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 .
Application Status
Claims 1-16 are pending and under consideration hereinafter.
Priority
Acknowledgment is made of Applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a), and claim for benefit under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c). The certified copy of Application No. CN202111127857.6 has been received. However, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of Application No. CN202111127857.6 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, Application No. CN202111127857.6 does not disclose SEQ ID NOs: 87-105 recited in instant claim 1. The first disclosure of SEQ ID NOs: 87-105 is Application No. PCT/CN2022/121254. The effective filing date of all claims under examination is September 26, 2022, accordingly.
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 - Sequences appearing in Fig. 3 of the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide amended 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 (i.e., “SEQ ID NO:X” or the like) 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.
Specific deficiency - Sequences appearing in the specification in Table 3 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 specification is objected to because of the following informalities:
The use of terms which are trade names or marks used in commerce has been noted in this application, e.g., ProSolv, Avicel, Pharmatose, Emcompress, and Magnasweet on pg. 17. The terms should be accompanied by the generic terminology. Furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Drawings
The drawings are objected to because the lines, numbers, and letters of Figs. 5 and 20 are not sufficient to provide satisfactory reproduction characteristics. 37 CFR 1.84(l) states that “all drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.” In the instant case, the graphs of Figs. 5 and 20 contain illegible lines, numbers, and letters.
Appropriate correction is required.
Claim Objections
Claim 4 is objected to because the phrase “preferably less than 1 nM or less” is redundant. The claim should be amended to recite “preferably less than 1 nM
Claims 5-16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 5-16 have not been further treated on the merits.
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 1-4 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 1 recites an “aptamer against DKK1… wherein the aptamer specifically binds to DKK1.” The phrase “specifically binds” renders the claim unclear, because neither the claim nor specification provide a metric to ascertain the degree of binding which would be considered “specific” to DKK1. Although the specification provides that “specific binding” of an aptamer means that the aptamer “binds to its target generally with a much higher degree of affinity than it binds to other, non-target, components in a mixture or sample” (pg. 6), this definition does not provide sufficient clarity for the degree of binding which would be considered “specific,” at least because the scope of “a much higher degree of affinity” is also unclear.
Claims 2-4 are rejected for depending from claim 1 and failing to remedy the indefiniteness. Claim 1 will be interpreted hereinafter as encompassing a nucleic acid meeting the structural features recited in the claims, with the function of binding to a DKK1 protein (pg. 6-7).
Claim 1 recites the phrase “at least about,” which renders the scope of aptamers encompassed by the claim unclear. The skilled artisan would not know the aptamers which meet the claim scope, because, for example, an aptamer comprising a nucleotide sequence having 88% identity with any one of the recited SEQ ID NOs would have “about” 90% identity, but would not have “at least” 90% identity.
Claims 2-4 are rejected for depending from claim 1 and failing to remedy the indefiniteness. Claim 1 will be interpreted hereinafter as reciting “at least
Claims 3 and 4 recite the term “preferably,” which renders the claims indefinite because it is unclear whether the limitation(s) 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 2-4 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.
Claim 2 recites the phrase “wherein the aptamer comprises a sequence of any one of SEQ ID NOs: 1-64 and 87-105,” which is interpreted as any two or more contiguous nucleotides, and up to all contiguous nucleotides, of one of SEQ ID NOs: 1-64 and 87-105. The claim recites SEQ ID NOs which are not encompassed by claim 1, i.e., SEQ ID NOs: 21-44, which based on Table 6 (pg. 24-25) are distinct sequences from those recited in claim 1. A sequence alignment with SEQ ID NO: 5, from which SEQ ID NOs: 21-44 are derived, shows that at least SEQ ID NOs: 21-26 lack identity over the region of SEQ ID NO: 5 specified in Table 6, such that they are not merely truncated versions of the aptamer corresponding to SEQ ID NO: 5. The claim also requires only two consecutive nucleotides of one of SEQ ID NOs: 1-20, 45-64, and 87-105, whereas claim 1 recites “at least [] 90%.... identity” or “at least 10… contiguous nucleotides” of one of the recited SEQ ID NOs. Thus, claim 2 expands the scope of claim 1, such that it fails to further limit the subject matter of the claim upon which it depends and fails to include all the limitations of the claim upon which it depends.
Claim 4 is rejected for depending from claim 2 and failing to remedy the improper dependent form.
Claim 3 recites “wherein the aptamer comprises a nucleotide sequence shown in SEQ ID NO: 5, 20, 35-38, 49, or 64, preferably a nucleotide sequence shown in SEQ ID NO: 37.” The phrase “a nucleotide sequence shown in SEQ ID NO:…” is interpreted as any two or more contiguous nucleotides, and up to all contiguous nucleotides, of one of the recited SEQ ID NOs. SEQ ID NOs: 35-38, which are not encompassed by claim 1, are truncated versions of the aptamer corresponding to SEQ ID NO: 5. The claim requires only two consecutive nucleotides of one of SEQ ID NOs: 5, 20, 49, or 64, or SEQ ID NOs: 35-38, which are truncated versions of SEQ ID NO: 5, whereas claim 1 recites “at least [] 90%... identity” or “at least 10… contiguous nucleotides” of one of SEQ ID NOs: 5, 20, 49, or 64. Thus, claim 3 expands the scope of claim 1, such that it fails to further limit the subject matter of the claim upon which it depends and fails to include all the limitations of the claim upon which it depends.
Claim 4 is rejected for depending from claim 3 and failing to remedy the improper dependent form.
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 - Borer
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Borer (Borer et al., 22 August 2013, US 2013/0217582 A1).
Regarding claim 1, Borer teaches an aptamer corresponding to SEQ ID NO: 17 (“GGTTGGGGTGGTTGG,” Table 2, pg. 7), which as shown in the alignment in Appendix I comprises at least 10 contiguous nucleotides of SEQ ID NO: 5. Borer is silent as to whether the aptamer binds to a DKK1 protein. However, MPEP 2112.01(I) states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” The aptamer of Borer comprises the claimed structure (“at least 10… or more contiguous nucleotides within any one of SEQ ID NOs: 1-20”), and therefore, the claimed DKK1 binding function is presumed to be inherent thereto.
Regarding claim 2, as shown in the alignment in Appendix I, the aptamer comprises a sequence of (i.e., any two or more consecutive nucleotides of) SEQ ID NO: 5.
Regarding claim 3, as shown in the alignment in Appendix I, the aptamer comprises a nucleotide sequence shown in (i.e., any two or more consecutive nucleotides shown in) SEQ ID NO: 5.
Regarding claim 4, the phrase “Kd to DKK1” is interpreted as referring to the dissociation constant (a measure of binding affinity) between the aptamer and a DKK1 protein (pg. 9). The claim is directed to a function of the aptamer. Borer is silent as to whether the aptamer binds to a DKK1 protein, and therefore, is silent as to the dissociation constant between the aptamer and a DKK1 protein. However, as described above, because the aptamer of Borer comprises the claimed structure (“at least 10… or more contiguous nucleotides within any one of SEQ ID NOs: 1-20”), the claimed DKK1 binding functions are presumed to be inherent. See MPEP 2112.01(I).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA L PERSONS whose telephone number is (703)756-1334. The examiner can normally be reached M-F: 9-5pm.
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/JENNA L PERSONS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600
