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 .
Claims 1 and 6-13 are pending and currently under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Election/Restrictions
Applicant's election of species with traverse of (A) SEQ ID NO: 49, in which R is G, S is G, K is U, and Vis G, and (B) an aptamer consisting of the nucleotide sequence of SEQ ID NO: 31 with one nucleotide substitution, wherein the 17th nucleotide A is replaced with G in the reply filed on 05/15/2026 is acknowledged. The traversal is on the ground(s) that species of nucleotide sequences defined by claim 1 are united by a single or corresponding inventive concept, because the species of nucleotide sequences share a special technical feature, namely the nucleotide sequences provide the aptamer with TGF-B1 binding activity. Similarly, the species of nucleotide sequences recited in claim 7 are united by the same single or corresponding inventive concept inasmuch as the species of nucleotide sequences share the special technical feature of providing the aptamer with TGF-β1 binding activity. Further the traversal argues that the Office would not encounter a serious burden in searching and examining the full scope of the pending claims at the present time.
Applicants were required to elect (1) for claim 1, a single sequence from among SEQ ID NOs: 34 and 49-52 with specific variants and (2) for claim 7, a single aptamer sequence from among SEQ ID NOs: 4 - 6, 9, 11, 13, 17 - 22, 26 - 29 or 31 or one of the recited sequences with specific substitutions, deletions or additions.
Upon further consideration, the species election requirement for claims 1 and 7 is withdrawn in view of the amendments.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application 17/625,308 filed on 01/06/2022 is a 371 national phase of PCT/ JP2020/026755 filed on 07/08/2020, and claims the benefit of Japanese Application No. 2019-126940, filed on 07/08/2019.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. It is noted that foreign priority is not perfected as no English translation was provided for the foreign priority document received on 01/26/2022. In order to perfect the foreign priority claim, please provide a certified English copy.
In the absence of a translated copy, the priority date of claim 1 and its dependents is determined to be 07/08/2020, the filing date of the national phase PCT/ JP2020/026755 application.
Response to Remarks filed 01/16/2026
The amendments and arguments presented in the papers filed 01/16/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 10/17/2025 listed below have been reconsidered as indicated.
Deficiencies in the sequence disclosure cited in the Office Action dated 10/17/2025 have been remedied and those objections are withdrawn in view of the replacement Sequence Listing and amendments to the specification.
The objection to claim 1 is withdrawn in view of amendments to the claim.
The 35 USC 112(b) indefiniteness rejections of claims 1, 6 and 8-12 have been withdrawn in view of the amendments to claims.
e) The rejection of claims 1-13 under 35 103 over Gold et al. (US6124449, on IDS dated 04/07/2022) is withdrawn in view of the amendments to the claims.
New and modified grounds of rejection necessitated by amendment are detailed below.
Nucleotide and/or Amino Acid Sequence Disclosures - New
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:
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).
Paragraph 118 of the specification recites “common sequence 1: UAAXGGRBGGSGARACUUGKGVBRGG” without a SEQ ID NO.
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.
Claim Objections
Claim 1 is objected to because of the following issues: The claim recites "comprising (a) a contiguous nucleotide sequence consisting of the following formula (III-1) or (111-2) ---; (b) a contiguous nucleotide sequence consisting of the following formula (III'-1) or (III'-2)---; or "a contiguous nucleotide sequence consisting of the following formula (III")---". It is suggested to amend the claim to recite ”comprising (a) the full length nucleotide sequence consisting of the following formula (III-1) or (111-2) ---; (b) the full length nucleotide sequence consisting of the following formula (III'-1) or (III'-2)---; or the full length nucleotide sequence consisting of the following formula (III")---" for clarity.
Claim 7 is objected to because of the following informalities: Claim 7 recites “The aptamer according to claim 1”. It is suggested to amend the claim to recite “The aptamer of claim 1” for clarity. As written, it is not clear whether claim 1 requires all of the requirements of claim 1.
Claim Interpretation
Claim 1 requires that the aptamer binds to TGF-β1 but provides no structural limitations beyond those in the claim. The binding of TGF-β1 is interpreted as inherent to the aptamer of claim 1.
Claim 8 recites “a nucleotide length of not more than 55” but does not specify what nucleotide sequence is limited, or if the overall length is intended to be limited. The claim is broadly interpreted as any consecutive nucleotide length of less than 55.
