DETAILED ACTION
Status of Application
The amendments and response filed 30 July 2026 are acknowledged and have been considered in their entireties. Claims 1-20 remain pending; Claims 12-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-11 are subject to examination on the merits.
Withdrawal of Previous Objections/Rejections
The objection to claim 1 for a small typographical error is withdrawn in view of the amendment to rectify it.
The claim interpretation for claims 1-11 under 35 U.S.C. 112(f) is no longer applicable as the claims have been amended to remove all “means for” limitations.
The rejection of claim 7 under 35 U.S.C. 112(b) for lack of antecedent basis for reference to a fragment of PEG10 is withdrawn in view of the amendment to make said claim depend from claim 6, which provides support for this limitation.
The rejection of claims 1-11 under 35 U.S.C. 112(b) as being indefinite for not clearly differentiating between proteins and genes being detected is withdrawn in view of the amendments to clearly recite proteins or genes after each PEG10 and UBQLN2 recitation.
The rejection of claims 1-11 under 35 U.S.C. 112(b), having invoked 35 U.S.C. 112(f), is withdrawn in view of the amendments to the claims to remove “means for” and replace with products found in the kit. With reference to claim 8, this claim also has been amended to recite the methods by which the detection of the sample(s) occur.
Maintained Rejection(s)
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-11 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.
The claims in their broadest are drawn to assay kits for determining the susceptibility to ALS in a subject, the kit comprising: (i) at least one reagent for detecting in a biological sample of the subject a level of PEG10 protein, the reagent selected from the group consisting of an antibody or antigen-binding fragment thereof, an aptamer, a peptide, a binding partner, an enzyme, and a small molecule; and ii) a control level selected from a) a control level for PEG 10 protein indicating susceptibility to the development of ALS; b) a control level for PEG10protein indicating non-susceptibility to the development of ALS;c) information containing a predetermined control level of the PEG10 protein that has been correlated with susceptibility to the development of ALS; and d) information containing a predetermined control level of the PEG10protein that has been correlated with non-susceptibility to the development of ALS. Dependent claim3 recites the same kind of detection reagents for UBQLN2 protein. Thus, the claims are drawn to an enormous and variable genus of components found within the kit, and with the exception of the antibodies purchased/used in Figure 6, do not have any definitive or particular structure; rather, these are just suggestions to those skilled in the art as to what might be in the kits. For example, the genus of small molecules that could be used to detect PEG10/UBQLN2 is huge, diverse and not necessarily predictable as no small molecules are even recited in the specification; binding partners, enzymes, peptides and aptamers all will have a huge and variable genus in terms of structure and function of each and every component and are also just generically recited. Furthermore, it is entirely unclear what the control levels are which indicate non-susceptibility or susceptibility of developing ALS because no threshold has been determined or even suggested in the specification. This is insufficient in terms of written description because this suggests Applicant’s have not completed their claimed invention. While one skilled in the art might be able to envisage some of the components encompassed in the claims and means for detecting PEG10 and further UBQLN2, this is insufficient in terms of written description because it is not up to a skilled artisan to come-up or finish the invention that Applicant’s are claiming.
The MPEP in section 2163(I) states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made/filed, of the specific subject matter claimed:
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonable conclude the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
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An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)"
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed. Circ. 1997).
The courts have also held that possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
Applicant’s Response and Examiner’s Rebuttal:
Applicants contend that the claims no longer recite means-plus-function language and this has been replaced with specific protein binding reagents selected from an antibody or antigen-binding fragment thereof, an aptamer, a peptide, a binding partner, an enzyme, and a small molecule. Since these reagents were disclosed in the assay kit portion of the specification, 0048-0062, for example, this satisfies written description (See Remarks, p. 7).
The Examiner acknowledges this argument but does not find it convincing given there is not a single representative demonstration of a kit in the application comprising all of the components, inclusive of exactly what control levels are which inform if one is susceptible to ALS or not. The genus of molecules that potentially can bind a PEG10 and UBQLN2 proteins are enormous and are only recited at the most generic level. As such, what is claimed is left up to the skilled artisan to complete. As noted in MPEP 2163.02:
the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
For these reasons, the rejection is maintained.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 09 October 2026
