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 of Invention I and Species B, readable on claims 1-4 and 6-11 in
the reply filed on 01/16/2026 is acknowledged. Because applicant did not distinctly and
specifically point out the supposed errors in the restriction requirement, the election has
been treated as an election without traverse (MPEP § 818.01(a)). Applicant asserts this election reads on claims 1-4 AND 6-11.
Status of Claims
Claims 1-20 are pending, claims 5 and 12-20 are withdrawn, and claims 1-4 and 6-11 are currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 has been considered by the examiner.
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, 2, 7, 8, 9, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2022/0054166 to Murray et al. (hereinafter “Murray”).
Regarding claim 1, Murray discloses a medical device, comprising:
a handle ([0030]) including an actuator (114, Fig. 1A, [0030]-[0031]);
a shaft extending distally from the handle (104, Fig. 1B, [0028], [0038]) , wherein the shaft includes a lumen (Fig. 1B); and
a distal cap (102, Fig. 1B, [0028]), wherein the distal cap includes:
a body (102, Fig. 1B, [0028]) including a first channel (126, Fig. 1B, [0038]), wherein the first channel is in communication with a distal portion of the lumen (Fig. 1B),
a distal face including an opening, wherein the opening is a distal opening of the first channel (128, Fig. 1B., [0039]), and
an expandable portion coupled to the body (110, Fig. 1B, [0029]- [0038]), wherein the expandable portion is configured to expand radially outwards from the body (Fig. 1B) and to retract radially inwards towards the body from an expanded position (Fig. 1A), and wherein the expandable portion includes at least one light (130, Fig. 1B, [0039]).
Regarding claim 2, Murray discloses the medical device of claim 1, and Murray further discloses wherein the actuator is in engagement with the expandable portion so that the actuator is configured to control expansion and retraction of the expandable portion (114, 110, Fig. 1A-Fig. 1B, [0031]).
Regarding claim 7, Murray discloses the medical device of claim 1, and Murray further discloses wherein the expandable portion is coupled to the body via a hinge (118, Fig. 1A, [0032]).
Regarding claim 8, Murray discloses the medical device of claim 7, and Murray further discloses wherein the expandable portion is coupled to a distal end of the body so that the expandable portion covers at least a portion of the opening in a retracted position and exposes an entirety of the opening in the expanded position (114, Fig 1A, Fig. 1B, [0030]-[0031]).
Regarding claim 9, Murray discloses the medical device of claim 8, and Murray further discloses wherein the expandable portion is semi-annular so that in the retracted position a portion of the opening remains exposed (Fig. 1A).
Regarding claim 11, Murray discloses the medical device of claim 8, and Murray further discloses wherein the actuator and the expandable portion engage one another via an opening wire and a closing wire, wherein a force applied to the opening wire is configured to expand the expandable portion, and wherein a force applied to the closing wire is configured to retract the expandable portion (114, Fig 1A, Fig. 1B, [0030]-[0031]).
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.
Claim(s) 3, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0054166 to Murray et al. (hereinafter “Murray”).
Regarding claim 3, Murray discloses the medical device of claim 1, but Murray fails to expressly teach wherein the expandable portion is biased towards a retracted position.
However, it would've been an obvious matter of design choice to a person of ordinary skill in the art to bias the expandable portion towards a retracted position since Murray already teaches a distal cap that expands and retracts, and because Applicant has not disclosed that such relative biasing provides an advantage, is used for a particular purpose, or solves a problem.
Regarding claim 4, Murray teaches the medical device of claim 3, and Murray further teaches wherein in the retracted position, an outer diameter of the distal cap is approximately the same as an outer diameter of a remaining portion of the shaft (Fig. 1A).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0054166 to Murray et al. (hereinafter “Murray”) and further in view of U.S. Publication No. 2019/0136070 to Aizenberg et al. (hereinafter “Aizenberg”).
Regarding claim 6, Murray discloses the medical device of claim 1.
Murray fails to expressly teach wherein a diameter of the opening is about 1.5 mm to 2.0 mm.
However, Aizenberg teaches of a medical device wherein a diameter of the opening is about 1.5 mm to 2.0 mm (Aizenberg: [0117], Figs. 2A-2B).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murray, to utilize a diameter opening of 2.0mm, as taught by Aizenberg. It would have been advantageous to make the combination for the purpose of inserting a device ([0117] of Aizenberg).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0054166 to Murray et al. (hereinafter “Murray”) and further in view of U.S. Publication No. 2012/0209074 to Titus.
Regarding claim 10, Murray discloses the medical device of claim 8.
Murray fails to expressly teach wherein the expandable portion is transparent.
However, Titus teaches of a medical device (Titus: Fig. 12 A) wherein the expandable portion is transparent (Titus: 410, Fig. 12A, [0078], [0112]-[0113]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murray, in view of Titus, so that the expandable portion is transparent. It would have been advantageous to make the combination for the purpose of allowing the probes to be passed to the targeted area ([0086] of Titus).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795