49. 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. 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.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the “first thread groove 54” and the “second groove 54” of the luer hub 22 as described in pr. 49 the instant specification. Instead, reference character 54 in figures 8 and 9 point to threads or possibly thread ridges of the luer hub 22. A “thread groove” is generally understood in the art to be the slot or low section between two threads or thread ridges. 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.
Specification
The amendment filed 11/18/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: a “first thread groove 54” stated a plurality of times in pr. 49 and a “second thread groove 54” stated a plurality of times in pr. 49. These are understood to be new matter since 54 was originally introduces as “a double or multi-start thread 54” in pr. 49 and is also show to be a thread in figs. 8-9. It is considered new matter since it is redefining what 54 by the amendments to the specification it is and reference character 54 that is/was already established as thread(s) by the specification and drawings.
Applicant is required to cancel the new matter in the reply to this Office Action.
The disclosure is objected to because of the following informalities:
Paragraph 49 of the instant specification is objected to since reference character “54” is used for the luer hub 22 to reference “a double start or multi-start thread 54”, “a first thread groove 54” and “a second thread groove 54”. It is improper to use the same reference character for three different parts.
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.
(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 and 7-9 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 mating feature of the luer hub (see outer threads 42 of female luer connector 40 fig. 4A);
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 the luer hub 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 possible luer hub to seal off the IV catheter assembly upon engagement of the cap/device 50 with the IV assembly, such as a luer hub with an opening corresponding to the finger 58 fig. 4A).
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).
Regarding Claim 7, Alpert discloses the disinfecting cap of claim 1, wherein the mating feature of the luer hub comprises a female luer connector comprising a threaded outer surface (see threads 42 of female Luer connector 40 in fig. 4A) engageable with the threaded inner surface of the sidewall (see threads 54 of sidewall 55 in fig. 4B).
Regarding Claim 8, Alpert discloses the disinfecting cap of claim 7, wherein the disinfecting member (matrix 56 fig. 4A) being configured to clean and/or disinfect the threaded outer surface of the female luer connector (matrix 56 shown to be able to clean/disinfect the threads 42 of the female Luer connector 40 in fig. 4B).
Regarding Claim 9, Alpert discloses the disinfecting cap of claim 7, wherein the tapered protrusion (finger 58 fig. 4A) 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 possible 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 would permit this capability).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alpert as applied to claim 1 above, and further in view of US 10828483, herein referenced as Detloff.
Regarding Claim 6, Alpert discloses the disinfecting cap of claim 1, but fails to anticipate wherein the tapered protrusion (male post 120 fig. 4A) comprises a hollow protrusion (male post 120 shown to be hollow in fig. 4A).
Alpert and Detloff are analogous art since they both relate to the field of endeavor of medical devices.
Detloff teaches wherein the tapered protrusion (male post 120 fig. 4A) comprises a hollow protrusion (male post 120 shown to be hollow in fig. 4A). This disclosure establishes that a hollow protrusion was known in the art.
Since Detloff discloses that having a hollow protrusion was known in the art, it would have been obvious matter of simple substitution to one of ordinary skill in the art to have substituted the solid protrusion of Alpert to be a hollow protrusion as disclosed by Detloff, which would have the predictable result of the cap of Detloff including a hollow protrusion/finger. One of ordinary skill in the art would have been motivated to make this modification for apparent reason such as reduction in material usage and weight. See MPEP 2143 subsection B “Simple substitution of one known element for another to obtain predictable results”.
Claim(s) 10, 16-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2020112749A1, herein referenced as Coyle, in further view of US 2018/0200500, herein referenced as Ziebol.
