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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “112” in Fig. 8. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities: para. 0039, line 1, the phrase “a circular planform” is believed to be a typo that should read “a circular platform.”
Appropriate correction is required.
Claim Objections
Claims 1-5 are objected to because of the following informalities:
Regarding claim 1, the phrase “the top wall“ in line 5 should read “the housing top wall” for clarity,
Regarding claim 1, the phrase “the top wall“ in lines 13-14 should read “the housing top wall” for clarity,
Regarding claim 1, the phrase “the respective inner surfaces of the collet prongs” in line 14 should read “the respective inner wall surfaces of the collet prongs” for clarity,
Regarding claim 1, the phrase “a female Luer connector:” in line 15 should read “a female Luer connector;” to replace the colon with a semi-colon,
Regarding claim 1, the phrase “the inner split threads and the top wall” in line 17 should read “the inner wall split threads and the housing top wall” for clarity,
Regarding claim 1, the phrase “the absorbent material compressing during advancement” in lines 22-23 should read “the absorbent material configured to compress during advancement” to more clearly distinguish the limitation from being a method-step limitation,
Regarding claim 2, the phrase “each prong” in line 3 should read “each collet prong” for consistency,
Regarding claim 2, the phrase “the protrusion tip of each prong deflecting radially inwardly” in lines 2-3 should read “the protrusion tip of each prong configured to deflect radially inwardly” to more clearly distinguish the limitation from being a method-step limitation,
Regarding claim 2, the phrase “prong tip” in line 5 should read “each protrusion tip” for clarity,
Regarding claim 3, the phrase “the threaded male Luer connector compressing the absorbent material upon insertion” in lines 2-3 should read “the threaded male Luer connector configured to compress the absorbent material upon insertion” to more clearly distinguish the limitation from being a method-step limitation,
Regarding claim 3, the phrase “the absorbent material scrubbing” in lines 3-4 should read “the absorbent material configured to scrub” to more clearly distinguish the limitation from being a method-step limitation,
Regarding claim 3, the phrase “the respective threads of the cap” in line 5 should read “the outer wall split threads of the cap” for clarity,
Regarding claim 4, the phrase “each prong” in line 3 should read “each collet prong” for consistency,
Regarding claim 4, the phrase “the protrusion tip of each prong deflecting radially inwardly and biasing” in lines 2-3 should read “the protrusion tip of each prong configured to deflect radially inwardly and bias” to more clearly distinguish the limitation from being a method-step limitation,
Regarding claim 5, the phrase “the absorbent material scrubbing” in line 1 should read “the absorbent material configured to scrub” to more clearly distinguish the limitation from being a method-step limitation,
Appropriate correction is required.
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 1-13 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 claim 1, the phrases “a male Luer connector” in line 10, “a female Luer connector” in line 12, “a male or a female Luer connector” in line 15, and “a male or a female Luer connector” in line 23 render the claim indefinite because they are unclear. It is unclear if these are all different connectors or the same as the aforementioned “a male or a female Luer medical connector” in line 1 of claim 1. Examiner is interpreting them as the same connectors, and thus suggests amending each phrase respectively, “the male Luer connector” in line 10, “the female Luer connector” in line 12, “the male or the female Luer connector” in line 15, “the male or the female Luer connector” in line 23.
Regarding claim 1, the phrase “cantilever-like” in line 18 renders the claim indefinite because it is unclear. The scope of a structure that is “like” a cantilever cannot be ascertained. Examiner is interpreting this limitation as each split flange comprises a distal axial contact surface that is to some degree fixed at one end and free at the opposite end.
Regarding claim 1, the phrase “a flange tip that is radially opposed to the other flange tips” in line 20 renders the claim indefinite because it is unclear. Examiner is interpreting the term “radially opposed” to mean radially opposite which is supported by the instant application in at least Fig. 5. Thus, it is unclear if there are more than two split flanges how they could all be radially opposed to one another. Examiner is interpreting this limitation as a pair of flange tips are radially opposite to one another.
Regarding claim 2, the phrase “a threaded male Luer connector” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear whether this is a different male Luer connector or the same male Luer connector aforementioned in claim 1. Examiner is interpreting it as the latter and suggests amending to recite “the male Luer connector.”
Regarding claim 4, the phrase “a threaded female Luer connector” in line 2 renders the claim indefinite because it is unclear. It is unclear whether this is a different female Luer connector or the same female Luer connector aforementioned in claim 1. Examiner is interpreting it as the latter and suggests amending to recite “the female Luer connector.”
Regarding claim 11, the phrase “the split-collar protrusion comprising a pair of collet prongs and respective split flanges” in lines 1-2 renders the claim indefinite because it is unclear. As written, this limitation is interpreted as each collet prong of the pair of collet prongs comprises respective split flanges, emphasis on plural split flanges. Thus, it is unclear in light of claim 1, whether each collet prong has a singular split flange or a plurality of split flanges as claimed in claim 11. Examiner is interpreting this limitation as the split-collar protrusion comprises a pair of collet prong and split flanges. Examiner suggests removing the term “respective”.
Regarding claims 3, 5-10, and 12-13, these claims are rejected due to their dependency upon a rejected base claim.
Allowable Subject Matter
Claims 1-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Marici et al. (U.S Patent Pub. No. 20190234540 A1, “Marici”), Rothenberg et al. (U.S Patent Pub. No. 20210322749 A1, “Rothenberg”), Davis et al. (U.S Patent Pub. No. 20160067422 A1, “Davis”), and Harandi et al. (U.S Patent Pub. No. 20210322750 A1, “Harandi”).
