Detailed Action
The present office action is in response to the response filed on 25 Nov 2025.
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 .
Status
Claims 1, 3, and 13-24 of the pending application have been examined on the merits. Claims 2, 4-12, and 25-29 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 25 Nov 2025.
Priority
Applicants identify the instant application, Serial #: 17/914,872 filed 27 Sep 2022, as a National Stage Entry of International Patent Application #: PCT/IB2021/052586, filed 29 Mar 2021, which claims foreign priority from Foreign Application #: IT102020000006517, filed 27 Mar 2020.
Response to Applicant Election
Applicant's election without traverse of Group I, claims 1-3 and 9-24, and the species of formula (I) in the reply filed on 12 Nov 2025 is acknowledged. Applicant additionally elected small molecules as the species of other medicaments and prior diseases as the species of disease.
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Claims 4-8 and 25-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 2 and 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Election was made without traverse in the reply filed on 12 Nov 2025.
Examiner Interpretation
Claim 17 recites the limitation, “A compound according to claim 1 for use as a medicament.” The phrase, “for use as a medicament” is construed as intended use and is of no significance to the claim construction. Claim 18 is dependent on claim 17 and limits the intended use of the compound of claim 1, but is still an intended use and is of no significance to the claim construction. Further, claims 19 and 20, which depend on claim 17, do not include limitations which are significant to the claim construction.
Claim 21 recites the limitation, “A compound according to claim 17, for use as a medicament in combination with one or more other medicaments.” The phrase “for use as a medicament in combination with one or more other medicaments” is construed as intended use and is of no significance to the claim construction. Claims 22 and 23, which depend on claim 21, do not include limitations which are significant to the claim construction.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because the instant specification discusses nucleotide sequences with an unbranched sequence of 10 or more specifically defined nucleotides (pg. 82).
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specific deficiency - Sequences appearing in the instant specification (pg. 82) are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Warnings
Applicant is advised that should claim 3 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections
Claim 1 is objected to because of the following informalities: there is a lack of consistency in claim 1 when listing options in a Markush group. Claim 1 alternatively uses commas, “or”, and a mixture of commas and “or” when listing a Markush group. See for example the limitations for variables X, R3, and R2. Applicant may overcome this rejection by amending the claims with a consistent format for Markush groups. Appropriate correction is required.
Claim 1 also contains a typo in the definition of ring B. The word “insaturated” should be “unsaturated.” Appropriate correction is required.
Claim 16 is objected to because of the following informality: claim 16 appears to depend from claim 1, but says, “according to 1” instead of “according to claim 1.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 and 14-15 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 claim 1, the phrases, “for instance,” “and/or,” “e.g.,” “may be,” and “preferably,” 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).
Further, claim 1 contains the limitation “ring C is a 5- or 6- membered aromatic ring wherein each atom may be -C- or -N-, e.g. Y may independently be -C(R3)- or -N(R3)- or -N=. ” It is unclear from the structure of formula (I) (below) and the definition of Y how ring C can be a 6- membered aromatic ring when ring C is represented as a 5-membered ring in formula (I) and Y can only be a single atom.
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It is also unclear if each atom of ring C includes the atoms bridged to ring B and whether those atoms may also be -N(R3)-, -N-, or -N=. Moreover, the definitions of ring C and Y are further confusing as they offer two different definitions of the atoms of ring C, where they may be -C- or -N-, but might also be -C(R3)-, -N(R3)-, or -N=.
Regarding the limitations of ring B in claim 1, it is unclear how ring B may be fully unsaturated as a pyridinone ring when formula (I) only contains single bonds between the X variables and the constant carbons of ring B. A person of ordinary skill in the art would be unsure how to interpret the claim limitations.
Claim 1 contains Markush groupings which do not have the coordinating conjunctions “and” or “or” to properly limit the alternatives defined in the list. See MPEP § 2117(I). Applicant may overcome this rejection by adding the proper coordinating conjunction to each Markush group in need of one.
Regarding claims 14-15, the phrase, “represented by” 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).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 17-24 do not further limit claim 1 because they recite an intended use (see “Examiner Interpretation” above).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3, and 13-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spagnolli et al. (bioRxiv, 2020, 2020-03), hereinafter Spagnolli.
The instant claims are drawn to compounds of general formula (I):
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Applicant has elected the following species of generic formula (I):
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Applicant has additionally elected small molecules as the species of other medicaments and prion diseases as the species of disease. The elected compound is identified by the instant specification as SM875 (Fig. 4).
Spagnolli teaches the instantly elected compound, SM875, along with both S and R enantiomers (pg. 47, Supp. Table 4; pg. 52, Fig. 3E). Thus Spagnolli anticipates the instant claims.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim(s) 1, 3, 13-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem CID 135959243 (https://pubchem.ncbi.nlm.nih.gov/compound/135959243, available online 19 Jan 2019, accessed 20 Feb 2026), hereinafter PubChem.
PubChem teaches the following compound which is the R enantiomer of the instantly elected compound:
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Thus, PubChem anticipates the instant claims.
Claim(s) 1, 3, 13, 16-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STNext (Chemical Abstracts Service, 1-(4-bromophenyl)-1,4,5,7-tetrahydro-4-(4-hydroxy-3-methoxyphenyl)-6H-pyrazolo[3,4-b]pyridine-6-one (CAS 919023-94-2) CAS Registry File Accessed 18 Feb 2026 from STN, entered into STN 02 Feb 2007), hereinafter STNext.
STNext teaches the following compound which is the instantly elected compound:
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Thus STNext anticipates the instant claims.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2012/054535 is considered pertinent for teaching compounds with the same core structure as compounds claimed by the instant application. US 2009/0163545 is considered pertinent for teaching compounds with the same core structure as compounds claimed by the instant application. Laiolo et al. (ACS Med Chem Lett, 2018, 9:1186-1192) is considered pertinent for teaching compounds with the same core structure as compounds claimed by the instant application. Patnaik et al. (Bioorg Med Chem Lett, 2019, 29:1113-1119) is considered pertinent for teaching compounds with the same core structure as compounds claimed by the instant application. Lichitsky et al. (ACS Comb Sci, 2019, 21:805-816) is considered pertinent for teaching compounds with the same core structure as compounds claimed by the instant application.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625