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 .
CONTINUING DATA
This application is a 371 of PCT/EP2021/025430 11/04/2021
FOREIGN APPLICATIONS
FRANCE 2011361 11/05/2020
Claims 1-10 are pending.
Claim Rejections - 35 USC § 112
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 1-10 are 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.
Claim 1 recites “diseases associated with hepatic steatosis.” The limitation is unclear because “associated with” is not defined in the specification and it could mean a condition caused by hepatic steatosis, a condition which causes hepatic steatosis, a condition which occurs along with hepatic steatosis, or some other association. The skilled artisan would not know which disorders are claimed and which are not. The specification paragraph [0018] recites a few examples of disorders associated with hepatic steatosis, but it is not a limiting definition. Claims 2-10 depend from claim 1 and recite all its limitations by incorporation.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “between 0.05 and 1.5,” and the claim also recites “preferentially between 0.2 and 1.2, even more preferably between 0.4 and 0.9, and most preferably between 0.6 and 0.8,” which is the narrower statement of the range/limitation. Claim 5 recites the broad limitation “C2 carbon of the glucopyranose units, or by the C3 and/or C6 carbons of the glucopyranose units, or by a combination of the C2, C3, and/or C6 carbons,” followed by the narrower limitation “preferably C2 and C6.” Claim 9 recites a broad limitation “lipid storage,” followed by the narrower limitation “preferably a reduction in lipid accumulation in the liver.” The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salome (US 2016/0361344, cited on IDS).
Salome teaches methods of treatment using a methyl-beta-cyclodextrin having a degree of molar substitution between 0.6 and 0.8. At least 50% of methyls are substituted on the hydroxyl borne by the C2 carbon. See claims. Oral dosage forms are disclosed [0149]. A KLEPTOSE CRYSMER solution was prepared, which would have been capable of being administered orally [0160]. The recitation “for use in the treatment and/or prevention of hepatic steatosis and diseases associated with hepatic steatosis” is merely an intended use recited in the preamble and does not further limit the composition. See MPEP 2111: If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
The product used by Salome was KLEPTOSE CRYSMER [0170], which is the same product which is used in the current specification.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10022392. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘392 patent claims the use of a methyl-beta-cyclodextrin having a degree of molar substitution between 0.6 and 0.8. At least 50% of methyls are substituted on the hydroxyl borne by the C2 carbon of the glucopyranose units. See claims 1-5. Thus, the ‘392 claims anticipate current claims 1-7 and 9-10. The ‘392 patent is silent about whether the composition is capable of being administered orally, but a pharmaceutical composition can only be administered by a finite, limited number of routes, and the skilled artisan would have chosen oral administration for patient convenience.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11266680. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘680 patent claims the use of a methyl-beta-cyclodextrin having a degree of molar substitution between 0.6 and 0.8. See claim 3. At least 50% of methyls are substituted on the hydroxyl borne by the C2 carbon of the glucopyranose units. See claim 7. The composition is administered orally. See claim 19. Thus, the ‘680 claims anticipate current claims 1-7 and 9-10
Claims 1-5 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11098135. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘135 patent claims a composition comprising a methyl cyclodextrin having a degree of molar substitution between 0.05 and 1.50 (claim 7) and a pharmaceutical composition (claim 5). Thus, the ‘135 patent anticipates current claims 1-3 and 8-10. The specification can be used as a dictionary to determine the meaning of a term in a claim, and those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent. The top of column 4 of the reference patent states that the scope of “methyl cyclodextrin” includes methyl-beta-cyclodextrin, so the skilled artisan would have chosen methyl-beta-cyclodextrin. The skilled artisan is also well aware that cyclodextrins used in medical treatment are limited to alpha, beta, and gamma cyclodextrins. The skilled artisan would have chosen any from this limited, finite number of possibilities with a reasonable expectation of success in choosing among them because all are used in pharmaceutical compositions. Regarding claim 5, the skilled artisan would have expected methyl substitution on at least C6 because C6 is less sterically hindered and more available for modification than the other hydroxyl groups. The ‘135 patent is silent about whether the composition is capable of being administered orally, but a pharmaceutical composition can only be administered by a finite, limited number of routes, and the skilled artisan would have chosen oral administration for patient convenience.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693