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 .
2. Applicant’s response filed on 09/18/2025 is acknowledged.
3. Claims 16 and 21-38 are pending.
4. Claims 29-32 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and claim 25 stands withdrawn as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/12/2025.
5. Claims 16, 21-24 and 26-38 are currently under consideration as they read on the full scope of the claims.
6. The following rejections are necessitated by the amendment filed on 09/18/2025.
7. 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.
8. Claims 16, 23-24, 26-28 and 33-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to many naturally occurring polypeptides. SEQ ID NO:5 encompasses many naturally occurring polypeptides. In addition, SEQ ID NOs 6-22, 30, 35 and 64-67 are all peptides of naturally occurring proteins. At least the polypeptides comprising SEQ ID NOs 6-22, 30, 35, 64-65 and 67 read on full length naturally occurring proteins. For example, as evidenced by Figure 4d in Thabault et al. (PTO-892 mailed on 06/18/2025; Reference U), naturally occurring lactate dehydrogenase from Homo sapiens comprises instant SEQ ID NOs:6-8 and 65-66. This judicial exception is not integrated into a practical application because the claims fail to recite additional elements which would integrate the judicial exception into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of a pharmaceutical composition, kit and medicaments comprising a pharmaceutically acceptable vehicle which reads on water and does not add significantly more (also known as an “inventive concept”) to the exception.
As such, claims 16, 23-24, 26-28 and 33-34 are not directed to patentable subject matter.
Applicant’s arguments filed on 09/18/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“The claimed limitations, when viewed as a whole, are directed toward significantly more than the alleged abstract idea of natural products. Claim 16 now recites: Specifically, claims 16-24 and 26-28 are amended to specify that the polypeptide is an isolated polypeptide and either that the linear polypeptide consists of from 8 to 30 amino acids or that the isolated polypeptide is cyclic.” and that “Figure 4d of Thabault depicts an alignment of a local region of a protein, the corresponding sequences, however, are not disclosed as naturally occurring products. Second, claim 16 is directed to linear or cyclic isolated polypeptides, whereas all natural proteins adopt secondary structures, as evidenced, for example, by Figures 1-3 of the instant specification. In fact, all exemplified polypeptides are synthesized as non-natural products. Furthermore, while the natural lactate dehydrogenase subunit hLDHA has a length of 332 amino acids (SEQ ID NO: 1) and subunit hLDHB has a length of 334 amino acids (SEQ ID NO: 2), the claimed linear polypeptides are expressly defined as consisting of from 8 to 30 amino acids, which is clearly distinct from naturally occurring proteins. Accordingly, there is no evidence that the claimed polypeptides exist in nature.”
It is the Examiner’s position that Applicant’s arguments are not persuasive as they read on the linear peptides. Peptide fragments of naturally occurring polypeptides, as discussed supra, are not patent eligible because they have no properties when isolated from the naturally occurring protein that the peptides do not have within the context of the naturally occurring protein. The sequence of the peptide is the same. Whether they have secondary structure or not is not sufficient, particularly since the naturally occurring protein can be denatured. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of a pharmaceutical composition, kit and medicaments comprising a pharmaceutically acceptable vehicle which reads on water and does not add significantly more (also known as an “inventive concept”) to the exception.
Claims 16, 23-24, 26-28 and 33-34 are not directed to patentable subject matter
9. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
10. Claims 16, 21-24 and 26-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is in possession of: the peptide consisting of SEQ ID NO:61 which inhibits tetramerization of the lactate dehydrogenase subunits; and the peptides of SEQ ID NOs 6-22, 30-35, 55-58, 61-65 and 67-68 without any specified function and compositions and kits thereof.
Applicant is not in possession of: a polypeptide that inhibits tetramerization of the lactate dehydrogenase subunits, said polypeptide comprising the amino acid sequence of SEQ ID NO:5-22, 30-35, 55-58, 62-65 and 67-68 and compositions and kits thereof.
