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 with traverse of Group I, claims 1-13 and 17-20 in the reply filed on 10/22/2025 is acknowledged. The traversal is on the ground(s) that no serious search burden exists on the examiner as they involve a similar search strategy because the groups include common elements. This is not found persuasive because the differences in the claims require diverging searches as they are drawn to structure vs different methods. Further, a reference applicable to one group is not necessarily applicable to another group, which the examiner believes to be further evidence of a serious burden.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 17 is objected to because of the following informalities: in the last line of claim 17 on page 28 of 31, “the central lumen of male connector” is grammatically incorrect, the examiner suggests adding “the” before “male connector”. Appropriate correction is required.
In claim 18, there is a capitalized word (“Wherein”) on the fifth line.
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 8 and 12 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.
In claim 8, “the sidewall of the protrusion” lacks antecedent basis.
In claim 12, “the housing, protrusion and shield” lacks antecedent basis for “shield”.
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.
Claim(s) 1-7, 9-13 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coyle (US 2022/0023609) in view of Gardner et al (US 2012/0302997).
Regarding claim 1, Coyle discloses a cap (figs 6 and 7) configured to engage a male connector (intended use, Coyle is capable of such; regardless see ¶25 and fig 5A), the cap comprising: a housing comprising an open first end (top of fig 7), a closed second end (bottom of fig 7, starting at boundary between figs 6 and 7), and a sidewall extending between the first end and the second end (fig 7); a protrusion (fig 7; labelled as 210 in fig 4) extending from the closed second end of the housing towards the open first end of the housing (fig 7) configured to engage the male connector for retaining the male connector within the housing (fig 5A) and defining a first recess between the sidewall of the housing and the protrusion (fig 7, in recess in which 52 is located); a second recess (in which 54 is located); an outer absorbent 52 support disposed in the first recess configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap (¶29); and an inner absorbent support 54 disposed in the second recess configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap (¶29, although 45 is listed instead of 54 in the paragraph, one would recognize this is a misspelling of 54).
While Coyle substantially discloses the invention as claimed, it does not disclose a center post extending from the closed second end of the housing towards the open first end of the housing configured to engage the male connector and defining a second recess between the protrusion and the center post.
Gardner discloses a cap with many similarities to Coyle, but also includes a center post 311 (fig 7) extending from the closed second end of the housing towards the open first end of the housing configured to engage the male connector (fig 7; ¶55) and defining a second recess between the protrusion and the center post (fig 7). The center plug serves the use of preventing antiseptic from entering the luer (¶55).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Coyle such that it includes a center post extending from the closed second end of the housing towards the open first end of the housing configured to engage the male connector and defining a second recess between the protrusion and the center post as taught by Gardner to prevent antiseptic from entering the luer.
Regarding claim 2, wherein the male connector comprises a luer stem comprising a tip and defining a central lumen and an annular shield extending about the stem, wherein the shield of the male luer connector comprises threads on an inner surface of the shield configured to engage corresponding threads of a female luer connector for securing the male connector to the female luer connector (this is all intended use and minimally limiting, the male connector is capable of having such structure), and wherein the protrusion comprises an outer surface and threads on the outer surface of the protrusion configured to engage the threads on the inner surface of the shield of the male connector thereby releaseably securing the male connector to the cap (capable of such, see fig 5A).
Regarding claim 3, when the male connector is engaged to the cap, the luer stem of the male connector is inserted into the second recess and in contact with the inner absorbent support, the center post is inserted into the central lumen of the male connector, and the annular shield of the male connector is in contact with the outer absorbent support (Coyle is arranged for and capable of such; this claim strongly depends on the structure of the male connector, which is only claimed as intended use).
Regarding claim 4, wherein, when the male connector is engaged to the cap, cleaning solution is exposed to the threads on the inner surface of the annular shield for cleaning and disinfecting the threads, cleaning solution is exposed to the outer surface of the luer stem for cleaning and disinfecting the outer surface of the luer stem; and the center post blocks cleaning solution from entering the central lumen of the male connector (Coyle is arranged for and capable of such, especially as the inner and outer absorbent supports are disclosed as sponges, ¶29 of Coyle, such that an inserted male connector may be arranged to reach, compress and cause antiseptic to be expressed from the supports/sponges; this claim strongly depends on the structure of the male connector, which is only claimed as intended use).
