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 elected Group 4, drawn to a polypeptide comprising amino acid sequence of SEQ ID NO: 12 or variants thereof. Claims 32, 35 and 36 are hereby examined on the merits. Claims 13, 17-19, 23-26, 30-31, 37-40, 45, 49, 54, 67, 70, 77-80, 82-83 and 87-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29th September 2025.
Priority
This application is a 371 of PCT/CN2019/115107, filed on 11/1/2019, and claims foreign priority to PCTCN2018113755 filed 11/2/2018. Applicant has claimed the effective filing date of 11/2/2018 based on PCTCN2018113755 but no translation has been made of record.
Information Disclosure Statement
The information disclosure statement filed April 4, 2021 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a copy of the translation for WO 2020/088667 A1 has not been provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 32, 35 and 36 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 2nd paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitation in Claim 32, wherein the “amino acid sequence selected from the group consisting of:” refers to ‘a’ and ‘b’, ‘c’, that can be interpreted as a list of potential alternatives which can vary, and ambiguity arises. Does the applicant mean that the Markush group is ‘a’ and ‘b’ with ‘c’ being a second component or does the applicant mean a group consisting of ‘a’, ‘b’ and ‘c’.
Claim 32 is indefinite as it is unclear as to what limitation it is referring to.
For examination the claim will be interpreted to be a Markush group, where the amino acid sequence is selected from the group consisting of: a, b and c (see MPEP 2117).
Claim 35 is dependent on claim 32 and recites “The polypeptide according to claim 32”. Accordingly, the limitation in claim 32 is intending to limit the polypeptide to SEQ ID NO: 12, and the Examiner is interpreting the scope of Claim 35, “wherein X10 is R, X11 is R and X15 is G” to achieve 16% sequence identity to SEQ ID NO: 12 (since other 15 amino acid positions comprise alternative substitutions).
Claim 36 which depends on claim 32 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112(pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 32.
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 32, 35 and 36 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claimed invention is directed to a cell-penetrating peptide comprising amino acids 1-18 of SEQ ID NO: 12 and variants thereof. The limitation in claim 32, wherein “an amino acid sequence comprising amino acid sequence (SEQ ID NO: 12) with substitution, deletion, or insertion of 1-10 amino acid residue(s)” lacks written description because the instant application does not provide sufficient guidance to one of ordinary skill in the art to determine the sequences falling within the scope of the genus or of a recitation of structural features common to the members of the genus. Applicant reduced to practice the sequences listed in Example 8-2, Table 8, Figure 59. There is no reduction to practice for the full scope of the SEQ ID NO: 12 variants as instantly claimed. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, the specification is insufficient to teach the entire genus.
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention. The description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Thus, an applicant complies with the written description requirement by describing the invention, with all its claimed limitations, not that which makes it obvious, and by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.
While the general knowledge and level of skill in the art for peptide amino acids is evident, this knowledge and level of skill does not supplement the omitted description because specific, not general guidance is needed for one or more sequences with cell penetrating properties, for which guidance is not provided at all. Since the disclosure fails to describe common attributes or core sequences that represent all members of the genus, and because the genus of 1-18 amino acids that correspond to the Influenza M2 protein is vast and variant, the examples in the specification is insufficient to teach the entire genus. One would only conclude that Applicant was in possession of a cell penetrating peptide as represented in Example 8-2, Table 8, Figure 59 and not the entirety of sequences within the scope of claims 32, 35 and 36.
Claim Rejections - 35 USC § 112
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 35 is 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. Claim 35 is directed to the polypeptide(s) in claim 32, consisting of 18 amino acids. However, claim 35, which is dependent upon claim 32, is directed to an amino acid sequence with substitutions at amino acid positions X1-X9, X12, X14, X16-X18. As such, claim 35 does not further limit the scope of claim 32. 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 § 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 32, 35, 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (natural product) without significantly more. The claims recite the judicial exception of “an amino acid sequence comprising DRLFFKCIYRRLKYGLKR”. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim to a naturally occurring M2 protein of the Influenza virus. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exceptions into something more than the judicial exception. See the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes, the claim recites an amino acid sequence. Under the broadest reasonable interpretation, the claimed sequence SEQ ID NO: 12 is the sequence of the Influenza A virus M2 protein that is naturally occurring.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the additional elements in the claim do not integrate the judicial exceptions into a practical application. The claim is directed only to the amino acid sequence and to the function incorporated by the sequence.
