DETAILED ACTION
Status of Claims
Claims 1-41 are currently pending. Claims 1-33 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 34-41 are withdrawn from consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-33) in the response filed on July 10, 2026 (to the May 12, 2026 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claims 34-41) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I without traverse.
Accordingly, the May 12, 2026 Requirement for Restriction is made FINAL, and claims 1-33 are examined as follows.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claim 29 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 pre-AIA , that applicant regards as the invention.
Claim 29 is drawn to:
29. The hydrogel composition of claim 1, wherein the nanoparticle comprises β-cyclodextrin succinate crosslinked with lysine, optionally wherein the β-cyclodextrin succinate and lysine have a ratio of about 1:1
which is indefinite because it is unclear as to whether the required ratio is “β-cyclodextrin succinate” to “lysine” or vice versa, thereby rendering the metes and bounds of the claim unclear. In this regard, it is noted that the Board has held: “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (expanded panel). To the extent applicant intends the former, the claim should be amended to read:
29. The hydrogel composition of claim 1, wherein the nanoparticle comprises β-cyclodextrin succinate crosslinked with lysine, optionally wherein the ratio of β-cyclodextrin succinate tois
Further clarification is required.
Allowable Subject Matter
Claims 1-33 are allowable pending address of the objects and issues under 35 U.S.C. § 112(b), discussed above. In this respect it is noted that:
Rodell, C.B., et al., Supramolecular Guest−Host Interactions for the Preparation of Biomedical Materials, Bioconjug. Chem. 26 (2015) pp. 2279-2289 (on 08/26/2024 IDS);
Rodell, C.B., et al., TLR7/8-agonist-loaded nanoparticles promote the polarization of tumour-associated macrophages to enhance cancer immunotherapy, Nat. Biomed. Eng. 2 (November 21, 2018) pp 578-588;
He, M., et al., Cyclodextrin/chitosan nanoparticles for oral ovalbumin delivery: Preparation, characterization and intestinal mucosal immunity in mice, Asian J. Pharm. Sci. 14 (2019) pp. 193-203; and
Soni, S.S., et al., Applications of Macrocyclic Host Molecules in Immune Modulation and Therapeutic Delivery, Front. Chem. 9 (Apr. 06, 2021) pp. 1-10 (on 08/26/2024 IDS);
are references of interest. Claim 34 can be rejoined by amending to remove “preventing,” which would otherwise be rejected under 35 U.S.C. § 112(a) as not being enabling.
Conclusion
Claim 29 is rejected. Claims 1-28 and 30-33 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
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