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
This application contains claims directed to the following patentably distinct species:
Figs. 1A-5B, drawn to a second swab and mounting post configuration (appears drawn to claims 7 and 16).
Figs. 6A-9B, drawn to a second swab and inner recess configuration (appears drawn to claims 8 and 16).
The species are independent or distinct because the represent mutually exclusive swab and attachment arrangements. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-6, and 9-20 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
A different field of search: Where it is necessary to search for one of the inventions in manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries, a different field of search is shown, even though the two are classified together). The indicated different field of search must in fact be pertinent to the type of subject matter covered by the claims. Patents need not be cited to show different fields of search. Furthermore, the groups have diverging subject matter and features that require employing different search queries (e.g. searching for swab shape and corresponding attachment means of one species would not necessarily yield the other).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with David Meibos on 1/6/2026 a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-7 and 9-20. Affirmation of this election must be made by applicant in replying to this Office action. Claim 8 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Status of Claims
Claims 1-20 are pending in the present application, with claims 1-7 and 9-20 under consideration and claim 8 being withdrawn from consideration.
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.
Claims 1-7 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardner et al. (US 2013/0197485 A1).
Regarding claim 1, Gardner discloses a drain spigot guard (Figs. 1-2, 6 and 7; Abstract), the drainage spigot guard comprising:
a shell comprising an interior cavity shaped to receive the spigot (cap holder 228 receives mail luer); and
a first disinfectant swab within the interior cavity (either cap 230, 330 or center insert 211; ¶ 48 describes the cap as being an absorbent material that retains an antiseptic fluid);
wherein:
the first disinfectant swab position to disinfect at least a portion of the spigot in response to insertion of the spigot into the interior cavity (¶s 55-68); and
the shell comprises an exterior shape (cap holder 128 inherently comprises a shape; Figs. 13-14 also show how additional retaining elements can be used).
Limitations of the drain spigot guard being ”configured to disinfect a spigot for a urinary catheter“ and the exterior shape being “configured to be received within a spigot retainer on a urinary catheter bag attached to the spigot” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of Gardner has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to be used with a urinary catheter and the shape would be configured to receive a spigot retainer on a urinary catheter bag attached to the spigot).
Regarding claim 2, Gardner further discloses a second disinfectant swab within the interior cavity (either cap 230 or center insert 211 may interchangeably comprise the first and second disinfectant swabs), wherein the second disinfectant swab is positioned to disinfect at least part of the spigot in response to insertion of the spigot into the interior cavity (¶s 55-62).
Regarding claim 3, Gardner further discloses the first disinfectant swab is annular in shape (cap 230 and threaded portion 234; ¶s 6-12 describe the device elements as annular; Fig. 3 also provides a perspective view) and is positioned to disinfect an exterior surface of the spigot in response to insertion of the spigot into the interior cavity (Fig. 6 shows how threaded portion 234 contacts an exterior surface of male luer 22; ¶s 55-62).
Regarding claim 4 Gardner further discloses the first disinfectant swab is cylindrical in shape (insert 211; ¶s 6-7 describe how the plug insert would be cylindrical) and is positioned to disinfect an interior surface of the spigot in response to insertion of the spigot into the interior cavity (Fig. 6 shows how the insert contacts the inner surface of male luer 22; ¶s 55-62).
Regarding claim 5, Gardner further teaches a proximal exterior diameter at a proximal end of the shell is larger than a distal exterior diameter at a distal end of the shell (Figs. 1, 6, and 7 show the cap holder having a flange, thus creating a larger diameter).
Regarding claim 6, Gardner further discloses the shell further comprising an opening and a seal positioned to cover the opening (opening of interior chamber 54; sealed by film 66; ¶ 53).
Regarding claim 7, Gardner further discloses the first disinfectant swab comprises an inside portion configured to receive a post formed in the shell (Fig. 7 shows how cap 330 would receive center plug 311).
Regarding claim 9, Gardner further discloses a proximal diameter at a proximal end of the first disinfectant swab is larger than a distal diameter at a distal end of the first disinfectant swab (Figs. 1, 6, and 7 show the cap holder having a flange, thus creating a larger diameter, of the cap holder, at a proximal end of the first disinfectant swab as opposed to a distal diameter, of the cap holder, at a distal end of the first disinfectant swab).
Regarding claim 10, limitations of the shell ”is configured to be received in a spigot retainer of a urinary catheter bag such that, with the shell on a spigot, locking arms secure the spigot to the spigot retainer” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of Gardner has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to be received in a spigot retainer via locking arms).
