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 without traverse of Group I (i.e., claims 1 and 5 directed to a polypeptide comprising the amino acid sequence of SEQ ID NO: 2) in the reply filed on August 24, 2026, is acknowledged. It is noted that Species A is not necessary for election of Group I.
Status of Claims
Claims 1-31 were originally filed on January 19, 2024.
Claims 1-8 are currently pending and claims 1 and 5 are under consideration as claims 1-5 and 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 24, 2026.
Priority
The present application claims priority under 119(a)-(d) to Korean Application No. 10-2023-0008885 filed on January 20, 2023.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Korean Application No. 10-2023-0008885, which papers have been placed of record in the file. Please note that the Korean application is in a foreign language and therefore cannot be reviewed.
Sequence Interpretation
For claims 1 and 5s, please note that the Examiner is interpreting the scope as open-ended requiring 100% identity to SEQ ID NO: 2 with any N- and/or C-terminal additions, and encompassing any sequence showing substantial identity to SEQ ID NO: 2. It is noted that the instant specification defines the polypeptide comprising the amino acid sequence of SEQ ID NO: 2 as being construed to include not only the amino acid sequence of SEQ ID NO: 2, but also a sequence showing substantial identity to the sequence of SEQ ID NO: 2 (See instant specification, pg. 4, last paragraph). As further articulated below in the 112(b) rejection, it is not clear what constitutes “substantial identity” because the “definition” for substantial identity in the specification utilizes ambiguous language, i.e., preferably. The Examiner is interpreting substantial identity as referring to at least 80% identity (not homology) given that the specification states that the substantial identity means at least 80% homology in sequences when the present nucleotide sequence is aligned with any other sequence so as to match each other as much as possible and the aligned sequences are analyzed using an algorithm commonly used in the art (See instant specification, pg. 4, last paragraph). Aligning sequences so as to match each other as much as possible would suggest the percent identity and not percent homology between sequences. Thus, the scope of claims 1 and 5 encompass any sequence that has up to 2 amino acid modifications, e.g., substitutions, deletions, and/or insertions, (i.e., SEQ ID NO: 2 is 11 amino acids in length where 80% identity encompasses up to 2 amino acid modifications).
Additionally, it is noted that SEQ ID NO: 2 has an amino acid sequence of EHWSYRLRFIP as depicted in the Sequence Listing. However, the structure of SEQ ID NO: 2 in Figure 5 contains pyroglutamic acid instead of glutamate at the N-terminus and the C-terminus is amidated instead of a natural carboxyl terminus. Thus, as further articulated below in the 112(b) rejection, the sequence for SEQ ID NO: 2 is unclear, but the Examiner is interpreting the scope of SEQ ID NO: 2 such that it contains the structure depicted in the Sequence Listing in order to advance prosecution.
Drawings
Figures 3-5 are objected to because each Figure depicts amino acid sequences without including SEQ ID NOs for each of the sequences. However, the SEQ ID NOs: need to be present in either the figure or the Brief Description of the Drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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.
The drawings; in particular, Figures 3 and 5, are objected to because of the following reason:
The drawings have a line quality that is too light to be reproduced (weight of all lines and letters must be heavy enough to permit adequate reproduction) or text that is illegible (reference characters, sheet numbers, and view numbers must be plain and legible) see 37 CFR 1.84(l) and (p)(1)); See Figure(s) 3 and 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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.
Specification
The disclosure is objected to because of the following informalities: on page 4, 2nd paragraph, discusses His tag sequences without an accompanying SEQ ID NO. Pursuant to MPEP 2422 and 37 CFR 1.821(a), any amino acid sequence with at least 4 defined amino acids in length requires a sequence identifier. Additionally, please update the Sequence Listing, if necessary. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 5 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.
Independent claims 1 and 5 includes a polypeptide comprising the amino acid sequence of SEQ ID NO: 2. The interpretation of this phrase is described above in the “Sequence Interpretation” section and in the 112(b) rejection below where a polypeptide comprising SEQ ID NO: 2 encompasses at least 80% identity to SEQ ID NO: 2. As such, the polypeptide of claims 1 and 5 encompasses amino acid sequences comprising up to 2 amino acid modifications such as substitutions, additions, and/or deletions. Moreover, the specification teaches that SEQ ID NO: 2 reduces the expression of telomerase reverse transcriptase (TERT) and activity of telomerase (See instant specification, pg. 3, last paragraph). In addition to certain manipulations of SEQ ID NO: 2, the polypeptide must also have “the function of the SEQ ID NO: 2” where the function is reducing the expression of telomerase reverse transcriptase (TERT) and activity of telomerase. Thus, in light of the specification, this is clearly the function of the claimed polypeptide.
