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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/09/2026 has been entered.
Applicants’ arguments, filed 07/09/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
1) Claims 1 and 4 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, “Compound A”, 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-l-yl]-3-oxopropanenitrile [abstract & 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 (i.e., salt of citric acid) [0063]. Okigami discloses that the eye drop pharmaceutical composition comprises the active ingredient, Compound A (i.e., delgocitinib), at a concentration of usually 0.0001% to 0.1% w/v [0066].
Compound A of Okigami, 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 a specific amount for the sodium citrate stabilizer.
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 the sodium citrate stabilizer within the instantly claimed amounts 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 amount of sodium citrate stabilizer in composition to provide the optimal stabilizing effect. One would have had an expectation of success because Okigami discloses sodium citrate stabilizes ophthalmic compositions comprising delgocitinib.
Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed 0.03-0.3 mass% delgocitinib (i.e., 0.03-0.3 w/v% delgocitinib according to the instant specification at paragraph 9) overlaps with the prior art range of 0.0001% to 0.1% w/v Compound A (delgocitinib) and so a prima facie case of obviousness exists.
Finally, 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, before the effective filling date of the claimed invention, to have formulated an ophthalmic composition comprising a salt of citric acid (sodium citrate) and delgocitinib. Wherein the salt of the citric acid and delgocitinib are present within the instantly claimed amounts.
2) Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Okigami et al. (US 2016/0367556 A1, publication date 12/22/2016) as applied to claims 1 and 4 above, and further in view of Houlsby et al. (Antimicrobial Agents And Chemotherapy, 1986, vol. 29, no. 5, p. 803-806).
Okigami, which is taught above, differs from the instant claims insofar as it does not disclose boric acid. Okigami desires buffers for the eye drop form of the compositions comprising Compound A (i.e., delgocitinib) [0063]. Okigami also discloses the compositions may comprise a preserving agent [0046].
Houlsby relates to the antimicrobial activity of borate buffered solutions [title] and discloses “borate-buffered medium, either with or without a carbon source, exhibited significant antimicrobial activity against 15 Pseudomonas strains, 12 strains of enteric bacteria, and 7 strains of staphylococci. The borate-buffered system appears suitable for use as a generic vehicle for ophthalmic pharmaceutical agents” [abstract]. The borate buffer medium comprises “1.00% boric acid and 0.22% Na2B407 10H20” [p. 803, col. 2, para. 3, lines 4-5].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the borate-buffer system of Houlsby as the buffer and preserving agent desired by Okigami because Houlsby discloses the borate buffer is a suitable buffer and preserving agent of ophthalmic solutions.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the compositions taught by Okigami, as discussed above, to further comprise a boric acid based on its suitability for its intended used in ophthalmic formulations, as taught by Houlsby.
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.
1) Claims 1 and 4-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-5 of copending Application No. 18018105 in view of Okigami et al. (US 2016/0367556 A1, publication date 12/22/2016).
The copending claims recite and ophthalmic composition comprising 0.03-0.3 mass% delgocitinib [claim 1] and boric acid [claim 5].
The copending claims do not disclose phosphoric acid, citric acid or salts thereof.
Okigami discloses a pharmaceutical composition for treating eye diseases comprising the active agent, “Compound A”, 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-l-yl]-3-oxopropanenitrile [abstract & 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 (i.e., salt of citric acid) [0063].
Compound A of Okigami, 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.
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the sodium citrate stabilizer of Okigami with the delgocitinib ophthalmic compositions of the copending claims. One would have been motivated to make this combination for the desirable effects of stabilizing the composition. One would have had an expectation of success because Okigami discloses that sodium citrate is a suitable stabilizer of ophthalmic compositions of delgocitinib. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Additionally, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising the sodium citrate stabilizer within the instantly claimed amounts 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 amount of sodium citrate stabilizer in composition to provide the optimal stabilizing effect. One would have had an expectation of success because Okigami discloses sodium citrate stabilizes the composition.
This is a provisional nonstatutory double patenting rejection.
2) Claims 1 and 4-5 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 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.
3) Claims 1 and 4-5 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) in amounts from 0.03-0.3 % by mass of the total composition [claim 1].
The copending application ‘419 does not discloses a citrate or phosphate buffer.
Okigami discloses a pharmaceutical composition for treating eye diseases comprising the active agent, “Compound A”, 3-[(3S,4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-l-yl]-3-oxopropanenitrile [abstract & 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 (i.e., salt of citric acid) [0063].
Compound A of Okigami, 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.
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the sodium citrate stabilizer of Okigami with the delgocitinib ophthalmic compositions of the copending claims. One would have been motivated to make this combination for the desirable effects of stabilizing the composition. One would have had an expectation of success because Okigami discloses that sodium citrate is a suitable stabilizer of ophthalmic compositions of delgocitinib. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Additionally, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising the sodium citrate stabilizer within the instantly claimed amounts 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 amount of sodium citrate stabilizer in composition to provide the optimal stabilizing effect. One would have had an expectation of success because Okigami discloses sodium citrate stabilizes the composition.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
1) On pages 3 and 4 of their Remarks, Applicant argues that the instantly claimed the 0.001 to 1 mass% of citric acid or phosphoric acid significantly and unexpectedly improves stability. Applicant cites Test Examples 1-3 and 6-11 in Table 1, Test Examples 14-19 in Table 2, and Test Examples 22-24 and 26-31 in Table 3 for support.
This argument is not persuasive. While the present specification discloses “the present inventor has found that by adding citric acid, phosphoric acid or a salt thereof to an aqueous composition containing delgocitinib and a minute amount of iron, the stability of the aqueous composition is remarkably improved” [0006], the specification does not indicate that these results are unexpected or surprising. Indeed, stabilization of an ophthalmic composition of delgocitinib by a citric acid salt appears to be entirely expected in view of Okigami and therefore does not overcome the case of prima facie obviousness set forth above.
Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) (MPEP 716.02(c)). In the present case, and as discussed above, Okigami discloses compositions of delgocitinib and further discloses that “[a]n eye drop can be prepared by using those selected from […] a stabilizer such as sodium citrate” [0063]. Therefore, as skilled artisan would have expected the compositions of the instant claims to demonstrate improved stability because they comprise citrate.
Furthermore, 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 not provided evidence outside the claimed range. Accordingly, the Examiner is not able to determine if the claimed ranges are truly critical to the function of the invention.
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)). In the present case the claims are not commensurate in scope with the evidence because the evidence appears to only pertain to solutions of delgocitinib that contain a minute amount of iron from the manufacturing process. For example, see paragraph 4 and 6 of the instant specification as originally filed:
“in the case where even a minute amount of iron is mixed in the production stage of an ophthalmic preparation containing delgocitinib, the ophthalmic preparation is colored and the stability thereof is lowered.” As such, it is not clear if the solutions of delgocitinib which are not manufactured with iron would exhibit the same stability improvements Applicant asserts to be unexpected.” [0004]
“the present inventor has found that by adding citric acid, phosphoric acid or a salt thereof to an aqueous composition containing delgocitinib and a minute amount of iron, the stability of the aqueous composition is remarkably improved” [0006].
As such, it is not clear if all solutions of delgocitinib would exhibit the same improvements to stability which Applicant asserts to be unexpected.
2) On pages 3 and 4 of their Remarks, Applicant argues that the instantly claimed the 0.001 to 1 mass% of citric acid or phosphoric acid significantly and unexpectedly suppress discoloration even in the presence of trace iron. Applicant cites Test Examples 1-3 and 6-11 in Table 1, Test Examples 14-19 in Table 2, and Test Examples 22-24 and 26-31 in Table 3 for support.
This argument is not persuasive. The instant specification does not disclose the suppression of discoloration by citric acid and phosphoric acid to be unexpected or surprising.
Furthermore, where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) (MPEP 716.02(c)). In the present case, the action of citric acid and phosphoric acid to suppression the discoloration caused by iron does not appear to be unexpected.
With respect to phosphoric acid see, for example, CHEMISTRY (Chemistry Stack Exchange, 2018 [retrieved 08/13/2026], https://chemistry.stackexchange.com /questions/44330/why-does-phosphoric-acid-mask-the-colour-of-ironiii-complex-in-water). CHEMISTRY demonstrates that phosphoric acid was known to reduce the yellow color caused by iron in solution before the effective filling date of the present invention because it discloses phosphoric acid forms colorless complexes with iron (page 1):
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With respect to citric acid, a skilled artisan would have understood complexing iron with citrate would have reduced yellowing of the solution cause by iron. See, for example, Krishnamurti et al. (Clays and Clay Minerals, 1991, Vol. 39, No. 1, p. 28-34) and Homescience (Homescience.net, 2019 [retrieved 08/13/2026], https://web.archive.org/web/20190923011019/https:/woelen.homescience.net/science/chem/solutions/fe.html). Krishnamurti discloses that “[t]he strong complexation of Fe(II) with citrate retarded the kinetics of Fe(II) oxidation and the formation and hydrolysis of Fe(III)” [abstract]. Homescience discloses that a “solution of an iron (II) salt is very pale green. Even at fairly high concentration of the iron, the solution looks almost colorless” [p. 2, para. 2]. Homescience further discloses that “[i]ron in the +3 oxidation frequently is said to have a brown/yellow color in aqueous solutions, but this is not correct. When an iron (III) salt is dissolved in water, then indeed a brown/yellow solution is obtained, but this color is due to formation of hydrolysed iron (III) species” [p. 3, para. 1]. Therefore, a skilled artisan would have expected citrate to reduce solution yellowing due to iron because citrate was known to retard the oxidation of the nearly colorless Fe(II) to the brown/yellow Fe(III) and hydrolyzed Fe(III).
Additionally, 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 not provided evidence outside the claimed range. Accordingly, the Examiner is not able to determine if the claimed ranges are truly critical to the function of the invention.
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)). In the present case the claims are not commensurate in scope with the evidence because the evidence appears to only pertain to solutions of delgocitinib that have been manufactured with iron at some stage of the production. For example, see paragraph 4 and 6 of the instant specification as originally filed:
“in the case where even a minute amount of iron is mixed in the production stage of an ophthalmic preparation containing delgocitinib, the ophthalmic preparation is colored and the stability thereof is lowered” [0004].
“the present inventor has found that by adding citric acid, phosphoric acid or a salt thereof to an aqueous composition containing delgocitinib and a minute amount of iron, the stability of the aqueous composition is remarkably improved” [0006].
As such, it is not clear if all solutions of delgocitinib would exhibit the same improvements to stability which Applicant asserts to be unexpected.
Furthermore, the claims are not commensurate in scope with the evidence because the claims do not recite a pH, whereas the solutions relied on to support the alleged unexpected results are at a pH of 5.5. This is important because iron precipitates at higher pH values (see, e.g., Homescience at page 2, paragraphs 3-4).
3) On pages 4 and 5 of their Remarks, Applicant argues that there is not motivated and expectation of success in modifying the reference claims to reach a compositions as instantly claimed and so the double patenting rejections should be withdrawn.
The examiner respectfully disagrees. The conflicting claims continue to read on the instant claims for the reasons above and of record. Additionally, skilled artisan would have expected sodium citrate to be compatible with the ophthalmic compositions of the conflicting claims because Okigami discloses sodium citrate is suitable for ophthalmic compositions comprising delgocitinib at paragraph 63.
Conclusion
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.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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