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 32, 35 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP3231441A1; Published (18 October 2017).
EP3231441A1 teaches amphipathic peptides ranging from 4 to 45 amino acids that bind antigens to form an antigen-complex composition for improving antigen delivery in cells and enhancing immune response. EP3231441A1 specifically teaches SEQ ID NO:5 from H5N1 type A influenza virus strain (see Table 1) with cell penetration function. EP3231441A1 teaches a function motif within the amphipathic peptide, with consensus sequence R-L/I/R-F-K and/or R-L-F-S/F-K for cell internalization properties of the amphipathic peptides. See paragraph [0056]. EP3231441A1 discloses cell internalization of SEQ ID NO: 5 using fluorometry, (see paragraph [0040], Figure 9A and Figure 10B) confocal microscopy (see Figure 8C) and transmission electron microscopy (see paragraph [0043] and Figure 8D).
Claim 32 teaches a polypeptide with an amino acid sequence comprising SEQ ID NO: 12 DRLFFKCIYRRLKYGLKR, and having a cell penetration function. SEQ ID NO: 5 disclosed in EP3231441A1 is a 100% query match and 100% best local similarity match to SEQ ID NO: 12 in the instant application. The core R-L-F-S/F-K motif [paragraph 0056] taught in EP3231441A1 is present in SEQ ID NO: 12 of the instant application.
Regarding claim limitations “with substitution, deletion or insertion of 1-10 amino acid residue(s)”, “that has at least 60%, at least 70%...or 100% sequence identity with SEQ ID NO:12”, EP3231441A1 teaches amphipathic peptides comprising an amino acid sequence including a A1B1B2A2 and /or A3B3B4B5A4 motif, wherein A1, A2 A3 and A4 are each individually selected from the group consisting of amino acids K, R; B1 is selected from the group consisting of K, R, I, L, V; B2 is selected from the group consisting of I, L, V, F, Y, W; B3 is selected from the group consisting of I, L V; B4 is selected from the group consisting of F, W, Y; and B5 is selected from the group consisting of F, Y, W, T, C, S. See paragraph [0010]. EP3231441A1 teaches specifically SEQ ID NO: 12 variants with at least 60% sequence identity to SEQ ID NO: 12. See paragraph [0010] and Table 1, SEQ ID NO:4, SEQ ID NO: 5, SEQ ID NO: 6.
Regarding claim 35, which is dependent on claim 32, EP3231441A1 specifically teaches SEQ ID NO: 12 and variants “that has at least 60%, at least 70%...or 100% sequence identity with SEQ ID NO:12.
Claim 36 recites “amino acid sequence selected from the group consisting of” which is a Markush grouping of a closed set of alternatives (MPEP 2173.05(h)). EP3231441A1 teaches SEQ ID NO:5 (see amino acids 2-18) which matches to amino acids 2-17 of SEQ ID NO: 82 in the instant application. SEQ ID NO: 6 taught in EP3231441A1 matches amino acids 2-18 in the instant application.
Regarding claim 36, EP3231441A1 teaches amphipathic peptides, comprising an amino acid sequence including a A1B1B2A2 and /or A3B3B4B5A4 motif, See paragraph [0010]. In the instant claim SEQ ID NO: 82, SEQ ID NO: 83, SEQ ID NO: 88, SEQ ID NO: 89, SEQ ID NO: 90, SEQ ID NO: 92, SEQ ID NO: 93, SEQ ID NO: 95 includes the A3B3B4B5A4 motif taught in EP3231441A1. The aforementioned sequences in the instant claim contain the consensus sequence of R-L/I/R-F-K and/or R-L-F-S/F-K taught by EP3231441A1, that is important for cell binding and internalization of the amphipathic peptide into the cell. See paragraph [0056].
Therefore, the disclosures of EP3231441A1 anticipate the claimed invention.
Conclusion
No claim is allowed
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658