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
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subspecies, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/17/2025.
Applicant's election with traverse of the species restriction in the reply filed on 10/17/2025 is acknowledged. The traversal is on the ground(s) that no serious search burden exists in examining the subspecies C1-C7 and subspecies A1, A3, A4, A5, and A6 in a single application. Claims 14-20 are independent and distinct from the embodiments covered by the elected claims 1-13 and 21-23. Claim 14 is drawn to subspecies C3. Claim 15 is drawn to subspecies C4. Claim 16 is drawn to a combination of subspecies C2 and C4. Claim 17 is drawn to subspecies C5. Claims 18-20 are drawn to subspecies C6. Claims 14-20 are not encompassed in the elected subspecies A1, B1, and C2. There would be a serious search burden to examine these claims because the configuration of the axle, the spool, the housing, and the hub are different and a search for one configuration would not necessarily produce results applicable to another configuration. For example, a search for claim 16 in which a hub defines a flow passageway would not necessarily produce results for claim 17 in which a seal is positioned between the axle of the spool and the housing. With regards to subspecies A1, A3, A4, A5, and A6, these subspecies are not directed towards to specific claims.
There is no statement on record by Applicant that the species/subspecies are all obvious variations of one another. Should applicant make such explicit assertion, then the requirement can be re-evaluated at that time. In this case, the requirement set forth reasons for search/examination burden and the examiner is not persuaded by the arguments that the requirement is in error.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-13 and 21-23 are hereby the current claims under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 04/24/2023, 10/04/2023, and 02/18/2026 are being considered by the Examiner.
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: 206’ and 208’. 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.
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 11 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.
Regarding Claim 11, the claim recites “a first connector configured to be coupled to an intravenous catheter device”. It is unclear if “an intravenous catheter device” is the same as or different than the “an intravenous catheter device” recited in claim 1, from which claim 1 is dependent. For the purposes of examination, “an intravenous catheter device” is herein interpreted to be the same as or different than the “an intravenous catheter device” recited in claim 1. Due to the aforementioned reason, claim 11 is rendered indefinite. Claim 12 is rejected due to its dependence on claim 11
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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iizuka et al. (US Patent Pub. No. 20050267327 – cited by Applicant) hereinafter Iizuka.
Regarding Claim 1, Iizuka discloses a delivery device for advancing a probe through a vascular access catheter (A storage device 10 for the treatment tool 4 [0032]; fig 1), the device comprising:
a housing comprising a distal end and a proximal end (reel cover 41 [0039]; fig 1), the distal end is configured to couple to an intravenous catheter device (A storage device 10 for the treatment tool 4 is mounted to the proximal end of the final operating element 2 via a treatment tool insertion/withdrawal device 9. [0032]);
a spool disposed within the housing (a reel 42 [0039]; fig 3);
a tube-shaped probe wound around the spool (treatment tool 4 wound on the reel 42 [0040]);
and an advancement wheel (a dial member 47 [0042]; fig 3), wherein at least a portion of the advancement wheel extends from the housing (fig 1), and wherein, in response to the advancement wheel being rotated, the spool rotates to cause the tube-shaped probe to advance and retract relative to the housing (The reel 42 rotates in direct relation to the amount of turning of the dial member 47, and the treatment tool 4 is delivered toward the treatment tool channel 7 correspondingly. As described above, since the respective rollers 32, 33 of the treatment tool insertion/withdrawal device 9 can be rotated freely when the power supply is cut, the treatment tool insertion portion 21 moves in the treatment tool insertion/withdrawal device 9 and the treatment tool channel 7 toward the front and the treatment section 22 (see FIG. 1) moves forward correspondingly. [0049]).
Regarding Claim 2, Iizuka discloses the invention as discussed above in claim 1. Iizuka further discloses the spool and the advancement wheel are monolithic or co-molded (The flange 45 of the reel 42 is further increased in diameter at the outer edge thereof, and the enlarged portion forms a dial member 47 constituting a fine-adjustment mechanism. [0042]; fig 3).