The claims encompass polypeptides which do not inhibit tetramerization of the lactate dehydrogenase subunits. The skilled artisan cannot envision all the polypeptide possibilities recited in the instant claims.
The claimed linear sequences of SEQ ID NOs:6-20 encompasses an enormous number of polypeptides. In addition to each of the 8-19 amino acids in SEQ ID NOs:6-20, the peptides may comprise up to 11-22 additional amino acids added onto the N- and/or C-terminus of the peptide. Furthermore, SEQ ID Nos 18-20 comprise variable amino acids within the recited sequences. In the same way, cyclic peptides 67 and 68 comprise a variable amino acid each.
The art of Thabault et al. (PTO-892 mailed on 06/18/2025; Reference U) teaches many of the peptides encompassed by the claimed invention do not inhibit tetramerization of the lactate dehydrogenase subunits . The reference teaches that only one peptide, “macrocyclic peptide 7” of Table 3 (CTLKCKLI p-tetrafluorophenyl linker) was able to inhibit the tetramerization of the lactate dehydrogenase subunits. (In particular, Figure 9, whole document) There is no correlation between the structure of the peptides and the function of being able to inhibit the tetramerization of the lactate dehydrogenase subunits. As such, the specification has not adequately described the genus of polypeptides comprising SEQ ID NO:6-20, 30-35, 55-58, 61-65 and 67-68 which have the function of inhibit the tetramerization of the lactate dehydrogenase subunits.
One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus.
"Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features" Ex parte Kubin (83 U.S.P.Q.2d 1410 (BPAI 2007)), at page 16. In this instant case, Applicants have not provided the requisite identifying structural features of the antibodies encompassed. "Without a correlation between structure and function, the claim does little more than define the claimed invention by function" supra, at page 17.
While the instant specification does disclose certain peptides with the claimed functional attributes, the instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of peptides of SEQ ID NO:5 encompassing the functional / structural limitations encompassed in the claims.
In addition, the specification does not provide sufficient written description as to the correlation between the chemical structure and function. Applicant was not in possession of the claimed genus by providing sufficient structural and functional characteristics of the species or genus of such claimed peptides encompassed by the instant claim language, coupled with a known or disclosed correlation between function and structure. A skilled artisan cannot visualize or recognize the identity of the members of the genus that exhibit this functional property.
The Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
The specification fails to provide a description of the function-identifying structures required for the genus of peptides encompassing the functional limitations encompassed in the claims.
The patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014).
The specification at best describes a plan for making the genus of peptides encompassing the functional limitations encompassed in the claims encompassed by the claimed limitations, and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient.Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011).
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the court stated that in order to show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genus or structural common to the members of the genus so the one of skill in the art can visualize or recognize the member of the genus. It is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361). An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
“When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” See Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005). “A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
A “representative number of species" means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
With respect to representative number of species, see AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) Also, see MPEP 2163 II(A)(3)(a))(ii) A representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The “structural features common to the members of the genus” needed for one of skill in the art to 'visualize or recognize' the members of the genus takes into account the state of the art at the time of the invention. For example, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural “stepping stone” to the corresponding chimeric antibody, but not to human antibodies. Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875 (Fed. Cir. 2011).
There is insufficient written description for genus of peptides of SEQ ID NO:5 encompassing the functional limitations encompassed in the claims at the time the invention was filed and as disclosed in the specification as filed under the written description provision of 35 USC 112.
Applicant’s arguments filed on 09/18/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Applicant respectfully disagrees, as the examples of the instant specification show that several additional linear (Table 2) or cyclic (Table 3) polypeptides are capable of binding LDH subunits and/or inhibiting LDH subunits tetramerization.
Without conceding to the Office Action's opinion, claim 16 is amended to recite that the polypeptide is:
- a linear polypeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 6 to SEQ ID NO: 20, consisting of from 8 to 30 amino acids;
or
- a cyclic polypeptide consisting of an amino acid sequence selected from the group consisting of SEQ ID NO: 30 to SEQ ID NO: 35, SEQ ID NO: 55 to SEQ ID NO: 58, SEQ ID NO: 61 to SEQ ID NO: 65, SEQ ID NO: 67 and SEQ ID NO: 68.
