DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-16 and 18-20, and Species A: Figs. 2-6C in the reply filed on 09/30/2025 is acknowledged.
Claims 9-15 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/30/2025.
Information Disclosure Statement
The information disclosure statements filed on 02/01/2023 and 06/18/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 4-5 are 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 claims 4, the recitation “wherein, when the open female luer connector is engaged to the cap, cleaning solution is exposed to portions of the open female luer connector for cleaning and/or disinfecting the open female luer connector” is indefinite because it is not clear if the “open female luer” is being positively recited being that in claim 1 the “female luer” is not positively recited. For examination purposes the aforementioned limitations are interpreted as a functional recitation.
Regarding claims 5, the recitation “wherein the open female luer connector further comprises an outer surface and a thread extending from the outer surface and the sidewall of the housing further comprises an inner surface that comprises threads to engage the thread on the outer surface open female luer connector” is indefinite because seemingly the “open female luer” is being positively recited and claim 5 depends from claim 1 and in claim 1 the “open female luer” is not positively recited. For examination purposes the aforementioned limitations are interpreted as a functional recitation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 1-5, 16 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avula et al. (Pub. No. 20210016077).
Regarding claim 1, Avula et al. teaches a disinfectant cap (900, Fig. 9B) configured to engage an open female luer connector (932, Fig. 9B) comprising a lumen (hollow space of 932, see 935, Fig. 9B), the cap (900) comprising: a housing (920, Fig. 9B) comprising an open first end (914, Fig. 9B), a second end (proximal opening of 900 opposite 914, see Fig. 9B), and at least one sidewall (inner wall of 920, Fig. 9B) extending between the first end (914) and the second end (proximal opening of 900 opposite 914) defining a recess (lumen of 920, see Fig. 9B); a plug (902, Fig. 9B) disposed in the recess of the housing (lumen of 920) configured to engage the open female luer connector (932) for sealing the lumen of the open female connector (see Fig. 9B and [0057]); and an absorbent support (912, Fig. 9B, see [0047] where the reservoir acts like a sponge; hence, the reservoir is absorbent and see [0033] and [0066]) disposed in the recess of the housing (lumen of 920) configured to contain a cleaning solution (see [0035] and [0066]) for cleaning and/or disinfecting portions of the open female luer (932) connector engaged to the cap (900, see abstract and [0035]).
Regarding claim 2, Avula et al. teaches wherein the absorbent support (912) comprises a sponge (see [0047] where the reservoir acts like a sponge).
Regarding claim 3, Avula et al. teaches wherein the cleaning solution comprises at least one of Isopropyl Alcohol (IPA) (see [0035] and [0066]), chlorhexidine, and povidone-iodine (see [0035]).
Regarding claim 4, Avula et al. teaches wherein, when the open female luer connector (932) is engaged to the cap (900), cleaning solution is exposed to portions of the open female luer connector for cleaning and/or disinfecting the open female luer connector (see [0035] and see 35 U.S.C. 112(b) interpretation above).
Regarding claim 5, Avula et al. teaches wherein the open female luer connector (932) further comprises an outer surface (outer surface of 932) and a thread (outer thread of 936, Fig. 9C) extending from the outer surface (outer surface of 932) and the sidewall of the housing (inner wall of 920) further comprises an inner surface (inner surface of 920 where 918 is located) that comprises threads (918, Fig. 9B) to engage the thread on the outer surface open female luer connector (see Fig. 9B, see 35 U.S.C. 112(b) interpretation above).
Regarding claim 16, Avula et al. teaches wherein insertion of the open female luer connector (932) into the housing (920) causes the absorbent support (914) to axially compress farther into the housing, and wherein the axial compression of absorbent support expels the cleaning solution from the absorbent support causing the cleaning solution to move through an interior of the housing contacting an outer surface of the open female luer connector inserted into the housing (see [0035] and 35 U.S.C. 112(b) rejection above for interpretation).
Regarding claim 20, Avula et al. teaches a cap (900, Fig. 9B) configured to engage a female connector (932, Fig. 9B) comprising a lumen (hollow space of 932, see 935, Fig. 9B), the cap (900) comprising: a rigid housing (920, Fig. 9B) comprising an open first end (914, Fig. 9B), a second end (proximal opening of 900 opposite 914, see Fig. 9B), and a sidewall (inner wall of 920, Fig. 9B) extending between the first end (914) and the second (proximal opening of 900 opposite 914) defining a recess (lumen of 920, see Fig. 9B); a sponge (912, Fig. 9B, see [0047] where the reservoir acts like a sponge; hence, the reservoir is absorbent and see [0033] and [0066]) disposed in the recess (lumen of 920) defined by the housing (920) configured to contain cleaning solution comprising at least one of Isopropyl Alcohol (IPA) (see [0035] and [0066]), chlorhexidine, or povidone-iodine (see [0035]) for cleaning and disinfecting portions of the female connector (932) engaged to the cap (see abstract and [0035]); a plug (902, Fig. 9B) configured to be inserted into the lumen (hollow space of 932) of the female connector to prevent IPA from entering the lumen of the female connector (see Fig. 9B where a portion of 904 is inserted into the hollow space of 932 thereby preventing IPA from entering the hollow space of 932).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6-8 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avula et al. (Pub. No. 20210016077) in view of Anderson (Pub. No. 2019/0070404).
Regarding claim 6, Avula et al. does not teach further comprising a bellow comprising a first open end, a second open end, and a sidewall defining a cylindrical opening that is configured to enclose the absorbent support wherein the first open end of the bellow is configured to connect to the plug to further enclose the absorbent support.