Regarding claim 5, further comprising a protective cover 620 configured to be affixed to the open first end of the housing to prevent exposure of the center post and inner absorbent support to contamination prior to use of the cap (fig 6).
While Coyle substantially discloses the invention as claimed, it does not disclose the cover is configured to prevent exposure of the protrusion and outer absorbent support.
Gardner discloses a cover which covers the entire cap opening, including the protrusion and recess 54 (in which outer absorbent support would be located).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Coyle such that the cover is also configured to prevent exposure of the protrusion and outer absorbent support (by extending it over the entire opening) as taught by Gardner to prevent evaporation and/or contamination of the antiseptic in the outer absorbent support.
Regarding claim 6, wherein the protrusion further comprises: a thread extending radially outward from the sidewall of the protrusion, the thread configured to engage threads on an inner surface of a shield of the male connector (figs 5A and 7).
Regarding claim 7, wherein the engagement between the thread of the protrusion and the threads of the shield of the male connector rotatably secures the male connector within the housing (capable of such, due to friction of threads).
Regarding claim 9, wherein insertion of the male connector into the second recess formed between the protrusion and the center post causes the inner absorbent support to axially compress farther into the second recess, and wherein the axial compression of the inner absorbent support expels the cleaning solution from the inner absorbent support causing the cleaning solution to move through the second recess contacting an outer surface of a stem of the male connector inserted in the second recess including the tip of the stem of the male connector (the combination is arranged for and capable of such, especially as the inner and outer absorbent supports are disclosed as sponges, ¶29 of Coyle, such that an inserted male connector may be arranged to reach, compress and cause antiseptic to be expressed from the supports/sponges; this claim strongly depends on the structure of the male connector, which is only claimed as intended use).
Regarding claim 10, wherein insertion of the male connector into the first recess formed between the housing and the protrusion causes the outer absorbent support to axially compress farther into the first recess, and wherein the axial compression of the outer absorbent support expels the cleaning solution from the outer absorbent support causing the cleaning solution to move through the first recess contacting a shield of the male connector inserted in the first recess (the combination is arranged for and capable of such, especially as the inner and outer absorbent supports are disclosed as sponges, ¶29 of Coyle, such that an inserted male connector may be arranged to reach, compress and cause antiseptic to be expressed from the supports/sponges; this claim strongly depends on the structure of the male connector, which is only claimed as intended use).
Regarding claim 11, wherein the central post is configured to seal an open end of the male connector, thereby preventing the cleaning solution from entering a lumen of the male connector, and wherein the center post is positioned to permit the cleaning solution expelled from the inner absorbent member to move past the center post towards the open first end of the housing and wet the outer surfaces of the male connector when the inner absorbent member is axially compressed (see combination in claim 1, Gardner discloses the post specifically to seal open end of male connector preventing entrance or exit of fluid from luer opening - ¶56; further center post is positioned as claimed as there is a gap between center post and protrusion).
Regarding claim 12, the shield is capable of being made of one of the materials below (even if the shield had proper antecedent basis, it has only been claimed as part of the male connector, which is only claimed as intended use). while Coyle substantially discloses the invention as claimed, it does not disclose the housing and protrusion comprise a rigid thermoplastic polymer comprising at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.
Gardner discloses a cap with many similarities. It also discloses polyethylene (¶37) as a suitable material.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Coyle such that the housing and protrusion comprised a rigid thermoplastic material comprising polyethylene as taught by Gardner as it is a known material for caps, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Regarding claim 13, further comprising the cleaning solution absorbed by the inner absorbent support, wherein the cleaning solution comprises at least one of Isopropyl Alcohol (IPA), Chlorhexidine Gluconate (CHG), chlorhexidine, povidone-iodine, or octenidine (IPA - ¶29).
Regarding claim 17, Coyle discloses a cap (fig 7) configured to engage a male connector comprising a central lumen and an annular shield (intended use, Coyle is capable of such; see fig 5A), the cap comprising: a housing comprising an open first end (top of fig 7), a second end (bottom of fig 7, starting at boundary between 200 and 300), and a sidewall extending between the first end and the second end (fig 7), and a protrusion (fig 7; labelled as 210 in fig 4) comprising an open first end and a sidewall extending from the second end of the housing towards the open first end generally parallel to the sidewall of the housing (fig 7) configured to engage the male connector for retaining the male connector within the housing (similar to fig 5A), an outer absorbent support 52 disposed in the housing between the sidewall of the housing and the sidewall of the protrusion configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap including the annular shield of the male connector (¶29); and an inner absorbent support 54 configured to contain a cleaning solution for cleaning and disinfecting portions of the male connector engaged to the cap (¶29, although 45 is listed instead of 54 in the paragraph, one would recognize this is a misspelling of 54).
