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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 22, 2026 has been entered.
Response to Amendment
2. Claims 1 and 35 have been amended as requested in the amendment filed on September 22, 2026. Following the amendment, claims 1-4, 6, 8, 12, 14, 16, 19-21, 23, 27, 29, 31, 34-38, 40, 42, 46, 48, 50, 52-55, 57, 61, 63, 65 and 68 are pending in the instant application.
3. Claims 20, 21, 23, 27, 29, 31, 34, 54, 55, 57, 61, 63, 65 and 68 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 02, 2026.
4. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are under examination in the instant office action.
5. The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
In this case, claim 38 is presented twice, one as Previously presented and one as Currently amended. Appropriate correction is required.
6. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
Claim Objections
7. Claims 1 and 35 are objected to because of the following informalities:
The claims recite “(TB)” as an abbreviation for traumatic brain injury. This appears to be a typo. Appropriate correction, “TBI,” is suggested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
8. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for practicing the methods by using samples of whole blood, serum, plasma and cerebrospinal fluid, does not reasonably provide enablement for using any tissue or bodily fluid sample, as currently claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification teaches diagnosis of traumatic brain injury (TBI) by performing an assay to evaluate critical levels of UCH-L1 and GFAP proteins specifically associated with TBI in blood samples of patients under testing. The instant clams broadly encompass using “a sample” to provide for the diagnosis of TBI. However, the instant specification is not found to be enabled for the methods when any sample is a part of the invention for the following reasons. The instant specification does not provide neither enough guidance for such method of differential diagnosis, nor working examples, which would show that the claimed method was successfully practiced with any biological sample other than blood, thus, requiring undue experimentation on part of one skilled in the art to discover how to practice the claimed invention for its full scope.
The nature of the invention places it in the class of invention which the Federal Circuit has characterized as "the unpredictable arts such as chemistry and biology." Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The prior art does not recognize that proteins found at certain levels in blood are also found at the exact same levels, or even be present, in any other fluid or tissue sample. The specification does not provide any factual evidence or sound scientific reasoning to support a conclusion that specific levels of UCH-L1, for example, see 400 pg/mL as in claim 1, are present within urine, breast milk or bone tissue sample obtained from a normal subject so that these levels are used as a meaningful reference to evaluate TBI presence. Thus, Applicant has left those skilled in the art with too much undue experimentation to research and discover for themselves what particular bodily fluid or tissue express UCH-L1 and GFAP in measurable amounts suitable for diagnostic purposes, as currently claimed. As such, Applicant has merely provided a starting point for research and experimentation and not a meaningful enabling disclosure of how to practice the full scope of the claimed invention.
The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100,(CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure”. The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art”, “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement”.
The instant specification is not enabling because one cannot follow the guidance presented therein and practice the full scope of the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,849,548, claims 1-14 of U.S. Patent No. 10,866,251, claims 1-16 of U.S. Patent No. 10,877, 038, claims 1-22 of U.S. Patent No. 10,877,048, claims 1-19 of U.S. Patent No. 11,016,092, claims 1-36 of U.S. Patent No. 11,016,105, claims 1-26 of U.S. Patent 11, 022,617, claims 1-18 of U.S. Patent 11, 931,161, claims 1-18 of U.S. Patent 12,085,567, claims 1-19 of U.S. Patent 12,092,647, claims 1-24 of U.S. Patent 12,099,069, claims 1-31 of U.S. Patent 12,105,098¸ claims 1-38 of U.S. Patent 12,105,100 and claims 1-19 of U.S. Patent 12,163,958 for reasons of record in section 10 of Paper mailed on March 27, 2026 and in section 11 of Paper mailed on July 06, 2026.
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 further stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/747,397 (reference application) for reasons of record in section 11 of Paper mailed on March 27, 2026 and in section 11 of Paper mailed on July 06, 2026.
Applicant’s request to hold the rejections in abeyance, p. 23 of the Response, has been acknowledged.
Conclusion
10. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, Jeffrey Stucker can be reached at (571)272-0911. 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.
/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
October 7, 2026
