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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on July 3rd, 2026. Claims 1, 5, 6, and 9 are pending. Claims 2-4, 7, and 8 are canceled.
Claim Objections
Claim 9 is recited to be dependent upon claim 2, wherein claim 2 is canceled herein. As such, claim 9 is treated as being dependent upon claim 1.
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, and 9 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.
The metes and bounds of the sought methodology in the claims are indefinitely defined.
Claim 1 recites the limitations:
The ground sludge sample
The sample tube
The steps of ultrasonic extraction and centrifugation
The supernatants
The previously collected ethyl acetate supernatants
The extraction solution
There is insufficient antecedent basis for these limitation in the claim.
With respect to item 1) Applicant may intend to previously recite “…grinding the freeze-dried sludge sample to obtain a ground sludge sample”
In item 2) it may be Applicant’s intention to recite “the centrifuge tube.”
In item 3) it may be Applicant’s intention to previously establish at the end of their respective recitations a denotation to the order of “…constituting an ultrasonic extraction step…constituting a centrifugation step”
In item 4) it may be Applicant’s intention to individually call out the respective supernatants collected the respective steps (and are these supernatants the n-hexane and ethyl acetate referenced shortly thereafter, or are these different supernatants?)
In item 5) Applicant should clarify the collected supernatants similarly to that discussed above.
In item 6) it appears Applicant intends to recite “an extraction solution.”
Further, the metes and bounds of the sought methodology are indefinitely defined by way of step 4 of claim 1 and the qualitative and quantitative analysis undergone in order to both qualitative and quantitatively analyze the recited 36 anti-depressants.
With respect to the qualitative analysis, the recitation to “performing qualitative analysis by…” does not amount to a showing of quantitative analysis, as the recitation does not set forth any analytical steps, but instead, is drawn to a general listing of elements/parameters involved.
Given these elements/parameters of “exact mass, retention time, and characteristic ions,” what are the active, analytical steps taken with such data to inform qualitative analysis of the 36 anti-depressants?
Further, the recitation “characteristic ions” is vague and indefinitely defined herein for the recited methodology.
Applicant’s specification does not remedy this lack of clarity as the specification is devoid of discussion that correlates particular “characteristic ions” to that of the individual 36 anti-depressants recited.
Examiner notes that Table 1 (subsequent to par.[0047] of Applicant’s pre-grant publication US 2024/0353434) provides mass-to-charge ratio, exact mass error, retention time, and Adductions, but does not make clear “characteristic ions” in setting forth particular signatures correlated to each individual 36 antidepressants.
Par.[0047] also speaks generally and prophetically to “…an analysis method was established…” that doesn’t particularly define such an analysis method beyond the general concept of comparison against a database of known measurements.
Further, the claim is absent any “quantitative analysis” itself. The step recites “…adding…of an actual environmental sludge sample to quantitative analysis of the standards,” however, the claim is absent active steps that previously provide such a quantitative analysis of the standards. An addition does not afford a quantitative analysis or differentiation of unknown elements and their concentration/amount relative to standards. And the prior recitation is merely drawn to data gathering and lacks any quantitative analysis.
This likewise follows in dependent claims 5 and 9. Examiner notes that “UNIFI” has been removed so as to remove a Trademark from the claims, however, it remains that the qualitative analysis itself is indefinitely defined.
Recitation to “key information” renders indefinite metes and bounds to the qualitative analysis as the metes and bound of what is encompassed by this and what active step(s) are afforded to the qualitative methodology are indefinitely defined. The specification does not make up for this as it does not offer any further particular discussion thereto.
Additionally, steps within the “performing a qualitative analysis” are codified by the vague and indefinitely defined “using” of (i.e. “using the standards to individual target compounds in the target drug database…” and “…qualitatively identifying the 36 target antidepressants…using the target drug database…”) wherein such “using” is indefinitely set forth in the actively provided steps thereto.
Similarly to above in the “characteristic ions,” the discussion to matching desired “fragment ions” is indefinitely defined as the specification does not make clear such fragment ions and their correlation with the respective, individual 36 antidepressants.
This is also seen as the step of “adding” such data to “quantitative analysis of the standards” is not clearly understood as in both of claims 1 and 5.
It is unclear what is meant by “adding” the MSe data from the actual environmental sludge sample to that of the quantitative analysis of the standards.
An act of addition of data does not provide a quantitative analysis to assess an unknown (the actual environmental sludge sample) for particular presence of 36 antidepressants against quantitative analysis of the standards.
The specification does not remedy this, and it is unclear what qualitative analysis constitutes such “adding” in order to particularly identify the unknown 36 antidepressants in the sample from that of a database of standards.
This likewise applies to “residues” thereof as in cl. 6.
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 9 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. As discussed above, claim 9 improperly depends from canceled claim 2, and has been construed to depend from claim 1. By this, it appears that claim 9 is a duplicate claim to that of claim 5. 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,5, 6, and 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As discussed above in view of the amendments to the claims, claims 1, 5, 6, and 9 are herein rejected under 35 USC 112 b/2nd paragraph.
Allowable Subject Matter
Claims 1, 5, 6, and 9, as best understood, would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, namely Zou, Sajid, Dermartirosian , Argun, Baker, and Viglino, does not teach or fairly suggest, as best understood herein, a method for simultaneous and efficient detection of residues of 36 antidepressants in sludge, including the steps of extraction, purification of the extraction solution, and detection of the 36 antidepressants as recited in claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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