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, 3-5, 7-12, 14-16, 25, 28-31, 33 and 42 are pending.
Election/Restrictions
Applicants' election without traverse of Group I, claims 1, 3-5, 7-12, 14-16 and 25, in the reply filed on 6/18/26 is acknowledged.
Claims 28-31, 33 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The election of coronary artery disease as the species of cardiovascular disease in the reply is also acknowledged. Each claim in the elected group reads on the species.
Claims 1, 3-5, 7-12, 14-16 and 25 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to for the following informalities:
The title of the invention is not descriptive because (1) it refers to “methods and systems”, but the elected invention under consideration is limited to a method, and no pending claims are directed to systems; (2) it refers to “quantifying lipoprotein(a)” but the claimed methods are directed to “quantifying apolipoprotein(a)”, and (3) it refers to using “candidate references”, which encompasses any references, but the claimed method is limited to using “candidate peptides”. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Methods for Quantifying Apolipoprotein(a) Using Candidate Reference Peptides”.
Appropriate correction is required.
Claim Objections
Claims 1, 3-5, 7-12, 14-16 and 25 are objected to for the following informalities:
In claim 1, lines 6 and 9 (two instances), “stable isotope labeled” should be “stable isotope-labeled”. This same correction should also be made throughout the dependent claims, including claim 7 (line 2), claim 9 (line 2), and claim 10 (lines 6-7).
Claim 3 is missing the word “wherein” following the comma in line 1; i.e., “The method of claim 1, wherein the ion signal…” Compare with claim 4.
In claim 9, line 2, “comprises” should be “comprise”; i.e., “the two or more … comprise”.
In claim 10, line 4, the abbreviations “Lp(a)”, “14K” and “apo(a) should be accompanied by the full terminology the first time they appear in a series of claims; e.g., “lipoprotein (a) (Lp(a))” (see ¶ 4 of the specification) and “recombinant apolipoprotein (a) containing 14 kringle IV domains (apo(a) r14K)” (see ¶ 25, 50, 62).
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, 3-5, 7-12, 14-16 and 25 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 recites the limitation “the ion signal of at least two candidate peptides” in line 8. There is insufficient antecedent basis for this limitation in the claim. Specifically, there is no earlier reference to an ion signal of at least two candidate peptides. Instead, line 3 refers to “an ion signal of at least two peptides”, without including the word “candidate”. If the ion signal of line 8 is intended to refer to the ion signal of line 3, the word “candidate” should be added to line 3, or removed from line 8, in order to make the antecedent basis definite.
Claim 4 is indefinite because it is unclear how the indicated measurement is integrated into parent claim 1, because the measuring step of claim 1 is limited to measuring an ion signal of two or three peptides selected from a group of three peptides that does not include the two peptides further recited in claim 4. Furthermore, because it is unclear if and how the “measured” of claim 4 applies to claim 1, it is unclear whether the ion signal of the peptides of claim 4 is being measured, and whether the measurement of the peptides of claim 4 is also applied to the normalizing and quantifying steps of the method.
Claim 9 recites the limitation “the two or more internal standards” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 9 depends from claim 1 and there is no reference to two or more internal standards in the parent claim 1. In this regard, proper antecedent basis could be established by amending claim 9 to depend from claim 8, which does refer to two or more internal standards.
In claim 10, lines 2 and 3 (two instances), the phrase “such as” 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).
Claim 14 is indefinite because it is unclear how comparing the measured “amount of apolipoprotein(a)” to a “predetermined amount of lipoprotein(a)” can indicate risk of developing CVD, when the comparison is between two different molecules found in different levels in biological samples. Specifically, “apolipoprotein(a)” is a protein, and can be found free or associated with lipid, whereas “lipoprotein(a)” is lipid and protein. Thus, it is unclear whether claim 14 is intended to compare the measured amount of apolipoprotein(a)” to a predetermined amount of apolipoprotein(a); i.e., comparing a measured protein to a predetermined standard amount of the same protein.
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.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.-Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Claim 8 limits the method of claim 1 to one wherein the ion signal of the peptides in the sample relative to the amount of two or more internal standards and to a reference amount of a calibrator is indicative of an amount of apolipoprotein(a) in the biological sample. However, parent claim 1 already includes a step of quantifying the apolipoprotein(a) based on the average ion signal of the at least two peptides (which is based on normalizing the ion signal of the at least two peptides with the ion signal of the stable-isotope labeled peptides) and a reference amount of a calibrator. Thus, parent claim 1 already uses the two or more internal standards and a reference amount of a calibrator to indicate the amount of the apolipoprotein(a) in the sample. Therefore, dependent claim 8 is of improper dependent form because it fails to further limit the subject matter of parent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Art of Note
The following articles, patents, and published patent applications were found by the Examiner during the art search while not relied upon for a rejection are considered pertinent to the instant application:
---WO 2018/136825, Van Eyk et al, published 7/26/18 (cited on the 6/15/23 IDS). ‘825 teaches a large group of peptides that can be used for protein panels for assessing the health of a subject, of which the group disclosed in Table 11 includes a group of 20 apolipoprotein(a) peptides including three having the same sequence as each of SEQ ID NO: 1, 2 and 3. However, the teachings of Van Eyk do not expressly spell or render obvious the limitations as particularly arranged in instant claim 1; specifically, a method of quantifying apolipoprotein(a) comprising three steps including one wherein the quantification is based on obtaining an average ion signal of a specific combination of at least two peptides selected from the group of SEQ ID NO: 1-3 (i.e., quantification based on an average ion signal of SEQ ID NO: 1 and 2; of SEQ ID NO: 1 and 3; of SEQ ID NO: 2 and 3; or of SEQ ID NO: 1, 2 and 3).
---U.S. Patent Application Publication 20190369114, Van Eyk et al, published 12/5/19. This document is continuation of PCT/US2018/014570, which was published as the ‘825 document cited above. As such, the ‘114 publication shares an identical disclosure with ‘825.
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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