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 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.
Response to Amendment
Acknowledgement is made to the amendment received 01/02/2026.
Acknowledgement is made to the amendment of claims 1.
Acknowledgement is made to the cancellation of claims 2, 8-11, 13-14, 16-19, and 29.
Acknowledgement is made to the withdrawal of claims 21-28 and 30.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1, 3-7, 12, 15, and 20 are pending as rejected below. A complete action on the merits appears below.
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.
Claims 1, 3-5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 20130046305 A1) in view of Cornell (US 4580565 A).
Regarding claim 1, Davies teaches an apparatus for use with an elongated flexible medical assembly (Fig. 2A-F; puncture device 200) and an elongated ancillary medical assembly (Fig. 2A-F; cannula 224), the apparatus comprising:
an elongated support assembly (Fig. 2A-F; dilator 242) being positionable, at least in part, in sliding relationship with the elongated flexible medical assembly (Fig. 2A-F; puncture device 200), the elongated support assembly defining a support lumen configured to slidably receive the elongated flexible medical assembly (Fig. 2A-F; puncture device 200);
the elongated support assembly (Fig. 2A-F; dilator 242) configured to support, at least in part, the elongated flexible medical assembly after the elongated support assembly is positioned ([0088]- [0089]), at least in part, in sliding relationship with the elongated flexible medical assembly (Fig. 2A-F; puncture device 200); and
the elongated support assembly being, at least in part, selectively maneuverable via the elongated ancillary medical assembly toward a distal portion of the elongated ancillary medical assembly ([0088]- [0089]).
Davies further teaches the puncture device, which is the innermost element which punctures tissue and teaches Applicant’s claimed elongated flexible medical assembly, and the dilator, which is the element which surrounds the innermost element and teaches Applicant’s claimed elongated support assembly, as being configured to have a control of the movements between the said elements (Fig. 2A-F).
However, Davies is silent on the control of this movement between the elongated support assembly and the elongated flexible medical assembly as being by an actuatable plunger located at a proximal end of the elongated support assembly and the actuatable plunger configured to push the elongated flexible medical assembly proximally, causing forward advancement of the elongated flexible medical assembly.
Cornell teaches a device (Fig. 1-5; device 10) an innermost element which punctures tissue (Fig. 1-5; lancet 60) and an element which surrounds the innermost element and is positionable in a sliding relationship with the innermost element (Fig. 1-5; housing 12), which has a distalmost portion (Fig. 1; cap 24) and a portion proximal to said distalmost end containing a manual slide control member (Fig. 1-4; control catch 48) for controlling the position of the innermost element (Fig. 1-5; lancet 60) relative to the element (Fig. 1-5; housing 12) which surrounds and is slidably positioned relative to the innermost element (Col. 2, Lines 50-60).
Cornell further teaches the control catch as being configured to be pushed proximally and cause a forward advancement of the lancet (Fig. 5 shows the control member 48 as being positioned in a retracted position in phantom in Fig. 5 which causes the lancet to move distally beyond the neutral position into a position where the lancet pierces the tissue).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the control member for controlling the relative position of the inner member relative to the member surrounding said inner member, as is taught by Cornell, into the device having an inner element and an element surrounding said inner element which are positionable relative to one another as is taught by Davies, to produce the predictable result of providing positioning between an innermost element and the element which surrounds said innermost element, as is taught by Cornell, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 3, Davies teaches the apparatus of claim 1, wherein:
the elongated support assembly is, at least in part, selectively maneuverable along, at least in part, toward the distal portion, while the elongated flexible medical assembly remains stationary relative to the elongated support assembly, and while the elongated support assembly, in use, continues to support, at least in part, the elongated flexible medical assembly ([0088]).
Regarding claim 4, Davies teaches the apparatus of claim 1, wherein:
the elongated support assembly is configured to remain stationary relative to the elongated flexible medical assembly while the elongated flexible medical assembly, in use, is selectively maneuverable toward the distal portion, and while the elongated support assembly, in use, continues to support, at least in part, the elongated flexible medical assembly ([0088]- [0089]).
Regarding claim 5, Davies teaches the apparatus of claim 1, wherein:
the elongated support assembly is, at least in part, configured to remain within the elongated ancillary medical assembly while the elongated flexible medical assembly, in use, is selectively extended outwardly away from the distal portion ([0088]- [0089]).
