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 .
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.
Election/Restrictions
This application contains claims directed to the following patentably distinct species.
Species of extension tube connection
I. at adapter side port, Fig. 1, Claim 23
II. at adapter proximal end, [0033], Claim 24
Species of second connector
A. needleless, Fig. 2A, Claim 27
B. PRN, [0038], Claim 28
The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. 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, no claim is 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.
There is a serious search burden because:
A. the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and/or
B. the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
There is a serious examination burden because non-prior art issues may be relevant to one species or grouping of patentably indistinct species and not another under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) that are not relevant to the other species or grouping(s) of patentably indistinct species.
In summary, Applicant is required to: elect between I and II above; elect between A and B above; and identify all claims that read on the elected species.
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.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
During a telephone conversation with Whitney Blair on 28 January 2026, a provisional election was made without traverse to prosecute the invention of species I and A, Claims 23 and 27. Affirmation of this election must be made by applicant in replying to this Office action. Claims 24 and 28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Priority
This application, which discloses and claims only subject matter disclosed in prior Application No. 16/518724, filed 22 July 2019, appears to claim only subject matter directed to an invention that is independent and distinct from that claimed in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a divisional application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: #32 (see [0036]), and #71 in Fig. 3 (id.).
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: #55 in Figs. 2A, 2B, 5D.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “56” has been used to designate both a space in a catheter connector in Fig. 3 and an air permeable barrier in Fig. 2A.
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: at [0065], line 3, “arms 82” probably should be “arms 84.”
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the Specification does not include the clause at the end of Claim 1, “which extend oppositely to the engagement arms and are disposed in one or more slots of a movable piece of the vent cap.”
Claim Objections
Claims 21, 25, and 30 are objected to because of the following informalities:
in Claim 21, line 13, and Claim 25, line 2, “or” invites confusion, and probably should be “which is” or an equivalent term, because the term after “or” appears to be a synonym for the term before the “or;” and
in Claim 30, line 2, “(New)” should be “and.”
While the foregoing issues with the claims do not, in the current view of the Examiner, rise to a level necessitating a rejection under 35 U.S.C. § 112(b), if Applicant asserts that the accused terms and phrases of the claim(s) are entirely unobjectionable and the Examiner disagrees, the objection may be changed to a rejection under sec. 112(b) because Applicant' s and the Examiner' s interpretations of the claims may therefore be at issue, and the scope of the claim would thus be unclear. Appropriate correction is thus 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 22 and 34 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 22, lines 1-2, “an introducer needle” renders the scope of the claim indefinite, because it is unclear if a second needle (in addition to that of Claim 21) is claimed, or if the claim should instead state, “wherein the [[catheter system further comprises an]] introducer needle [[having]] comprises a distal notch,” which is how the claim has been treated.
In Claim 34, lines 1-2, “air or gas” renders the scope of the claim indefinite, because air is a gas, and thus it is unclear what the scope of “gas” is if it is an alternative to, and thus appears to exclude, “air;” the clause has been treated as “gas” only.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-23, 25-27, and 29-40 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2017/0120016, by Burkholz et al. (“Burkholz”) in view of U.S. Patent App. Pub. No. 2008/0200904, by Cluff et al. (“Cluff”) and U.S. Patent App. Pub. No. 2005/0085789, by Khan et al. (“Khan”).
Burkholz describes a device substantially as claimed by Applicant, as follows.
Claim 21: A catheter system (100), comprising:
a catheter adapter (120);
a catheter (126) extending distally from the catheter adapter (Fig. 1);
an extension tube (106) extending from the catheter adapter (Fig. 1);
a needle assembly (204 in Fig. 2A), comprising a needle hub (262) and an introducer needle (254), wherein the needle hub is coupled to a proximal end of the catheter adapter (dotted line in Fig. 2A) and comprises a flashback chamber (212), wherein a proximal end of the introducer needle is secured within the needle hub (Fig. 2A), wherein the flashback chamber comprises a vent feature (701 in Fig. 7B; [0140]: “a similar side vent could be incorporated into any of the above-described embodiments having a needle component that includes a flash chamber.”)
a Y-adapter (110) having a distal end, a first arm (116), and a second arm (116), wherein the distal end of the Y-adapter is coupled to the extension tube (unlabeled in Fig. 1, end of tube 106 joined to 110).
