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 .
Status of the Claims
Claims 1, 3, 5, 7, 9-10, 12-14, 21-22, 28-29, 31-32, 37-39, 44, and 47 are pending and examined herein.
Priority
This application, filed 09/02/2022, claims benefit to PRO 63/241,902, filed 09/08/2021. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 09/08/2021.
Withdrawn Rejections/Objections
The rejection of claim 21 under 35 U.S.C. 112(b) has been withdrawn in response to Applicant’s amendment.
The rejection of claims 1, 13, and 21 under 35 U.S.C. 102 has been withdrawn in response to Applicant’s amendment.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 7, 9, 10, 12, 22, 28, 29, 31, and 37-39 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2017/0202982, “HYALURONIC ACID-BASED NANOPARTICLES AS BIOSENSORS FOR IMAGING-GUIDED SURGERY AND DRUG DELIVERY VEHICLES AND METHODS ASSOCIATED THEREWITH” (published 07/20/2017, herein referred to as Mohs).
Regarding claims 1, 22, and 37, Mohs teaches making a composition comprising a fluorophore, “ICG”, and hyaluronic acid (para. 0027, lines 4-9).
Regarding claims 3, 5, 29, and 38-39, Mohs teaches making a dye preparation comprising DAPI (para. 0054, lines 1-4).
Regarding claim 7, Mohs teaches ICG conjugated to an antibody (para. 0009, lines 21-25).
Regarding claim 9 and 28, Mohs teaches making a total composition concentration of 0.0001 mg/mL to 1 mg/mL with 20 wt% fluorophore (Figure 5). This amounts to a fluorophore concentration range from 0.05µg/mL to 200µg/mL.
Regarding claim 10, Mohs teaches a composition without DMSO (para. 0017, lines 1-2).
Regarding claims 12 and 31, Mohs teaches making a composition with 2.3% wt hyaluronic acid (para. 0034, lines 1-2).
Claims 1, 7, 13, 14, 21, 22, 32, 37, 44, and 47 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2009/0232730, “METHOD OF PRODUCING IMMUNOLIPOSOMES AND COMPOSITIONS THEREOF” (published 09/17/2009, referred to herein as Peer).
Regarding claims 1, 7, 21, 22, and 37, Peer teaches making a composition comprising cy3 dye conjugated to an antibody and hyaluronic acid (para. 0089, lines 1-6). Peer teaches that hyaluronic acid is included for cryoprotection of the composition (para. 0049, lines 1-4) and protects against freeze-thawing (para. 0048, lines 1-3).
Regarding claims 13, 14, and 44, Peer teaches storage at -80°C and lyophilization (para. 0077, lines 1-3). Peer teaches the storage of the composition for 0, 2, 90, and 270 days (Table VII, para. 0154, lines 1-10). Peer teaches that fluorescence is unchanged after lyophilization (Figure 1B).
Regarding claims 32 and 47, Peer teaches dividing the composition into 1 mL aliquots and storing the aliquots at -80°C (para. 0077, lines 1-3).
Response to Arguments
Applicant's arguments filed 03/25/2026 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on page 5 on the rejection of claim 21 under 35 U.S.C. 112(b), the rejection has been withdrawn in response to Applicant’s amendment.
Regarding the remarks on page 6 on the rejection of claims 1, 3, 5, 7, 9, 10, 12, 22, 28, 28, 31, and 37-39 under 35 U.S.C. 102 as being anticipated by Mohs, Applicant argues that Mohs fails to teach a liquid mixture of a dye preparation and an HA salt solution.
This argument is not persuasive. Mohs teaches creating a liquid HA salt solution (para. 0049, lines 1-2) and adding ICG fluorophore to the solution (para. 0050, lines 12-14). This is considered to be a HA salt solution mixed with a fluorescent dye preparation. Although this composition may be considered to be an intermediate composition during a method of producing a lyophilized product, it is still considered to anticipate the solution as claimed.
Regarding the remarks on pages 6 and 7 on the rejection of claims 1, 7, 13, 14, 22, 32, 37, 44, and 47 under 35 U.S.C. 102 as being anticipated by Peer, Applicant argues that Peer teaches liposomes coated with HA and does not teach a liquid mixture of a dye preparation with an HA salt solution.
This argument is not persuasive. Peer teaches making a liquid composition comprising cy3 dye conjugated to an antibody and hyaluronic acid (para. 0089, lines 1-6) which is made by dissolving hyaluronic acid salt in water (para. 0074, lines 1-8). This is considered to be a HA salt solution mixed with a fluorescent dye preparation.
Regarding the remarks on page 7 on the rejection of claims 1, 13, and 21 under 35 U.S.C. 102 as being anticipated by Iyer, the rejection has been withdrawn in response to Applicant’s amendment.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 June 15, 2026
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