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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 28, 2026 has been entered.
Response to Amendment
2. Claims 1, 14 and 26 have been amended and claims 9, 12, and 20 canceled as requested in the amendment filed on April 28, 2026. Following the amendment, claims 1, 2, 7, 8, 13-15, 21-24, 26, 28, 29, 31, 33 and 34 are pending in the instant application.
3. Claims 1, 2, 7, 8, 13-15, 21-24, 26, 28, 29, 31, 33 and 33 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on April 28, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections - 35 USC § 112
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.
6. Claims 1, 2, 7, 8, 13-15, 21-24, 26, 28, 29, 31, 33 and 34 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.
7. Claim 1, as amended, is vague and indefinite for reasons that follow. The claim is drawn to a method of diagnosing and treating a pediatric subject comprising performing an assay to measure the levels of GFAP and/or UCH-L1; and identifying the subject as having the levels of GFAP and/or UCH-L1 greater than the reference levels “based on the results of the assay;” and treating a subject identified as having a mild TBI. Applicant submits at p. 8 of the Response that the claim has been amended “to recite the method identifies a subject as having a mild traumatic brain injury (TBI),” however, claim 1 is void of any indication to support the statement. The claim clearly recites identification of “the subject as having” different levels of the markers, but provides no meaningful connection between the levels of the markers and mTBI. Applicant is advised to rewrite the claim so that every element and/or step of the claim is set forth in clear intelligible language so that there is no uncertainty of what is claimed.
8. Claims 2 and 15 are indefinite in reciting the critical levels of GFAP in conflicting terms. Briefly, step (a) “a level of GFAP in the sample greater than a reference level of GFAP, wherein the reference level of GFAP is between about 30 pg/mL to about 1000 pg/mL” makes no sense because it is not clear whether, for example, if 50 pg/mL is considered greater than the reference level, such as being greater than 30 pg/mL but lower than 1000 pg/mL.
9. Claims 7, 8, 13, 22-24, 26, 28, 29, 31, 33 and 34 are indefinite for being dependent from indefinite claim(s).
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.
10. Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 specifically requires possession of the “biomarkers that are not UCH-L1 or GFAP.” The claim does not require that these biomarkers possess any particular conserved structure or other disclosed distinguishing feature. Thus, the claim is drawn to a genus of molecular compounds that is defined only by the requirement of being “not UCH-L1 or GFAP.” However, the instant specification fails to describe the entire genus of molecules, which are encompassed by this claim.
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
To provide adequate written description and evidence of possession of a recited genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the claim is a requirement of the biomarker not to be UCH-L1 or GFAP. The specification does not provide a complete structure of those biomarkers that are not UCH-L1 or GFAP, and fails to provide a representative number of species for the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of biomarkers, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
11. Claims 14, 15 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection under the provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), written description.
MPEP § 714.02 states that Applicant’s reply to the Office action must be fully responsive. Specifically, “Applicant should also specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06”. Further, MPEP § 2163.06 states that if new matter is added to the claims, the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) - written description requirement, is appropriate. The proscription against the introduction of new matter in a patent application serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981). Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph sets forth the written description requirement as follows: 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. Compliance with the written description requirement is a question of fact. See Vas-Cath lnc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991).
The basic function of a patent specification is to disclose an invention. The written description serves a quid pro quo function “in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’” Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922, 69 USPQ2d 1886, (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970, 63 USPQ2d 1609. 63 USPQ2d 1618, (Fed. Cir. 2002)). In other words, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,” Vas-Cath Inc., 935 F.2d at 1563-64, and demonstrate that by disclosure in the specification of the patent.
In the instant case, claim 14, as currently presented, specifically requires possession of a method, intended for performing a CT scan only, that follows the steps of measuring the levels of GFAP and/orUCH-L1, performing CT scan when the levels of GFAP reach the critical levels, and, after that, treat the subject with the protocol designed for mTBI. The specification as originally filed does not provide support for the inventive concept as currently claimed. This affects all dependent claims.
Because the instant claims now recite limitations which were not clearly disclosed in the specification as filed, these limitations introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. 112.
To obviate the instant rejection of record, Applicant is invited to provide sufficient written support for the limitations indicated above. See MPEP 714.02 and 2163.06.
12. Claims 1, 2, 7, 8, 13-15, 21-24, 26, 28, 29, 31, 33 and 33 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 glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) protein 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 a tissue or bodily fluid samples are 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 bodily fluid or tissue. 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 55 pg/mL as in claim 1, are present in 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 GFAP and UCH-L1 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
13. Claims 1, 2, 7, 8, 13, 22-24, 26, 28, 29, 31, 33 and 33 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the following issued US Patents: U.S. Patent No. 10,849,548; 10,866,251;10,877,038; 10,877,048; 11,016,092; 11,016,105; 11,022,617; 11,931,161; 12,085,567; 12,092,647; 12,099,069; 12,105,098; 12,105,100 and 12,163,958 for reasons of record in section 8 of Paper mailed on May 09, 2025 and section 10 of Paper mailed on January 28, 2026.
Applicant traverses the rejection at pp. 13-15 of the Response. In relevant parts, Applicant argues that the subject of the instant claims is “a pediatric subject,” which distinguishes the subject from any subject as in patented claims. While this has been fully considered, the argument is not persuasive because “a subject” of the patented claims encompasses any human subject, not including or excluding particular sex, race, age or any other group of the subject. Thus, the patented invention is suitable to be practiced on any group of the “human subject.”
Next, Applicant submits that the patented claims refer to the different critical levels of GFAP and UCH-L1. Applicant’s argument has been given full consideration but found to be not persuasive for reasons that follow. For Applicant’s convenience, the levels of GFAP and UCH-L1 are compared using the instant claims 1 and 2, levels of GFAP greater than 30 pg/mL or greater than 1000 pg/mL, levels of UCH-L1 greater than 55 pg/mL or greater than 300 pg/mL. The levels of GFAP and UCH-L1 that fall and meet the range of the levels of the instant claims 1 and 2 are encompasses by at least claims 1 and 6 of the ‘548 patent; claim 1 of the ‘251 patent; claims 10 and 14 of the ‘038 patent; claim 1 of the ‘048 patent; claim 7 of the ‘092 patent; claim 4 of the ‘105 patent; claim 1 of the ‘617 patent; claim 6 of the ‘161 patent; claim 1of the ‘567 patent; claim 7 of the ‘647 patent; claim 1 of the ‘069 patent; claim 1 of the ‘098 patent; claim 1 of the ’100 patent; claim 7 of the ‘958 patent.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
14. 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.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
June 10, 2026
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