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 Invention I, Species A in the reply filed on December 16, 2025 is acknowledged. The traversal is on the ground(s) that there is no serious search burden.
With respect to the restriction requirement between inventions I and II, this is not found persuasive because there are structural and functional distinctions between the product and process which result in divergent search strategies. For example, the product can be used in a materially different process. The process is explicitly drawn to blood draw and would necessitate a search in A61B5/150992 [9636 hits] whereas the product necessitate a search in A61M25/0133 [11339 hits]. Similarly, with respect to the species election requirement, the species have functional and structural distinctions which necessitate divergent search strategies. For example, while both species would be searched in A61M25/0113 and A61M25/0606, the species would use different search terms. A search for Species A would use the terms “displac$4”, “slid$4”, “translat$4”, and “linear” [16771 hits] whereas a search for Species B would use the term “rotat$4” [11953 hits].
It is additionally pointed out that, the examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 16, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: the claim should be amended to recite “a user” in line 2 to provide antecedent basis for the claim terminology. Appropriate correction is required.
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) 1-6, 9-11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McWeeney (US 20120116248).
Regarding claim 1, McWeeney discloses a blood draw device for delivery of a probe into a patient's vascular system (device shown in fig. 1 is capable of being used for blood draw and can deliver a needle sub-assembly 15 in fig. 2 into the vascular system), the blood draw device comprising:
an introducer body having a proximal end and a distal end (distal handle member 10c in fig. 1);
an actuator (proximal handle member 10a in fig. 1), wherein the actuator is displaceable along at least a portion of the introducer body (fig. 5 and paragraph 68 discloses handle members 10a-c in fig. 1 are telescoping handle members which are all slidable relative to each other so that the handle members are capable of being moved to a position where the proximal handle member is displaceable along a portion of the distal handle member), and wherein the actuator is operably coupled to the probe to advance and retract the probe based on direction of displacement of the actuator (paragraph 68 discloses that the needle-subassembly 15 can be attached/detached from the proximal handle 10a; paragraph 69 discloses that proximal handle 10a is moved proximal/distally to retract/extend the needle relative to catheter sheath 14); and
an advancement stop member (middle handle member 10b in fig. 1), wherein the advancement stop member is displaceable along at least a portion of the introducer body (paragraph 68 discloses middle handle member 10b is slidably disposed over at least a portion of distal handle member 10c) and is configured to selectively limit travel of the actuator along the introducer body (proximal handle 10a can translate between positions 0-8 on the middle handle 10b but would be prevented from moving distally beyond position 8 due to the thumb screw 13).
Regarding claim 2, McWeeney discloses the advancement stop member comprises a distal interface portion and a probe position indicator portion (see below), wherein the probe position indicator portion is coupled to and extends proximally from the distal interface portion (see below; fig. 1).
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Regarding claim 3, McWeeney discloses the probe position indicator portion extends along at least one sidewall of the introducer body (fig. 1 shows the middle handle 10b as tubular so that it extends around the entirety of the introducer body).
Regarding claim 4, McWeeney discloses the probe position indicator portion extends along two opposing sides of the introducer body (fig. 1 shows the middle handle 10b as tubular so that it extends around the entirety of the introducer body).
Regarding claim 5, McWeeney discloses the probe position indicator portion comprises a plurality of probe position indicators (numbers 0-8 on middle handle 10b in fig. 1), wherein each of the probe position indicators relate to a position of a distal tip of the probe relative to a distal tip of an indwelling catheter to which the blood draw device is coupled (paragraph 69 discloses setting depth of needle relative to catheter 14).
Regarding claim 6, McWeeney discloses the plurality of probe position indicators comprise visual indicators (fig. 1 shows numbers 0-8 which are visible).
Regarding claim 9, McWeeney discloses the introducer body comprises a plurality of catheter length indicators formed on a distal end portion thereof (fig. 1 shows numbers 3-5 positioned on the distal end portion of handle 10c, see below).
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Regarding claim 10, McWeeney discloses each of the catheter length indicators corresponds to a length of a catheter to which the blood draw device is coupled (paragraph 69 discloses that the numbers correspond to a “depth”, which is a length, of the catheter relative to the end of the endoscope).
Regarding claim 11, McWeeney discloses the advancement stop member is configured to selectively engage with the catheter length indicators so as to provide discrete stop positions for the advancement stop member along the introducer body (paragraph 69 discloses that thumbscrew 13 can be moved to translate middle handle 10b, and thus proximal handle 12a, along distal handle 10c to discrete positions).
Regarding claim 13, McWeeney discloses each of the catheter length indicators comprise visual indicia pertaining to a catheter length (fig. 1 shows numbers 4 and 5 which are visible).
Regarding claim 14, McWeeney discloses a connector (6 in fig. 1) and a blunt introducer extending from the distal end of the introducer body (catheter sheath 14 in fig. 1).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney, as applied to claims 1, 2, 5, and 6 above, and further in view of Sperry (US 20170303940).
Regarding claim 7, McWeeney discloses all of the claimed limitations set forth in claims 1, 2, 5, and 6, as discussed above, and further discloses the visual indicators comprise indications (fig. 1 shows numbers 0-8). However, McWeeney does not teach or disclose the visual indicators comprise indications of when the distal tip of the probe is a) at the distal tip of the indwelling catheter, b) 1 cm beyond the distal tip of the indwelling catheter, c) 2 cm beyond the distal tip of the indwelling catheter, and d) 3 cm beyond the distal tip of the indwelling catheter.
Sperry is directed towards a similar depth guide in which indications are shown every centimeter (paragraph 55). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of McWeeney so that the indications correspond to centimeters, as taught by Sperry, as it appears the device of McWeeney would operate as intended and a user would know precisely what length the needle extends from the catheter to ensure patient safety.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney, as applied to claims 1, 2, and 5, above, and further in view of Devgon (US 10300247).
Regarding claim 8, McWeeney discloses all of the claimed limitations set forth in claims 1, 2, and 5, as discussed above, but does not teach or disclose the plurality of probe position indicators are configured to provide tactile feedback to the user.
Devgon teaches a similar system which comprises a plurality of position indicators (ribs 236 in fig. 5) which are configured to provide tactile feedback to a user as an actuator travels along the position indicators due to the tab of the actuator (24:23-30). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the slot and thumbscrew (12 in fig. 1) of McWeeney to comprise ribs along the advancement stop member (middle handle 10b in fig. 1) and a tab on the actuator (proximal handle 10a in fig. 1), as taught by Devgon, so that the ribs correspond to the numeric values of McWeeney. This modification would provide a tactile indication of the position of the needle of McWeeney which may assist a visually impaired user.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney, as applied to claims 1 and 9 above, and further in view of Lenker (US 20170245885).
Regarding claim 12, McWeeney discloses all of the claimed limitations set forth in claims 1 and 9, as discussed above, but does not teach or disclose each of the catheter length indicators comprise one of a projection or a detent.
Lenker teaches that in addition to providing a visual alphanumeric character, the indicators can be a depressed character of the same configuration (paragraph 158), which is equated to the claimed “detent”. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the alphanumeric indicators of McWeeney to be depressed alphanumeric characters instead as Lenker teaches that this is a suitable alternative to printed characters (paragraph 158) and would provide an advantage to visually impaired users.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783