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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 5, 2026, that includes a response to the Final Office Action mailed October 6, 2025, has been entered. Claims 1, 5, 7, 8, 11, and 41 have been amended; and claims 2-4, 6, 9, 10, 12-16, and 19-39 have been canceled. Claim 40 has been withdrawn. Claims 1, 5, 7, 8, 11, 17, 18, and 41 are currently under examination.
Withdrawal of Prior Objection - Abstract
The abstract of the disclosure has been satisfactorily amended. Therefore, the objection to the abstract presented in the Final Office Action mailed October 6, 2025 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 103
Neither Mendes et al. (Eur J Pharm Sci. 2018; 117: 255-269), Fang et al. (ACS Appl Mater Interfaces. 2015; 7: 6674-6682), nor Hayward et al. (Oncotarget. 2016; 7(23): 34158-34171) explicitly disclose a ligand which is hyaluronic acid, wherein folic acid, cRGDfk peptide, and H7k(R2)2 peptide are coupled to the hyaluronic acid, as now stipulated in newly amended claim 1. Therefore, the 35 USC 103 rejection presented in the Final Office Action mailed October 6, 2025 is hereby withdrawn.
Applicant is advised that the metes and bounds of claim 1, as now amended, are indefinite, as explained in detail below. For examination at this time, the claim is being interpreted as intending to limit the scope of the claim to require the hyaluronic acid, folic acid, cRGDfk peptide, and H7k(R2)2 peptide to be in the form of a conjugate or complex, in which the hyaluronic acid is directly coupled to folic acid, cRGDfk peptide, and H7k(R2)2 peptide via covalent or non-covalent (e.g. ionic) bonds, such that the ligand is novel in structure and function from the prior art. Therefore, no new prior art rejection under 35 USC 103 is being applied at this time.
Claim Objections
Claims 5, 8, and 11 are objected to because of the following:
i). In claim 5, the recited weight ratios should not have units, since the ratio values are unitless. To remedy this issue, Applicant is advised to amend the phrase “wherein the solid lipid fraction:liquid lipid fraction ratio is from 25:75 (w/w) to 75:25 (w/w)” to “wherein the solid lipid fraction:liquid lipid fraction weight ratio is from 25:75 to 75:25”.
ii). Claim 8 is in improper Markush format. Applicant is advised that a proper Markush group has the general format “selected from the group consisting of A, B, C, and D”, not “selected from the group consisting of A, B, or C, D, or E, and F”. Hence, for example, the expression “mono-, di-, or triglyceride esters of fatty acids having from 8 to 12 carbon atoms” should be “monoglyceride esters of fatty acids having from 8 to 12 carbon atoms, diglyceride esters of fatty acids having from 8 to 12 carbon atoms, triglyceride esters of fatty acids having from 8 to 12 carbon atoms”.
iii). Claim 11 remains in improper Markush format. Applicant is advised that a Markush claim has the general format “selected from the group consisting of A, B, and C, not “selected from the group consisting of A at 0.5-3 wt%, B at 1-5 wt%, and C”. Applicant is advised to remove the weight percent values out of the Markush group and recite them separately, or to amend the claim to a format other than the Markush format.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 5, 7, 8, 11, 17, 18, and 41 are 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.
Claim 1 is indefinite for the following reasons:
1. Claim 1 provides for “at least one ligand” and then stipulates that the ligand “is hyaluronic acid”. One of ordinary skill in the art would understand “at least one ligand” to mean one ligand only or two or more ligands. However, when the claim then stipulates that the ligand “is hyaluronic acid” this implies that there is necessarily only one ligand and that the one ligand is hyaluronic acid. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claim 1 first provides for “at least one ligand”, then stipulates “the ligand…is hyaluronic acid”, which is “coupled to the surface of the nanoplatform”, then later stipulates in a wherein clause that “folic acid, cRGDfk peptide and H7k(R2)2 peptide are coupled to hyaluronic acid”. There seems to be at least two possible interpretations of this claim presentation. First, the claim could be interpreted to mean that hyaluronic acid, folic acid, cRGDfk peptide, and H7k(R2)2 peptide are all separate individual ligands (i.e. the at least one ligand) in the membrane, and since hyaluronic acid is coupled to the membrane, these other separate ligands also in the membrane are thus coupled indirectly to hyaluronic acid. Alternatively, the claim could be interpreted to mean that the hyaluronic acid, folic acid, cRGDfk peptide, and H7k(R2)2 peptide form a conjugate or complex in which the hyaluronic acid is directly coupled to folic acid, cRGDfk peptide, and H7k(R2)2 peptide via covalent or non-covalent (e.g. ionic) bonds. Therefore, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
***For examination at this time, the claim is being interpreted as intending to limit the scope to the latter case in which the hyaluronic acid, folic acid, cRGDfk peptide, and H7k(R2)2 peptide form a conjugate or complex in which the hyaluronic acid is directly coupled to folic acid, cRGDfk peptide, and H7k(R2)2 peptide via covalent or non-covalent bonds, such that the ligand is novel in structure and function from the prior art.
Claim 8 is in improper Markush format and thus one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. Applicant is advised that a proper Markush group has the general format “selected from the group consisting of A, B, C, and D”, not “selected from the group consisting of A, B, or C, D, or E, and F”. Hence, for example, the expression “mono-, di-, or triglyceride esters of fatty acids having from 8 to 12 carbon atoms” should be “monoglyceride esters of fatty acids having from 8 to 12 carbon atoms, diglyceride esters of fatty acids having from 8 to 12 carbon atoms, triglyceride esters of fatty acids having from 8 to 12 carbon atoms”.
Claim 11 remains in improper Markush format and thus one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. Applicant is advised that a Markush claim has the general format “selected from the group consisting of A, B, and C, not “selected from the group consisting of A at 0.5-3 wt%, B at 1-5 wt%, and C”. Applicant is advised to remove the weight percent values out of the Markush group and recite them separately, or to amend the claim to a format other than the Markush format.
Claim 41 recites at least one broad limitation (e.g. phospholipid) together with at least one narrower limitation (e.g. phosphatidylcholine) that falls within the broad limitation in the alternative in the same claim which is indefinite.
Claims 5, 7, 8, 11, 17, 18, and 41 are (also) indefinite for depending from an indefinite claim.
Potential Future Rejoinder
Claim 40 remains withdrawn at this time. However, in view of the fact that Applicant appears likely to be able to put claim 1 into condition for allowance, claim 40 may be rejoined for examination at such time claim 1 is found to be allowable. Applicant is advised that claim 40 is directed to “an intravenous composition” which is awkward, since an “intravenous composition” is a composition that is necessarily in the vein, e.g. blood. Presumably, Applicant intends the claim to be directed to “a composition for intravenous administration”, which is distinct from “an intravenous composition”. Applicant is thus advised to make any necessary amendment to avoid a future 112 issue upon rejoinder.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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, Johann Richter can be reached at 571-272-0646. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID BROWE/Primary Examiner, Art Unit 1617