DETAILED ACTION
Claims 1-8 are pending and being examined on the merits in this office 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 .
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
The abstract is objected to.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc.
The abstract should further be revised to recite complete sentences. The current abstract is a run-on sentence. The term “Cyclosporine” should be in lower case, cyclosporine.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claims 1 and 2 should be amended to recite “cyclosporine
Claims 2 and 3 should be amended to recite “preservative-free ophthalmic pharmaceutical composition” for consistency with the other claims. Insert a hyphen in the claim term “preservative-free”.
Claim 3 should be amended to recite “according to claim 1, further comprising adequate amounts of a tonicity agent, an oily material, an emulsifying agent, an [[on]] emulsion stabilizing agent, and an acid or a base
Claim 4 should be amended to recite “type A, and the pH adjuster”.
Claim 5 should be amended to recite “glycerine is from 1.5% to 2.5% and the amount of carbomer”.
Claim 6 should be amended to recite “in a range of”.
Claim 7 should be amended to recite “according to claim 1,” for claim consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the quantity". There is insufficient antecedent basis for this limitation in the claim.
The term “adequate amounts” in claim 2 is a relative term which renders the claim indefinite. The term “adequate amounts” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear from the claim and specification as to what constitutes “an adequate amount” of a tonicity agent, an “oily material”, etc with respect to the claimed preservative-free ophthalmic pharmaceutical emulsion. The skilled artisan is not apprised of the metes and bounds of an amount of the each recited component, that could be construed as “adequate”, as opposed to an amount that falls outside of the claimed boundaries rendering a given amount “inadequate” for inclusion in the claimed compositions.
Claim 4 recites the limitation "the pH adjuster ". There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the amount" four times in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the pH". There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the form". There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the phrase “wherein it is packed”. The phrase is indefinite because it is not clear what is meant by the word “it”.
The term “integral bacterial protection system” in claim 8 is a relative term which renders the claim indefinite. The term “integral bacterial protection system” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further regarding claim 8, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus (or composition) must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
It is further noted that the metes and bounds of the term “multi-use container equipped with an integral bacterial protection system” is deemed to be indefinite. The skilled artisan would recognize the term “multi-use container”. As noted above the term “integral bacterial protection system” is indefinite. It is further unclear from the claimant specification as to how exactly a claimed multiuse container would be “equipped” with an “integral bacterial protection system”. The claim lacks clarity as to as to how the claimed elements structurally and physically interact with each other to render the multi-use container “equipped”. The specification does not fully define what is meant by “equipped with”.
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.
(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) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Karavas et al (U.S. 20220378698 (earliest effective filing date 7/12/2019; Appl. No 17/626625 in ODP rejection).
The applied reference has a common applicant and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Karavas et al teach a stable preservative-free cyclosporine emulsion in the form of eye drops and a process for the manufacturing thereof, packed in a container that ensures stability of the product (e.g., abstract; paras. [0017], [0031]-[0041], examples). Accordingly the limitations of instant claim 1 are satisfied. Regarding claim 2, Table 1 teaches and emulsion composition comprising 0.05% cyclosporine. Regarding claims 3 and 4, Karavas et al teach a preservative-free pharmaceutical emulsion is provided comprising Cyclosporine as active ingredient, a tonicity agent [glycerin], an emulsifying agent [Polysorbate 80], a viscosity modifying agent [carbomer copolymer type A], an oily component [castor oil], and one or more pH adjusting agents [sodium hydroxide] (e.g., paras. [0015], [0035]-[0040], examples). Regarding claim 5, Karavas et al teach that castor oil is in an amount of 1%-2% (w/v), most preferably 1.25% w/v. Polysorbate 80 in an amount of 0.25%-2% (w/v), most preferably 0.50%-1% w/v. Glycerin in an amount of 1.5%-2.5% (w/v), most preferably 2.20% w/v. Carbomer copolymer type A is present in an amount of 0.03%-1% (w/v), most preferably 0.05% w/v. See paras. [0036]-[0039]. Table 1 teaches and emulsion composition comprising castor oil at 1.25%, polysorbate 80 at 1%, glycerin and2.2%, and carbomer copolymer type A at 0.05%. Regarding claim 6, Karavas et al teach that the pH of the range of 6.5 to about 8 (paras. [0040], Tables 1 and 10, claim 9). Regarding claim 7, the composition is in the form of eyedrops ((abstract, paras. [0025], [0028]-[0030]). Regarding claim 8, Karavas et al teach that the composition is packed in a multi-use container equipped with an integral bacterial protection system (e.g., claim 11; paras. [0013], [0027]-[0030]).
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding et al. (U.S. Pat. No 5474979).
