DETAILED ACTION
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 .
Acknowledgement of Receipt
Applicant’s Response, filed 12/18/2025, in reply to the Office Action mailed 6/30/2025, is acknowledged and has been entered. Claims 1-3, 5, 9 and 10 have been amended. Claims 1-3, 5-12, 14 and 15 are pending, of which claims 6-8, 11, 12, 14 and 15 are withdrawn from consideration at this time as being drawn to a non-elected invention. Claims 1-3, 5, 9 and 10 are readable upon the elected invention and are examined herein on the merits for patentability.
Response to Arguments
Any rejection not reiterated herein has been withdrawn as being overcome by claim amendment. New grounds for rejection are set forth herein, necessitated by claim amendment.
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.
Claim(s) 1-3, 5, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gatzinksy et al. (Brain Research, 2001, 920, 226–238).
Gatzinsky discloses development and testing the biological activity and specificity of a novel fluorescent dextran-Texas Red–nerve growth factor (DTR–NGF) conjugate. DTR–NGF was found to promote survival and neurite outgrowth in cultured dissociated sympathetic neurons similarly to native NGF. The conjugate was taken up and transported retrogradely by terminal sympathetic nerves innervating the iris to neurons in the ipsilateral superior cervical ganglion (SCG) of young adult rats (abstract).
Preparation of dextran-Texas Red–NGF (DTR NGF) conjugates is taught on page 227, including linking chemistry, wherein standard dextran 50 000 was derivatized with 10 mol of amines per mol of dextran and subsequently labelled with Texas Red sulfonyl chloride to obtain 4 mol of dye per mol of dextran. Murine 2.5S NGF was treated with dimethylmaleic anhydride to reversibly block the amines. Some of the carboxyl groups of the NGF were activated by a proprietary method to react with the remaining amines of the Texas Red-amino dextran. The stoichiometry was designed to yield conjugates in the ratio of one molecule of DTR to one of NGF.
It is noted that protein dimer is not disclosed. With regard to claim 10, wherein the dye-protein conjugate facilitates one or more of a) endocytosis; b) axonal transport; and c) pharmacological activity in the neuronal cell body, it is noted that the Texas Red-NGF conjugate meets the structural limitations of the instant claims. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure or composition as that which is claimed, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The “discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Power Co. v. Ireco Inc., 51 USPQ 2d 1943, 1947 (Fed. Cir. 1999). Therefore, merely claiming a new use, new function, or new property, which is inherently present in the prior art does not make the claim patentable. See In re Best, 195 USPQ 430, 433 (CCPA 1977), and MPEP § 2112.
Claim(s) 1-3, 5, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kasaian et al. (Exp Cell Res, 1994, 210, 77-85).
Kasaian discloses that the interaction of fluorescein-labeled nerve growth factor (NGF) with human melanoma cells (A875) has been studied in order to assess better methodology for rigorous NGF binding studies. The NGF was modified at a single carboxyl group with iodoacetamidofluorescein after reaction with carbodiimide and cystamine (abstract).
Samples showed that they contained a fluorescein:protein ratio of 1:1. The major band in the FL-NGF lanes corresponds to NGF with one conjugated fluorescein molecule, and the faint more acidic bands probably represent small amounts of NGF with one or two more fluoresceins bound. The correspondence of one focused band in the preparation with one fluorescein per molecule indicates that random labeling of the 10 carboxyls of NGF does not occur (which would produce numerous acidic bands) and that a single, unique Asp or Glu is preferentially modified (page 80).
Preparation of fluorescein-labeled NGF is set forth on page 78, including EDAC-based linker chemistry. It is noted that protein dimer is not disclosed. With regard to claim 10, wherein the dye-protein conjugate facilitates one or more of a) endocytosis; b) axonal transport; and c) pharmacological activity in the neuronal cell body, it is noted that the fluorescein-NGF conjugate meets the structural limitations of the instant claims. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure or composition as that which is claimed, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The “discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” See Atlas Power Co. v. Ireco Inc., 51 USPQ 2d 1943, 1947 (Fed. Cir. 1999). Therefore, merely claiming a new use, new function, or new property, which is inherently present in the prior art does not make the claim patentable. See In re Best, 195 USPQ 430, 433 (CCPA 1977), and MPEP § 2112.
Conclusion
No claims are allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH H SCHLIENTZ whose telephone number is (571)272-9928. The examiner can normally be reached Monday-Friday, 8:30am - 12:30pm 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, MICHAEL HARTLEY can be reached at 571-272-0616. 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.
/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618