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 .
Applicants’ arguments, filed 10/14/2025, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of the Claims
Applicant cancelled instant claim 2.
Claims 1 and 3 are pending and under current examination.
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.
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 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Okigami et al. (US 2016/0367556 A1, publication date 12/22/2016).
Regarding instant claim 1, Okigami discloses a pharmaceutical composition for treating eye diseases comprising the active agent 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-l-yl]-3-oxopropanenitrile (Okigami, abstract and paragraph 1). Okigami also discloses that when formulated as an eye drop (i.e., ophthalmic composition), the pharmaceutical composition can be prepared with stabilizers such as sodium citrate (paragraph 63). Okigami discloses that the eye drop pharmaceutical composition comprises the active ingredient delgocitinib, referred to as Compound A, at a concentration of usually 0.0001% to 0.1% w/v (paragraph 66).
The prior art compound, 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-l-yl]-3-oxopropanenitrile, is delgocitinib according to paragraph 2 of the instant specification.
Okigami does not disclose 0.3% w/w delgocitinib.
However, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising 0.3% w/w delgocitinib through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the composition disclosed by Okigami in order to effect the dosage of the active ingredient, delgocitinib.
Additionally, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application, and following the teachings of Okigami to have selected and combined known components for their established functions with predictable results. MPEP 2143 and 2144.06(I).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated an ophthalmic composition comprising a salt of citric acid (sodium citrate) and 0.3% w/w delgocitinib.
Regarding instant claim 3, Okigami also discloses that when formulated as an eye drop, the pharmaceutical composition can be prepared with stabilizers such as sodium citrate (paragraph 63).
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). It would have been obvious, through routine experimentation, to arrive at the instantly claimed range of sodium citrate, a salt of citric acid. One would have been motivated to optimize the amount of sodium citrate in the eye drop to improve stability. One would have had an expectation of success in optimizing the stability of the composition by adjusting the amount of sodium citrate present because sodium citrate was disclosed as a stabilizer. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have provided an ophthalmic composition comprising 0.3% w/w delgocitinib and a citric acid salt (sodium citrate) in amounts from 0.0001 to 1 w/v%.
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 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 17/788,378 in view of Okigami et al. (US 2016/0367556 A1, publication date 12/22/2016).
The claims of ‘378 disclose a composition comprising delgocitinib or a salt thereof and a buffer (claims 1 and 5). The specification discloses the salt of delgocitinib is not particularly limited as long as it is pharmaceutically, pharmacologically (in drug manufacturing) or physiologically acceptable (paragraph 12). For example, salts of citric acid (i.e., salt of delgocitinib and salt of citric acid; paragraph 13).
The copending application ‘378 does not discloses a citrate or phosphate buffer.
Okigami discloses an acceptable buffer for ophthalmic composition of delgocitinib include sodium citrate (paragraph 56).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected sodium citrate as the buffer for the composition disclosed by ‘378 because Okigami teaches it is suitable for that purpose. See MPEP 2144.07.
The exact ranges would have been obvious through routine experimentation. See MPEP 2144.05 II.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8-22 of copending Application No. 17/632,419 in view of Okigami et al. (US 2016/0367556 A1, publication date 12/22/2016).
The claims of ‘419 disclose an eye drop composition comprising 3- [(3S,4R)-3-methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile (i.e., delgocitinib).
The copending application ‘419 does not discloses a citrate or phosphate buffer.
Okigami discloses an acceptable buffer for ophthalmic composition of delgocitinib include sodium citrate (paragraph 56).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected sodium citrate as the buffer for the composition disclosed by ‘378 because Okigami teaches it is suitable for that purpose. See MPEP 2144.07.
The exact ranges would have been obvious through routine experimentation. See MPEP 2144.05 II.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
1) Applicant argues that one of ordinary skill in the art would not have a reason to optimize the amount of compound A (i.e., delgocitinib) because there is nothing in the cited reference that indicates that 0.3 mass% would have any impact on the effect of the claimed ophthalmic composition.