However, Anderson teaches comprising a disinfectant cap (10, Fig. 2A) comprising a bellow (30, Fig. 2A) comprising a first open end (top open end of 30, see Fig. 1G), a second open end (bottom open end of 30, see Fig. 2A), and a sidewall (inner wall of 30) defining a cylindrical opening (lumen of 30, see Fig. 2B) that is configured to enclose an absorbent support (80, Fig. 2B, see [0065]) wherein the first open end (top open end of 30) of the bellow (30) is configured to connect to a plug to further enclose the absorbent support (the top open end of 30 is capable of connecting to a plug to enclose 80).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Avula et al. by adding the resilient inner body to the inside of that cap such that the top open end is engages 902 and at least a portion of 912 is within the resilient inner body as taught by Anderson for permitting the user to rotate the cap; thereby permitting spinning and rotation of the cap in relation to the resilient inner body to cleanse medical connectors (see [0031]). Further, Avula et al. teaches that changes may be made to the device (see [0065]). It is the examiner’s position that with the modification the first open end (top open end of 30) of the bellow (30) is configured to connect to the plug (902) to further enclose the absorbent support (the top open end of 30 is capable of connecting to a plug to enclose 902).
Regarding claim 7, Avula et al. in view of Anderson teaches wherein the bellow (30) further comprises a sidewall (outer wall of 30) comprising ridges and troughs (ridges and troughs formed by 33, Fig. 2A) configured to be compressed (see [0021]) and a plurality of openings (openings formed in top portion of 30, see Fig. 1G) in the sidewall (outer wall of 30) configured to allow cleaning solution to flow from the absorbent support into the recess formed by the housing to clean and disinfect portions of the open female luer connector when the absorbent support is compressed by the insertion of the open female luer connector into the cap (the openings in the top portion of 30 are capable of allowing cleaning solution to flow from the absorbent support into the recess formed by the housing to clean and disinfect portions of the open female luer connector when the absorbent support is compressed by the insertion of the open female luer connector into the cap).
Regarding claim 8, Avula et al. in view of Anderson teaches wherein the cleaning solution comprises at least one of Isopropyl Alcohol (IPA) (see Avula et al. [0035] and [0066]), chlorhexidine, or povidone-iodine (see [0035]) and the absorbent support comprises a sponge (see Avula et al. [0047] where the reservoir acts like a sponge).
Regarding claim 18, Avula et al. Regarding claim 18, Avula et al. teaches a cap (900, Fig. 9B) configured to engage an open female connector (932, Fig. 9B) comprising a lumen (hollow space of 932, see 935, Fig. 9B), the cap (900) comprising: a housing (920, Fig. 9B) comprising an open first end (914, Fig. 9B), a second end (proximal opening of 900 opposite 914, see Fig. 9B), and at least one sidewall (inner wall of 920, Fig. 9B) extending between the first end (914) and the second (proximal opening of 900 opposite 914) defining a recess (lumen of 920, see Fig. 9B); an absorbent support (912, Fig. 9B, see [0047] where the reservoir acts like a sponge; hence, the reservoir is absorbent and see [0033] and [0066]) and a plug (912) configured to further contain the absorbent support and prevent the cleaning solution from entering the lumen of the female connector (see Fig. 9B and [0057]) but does not teach disposed in the cavity defined by the bellow and contained by the sidewall of the bellow configured to contain a cleaning solution for cleaning and disinfecting portions of the female connector engaged to the cap; a plug connected to the open first end of the bellow configured to further contain the absorbent support and prevent the cleaning solution from entering the lumen of the female connector.
However, Anderson teaches a disinfectant cap (10, Fig. 2A) comprising a bellow (30, Fig. 2A) comprising a first open end (top open end of 30, see Fig. 1G), a second open end (bottom open end of 30, see Fig. 2A), and a sidewall (inner wall of 30) defining a cylindrical opening (lumen of 30, see Fig. 2B), the bellow (30) configured to contain a cleaning solution for cleaning and disinfecting portions of the female connector engaged to the cap (see [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Avula et al. by adding the resilient inner body to the inside of that cap such that the top open end is engages 902 and at least a portion of 912 is within the resilient inner body as taught by Anderson for permitting the user to rotate the cap; thereby permitting spinning and rotation of the cap in relation to the resilient inner body to cleanse medical connectors (see [0031]). Further, Avula et al. teaches that changes may be made to the device (see [0065]). It is the examiner’s position that with the modification 912 disposed in the cavity in the lumen of 30 and 30 is configured to contain a cleaning solution for cleaning and disinfecting portions of the female connector 934 engaged to the cap 900; and a plug 904 is connected to the top open first end of the bellow 30 and configured to further contain the absorbent support and prevent the cleaning solution from entering the lumen of the female connector.
Regarding claim 19, Avula et al. in view of Anderson teaches wherein the absorbent support (912) comprises a sponge (see Avula et al. [0047] where the reservoir acts like a sponge) and the cleaning solution is a disinfecting liquid such as but not limited to Isopropyl Alcohol (IPA) (see Avula et al. [0035]), chlorhexidine, and povidone-iodine (see Avula et al. [0035]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY LEGETTE-THOMPSON whose telephone number is (571)270-7078. The examiner can normally be reached 7:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Srilakshmi Kumar can be reached at 571-272-7769. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIFFANY LEGETTE-THOMPSON
Supervisory Patent Examiner
Art Unit 1723
/TIFFANY LEGETTE/Supervisory Patent Examiner, Art Unit 1723
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