Regarding Claim 3, Iizuka discloses the invention as discussed above in claim 1. Iizuka further discloses the spool comprises an axle, and wherein the spool and the advancement wheel rotate about the axle (A revolving shaft 43 of the reel 42 is disposed at a position offset from the axis of the treatment tool channel 7 in a direction substantially orthogonal to the axis. [0040]; fig 3).
Regarding Claim 4, Iizuka discloses the invention as discussed above in claim 3. Iizuka further discloses the axle defines a passageway (The revolving shaft 43 is offset with respect to the treatment tool channel 7 to enable smooth delivering of the treatment tool 4 wound on the reel 42 to the treatment tool insertion/withdrawal device 9. [0040]; fig 3), and wherein a portion of the tube-shaped probe is received within the passageway of the axle (Such the treatment tool 4 has a treatment tool insertion portion 21 to be inserted into the treatment tool channel 7. [0034]).
Regarding Claim 5, Iizuka discloses the invention as discussed above in claim 4. Iizuka further discloses the spool defines a radial passage extending radially from the axle toward an outer surface of the spool (The revolving shaft 43 is offset with respect to the treatment tool channel 7 to enable smooth delivering of the treatment tool 4 wound on the reel 42 to the treatment tool insertion/withdrawal device 9. [0040]; fig 3), the radial passage receiving a portion of the tube-shaped probe (Such the treatment tool 4 has a treatment tool insertion portion 21 to be inserted into the treatment tool channel 7. [0034]).
Regarding Claim 6, Iizuka discloses the invention as discussed above in claim 5. Iizuka further discloses the radial passage is arcuate (fig 3).
Regarding Claim 7, Iizuka discloses the invention as discussed above in claim 4. Iizuka further discloses a proximal end of the tube-shaped probe is received within the passageway of the axle (The operating wire 25 is inserted into the treatment tool insertion portion 21, and the operating wire 25 and the treatment tool insertion portion 21 pass through the treatment tool channel 7, and are drawn out from the insertion port 8 at the proximal side, inserted through the treatment tool insertion/withdrawal device 9, and are wound in the storage device 10. The proximal end of the operating wire 25 is attached to a final operating element 26 provided outside the storage device 10. [0034]).
Regarding Claim 8, Iizuka discloses the invention as discussed above in claim 3. Iizuka further discloses the spool comprises a body extending radially outward from the axle (final operating element 26 provided outside the storage device 10 [0034]; fig 2), the body of the spool and the housing defining a spool space that receives a portion of the tube-shaped probe (the treatment tool 4 has a treatment tool insertion portion 21 to be inserted into the treatment tool channel 7. The treatment tool insertion portion 21 is provided with a flexible and tightly-wound sheath. [0064]; fig 2).
Regarding Claim 9, Iizuka discloses the invention as discussed above in claim 8. Iizuka further discloses the advancement wheel extends radially outward from the body of the spool (final operating element 26 provided outside the storage device 10 [0034]; fig 2).
Regarding Claim 10, Iizuka discloses the invention as discussed above in claim 3. Iizuka further discloses the delivery device further comprising a hub received by the housing and defining a flow passageway (two flanges 44, 45 [0041]; The treatment tool insertion portion 21 of the treatment tool 4 is wound on an outer peripheral surface 42a of the reel 42, between the two flanges 44, 45. [0041]; figs 3-4), the hub receiving at least a portion of the axle of the spool, with the flow passageway in fluid communication with the tube-shaped probe (As shown in FIG. 4, edges of the reel 42 in the longitudinal direction of the revolving shaft 43 have increased diameters and form flanges 44, 45. [0041]; fig 3).
Regarding Claim 11, Iizuka discloses the invention as discussed above in claim 10. Iizuka further discloses the delivery device further comprising a first connector configured to be coupled to an intravenous catheter device (a distal opening 6 of a treatment tool channel 7 for receiving a treatment tool 4 to be inserted therethrough is provided at the distal end thereof [0032]; fig 1) and a second connector configured to be connected to a medical connector (A universal cable 13 to be connected to a control device (not shown) is connected to the side portion of the final operating element 2. [0033]; fig 1), the tube-shaped probe extending through the first connector (a distal opening 6 of a treatment tool channel 7 for receiving a treatment tool 4 to be inserted therethrough is provided at the distal end thereof [0032]; fig 1), wherein the hub is in fluid communication with the second connector (fig 3).