This argument is not persuasive. The prior art discloses the concentration of delgocitinib is a result effective variable insofar as disclosing delgocitinib as the active agent. One of ordinary skill in the art would have appreciated that varying the concentration of the active (i.e., delgocitinib) would have affected the dosage of the composition. Therefore, the instantly claimed amount of delgocitinib would have been obvious because 1) "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)), and 2) the prior art identifies the concertation of delgocitinib as a result effective variable.
2) Applicant argues it is unexpected that for “an aqueous composition containing 0.3 mass% of delgocitinib, the addition of citric acid or phosphoric acid significantly suppresses discoloration and improves stability even in the presence of trace amounts of iron” [Remarks, p. 3, last para.]. Applicant references Test Examples 6-11 in Table 1, Test Examples 14-19 in Table 2, and Test Examples 26-31 in Table 3 of the instant specification for support of the allegedly unexpected results.
This argument is not persuasive. While the specification discloses advantages of the invention (see [0008]) it does not appear to identify any unexpected results or indicate that the stability and color improvements are, in fact, unexpected. Furthermore the results appear to be expected in view of the prior art.
Okigami specifically discloses “a stabilizer such as sodium citrate” [0063]. As such, improved stability upon addition of a citrate salt, as claimed, would have been expected to one of ordinary skill in the art.
Additionally, one of ordinary skill in the art would have understood that citric acid, phosphoric acid and salts thereof are chelating agents and that chelating agents may be employed to solubilize metal (e.g., iron). One of ordinary skill in the art would have also understood that discoloration due to iron is, in part, the result of insoluble iron particles. See, for example, IDPH (Iron in Drinking Water, 2010 [retrieved 12/30/2025], https://dph.illinois.gov/topics-services/environmental-health-protection/private-water/fact-sheets/iron-drinking-water.html) which illustrates this by disclosing “Iron is mainly present in water in two forms: either the soluble ferrous iron or the insoluble ferric iron. Water containing ferrous iron is clear and colorless because the iron is completely dissolved. When exposed to air in the pressure tank or atmosphere, the water turns cloudy and a reddish brown substance begins to form. This sediment is the oxidized or ferric form of iron that will not dissolve in water” [paragraph 2]. Therefore, one of ordinary skill in the art would have expected a clearer solution upon the addition of a chelating agent which solubilizes the iron responsible for coloring the solution.
With respect to the criticality of the delgocitinib concentration: To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). (MPEP 716.02(d)). In the present case, applicant has provided results for compositions comprising delgocitinib in amounts of 0.03% w/w and 0.3% w/w. In both cases, the addition of citric acid and phosphoric acid result in improved solution coloration and stability. Therefore, it does not appear that 0.3 % w/w is critical to the allegedly unexpected results.
Finally, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). Even if applicant’s data supported evidence of unexpected results, in the present case, the independent claim is not commensurate in scope with that evidence. Table 1 on page 15 of the instant specification (provided below) demonstrates that the concentration of citric acid and phosphoric acid are important variables that affect the average color rate (bottom row; 0 is no coloring and 3 means coloring clearly visible). Compare, for example, the average coloring rating of example 7, at 0.5, and example 9, at 1.8. There is a dramatic increase in the coloration of the sample with the only change being the concentration of citric acid.
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Therefore, the claims are not commensurate in scope because the independent claim does not recite a concentration of citric acid, phosphoric acid or salts thereof which has been shown to affect the coloring average rating.
3) Applicant argues the instant claims are not obvious over the copending application 17/788,378 because the copending claims have a different scope, i.e., they require a pH of 4-6.5.
This argument is not persuasive. The copending claims in view of Okigami render obvious all the require elements of the instant claims. The fact the copending claims recite additional limitations does not mean the instant claims do not read on the copending claims. The copending claims continue to read on the instant claims and the instant claims stand rejected.
4) Applicant argues the instant claims are not obvious over the copending application 17/632,419 because the copending claims are directed to a method.
This argument is not persuasive. While the copending claims are directed to a method they nevertheless disclose a composition. That compositions in view of Okigami renders all the require elements of the instant claims obvious. The copending claims continue to read on the instant claims and the instant claims stand rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm 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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612