DETAILED 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 .
Specification
The disclosure is objected to because of the following informality: Applicant has amended the specification, by preliminary Amendment, as follows,
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However, the brief description of the figure is
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Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informality: in claim 1, line 4, the indefinite article – a – should be inserted between “of and “S1) (so, --Preparation of a S1 protein-binding group: . . . .”).
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: S11 and S12 in claim 2.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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 1-141 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. There is no need to go through the Wands undue experimentation factors (MPEP 2164.01(a)) as the claims, especially independent claim 1, are so confusing that one of ordinary skill in the art would not know what steps are to be performed in the claimed electrochemical detection method or even what is to be detected by the claimed method. Indeed, at least two aspects of the claims seem impossible on their face. So, there would be no point in even attempting to figure out how to carry out the claimed method steps. The indefiniteness issues are numerous and significant (see the rejections under 35 U.S.C. 112(b) below). Some of the more significant ones are noted again here
What is to be detected by the method of claim 1?
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The claim 1 preamble is silent as to what is be detected by the electrochemical detection method. Step S3, though, requires that the screen-printed electrode is to be detected (with no disclosure as to how to detect an electrode using a protein-binding group), but step S4 vaguely mentions “to obtain a detection result”, presumably relating to a target protein.
How is the method claim 1 to be practiced?
Claim 1 requires using “basic protein”, which is a phrase unique to Applicant and undefined, so leaving one of ordinary skill in the art confused as to what type of protein is to be used in practicing the claimed method.
The claim 1 preamble is “An electrochemical detection method based on screen- printed electrodes, . . . .”; however, there is only one screen-printed electrode mentioned in the body of the claim (step S3) and it itself is to be detected.
Claim 1 has the inconsistent, if not contradictory, steps of on the one hand, “S3 blocking basic protein: using blocking solution to block the basic protein reacted in the step S2 . . . . [italicizing by the Examiner]”, but later in the claim “the basic protein reacts specifically with the target protein, . . . .” How can the basic protein react specifically with the target protein if it has been previously been blocked?
Claim 1 requires “and perform electrochemical analysis on data collected by working electrode”. This step does not make sense. How can electrochemical analysis (for example, amperometry) be performed on data (numbers, words, or other forms of information)? This seems impossible.
The dependent claims add further confusion
For example, dependent claims 5-10 just refer to vague “detection projects”.
Claims 4 and 13 use the vague “corresponding” when referring to proteins, as in “wherein the basic protein in the step S2 and the target protein in the step S4 are corresponding . . . .” (see claim 4). Such a use of the word “corresponding” to refer to proteins is unique to Applicant and undefined.
Claim 12 requires “wherein in the step S4, the collected data comprise impedance or voltage difference between the working electrode and a reference electrode in the screen-printed electrode.” That is, the working electrode and a reference electrode, which are typically two distinct electrodes, are in the same electrode (which is a third electrode). This seems impossible.
Claim 13 requires “wherein the basic protein in the step S2 and the target protein in the step S4 are corresponding and used for different detection projects.” Likewise for claim 14. It is not clear at all how the phrase “are corresponding and used for different detection projects…” is to be further limiting.
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 1-14 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:
a) claim 1, line 4, recites “Preparation of S1 protein-binding group: . . . . [italicizing by the Examiner]” What is meant by a S1 protein-binding group? If Applicant is being his own lexicographer, please heed MP2173.05(a);
b) claim 1, lines 4-5, recites “a working electrode on a screen-printed electrode substrate is processed, . . . .” The phrase “is processed” is too vague. What techniques are used in this processing and/or for what purpose is the processing done?
c) claim 1, line 5, recites “. . . ., and the protein-binding group is adhered; . . . .” To what is the protein-binding group adhered?
d) claim 1 recites the limitation “the protein-binding group” in line 5. There is insufficient antecedent basis for this limitation in the claim. “Preparation of S1 protein-binding group: . . . .” does not provide antecedent basis for the protein-binding group as this phrase is only a label for or naming of this step, not a step itself;
e) claim 1, line 6, recites “S2 basic protein reaction: add basic protein, . . . .” What is meant by a “basic” protein? If Applicant is being his own lexicographer, please heed MP2173.05(a);
f) claim 1, line 6, recites “S2 basic protein reaction: add basic protein, . . . .” To what is the basic protein added?
g) claim 1 recites the limitation "in the step S1" in line 7. There is insufficient antecedent basis for this limitation in the claim (there is no prior step S1, only “Preparation of S1 protein-binding group: . . . . “;
h) claim 1, lines 8-9, recites “S3 blocking basic protein: using blocking solution to block the basic protein reacted in the step S2 to obtain the screen-printed electrode to be detected; . . . .” What is meant by blocking basic protein that has reacted with a protein-binding group?
