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 .
Status of Claims
There are two (2) sets of claims submitted on 19 DECEMBER 2023. The claim set considered is the claim set consisting of nine (9) pages and the claims have status identifiers.
In the claim set, Claims 1-14 are ‘Currently Amended’.
Current pending claims are Claims 1-14 and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 DECEMBER 20203 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification/Abstract
The abstract of the disclosure is objected to because the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 limitation(s) is/are:
A “means … to allow the separation” in claim 12.
A “means” does not connote any particular structure. The specification does not describe what this “means” is nor does not describe what a step A or step B is.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) 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 Objections
Claim 1 is objected to because of the following informalities: the superscripts are not properly noted. In step a), the concentrations should be 10-7 and 10-3. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in step a), in the instance of “between 3 and 6, ii) a strong acid in an amount” ; should be changed to ““between 3 and 6, and ii) a strong acid[[ ]] in an amount”. The word ‘and’ should be added and the underline should be deleted.
Claim 14 is objected to because of the following informalities: there is a period missing at the end of the sentence. Appropriate correction is required.
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 and 13 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.
In claim 1, step a) i) , it is unclear how a mixture can be define as one organic solvent. A mixture would imply 2 or more, not an alternative of 1 solvent. Examiner suggest amending this language.
In claim 1, in the instant that recites ka, this short hand should first be define. Does applicant mean the acid dissociation constant?
In claim 1, its unclear how one of ordinary skill is to “determine and/or quantify” by performing step c). There is no detection step or quantification step occurring. What is being done with the data obtain from steps b) and c).
Regarding claims 1 and 13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “sufficient” in claim 1 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, the ‘amount sufficient for the extraction mixture to have a normality’ ; is interpreted to be ‘the amount for the extraction mixture to have a normality’.
In Claim 6, it is unclear to the Examiner when or how the ‘detected and/or quantified’ step is occurring?
Claims 12 and 13 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.
In Claims 12 and 13, the claim language recites “a step A” and “a step B”; however it is unclear what these steps are. It just appears something is happening but nothing is described in these steps A and B in the claim language.
Claim 12 recites the limitation "the analytes". There is insufficient antecedent basis for this limitation in the claim.
Claims 2-13 are rejected also under 112(b) as being dependent upon a rejected base claim.
Claim 12 is 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.
Claim limitation “means … to allow the separation” 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 specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of “to allow the separation” is performed by a step A and step B. There is no disclosure of any particular structure, either explicitly or inherently, to perform these steps A and B. The use of the term “means” is not adequate structure for performing the maintaining function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which brightening structure or structures perform(s) the claimed function. 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.
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.
Claim 12 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. As described above, the disclosure does not provide adequate structure to perform the claimed function of “to allow separations”. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Allowable Subject Matter
Claims 2-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Examiner’s Note: The only pending rejections are the claim objections and 112(b) rejection mentioned above. The closest prior art of record is to RAFFERTY, WO 2015/109263 A2 and further in view of KONIECZNA, WO 2018/117881 A1, both submitted on the Information Disclosure Statement.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference RAFFERTY discloses a multiresidual method for detecting and/or quantifying at least one amino acid or derivative thereof, abstract, at least one organic acid, and/or at least one modified nucleotide, in a sample of biological liquid or circulating cells, [0007, 0010], comprising the steps of:
a) treating the sample with an extraction mixture at room a temperature, [0121], preferably refrigerated at a temperature lower than -20°C, [0121], comprising :
b) performing a hydrophilic interaction liquid chromatography (HILIC) on the sample treated in step a), [0122]; and
c) performing an analysis by tandem mass spectrometry on the sample obtained in step b) for detecting and/or quantifying the at least one amino acid or derivative thereof, the at least one organic acid, and/or the at least one modified nucleotide, [0127].
The RAFFERTY reference discloses the claimed invention, but is silent in regards to the specific extraction mixture.
The KONIECZNA reference discloses a multiresidual method for detecting and/or quantifying at least one amino acid or derivative thereof, abstract, at least one organic acid, and/or at least one modified nucleotide, abstract, page 1, in a sample of biological liquid or circulating cells, page 1 , page 10-11, Example 1, comprising the steps of:
a) treating the sample with an extraction mixture at room a temperature, page 10-11, Example 1, comprising :
i) a mixture of one or more organic solvent, page 10-11, Example 1, methanol ; and
ii) a strong acid in an amount sufficient for the extraction mixture, page 10-11, Example 1, HCl and methanol.
b) performing a hydrophilic interaction liquid chromatography (HILIC) on the sample treated in step a), page 10-11, Example 1; and
c) performing an analysis by tandem mass spectrometry on the sample obtained in step b) for detecting and/or quantifying the at least one amino acid or derivative thereof, the at least one organic acid, and/or the at least one modified nucleotide, Claim 1.
The combination of reference do not teach or suggests the specifics of i) a mixture of one or more organic solvents having final polarity index between 3 and 6, ii) a strong acid in an amount sufficient for the extraction mixture to have a normality from 0.005 to 0.025 N or a weak acid with ka in the range between 3.5 x 10-7 and 7.0 x 10-3 with a final concentration in the extraction mixture from 5 to 30 mM, wherein the extraction mixture comprises: [[-]] acetonitrile, dichloromethane and formic acid; or [[-]] acetonitrile and hydrochloric acid; or [[-]] acetone and formic acid; or [[-]] methanol and formic acid; or [[-]] acetonitrile and formic acid; or[[-]] methanol and dimethyl sulfoxide; or[[-]] acetonitrile and dimethyl sulfoxide; or[[-]] acetonitrile, methanol and hydrochloric acid; or[[-]] acetonitrile and methanol.
There is no teaching or suggestion in the prior arts mentioned above to have a i) a mixture of one or more organic solvents having final polarity index between 3 and 6, and ii) a strong acid in an amount sufficient for the extraction mixture to have a normality from 0.005 to 0.025 N or a weak acid with ka in the range between 3.5 x 10-7 and 7.0 x 10-3 with a final concentration in the extraction mixture from 5 to 30 mM. While both reference teach an extraction solution or mixture, the claimed mixture is not found or suggested in the prior art. KONIECZNA teaches a mixture (two or more solvents), but not the desired mixture as recited in Claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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