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 .
DETAILED ACTION
Application Status
This application is a Non-Provisional US patent Application, filed on02/03/2023.
Claims 1-12 are currently pending in the instant patent application.
The claims set filed on 06/21/2023 without any claims amendment is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, Claims 1-8, drawn to a method for preparing a polymeric DNA network with controlled crystallinity in the response filed on 12/23/2025 is acknowledged.
Claims 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application Republic of Korea 10-2022-0013991, filed on 02/03/2022 without English translation.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner. The signed copy of 1449 is enclosed herewith.
Drawings objections
Drawings submitted on 06/21/2023 are accepted by the Examiner.
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Specification objections
The disclosure is objected to because of the following informalities:
2422.01-.04 The Requirement for Exclusive Conformance; Sequences Presented
in Specification, and Drawing Figures 37 CFR 1.821(b) requires….Any sequence more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawings the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, page 23 of the Specification). Appropriate correction is required.
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.
A. Written Description
Claims 1-8 are rejected under 35 U.S.C. 112(a), as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is interpreted under Broadest Reasonable Interpretation (BRI), and claim 1 is directed to encompass: a method for preparing a polymeric DNA network with controlled crystallinity, the method comprising: hybridizing a first single-stranded circular DNA comprising a stimulus- sensitive moiety and a first hybridization site and a second single-stranded circular DNA comprising a target-attachment moiety and a second hybridization site; and synthesizing a polymeric DNA network through rolling circle amplification (RCA) in a reaction solution comprising the hybridized circular DNA, DNA polymerase, magnesium chloride (MgCl2) and dithiothreitol (DTT), wherein the crystallinity of MgPPi crystals in the polymeric DNA network is controlled by controlling the molar (M) ratio of DTT to magnesium chloride (MgCl2) from 0.1 to 50. Claims 4 and 6 are also lacking WD requirement because of the recitation “a base sequence of SEQ ID NO: 1 and 2”, which is interpreted as any fragments of SEQ ID NO: 1 and 2.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that 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.
Claim 1 directed to a method for preparing a polymeric DNA network with controlled crystallinity, the method comprising: hybridizing any first single-stranded circular DNA having no structural feature comprising a stimulus-sensitive moiety and a first hybridization site and any second single-stranded circular DNA having no structural feature, comprising a target-attachment moiety and a second hybridization site; and synthesizing a polymeric DNA network through rolling circle amplification (RCA) in a reaction solution comprising the hybridized circular DNA, DNA polymerase, magnesium chloride (MgCl2) and dithiothreitol (DTT), wherein the crystallinity of MgPPi crystals in the polymeric DNA network is controlled by controlling the molar (M) ratio of DTT to magnesium chloride (MgCl2) from 0.1 to 50, i.e. No Structure-Function Correlation for first and second circular DNA, which are disclosed in claims 4 and 6 reciting SEQ ID NO: 1 and 2, which is required for fulfilling the Written Description requirement. However, Claims 4 and 6 are also included in this rejection because of the recitation “a base sequence” which interprets as fragments of DNA comprising any size of the DNA fragments, having no structural feature under BRI.
As discussed in the written description guidelines the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by 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 claimed 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.
Thus, Claims are drawn to a method for preparing a polymeric DNA network with controlled crystallinity, the method comprising: hybridizing any first single-stranded circular DNA having no structural feature comprising a stimulus-sensitive moiety and a first hybridization site and any second single-stranded circular DNA having no structural feature, comprising a target-attachment moiety and a second hybridization site; and synthesizing a polymeric DNA network through rolling circle amplification (RCA) in a reaction solution comprising the hybridized circular DNA, DNA polymerase, magnesium chloride (MgCl2) and dithiothreitol (DTT), wherein the crystallinity of MgPPi crystals in the polymeric DNA network is controlled by controlling the molar (M) ratio of DTT to magnesium chloride (MgCl2) from 0.1 to 50, i.e. No Structure-Function Correlation for first and second circular DNA, which is required for fulfilling the Written Description requirement. However, Claims 4 and 6 are also included in this rejection because of the recitation “a base sequence” interprets as fragments of DNA comprising any size of the DNA fragments, having no structural feature, and thus, whose structures are not fully described in the specification. No information, beyond the characterization of few circular DNAs including SEQ ID NO: 1 and 2 recited in claim 4 and 6 has been provided, which would indicate that applicants had possession of the claimed genus.
As stated, no information, beyond the characterization of few circular DNAs including SEQ ID NO: 1 and 2, has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the circular DNAs within the scope of the claimed genus. The genus of polynucleotides encompasses many mutants, variants and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated circular DNAs are encompassed within the scope of these claims. The specification teaches the structure of only few representative species of such circular DNAs. Moreover, the specification fails to describe any other representative species by any identifying characteristics or properties other than the functionality of making polymeric DNA. Given this lack of description of representative species encompassed by the genus of circular DNAs of the claim, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
The Relevant Prior Art References
i) WANG, H., et al., "Construction of Smart Stimuli-Responsive DNA Nanostructures for Biomedical Applications," Chem Eur J. 27:3929-3943, Wiley, United States, (February 2021), see IDS; ii) YAO, C., et al., "Rolling circle amplification (RCA)-based DNA Hydrogel," Nature Protocols 16:5460-5483, Springer, Germany (December 2021); and iii) YUAN, X., et al., "High-Yield Method To Fabricate and Functionalize DNA Nanoparticles from the Products of Rolling Circle Amplification," ACS Appl Biol Mater. 1:511-519, American Chemical Society, United States (August 2018).
Conclusion
Status of the claims:
Claims 1-8 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F from 9:00 AM-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, PhD.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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