DETAILED ACTION
This office action is in response to applicant’s filings dated May 6, 2025.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 6, 2025 has been entered.
Advisory Notice
Claims 1-26, previously indicated as canceled, have been omitted.
MPEP 714.C.(C) states:
The text of all pending claims under examination and withdrawn claims must be submitted each time any claim is amended. A claim being canceled must be indicated as "canceled;" the text of the claim must not be presented. Providing an instruction to cancel is optional. Canceled and not entered claims must be listed by only the claim number and status identifier, without presenting the text of the claims. When applicant submits the text of
canceled or not-entered claims in the amendment, the Office may accept such an amendment, if the amendment otherwise complies with 37 CFR 1.121, instead of sending out a notice of non-compliant amendment to reduce the processing time.
In the interest of compact prosecution, based on the fact that claims 1-26 having been previously canceled, in view of the amendment otherwise being compliant with 37 CFR 1.121, the amendment is being accepted to reduce the processing time.
Status of Claims
Claims 26-28, 30-42, and 44-53 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed May 6, 2025. Acknowledgement is made of Applicant's amendment of claims 26, 32, 40, and 46. Claims 1-25, 29, and 43 were previously canceled.
Applicants elected without traverse a formulation comprising (1) prednisolone PO4 about 1%, moxifloxacin HCL about 0.5%, and bromfenac about 0.075 as the elected formulation species and care after cataract surgery as the elected ocular condition in the reply filed on August 23, 2021. The requirement is still deemed proper. Examination was expanded to encompass a composition comprising boric acid in view of the disclosure of the cited art in the Office Action dated February 23, 2023.
In order to accelerate prosecution, examination has been expanded to the following species: care after LASIK surgery, care for a retina of the eye after cataract surgery, care for a retina of the eye after retina surgery, in preparation for an intraocular procedure, or during the intraocular procedure, because care after LASIK surgery, care for a retina of the eye after cataract surgery, care for a retina of the eye after retina surgery, in preparation for an intraocular procedure, or during the intraocular procedure were identified during the prior art search.
Claims 26-28, 30-42, and 44-53 are presently under examination as they relate to the elected species: a formulation comprising (1) prednisolone PO4 about 1%, moxifloxacin HCL about 0.5%, and bromfenac about 0.075 and the expanded formulation species further comprising boric acid and care after cataract surgery and the expanded species care after LASIK surgery, care for a retina of the eye after cataract surgery, care for a retina of the eye after retina surgery, in preparation for an intraocular procedure, or during the intraocular procedure.
Priority
The present application claims benefit of US Provisional Application No. 63/037,171 filed on June 10, 2020. The effective filing date of the instant application is June 10, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 6, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 26-28, 30-35 and 37 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 has been rendered moot in view of the amendment of claim 26.
New Objections and/or Rejections
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 26-28, 30-42, and 44-53 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.
Claims 26, 32, 40, and 46 recite the phrase “prednisolone phosphate or pharmaceutically acceptable thereof.” Prednisolone phosphate is a pharmaceutically acceptable salt. It is not clear if the claim is intended to encompass different phosphate salts, e.g. PO4, PO3, or PO2) or if the claim is intended to encompass different pharmaceutical salts of prednisolone. Thus, the metes and bounds of the instant claim are not clear.
Claims 27, 28, 30, 31, 33-39, 41, 42, 44, 45, and 47-53 are rejected as being dependent on and including all the limitations of rejected claims 26, 32, 40, and/or 46.
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 26-28, 31-42, and 45-53 are rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al (US 2019/0111045 A1, published April 18, 2019, cited in the IDS filed May 6, 2025) in view of Sampietro et al (US 2018/0318319 A1, cited in the IDS filed July 29, 2021).
Regarding claims 26-28, 36, 40-42, and 50, Wiley teaches a method for treating an ophthalmological disease, condition or pathology in a mammalian subject in need of such treatment comprising: (a) performing a keratomileusis surgery on the subject; and (b) administering to the subject a composition (claim 17); wherein the keratomileusis surgery is LASIK surgery (claims 18 and 19); wherein the composition is administered via drops after the surgery (claim 20); wherein the pharmaceutical composition formulated as a suspension that consists of (a) a dispersed phase consisting of solid particles consisting of a therapeutically effective quantity of a corticosteroid, including prednisolone; (b) a dispersion medium consisting of: (b1) a therapeutically effective quantity of at least one anti-bacterial agent including a fluorinated quinolone; (b4) optionally, a therapeutically effective quantity of at least one non-steroid anti-inflammatory drug including bromfenac (claim 1); wherein the fluorinated quinolone is moxifloxacin (claims 3-6). Moreover, Wiley teaches preparing a pharmaceutical composition containing NSAID Bromfenac, comprising prednisolone acetate, moxifloxacin hydrochloride, and bromfenac sodium, and boric acid [0112-0125]; and the composition obtained can then be administered to a patient by ordinarily skilled ophthalmologists as eye drops after performing a keratomileusis surgery such as LASIK surgery, e.g. as follow-up care [0125].
