DETAILED ACTION
Notice of 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 with traverse of a single species in the reply filed on 8/14/2026 is acknowledged. As argued by Applicant, “[t]he special technical feature... is a pharmaceutical composition comprising a combination of Lifitegraast and Loteprednol. The Office has not demonstrated how a person of ordinary skill in the art would have arrived at this specific combination from the disclosures of the art cited” (Applicant Arguments, Page 2).
The argument is not found persuasive. Applicant is directed to Paragraph 2 of the Requirement for Restriction/Election mailed on 6/16/2026 where it is stated:
“even though the species require the technical feature of a pharmaceutical composition comprising Lifitegrast and Loteprednol, this technical feature is not a special technical feature as it does not make a contribution of the prior art in view of Musunuri et al (US 2018/0333414) and Meyering (US 2005/0182039) which respectively teach compositions comprising Lifitegrast (Paragraph 0008) and Loteprednol (Abstract) for the treatment of dry eye. As such, it would not entail an inventive step to combine the actives into a single composition as claimed”.
As stated in MPEP 2144.06, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
The elected species read upon claims 1-10.
Claim Objections
Claims 3-10 are objected to for the following reasons:
Claim 1 is drawn to a pharmaceutical composition comprising lifitegrast, loteprednol and one or more pharmaceutical excipients.
Claim 3 is drawn to the composition of claim 1, “wherein composition comprises...”.
The claim should recite “wherein said pharmaceutical composition comprises”.
Claim 4 is drawn to the composition of claim 1, “wherein one or more excipient comprises”.
The claim should recite “wherein said one or more excipient is selected from”
Claim 5 is drawn to the composition of claim 4, “wherein the buffering agents include... pH-adjusting agent include... osmotic/tonicity adjusting agent include...”.
The claim should recite “wherein the buffering agents are selected from... the pH-adjusting agent is selected from... the osmotic/tonicity adjusting agent is selected from...”.
Claim 6 is drawn to the composition of claim 1 “wherein the pharmaceutical composition having osmolality is about 250 to 400 mOsm”.
The claim should recite “wherein the osmolality of said pharmaceutical composition
Claim 7 is drawn to the composition of claim 1, “wherein said composition is...”.
The claim should recite “wherein said pharmaceutical composition is”.
Claim 8 is drawn to the composition of claim 7, “wherein pharmaceutical composition comprises...”.
The claim should recite “wherein said pharmaceutical composition comprises...”.
Claim 9 is drawn to the composition of claim 1, “wherein said composition used...”.
The claim should recite “wherein said pharmaceutical composition is used”.
Claim 10 is drawn to the composition of claim 1, “wherein said composition is...”.
The claim should recite “wherein said pharmaceutical composition is”.
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.
Claims 4, 7 and 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 is drawn to a composition comprising one more excipients selected from the group consisting of buffering agents, pH-adjusting agents, “and the like”.
Similarly, claim 7 is drawn to a composition in the form of a solution, suspension, “and the like”.
The recitations of “and the like” renders the claims indefinite because the claims include elements not actually disclosed (those encompassed by “and the like”), thereby rendering the scope of the claims unascertainable (see MPEP § 2173.05(d)).
Claim 7 is further rejected as indefinite as reciting a broad recitation as well as a narrower statement of the broad limitation. Specifically, claim 7 recites a composition “in the form of... solution, suspension, emulsion... gel forming solution, dispersion”. A gel forming solution is a narrower statement of the broad recitation of a solution. And an emulsion is the narrower statement of the broad recitation of a dispersion.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 is drawn to “[t]he pharmaceutical composition as claimed in claim 1; wherein said composition is administered topically to an eye of the subject”.
The recitation of “the subject” in claim 10 lacks antecedent basis in claim 1.
Claim Rejections - 35 USC § 102
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.
Claim 1 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Musunuri et al (US 2018/0333414; of record).
Claim 1 is drawn to a pharmaceutical composition comprising:
(a) lifitegrast or a pharmaceutically acceptable salt thereof;
(b) loteprednol or a pharmaceutically acceptable salt thereof; and
(c) one or more pharmaceutically acceptable excipients.