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Figure 5C of Coyle
Regarding Claim 10, Coyle discloses an intravenous (IV) catheter assembly comprising:
a luer hub (female needleless connector 70 fig. 5C); and
a disinfecting cap (female luer capping portion 300 fig. 5C) configured to mate with the luer hub (70 fig. 5C), the disinfecting cap comprising:
a housing (see housing 20 of 300 fig. 5C) defining an inner cavity (cavity 28 fig. 4), the housing comprising a top wall (see wall 22 at top of housing 20 of 300 in fig. 5C), a sidewall (sidewall portion 26 fig. 5C) extending down from the top wall (22 fig. 5C) and having a threaded inner surface (see one or more threads 36 fig. 5C), an open bottom end (open end 303 fig. 5C) formed by the sidewall (26 fig. 5C) configured to receive the luer hub (see female connector 70 fig. 5C), and a tapered protrusion (see protrusion 310 in fig. 5C; “a protrusion 310 (which can be essentially cylindrical, or frustoconical, extending from inner surface 25 and coaxial with sidewall 26)” pr. 27) extending a length downward from the top wall (22 fig. 5C) and being integrally formed with the top wall and sidewall (protrusion 310 shown to be integrally formed with the top wall and side wall in fig. 5C), the protrusion having a single taper angle along the length (shown in fig. 5C; ‘the protrusion can be essentially frustoconical’ pr. 27); and
an annular shaped absorbent disinfecting member (see a disinfecting member or members, such as an IPA soaked sponge 50 for the female luer capping portion 300 in fig. 7; the sponge 50 in fig. 7 would be provided around the protrusion 310 in fig. 5C, this would make it annular) disposed within the inner cavity adjacent an inner surface of the top wall (shown in fig. 7) and positioned about the tapered protrusion (the sponge 50 in fig. 7 is shown such that it would be provided around the protrusion 310 in fig. 5C), the absorbent disinfecting member including a disinfecting solution and being configured to disinfect portions of the luer hub (the isopropyl soaked sponge 50 in fig. 7 possess the structure to disinfect portions of the female connector 70 in fig. 5C);
wherein the tapered protrusion (310 fig. 5C) is configured to interfit (see interfit between outer surface 311 of protrusion 310 and open luer end 76 of female connector 70 in fig. 5C) with the luer hub (70 fig. 5C) to seal off the IV catheter assembly upon engagement of the disinfecting cap (300 fig. 5C) with the IV catheter assembly (“having an outer surface 311 configured for extending into, or mating with, female open luer end 76” pr. 27).
However, Coyle fails to anticipate an intravenous (IV) catheter assembly comprising: a catheter hub comprising a distal end and a proximal end;
a catheter coupled to the distal end of the catheter hub and extending out distally therefrom, so as to be positionable intravenously within a patient;
an extension line coupled to the proximal end of the catheter hub;
[the] luer hub positioned at a proximal end of the extension line, the luer hub in fluid communication with the catheter through the extension line and the catheter hub; and
[the integrally formed protrusion, top wall and sidewall being formed] from a rigid thermoplastic polymer.
Coyle and Ziebol are analogous art since they both relate to the field of endeavor of medical devices.
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Figure 4A of Ziebol
Ziebol teaches of an intravenous (IV) catheter assembly (catheter 70 fig. 4A) comprising: a catheter hub (junction 86 fig. 4A) comprising a distal end (see end of junction 86 coupled with the two-lumen tube 87 in fig. 4A) and a proximal end (see left end of junction 86 fig. 4A);
a catheter (see catheter tip 89 fig. 4A) coupled to the distal end of the catheter hub (junction 86 fig. 4A) and extending out distally therefrom, so as to be positionable intravenously within a patient (see catheter tip 89 in fig. 4A);
an extension line (see the extension tubes 80 fig. 4A) coupled to the proximal end of the catheter hub (junction 86 fig. 4A);
a luer hub (see arterial hub 72’ fig. 4A) positioned at a proximal end of the extension line (80 fig. 4A), the luer hub in fluid communication with the catheter (see catheter tip 89 fig. 4A) through the extension line (80 fig. 4A) and the catheter hub (86 fig. 4A);
[a disinfecting cap with] a tapered protrusion (male luer 31 fig. 2B) extending a length downward from the top wall (shown in fig. 2B) and being integrally formed with the top wall and sidewall (male luer 31 shown to be integrally formed with the top wall and sidewall in fig. 2B) from a rigid thermoplastic polymer (“cap 20 can be injected molded as a single unit out of a thermoplastic polymer resin to allow high volume production at low manufacturing costs” and “Various polymer materials may be used that meet these requirements, such as polyester, nylon, polyetherimide, polypropylene, polyvinyl chloride or other similar materials” from pr. 63, two of these materials being a material provided in the instant specification). Ziebol further teaches that “the cap 20 is shown fully inserted into the catheter hub 72. When fully inserted, the male luer 31 contacts the female luer 75 to create a fluid tight seal. The cap threads 41 engage the catheter threads 78 to retain the cap 20 on the hub 72” in pr. 71.
