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 .
Priority
The present application is a 371 National Stage Entry of PCT/US2021/049833 (filed on 09/10/2021), which claims benefit of U.S. provisional application 63/077,229 (filed on 09/11/2020).
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 03/06/2023 and 07/20/2023 are in compliance with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
The listing of references in p. 40 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Status
Claims 1, 3-19, and 35-36 are currently pending and have been examined on their merits.
Claim Objections
Claim 5 is objected to because the article “a” should be inserted before “growth factor receptor” in order to maintain consistency with the language used when introducing the other types of receptors.
Claim 10 is objected to because the phrase “the collagen” should be amended to read “the collagen fibers” to maintain consistency with the language of claim 1. Although claim 1 recites a “collagen material” and “collagen fibers”, a rejection under 35 U.S.C. § 112(b) has not been made because it is readily apparent that this claim limits the type of “fiber” used in the collagen material.
Claim 16 is objected to because the conjunction “and” should be added between the steps of this claim (i.e., after the semicolon in line 2).
Claim 18 is objected to because the unit “mV/mm” should be added after “about 0” to maintain consistency with the use of units elsewhere in the claims.
Appropriate correction is required.
Drawings
The drawings are objected to for the following reasons:
Figures 5A-5B, 6, 7, 19A-19C, 20A-20B, and 21-23 contain text which is too small to be legible when reproduced. Rule 1.84 requires numbers, letters, and reference characters to be at least .32 cm (1/8 inches) in height (37 CFR 1.84(p)(3))
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.
Nucleotide and/or Amino Acid Sequence Disclosures
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/patents-application- process/filing-online/legal-framework-efs-web), 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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item (1)(a)(iii) above. Specifically, the incorporation by reference
paragraph recites the size of the sequence listing in kilobytes. Compliant sequence listing file sizes must be presented in bytes, rather than kilobytes.
Required response - Amendment of the Sequence Listing paragraph of the specification to recite the size of the sequence listing file in bytes.
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.
Claims 3, 5, 7-8, 14-15, 17-18, and 36 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 is indefinite because it limits “at least one of the one or more DNA aptamers” and there is insufficient antecedent basis for this claim. The claim from which this claim depends recites “a plurality of DNA aptamers”. As such, the independent claim requires more than one DNA aptamer (i.e., a plurality) and it is therefore unclear what applicant seeks to limit because the claim refers to “one or more DNA aptamers” (a term encompassing a single aptamer or a plurality of aptamers).
In the interest of compact prosecution, it is interpreted that this claim limits the “plurality of DNA aptamers” because this appears to be an erroneous recitation. This interpretation is consistent with the amendments to claims 4 and 6 wherein applicant changes “at least one of the one or more DNA aptamers” to “at least one of the plurality of DNA aptamers”.
Claim 5 is indefinite because it limits “the cell surface receptor” and there is insufficient antecedent basis for the term. Claim 4 recites “a cell receptor” but does not recite a “cell surface receptor”. Because not all cell receptors are cell surface receptors (e.g., intracellular receptors), it is not clear what receptor applicant intends to limit.
In the interest of compact prosecution, it is interpreted that this claim requires the cell receptor to be a cell surface receptor and then further limits the cell surface receptor to a “signaling receptor, a stem cell receptor or [a] growth factor receptor”.
Claims 7-8 are indefinite because there are two reasonable interpretations for these claims. These claims limit the length of the DNA aptamers (15 to 100 nucleotides) and the number of stem loops (1 to 5), respectively.
The first reasonable interpretation for these limitations is that the limitations describe the total nucleotide length and number of stem loops (ex: the sum of the nucleotides in the “plurality of DNA aptamers” is 15 to 100).
The second reasonable interpretation for these limitations is that the limitations describe the individual nucleotide length and number of stem loops (ex: each DNA aptamer has a length of 15 to 100 nucleotides).
In the interest of compact prosecution, the broader (i.e., latter) interpretation has been adopted. If applicant intends to limit to the first interpretation, it is recommended that the phrase “the DNA aptamers” be changed to “the plurality of DNA aptamers” (similar to the language of claim 9). If applicant intends to limit to the second interpretation, it is recommended that the phrase “the DNA aptamers” be amended to read “each of the DNA aptamers in the plurality of DNA aptamers”.
Claims 14-15, 17-18, and 36 are indefinite because they recite approximations which are not clearly defined. In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application (MPEP § 2173.05(b)(III)(A)). Applicant’s specification has been fully considered but does not sufficiently establish the metes and bounds of these claims. Claim 14 limits the length of the electrospun fibers to “about 1 µm to about 100 µm”. The specification does not provide any guidance as to what applicant considers to be encompassed by this range. For example, does applicant consider 0.5 µm to be “about 1 µm”? Or is there some other definite beginning and end to the claimed range such that a person having ordinary skill in the art would be apprised of the metes and bounds of the claim? Because the answer is not clear for each of the above claims, a rejection under 35 U.S.C. § 112(b) is required.
Pertinent Prior Art
The closest prior art is Farokhzad et al. (WO 2008/105773 A2; cited in IDS filed on 03/06/2023). Farokhzad teaches drug delivery systems for targeted delivery of therapeutic agent-containing particles to tissues, cells, and intracellular compartments (abstract). Specifically, Farokhzad teaches targeted particles which may comprise a matrix of polymers ([0085]) such as collagen ([0097])(i.e., a collagen material) and a targeting moiety which can be covalently associated with the surface of the polymeric matrix ([0085]). Farokhzad teaches that the targeting moiety can be inter alia a nucleic acid targeting moiety (e.g., an aptamer)([00129]-[[00131]). As such, Farokhzad teaches compositions comprising a collagen material, wherein the collagen material comprises collagen fibers crosslinked with a plurality of DNA aptamers. Farokhzad further teaches that the composition may further comprise magnetic particles which may contain a magnetic material and one or more nonmagnetic materials ([00303]-[00305]) and in certain embodiments the particle is a composite particle comprising an inner core or layer containing a first material and an outer layer or shell containing a second material, wherein at least one of the materials is magnetic ([00304]).
James et al. (ACS Biomaterials Science and Engineering, 2020, Vol. 6, pages 213-218; cited in IDS filed on 07/20/2023; hereinafter James) teaches that DNA and proteins interact with each other to modify their respective functions (p. 213, left col., par. 1). James discloses that short (<100 nucleotide) monodisperse ssDNA oligomers complex with type I collagen to form self-assembled fibers (p. 213, right col., par. 2) and because these fibers are rapidly synthesized, they can be used to form fibrous structures resembling extracellular matrix (ECM)(p. 214, left col., par. 1). James concludes that these self-assembled fibers show “great promise” as a strategy to fabricate advanced biomimetic extracellular matrices containing intercalated bioactive DNA aptamers (p. 216, left col., par. 1).
However, although the prior art contemplates the use of magnetic particles in association with collagen materials and DNA aptamers, there is no motivation provided in Farokhzad (or the prior art as a whole) which would have motivated a person having ordinary skill in the art to combine a magnetoelectric composite material with a collagen material, wherein the collagen material comprises collagen fibers crosslinked with DNA aptamers (such as by replacing Farokhzad’s magnetic material with a magnetoelectric composite).
For at least these reasons, applicant’s claims are free of the art.
Conclusion
Claims 1, 4, 6, 9, 11-13, 19, and 35 are allowable.
Claims 10 and 16 are allowable but are objected to for minor informalities.
Claims 3, 5, 7-8, 14-15, 17-18, and 36 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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