Regarding claim 11, Gardner discloses a drain spigot guard (Figs. 1-2, 6 and 7; Abstract), the drainage spigot guard comprising:
a shell comprising an interior cavity shaped to receive the spigot (cap holder 228 receives mail luer); and
a first disinfectant swab within the interior cavity (cap 230 and threaded portion 234; ¶ 48 describes the cap as being an absorbent material that retains an antiseptic fluid); and
a second disinfectant swab within the interior cavity (insert 211);
wherein:
the first disinfectant swab position to disinfect an exterior surface of the spigot in response to insertion of the spigot into the interior cavity (¶s 55-68; Fig. 6 shows how cap 130 and threaded portion 234 contacts an exterior surface of male luer 22; ¶s 55-62);
the second disinfectant swab position to disinfect an interior surface of the spigot in response to insertion of the spigot into the interior cavity (¶s 55-68; Fig. 6 shows how the insert contacts the inner surface of male luer 22; ¶s 55-62); and
the shell comprises an exterior shape (cap holder 128 inherently comprises a shape; Figs. 13-14 also show how additional retaining elements can be used).
Limitations of the drain spigot guard being ”configured to disinfect a spigot for a urinary catheter“ are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of Gardner has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to be used with a urinary catheter).
Regarding claim 12, Gardner further discloses the shell further comprising an opening and a seal positioned to cover the opening (open end 60; sealed by film 66; ¶ 53).
Regarding claim 13, Gardner further discloses the first disinfectant swab is annular in shape (cap 230 and threaded portion 234; ¶s 6-12 describe the device elements as annular; Fig. 3 also provides a perspective view) and is positioned to disinfect an exterior surface of the spigot in response to insertion of the spigot into the interior cavity (Fig. 6 shows how threaded portion 234 contacts an exterior surface of male luer 22; ¶s 55-62).
Regarding claim 14, Gardner further discloses the first disinfectant swab is cylindrical in shape (insert 211; ¶s 6-7 describe how the plug insert would be cylindrical) and is positioned to disinfect an interior surface of the spigot in response to insertion of the spigot into the interior cavity (Fig. 6 shows how the insert contacts the inner surface of male luer 22; ¶s 55-62).
Regarding claim 15, Gardner further teaches a proximal exterior diameter at a proximal end of the shell is larger than a distal exterior diameter at a distal end of the shell (Figs. 1, 6, and 7 show the cap holder having a flange, thus creating a larger diameter).
Regarding claim 17, Gardner further discloses a proximal diameter at a proximal end of the first disinfectant swab is larger than a distal diameter at a distal end of the first disinfectant swab (Figs. 1, 6, and 7 show the cap holder having a flange, thus creating a larger diameter, of the cap holder, at a proximal end of the first disinfectant swab as opposed to a distal diameter, of the cap holder, at a distal end of the first disinfectant swab).
Regarding claim 18, Gardner discloses a drain spigot guard (Figs. 1-3, 6 and 7; Abstract), the drainage spigot guard comprising:
a shell (cap holder 228 receives mail luer) comprising :
an opening (open end 60); and
an interior cavity, accessible through the opening and shaped to receive the spigot (interior chamber 54; Figs. 1, 6, and 7 show how the spigot is received into the interior cavity);
a seal positioned to cover the opening (film 66; ¶ 53); and
a first disinfectant swab within the interior cavity, adjacent the opening and the seal (cap 230 and threaded portion 234; ¶ 48 describes the cap as being an absorbent material that retains an antiseptic fluid);
wherein the first disinfectant swab is positioned to disinfect an exterior surface of the spigot in response to insertion of the spigot into the interior cavity (¶s 55-68; Fig. 6 shows how cap 130 and threaded portion 234 contacts an exterior surface of male luer 22; ¶s 55-62); and
Limitations of the drain spigot guard being ”configured to disinfect a spigot for a urinary catheter“ are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, device of Gardner has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to be used with a urinary catheter).
Regarding claim 19, Gardner discloses the seal comprises a pull tab (pull tab 68; ¶ 53).
Regarding claim 20, Gardner discloses the shell further comprises a flange at a proximal end to facilitate attachment of the seal (flange 56; ¶ 51).
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gardner, as applied to claim 11 above, and further in view of Terry et al. (US 20130197485 A1).
Regarding claim 16, Gardner does not explicitly teach the second disinfectant swab comprises an inside portion configured to receive a post formed in the shell.
In addressing the same problem as Applicant, the problem being the securing of cleaning solution holding materials, Terry teaches a cleaning device (Fig. 4; Abstract) comprising a cleaning fluid impregnable swab (Fig. 4, swab 14; ¶ 23) which is configured to receive a post formed in a shell (¶s 23 and 33 describes how spokes are used to attach cleaning pads and sponges).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Gardner such that the second disinfectant swab comprises an inside portion configured to receive a post formed in the shell, as taught by Terry. Doing so would be advantageous in providing easy attachment and replacement of the swab (¶s 23 and 33 of Terry).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781