Burkholz does not, however, describe:
that the vent at the needle hub is movable between a vent feature actuated position in which the flashback chamber is vented and a vent feature unactuated position in which the flash chamber is not vented;
a vent cap coupled to the second arm in a first position or (see treatment above: “which is”) a vent cap unactuated position, wherein a distal end of the vent cap comprises a plurality of engagement arms and wherein the vent cap further includes one or more other arms, which extend oppositely to the engagement arms and are disposed in one or more slots of a movable piece of the vent cap; or
that a distal end of the vent cap comprises a plurality of engagement arms.
Cluff relates to over-the-needle IV catheter sets having proximal Y-adapters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Cluff teaches (see Fig. 28 and accompanying text) that:
that a vent (22) of such a catheter set can be constructed so that it is movable between a vent feature actuated position in which the flashback chamber is vented (when vent tube 196 is inserted through septum 30) and a vent feature unactuated position in which the chamber is not vented (orientation of Fig. 28), so that portion of the IV catheter set can be vented selectively by the practitioner;
the vent (22) can be coupled to the second arm (see Fig. 1) in a first position or (see treatment above: “which is”) a vent cap unactuated position (Fig. 28 orientation), also so that portion of the IV catheter set can be vented selectively by the practitioner; and
that a distal end of the vent cap comprises a plurality of engagement arms (106 in Fig. 15) instead of using a threaded connection (of Fig. 28, 200, 202), so that the device can be “rapidly secured to and detached from the threads 108 of the device 28” ([0073]).
It 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, to construct the IV catheter set of Burkholz so that that the vent at the needle hub is movable between a vent feature actuated position in which the flashback chamber is vented and a vent feature unactuated position in which the flash chamber is not vented, with a vent cap coupled to the second arm in a first, vent cap unactuated position, and a distal end of the vent cap comprises a plurality of engagement arms, because Cluff teaches providing catheter IV sets that have Y-adapters and flashback chambers with these features, so that each portion of the IV catheter set can be vented selectively by the practitioner, and to enable rapidly securing the vent to the vest of the device.
Burkholz and Cluff together describe a device substantially as claimed by Applicant; see above. They do not, however, describe that the vent cap further includes one or more other arms, which extend oppositely to the engagement arms and are disposed in one or more slots of a movable piece of the vent cap.
Khan relates to selectively openable hemostasis valves for catheter sets (as do Burkholz and Cluff) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Khan teaches that the movable portion of the valve (216 in Fig. 11), which corresponds to the vent element (204) of Cluff’s valve, can include an arm (235), which extend oppositely to the engagement element (nut 205, which corresponds to Cluff’s arms 106) and is disposed in a slot (237, 238), in order “to guide the plunger tube 216” [0215]).
It 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, to construct a Burkholz - Cluff device such that the vent cap further includes one or more other arms, which extend oppositely to the engagement arms and are disposed in one or more slots, because Khan teaches doing so in a closely related device, in order to guide the vent element relative to its housing.
Khan’s arm 235 is part of the movable element 2016 and the slot 238 is part of the device’s stationary element 204, opposite of that required by Claim 21, which requires that the “slot is of a movable piece of the vent cap.” Reversing these two elements, namely, to put the slot in movable element 216 and the arm in stationary element 204 would not change the function of these two elements relative to each other, or the function of a Burkholz - Cluff - Khan device overall. Accordingly, the reversal of these two elements is considered to be an obvious modification. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.)
Claim 22: (The catheter system of claim 21,) wherein the catheter system further comprises an introducer needle having a distal notch (Burkholz, [0150], describing the needle having a notch).
Claim 23: (The catheter system of claim 21,) wherein the catheter adapter comprises a side port (Burkholz, 124), wherein the extension tube extends from the side port (Fig. 1).
Claim 25: (The catheter system of claim 21,) wherein the vent cap is actuatable by moving the vent cap to a second position or a vent cap actuated position (Cluff, Fig. 28 and [0097]).
Claim 26: (The catheter system of claim 21,) wherein the catheter system further comprises a first connector coupled to the first arm (Burkholz Fig. 1, Luer connector at proximal-most end of each arm) and a second connector coupled to the second arm (Burkholz Fig. 1, Luer connector at proximal-most end of each arm), wherein the vent cap is coupled to the second connector (Cluff, Fig. 1 and [0053], describing replacing vent plug 22 with another element, and thus vent plug 22 is removable; Luer threads at distal end of vent element in Fig. 28).
Claim 27: (The catheter system of claim 26,) wherein first connector and the second connector each comprise a needleless connector (Luer screw connectors are needleless).
Claim 29: (The catheter system of claim 26,) wherein the plurality of engagement arms are flexible (Cluff [0071], “snap thread arms 106”) and engaged in a snap fit with a flange of the second connector (Cluff 108).
