DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
2-3, 8-20, 22, 24-25 and 29-54
Pending:
1, 4-7, 21, 23, 26-28 and 55-60
Withdrawn:
none
Examined:
1, 4-7, 21, 23, 26-28 and 55-60
Independent:
1
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 10/28/2022 filing receipt, this application claims priority to as early as 3/3/2021. At this point in examination, all claims have been interpreted as being accorded this priority date.
IDSs
IDSs have been considered as indicated on the accompanying form PTO-326 with exceptions as noted on the accompanying forms 1449.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objections to the specification and drawings are withdrawn.
The objections to the claims are withdrawn.
The 112/b rejections are withdrawn, except as noted below, and new rejections are applied.
The 103 rejections are withdrawn at least because the previously cited art as well as the art in the search histories does not teach the particularly recited analysis steps. Applicant's 2/11/2026 remarks at pp. 14-21 further support withdrawal of the rejections.
The previous 101 rejections are withdrawn. Referring to 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 1st consideration relating to an improvement over the previous state of the technology field integrating possible judicial exceptions into a practical application (MPEP 2106.04(d) and (d)(1)), the improvement in this instance comprising enabling absolute quantification of one or more MHC molecules per cell. In this regard, Applicant's 2/11/2026 remarks at pp. 22-23 further support withdrawal of the rejections. Also, the 101 rejections are withdrawn at least in view of the analysis Step 2B relating to a non-conventional additional element causing the claim to read on significantly more than any recited JE (MPEP 2106.05(d)), the non-conventional additional element in this instance comprising at least the recited laboratory steps requiring specific SEQ ID NOs. In this regard, Applicant's 2/11/2026 remarks at p. 24 support withdrawal of the rejection.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1, 4-7, 21, 23, 26-28 and 55-60 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
A method for the absolute quantification
Requires but lacks clear antecedent. Possibly: "a..."
1
a)... the total cell count in the sample;
Requires but lacks clear antecedent. Possibly: "a..."
1
b)... the total protein concentration in the sample
prior to digestion
Requires but lacks clear antecedent. Possibly: "a total protein concentration..."
1
e)
... the number
Requires but lacks clear antecedent. Possibly: "a..."
1, 55-56
e-ii)
... the molar
... the molar
Requires but lacks clear antecedent. Possibly: "a..."
1,
21, 23, 27, 55, 56, 58, and 59
internal standard
This term is instantiated more than once (e.g. steps c-1 and c-2), and the relationship between the instantiations is unclear. It may help to overcome this rejection to recite "a first internal standard," "a second...," etc.
Relatedly, in the "wherein" clause after step c-2, the recited "said internal standard" requires but lacks clear antecedent at least because it is preceded by the multiple instantiations of "internal standard." It is unclear to which this "said internal standard" refers. The relationship is unclear between this "said internal standard" and the earlier instantiations. This same issue also occurs in the final "wherein" clause before step d), again in step (e-i) and in claims 21, 23, 27 (thrice), 55, 56, 58 (thrice) and 59.
For similar reasons, in claim 27, "as defined in claim 1" is unclear.
55-56, 58
The method according to claim 1...
It is unclear how the claim relates to claim 1 at least because it is unclear whether the dependent claim steps replace or are in addition to the same step(s) in the parent claim.
27
subjecting the digested sample to a step of chromatography and/or spectrometry analysis
The relationship is unclear between this step and the same recitation in claim 1. This rejection is maintained.
Conclusion
No claim is allowed.
Applicant's amendments necessitated the new grounds for rejection in this action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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