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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 5/12/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 8, 13, 15, 16, 22, 24, 25, 39, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clauson et al. (US 2018/0318132 A1, hereinafter Clauson).
For claim 1, Clauson discloses a device for ocular fluid collection (Figs 28A-28N) ([0189-0207]), the device comprising inter alia:
a housing (2700) (Figs 28A-28N) ([0189-0207]) comprising a handle (2760) (Figs 28A-28N) ([0189-0207]), a hub (2762) (Figs 28A-28N) ([0189-0207]), and a button (input actuator as button of [0189]) disposed on the housing (Figs 28A-28N) ([0189-0207]);
a collection chamber (2703) (Figs 28A-28N) ([0189-0207]);
a vacuum conduit (2763) that is fluidically coupled to the collection chamber and extends within the housing (Figs 28A-28N) ([0189-0207]), wherein a negative pressure is generated in the vacuum conduit to pull the ocular fluid from the eye and into the collection chamber (Figs 28A-28N) ([0189-0207]); and
a valve (2707) (Figs 28A-28N) ([0189-0207, especially 0195]) disposed in the housing and coupled along the vacuum conduit (Figs 28A-28N) ([0189-0207]), wherein the valve is configured to be actuated by the button to modulate flow of the ocular fluid into the collection chamber when the negative pressure is generated in the vacuum conduit (Figs 28A-28N) ([0189-0207]).
For claim 4, Clauson discloses the device of claim 1, comprising a needle (2761) configured for insertion into the eye (Figs 28A-28N) ([0189-0207]).
For claim 5, Clauson discloses the device of claim 1, further comprising a second valve (2713) (Figs 28A-28N) ([0189-0207]) to prevent retrograde flow of ocular fluid, wherein the second valve comprises a pinch valve, a microfluidic valve, a ball check valve, a diaphragm check valve, a swing check valve, a flapper valve, a stop-check valve, a lift-check valve, an in-line check valve, a duckbill valve, a pneumatic non-return valve, a Tesla check valve, or combinations thereof (Figs 28A-28N) ([0189-0207, especially 0196]).
For claim 8, Clauson discloses the device of claim 1, wherein a distal end of the collection chamber comprises a fluid separation membrane (2713) (Figs 28A-28N) ([0189-0207]) configured to prevent collected fluid from exiting the collection chamber (Figs 28A-28N) ([0189-0207]).
For claim 13, Clauson discloses the device of claim 1, further comprising a dolphin nose tip coupled to the housing ([0177-0179]).
For claim 39, Clauson discloses the device of claim 1, comprising a compression assembly (2799) (Figs 28A-28N) ([0189-0207]) that is configured to slide distally with respect to the housing to generate the negative pressure in the vacuum conduit (Figs 28A-28N) ([0189-0207]).
For claim 40, Clauson discloses the device of claim 1, wherein the button is disposed on the handle of the housing (Figs 28A-28N) ([0189-0207, especially 0189]).
For claim 15, Clauson discloses a device for ocular fluid collection from an eye (Figs 28A-28N) ([0189-0207]), the device comprising inter alia:
a housing (2700) (Figs 28A-28N) ([0189-0207]) comprising a handle (2760) (Figs 28A-28N) ([0189-0207]), a hub (2762) (Figs 28A-28N) ([0189-0207]), and a button (input actuator as button of [0189]) disposed on the housing (Figs 28A-28N) ([0189-0207]);
a needle (2761) (Figs 28A-28N) ([0189-0207]) having a proximal and distal end (Figs 28A-28N) ([0189-0207]);
a collection chamber (2703) (Figs 28A-28N) ([0189-0207]) fluidly coupled to the needle (Figs 28A-28N) ([0189-0207]); and
a vacuum system (2774) (Figs 28A-28N) ([0189-0207]) comprising a vacuum conduit (2763) (Figs 28A-28N) ([0189-0207]) that is fluidically coupled to the collection chamber and extends within the housing (Figs 28A-28N) ([0189-0207]), wherein a negative pressure is generated in the vacuum conduit to pull the ocular fluid from the eye and into the collection chamber (Figs 28A-28N) ([0189-0207]); and
a valve (2707) (Figs 28A-28N) ([0189-0207]) disposed in the housing and coupled along the vacuum conduit (Figs 28A-28N) ([0189-0207]), wherein the valve is configured to be actuated by the button to modulate flow of the ocular fluid through the needle and into the collection chamber when the negative pressure is generated in the vacuum conduit (Figs 28A-28N) ([0189-0207]).
For claim 16, Clauson discloses the device of claim 15, wherein at least a portion off the needle is disposed outside the housing (Figs 28A-28N) ([0189-0207]).
For claim 22, Clauson discloses the device of claim 15, wherein the device further comprises a dolphin nose tip coupled to the housing ([0177-1079]).
For claim 24, Clauson discloses the device of claim 15, comprising a second valve (2713) (Figs 28A-28N) ([0189-0207]) configured to prevent retrograde flow of the ocular fluid, wherein the second valve comprises a pinch valve, ball check valve, a diaphragm check valve, a swing check valve, a flapper valve, a stop-check valve, a lift-check valve, an in-line check valve, a duckbill valve, a pneumatic non-return valve, a Tesla check valve, or combinations thereof (Figs 28A-28N) ([0189-0207]).
For claim 25, Clauson discloses the device of claim 15, wherein the vacuum system comprises a vacuum chamber, a decompression handle, a vacuum septum, or combinations thereof (Figs 28A-28N) ([0189-0207]).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 5, 8, 13-16, 22, 24, 25, 39, and 40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for collecting ocular fluid.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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