DETAILED ACTION
The amendment and RCE filed on 11/20/2025 has been entered and fully considered. Claims 1, 5-6, 10-13, 22-27, 37, 40-41 and 45-47 are pending, of which claims 1 and 37 are amended.
Response to Amendment
In response to amendment, the examiner maintains rejection under 112b established in the previous Office 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 .
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.
Claims 1, 5-6, 10-13, 22-27, 37, 40, 41, and 45–47 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.
I. Claim 1 – Indefiniteness
A. Internal Contradictions Between the Method Steps
Claim 1 recites the following steps:
Contacting the non-ceruloplasmin sample with a chelator “to give labile-bound copper bound to the chelator”;
“Removing non-labile-bound copper… thereby isolating chelator-bound labile-bound copper… to obtain a labile-bound copper sample.”
These steps are logically inconsistent:
Step (a) states that labile-bound copper binds to the chelator.
Step (b) does not remove the chelator-bound copper, but instead removes “non-labile copper,” meaning the chelator-bound copper remains in the sample, yet the sample is termed “labile-bound copper sample.”
Thus, the claim is unclear as to:
Whether the chelator-bound copper is the material that is ultimately measured,
Whether the non-chelator-bound fraction is measured instead, or
Whether both are present.
Because the sequence defines the sample both by what has been removed and by what is bound to the chelator, the scope of the “labile-bound copper sample” is unclear.
B. Indefiniteness of “labile-bound copper sample”
The specification describes “labile-bound copper” as NCC/LBC loosely associated with plasma proteins.
However, claim 1 defines the “labile-bound copper sample” operationally, not chemically.
Because the chelator binds LBC in step (a), yet the removal step does not remove chelator-bound copper, the resulting sample composition is ambiguous.
Accordingly, the claim fails to inform one of ordinary skill, with reasonable certainty, what copper species constitute the “labile-bound copper sample.”
C. Functional Definition of the Chelator Without Boundaries
Claim 1 requires:
“a chelator which does not bind copper present in Mo-albumin tripartite-bound copper and binds to labile-bound copper.”
No structural, concentration, or affinity criteria are recited.
Because the claim defines the chelator solely by the desired result—binding LBC while not binding MAC—its scope depends entirely on an unbounded functional result.
Such purely functional language fails to provide clear metes and bounds and is therefore indefinite.
II. Claim 37 – Indefiniteness
Claim 37 recites a kit comprising:
a chelator “which does not bind copper present in Mo-albumin tripartite-bound copper and binds to labile-bound copper”; and
“instructions for use to measure copper concentration in a biological sample.”
A. Ambiguity of “labile-bound copper”
As with claim 1, the term is defined functionally and inconsistently.
The chelator is distinguished solely by its effect on two different copper pools without providing:
affinity or selectivity criteria,
chelator structure,
reaction conditions, or
a measurable standard by which a skilled artisan could evaluate compliance.
Therefore, it is unclear what reagents fall within the scope of the chelator limitation.
B. Functional Definition of the Chelator
Because the claim defines the chelator by the result it must achieve (binding LBC while not binding MAC), without structural or operational parameters, the scope is not reasonably certain.
C. Indefiniteness of “instructions for use”
The claim recites only generic “instructions for use.”
The claim does not distinguish whether the instructions relate to:
measuring labile copper,
measuring chelator-resistant copper,
measuring total copper, or
using the immunocapture reagent before or after chelation.
Thus, it is unclear what the kit is actually configured to perform.
III. Dependent Claims
Claims 5, 6, 10–13, 22–27, 40, 41, and 45–47 depend from claims that are themselves indefinite.
When a base claim is indefinite, the dependent claims necessarily inherit the same defect.
Therefore, these claims are also indefinite under §112(b).
IV. Conclusion
For the reasons above, claims 1, 5, 6, 10–13, 22–27, 37, 40, 41, and 45–47 are indefinite under 35 U.S.C. §112(b) because the claims, viewed as a whole, do not particularly point out and distinctly claim the subject matter regarded as the invention.
The §112(b) rejection is therefore maintained.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
I. Claim 1
1. Claim 1 Still Contains Internal Inconsistencies as to What Is Being Removed and What Is Being Measured
Even after amendment, claim 1 recites the following steps:
Step 3: contacting the non-ceruloplasmin sample with a chelator that “does not bind copper present in Mo-albumin tripartite-bound copper” and that results in “labile-bound copper bound to the chelator.”
Step 4: “removing non-labile-bound copper from the non-ceruloplasmin sample thereby isolating chelator-bound labile-bound copper… to obtain a labile-bound copper sample.”
Applicant argues that these amendments clarify that the non-labile fraction (MAC) is removed, leaving LBC behind in the sample.