Therefore, it would have been obvious before the effective filing date of invention to one of ordinary skill in the art to have modified Coyle to be used with the intravenous assembly disclosed by Ziebol so as to obtain the benefit of ‘creating a fluid tight seal for a catheter hub of a catheter assembly’ as taught by Ziebol. Further, it would have been obvious before the effective filing date of invention to one of ordinary skill in the art to have modified the integrally formed parts of the disinfecting cap of Coyle such that is injected moulded as a single unit of a thermoplastic polymer resin (such as polyester, nylon, and polypropylene) as disclosed by Ziebol, so as to obtain the benefit of ‘allowing high volume production at low manufacturing costs’ as taught by Ziebol.
Regarding Claim 16, the combination of Coyle and Ziebol comprises the IV catheter assembly of claim 10, wherein the disinfecting cap further comprises a peel-off protective cover (see peel sealing film 610 fig. 6 of Coyle) positioned over the open bottom end of the housing (see opening 27 at open end 303 fig. 5C of Coyle; “a peel sealing film 610 can be provided to seal the opening 27 prior to use of cap 10” pr. 28 of Coyle).
Regarding Claim 17, the combination of Coyle and Ziebol comprises the IV catheter assembly of claim 16, wherein a bottom edge of the sidewall (see rim 29 in fig. 4 of side wall 26 fig. 5C of Coyle) comprises a flange (see small flange that is provided at the open end 303 for female connector 300 in fig. 4 and fig. 6 of Coyle) formed thereon, with the peel-off protective cover sealed on the flange (the film 610 is shown to sealed on the small flange of the cap 10 in fig. 6 of Coyle).
Regarding Claim 19, the combination of Coyle and Ziebol comprises the IV catheter assembly of claim 10, wherein the tapered protrusion (310 fig. 5C of Coyle) extends to a bottom edge of the sidewall (see end 303 which sidewall 26 extends too in fig. 5C of Coyle), such that the tapered protrusion is flush with the open bottom end (the end of the protrusion 310 is shown to be flush with the open end 303 that represents the end of the sidewall 26 in fig. 5C of Coyle).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Coyle and Ziebol as applied to claim 10 above, and further in view of US 2013/0338644, herein referenced as Solomon.
Regarding Claim 15, the combination of Coyle and Ziebol comprises the IV catheter assembly of claim 10, wherein the absorbent disinfecting member comprises a compressible sponge (“an IPA soaked sponge 50” pr. 29 of Coyle) or open cell foam.
However, the combination of Coyle and Ziebol fails to teach wherein the sponge or open cell foam is compressed to release at least some of the disinfecting solution not before the tapered protrusion is interfit with the luer hub, to seal of the IV catheter assembly.
Solomon is analogous art since it relates to the field of endeavor of IV assemblies and/or disinfecting caps.
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Figure 23B of Solomon
Solomon teaches wherein the sponge or open cell foam (annular pad 932 fig. 23A; “the pad 132 can comprise any suitable sponge-like material, such as an elastomeric foam, any open-cell foam, felt, or non-woven fiber matrix” pr. 61) is compressed to release at least some of the disinfecting solution (see fig. 23C; “After formation of the seal, a distal end of the medical connector can come into contact with the pad 632 so as to compress the pad 632 and expel antiseptic therefrom” pr. 129) not before the tapered protrusion is interfit with the luer hub (see fig. 23B where a seal is formed between connector 302 and sealing member 941), to seal of the IV catheter assembly. Solomon further teaches that “a distal end of the connector 302 may be spaced from the pad 932 at this point, so as to prevent antiseptic from entering into the lumen 322 prior to creation of the seal” in pr. 135.
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 combination of Coyle and Ziebol such that the formation of the seal is created before the medical connector can come into contact and compress with the pad, such as by spacing the distal end of the connector from the pad, as disclosed by Solomon, so as to obtain the benefit of preventing antiseptic from entering the lumen 322 prior to creation of the seal’ as taught by Solomon. This modification can take of the form of modifying: 1) the dimensions/shape of the protrusion, cap, and/or sponge; 2) the dimensions/shape of parts of the luer hub; and/or 3) modifying the material of components (such as the luer hub); after a seal is initially formed, the cap could be further twisted onto the connector.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Coyle and Ziebol, as applied to claim 10 above, and further in view of US 11944776, herein referenced as Robert.
Regarding Claim 18, the combination of Coyle and Ziebol comprises the IV catheter assembly of claim 10, but fails to teach wherein the length is less than a length of the sidewall.
Robert is analogous art since it relates to the field of endeavor of disinfecting caps.