Claim 9 requires that the aptamer inhibits binding between TGF-β1 and a TGF-β1 receptor, but provides no structural limitations beyond those in independent claim 1, which the claim depends from. The inhibition of binding between TGF-β1 and a TGF-β1 receptor is interpreted as inherent to the aptamer of claim 1, which claim 9 depends from.
Claim 13 requires that the aptamer inhibits binding between TGF-β1 and a TGF-β1 receptor, but provides no structural limitations beyond those in independent claim 1, and claim 7, which the claim depends from. The inhibition of binding between TGF-β1 and a TGF-β1 receptor is interpreted as inherent to the aptamer of claims 1 and 7, which claim 13 depends from.
Claim Rejections - 35 USC § 112(a)
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 7 and 13 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.
Claim 7 is drawn to an aptamer according to claim 1, comprising (a) the nucleotide sequence of SEQ ID NO:4-6, 9, 11, 13, 17-22, 26-29, 31, or (b) the nucleotide sequence of the above-mentioned (a), wherein one to five nucleotides are substituted, deleted, or added. The claim reads on a massive genus of sequences.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
As written, part (a) of the claim encompasses a genus of aptamers that includes aptamers of claim 1 ligated to or otherwise combined with the nucleotide sequences of claim 7 at (a). Such aptamers would meet the requirements of claim 1 of an aptamer 25 to 200 nucleotides in length that comprise a contiguous nucleotide sequence selected from parts (a), (b), and/or (c).
The specification (para 118) recites “common sequence 1: UAAXGGRBGGSGARACUUGKGVBRGG” is reported to be present in SEQ ID NOs: 4, 6, 9, and 21 (para 117), and SEQ ID NOs: 29 and 31 (example 5) and further states that an aptamer having the common sequence “was considered to be an aptamer that specifically and remarkably strongly binds to TGF-β1 (para 120). Common sequence 1 is not provided a SEQ ID NO. in the specification but is equivalent to Formula (III'-1) (SEQ ID NO. 51) or (III' -2) (SEQ ID NO. 52) of claim 1 part (b). Alignment between SEQ ID NO: 4 and SEQ ID NOs: 51 and 52, showing the presence of common sequence 1 is shown below as an example:
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122
532
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The specification is silent regarding the presence of common sequence 1 in SEQ ID NOs: 5, 11, 13, 17-19, and 26-28. However as shown below SEQ ID NO: 5 does not include the entirety of common sequence 1:
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85
534
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Greyscale
The common sequence is not disclosed to be present in all the claimed sequences of claim 7 part (a). Nor does the specification disclose aptamers encompassed by part (a) of the claim comprising an aptamer of claim 1 parts (a), (b), or (c) in addition to an aptamer with all of the claimed sequences of claim 7 part (a). It is also noted that common sequence 1 is found in part (b) of claim 1, and not the alternative of part (a) or part (c).
Thus, there is a lack of guidance or support in the claims and/or specification as to what features of claimed nucleotide sequences must be present to bind to TGF-β1, or which features would prevent binding to TGF-β1. No guidance is provided regarding what changes can be made and still have the intended function of binding TGF-β1. Further, Tables 1 and 2 (left column in each) indicates that not all of the claimed SEQ NOs of claim 7 part (a) were tested for binding specifically to TGF-β1.
Regarding claim 7 part (a), the specification does not provide sufficient written description for all of the encompassed nucleotide sequences, there is a lack of guidance or support in the claims or specification as to what general features of aptamer must be present to provide function. The specification does not provide specific guidance for determining what the structure of claimed aptamer species should be that will work as expected. The specification only describes a subset of the claimed aptamers that were screened for binding to TGF-β1 and include a common sequence. The claims cover all possible nucleotide sequences of SEQ ID NOs: 4 - 6, 9, 11, 13, 17 - 22, 26 - 29 or 31 alone or in combination with the possible nucleotides sequences of SEQ ID NOs:49-52 and 34 of claim 1, and the specification lacks written description for this complete genus.
