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 August 20, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
There is no disclosure in the application as originally filed discussing the viscosity of the compositions either generally or specifically, let alone that the viscosity of the disclosed compositions is “about the same as water” as required by new claim 21.
The arguments filed on August 20, 2026 state that support comes from the formulations prepared in the examples that inherently have a viscosity about the same as water.
These arguments are unpersuasive. While the prepared compositions do inherently have a viscosity, the evidence of record does not establish that the formulations of the examples have viscosities that are about the same as water as required by new claim 21. Arguments without factual support are mere allegations and are not found persuasive. The complete absence of any discussion as to composition viscosity and lack of evidence as to the properties of what was results in claim 21 containing new matter.
If Applicant is in disagreement with the Examiner regarding support for the new claim, Applicant is respectfully requested to point to additional locations where support may be found for the instant invention and/or provide evidence as to the properties of the formulations from the examples and an explanation as to how those specific examples are sufficient to support the full scope of claim 21.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 10 – 21 were 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. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed February 23, 2026 and those set forth herein.
The claims were rejected as indefinite due to the phrase “to substantially alleviate the episodic flare up” indicating that complete alleviation of the flare up was not required but the degree to which the flare up had to be alleviated to fall within the scope of the claim was not clear.
In response, Applicants argue that this means that the second composition treats the heightened pain or discomfort but does not absolutely need to return to baseline, consistent with the reference to “a reduction in the severity of the condition” as the definition of treat at ¶ [0038].
These arguments are unpersuasive. Claim 10 does not require that the second composition being administered until the flare up is treated, which would be any reduction in the severity of the flare up, but that the episodic flare up is substantially alleviated and that upon this condition being met, the second composition is no longer administered. The arguments do not provide a clear demarkation of the amount of alleviation required to be considered substantially alleviated, that is the required effect of the claimed administration step. Therefore the metes and bounds of claim 10 cannot be determined and the dependent claims still fall therewith.
Claim 21 is 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. New claim 21 requires that the viscosity of each of the first and second compositions be “about the same as water”. There is no discussion in the specification as to the metes and bounds of “about” and how close the viscosity of the first and second composition must be in order to be considered “about the same as water”. Therefore the scope of new claim 21 cannot be determined. Please clarify.
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.
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.
Claim(s) 10, 11, 13 – 19 and 21 were rejected under 35 U.S.C. 103 as being unpatentable over Karolchyl et al. (US 2017/0112936) in view of Brady et al. (WO 2017/196881) and Lienert et al. (Ophthalmology, 2016). This rejection is MAINTAINED for the reasons of record set forth in Office Action mailed February 23, 2026 and those set forth herein.
Claim 10, from which all other examined claims depend, has been amended with a negative proviso that the second composition “lacks an immunosuppressant”. The compositions disclosed by Karolchyl et al. for ophthalmological applications include at least one active component or combination thereof selected from a list that incudes but is not limited to an immunosuppressant (e.g., ¶ [0008]). The ophthalmological preparation described in [0009] contains a therapeutically effective amount of a corticosteroid and no immunosuppressant is present. ¶ [0072] states “[t]he active component may or may not be an immunosuppressant, as desired”. One having ordinary skill in the art will determine, taking into account medical, pharmaceutical and other requirements and limitations, which active components are to be used depending on the kind of disease, disorder, pathology or syndrome that the ophthalmological pharmaceutical composition is intended for treating (¶ [0071]). It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to select the active components used in each formulation that can include an immunosuppressant but that is not a required ingredient as disclosed by Karolchyl et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Karolchyl et al. discloses that one or more of a variety of active components can be present and that it is within the skill of those of ordinary skill in the art to select the active components for a particular use. There is no evidence of record reasonably commensurate in scope with the claims as to the criticality of the second composition not containing an immunosuppressant that is.
As to new claim 21, Karolchyl et al. discloses that the composition at the pre-delivery stage is cool (below body temperature) and is a fluid but when administered and the temperature rapidly rises to that of body temperature, the composition then becomes gel-like (¶ [0115]). Therefore the composition in the kit and as administered is a liquid and there is no evidence of record that the composition does not have a “viscosity about the same as water”. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products y the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113
Applicants traverse this rejection on the grounds that it was surprisingly found that a higher dose, not desirable for long term treatment, can be administered temporarily when a patient is undergoing an episodic flare up, and the symptoms would subside and be returned to the lower corticosteroid dose to avoid its long-term adverse effects. Karolchyl et al. discloses gels that can include immunosuppressants with the same ranges disclosed for the amount of immunosuppressant and steroid. There is no suggestion as to when to use one combination over another, what should not be administered, the implications of heightened dose administration, or correlations for swapping between therapeutics based on symptoms. Applicants briefly mention the teachings of the secondary references Brady and Lienert. The lack of guidance in Karolchyl et al. as to specific combinations but attempting to broadly incorporate known elements into a gel delivery system means it would not have been obvious to adopt Applicant’s two composition kit for the treatment of dry eye. The claimed method is more than increasing the dose when symptoms are more extreme and following the logic of the Office Action, one would not omit the immunosuppressant but rather maintain or increase the dose of the immunosuppressant.
These arguments are unpersuasive. Information which is well known in the art need not be described in detail in the specification (MPEP 2163 (II)(A)(2)). Karolchyl et al. discloses that one of ordinary skill in the art can select the active component(s) for a particular use. For example, worsening symptoms can be an indication to treat using a higher dose to maintain therapeutic effectiveness and the arguments of record do not establish any unexpected results as to the claimed treatment regimen (see MPEP 716.02 et seq. for a complete discission of unexpected results). The lack of an explicit disclosure in the applied prior art does not patentably distinguish the instant claims over the applied prior art.