Robert teaches of wherein the length [of the protrusion] (see elongate member 620 fig. 10) is less than a length of the sidewall (the elongate member 620 is shown to extend less than a length of the sidewalls of cap 420 in fig. 10). This disclosure establishes that having a protrusion with a length less than a length of the sidewall was known in the art.
Since Robert discloses that having a protrusion with a length less than a length of the sidewall was known in the art, it would have been obvious matter of simple substitution to one of ordinary skill in the art to have substituted an extending flush protrusion in the combination of Coyle and Ziebol to be a protrusion which extends less than a length of the sidewall as disclosed by Robert, which would have a predictable result of a protrusion which is still capable of forming a seal. See MPEP 2143 subsection B “Simple substitution of one known element for another to obtain predictable results”.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Coyle and Ziebol, as applied to claim 10 above, and further in view of Detloff.
Regarding Claim 20, the combination of Coyle and Ziebol comprises the IV catheter assembly of claim 17, but fails to teach wherein the tapered protrusion comprises a hollow protrusion.
Detloff is analogous art since it relates to the field of endeavor of disinfecting caps.
Detloff teaches wherein the tapered protrusion (male post 120 fig. 4A) comprises a hollow protrusion (male post 120 shown to be hollow in fig. 4A). This disclosure establishes that a hollow protrusion was known in the art.
Since Detloff discloses that having a hollow protrusion was known in the art, it would have been obvious matter of simple substitution to one of ordinary skill in the art to have substituted the solid protrusion in the combination of Coyle and Ziebol to be a hollow protrusion as disclosed by Detloff, which have the predictable result of the cap of the combination possessing a hollow protrusion. One of ordinary skill in the art would have been motivated to make this modification for apparent reason such as reduction in material usage and weight. See MPEP 2143 subsection B “Simple substitution of one known element for another to obtain predictable results”.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coyle in view of Solomon.
Regarding Claim 10, Coyle discloses an [assembly] comprising:
a disinfecting cap (female luer capping portion 300 fig. 5C) configured to mate with the luer hub (70 fig. 5C), the disinfecting cap comprising:
a housing (see housing 20 of 300 fig. 5C) defining an inner cavity (cavity 28 fig. 4), the housing comprising a top wall (see wall 22 at top of housing 20 of 300 in fig. 5C), a sidewall (sidewall portion 26 fig. 5C) extending down from the top wall (22 fig. 5C) and having a threaded inner surface (see one or more threads 36 fig. 5C), an open bottom end (open end 303 fig. 5C) formed by the sidewall (26 fig. 5C) configured to receive the luer hub (see female connector 70 fig. 5C), and a tapered protrusion (see protrusion 310 in fig. 5C; “a protrusion 310 (which can be essentially cylindrical, or frustoconical, extending from inner surface 25 and coaxial with sidewall 26)” pr. 27) extending a length downward from the top wall (22 fig. 5C) and being integrally formed with the top wall and sidewall (protrusion 310 shown to be integrally formed with the top wall and side wall in fig. 5C), the protrusion having a single taper angle along the length (shown in fig. 5C; ‘the protrusion can be essentially frustoconical’ pr. 27); and
an annular shaped absorbent disinfecting member (see a disinfecting member or members, such as an IPA soaked sponge 50 for the female luer capping portion 300 in fig. 7; the sponge 50 in fig. 7 would be provided around the protrusion 310 in fig. 5C, this would make it annular) disposed within the inner cavity adjacent an inner surface of the top wall (shown in fig. 7) and positioned about the tapered protrusion (the sponge 50 in fig. 7 is shown such that it would be provided around the protrusion 310 in fig. 5C), the absorbent disinfecting member including a disinfecting solution and being configured to disinfect portions of the luer hub (the isopropyl soaked sponge 50 in fig. 7 possess the structure to disinfect portions of the female connector 70 in fig. 5C);
wherein the tapered protrusion (310 fig. 5C) is configured to interfit (see interfit between outer surface 311 of protrusion 310 and open luer end 76 of female connector 70 in fig. 5C) with the luer hub (70 fig. 5C) to seal off the IV catheter assembly upon engagement of the disinfecting cap (300 fig. 5C) with the IV catheter assembly (“having an outer surface 311 configured for extending into, or mating with, female open luer end 76” pr. 27).
