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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 15-21, in the reply filed on 5/12/2026 is acknowledged. The traversal is on the ground(s) that 1) Tanaka (CA2342602, published 10/18/2001) does not state that SEQ ID NO: 24553 consists of the instant SEQ ID NO: 6 that is 200 amino acids long or less, and 2) Tanaka is silent to the inhibition of the tetramerization of the LDH subunits. This is not found persuasive.
Regarding 1), instant claim 15 recites a polypeptide comprising formula I, wherein the polypeptide comprises 16-200 amino acids. As stated in the restriction requirement, SEQ ID NO: 24553 is 104 residues in length and is not SEQ ID NO: 87. Thus, Tanaka anticipates the instant claim 15. Regarding 2), the limitation that the polypeptide has the ability to inhibit the tetramerization of LDH subunits is a property inherently endowed by the structural limitations of the polypeptide itself; see Claim Interpretation and art rejections below for more.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of the species SEQ ID NO: 29 in the reply filed on 5/12/2026 is acknowledged.
Claim Status
Claims 15-28 are pending. Claims 17-18 and 22-28 are hereby withdrawn as non-elected inventions (claims 22-28) and species (claims 17-18).
Priority
The instant application is the 371 national stage entry of PCT/EP2022/052282, filed 2/1/2022, which claims priority to EP21154636.1, filed 2/1/2021. The priority date of 2/1/2021 is acknowledged.
Information Disclosure Statement
The IDS’s filed on 8/1/2023, 9/19/2023, and 5/12/2026 are under consideration. Any strikethrough is owed to lack of a legible copy. Additionally, it is noted that the IDS filed on 8/1/2023 is effectively the same as the one filed on 9/19/2023, the only difference being the US patent number.
Drawings
Figure 1A and 1E should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
1. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
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.
Specifically, see the Abstract.
2. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
See Figure 4A and 4B; SEQ ID NO’s can be in either the Drawings themselves or the corresponding Brief Description of the Drawings.
3. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 incorporation-by-reference paragraph, 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 disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 42, line 17). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claim 15 recites the limitation “a polypeptide that inhibits the tetramerization of the LDH subunits”. This limitation is being interpreted as a functional limitation that is endowed by the structure of the polypeptide recited in claim 15.
Claims 19 and 20 also recite functional limitations endowed by the structure of claim 15 and are being interpreted in the same manner.
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 15-16 and 19-21 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 15 recites the limitation "the LDH subunits" in line 1. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of “LDH subunits”.
Claim 15 further recites the limitation “the polypeptide comprising the amino acid sequence of formula (I)… wherein said polypeptide comprises from 16 to 200 amino acid residues”. This limitation renders the scope of claim 15 indefinite as it is unclear whether the polypeptide comprising the amino acid sequence of formula (I) is open to a polypeptide of any length, as suggested by the use of the transitional phrase comprising, or whether said polypeptide is limited to only 16-200 amino acids in length. For purposes of examination, the polypeptide of claim 15 and all dependent claims is being interpreted as open to polypeptides of any length.
Claims 16 and 19-21 are also hereby rejected by virtue of their dependency on claim 15.
Further, claim 19 recites the limitation "the lactate dehydrogenase subunits" in line 1. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of “lactate dehydrogenase subunits,” only “LDH subunits”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-16 and 19-21 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), the claims are drawn to polypeptides, which are compositions of matter.
Regarding 2a), the polypeptides claimed read on products of nature. Formula I, wherein X1 is E, X2 is D, X3 is L, X4 is F, and X5 L, as in the elected SEQ ID NO: 29, reads on several naturally-occurring L-lactate dehydrogenase B chains:
UniProt ID A0A8C0SK88_CANLF
UniProt ID A0A8C0P8E1_CANLF
UniProt ID A0A2J8QRC2_PANTR
A6IMU6_RAT
Q6XA07_HORSE
Others not listed here
It is also noted that the following non-elected species also read on natural products:
SEQ ID NO: 6 - A0A8C0SK88_CANLF and several others;
SEQ ID NO: 26 and 49 - UniProt ID LDHB_MONDO;
Regarding 2b), none of the claims recite additional structural features that would distinguish the elected SEQ ID NO: 29/formula (I) from the above naturally-occurring products. It is also noted that a nucleic acid encoding such a polypeptide reads on the naturally-occurring genes in each of these organisms. As such, they do not contain elements added to the judicial exception sufficient to render the claims significantly more than the exception.
In sum, the claims are drawn to patent ineligible subject matter and are rejected here.
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.
(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) 15-16 and 19-21 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bancel et al. (US20140010861A1, published 1/9/2014).
Bancel teaches compositions and methods for the preparation, manufacture, and therapeutic use of polynucleotides, primary transcripts, and mmRNA molecules (Abstract). Bancel teaches SEQ ID NO: 51046, which comprises the elected SEQ ID NO: 29 (Sequence Listing). Thus, claims 15, 16, and 21 are anticipated.
Additionally, per the Claim Interpretation section above, claims 19 and 20 are also anticipated.
Prior Art Cited but not Referenced
Several other references anticipate SEQ ID NO: 29, including:
SEQ ID NO: 49259, 49567, 50552, and 50555 of US20050196754A1, filed 8/23/200
SEQ ID NO: 1059 of US20110053787A1, filed 7/15/2010
SEQ ID NO: 14 of US20150147793A1, filed 7/11/2012
SEQ ID NO: 436 of US20150087602A1, filed 3/26/2012
SEQ ID NO: 262 of US20030124128A1, filed 3/5/2002
Additional references not listed here
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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