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
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 September 2020, 8 December 2021, 20 April 2022, 3 September 2025, and 16 December 2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicants’ election with traverse of Group I (claims 74-83 and 85-88) in the reply filed on 16 December 2025 is acknowledged. The traversal is on the ground(s) that the Office Action has not shown that a serious burden would be required to examine all claims. This is not found persuasive because the application was filed as a national stage entry of PCT/US2019/025839. Thus the standard is not a serious search burden but instead a lack of special technical feature. As stated in the restriction, the technical feature of a core with crosslinked polymer shell conjugated to a fibrin moiety does not make a contribution over Brown et al.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application
3. The instant application is a national stage entry of PCT/US2019/025839 filed 4 April 2019. Claims 1-73 are cancelled. Claims 74-93 are currently pending. Claims 84 and 89-93 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 16 December 2025. Claims 74-83 and 85-88 are examined on the merits within.
Claim Rejections – 35 U.S.C. 102
4. 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.
5. Claim(s) 74-76 and 81 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (Nat Mater. 2014).
Regarding instant claims 74-76, Brown et al. disclose the creation of fully synthetic platelet-like particles that augment clotting in vitro. See abstract. Figure 1C shows a hollow platelet like particle made of deformable microgel and fibrin-photofibril binding nanobody bound the to the hollow core. The microgels are formed from ultra-low crosslinked poly(N-isopropylacrylamide-co-acrylic acid). See page 1108.
Regarding instant claim 81, Brown et al. teach sdFV or single chain antibodies with high affinity for fibrin used in assays and clone H6 coupled to the ultra-low crosslinked microgel. See Methods, page 1113.
Thus the instant claims are anticipated by Brown et al.
Claim Rejections – 35 U.S.C. 103
6. 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.
7. Claim(s) 74-82 and 85-88 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (Nat Mater. 2014) in view of Blackburn et al. (Bioconjug Chem, 2009).
Brown et al. teach the creation of fully synthetic platelet-like particles that augment clotting in vitro. See abstract. Figure 1C shows a hollow platelet like particle made of deformable microgel and fibrin-photofibril binding nanobody bound the to the hollow core. The microgels are formed from ultra-low crosslinked poly(N-isopropylacrylamide-co-acrylic acid). See page 1108. Brown et al. teach sdFV or single chain antibodies with high affinity for fibrin used in assays and clone H6 coupled to the ultra-low crosslinked microgel. See Methods, page 1113.
Brown et al. do not teach methacrylic acid, nanogels, or the claimed percentages.
Blackburn et al. teach core/shell hydrogel nanoparticles (nanogels) with surface localized peptides used for encapsulating siRNA and enabling cell specific delivery of oligonucleotides in serum containing medium. See abstract. The shell of the nanogel is made by reacting a monomer solution with molar ratios of 97.5% N-isopropylmethacrlyamide, 2% N,N’-methylenebis(acrylamide) (crosslinker), and 0.5% aminopropyl methacrylate. The core was synthesized with 98% N-isopropylmethacrlyamide and 2% N,N’-methylenebis(acrylamide) (crosslinker). See page 3.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one monomer for another to yield predictable results because Blackburn et al. teach the effectiveness of methacrylic acid monomers in combination with N-isopropylmethacrlyamide to form nanogels for delivery of therapeutic agents. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the amounts of each monomer and crosslinker, including modifying the density of each layer, to formulate a nanogel with the desired properties to achieve the desired effect. It would have been obvious to form the platelet like particle as a nanogel because Blackburn et al. teach cell specific delivery of therapeutics using core shell nanogel technology.
8. Claim(s) 74-76 and 81-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (Nat Mater. 2014) in view of Ingber et al. (U.S. Patent Application Publication No. 2013/0295012).
Brown et al. teach the creation of fully synthetic platelet-like particles that augment clotting in vitro. See abstract. Figure 1C shows a hollow platelet like particle made of deformable microgel and fibrin-photofibril binding nanobody bound the to the hollow core. The microgels are formed from ultra-low crosslinked poly(N-isopropylacrylamide-co-acrylic acid). See page 1108. Brown et al. teach sdFV or single chain antibodies with high affinity for fibrin used in assays and cloned H6 couple to the ultra-low crosslinked microgel. See Methods, page 1113.
Brown et al. do not teach tissue plasminogen activator.
Ingber et al. teach compositions for treating stenosis, stenotic lesions, occluded lumens, embolic phenoma or thrombotic disorders. See abstract. Figure 5 shows tPA coated platelet mimetics. See paragraph [0017]. tPA is tissue plasminogen activator.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one therapeutic agent for another to yield predictable results because Ingber et al. teach the effective delivery of tissue plasminogen activators by coating the agent on platelet mimetics.
Conclusion
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615