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 Group I (claims 1-22) in the reply filed on 8/17/2026 is acknowledged.
Claims 23-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Claim Objections
Claim 13 is objected to because of the following informalities:
Re Claim 13, at the end of the claim, the word “through” is misspelled in “to permit entry and passage of air though the air inlet port”.
Appropriate correction is required.
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, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Py (US 5,613,957) in view of Davis (US 2026/0199130).
Re Claim 1, Py discloses a fluid dispenser system, which comprises:
a nozzle assembly (see Fig. 1) configured for coupling to a container (medicament container 48) configured to hold medicants for treatment of one or more conditions of an eye of a subject (see Title), the nozzle assembly including:
a container coupler segment (piston body 16) configured to engage with the container (clearly shown in Fig. 1);
a medicant chamber segment (medicament chamber 33 defined by bellows 30, see Fig. 1) defining an internal volume configured to receive medicants from the container;
a nozzle (nozzle 20, formed by outer body 12 and inner body 14) depending from the medicant chamber segment, the nozzle defining a nozzle passage (extending from within the cylindrical wall 36 of inner body 14 through drop cavity 38 and channel 44, to interface 25) in fluid communication (via channel 44, see Fig. 1) with the medicant chamber segment and having a nozzle port (the port is open when outer nozzle portion 22 flexes relative to the inner nozzle portion 24, thus opening up interface 25 to allow fluid to pass through; see col. 3 lines 15-23 and col. 4 lines 14-22) for distribution of the medicants from the nozzle passage in response to pressurization of the internal volume of the medicant chamber segment; and
a reciprocating nozzle valve (piston 18) at least partially disposed in the nozzle passage of the nozzle (see Fig. 1 where piston 18 is shown mid-stroke and disposed within cylindrical wall 36 of inner body 14), the reciprocating nozzle valve configured to selectively move in the nozzle port to selectively permit and prevent flow of medicants through the nozzle passage and out the nozzle port (col. 4 lines 14-22).
Py does not disclose a positioning arm including an engagement segment displaced from the medicant chamber segment, the engagement segment configured to engage at least one of an upper or lower eye lid surrounding the eye to stabilize the one eye lid to facilitate distribution of the medicants into the eye.
Davis discloses a system for dispensing medicament into the eye of a patient, the system comprising a container (40) and a nozzle portion (compressor assembly 60), wherein the nozzle portion comprises a positioning arm (retractor 82) and an engagement segment (retractor pad 84), the engagement segment configured to engage at least one of an upper or lower eyelid of the eye ([0064]). It would have been obvious to one skilled in the art at the time of filing to add the positioning arm and engagement segment as taught by Davis because this will allow a user more easily and accurately dispense the medicament to the correct location.
Re Claim 20, Py and Davis combine to disclose claim 1 but they do not explicitly disclose that the medicant chamber segment, the nozzle and the container coupler segment are a monolithic unit. However, Py discloses that these structures are joined together and that each of these structures can only function when joined to each other, therefore one skilled in the art would find it desirable to combine all these structures into a monolithic unit for benefits such as fewer assembling steps.
Re Claim 21, Py and Davis combine to disclose claim 1 and that the nozzle and the container coupler segment are coupled to the medicant chamber segment (via bellows 30 and flange 32) but they do not explicitly disclose that the nozzle and the container coupler segment are a monolithic unit. However, Py discloses that the nozzle and the container coupler segment are joined together and that each of these structures can only function when joined to each other, therefore one skilled in the art would find it desirable to combine all these structures into a monolithic unit for benefits such as fewer assembling steps.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Py and Davis as applied to claim 1 above, and further in view of Yang et al. (US 2020/0009014).
Re Claims 16-17, Py and Davis combine to disclose claim 1 but they do not teach a medicant seal disposed between the internal volume of the medicant chamber segment and the container and wherein the medicant seal includes one or more seal passages to permit passage of fluids therethrough. Yang discloses a medicant dispenser (see Figs. 2-3) that comprises a seal (first check valve 13) at an inlet between a medicant container and a medicant chamber (storage space 123) within the dispenser to control inflow of medicant into the medicant chamber (e.g., [0059] and Fig. 6B). It would have been obvious to one skilled in the art at the time of filing to install a check valve in the opening (apertures 50 in Fig. 1 or Py) between a container and a medicant chamber of a nozzle assembly to help control the amount of medicant entering the nozzle assembly and to prevent backflow that may lead to contamination in the container.
Allowable Subject Matter
Claims 2-15, 18-19, 22 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claim 2, while Py discloses the nozzle valve capable of reciprocating motion, Py fails to disclose that the nozzle valve moves toward the nozzle port in response to pressurization of the internal volume of the medicant chamber segment. In fact, it is the forward movement of the nozzle valve (piston 18) that causes the pressurization within the medicant chamber segment (see col. 4 lines 14-22) and subsequently pushes the medicant from the medicant chamber segment to the nozzle port (space formed at interface 25 due to flexing of outer nozzle portion 22). Similarly, the nozzle valve does not move away from the nozzle port in response to release of pressurization in the medicant chamber segment. Instead, the nozzle valve is pulled back from the nozzle port by coil spring (52, Fig. 1) and the movement causes the release of pressurization.
Claims 3-8 are allowable at least for being dependent from Claim 2.
Re Claim 9, Py fails to disclose an inlet port that allows ingress of air into the medicant chamber segment. Py explicitly discloses closing the nozzle to prevent air and contaminants from entering.
Claims 10-15 are allowable at least for being dependent from Claim 9.
Re Claim 18, Py is concerned with contamination and discloses quickly closing the nozzle to prevent air from entering the nozzle assembly and therefore would not be reasonable to create a path to allow air into the container.
Re Claim 19, no prior art is found to disclose two valve segments configured in the way as claimed.
Re Claim 22, while the Davis positioning arm (retractor 82) is shown to be extending from the nozzle (Fig. 3) and, in the different embodiment, is movable (Figs. 12A-12C), the positioning arm is incapable of deforming the medicant chamber segment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kneer (US 2011/0079300) discloses an eyedrop dispensing nozzle having a tubular valve portion (central projection 12 of valve body 6) within the nozzle passage (exit channel 7), wherein normal operation of the nozzle requires reciprocating movement of the valve portion.
Greiner-Perth et al. (US 9,204,994) discloses a discharge device having a nozzle structure that can have reciprocating motion (see Figs. 2B & 2C).
WO 2023/212216 is related to the current Application.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
3 September 2026
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