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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claims 1-3 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,133,815 in view of Hanley (US 2004/0111070 A1).
Regarding application claim 1, patent claim 1 recites all the elements of application claim 1 except for the top cavity comprising an opening at a top end of the applicator body and the bottom cavity comprising a bottom opening at a bottom end of the applicator body. Hanley teaches an eye drop applicator (Figs. 1A-1C, feat. 10; ¶0019) comprising an applicator body (20) with a top cavity comprising an opening at a top end of the applicator body (Annotated Fig. 1, feat. A; Fig. 1B, feat. 36; ¶0021) and a bottom cavity comprising a bottom opening at a bottom end of the applicator body (Annotated Fig. 1, feat. B). The opening at the top end forms a presentation surface for presenting a droplet to the user (¶0021), while the bottom opening at the bottom end allows an applicator container to be received in the bottom cavity (Fig. 1B, feat. 18). Therefore, one of ordinary skill in the art would conclude that the invention of application claim 1 is an obvious variation of the invention of patent claim 1 in view of the teachings of Hanley in order to provide a presentation surface for droplet and allow the applicator container to be received in the bottom cavity.
Regarding application claim 2, Hanley further teaches that the top cavity comprises a droplet presentation surface (¶0021) and that the top cavity (Annotated Fig. 1, feat. A) is smaller than the bottom cavity (Annotated Fig. 1, feat. B). Therefore, one of ordinary skill in the art would have concluded that the invention of application claim 2 is an obvious variation of the invention of patent claim 1 in view of the teachings of Hanley.
Regarding application claim 3, Hanley further teaches that the bottom cavity comprises threads (Fig. 1B, feat. 32) in the bottom opening for engaging threads (34) on the neck of the application container (18). Therefore, one of ordinary skill in the art would have concluded that the invention of application claim 3 is an obvious variation of the invention of patent claim 1 in view of the teachings of Hanley.
Regarding claim 5, Hanley further teaches a compressible applicator container (Figs. 1A-1B, feat. 18; ¶0018). Therefore, one of ordinary skill in the art would have concluded that the invention of application claim 5 is an obvious variation of the invention of patent claim 1 in view of the teachings of Hanley .
Application claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,133,815.
Regarding application claim 18, patent claim 5 is dependent on patent claim 4. Patent claim 4 recites all the elements of application claim 18 except for the relief controller configured to selectively open and close the relief passage. Patent claim 5 further recites the relief controller configured to selectively open and close the relief passage. Therefore, application claim 18 is not patentably distinct from patent claim 5.
Application claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,133,815 in view of Hanley (US 2004/0111070 A1).
Regarding application claim 20, application claim 20 is dependent on application claim 18, which is not patentably distinct from patent claim 5 as discussed above. Hanley teaches an eye drop applicator (Figs. 1A-1C, feat. 10; ¶0019) comprising an applicator body (20) with a top cavity comprising an opening at a top end of the applicator body (Annotated Fig. 1, feat. A; Fig. 1B, feat. 36; ¶0021) and a bottom cavity comprising a bottom opening at a bottom end of the applicator body (Annotated Fig. 1, feat. B). The bottom cavity further includes a tube engagement feature opposite from the bottom end (Fig. 1B, feat. 42; ¶0025) which partially defines the dispensing channel (Fig. 1B; ¶0022-0024) and engages a dispensing tube within the bottom cavity (40; ¶0025). Hanley further teaches that a relief controller is supported on the tube engagement feature (Fig. 1B, feat. 48). Hanley teaches that such a tube engagement feature allows fluid to be communicated from an applicator container to the applicator via the dispensing tube (¶0025). Therefore, one of ordinary skill in the art would conclude that the invention of application claim 20 is an obvious variation of the invention of patent claim 5 in view of the teachings of Hanley in order to allow fluid communication between an applicator container and the applicator body.
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.
Claims 1-3, 5, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanley (US 2004/0111070 A1).
Regarding claim 1, Hanley discloses an eye drop applicator (Figs. 1A-1C, feat. 10; ¶0019) comprising an applicator body (20), the applicator body comprising: a top cavity comprising an opening at a top end of the applicator body (Please see annotated fig. 1, feat. A; Fig. 1B, feat. 36; ¶0021); a bottom cavity comprising a bottom opening at a bottom end of the applicator body (Please see annotated fig. 1, feat. B), wherein the bottom cavity is configured to receive a portion of an applicator container (18; ¶0019) within the bottom cavity (¶0020: Neck 30 of the bottle 18 comprises external threads 34 which screw into internal threads 32 on the inside of the applicator body); and a dispensing channel connecting the bottom cavity with the top cavity such that fluid can selectively flow through the dispensing channel and to the top cavity (38; ¶0021).
