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 .
Response to Amendment
Applicant amended claims 1, 3-8, 10, 19, 22, 25, and 29, canceled claims 2, 9, 11, and 17, and added claims 31-34. Claims 1, 3-8, 10, 12-16, and 18-34 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 9-13 of Applicant’s Remarks, filed 11/24/25, with respect to the rejections of claims 25 and 29 under 35 U.S.C. 112(b) as being indefinite have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see pages 9-13 of Applicant’s Remarks, with respect to the rejections of claims 1-6, 10-13, 19-24, 26-28, and 30 under 35 U.S.C. 103 as being unpatentable over Berger in view of Pedersen, of claim 7 in further view of Py, of claims 8-9 and 17-18 in further view of Bolden, of claim 14 in further view of Galdeti, of claims 15-16 in further view of Mosley, and of claims 25 and 29 in further view of Benktzon have been fully considered and are persuasive in light of the amendments to the independent claims to require that the skin engaging tip move toward the nozzle. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Independent claims 1, 19, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant amended claim 1 to require that “when the skin engaging tip is in engaged relation with the skin surrounding the eye, manipulation of the container causes the arm to pivot or move relative to at least the container from an initial condition to a flexed condition to cause the skin engaging tip to move inwardly toward the nozzle to thereby retract the skin surrounding the eye and position the nozzle in alignment with the eye”, amended claim 19 to require that “manipulation of the container causes: 1) the arm to move relative to the nozzle or the fluid chamber to cause the skin engaging tip to move toward the nozzle and displace the issue surrounding the eye and 2) the one of a protruding segment or extension of the arm to deform the nozzle or the fluid chamber inwardly to the nozzle axis to cause dispensing of the fluid from the nozzle end of the nozzle and into the eye of the user”, and amended claim 22 to require “manipulating the fluid container to cause the skin engaging tip of the arm to move toward the nozzle such that the skin engaging tip moves the tissue surrounding the eye; and dispensing the fluid from the nozzle end of the nozzle and into the eye” (amended claim limitations have been emphasized by the examiner). These limitations contain subject matter which is not clearly supported by the written description. As best understood by the examiner from ¶0069-0073 of the present specification and at least figure 4A of the drawings, the written description contains support for the skin engaging tip of the arm engaging the lower eyelid of the patient and exerting force on the nozzle assembly and/or container to retract the lower eyelid to open the eye, align the nozzle with the eye, and dispense fluid into the eye. However, “manipulating the fluid container” to cause the “skin engaging tip to move toward the nozzle” as claimed includes two situations within its scope: 1) the skin engaging tip moving towards the nozzle by the nozzle moving downwards towards the tip, which would result in lower eyelid retraction and is supported by the written description, and 2) the skin engaging tip moving towards the nozzle by the tip moving upwards towards the nozzle, which would displace the lower eyelid to a closed position and prevent the nozzle from being in alignment with the eye for fluid dispensing, and is not supported by the written description. Therefore, independent claims 1, 19, and 22 include subject matter which is not described in the specification.
Because independent claims 1, 19, and 22 are rejected as not complying with the written description requirement, their respective dependent claims 3-8, 10, 12-16, 18, 20-21, and 23-34 are also rejected as not complying with the written description requirement, and if the rejections of the independent claims are overcome, then so will those of the dependent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pedersen (US 2012/0310184 A1) discloses an eye-washing device with eyelid retractors which move outwardly from the dispenser nozzle.
Galdeti (US 2009/0259204 A1) discloses an eye drop applying device with eyelid retractors which move outwardly from the dispenser nozzle.
Keene (US 4,543,096 A) discloses an eyedrop dispenser with an eyelid retractor which moves outwardly from the dispenser nozzle.
Bosshold (US 4,085,750 A) discloses an eyedrop dispenser attachment with eyelid retractors which move outwardly from the dispenser nozzle.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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