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 . 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.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Broad to Narrow Limitations,
Indefinite Language and Lack of Antecedent Basis
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 7, 19, 22 and 25-26 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.
Regarding broad to narrow limitations, 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 7 recites the broad recitation “Wilson disease”, and the claim also recites “(i.e., a treatment-naïve subject) which is the narrower statement of the range/limitation.
In the present instance, claim 19 recites the broad recitations “concentration of …copper” and “area under the effect-time curve”, and the claim also recites limitations in parentheses which are the narrower statements of the range/limitation.
In the present instance, claim 22 recites the broad recitation “plasma ultrafiltrate”, and the claim also recites “(PUF) which is the narrower statement of the range/limitation.
In the present instance, claim 25 recites the broad recitation “Unified Wilson Disease Rating Scale”, and the claim also recites “(UWDRS) which is the narrower statement of the range/limitation
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.
The Applicant is encouraged to remove the parentheses from the claims, at each instance of occurrence.
Regarding indefinite language, and further regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The Applicant is encouraged to remove the indefinite language from the claim.
Claim 26 recites the limitation "the patients" in line two. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102 - Anticipation
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 3-4, 6-7, 10, 15, 17, 19, 22, 25-26, 30, 34, 42, 49, 52-53, 57-58 and 61-62 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bjartmar et al (US 2021/0137972 A1).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claims 4, 6 and 57 are anticipated because Bjartmar taught methods for treating Wilson Disease with bis-choline tetrathiomolybdate therapy. The methods included administering bis-choline tetrathiomolybdate once daily to a patient [abstract], in a therapeutically effective dose [0078]. Patients were 18 years or older [0160].
Claim 3 is anticipated because Bjartmar taught 48 weeks of administration [claim 11].
Claims 7-8 and 15 are anticipated because Bjartmar taught standard of care (penicillamine, trientine, zinc) for 48 weeks [Example 3].
Claim 17 is anticipated because Bjartmar taught 15 mg bis-choline tetrathiomolybdate daily [abstract].
Claims 19 and 22 are anticipated because Bjartmar taught determining the total concentrations of copper, ceruloplasmin [0165] and molybedenum [0231] in the plasma.
Claim 26 is anticipated because Bjartmar taught the “Unified Wilson Disease Rating Scale” or “UWDRS” [0125], to evaluate clinical symptoms [0095].
Claims 30 and 34 are anticipated because Bjartmar taught that bis-choline tetrathiomolybdate rapidly binds free plasma copper, creating a stable tripartite complex of tetrathiomolybdate with copper and albumin [0159].
Claim 42 is anticipated because Bjartmar taught calculating plasma total copper in the tetrathiomolybdate-copper-albumin complex [0165].
Claims 49, 52-53 and 58 are anticipated because Bjartmar taught mobilizing [0091] and reducing, by 75 % [0023], copper from the liver, with bis-choline tetrathiomolybdate.
Claim 61 is anticipated because Bjartmar taught inhibiting neurological deterioration [0174].
Claim 62 is anticipated because Bjartmar taught an improvement in one or more neurological manifestation of Wilson’s Disease [0049].
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 3-4, 6-7, 10, 15, 17, 19, 22, 25-26, 30, 34, 42, 49, 52-53, 57-58 and 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Bjartmar et al (US 2021/0137972 A1).
Bjartmar et al is believed to be anticipatory as described above, but if en arguendo it is not, in the interest of completeness of prosecution, purely arguendo, and for the purposes of this ground of rejection only, Bjartmar will be interpreted as if it is not anticipatory.
In that case, claims 3-4, 6-7, 10, 15, 17, 19, 22, 25-26, 30, 34, 42, 49, 52-53, 57-58 and 61-62 are rendered prima facie obvious over the teachings of Bjartmar, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., administering bis-choline tetrathiomolygdate for at least 48 weeks, in patients at least 12 years old, to treat Wilson’s disease) were known in the prior art (e.g., Bjartmar) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results (e.g., a method of treating a copper metabolism-associated disease or disorder) to one of ordinary skill in the art. MPEP 2143.A.
Nonstatutory Double Patenting
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 3-4, 6-7, 10, 15, 17, 19, 22, 25-26, 30, 34, 42, 49, 52-53, 57-58 and 61-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 41 and 45-49 of copending Application No. 18/036,617, in view of Bjartmar et al (US 2021/0137972 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require a subject that is at least 12 years old, which is not recited in the copending claims.
Bjartmar taught methods for treating Wilson Disease with bis-choline tetrathiomolybdate therapy. The methods included administering bis-choline tetrathiomolybdate once daily to a patient, in a therapeutically effective dose. Patients were 18 years or older.
The ordinarily skilled artisan would have been motivated to include, within the teachings of the copending claims, a subject that is at least 12 years old, as taught by Bjartmar. The ordinarily skilled artisan would have been motivated to include a clinically relevant population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3-4, 6-7, 10, 15, 17, 19, 22, 25-26, 30, 34, 42, 49, 52-53, 57-58 and 61-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-18 and 25-27 of copending Application No. 18/685,127, in view of Bjartmar et al (US 2021/0137972 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (methods of treating Wilson’s disease) recited in the copending claims falls within the genus (methods of treating copper metabolism-associated diseases or disorders) recited in the claims of the instant application, and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612