Claim(s) 12 was rejected under 35 U.S.C. 103 as being unpatentable over Karolchyl et al., Brady et al. and Lienert et al. further in view of Musunuri et al. (US 2018/0333414). This rejection is MAINTAINED for the reasons of record set forth in Office Action mailed February 23, 2026 and those set forth herein.
Applicants argue that Musunuri et al. fails to cure the deficiencies of Karolchyl et al., Brady et al. and Lienert et al. as discussed above.
As discussed in greater detail above, Karolchyl et al., Brady et al. and Lienert et al. are not deficient as alleged by Applicants so Musunuri et al. need not cure the deficiencies of Karolchyl et al., Brady et al. and Lienert et al.
Claim(s) 14 was rejected under 35 U.S.C. 103 as being unpatentable over Karolchyl et al., Brady et al. and Lienert et al. further in view of Koverech et al. (WO 2012/084446). This rejection is MAINTAINED for the reasons of record set forth in Office Action mailed February 23, 2026 and those set forth herein.
Applicants argue that Koverech et al. fails to cure the deficiencies of Karolchyl et al., Brady et al. and Lienert et al. as discussed above.
As discussed in greater detail above, Karolchyl et al., Brady et al. and Lienert et al. are not deficient as alleged by Applicants so Koverech et al. need not cure the deficiencies of Karolchyl et al., Brady et al. and Lienert et al.
Claim(s) 19 and 20 were rejected under 35 U.S.C. 103 as being unpatentable over Karolchyl et al., Brady et al. and Lienert et al. further in view of Lindstrom (US 7,820,639) and Matsumuru et al. (US 2010/0137252). This rejection is MAINTAINED for the reasons of record set forth in Office Action mailed February 23, 2026 and those set forth herein.
Applicants argue that Lindstrom and Matsumuru et al. fails to cure the deficiencies of Karolchyl et al., Brady et al. and Lienert et al. as discussed above.
As discussed in greater detail above, Karolchyl et al., Brady et al. and Lienert et al. are not deficient as alleged by Applicants so Lindstrom and Matsumuru et al. need not cure the deficiencies of Karolchyl et al., Brady et al. and Lienert et al.
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.
Regarding the previous nonstatutory double patenting rejections, Applicants only mention Application No. 17/582,627 and state that they agree to submit a terminal disclaimer to expedite allowance.
Both Application No. 17/582,627 mentioned by Applicants and the other application, Application No. 18/100,505, that formed the basis of a provisional nonstatutory double patenting rejection, have been abandoned since the mailing of the previous Office Action. Therefore those provisional nonstatutory double patenting rejections have been withdrawn.
Applicant' s failure to argue the rejections on the grounds of non-statutory double patenting over US Patent Nos. 11,766,421 and 12,070,442 is noncompliant with the regulations under 37 C.F.R. 1.111. The instant rejection is not a provisional rejection as the claims of US Patent Nos. 11,766,421 and 12,070,442 have been issued. In the interest of compact prosecution, the Examiner has examined the instant application. However, in order for the response to the instant Office Action to be fully responsive and in compliance with the regulations under 37 C.F.R. 1.111, the Applicant should either file a terminal disclosure or traverse the rejection based on US Patent No. Nos. 11,766,421 and 12,070,442. Because Applicant did not distinctly and specifically point out the supposed errors in the instant non-statutory double patenting rejection based on US Patent No. Nos. 11,766,421 and 12,070,442 and no Terminal Disclaimer has been filed, the claims of these two patents are not patentably distinguished over those of the instant application as discussed below.
Claims 10 – 21 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 15 of U.S. Patent No. 11,766,421 in view of Karolchyl et al. (US 2017/0112936) in view of Brady et al. (WO 2017/196881) and Lienert et al. (Ophthalmology, 2016) optionally further in view of Musunuri et al. (US 2018/0333414) and Lindstrom (US 7,820,639) and Matsumuru et al. (US 2010/0137252). This rejection is MAINTAINED for the reasons of record set forth in Office Action mailed February 23, 2026 and those set forth herein.
The compositions US’421 contain the immunosuppressant mycophenolic acid or a pharmaceutically acceptable salt thereof. In view of the teachings of Karolchyl et al. discussed above, one of ordinary skill in the art can select the active components for a particular use, e.g., episodic flare ups, and there is no evidence of record as to unexpected results.
As to new claim 21, the compositions can be in the form eye drops (claim 15) which is a liquid formulation. While the viscosity is not claimed, there is no evidence of record that the compositions of US’421 do not have a viscosity about the same as water. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products y the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113
Claims 10 – 21 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 23 of U.S. Patent No. 12,070,442 in view of Karolchyl et al. (US 2017/0112936) in view of Brady et al. (WO 2017/196881) and Lienert et al. (Ophthalmology, 2016) optionally further in view of Musunuri et al. (US 2018/0333414) and Lindstrom (US 7,820,639) and Matsumuru et al. (US 2010/0137252). This rejection is MAINTAINED for the reasons of record set forth in Office Action mailed February 23, 2026 and those set forth herein.
The compositions US’442 contain the immunosuppressant mycophenolic acid or a pharmaceutically acceptable salt thereof. In view of the teachings of Karolchyl et al. discussed above, one of ordinary skill in the art can select the active components for a particular use, e.g., episodic flare ups, and there is no evidence of record as to unexpected results.
As to new claim 21, the compositions can be in the form eye topical drugs or an injectable form (claim 19) which are liquid formulations. While the viscosity is not claimed, there is no evidence of record that the compositions of US’442 do not have a viscosity about the same as water. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products y the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