Regarding Claim 12, Iizuka discloses the invention as discussed above in claim 11. Iizuka further discloses the hub is in fluid communication with the second connector via a hub tube (The opening 49 is provided on the side of the universal cable 13 with respect to the axis of the treatment tool channel 7 [0042]; fig 4; Examiner notes that opening 49 is a tube that is in fluid communication with the two flanges 44, 45 and universal cable 13).
Regarding Claim 13, Iizuka discloses the invention as discussed above in claim 10. Iizuka further discloses further comprising an O-ring seal positioned between the axle of the spool and the hub (The treatment tool insertion portion 21 of the treatment tool 4 is wound on an outer peripheral surface 42a of the reel 42, between the two flanges 44, 45. [0041]; figs 3-4).
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.
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Iizuka (US Patent Pub. No. 20050267327 – cited by Applicant) as applied to claim 1 above, and further in view of Ha et al. (US Patent Pub. No. 20190240467) hereinafter Ha.
Regarding Claim 21, Iizuka discloses the invention as discussed above in claim 1. Iizuka fails to disclose the delivery device further comprising a second wheel, wherein the second wheel is configured to rotate about a common axle with the advancement wheel.
However, Ha teaches a delivery device (Guidewire movement mechanism (300) [0143]) comprising: a housing (body (302) [0142]; fig 18); an advancement wheel (a first member (322) [0144]; fig 18) and a second wheel (a second member (324) [0144]; fig 18), wherein the second wheel is configured to rotate about a common axle with the advancement wheel (second member (324) is rotatably disposed about first member (322) [0144]; fig 17). Ha also teaches the advancement wheel and the second wheel comprise projections that help limit the rotation/advancement of a catheter device (projections (304, 326, 328, 329) are configured to engage one another during rotation of first member (322) and second member (324) to thereby limit rotation of guidewire (106) [0145]; fig 18).
Ha is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the delivery device of Iizuka such that the delivery device further comprising a second wheel, wherein the second wheel is configured to rotate about a common axle with the advancement wheel, as taught by Ha, because it would provide a mechanism to limit the rotation/advancement of the tube-shaped probe.
Regarding Claim 22, Iizuka in view of Ha teaches the invention as discussed above in claim 21. Iizuka in view of Ha fails to teach the housing further comprises a housing stop member, the advancement wheel comprises a wheel stop member, and the second wheel comprises a tab.
However, Ha teaches a delivery device (Guidewire movement mechanism (300) [0143]) comprising: a housing comprising a housing stop member (Projection (304) is a unitarily integral feature of body (302) such that projection (304) serves as a hard stop. [0145]; fig 18); an advancement wheel comprising a wheel stop member (First member (322) comprises a projection (326) [0145]; fig 18); and a second wheel comprising a tab (Second member (324) comprises a distal projection (328) extending distally from a distal face of second member (324); and a proximal projection (329) extending proximally from a proximal face of second member (324). [0145]; fig 18). Ha also teaches the projections help limit the rotation/advancement of a catheter device (projections (304, 326, 328, 329) are configured to engage one another during rotation of first member (322) and second member (324) to thereby limit rotation of guidewire (106) [0145]; fig 18).
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the delivery device of Iizuka in view of Ha such that the housing further comprises a housing stop member, the advancement wheel comprises a wheel stop member, and the second wheel comprises a tab, as taught by Ha, because it provide a mechanism to limit the rotation/advancement of the tube-shaped probe.
Regarding Claim 23, Iizuka in view of Ha teaches the invention as discussed above in claim 22. Iizuka in view of Ha teaches the tab of the second wheel is configured to selectively bridge a gap between the housing stop member and the wheel stop member (In this position, projection (326) of first member (322) is engaged with a first surface of proximal projection (329) of second member (324), and distal projection (328) is also engaged with a first surface of projection (304) of body (302) such that guidewire (106) is unable to be rotated counter-clockwise any further. [0146 of Ha]; fig 20A of Ha).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791