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 .
Claim Status
Applicant's election with traverse of claims 1 – 7 and 11 – 18 in the reply filed on 08/03/2026 is acknowledged. The traversal is on the ground(s) that there would not have been a serious burden on the Examiner to search groups I – III together. This is not found persuasive because the process as claimed can be used to make a different organoid (inflamed or not) such as a liver, kidney, or intestinal organoid.
The requirement is still deemed proper and is therefore made FINAL.
Claims 55 – 56 and 60 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/03/2026.
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.
1) 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:
a) 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:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
b) 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:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
a) In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
b) In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
1) 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.
a) 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.
b) 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/claims 7 and 11 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification/claims in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
Amended claims containing the required sequence identifiers
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 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.
Claim 17 is 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.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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, 3 – 5, 13, 15 and 17 – 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Modeling early stage atherosclerosis in a primary human vascular microphysiological system).
Regarding claims 1, 3 – 5 and 13, Zhang discloses a study related to modeling early stage atherosclerosis in a primary human vascular microphysical system, in which tissue-engineered blood vessels (TEBVs) are created with three layers of primary endothelial cells (p. 11, Methods, Cells isolation…’from umbilical cord’; Human Coronary Artery), smooth muscle cells, and fibroblasts (Fig. 1g). Zhang further discloses collagen-gelled layers for the cells (p. 13, Fabrication, endothelialization, and perfusion…).
Regarding claims 15 and 17 – 18, Zhang discloses that through the perfusion of enzyme-modified LDL, TNFα, and monocytes in the system (Fig. 6; p. 11, col. 2, para. 1 ‘dysfunction’) they were able to develop a model of early stage atherosclerosis in vitro, which also led to an increase in IL-1β gene expression (Fig. 5 c) in the TEBVs. Zhang further discloses macrophage foam cells in the TEBVs (Fig. 6, j – l).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang.
Regarding claim 2, Zhang teaches all of the elements of the current invention as stated above except additional layers of SMCs between the three layers.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional layers of SMCs. Doing so would reinforce the vascular tissue architecture of the nanomatrix, which is important for supporting cell-matrix interactions and enabling physiological-like behavior (contractile vs synthetic phenotype).
Regarding claim 14, Zhang discloses the use of primary normal human dermal fibroblasts (p. 11, Methods, Cells isolation…).
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute in primary cardiac fibroblasts for studying cardiovascular diseases.
Regarding claim 16, Zhang discloses that through the perfusion of enzyme-modified LDL, TNFα, and monocytes in the system (Fig. 6; p. 11, col. 2, para. 1 ‘dysfunction’) they were able to develop a model of early stage atherosclerosis in vitro, which also led to an increase in IL-1β gene expression (Fig. 5 c) in the TEBVs.
Claims 6 – 7, 11 – 12, and 15 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Jun et al. (U.S. Patent Application Publication No. 20150037293 A1; hereinafter Jun).
Regarding claims 6 – 7 and 11 – 12, Zhang teaches all of the elements of the current invention as stated above except the nanomatrix comprising a peptide amphiphile (PA). However, Jun discloses an invention related to technologies for pancreatic islet transplantation, in which biocompatible nanomatrices composed of peptide amphiphiles (para. [0197] including cell adhesion ligands: PA-RGDS, PA-YIGSR; Fig. 5A Peptide schematic) are provided for the embedding of cell populations for their implantation. The enzyme-mediated degradable site specific for MMP-2, SEQ ID NO: 1 (GTAGLIGQ) of the instant application is 100% identity match to SEQ ID NO: 2 of Jun (ABSS SEARCH Results in DAV; 08/24/2026 file-Published_Applications_AA_Main-Result No. 1-US-14-383-406). Also, Jun discloses a PA self-assembled nanomatrix gel formed as a sphere-shaped hydrogel (para. [0173]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the (sphere-shaped hydrogel) peptide amphiphiles (cell adhesion ligands + degradable site) of Jun with the TEBVs of Zhang in order to generate an atherosclerotic nanomatrix vascular sheet in vitro that has improved capability of adhering to cell populations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