Regarding claim 15, Davies teaches the apparatus of claim 1, wherein: the elongated flexible medical assembly includes: a distal puncture device configured to puncture a biological feature ([0060]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 20130046305 A1) in view of Chan (US 20170259043 A1).
Regarding claim 6, Davies teaches the apparatus of claim 1.
However, Davies is silent on the teaching of the apparatus wherein: the elongated support assembly is configured to increase, at least in part, stiffness of the elongated flexible medical assembly and of the elongated ancillary medical assembly.
Chan teaches an elongated medical element for insertion into the body (Fig. 13-15; guidewire 106).
Chan further teaches the guidewire as being configured to be selectively secured to a stabilizing assembly including a stabilizing tube (Fig. 13-15; stabilizing tube 501) which provides support to the elongated element for insertion into the body so as to adjust or fine tune the assembly as necessary during a medical procedure ([0134]- [0135]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the supporting element which surrounds the innermost element for insertion into the body of the patient as being an element which is configured to provide rigidity and stability to the innermost element, as is taught by Chan, into the innermost element for insertion into the patient, which is the described as the puncture device, as is taught by Davies, to produce the predictable result of using a tubular element which surround an elongated element to provide rigidity and stability as is desirable or necessary during a medical procedure, as is taught by Chan.
Regarding claim 7, in accordance with the above rejection of claim 6, Chan further teaches the apparatus of claim 1, wherein: the elongated support assembly is configured to increase, at least in part, stiffness of the elongated flexible medical assembly and of the elongated ancillary medical assembly ([0134]- [0135]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 20130046305 A1) in view of Kontos (US 5728133 A).
Regarding claim 12, Davies teaches the apparatus of claim 1.
However, Davies fails to teach the apparatus wherein: the elongated ancillary medical assembly includes a dilator assembly.
Kontos teaches a device having an elongate medical element for treating punctured patient tissue (Abstract).
Kontos further teaches the outermost element as including an expandable member for occluding patient tissue (Col. 3, Line 55-Col. 4, Line 15).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the outermost element of a device for treating punctures of patient tissue as being an expandable member, as is taught by Kontos, into the device for puncturing patient tissue as is taught by Davies, so as to produce the predictable result of occluding patient tissue by the use of an expandable member at the point of a puncture, as is taught by Kontos.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 20130046305 A1) in view of Lenker (US 20170259041 A1).
Regarding claim 20, Davies teaches the apparatus of claim 1.
However, Davies fails to teach the apparatus wherein:
a rotatable device is configured to control movement between the elongated support assembly and the elongated flexible medical assembly; and
the rotatable device is located at a proximal end of the elongated ancillary medical assembly; and
the rotatable device is configured to be rotated; and
the rotatable device is configured to threadably engage an outer surface of the elongated support assembly; and
the rotatable device is configured to urge selective motion of the elongated support assembly.
Lenker teaches an apparatus for insertion within a vessel or body tissue (Abstract), wherein the apparatus has an outermost elongate member (Fig. 3; control knob 314), an innermost elongate member (Fig. 3; inner tube 104), and an elongate member which is situated therebetween (Fig. 3; outer proximal tube 110). Wherein the movement of the innermost elongate member and the elongate member which surrounds the innermost elongate member is controlled by a rotatable device (Fig. 3; jackscrew body 316).
Lenker further teaches the jackscrew body as comprising a plurality of threads which are affixed do as to engage and provide control of the movement of the outer proximal tube ([0015], [0068]- [0070]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate a rotatable device so as to control an elongated member which is located around an innermost elongated member, as is taught by Lenker, into the device of having an innermost elongated member and an elongated member which surrounds it, as is taught by Davies, to produce the predictable result of controlled movement as is taught by Lenker, as broadly as is currently is claimed.
Response to Arguments
Applicant’s argument that the control member of Cornell operates differently than that of the Applicant’s invention due to Cornell’s mechanism which utilizes inertia for distal movement are currently unpersuasive as a mechanism relying on inertia does not constitute a teaching away nor does it necessarily preclude the incorporation of the teaching as provided above as broadly as is required by the claim as is currently presented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY REGAN LANCASTER whose telephone number is (571)272-7259. The examiner can normally be reached Monday-Thursday 8-4 EST.
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, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794
Prosecution Insights