Wiley does not teach that the prednisolone salt is prednisolone phosphate.
However, Sampietro teaches a method for treating an ocular condition of an eye; wherein the method comprises a step of administering a pharmaceutical composition at, in, or around the eye via a deliver device and per a predetermined dosing regimen (claim 1) wherein the ocular condition is care after LASIK surgery (claim 2); wherein the pharmaceutical composition comprises prednisolone PO4 1% and bromfenac 0.07% with a pH of 8.3 to 8.5 (claim 3). Sampietro also teaches the use of a pharmaceutical composition comprising moxifloxacin HCl 0.5% (claim 3), wherein the composition is preservative free (claim 6). Thus, Sampietro also teaches that prednisolone phosphate, moxifloxacin hydrochloride, and bromfenac are useful in a method of treating an ocular condition, care after LASIK surgery.
Since Wiley teaches a method of treating a method of treating an ocular condition, care after LASIK surgery comprising administering prednisolone acetate, moxifloxacin hydrochloride, and bromfenac sodium, and since Sampietro teaches a composition comprising prednisolone and bromfenac and a composition comprising moxifloxacin hydrochloride are useful in a method of treating an ocular condition, care after LASIK surgery, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date for a person of ordinary skill in the art to substitute one functional equivalence (any pharmaceutically acceptable prednisolone salt) for another (prednisolone PO4) with an expectation of success, since the prior art establishes that both function in similar manner.
Regarding the limitations wherein the delivery device is a multidose eye dropper (instant claims 26 and 40), wherein the multidose eye dropper is a sterile ophthalmic dropper bottle (instant claims 27 and 41), wherein the sterile ophthalmic dropper bottle is a drop-tainer (instant claims 28 and 42), Wiley teaches a method of compounding prednisolone, moxifloxacin hydrochloride, and bromfenac sodium and administering and that the composition can be administered to a patient by ordinarily skilled ophthalmologists as eye drops after performing a keratomileusis surgery such as LASIK surgery, e.g. as follow-up care. Thus, Wiley suggests administering the combination in a drop formulation. Wiley does not teach the composition is administered via a delivery device wherein the delivery device is a multidose eye dropper.
However, Sampietro teaches wherein the delivery device is an eye dropper (claims 9 and 19). Moreover, Sampietro teaches it would be desirable if such different packaged medications could be formulated to exist in a single package or delivery device, which may be improve patient compliance and reduce costs to the patient; dosing from a single container (that combines APIs) as opposed to multiple containers where the APIs are in separate and different containers, also exposes the patient to fewer preservatives; it would also be desirable if such a combined single packaging or delivery device, also increased efficacy and/or minimized side-effects [0006]. Sampietro further teaches the prednisolone PO4 1% and the bromfenac 0.07% pharmaceutical composition may be delivered to the eyes of a patient via use eye drops from an eye dropper, on some embodiments, a fill volume of 4 mL of this pharmaceutical composition may be contained within a 10 mL ophthalmic dropper (e.g., droptainer or the like) [0186] and a method of compounding the pharmaceutical composition and transferring to a final delivery device, e.g., a sterile ophthalmic dropper bottle [0188].
Moreover, Sampietro teaches in some embodiments, a pharmaceutical composition may comprise at least three active ingredients (APIs), prednisolone PO4, gatifloxacin and bromfenac [0197] and a method of compounding the pharmaceutical composition and transferring to a final delivery device, e.g., a sterile ophthalmic dropper bottle [0205]. As such, it would have been prima facie obvious to one of ordinary skill in the art to formulate the combination of prednisolone PO4 about 1%, moxifloxacin HCL about 0.5%, and bromfenac 0.07% rendered obvious by Wiley and Sampietro in a compounded composition and transferred to a final delivery device as suggested by Sampietro, since Sampietro teaches formulating the compositions into a single delivery device improves patient compliance, reduces costs to patient, exposes the patient to fewer preservatives and may also increase efficacy and/or minimize side-effects. A final delivery device, a sterile ophthalmic dropper bottle reads on a drop-tainer as evidenced by the instant application (see [0032] which teaches a final delivery device, e.g., a sterile ophthalmic dropper bottle (e.g., a “drop-tainer”).
Regarding claims 40, Example 5 of Wiley does not contain benzalkonium. This reads on, a composition comprising 0% benzalkonium.
Regarding claims 33, 34, 47, and 48, the composition of Example 5 contains boric acid.
