DETAILED ACTION
A final Office action was mailed 15 September 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 12 March 2026 (“Reply”).
The Reply was submitted with a Request for Continued Examination (RCE).
Status of the Claims
The listing of claims filed with the Reply and RCE has been entered and examined.
Claims 1, 2, and 4 are pending. Claims 3, 5, and 6 are canceled.
Improper Claim Listing
Claim 5 is canceled but still contains text. Appropriate correction is required.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for any non-statutory double patenting rejections not included in this action can be found in a prior Office action. Unless repeated herein, any objection or rejection set forth in a prior Office action is withdrawn.
Claim Rejections - 35 U.S.C. § 112 and 35 U.S.C. § 132
The following is a quotation 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 35 U.S.C. § 132(a):
(a) Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. No amendment shall introduce new matter into the disclosure of the invention.
As shown above, 35 U.S.C. § 132(a) states: “no amendment shall introduce new matter into the disclosure of the invention.”
Claim 1 is rejected under 35 U.S.C. § 132(a) because it introduce new matter into the disclosure and under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claim contains subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The subject matter that is not supported by the original disclosure is: “boronic acid.”
In the listing of claims dated 20 August 2025, claim 6 recites: “boric acid.”
In the listing of claims filed with the Reply, claim 6 is canceled. In the Remarks filed with the Reply, Applicant states, “claim 1 has been amended to include the features of dependent claim 6 (i.e., the composition further comprises boric acid).” (Remarks, p.3). But claim 1 recites boronic acid instead of boric acid, and one of ordinary skill in the art would appreciate the terms are not interchangeable.
Support for boric acid can be found in the specification (p.6, ¶¶17–19), which states:
[0017] [Buffer]
The aqueous composition according to the present embodiment may further contain a buffer. The aqueous composition further containing a buffer allows the effect of the present invention to be more remarkably exhibited. The buffer is not particularly limited as long as it is pharmaceutically, pharmacologically (in drug manufacturing) or physiologically acceptable.
[0018] Examples of the buffer include a boric acid buffer (for example, boric acid and a combination of boric acid and borax). As the buffer, a commercially available one may be used. The buffer may be used alone or in combination of two or more. Boric acid is preferred as the buffer.
[0019] The content of the buffer in the aqueous composition according to the present embodiment is not particularly limited, and is appropriately set according to the type of the buffer, the type and content of other compounding components, the use and formulation form of the aqueous composition, etc. From the viewpoint of exerting the effect of the present invention more remarkably, the content of the buffer is as follows. For example, the total content of the buffer based on the total amount of the aqueous composition is preferably 0.01 mass% to 10 mass%, more preferably 0.05 mass% to 5 mass%, and still more preferably 0.1 mass% to 3 mass%.
The term “boronic acid” is not disclosed in the original disclosure. As shown above, only boric acid is mentioned when discussing the use of a buffer.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 U.S.C. § 103
Claims 1, 2, and 4 are rejected under 35 U.S.C. § 103 as being unpatentable over U.S. 2016/0367556 A1 (“Okigami”) in view of WO 2017/050891 (“Sierra”) and Practical Pharmaceutics – An International Guideline for the Preparation, Care and Use of Medicinal Products, Bouwman-Boer et al. (Eds.) (Springer 2009), Chapter 10 (Eye) by Ludwig et al., pp. 162–188 (“Ludwig”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Okigami discloses an aqueous ophthalmic composition comprising delgocitinib. (Okigami, ¶¶89, 98, 106).
Okigami discloses the composition can include a buffer. (Id., ¶62).
Okigami discloses the composition can be at a pH of 4 to 8. (Id., ¶63).
Okigami discloses the delgocitinib can be included at 0.0001 to 2000 mg or at a concentration of 0.0001% to 0.1% (w/v). (Id., ¶67).
Sierra discloses compositions comprising delgocitinib in an amount ranging from 0.1 to 100% by weight, including, preferably, 0.3% by weight. (Sierra, 5:12–24) (col:lines).
Ludwig discloses polyethylene containers are popular for ophthalmic medicants. (Ludwig, p.176).
Ludwig discloses boric acid is commonly used as an excipient in ophthalmic medicants to adjust pH. (Id., p.172, Table 10.5 and accompanying text).
Ascertaining the differences between the prior art and the claims at issue
Okigami discloses the concentration of delgocitinib in terms of mass per volume, whereas the instant claims refer to concentration in terms of mass per weight. Sierra is relied on for that feature in the claims.
Okigami does not disclose boric acid as a buffer. Ludwig is relied on for that feature.
Okigami does not disclose a polyethylene container for the aqueous ophthalmic composition comprising delgocitinib. Ludwig is relied on for that feature.