Marici discloses a universal, disinfecting cap (10 in Fig. 3a and 5-6B) comprising:
a housing (20) having an axial centerline, defining a first cavity (28 in Fig. 5) formed within a top wall (22 in Fig. 5) and circumscribing housing sidewall (26 in Fig. 5), and an open bottom (27, see para. 0097).
Further comprising a split-collar protrusion (30 in Fig. 3 and 6A-6b) within the first cavity (28), coupled to the top wall (22 see Fig. 5), circumscribing the axial centerline and projecting toward the open bottom (27 see Fig. 5 and para. 0096 – examiner notes the protrusion 30 is a collar shape protrusion having splits 35 interposed between the pair of collet prongs seen in Fig. 3A). The protrusion (30) having a plurality of opposed, parallel, sector-shaped, collet prongs (see para. 0105, Fig. 3A and Fig. 6A-6B – the collet prongs are the pair of prongs separated by the splits 35). Each prong respective having a distal protrusion tip (distal tip of the pair of prongs in Fig. 3A), a protrusion outer wall surface (33 in Fig. 3A) defining outer wall split threads (38 in Fig. 3A) configured to mate with corresponding threads of a male Luer connector (see para. 0097 and 0103), and an inner wall surface (31 in Fig. 3A) defining inner wall split threads (36 in Fig. 3A) configured to mate with corresponding threads of a female Luer connector (see para. 0096). The respective inner wall split threads (36) and outer wall split threads (38) starting at the distal protrusion tip (distal tip of each prong of protrusion 30) and terminating proximate the top wall (22, see Fig. 5), and the respective inner surfaces (31 in Fig. 3A)) of the collet prongs defining a second cavity configured for receipt of the male or female Luer connector (see para. 0096).
Further, the cap (10) comprises an absorbent material (50 in Fig. 4C) interposed within the second cavity (see para. 0101) and which is compressed during advancement of the male or female Luer connector (see para. 0104).
However, Marici fails to disclose the split-flanges coupled to the inner wall surface of each respective collet prongs, wherein each-split flange comprises a cantilever-like distal axial contact surface which is biased toward the top wall of the housing during advancement of the male or female Luer connector which deflects the respective collet prong inwardly.
Rothenberg discloses a cap (600 in Fig. 21-22 and 25-26) comprising a housing (610 in Fig. 26) and a split-collar protrusion (650 in Fig. 25A-25B) placed within a cavity (630) of the cap (600, see Fig. 26), circumscribing an axial centerline and projecting toward an open bottom of the housing (610, see Fig. 26, para. 0158). The split-collar protrusion (650) comprising a pair of opposed, parallel, sector-shaped, collet prongs (660 in Fig. 25A-25B) each having a distal protrusion tip (distal end of 660). The collet prongs (660) are connected at their proximal ends by a discoid body (652 in Fig. 25A-25B) having a pair of halves separated by a living hinge (676 in Fig. 25B) wherein the pair of halves of the discoid body (652) could be interpreted as respective split flanges coupled to an inner wall surface of each prong (660) by a flange root at the proximal end of each prong (660). The surface (654) of each halve of the body (652) being interpreted as the cantilever-like, distal axial contact surface as this surface is configured to bend when a connector is inserted and applies a force to said surface such that it acts cantilever-like. Such bending at the living hinge (676) causing the prongs (660) to inwardly displace to engage with the threads of the connector (see para. 0162). However, Rothenberg fails to disclose the split-flanges terminating in a flange tip that is radially opposed to the other flange tips. Instead, Rothenberg teaches the split-flanges being connected to each other by a living hinge.
There is no reference to modify Rothenberg with to teach a split-flange having a flange tip that is radially opposed to other flange tips of the respective collet prongs of a split-collar protrusion.
Davis discloses a cap (500 in Fig. 18-21) comprising a split-collar protrusion in the form of clips (542) extending from the top wall of the housing (512, see Fig. 21), wherein the clips (542) form a plurality of opposed, parallel, sector-shaped, collet prongs each having a distal tip and an inner surface defining inner split threads (546, see Fig. 21 and para. 0058). Each clip (542) forming the collet prong comprises a radially inwardly extending rib (570 in Fig. 20-21). However, the ribs (570) do not meet the claim limitations of the split-flanges as they do not have a cantilever-like, distal axial contact surface nor a flange tip as the ribs (570) extend from the inner surface of each prong (542) to an internal coupling (534, see Fig. 20 and para. 0058). Further, the ribs (570) are not designed to be biased as they are formed to provide an amount of rigidity the clips (542, see para. 0058). Therefore, Davis fails to disclose the split-flanges of claim 1 and cannot be modified to do so as this would render the clips (542) and their respective ribs (570) inoperable for their intended operation.
Harandi discloses a cap (100 in Fig. 3) comprising an insert (150 in Fig. 4-5) forming a split-collar protrusion having a plurality of opposed, parallel, sector-shaped, collet prongs (162 in Fig. 4) with inner wall split threads (170 in Fig. 4) and outer wall split threads (172 in Fig. 4, see para. 0067). Further, each collet prong (162) comprises a split-flange (176 in Fig. 4) having a cantilever-like, distal axial contact surface and terminating in a flange tip (see Fig. 4 and para. 0075-0076). However, Harandi fails to disclose the split-flanges coupled at a flange root to the inner wall surface of each respective collet prong and configured to be biased upwardly to deflect the collet prongs inwardly. Instead, the split-flanges (176) are formed as ledges that extend from an outer surface of each collet prong (162) and are configured to push against the sidewall (120 in Fig. 8-9) of the housing (120) when the collet prongs (162) deflect outwardly to accommodate a connector (see para. 0076). Thus, Harandi fails to disclose the split-flanges of claim 1 and cannot be modified to do so as this would render the ledges (162) inoperable for their intended operation.
Therefore, there is no reference that teaches or discloses the cap of claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783