However, Coyle fails to anticipate an intravenous (IV) catheter assembly comprising: a catheter hub comprising a distal end and a proximal end;
a catheter coupled to the distal end of the catheter hub and extending out distally therefrom, so as to be positionable intravenously within a patient;
an extension line coupled to the proximal end of the catheter hub;
[the] luer hub positioned at a proximal end of the extension line, the luer hub in fluid communication with the catheter through the extension line and the catheter hub; and
[the integrally formed protrusion, top wall and sidewall being formed] from a rigid thermoplastic polymer.
Coyle and Solomon are analogous art since they both relate to the field of endeavor of IV assemblies and/or disinfecting caps.
Solomon teaches of an intravenous (IV) catheter assembly (see fig. 25) comprising:
a catheter hub (see center of medical connector 300 in fig. 9 and fig. 25; the center of which is shown to form a hub in fig. 9) comprising a distal end (see end of central hub of medical connector 300 in fig. 9 which is coupled with male connector portion 303 in fig. 9; also see distal end in Examiner Figure 1) and a proximal end (see end of central hub of medical connector 300 in fig. 9 which is coupled with connection interface 312; also see proximal end in Examiner Figure 1);
a catheter (see catheter or line which connects medical connector 300 to the patent in fig. 25) coupled to the distal end of the catheter hub and extending out distally therefrom (shown in fig. 25), so as to be positionable intravenously within a patient (see catheter inserted intravenously within patient P in fig. 25);
an extension line (see extension line in Examiner Figure 1) coupled to the proximal end of the catheter hub (see proximal end of catheter hub in Examiner Figure 1);
a luer hub (see connection interface 132 of connector 302 in fig. 9) positioned at a proximal end of the extension line (connection interface 132 shown to be at a proximal end of the extension line in Examiner Figure 1), the luer hub in fluid communication with the catheter through the extension line and the catheter hub (see extension line and catheter hub in Examiner Figure 1); and
a disinfecting cap (cap 502 fig. 16-19B; “Any suitable combination of the features and variations of the same described with respect to the assembly 100 can be employed with the assembly 400, and vice versa. Such disclosure methods apply to additional embodiments disclosed hereafter, such as those shown in each of FIGS. 16-19B, 20, 21, 22, 23A-23C, and 24” pr. 112) configured to mate with the luer hub (shown in figs 19A-B);
a tapered protrusion (central post 509 fig. 18) extending a length downward from the top wall (513 fig. 18) and being integrally formed with the top wall and sidewall (see base wall 513, sidewall 512 and post 509 integrally formed for the housing 510 in fig. 18) from a rigid thermoplastic polymer (“the post 509 and/or the housing 510 can comprise any suitable form of injection moldable, medical grade plastic, including, for example, polypropylene, polyethylene, polycarbonate, polyurethane, ABS, thermoplastic materials” pr. 121; “polypropylene, polyethylene, polycarbonate, and ABS being materials listed in the instant specification).
Solomon further teaches that a “female cap can include a sealing member that is configured to plug or seal the open conduit” in pr. 40.
Therefore, it would have been obvious before the effective filing date of invention to one of ordinary skill in the art to have modified Coyle to be used with the intravenous assembly disclosed by Solomon so as to obtain the benefit of ‘plugging or sealing the open conduit’ as taught by Solomon. Further, it would have been obvious before the effective filing date of invention to one of ordinary skill in the art to have modified the integrally formed parts of the disinfecting cap of Coyle such that it formed of a rigid thermoplastic (such as polypropylene, polyethylene, polycarbonate, and ABS) as disclosed by Solomon, so as to obtain the benefit of ‘utilizing an injection moldable, medical grade plastic’ as taught by Solomon.
Regarding Claim 11, the combination of Coyle and Solomon comprises the IV catheter assembly of claim 10, wherein the luer hub comprises a female luer connector (see connection interface 312 of 302 in fig. 9 of Solomon, as used to modify Coyle; “the female connector portions 301, 302 each comprise a female luer lock fitting” pr. 102 of Solomon) including:
a hub body comprising a threaded outer surface (see threads 313 on outer surface of connection interface 312 in fig. 9 of Solomon, as used to modify Coyle) configured to engage the threaded inner surface of the sidewall (see threads 36on inner surface of capping portion 300 in fig. 5C of Coyle); and
a tapered cavity formed in the hub body (see tapered cavity defined by the inner surface 323 of the port 302 in figs. 9 and 19B of Solomon, as used to modify Coyle) and configured to mate with the tapered protrusion (“having an outer surface 311 configured for extending into, or mating with, female open luer end 76” pr. 27 of Solomon) to seal off the IV catheter assembly.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Coyle and Solomon, as applied to claim 11 above, and further in view of US 2018/0361003, herein referenced as Dombrowski.
