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 without traverse of Species I (Figs. 2A/2B) in the reply filed on 05/15/2026 is acknowledged.
Claims 13 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/15/2026. (Examiner’s note: it should be understood that claims 13 – 15 require a slider with an integrated rack, which are not a part of the elected species; therefore, claims 13 – 15 have been withdrawn)
Specification
The disclosure is objected to because of the following informalities:
Page 12, paragraph [000102] line 12 recites “instrument (00)”, however, it appears that the line should read “instrument (10)” as previously, and repeatedly, recited.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 1 – 12 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi et al (US 2020/0187967 A1) and further in view of Wu et al (US 2005/0060016 A1).
Regarding claim 1, Palushi discloses an apparatus (dilation instrument 10) (abstract, paragraphs [0032 – 0039], and Figs. 1A-2C), comprising:
a handle (handle assembly 20) (paragraph [0033] and Fig. 1A-1C);
a guide member (guide member 50) extending distally from the handle (paragraph [0033] and Fig. 1A-1C,2A);
a dilation catheter (dilation catheter 70) slidably disposed relative to the guide member (paragraph [0036] and Fig. 2B-2C), the dilation catheter (dilation catheter 70) being operable to translate relative to the handle (handle assembly 20) along a longitudinal range of motion from a proximal-most position to a distal- most position (paragraph [0036] and Fig. 2B-2C), the dilation catheter including:
an expandable element (dilator 72) configured to dilate a passageway within a head of a patient (paragraph [0037] and Figs. 2B-2C), and
a distal end (distal end of dilator 72 – shown in Figs. 2B-2C); and
a dilation catheter actuator (slider 74) to thereby drive translation of the dilation catheter along the longitudinal range of motion (paragraph [0036]).
However, Palushi is silent regarding (i) wherein the dilation catheter actuator comprising a rotary member operable to rotate relative to the handle to thereby drive translation of the dilation catheter along the longitudinal range of motion.
As to the above, Wu teaches an apparatus (a delivery system 10) comprising a handle (control handle 12), a guide member (inner catheter member 22) slidable relative to a catheter (outer restraining member 26; which is equated to the dilation catheter 70 of Palushi) (abstract, paragraphs [0026 – 0028] and Figs. 1 – 6), the catheter (outer restraining member 26) being operable to translate relative to the handle (control handle 12) along a longitudinal range of motion from a proximal-most position to a distal- most position (paragraphs [0027 – 0029], [0041], and Figs. 1,2,4,5), and a catheter actuator (thumbwheel 18 and actuating mechanism – paragraph [0044]) comprising a rotary member (thumbwheel 18) operable to rotate relative to the handle to thereby drive translation of the dilation catheter along the longitudinal range of motion (paragraphs [0027 – 0029], [0041], [0038], [0044] and Figs. 1,2,4,5).
It should be understood that Palushi and Wu are known references in the art that teach a medical instrument comprising a handle assembly with an actuation mechanism used to retract a catheter (abstract, paragraphs [0032 – 0039], and Figs. 1A-2C – Palushi ; abstract, paragraphs [0027 – 0029], [0041], [0038], [0044] and Figs. 1,2,4,5 – Wu); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one actuation assembly for another, and the results of the substitution would have been predictable and resulted in the modified system of Palushi being able to function as intended to properly translate the dilation catheter. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Regarding claim 2, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Wu teaches the rotary member (thumbwheel 18) comprising a pinion (actuating gear 78) (paragraph [0044] and Fig. 5 – Wu). Therefore, the combination encompasses the limitations above.
Regarding claim 3, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Wu teaches comprising a rack (gear rack 70) slidably disposed in the handle (paragraph [0044] and Fig. 5 – Wu), the pinion (actuating gear 78) being engaged with the rack (gear rack 70) such that the rotary member is rotatable to drive translation of the rack (paragraph [0044] and Fig. 5 – Wu); therefore, the combination encompasses the limitations above and further encompasses wherein the rack (gear rack 70 – Wu) configured to drive translation of the dilation catheter (dilation catheter 70 – Palushi).
Regarding claim 4, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Wu teaches further comprising an idler gear (spur gear 74) rotatably supported by the handle (paragraph [0044] and Fig. 5 – Wu), the pinion being engaged with the rack (gear rack 70) via the idler gear (spur gear 74) (paragraph [0044] and Fig. 5 – Wu). Therefore, the combination encompasses the limitations above.
Regarding claim 5, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Wu teaches a first portion (top) of the rotary member (thumbwheel 18 – Wu) being exposed relative to the handle (Figs. 4,5 – Wu), a second portion (bottom) of the rotary member (thumbwheel 18 – Wu) being positioned in an interior region of the handle (Figs. 4,5 – Wu). Therefore, the combination encompasses the limitations above.
Regarding claim 6, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses the guide member (guide member 50) comprising a guide rail (guide member 50) having a distal end (distal end 52).
Regarding claim 7, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses the guide rail (guide member 50) being slidably positioned within a lumen of the dilation catheter (dilation catheter 70) (Examiner’s note: the guide member 50 slides relative to the dilation catheter, discussed in paragraph [0036], therefore, guide member 50 is slidably received within the lumen of the dilation catheter).
Regarding claim 8, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses at least a portion of the guide rail (guide member 50) being malleable (paragraph [0034]).
Regarding claim 9, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses the guide member (guide member 50) and the dilation catheter (dilation catheter 70) being configured such that the distal end (distal end 52) of the guide rail (guide member 50) is distal to the distal end (distal end shown in Fig. 2C) of the dilation catheter (dilation catheter 70) when the dilation catheter (dilation catheter 70) is in the proximal-most position (Fig. 2A), the guide member (guide member 50) and the dilation catheter (dilation catheter 70) being further configured such that the distal end (distal end 52) of the guide rail (guide member 50) is proximal to the distal end of the dilation catheter (dilation catheter 70) when the dilation catheter (dilation catheter 70) is in the distal-most position (paragraph [0036] and Figs. 2B-2C).
Regarding claim 10, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses comprising a rigid sheath (rigid guide member 30) extending distally from the handle (handle assembly 20) (paragraphs [0033 – 0034] and Figs. 1A-1C), the dilation catheter (dilation catheter 70) being positioned within the rigid sheath (rigid guide member 30) (paragraph [0036] and Figs. 1A-2C).
Regarding claim 11, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses the guide member (guide member 50) being positioned within the dilation catheter (dilation catheter 70) (paragraphs [0036 – 0038] and Figs. 1B-2C).
Regarding claim 12, as discussed above, it would have been obvious to modify the system / handle of Palushi to incorporate the actuating assembly of Wu. Additionally, Palushi discloses the expandable element (dilator 72) comprising a balloon (paragraph [0037]).
Related prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sandstrom (US 12,582,521 B1), Gaschino et al (US 2004/0153137 A1), and Weldon et al (7,052,511 B2) teach various actuation mechanisms for retracting a catheter.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
Prosecution Insights