The written description requirement may be met by provided a representative number of species of the genus and/or in light of the state of the art. With regard to the state of the art, Park et al. teaches that instant SEQ ID NO: 2 is a modified or fusion peptide comprising the N-terminal five amino acid residues (E1H2W3S4Y5) from GnRH and the following six residues (R6L7R8F9I10P11) are from GV1001 (See Park et al., MedComm. 7:e70630 (15 pages) (2026) at pg. 2, col. 1, last paragraph). Specifically, SEQ ID NO: 2 (i.e., HS1002) was constructed by connecting the Arg-Leu-Arg-Phe-Ile sequence from the hTERT:611-626 peptide to the pGlu-His-Trp-Ser-Tyr sequence involved in GnRHR activation from the GnRH peptide after cleavage of the Gly region susceptible to peptide degradation (See Park, pg. 2, col. 1, last paragraph). Figure 1 depicts five sequences, one being instant SEQ ID NO: 2, and three sequences that would constitute at least 80% identity to SEQ ID NO: 2, i.e., G6R, G6R/PSF, and G6R/P9F/G10I (See Park, Figure 1F). Furthermore, Kim et al. teaches the 16mer amino acid fragment of hTERT known as GV1001 and the GnRH amino acid fragment sequence (See Kim et al., Endocrine-Related Cancer 26:147-162 (2019) at Figure 1A). Kim et al. also depicts the structure of two GnRH analogs, i.e., Leuprolide and Cetrolix (See Kim, Figure 1B). However, none of these four sequences taught by Kim et al. are species within the claimed genus of at least 80% identical to instant SEQ ID NO: 2. Therefore, the art fails to teach a representative number of species that fall within the claimed genus, and fails to demonstrate a core structure or sequence that is necessary for each species within the claimed genus to exhibit the function of reducing the expression of telomerase reverse transcriptase (TERT) and activity of telomerase. Thus, the claims are directed to polypeptides with a certain function but no correlated structure associated with that function. Without such structure, the specification does not convey possession of the breadth of the claimed genus.
Alternatively, the written description requirement may be met by provided a representative number of species of the genus. In this, the specification teaches SEQ ID NOs: 3-4 in addition to SEQ ID NO: 2 where each contains a single substitution at position 6 or 8, respectively (See instant, Figure 4). While two examples of a single substitution mutant are provided (SEQ ID NOs: 3-4) and it is these two substitutions, i.e., positions 6 and 8 or SEQ ID NO: 2, that might be referred to in the specification as preserving function (See instant, Table 1), such polypeptides are not representative of the scope of claims 1 and 5 because these two mutant species contain a single specific substitution at a specific amino acid location in SEQ ID NO: 2 whereas the scope of claims 1 and 5 encompass up to two amino acid modifications, insertions and/or deletions at any position. Further, there remain no examples of insertions or deletions. As such, two specific species do not constitute a representative number of species given the breadth of the claimed genus. Thus, the specification is not sufficient for the skilled artisan to envisage other substitutions at the other residue sites which preserve function nor to envisage those substitutions other than those in SEQ ID NOs: 3-4 with an expectation that function will be preserved.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, what is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides which preserve the required function, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Therefore, claims 1 and 5 do not meet the written description requirement.
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 1 and 5 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 1 and 5 are directed to a polypeptide comprising the amino acid sequence of SEQ ID NO: 2. As discussed in the “Sequence Interpretation” section supra, the instant specification defines the polypeptide comprising the amino acid sequence of SEQ ID NO: 2 as being construed to include not only the amino acid sequence of SEQ ID NO: 2, but also a sequence showing substantial identity to the sequence of SEQ ID NO: 2 (See instant specification, pg. 4, last paragraph). “Substantial identity” is defined as preferably at least 80% homology, more preferably at least 85% homology, still more preferably at least 90% homology, most preferably at least 95% homology in sequences when the present nucleotide sequence is aligned with any other sequence so as to match each other as much as possible and the aligned sequences are analyzed using an algorithm commonly used in the art (See instant specification, pg. 4, last paragraph). The phrase "preferably", etc., 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). Since the definition of substantial identity includes language that is indefinite, it would then follow that the claim encompasses indefinite language. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently invention with respect to what constitutes a polypeptide comprising the amino acid sequence of SEQ ID NO: 2.
Please note that the Examiner is interpreting that a polypeptide comprising the amino acid sequence of SEQ ID NO: 2 such that substantial identity refers to at least 80% identity (not homology) given that the specification states that the substantial identity means at least 80% homology in sequences when the present nucleotide sequence is aligned with any other sequence so as to match each other as much as possible and the aligned sequences are analyzed using an algorithm commonly used in the art (See instant specification, pg. 4, last paragraph). Aligning sequences so as to match each other as much as possible would support the percent identity and not percent homology between sequences.
Claims 1 and 5 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 1 and 5 are directed to a polypeptide comprising the amino acid sequence of SEQ ID NO: 2. As discussed in the “Sequence Interpretation” section supra, it is noted that SEQ ID NO: 2 has an amino acid sequence of EHWSYRLRFIP as depicted in the Sequence Listing. However, the structure of SEQ ID NO: 2 in Figure 5 contains pyroglutamic acid instead of glutamate at the N-terminus and the C-terminus is amidated instead of a natural carboxyl terminus. As such, it is unclear which sequence/structure constitutes SEQ ID NO: 2. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds with respect to the structure/sequence of SEQ ID NO: 2.
Please note that the Examiner is interpreting the scope of the structure/sequence of SEQ ID NO: 2 such that it contains the structure/sequence depicted in the Sequence Listing in order to advance prosecution.
Examiner Comment
Notwithstanding the 112 rejections supra, claims 1 and 5 are free of the prior art because there is no teaching or suggestion in the art to achieve a polypeptide comprising an amino acid sequence having at least 80% identity to SEQ ID NO: 2. The closest prior art is Kim et al., Endocrine-Related Cancer 26:147-162 (2019), which teaches the 16mer amino acid fragment of hTERT known as GV1001 and the GnRH amino acid fragment sequence (See Kim et al., Endocrine-Related Cancer 26:147-162 (2019) at Figure 1A). Kim et al. also depicts the structure of two GnRH analogs, i.e., Leuprolide and Cetrolix (See Kim, Figure 1B). However, Kim et al. does not teach or suggest taking a fragment of GnRH and a fragment of GV1001 and fusing them together. Thus, the scope of claims 1 and 5 are free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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