Regarding Claim 12, the combination of Coyle and Solomon comprises the IV catheter assembly of claim 11, wherein the threaded outer surface of the female luer connector comprises a double-start thread defining two thread grooves (see double start threads or pair of threads 313 at outer surface of connection interface 312 which is shown to have two thread grooves in fig. 9 of Solomon, as used to modify Coyle).
However, the combination of Coyle and Solomon fails to teach wherein the threaded inner surface of the sidewall comprises a single-start thread.
Dombrowski is analogous art since it relates to the field of endeavor of disinfecting caps.
Dombrowski teaches of wherein the threaded inner surface (thread 30 fig. 2) of the sidewall (see sidewall of casing 14 fig. 2) comprises a single-start thread (“the configuration of the thread 30 can also vary. For example, the thread may comprise a single thread or dual threads that do not intersect (e.g., a double start, right hand thread)” pr. 26; the single thread would be equivalent to a single-start thread). This disclosure from Dombrowski establishes that it was known in the art before the effective filing date of the instant invention to have a threaded inner surface of a disinfecting cap to comprise a single-start thread.
Since Dombrowski establishes that a threaded inner surface of a disinfecting cap comprising a single-start thread was known in the art before the effective filing date of invention, it would have been obvious matter of simple substitution to one of ordinary skill in the art to have substituted the internal threading of the cap of Coyle, in the combination of Coyle and Solomon, to be a single-start thread, as disclosed by Dombrowski, for the predictable result of a suitable thread arrangement for a disinfecting cap. See MPEP 2143 subsection B “Simple substitution of one known element for another to obtain predictable results”.
Regarding Claim 13, the combination of Coyle, Solomon and Dombrowski comprises the IV catheter assembly of claim 12, wherein the single-start thread (“single thread” pr. 26 of Dombrowski, as used to modify the combination of Coyle and Solomon above) engages a first thread groove of the double start thread (see one of the thread grooves 313 in fig. 9 of Solomon, as modified by Coyle above), and wherein a second thread groove of the double start thread remains open (see the other thread groove in fig. 9 of Solomon, as modified by Coyle above), with 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 cap (The structure of the double-start threads 313 in fig. 9 of Solomon, as used to modify Coyle, and the single-start thread in fig. 2 of Dombrowski, as used to modify the combination of Coyle and Solomon, would result in one of the thread grooves forming a fluid channel through which the disinfectant can flow).
Regarding Claim 14, the combination of Coyle and Solomon comprises the IV catheter assembly of claim 11, wherein the threaded outer surface of the female luer connector comprises a double-start thread (see double start threads or pair of threads 313 at outer surface of connection interface 312 in fig. 9 of Solomon, as used to modify Coyle).
However, the combination of Coyle and Solomon fails to teach wherein the threaded inner surface of the sidewall comprises a double-start thread.
Dombrowski is analogous art since it relates to the field of endeavor of disinfecting caps.
Dombrowski teaches of wherein the threaded inner surface (thread 30 fig. 2) of the sidewall (see sidewall of casing 14 fig. 2) comprises a double-start thread (“the configuration of the thread 30 can also vary. For example, the thread may comprise a single thread or dual threads that do not intersect (e.g., a double start, right hand thread)” pr. 26). This disclosure from Dombrowski establishes that it was known in the art before the effective filing date of the instant invention to have a threaded inner surface of a disinfecting cap to comprise a double-start thread.
Since Dombrowski establishes that a threaded inner surface of a disinfecting cap comprising a single-start thread was known in the art before the effective filing date of invention, it would have been obvious matter of simple substitution to one of ordinary skill in the art to have substituted the internal threading of the cap of Coyle, in the combination of Coyle and Solomon, to be a double-start thread, as disclosed by Dombrowski, for the predictable result of a suitable thread arrangement for a disinfecting cap. See MPEP 2143 subsection B “Simple substitution of one known element for another to obtain predictable results”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8721627, US 12440659 US 11389634 – US patent grant of prior art cited above.
US 7780794 – discloses a disinfecting cap, states that polyethylene is a good material choice for these caps since it is stable when in the presence of alcohol.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/W.L.F./Examiner, Art Unit 3745
/COURTNEY D HEINLE/Supervisory Patent Examiner, Art Unit 3745