Taken together, all this would result in the practice of the method of claims 26-28, 31, 33, 34, 36, 40-42, 47, 48, and 50 with a reasonable expectation of success.
Regarding claims 31 and 45, Sampietro teaches wherein the predetermined dosing regimen is selected from: once per day, twice per day, three times per day, once every other day, once per week, once every other week, or once monthly (claims 10 and 20).
Regarding the claimed amounts of prednisolone, moxifloxacin, and bromfenac of instant claims 32 and 46, Wiley teaches preparing a pharmaceutical composition containing NSAID Bromfenac, comprising about 10.0 g of prednisolone acetate, 5.454 g of moxifloxacin hydrochloride, and 1.035 g of bromfenac sodium, and about 1 L of sterile water [0112-0121]. This reads on a composition comprising 1% prednisolone acetate, 0.5454% moxifloxacin hydrochloride, and 0.1035% bromfenac sodium. Moreover, Sampietro teaches a composition comprising moxifloxacin HCl 0.5% and a composition comprising prednisolone PO4 1% and bromfenac 0.07%. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the practice of the method of claims 31, 32, 45, and 46 with a reasonable expectation of success.
Regarding claims 35, 37-39, 49, and 51-53, as set forth above, Wiley and Sampietro teach method for treating an ophthalmological disease, condition or pathology in a mammalian subject in need of such treatment comprising administering a composition comprising prednisolone PO4, moxifloxacin hydrochloride, and bromfenac sodium, including care after Lasik surgery. Wiley does not explicitly teach the ocular condition is care after cataract surgery, care for a retina of the eye after cataract surgery, care for a retina of the eye after retina surgery, in preparation for an intraocular procedure, or during the intraocular procedure. However, Sampietro teaches the ocular condition is one or more of: glaucoma, care after cataract surgery, care after LASIK surgery, care for a retina of the eye after cataract surgery, dry eyes disease, in preparation of an intraocular procedure, during the intraocular procedure. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize the method of treating ocular conditions comprising administering prednisolone PO4, moxifloxacin hydrochloride, and bromfenac sodium in view of the cited art, since the prior art teaches the same or very similar components are useful in a method of treating glaucoma, care after cataract surgery, care after LASIK surgery, care for a retina of the eye after cataract surgery, dry eyes disease, in preparation of an intraocular procedure, during the intraocular procedure.
Taken together, all this would result in the practice of the method of claims 35, 37-39, 49, and 51-53 with a reasonable expectation of success.
Claims 30 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Wiley et al (US 2019/0111045 A1, published April 18, 2019, cited in the IDS ) in view of Sampietro et al (US 2018/0318319 A1, cited in the IDS filed July 29, 2021) as applied to claims 26-28, 31-42, and 45-53 above, and further in view of Painchaud et al (US 2011/0155770 A1, cited in a previous Office Action).
Wiley and Sampietro teach all the limitations of claims 30 and 44 (see above 103 rejection), except wherein the multidose eye dropper is a dropper bottle comprising a non-return position preventing the liquid from flowing back into the dropper bottle.
However, Painchaud teaches a device for dispensing predetermined metered quantities of liquid while also improving the sterility of the dispensed liquid [0004]; device includes a sealing member than can take up a liquid release position, allowing liquid to flow out of the device, and a non-return position preventing liquid from flowing back into the device, wherein the sealing member is provided with a metering means for metering out the liquid to be dispensed [0005]; generally the predetermined metered quantities of liquid are drops of liquid [0006]; penetration of liquid into undesired zones is a source of contamination, in particular through development of bacteria; in order to avoid such a risk, it is necessary to provide specific means for procuring sealing [0007]; incorporating the metering means into the sealing member makes it easier to reduce any "dead volume" that might contain contaminated liquid; such dead volume corresponds to the volume situated between the sealed zone and the metering means for metering out the drops [0008]; the device makes it possible to dispense predetermined metered quantities of liquid, and more particular drops of liquid, for eye [0023].
As such, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention to incorporate the combination of prednisolone PO4, moxifloxacin HCL, and bromfenac suggested by Wiley and Sampietro in the eye dropper device comprising a non-return position preventing liquid from flowing back into the device since the prior art teaches it is desirable to prevent backflow of liquid into the source/reservoir of the composition to prevent contamination, thus resulting in the practice of the method of claims 4 and 14 with a reasonable expectation of success.
Response to Arguments
The Declaration of Amy Frost under 37 CFR 1.132 filed May 6, 2025 is sufficient to overcome the rejection of claims 26-28, 31-35, 37, 40-42, 45-49, and 51 based upon Sampietro. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wiley in view of Sampietro and is set forth above.
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself.
Conclusion
Claims 26-28, 30-42, and 44-53 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628