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 .
New claims 46-65 are pending and examined on the merits.
See also extensive Interview Summary (attached).
The examiner has proceeded without restriction here. However, it is noted that in the closely related family application U.S. Serial Number 18247465 the following three (3) species elections for eye disorder was uveitis (here the base claim is expressly drawn to a subclass species acute anterior uveitis as one of two required options); lipid binding protein of CER-001 (also present here in dependent claim 52); and ophthalmic drug dexamethasone palmitate (DXP; also present here, last line dependent claim 55).
The examiner remains open to interview to advance prosecution on the merits.
Claim Rejections - 35 USC § 103- Obviousness
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.
Claim(s) 46-64 (method of use) and claim 65 (product, equally rejected based on the same prior art, even were there were no prior art recited with rationale for ‘implant’ for eye treatment, as ‘implant’ here is merely recited in the preamble with no further elements/limitations recited thereto in the body of the claim; thus under the old patent law tenet a product is product no matter what the preamble may call it without further elements/limitations claimed in the body);
comprising e.g. CER-001 as the lipid binding protein and dexamethasone palmitate (DXP) as the ophthalmic drug for the treatment of an eye disorder such as acute anterior uveitis;
is/are rejected under 35 U.S.C. 103 as being unpatentable over:
Santen (CA2653902; 12/6/2007) – directed to using dexamethasone palmitate (DXP) for the treatment of the elected eye disorder species uveitis (claims 61, 65, 82, and 86); but not in combination with CER-001;
in view of the prior art directed to CER-001 for the treatment of the eye disorders such as the species uveitis, as already of record (IDS) and applied by the International Authority in the related PCT written opinion – the entirety of which is incorporated by reference here, including the following relied upon references and passages –
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- where Macregen and Roizman (cited in the related PCT above, see passages in each above) teach CER-001 for the treatment of the eye disorder species uveitis. But not ‘complexed’ with another opthalmic agent e.g. anti-inflammatory DXP;
further in view of Oculis SA (WO 2021001366), as for instant claim 46, teaching acute anterior uveitis is a known form of uveitis treated by dexamethasone (page 25, lines 18, 19, 24);
further in view of Green (U.S. Patent Publication No. 20180050088) as for instant claims 47-49, teaching treating with dexamethasone (para 17), including palmitate (para 166) for treatment of eye diseases known to be associated with lipid accumulation such as corneal dystrophies (para’s 9, and 152); where the latter naturally comprise corneal opacity and where administering an effective amount of dexamethasone palmitate based on Green would naturally improve “contrast sensitivity” (vision) by reducing inflammation associated with the corneal dystrophy; and
further in view of Higuchi (U.S. Patent Publication No. 20200030230) as for instant claims 56-64, teaching representative routes of administration for eye disorders such as uveitis and cataracts (para 88, 149) involving the anterior of the eye (paras 89, 167, 194) as instantly claimed such as intraocular injection options such as subconjuntival; implants such as pellets; and local administration by iontophoresis or electroporation (see e.g. para’s 27, 38, 68).
As a matter of law, "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (here 3 known cancer agents), in order to form a third composition which is to be used for the very same purpose." In re Susi, 169 USPQ 423, 426 (CCPA 1971); In re Kerkhoven, 205 USPQ 1069 (CCPA 1980). As a result, it would have necessarily been prima facie obvious to one of ordinary skill in the art to combine the compositions taught in the prior art to arrive at the instantly claimed invention.
Any further choice of concentrations, forms, routes and any further additives not expressly recited in the prior art combination in the old art of ocular preparations and methods of use thereof constitute merely routine optimization by one of ordinary skill in the art (see also MPEP 2144.03).
Regarding the ‘complex’, there is no definition found in the specification as to what constitutes a “complex” as claimed. Such could merely be an “associative” “complex” in formulation. Further, there is no structural “complex” found described anywhere in the specification as to CER-001 with DXP. By example, no structural identity of such a complex is provided per se (see e.g. 7.1.2 Example 4 DXP combined with CER-001). Thus, based on the broadest reasonable interpretation of the claims, the combination of elected CER-001 and DXP for the treatment of a uveitis subspecies into a third composition is deemed prima facie obvious based on the references of record, as both are taught for treating a uveitis. The “complex” thereof could merely be “associative” in that third composition for treating a uveitis. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Thus, the instantly claimed invention would have been prima facie obvious in view of the prior art combination applied, advancing Santen in view of either Macregen or Roizman into a third composition for the same purpose of treating a subspecies of uveitis with a ‘complex’ of DXP and CER-001.
