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 .
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 states” interrupted by an heteroatom”, should state “interrupted by a heteroatom”
Appropriate correction is required.
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 19-24, 31, and 33 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.
Claims 22 and 31 recite compounds of Table 1 of the specification, MPEP 2173.05(s) states, “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing
or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.”
Ex parte Fressola,
27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Appropriate correction is required.
Claims 19, 24 use the statement “interrupted by a heteroatom”, and this term is determined to be undefined because it is unclear what “interrupted” means. The specification uses the term “interrupted” but does not define its meaning. The examiner in interpreting the statement “interrupted by a heteroatom”, as a heteroatom in the middle of an alkyl chain. Claims 20-22 are rejected in view of their dependency on claim 19, as they do not cure its deficiencies and therefore are deficient for the same reasons.
Claim 33 recites the limitation "a compound" according to claim 23. There is insufficient antecedent basis for this limitation in the claim. Claim 23 states “a compound of general formula (I)”, as the first mention of a compound, and since claim 33 is dependent on Claim 23, stating “a compound” lacks the proper antecedent basis.
Claim 23 discloses compounds of “general formula (I), see below, but does not define variable X. Since variable X is not defined in the claim, the meets and bounds of the claim are unclear. The examiner is interpreting the substituent X, as defined in Claim 19.
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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.
Claims 19-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chadeayne (Andrew Chadeayne, “Tryptamine Derivatives and Their Therapeutic Uses”, WO 2022081549 A1, Pub. Date: 2022-04-21).
Regarding Claims 19-21 and 33-35, Chadeayne discloses tryptamine derivatives, and pharmaceutical compositions administered for treating various diseases (Abstract). Chadeayne discloses A method for preventing and or treating brain disorder, and lists “Huntington's disease, Alzheimer's disease, dementia, and Parkinson's disease” as embodiments [143].
Regarding Claim 32, Chadeayne discloses compounds administered in pharmaceutical compositions with excipients that are pharmaceutically acceptable carriers [011].
Chadeayne discloses compound 41 (Pg. 37), bottom left, that is the same as compound 022 disclosed in Table 1 of the specification. To map compound 41 disclosed in Chadeayne with instant Formula (I), bottom right, Y1, Y2, and Y3 are absent (Claim 19, 23, 29, 30), Y0 is oxygen (Claim 19, 23, 29, 30), R5, R6, R7 and R8 are hydrogen (Claims 19, 23, 25) R4 is hydrogen (19, 23, 26), R1 is hydrogen (Claim 19, 23, 27), X is an unsubstituted C2 alkyl (Claim 19, 23, 24), R2 is Hydrogen (Claim 19, 23, 28) and R3 is C3 alkyl (Claim 19, 23, 28).
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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.
Claim 19-24, and 26-35 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7,9-12,14,15,17, 18, of copending Application No. 18/684,600, herein ‘600, and in further view of Ward (Roberta J Ward et al., “The role of iron in brain ageing and neurogenerative disorders”, The Lancet Neurology, Volume 13, Issue 10, Pub. Date: October 2014, Pgs. 1045-1060).
Regarding instant Claims 23, 24, and 26-32, claims 1-7, 12, 14-16, and 17 in copending application ‘600 disclose the compounds below, compound 001 on the left, and compound A1 on the right. Both compounds can also be found in Table 1 of the instant specification.
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Regarding instant Claims 33-35, claims 9-11, 18 in copending application ‘600 discloses “a method for preventing or treating iron-associated disorders in a subject in need thereof, comprising administering a therapeutically effective amount of a compound as defined in claim 1 to said subject”, and include disorders such as chronic liver diseases, chronic inflammation linked to cancer, autoimmune or inflammatory, HFE related hemochromatosis, and non HFE-related hematochromatosis.
Instant Claim 34 discloses iron associated disorders as chronic liver diseases, chronic inflammation linked to cancer, autoimmune or inflammatory, HFE related hemochromatosis, and non HFE-related hematochromatosis.
It would have been prima facie obvious, for one of ordinary skill, to take the method disclosed in copending application ‘600, for preventing an iron-associated disorder by administering compound 001, and compounds of Formula (I), to arrive at the limitations of the instant claims because the copending claims and instant claims both teach overlapping genus’s, with compound 001 as an embodiment, and both disclose administering the compounds to treat the same diseases. Administering the same compounds, to treat the same diseases, would yield a predictable result with the same patient population.
Regarding instant Claims 19-21, Claim 18 in copending application ‘600 discloses “the method according to Claim 9, wherein the iron-associated disorders are iron overload-associated disorders, and lists neurodegeneration with brain iron accumulation-associated diseases as an embodiment.
Regarding instant Claim 22, Claim 12 in copending application ‘600 discloses a pharmaceutical composition comprising a compound according to claim 1, and at least one pharmaceutically acceptable excipient.
Copending application ‘600 does not disclose any of the metalloptosis associated disorders listed in instant Claim 21.
Ward discloses the role of iron in brain ageing and neurodegenerative disorders (Title). Ward teaches that during the ageing process, different iron complexes can accumulate in the brain regions associated with motor and cognitive impairment, and diseases such as Alzheimer’s and Parkinson’s disease are the result of changes in iron homeostasis resulting in iron accumulation in the brain (Summary).
It would have been prima facie obvious for one of ordinary skill, to administer the compounds of Formula (I) in copending application ‘600 to treat iron overload-associated disorders such as neurodegeneration, and include aging related diseases like Alzheimer’s and Parkinson’s to arrive at the limitations of the instant claims, because Ward teaches that during the ageing process, iron accumulates in the brain and is associated with Alzheimer’s and Parkinsons disease. One of ordinary skill would be motivated to administer the compounds of Formula(I) to treat Alzheimer’s and Parkinson’s because they are diseases associated with iron accumulation in the brain and aging.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIERRA M ROCHELLE whose telephone number is (571)272-9962. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/CIERRA M ROCHELLE/ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