However, the steps remain internally contradictory:
Step 3 expressly states that the chelator binds the labile-bound copper.
Step 4 does not remove the chelator-bound copper; instead, it removes “non-labile-bound copper.”
As a result, the chelator-bound copper remains in the sample and the sample is then defined as the “labile-bound copper sample.”
This leaves unclear:
Whether the analyte to be measured is chelator-bound copper,
Or the unchelated fraction remaining after removing non-labile copper,
Or some mixture of both.
Thus, the sequence renders the identity of the “labile-bound copper sample” indefinite.
Applicant’s amendment does not resolve this inconsistency.
2. “Labile-bound Copper Sample” Remains Indefinite
Applicant cites par [0004] and par [0050] as defining “labile-bound copper” as non-ceruloplasmin-bound copper (NCC/LBC) loosely associated with blood proteins
However, this does not clarify the sample recited in the claim.
The claim defines the “labile-bound copper sample” strictly by the sequence of removals — not by the chemical species described in the specification.
Because Step 3 captures LBC onto a chelator and Step 4 removes only the non-labile fraction, the resulting sample:
contains chelator-bound copper,
does not match the LBC definition in par [0004],
and does not correspond to CuEXC, which Applicant argues is analogous to their definition.
Accordingly, even though the term “labile-bound copper” is described in the specification, the claim’s operational definition does not correspond to that description, and therefore the scope remains unclear.
3. The Chelator Limitation Remains Functionally Undefined
The claim recites:
“a chelator which does not bind copper present in Mo-albumin tripartite-bound copper.”
Applicant asserts that par [0050] explains that certain chelators bind LBC but not MAC.
However:
No affinity constants, conditions, concentrations, or structural features are recited.
The specification lists broad examples (penicillamine, trientine, EDTA) but does not teach which of these distinguish LBC from MAC, nor under what conditions.
Thus, the chelator is still defined purely by the desired result (“binds LBC but not MAC”), without objective boundaries.
Functional claiming without objective criteria fails to inform a skilled artisan, with reasonable certainty, whether a given chelator meets the limitation.
Therefore, the rejection remains proper.
4. Applicant’s Reliance on par [0050] Does Not Resolve Indefiniteness
Applicant argues that par [0050] corresponds to the claim steps and clarifies the nature of the sample remaining after removal of MAC
However, par [0050] describes a different sequence:
Contact sample with chelator binding LBC.
MAC is then removed from the sample.
LBC remains.
In contrast, claim 1 recites:
Chelator binding LBC.
Removal of non-labile-bound copper, but
Still retaining the chelator-bound copper while calling that “labile-bound copper sample.”
The claim steps do not match the par [0050] description, leading to confusion about what is actually isolated and measured.
Thus, citation to par [0050] does not cure the ambiguity within the claim itself.
II. Claim 37.
Applicant contends that:
The specification (e.g., par [0004] and ¶[0050]) defines “labile-bound copper” as non-ceruloplasmin-bound copper (NCC) loosely associated with plasma proteins, and that such term is therefore clear.
Claim 37 has been amended to recite that the chelator “does not bind copper present in Mo-albumin tripartite-bound copper and binds to labile-bound copper.”
The “instructions for use” limitation is clear because the kit is plainly for measuring copper concentration in a biological sample.
Applicant therefore requests withdrawal of the §112(b) rejection
2. Examiner’s Response
The arguments have been fully considered but are not persuasive.
(a) Indefiniteness of “labile-bound copper.”
While the specification cites paragraph [0004] to describe NCC and LBC, those passages equate “labile-bound copper” with “non-ceruloplasmin-bound copper” and “free copper.” However, the claim also excludes copper present in “Mo-albumin tripartite-bound copper.” It is unclear whether such tripartite copper is a subset of NCC/LBC or a distinct species. Because the claim attempts to define the chelator by what it binds (LBC) and by what it does not bind (Mo-albumin-Cu), the boundaries of the claimed reagent cannot be determined with reasonable certainty. Thus, one of ordinary skill would not be able to identify whether a given chelator falls within or outside the scope.
(b) Functional definition of the chelator.
The limitation “a chelator which binds to labile-bound copper” remains a purely functional definition without objective structural or compositional parameters (e.g., affinity constant, concentration, or representative species). The specification lists several chelators (EDTA, trientine, etc.) but does not disclose conditions under which each selectively binds LBC without affecting Mo-albumin-Cu. Therefore, the claim still defines the reagent only by the desired result, rendering its scope uncertain.
(c) “Instructions for use.”
Although amended to recite that the instructions are for “measuring copper concentration,” this phrase remains generic and does not clarify whether the measurement concerns total copper, labile copper, or chelator-resistant copper. The function of the kit as claimed therefore remains ambiguous.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797