Sierra discloses compositions comprising delgocitinib for treating alopecia.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The specification includes stability testing for various embodiments. (Spec., ¶¶40–43). Each of the examples used a polyethylene storage container. Examples 1–3, 7, and 8 include delgocitinib at a concentration of 0.02 mass%, and Examples 4–6 and 9–14 include delgocitinib at a concentration of 0.3 mass%. (Id., Tables 1–3). The examples were stored at a pH in the range of 4.0–6.0. In each example, the residual ratio of delgocitinib (%) was over 96% after the two-month storage period. The Comparative Examples, which also include delgocitinib at a concentration of 0.02 or 0.3 mass%, were stored at a pH of 7.0. The Comparative Examples resulted in a residual ratio of delgocitinib (%) of less than 94%.
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Okigami, Sierra, and Ludwig to arrive at the claimed invention because Okigami and Sierra are both directed to compositions of delgocitinib and Ludwig is directed to pharmaceuticals for the eye. While it is unclear if Okigami discloses the claimed concentration of 0.3 mass% due to its use of different units, Sierra discloses compositions comprising delgocitinib and teaches a preferred concentration of 0.3 mass%. Although Sierra is directed to treating alopecia, one of skill in the art would appreciate the disclosed dosage is safe and efficacious for human subjects. And while Okigami is silent with respect to the material of the storage container, Ludwig teaches that polyethylene containers were popular for ophthalmic medicants at the time of filing. Ludwig further teaches boric acid is a common buffer for eye drop solutions. Thus, all of the claimed features were known in the art at the time of filing the instant application.
One of ordinary skill in the art would have been motivated to combine the teachings of Okigami and Sierra because they are both directed to compositions of delgocitinib and the treatment of human subjects. One of ordinary skill in the art would have been motivated to combine the disclosures of Okigami and Ludwig because Okigami is directed to treating diseases including eye diseases and Ludwig discloses boric acid is a common buffer for eye drop solutions and polyethylene containers were popular for ophthalmic medicants at the time of filing. There would have been a reasonable expectation of success at arriving at the claimed invention because modifying the buffer, pH, and/or concentration of an active ingredient in a solution is routine in the art, polyethylene containers are popular for ophthalmic medicants, and the high level of ordinary skill in the art would be capable of recognizing appropriate buffers and containers for ophthalmic medicants.
The experimental data disclosed in the instant application has been considered. Regarding claims 2 and 4, there is no evidence relevant to the material of the storage bottle. Regarding claim 1, there is no evidence relevant to the buffer, and there is no evidence of unexpected results related to the concentration of delgocitinib. Regarding concentration, Example 7 (delgocitinib, 0.02 mass%) resulted in a higher residual ratio of delgocitinib (98.1% versus 97.7%) than Example 11 (delgocitinib, 0.3 mass%). Thus, one of ordinary skill in the art would not consider the claimed 0.3 mass% as a critical element. The skilled artisan would have considered the improvement illustrated by the examples to be related to the pH of the solution. Each example includes the same amount of boric acid. And the Examples stored at a pH in the range of 4.0–6.0 resulted in a higher residual ratio of delgocitinib than the Comparative Examples stored at a pH of 7.0. However, because Okigami discloses compositions at a pH of 4 to 8, the critical feature of the instant claims was already known in the art and could not been considered unexpected.
Response to Arguments
Applicant’s arguments submitted with the Reply have been fully considered but are not persuasive. Applicant first argues, “dependent claim 6 was not even subject to any rejection in the Non-Final Office Action . . . and presumably contained allowable subject matter at least at some point during exam.” (Remarks, p.4). Examiner directs Applicant to the non-final Office action dated 21 May 2025, in which claims 1–5 were pending. Claim 6 was not rejected because it did not exist at that time. Thus, Applicant’s argument is misplaced and lacks merit.
Applicant next argues one of ordinary skill in the art would not have been motivated to select boric acid from the examples provided in Ludwig because there would have been no reasonable expectation of success. (Id.). This argument is not persuasive. Ludwig does not disclose an unlimited, or even large, number of excipients for adjusting the pH of eye drops. Rather, Ludwig discloses a very limited number of examples in Table 10.5, including boric acid. As such, Applicant’s argument is quite similar to the argument that was rejected in Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1362–363 (Fed. Cir. 2007) (Explaining, “a suggestion, teaching, or motivation to combine the relevant prior art teachings to achieve the claimed invention does not have to be found explicitly in the prior art references sought to be combined, but rather ‘may be found in any number of sources, including common knowledge . . . Of course, new salts can always be made or attempted. However, irrefutable evidence shows that a skilled chemist at the time would simply make known pharmaceutically-acceptable salts of whatever active ingredient with which he or she was working at the time.”).
Applicant next argues the examples in the specification demonstrate excellent stability relative to other buffers tested, and Okigami does not disclose or suggest a stability-improving effect. (Remarks, p.4). This argument is not persuasive because there is no factual evidence to support such assertions. Attorney arguments are not evidence. In re de Blauwe, 736 F.2d 699, 705, 705 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice”). In this case, each of examples 1–14 include boric acid; the specification does not include any examples comparing a composition with boric acid to a composition with a different buffer.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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