[AltContent: textbox (Annotated figure 1: Adapted from figure 1B of Hanley. Top cavity A is the dish at the top of the applicator body and bottom cavity B is formed between the threads 32 securing the applicator body to the neck 30 of the body. C is the outer surface of the applicator body.)]
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Regarding claim 2, Hanley discloses the eye drop applicator of claim 1, and further discloses that a volume of the top cavity (Annotated figure 1, feat. A) is less than a volume of the bottom cavity (Annotated figure 1, feat. B), and wherein the top cavity is configured to retain a predetermined amount of liquid medication as the fluid (Figs. 1B-1C, feat. 16; ¶0021-0024).
Regarding claim 3, Hanley discloses the eye drop applicator of claim 1, and further discloses that the applicator body further comprises a container engagement feature (Figs. 1A-1C; ¶0020 – internal threads 32) within the bottom cavity for selectively engaging the portion of the applicator container within the bottom cavity (¶0020; internal threads 32 engage the external threads 34 on the neck 30 of the bottle 18).
Regarding claim 5, Hanley discloses the eye drop applicator of claim 1, and further discloses the applicator container (Figs. 1A-1B, feat. 18; ¶0019) and that the applicator container is compressible (¶0019: Bottle 18 is squeezable).
Regarding claim 18, Hanley discloses an eye drop applicator (Figs. 1A-1C, feat. 10; ¶0019) comprising an applicator body (20), the applicator body comprising: a top cavity comprising an opening at a top end of the applicator body (Please see annotated fig. 1, feat. A; Fig. 1B, feat. 36; ¶0021); a bottom cavity comprising a bottom opening at a bottom end of the applicator body (Please see annotated fig. 1, feat. B); a dispensing channel connecting the bottom cavity with the top cavity (38; ¶0021); and a relief passage extending from the bottom cavity to the outer surface between the top end and the bottom end (Fig. 1B, feat. 50; ¶0028); and a relief controller configured to selectively open and close the relief passage (Fig. 1B, feat. 48; ¶0027-0029).
Regarding claim 20, Hanley discloses the eye drop applicator of claim 18, and further discloses a tube engagement feature within the bottom cavity opposite from the bottom end (Fig. 1B, feat. 42; ¶0025), wherein the tube engagement feature at least partially defines the dispensing channel (Fig. 1B; ¶0022-0024; tube engagement groove 42 surrounds the capillary tubes 38 which make up the dispensing channel, and therefore defines the limits on the configurations of the dispensing channels) and is configured to selectively engage a dispensing tube within the bottom cavity (40; ¶0025), and wherein the relief controller is supported on the tube engagement feature (Fig. 1B, feat. 48; Relief valve 48 is attached in part to the outer wall of the groove 42 which engages tube 40).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hanley in view of Gaynes (US 2007/0262096 A1).
Regarding claim 4, Hanley discloses the eye drop applicator of claim of claim 1. Hanley further discloses that the applicator body (Figs. 1A-1C, feat. 20) may be made of plastic or rubber, among other suitable materials (¶0021), but is silent with respect to any particular plastic or rubber.
Gaynes teaches drop dispensers for therapeutic solutions (¶0007) which may comprise removable dispensing cannula tips (Figs. 5-6, feats. 50 and 60; ¶0023). Gaynes teaches that the removable tips may be made of silicone because it is non-irritating to the eyes and skin (¶0029). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the applicator disclosed by Hanley so that the applicator body comprises silicone so that it is non-irritating as taught by Gaynes.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hanley and in further view of Valavala et al. (US 2021/0389166 A1).
Regarding claim 19, Hanley discloses the eye drop applicator of claim 18. Hanley discloses that the relief controller valve is attached to the applicator body (Fig. 1B, feat. 48; ¶0028) in contrast to the relief controller being monolithically formed with the applicator body as claimed. Therefore, the applicator of Hanley differs from the claimed applicator by the substitution of a non-integral relief valve for the claimed integral relief valve.
Valavala teaches a fluid dispenser (Figs. 2A-3, feat. 10; ¶0039) comprising an applicator body (Fig. 2B, feat. 12; ¶0039) with monolithically formed one-way valves, including multiple dispensing valves (Figs. 2A-2B, feats. 32a-32d; ¶0048-0049) and a single pressure relief valve (Figs. 2A-2B, feat. 42; ¶0050-0051). Therefore, a relief valve that is integral to the dispenser body is known in the art. One of ordinary skill in the art could have substituted the integrally formed relief valve of Valavala for the non-integrally formed relief valve of Hanley by molding the relief valve and applicator body together, and the resulting applicator body would predictably function in the same way as an applicator body with a non-integral valve because the integral valve of Valavala (Figs. 2B, feat. 42; ¶0050-0051) and non-integral valve of Hanley (Fig. 1B, feat. 48; ¶0027-0028) are constructed in similar ways. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the eye drop applicator disclosed by Hanley so that the relief controller is monolithically formed with the applicator body. Please see MPEP §2143.I(B).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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