While Coyle substantially discloses the invention as claimed, it does not disclose a center post extending from the center of the second end of the housing towards the center of the open first end of the housing configured to be inserted into and block the central lumen of male connector, nor the inner absorbent support disposed between the protrusion and center post
Gardner discloses a cap with many similarities to Coyle, but also includes a center post 311 (fig 7) extending from the closed second end of the housing towards the open first end of the housing configured to engage the male connector (fig 7; ¶55) and defining a second recess between the protrusion and the center post (fig 7). The center plug serves the use of preventing antiseptic from entering the luer (¶55).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Coyle with a center post extending from the center of the second end of the housing towards the center of the open first end of the housing configured to be inserted into and block the central lumen of male connector, and the inner absorbent support disposed between the protrusion and center post as taught by Gardner to prevent antiseptic from entering the luer while disinfecting the exterior of the luer.
Regarding claim 18, Wherein the outer absorbent support and the inner absorbent support comprise sponges (¶29).
While Coyle substantially discloses the invention as claimed, it does not disclose wherein the housing including the protrusion and the center post comprises a rigid thermoplastic polymer, comprising at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene; and
Gardner discloses a cap with many similarities. It also discloses polyethylene (¶37) as a suitable material.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Coyle such the housing including the protrusion and the center post comprises a rigid thermoplastic polymer, comprising polyethylene as taught by Gardner as it is a known material for caps, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Regarding claim 19, wherein the male connector comprises: a male luer connector comprising a luer stem comprising a tip and defining the central lumen and the shield extends about the stem; and wherein the shield of the male luer connector comprises threads on an inner surface of the shield configured to engage corresponding threads of a female luer connector for securing the male connector to the female luer connector (mostly intended use as the male connector is only claimed as part of intended, Coyle is capable of acting in such a manner; see fig 5B).
Regarding claim 20, wherein when the male connector is engaged to the cap: the shield of the male connector is disposed in a recess defined by the sidewall of the housing and the sidewall of the protrusion (fig 5B) such that the shield contacts and axially compresses the outer absorbent support thereby releasing cleaning solution from the outer absorbent support that wets and thereby cleans and disinfects the shield of the male connector (capable of such as the outer absorbent support is a sponge); the threads on the inner surface of the shield engage a thread extending from the sidewall of the protrusion thereby releaseably connecting the male connector to the cap (fig 5B); the luer stem of the male connector is disposed in a recess defined by the sidewall of the protrusion and the center post such that the luer stem contacts and axially compresses the inner absorbent support thereby releasing cleaning solution from the inner absorbent support that wets and thereby cleans and disinfects the outside of the luer stem of the male connector including the tip of the luer stem (capable of such due to sponge material of inner absorbent support); and the center post is disposed within the central lumen of male connector thereby blocking entry of the cleaning solution into the lumen (see combination in claim 17).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coyle (US 2022/0023609) in view of Gardner et al (US 2012/0302997) and Ryan (US 11,511,100).
Regarding claim 8, while Coyle substantially discloses the invention as claimed, it does not disclose wherein the sidewall of the protrusion comprises at least one opening for permitting the cleaning solution to pass from the inner absorbent support through the protrusion to the outer absorbent support.
Ryan discloses a protrusion split into one or more cantilevered prongs 44 with gaps 35 with allow the prongs to elastically deform or bend to facilitate interference fit between the mating feature of male or female needleless connectors (Col.7 ll 37-47). The gaps being an opening in the sidewall of the protrusion which permits the cleaning solution to pass from the inner absorbent support through the protrusion to the outer absorbent support.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Coyle such that the sidewall of the protrusion comprises at least one opening for permitting the cleaning solution to pass from the inner absorbent support through the protrusion to the outer absorbent support as taught by Ryan to facilitate interference fit between the mating feature of male or female needleless connectors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783