DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-18, 20 and 22-26 are pending.
Election/Restrictions
Applicants' elections of (1) trastuzumab as the species of first binder; (2) pertuzumab as the species of second binder; and (3) tobacco etch virus (TEV) protease as the species of protease in the reply filed on 6/25/26 are acknowledged.
Claims 8-14 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-7, 15-18, 20 and 22-23 are under consideration, as they read upon the elected species.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 4 and 6-7 are objected to because of the following informalities:
In claims 4 and 6, the abbreviation “cTnI” should be accompanied by the full terminology, i.e., “cardiac troponin I (cTnI)” prior to using the abbreviation. Compare with withdrawn claim 8, lines 2-3.
In claims 6 and 7, the abbreviations “HER2” should be accompanied by the full terminology, i.e., “human epidermal growth factor receptor-2 (HER2)” prior to using the abbreviation. See the specification at ¶ 71 (published application)
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-7, 15-18, 20 and 22-23 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 pre-AIA the applicant regards as the invention.
Claim 1 is directed to a “method for detecting a target substance treating composition comprising” five elements (i)-(v), which are each products. Thus, the claim recites an intended use (detecting a target substance treating composition) and five products but does not set forth any steps of how the method is actually practiced. A claim is indefinite where it merely recites a process of use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q), which states:
"Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986)."
MPEP 2173.05(q) further states, “It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections”. As such, claim 1 is indefinite under 35 U.S.C. 112(b) for reciting a use without any active, positive steps. See also the rejection of the claim below in the section titled "Claim Rejections - 35 USC § 101".
Claim 1 is also indefinite because it is unclear whether the method or the composition comprises the five elements (i)-(v).
Claim 1 is also indefinite with respect to the recitation of “an enzyme source (zymogen)”, because an “enzyme source” broadly encompasses any source of an enzyme, whereas a zymogen is limited to an inactive precursor of an enzyme. Thus, the scope is indefinite because it is unclear whether the claim is limited to a zymogen or more broadly encompasses any source of an enzyme.
Claims 2-7 and 15-17 depend from claim 1 and further limit one of the five elements (i)-(v) recited in the parent claim. None of claims 2-7 introduce any method steps. As such, claims 2-7 are rejected as indefinite for the same reason as for claim 1.
Claim 4 recites the limitation “the antibody” and “the antigen” in line 1. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 4 depends from claim 3, in which both the first and second binder can each independently be an antibody and an antigen. Thus, it is unclear whether the “the antibody” refers to the first binder, the second binder or both. It is unclear whether claim 4 limits both the first binder and the second binder to the same antibody or the same antigen or not. Claim 4 is also indefinite because the first and second binder of claim 3 are an antibody or an antigen but claim 3 refers to an antibody and an antigen.
Claim 6 is indefinite because parent claim 5 limits the target substance to one selected from a group including an antigen or an antibody but claim 6 further limits the antigen and the antibody. In this regard, claim 6 could be rendered definite by amending the claim to recite “or” on line 2 instead of “and”.
Claim 18, line 3, recites “mixing the composition with a sample containing a target substance”. This recitation is indefinite because the only composition recited in parent claim 1 is “a target substance treating composition”. Thus, in the parent claim, the only composition that can provide antecedent basis for the recitation in claim 18 already contains a “target substance”, and thus it is unclear how it can be mixed with the target substance.
In claim 20, line 5, it is unclear if “a substrate” is the same substrate recited in parent claim 1 (“a substrate specific to the enzyme source”. If it is, the claim could be clarified by amending it, for example, to recite “the substrate”.
Claim 22 contains the trademark/trade name “CENTATM”. Where a trademark is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark cannot be used properly to identify any particular material or product. A trademark is used to identify a source of goods, and not the goods themselves. Thus, a trademark does not identify or describe the goods associated with the trademark. In the present case, the trademark is used to identify/describe a particular substrate and, accordingly, the identification is indefinite.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above and encompass the same indefinite subject matter.
Claims 1-7 and 15-17 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
The omitted steps are: one or more method steps that indicate how the five recited elements (i)-(v) will be used to achieve intended goal of the method; i.e., detecting a target substance treating composition. Currently, the claim simply states this goal and the five elements without indicating how these elements are to be used.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter.
Claims 1-7 and 15-17 are directed to a method of using an antibody but without reciting any method steps. See above in the section titled, “Claim Rejections – 35 USC 112(b)”. As such, these claims do not fall within at least one of the four categories of patent eligible subject matter because, per MPEP 217.05(q): ““Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”).”
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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