i) claim 1 recites the limitation " the screen-printed electrode to be detected " in lines 8-9. There is insufficient antecedent basis for this limitation in the claim (lines 3-4 of the claim only recites “a working electrode on a screen-printed electrode substrate”);
j) claim 1, lines 8-9, recites “S3 blocking basic protein: using blocking solution to block the basic protein reacted in the step S2 to obtain the screen-printed electrode to be detected; . . . .” Is Applicant actually claiming that the screen-printed electrode is to be detected rather than a target protein (see S4)?
k) claim 1, line 10, recites “add a detection reagent containing target protein, . . . .” To what is the detection reagent added?
l) claim 1, lines 10-11, recites “the basic protein reacts specifically with the target protein, . . . .”; however, the claim previously requires “S3 blocking basic protein: using blocking solution to block the basic protein reacted in the step S2 . . . .” How can the basic protein react specifically with the target protein if it has been previously been blocked?
m) claim 1, lines 11-12, recites “and perform electrochemical analysis on data collected by working electrode” What is meant by performing electrochemical analysis on data?
n) claim 1, lines 11-13, recites “and perform electrochemical analysis on data collected by working electrode after a reaction to obtain a detection result.” Is the “a reaction” in this clause the previous reaction in this step of “the basic protein reacts specifically with the target protein, . . . .”?
o) claim 1, lines 11-13, recites “and perform electrochemical analysis on data collected by working electrode after a reaction to obtain a detection result.” It Is not clear from the claim what is actually meant to be detected;
p) the claim 1 preamble is “An electrochemical detection method based on screen- printed electrodes, . . . .”; however, there is only one screen-printed electrode mentioned in the body of the claim (step S3) and it itself is to be detected;
r) the preamble in each of dependent claims 2-14 include the phrase “screen printed electrodes [plural]”; however, the body of claim 1 only mentions a single screen printed electrode;
s) Claim limitation “S11 cleans the surface of the working electrode:” invokes
35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The Examiner has found no disclosure as to what object or mechanism cleaning means S11 may be. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
t) in claim 2 what is meant by the limitation “S11 cleans the surface of the working electrode: mechanical grinding and polishing to mirror surface of the working electrode; . . . .”? In particular, what is meant by the phrase “to mirror surface of the working electrode”/
u) Claim limitation “S12 identification of electrode surface cleanliness:” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The Examiner has found no disclosure as to what instrument or mechanism ident cation means S12 may be. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
v) claim 2 requires “scan in 1 x10-3 mol/L K3Fe(CN)6 phosphate buffer solution until reversible cathode and anode peaks appear, . . . .” It is not clear what is scanned, presumably it is the working electrode.
w) claim 2 requires “scan in 1 x10-3 mol/L K3Fe(CN)6 phosphate buffer solution until reversible cathode and anode peaks appear, that is, the surface of the working electrode is clean, otherwise return to the step S11.” It is not clear what patentable weight Applicant intends for the phrase “that is, the surface of the working electrode is clean, . . . .” Is it optional?
x) claim 2 requires “scan in 1 x10-3 mol/L K3Fe(CN)6 phosphate buffer solution until reversible cathode and anode peaks appear, that is, the surface of the working electrode is clean, otherwise return to the step S11.” This claim limitation is confusing as it requires a scanning, perhaps endlessly, until a certain result is achieved (reversible cathode and anode peaks appear), but then seems to state that it may not be achieved (“otherwise return to the step S11”). Put another way, how many scans must be performed or for how long must scanning be performed before returning to step S11 if reversible cathode and anode peaks have not appeared.
y) claim 2 recites the limitation " returning to step S11” in the last line of the claim.
There is insufficient antecedent basis for this limitation in the claim. In line 5 of the claim “S11” is used as a noun (cleaning mechanism).
z) claim 3 recites the limitation "the step S1” in line 2 of the claim.
There is insufficient antecedent basis for this limitation in the claim.
aa) claims 4-10 refer to certain “detection projects”. The scope of “detection projects” is indefinite (as is that of the singular “detection project”);
ab) in claims 4 and 13 how is the word “corresponding” being used? What is meant in claim 4, by the phrase “wherein the basic protein in the step S2 and the target protein in the step S4 are corresponding”? Likewise for claim 13;
ac) claim 11 is confusing as it recites “the blocking solution is BSA bovine serum albumin or casein or a protein-free compound.” A “solution” is not synonymous with “compound”.
ad) claim 12 requires “wherein in the step S4, the collected data comprise impedance or voltage difference between the working electrode and a reference electrode in the screen-printed electrode.“ What does it mean for the
working electrode and a reference electrode to be in the screen-printed electrode?
ae) claim 13 recites the limitation " screen printing electrodes” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
af) claim 14 recites the limitation " screen printing electrodes” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 As set forth in the preliminary Amendment of March 26, 2024.