Musunuri et al teach “a composition comprising two or more of the following pharmaceutically active compounds: (i) an alpha 2 adrenergic agonist; (ii) a corticosteroid; (iii) a lymphocyte function-associated antigen antagonist; (iv) a non-steroidal anti-inflammatory drug (NSAID); (v) a sodium channel blocker; and (vi) an antibiotic, provided at least one of the pharmaceutically active compounds is selected from (i) alpha 2 adrenergic agonist and (ii) corticosteroid” (Abstract), more specifically wherein the “compositions of the invention comprise (a) a corticosteroid; and (b) a lymphocyte function-associated antigen antagonist” (Paragraph 0012) and, even more specifically, “an aqueous ophthalmic solution” wherein “[o]ne particular composition of the invention has a corticosteroid containing loteprednol and lifitegrast in a pharmaceutically acceptable excipient” (Paragraph 0020).
Accordingly, claim 1 is anticipated.
Claims 9-10 are drawn to the composition of claim 1, wherein the composition is for treatment of dry eye disease (claim 9) and wherein the composition is administered topically to an eye of a subject (claim 10).
Applicant is advised that use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the composition of Musunuri et al could be topically administered to an eye of a subject for treatment of dry eye disease. Indeed, as specifically taught by Musunuri et al, “[a] method for treating an eye disorder by administering to a patient... a therapeutically effective amount of any of the compositions... is also provided” wherein “[t]he eye disorder can be dry eye syndrome” and “the composition is administered topically to an eye of the subject” (Paragraph 0020).
Accordingly, the intended use limitations do not carry patentable weight and claims 9-10 are also anticipated.
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.
Claims 2-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Musunuri et al (US 2018/0333414; of record).
Claims 2-3 are drawn to the composition of claim 1, wherein the composition comprises lifitegrast at a concentration range from about 1.0% w/v to about 5.0% w/v (claim 2) and loteprednol etabonate at a concentration range from about 0.1% w/v to about 0.5% w/v (claim 3).
As further taught by Musunuri et al, the aqueous ophthalmic solution (more specifically, the heterogenous aqueous solution) can comprise lifitegrast in an amount ranging from 3 to 100 mg/g (i.e., 0.3% to 10% w/v) and loteprednol etabonate in an amount ranging from 0.1 to 20 mg/g (i.e., 0.01 to 2% w/v) (Paragraphs 0097-0104 and Table following Paragraph 0104).
As discussed by MPEP 2144.05, “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (citing In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)).
As such, claims 2-3 are rejected as prima facie obvious.
Claims 4-5 are drawn to the composition of claim 1, wherein one or more excipients comprise a buffering agent and/or an osmotic/tonicity adjusting agent (claim 4), more specifically sodium citrate dihydrate and/or glycerin (claim 5).
Musunuri et al teach sodium citrate dihydrate and glycerin as excipients (Paragraphs 0097-0104 and Table following Paragraph 0104).
As such, claims 4-5 are also rejected as prima facie obvious.
Claim 6 is drawn to the composition of claim 1, wherein the osmolality of the composition is about 250 to 400 mOsm.
Musunuri et al teach related compositions comprising and lifitegrast and brimonidine tartrate (as opposed to loteprednol etabonate) wherein formulating the composition includes the step of “[a]djust[ing] osmomolarity” (Paragraph 0112) and wherein the osmolality of the composition is from “200-400 mOSm” (Paragraphs 0107-0118 and the table following Paragraph 0118).
It would have been prima facie obvious to similarly adjust the osmolality of the “[o]ne particular composition of the invention [having] a corticosteroid containing loteprednol and lifitegrast in a pharmaceutically acceptable excipient” (Paragraph 0020).
As such, claim 6 is also rejected as prima facie obvious.
Claims 7-8 is drawn to the composition of claim 1, wherein the composition is in the form of a solution or suspension.
As discussed above, Musunuri et al teach the composition as “an aqueous ophthalmic solution” (Paragraph 0020) and, more specifically, a heterogenous aqueous solution (Paragraphs 0097-0104), wherein as further taught by Musunuri et al, “[h]eterogenous solutions include, but are not limited to... suspensions” and so on (Paragraph 0016).
As such, claims 7-8 are also rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