Claim 30: (The catheter system of claim 21,) wherein the first arm comprises a first luer adapter (Burkholz 116), (New) [sic: “and”] wherein the second arm comprises a second luer adapter (Burkholz 116) .
Claim 31: (The catheter system of claim 30,) wherein the vent cap comprises a third luer adapter (Cluff, Fig. 28, Luer threaded connection at distal end of the device) coupled to the second luer adapter (when attached to Burkholz’s Luer 116).
Claim 32: (The catheter system of claim 21,) wherein the catheter system further comprises an IV line attached to the first arm (Burkholz [0065], describing attaching an IV bag and line to the system; Cluff, [0005], describing the “BD NEXIVATM Closed IV (intravenous) Catheter System”).
Claim 33: A catheter system, comprising:
a catheter adapter (Burkholz 120);
a catheter (Burkholz 126) extending distally from the catheter adapter (Burkholz Fig. 1);
an extension tube (Burkholz 106) extending from the catheter adapter (Burkholz Fig. 1);
a needle assembly (Burkholz 204), comprising a needle hub (Burkholz 262) and an introducer needle (Burkholz 254), wherein a proximal end of the introducer needle is secured within the needle hub (Fig. 2A);
a Y-adapter (Burkholz 110) having a distal end, a first arm (Burkholz including 116), and a second arm (Burkholz including 116), wherein the distal end of the Y-adapter is coupled to the extension tube (unlabeled in Burkholz Fig. 1, end of tube 106 joined to 110);
a needleless connector coupled to the second arm (Burkholz’s connector 116 is a threaded Luer connector and is thus needleless) and comprising a compression seal (Cluff, 30); and
a vent cap (Cluff, 198) coupled to the needleless connector (at Luer threads at the bottom of Fig. 28 in Cluff) and comprising a vent path (Cluff 196) and an air permeable barrier (Cluff 206) within the vent path, wherein in response to movement of the vent cap from an unactuated position to a depressed position, the compression seal is compressed by the vent cap to permit fluid to pass through the vent path (Cluff, [0097]).
Claim 34: (The catheter system of claim 33,) wherein the air permeable barrier permits air or gas (see treatment above) to vent but inhibits passage of blood (Cluff, [0096]).
Claim 35: (The catheter system of claim 33,) wherein the vent cap is constructed of a transparent material (Burkholz [0066], describing its flash chamber; Fig. 1, illustrating the flash chamber as being transparent because its interior 114 is visible).
Claim 36: (The catheter system of claim 33,) wherein the vent cap comprises a nose configured to compress the compression seal in response to the movement of the vent cap from the unactuated position to the depressed position (Cluff, Fig. 28, distal end of vent tube 204 is a nose which compresses and opens the seal 30 as claimed).
Claim 37: (The catheter system of claim 36,) wherein the vent cap further comprises a push plate at a proximal end of the vent cap (Cluff, Fig. 28, unlabeled, plate which includes membrane 206).
Claim 38: (The catheter system of claim 37,) wherein the push plate comprises a flange (same).
Claim 39: A catheter system, comprising:
a catheter adapter (Burkholz 120);
a catheter (Burkholz 126) extending distally from the catheter adapter (Fig. 1); an extension tube (Burkholz 106) extending from the catheter adapter (Fig. 1); and
a needle assembly (204 in Burkholz Fig. 2A), comprising a needle hub (Burkholz 262) and an introducer needle (Burkholz 254), wherein the needle hub is coupled to a proximal end of the catheter adapter (dotted line in Burkholz Fig. 2A) and comprises a flashback chamber (Burkholz 212), wherein a proximal end of the introducer needle is secured within the needle hub (Burkholz Fig. 2A), wherein the flashback chamber comprises a vent feature (701 in Burkholz Fig. 7B; [0140]: “a similar side vent could be incorporated into any of the above-described embodiments having a needle component that includes a flash chamber.”) movable between a vent feature actuated position in which the flashback chamber is vented (Cluff, Fig. 28, [0097]) and a vent feature unactuated position in which the flash chamber is not vented (id.).
Claim 40: (The catheter system of claim 39,) wherein the catheter adapter comprises a side port (Burkholz 124), wherein the extension tube extends from the side port (Fig. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 20080287906 describes another of Applicant’s prior disclosures of vent caps used on side arms of similar IV systems.
The balance of the documents cited with this Office Action relate generally to multi-arm IV infusion sets and medical fluid connectors.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783