Ding et al teach preservative free ophthalmic pharmaceutical emulsion comprising a therapeutically effective amount of cyclosporine (title, abstract, Examples 1-4, claims 1-8). The ophthalmic pharmaceutical emulsion formulations presented in examples 1-4 do not include a preservative, and are therefore preservative free. Accordingly, the limitations of claim 1 are satisfied. Regarding claim 2, Ding et al teach that the compositions comprise 0.05% and about 0.40% cyclosporine (Examples 1-4, claims 7-8). Regarding claims 3 and 4, Ding et al teach ophthalmic pharmaceutical emulsions comprising a tonicity agent [glycerin], an emulsifying agent [Polysorbate 80], a viscosity modifying agent [carbomer copolymer type A- also known as Pemulen], an oily component [castor oil], and one or more pH adjusting agents [sodium hydroxide] (e.g., col. 4, Examples 1-4, claims 6-8). Regarding claim 5, Ding et al teach an ophthalmic pharmaceutical emulsion comprising castor oil at 0.625-5.0%, polysorbate 80 at about 1%, glycerin and about 2.2%, and carbomer copolymer type A/Pemulen at about 0.05% (Examples 1-4, claims 6-8). Regarding claim 6, the pH of the emulsions can be adjusted with sodium hydroxide to a neurophysiological pH (col 4; claim 8). Examples 1-4 teach formulations having a pH of 7.2-7.6.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Acheampong et al (U.S. 20050059583).
Acheampong et al teach preservative free ophthalmic pharmaceutical emulsion comprising a therapeutically effective amount of cyclosporine [inclusion of a preservative is optional] (e.g., abstract, paras. [0028]-[0029]; claims 1, 21-25, Example 1). Accordingly, the limitations of claim 1 are satisfied. Regarding claim 2, Acheampong et al teach that the compositions comprise 0.05% or 0.1 % cyclosporine (Example 1). Regarding claims 3-5, Acheampong et al teach ophthalmic pharmaceutical emulsion formulations comprising cyclosporine at0.05% or 0.1 %; castor oil at 1.25% (oily material); polysorbate 80 at 1% (emulsifying agent); glycerin at 2.2% (tonicity agent); and carbomer copolymer type A/Pemulen at about 0.05% (emulsion stabilizing agent). The pH adjuster is sodium hydroxide (Example 1, paras.[0099]-[0110], claims 21-36). Regarding claim 6, the pH of the emulsions can be adjusted with sodium hydroxide to a pH of 7-8 (e.g., para. [0093]; Ex 1;claims 35 and 36). Example 1 teach formulations having a pH of 7.2-7.6. Regarding claim 7, Acheampong et al teach that the ophthalmic pharmaceutical emulsion comprising cyclosporine can be in the form of eyedrops (e.g., paras. [0029], [0091]). Regarding claim 8, Acheampong teach that the ophthalmic pharmaceutical emulsion can be sterilized and maintained in a sterile condition prior to use, e.g. a sealed package. The composition can be administered, repeated daily basis, reads on multi-use container and integral bacterial protection system of (e.g., paras. [0032], [0048]).
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.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-15of copending Application No. 17/626625 (hereinafter “the ‘625 application”; US PBPUB 2022/0378698). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1 and 2, claims 1-6 and 10 of the ‘625 application are drawn to a process for the manufacture of an ophthalmic composition of Cyclosporine as the active pharmaceutical ingredient, comprising: a. preparation of an emulsion by mixing an aqueous phase with an oil phase and sterilization thereof, wherein the aqueous phase comprises polysorbate 80, and the oil phase comprises Cyclosporine, glycerin, and castor oil; b. preparation of a separate aqueous phase comprising a viscosity modifying agent and sterilization thereof; c. mixing the emulsion of (a) with the aqueous phase of (b) to obtain the composition and aseptically filling an appropriate ophthalmic container, wherein the polysorbate 80 is present in the composition at a concentration of 0.25% - 0.5% (w/v), the Cyclosporine is present at a concentration of 0.05% - 0.25% (w/v), the glycerin is present at a concentration of 1.5% - 2.5% (w/v), and the castor oil is present at a concentration of 1% - 2% (w/v). Claim 10 of the ‘625 application recites that the process yields a preservative-free ophthalmic composition of Cyclosporine.
Regarding claims 3 and 4, claims 1 , 9, and 15 of the ‘625 application teach a process of preparing a preservative-free ophthalmic composition comprises glycerin, castor oil, polysorbate 80, carbomer copolymer type A, and sodium hydroxide to adjust the pH.
Regarding claim 5, claims 1 and 15 of the ‘625 application teach a process of preparing a preservative-free ophthalmic composition glycerin (1.5-2.5% w/v), castor oil (1-2% w/v), polysorbate 80 (0.5-0.25% w/v), carbomer copolymer type A (0.03-1% w/v).
Regarding claim 6, claim 9 of the ‘365 application teaches that the pH is adjusted to 6.5-8.
Regarding claim 7, claims 13 and 14 of the ‘625 application recite wherein the ophthalmic composition of Cyclosporine has an average drop volume from the appropriate ophthalmic container in the range of 22 µL -39 µL; 24 µL -34 µL [reads on eyedrops].
Regarding claim 8, claim 11 of the ‘625 application recites wherein the ophthalmic composition of Cyclosporine is packed in a multi-use container equipped with an integral bacterial protection system.
Accordingly, instant claims 1-8 are rendered obvious.
Conclusion
No claims are allowed.
Claims 1-8 are pending and are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTINA M HELLMAN/Examiner, Art Unit 1654