Alternately, claim 7 part (b) recites the aptamer comprises “the nucleotide sequence of the above-mentioned (a), wherein one to five nucleotides are substituted, deleted, or added”, which greatly expands the pool of potential sequences. Part (b) encompasses a massive genus of species with undetermined structure-function dependence.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The specification does place limits on the location of substituted, deleted, or added nucleotides or demonstrate the function of the large genus of claimed aptamers. The specification does not provide guidance for location of substituted, deleted, or added nucleotides that enable aptamers to function in binding to TGF-β1 in such a way as to preserve any secondary structure or other structure required for binding. The specification states that the inventors “investigated diligently to solve the problem described above and succeeded in producing aptamers that specifically bind to TGF-β1, (para 10). This indicates that not all possible sequences are capable of binding to TGF-β1. Thus, applicant could not have been in possession of the genus of aptamers of claim 7 that comprises any nucleotide sequence of one to five substitutions, deletions, or additions to SEQ ID NOs: 4-6, 9, 11, 13, 17-22, 26-29 or 31 with the ability to bind to TGF-β1. Further, Applicant does not provide sufficient guidance (structure or other properties) for selecting from among all possible sequences of claim 7 for the ability to bind TGF-β1.
The limited disclosure of the specification in view of the vast genus of molecules encompassed by part (b) of the claim does not adequately describe the entire genus of molecules encompassed by the claim. Thus Applicant was not in possession of genus of aptamers of claim 7 (b) with substitution, deletion or insertion of several nucleotides at the time the invention was made.
Claim 7 encompasses all possible sequences of (a) or (b), a massive genus. The specification discloses only specific species of sequences that possess the ability to bind to TGF-β1. One of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of aptamers of claim 7.
Regarding claim 13, the claim further requires that the aptamer inhibits binding between TGF-β1 and a TGF-β1 receptor. Applicant additionally fails to disclose structure or other properties that would indicate possession of the claimed genus of aptamers that inhibits binding between TGF-β1 and a TGF-β1 receptor.
Claim 13 depends from claim 7 and encompasses the massive genus of aptamers described above with the additional functional requirement that the aptamers inhibit binding between TGF-β1 and a TGF-β1 receptor.
The specification (Tables 1 and 2, middle column) reports inhibition of binding between TGF-β1 and a TGF-β1 receptor only for SEQ ID NOs: 6, 9, 19,21, 26 (Table 1) and SEQ ID NOs: 21, 29, and 31 (Table 2).
There is a lack of guidance/support in the claims and/or specification as to what features of claimed nucleotide sequences must be present to inhibits binding between TGF-β1 and a TGF-β1 receptor. The specification does not provide specific guidance or description of structures required to achieve the claimed function of inhibiting binding between TGF-β1 and a TGF-β1 receptor. The limited disclosure of examples meeting the functional requirement within the specification in view of the vast genus of molecules encompassed by claims 1 and 7, which claim 13 depends from, does not adequately describe the entire genus of molecules encompassed by the claim. Thus Applicant was not in possession of genus of aptamers of claim 13 with the ability to inhibit binding between TGF-β1 and a TGF-β1 receptor at the time the invention was made. The specification discloses only specific species of sequences that possess the ability to inhibit binding between TGF-β1 and a TGF-β1 receptor. One of skill at the time of the invention could not have concluded that Applicant was in possession of the genus of aptamers of claim 13.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 11 is directed to “a medicament comprising the aptamer according to claim 1”. The claim encompasses a pharmaceutical composition or medication with therapeutic function. The specification does not reasonably provide enablement for a medicament comprising the aptamer of claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The Court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation'." (Wands, 8 USPQ2d 1404). There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention/Breadth of the claims.
As explained in the written description rejection above, the claims encompass a large genus of aptamers that are claimed to bind TGF-β1.
State of the prior art/Predictability of the art.
Zhou et al. (Aptamers as targeted therapeutics: current potential and challenges. Nat Rev Drug Discov. 2017 Mar;16(3):181-202) teaches that “the in vivo therapeutic potency of aptamers is critically limited by their inherent physicochemical characteristics. These characteristics can affect pharmacokinetic properties such as metabolic instability, rapid renal filtration, rapid distribution from the plasma compartment into the tissues (e.g. liver, spleen), non-specific immune activation, and polyanionic effects” (p. 6).
Zhou further teaches that “since the affinity/specificity and function of an aptamer is sensitive to its structure, post-SELEX modification may affect the inherent properties and folding structures of the original aptamers, thereby compromising the binding affinity. … Unfortunately, universal rules are not available for all the aptamers, and laborious evaluation/optimization is often needed” (p. 7).