Additionally, new claims 33-38 are added to further specify the sequences were introduced. The addition of these claims does not introduce new matter but merely provides further clarification and refinement of the originally disclosed subject matter.
Applicant notes that the applicable standard for a rejection of a claim based on the written description requirement requires a presentation by a preponderance of the evidence why a person skilled in the art would not recognize in an applicant's disclosure a description of the invention defined by the claims.2 With the amendments of claim 16, Applicant contends that a person skilled in the art would be able to recognize in Applicant's disclosure a description of these limitations.”
It is the Examiner’s position for all of the reasons cited supra that the rejection stands for reasons of record. The art of Thabault et al. (PTO-892 mailed on 06/18/2025; Reference U) is Applicant’s own work and it teaches many of the peptides encompassed by the claimed invention do not inhibit tetramerization of the lactate dehydrogenase subunits . The reference teaches that only one peptide, “macrocyclic peptide 7” of Table 3 (CTLKCKLI p-tetrafluorophenyl linker) was able to inhibit the tetramerization of the lactate dehydrogenase subunits. (In particular, Figure 9, whole document). There is no correlation between the structure of the peptides recited in claim 16 and the function of being able to inhibit the tetramerization of the lactate dehydrogenase subunits. Applicant’s argument that the peptides are “capable of binding LDH subunits and/or inhibiting LDH subunits tetramerization” is not persuasive. The claims do not recite this. The claims recite that the peptides are able to inhibit the tetramerization of the lactate dehydrogenase subunits. The art of Thabault et al. shows that these claimed peptides cannot perform this function. So, the sequences themselves in the claim are not adequately described, much less peptides which comprise additional amino acids added onto the recited peptides which cannot perform this function by themselves. It is noted that LB8 is SEQ ID NO:65, the peptides 1 and 7-9 in Table 3 are encompassed by SEQ ID NOs 31, 55 and 61-63; peptide 2 is encompassed by SEQ ID NOs 33 and 56; peptide 3 is encompassed by SEQ ID Nos 30 and 57; peptide 4 is encompassed by SEQ ID No:58; peptide 6 is encompassed by SEQ ID NO:34; peptide 10 is encompassed by SEQ ID NO:64; and peptides 11-12 are encompassed by SEQ ID NO:65. The reference teaches that the only one of these cyclic peptides that inhibit the tetramerization of the lactate dehydrogenase subunits is “macrocyclic peptide 7” of Table 3 (CTLKCKLI p-tetrafluorophenyl linker).
As such, the specification has not adequately described the genus of polypeptides comprising SEQ ID NO:6-20, 30-35, 55-58, 61-65 and 67-68 which have the function of inhibiting the tetramerization of the lactate dehydrogenase subunits.
11. 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.
12. Claims 16, 23, 26-28 and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication 2015/0079119 (PTO-892; Reference A).
U.S. Patent Application Publication 2015/0079119 teaches the sequence of reference SEQ ID NO:370 ‘MATLKEKLIAGSF’ (which is 100% sequence identical over length and sequence to instant SEQ ID NOs 8 and 14) for use a peptide component of an anti-cancer vaccine (In particular, paragraph [252], Table 12, whole document).
The reference teaches the use of peptides in cancer vaccines further comprising pharmaceutically acceptable carriers and vehicles (In particular, paragraph [0188]-[0192], whole document) and kits thereof (In particular, paragraph [0198], whole document).
The reference teachings anticipate the claimed invention.
13. No claim allowed.
14. It appears that the cyclic peptides consisting of an amino acid sequence selected from the group consisting of SEQ ID Nos 30-35, 55-58, 61-65 and 67-68 are free of the art.
15. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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December 19, 2025
/Nora M Rooney/
Primary Examiner, Art Unit 1644