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 46-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18,247,465 as teaching/suggestion the nearly identical invention instantly claimed (see further below);
in view of Oculis SA (WO 2021001366), as for instant claim 46, teaching acute anterior uveitis is a known form of uveitis treated by dexamethasone (page 25, lines 18, 19, 24);
further in view of Green (U.S. Patent Publication No. 20180050088) as for instant claims 47-49, teaching treating with dexamethasone (para 17), including palmitate (para 166) for treatment of eye diseases known to be associated with lipid accumulation such as corneal dystrophies (para’s 9, and 152); where the latter naturally comprise corneal opacity and where administering an effective amount of dexamethasone palmitate based on Green would naturally improve “contrast sensitivity” (vision) by reducing inflammation associated with the corneal dystrophy; and
further in view of Higuchi (U.S. Patent Publication No. 20200030230) as for instant claims 56-64, teaching representative routes of administration for eye disorders such as uveitis and cataracts (para 88, 149) involving the anterior of the eye (paras 89, 167, 194) as instantly claimed such as intraocular injection options such as subconjuntival; implants such as pellets; and local administration by iontophoresis or electroporation (see e.g. para’s 27, 38, 68).
By example, ‘465 teach/suggest a complex comprising CER-001 complexed with DXP, and teach/suggest that such may be used to treat acute, anterior, forms of uveitis, by way of any type of intraocular injection, without limitation, listing such examples of such known options as “for example” (see e.g. para 274 and 7.4 Example 4). More specifically, ‘465 teach/suggest treatment of endothelin-induced uveitis, which stimulates and immediate acute form of uveitis (see 7.4 Example 4 below). Likewise, ‘465 also teach/suggest where such may be anterior uveitis, of which the 7.4 Example 4 would reasonably be expected to be as no teaching away thereof is found in that section that such is not or that it is only in some other area of the eye.
[0274] In some embodiments, inflammatory eye disease such as uveitis (e.g., anterior uveitis, intermediate uveitis, posterior uveitis, or panuveitis), which may or may not be caused by bacterial infection, can treated by the administration of a composition comprising CER-001 and dexamethasone, a composition comprising CER-001 and dexamethasone palmitate, or a composition comprising CER-001 and tacrolimus. The use of such compositions to treat uveitis can be accomplished by administering a therapeutically effective amount of the composition to a subject in need thereof, e.g., an amount which reduces the severity of the uveitis (e.g., by alleviating one or more symptoms of the uveitis). The composition can be suitably formulated for the intended route of administration. Exemplary formulations are described in Section 6.1.9. For the treatment of uveitis, local administration of the composition such as topical administration or intraocular administration to a subject in need thereof is preferred. Intraocular administration can be by, for example, intraocular injection, for example intra-vitreal injection, sub-conjuctival injection, parabulbar injection, peribulbar injection or retro-bulbar injection. For topical administration, the composition can be administered, for example, as an eye drop. As shown in Examples 3 and 4, good ocular tolerance of such compositions was observed even with repeated administrations.
[ ]
7.4. Example 4: CER-001 Treatment of Endotoxin-Induced Uveitis (Severe Inflammation) in Rabbits
[0390] A study was performed to assess the ability of CER-001, with or without complexed dexamethasone palmitate (DXP), to treat endotoxin-induced uveitis (severe inflammation) in albino rabbits when administered topically or by single intravitreal injection (IVT). CER-001 vehicle and Solu-Medrol®, an injectable formulation containing the anti-inflammatory glucocorticoid methylprednisolone sodium succinate, were included as controls. Tolerance was assessed by the McDonald-Shadduck scoring system (see, Eaton et al., Journal of Ocular Pharmacology and Therapeutics 33(10):718-734) 6 and 24 hours after administration. Cell infiltration and protein content in the aqueous humor were measured 24 hours after administration.
Thus, the instantly claimed invention would have been prima facie obvious to arrive in view of ‘465.
This is a provisional nonstatutory double patenting rejection.
Claim Observations
Claim 46, subpart (a) and (b) should be put into standard Markush group language (selected from the group consisting of . . . a, b, and c) and the dependent claims 56-65 amended so as to still be further limiting. While the examiner is not raising 35 USC 112(b)/(d) indefiniteness/further limiting issues thereto deeming a PHOSITA would understand that base claim 46 requires one of the alternatives in (a) and (b) respectively, the later dependent claims carry overlap that should be cleaned up for consistency of flow from independency to dependency per accepted claim-formatting practice.
In claim 49, the symptoms (3) of corneal opacity capable of being treated should be amended into standard Markush group language, e.g. to reduce one or more symptoms selected from the group consisting of a, b, and c.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