Therefore, there is no evidence to suggest that an aptamer is naturally a medicament and thus capable of therapeutic function without an undue level of experimentation to determine how to modify the aptamer.
Working examples/Guidance in the specification
No working example is disclosed in the specification in which a claimed aptamer functions as a medicament or therapeutic. The specification provides no guidance towards using a claimed aptamer as a medicament or therapeutic.
Amount of experimentation necessary
Since there is not sufficient guidance provided by the inventors of a medicament comprising the aptamer of claim 1, an undue amount of experimentation would have been necessary for one skilled in the art to practice the entire scope of the claims.
Zhou teaches chemical modifications and conjugations can improve the pharmacokinetic properties of aptamer-based therapeutics (p. 6), but that laborious evaluation/optimization is often needed in order to develop aptamer-based therapeutics (i.e. medicaments) (p. 7). Zhou specifically teaches challenges include nuclease degradation, renal filtration, toxicity as well as the ability to maintain aptamer structure and binding affinity (p. 6-8)
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
Since there is not sufficient guidance provided by the inventors of a medicament comprising aptamers, an undue amount of experimentation would have been necessary for one skilled in the art to practice the entire scope of the claims
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 and 6-13 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 the limitation “wherein R, S, K, and V are selected in a combination that forms four sets of 2 to 5 consecutive G bases” in parts (a) and (b). The phrase forms does not clearly set forth the metes and bounds and is therefore indefinite. In the context of an aptamer it is unclear if the phrase forms is intended to require secondary structure (e.g. a hairpin or stemloop required to form the aptamer) or instead is intended to limit the requirement to only the nucleotide sequence.
Claims 6-13 are similarly indefinite because they directly or indirectly depend from claim 1.
Regarding claim 7, it is unclear which aptamer sequence or combination of sequences selected from a), b), or c) in claim 1 is required. It is unclear if claim 7 requires all of the limitations of claim 1 or how the sequences of claim 7 related to the sequences of claim 1- if they are required to be alternatives to the options of claim 1 or required to be part of the selected formula of claim 1 in combination as individual sequences or combined into a single sequence. Claim 1 is subject to multiple interpretations and does not clearly set forth the metes and bounds of the patent protection desired and is thus indefinite.
Claim 7 part (b) recites the limitation “the nucleotide sequence of the above-mentioned (a), wherein one to five nucleotides are substituted, deleted, or added”. It is unclear if the substituted, deleted or added nucleotides are limited in position within the nucleotide sequences of (a) or any of the aptamers of claim 1, or can be added anywhere in the sequences, including any sequence necessary for the intended use of binding to TGF-β1.
Claim 10 is indefinite in its recitation of “a functional substance”. It is unclear what are the metes and bounds of this term. It is unclear what limits a functional substance, what structure is required, how function would be determined, or any binding requirements.
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.
Claim 7 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.
In part (b) claim 7 recites the limitation “the nucleotide sequence of the above-mentioned (a), wherein one to five nucleotides are substituted, deleted, or added”. Claim 1, which claim 7 depends from, recites the limitation “An aptamer that binds to TGF- β1, which aptamer is 25 to 200 nucleotides in length and comprises (a) a contiguous nucleotide sequence consisting of the following formula (III-1) or (III-2) --- wherein R, S, K, and V are selected in a combination that forms four sets of 2 to 5 consecutive G bases, wherein each set of consecutive G bases is separated by at least one non-G base, (b) a contiguous nucleotide sequence consisting of the following formula (III'-1) or (III'-2) --- wherein R, S, K, and V are selected in a combination that forms four sets of 2 to 5 consecutive G bases, wherein each set of consecutive G bases is separated by at least one non-G base, or (c) a contiguous nucleotide sequence consisting of the following formula (III") ----.”
No specific positions are required for the substituted, deleted, or added nucleotides of claim 7. Positions could be substituted, deleted, or added anywhere within the claimed nucleotide sequences, deleted from or added to the ends, or be added or deleted between the SEQ ID NOs alternates of claim 1 ligated to the SEQ ID NOs of claim 7. Thus claim 7 fails to further limit claim 1.
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.
Conclusion
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682