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 .
Claims 1-4, 8, 9, and 11-19 are pending.
Claims 5, 6, 7, 10, and 20 has been withdrawn.
Claims 1 and 16 have been amended.
Information Disclosure Statement
The information disclosure statement filed 8/5/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the source of a fresh hematoxylin solution, first fluid path, cleaning composition reservoir, first cleaning composition dispenser, processor, second cleaning composition dispenser, a batch stainer, individual sample stainer, drip tray, hematoxylin reservoir, drainage valve or vacuum nozzle, manifold valve, waste tray, tray stainer, waste line strainer, pump line, and second fluid flow path must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-16 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.
Claim 1 is unclear in where the source of fresh hematoxylin solution is stored. The addition of --a hematoxylin reservoir-- would make it clear where the solution is stored and it would clear up dependent claims 14-16 if they were dependent on claim 1.
-Is unclear how the fresh hematoxylin solution is dispensed to the biological sample. The addition of –on—“to a biological sample” in line 6 would clear up the confusion.
-Is unclear in the recitation “a first fluid path between the source of the fresh hematoxylin solution and the hematoxylin waste system” in lines 10 and 11. Appropriate correction is needed to change to –waste container—or --hematoxylin dispenser--.
-Is unclear in the recitation “hematoxylin waste solution the cleaning composition” in lines 40 and 41 if it’s the dispensed cleaning composition or a different cleaning composition. Recommending changing to --hematoxylin waste solution the dispensed cleaning composition—as recited in (i) and (ii) above.
- The recitation "at least one of the hematoxylin waste system or the first fluid path” in lines 46 and 47 has insufficient antecedent basis as only one hematoxylin waste system is claimed. Appropriate correction is needed to remove “at least one of”.
Claim 3 is indefinite and unclear in the recitation “is a batch stainer”. Appropriate correction is needed to remove [is].
Claims 11, 12, 13, 14, and 18 recite “cleaning system injects” which is unclear and indefinite. Appropriate correction is needed to change to --the first cleaning composition dispenser injects—
Claims 14, 15, and 16 recite “the hematoxylin reservoir” which has insufficient antecedent basis. Appropriate correction is needed to either change to –a hematoxylin reservoir—or change dependency to claim 1 and change the “waste hematoxylin solution” which is purged in claim 14 and “waste hematoxylin” which is removed from claim 16 –fresh hematoxylin solution--.
Claim 16 recites “removing waste hematoxylin” in lines 2 and 3 is indefinite and unclear if it is new waste or should read --waste hematoxylin solution—or –fresh hematoxylin solution--.
Response to Amendments
Claim Amendments
Applicant’s amendments to claim 1 has changed the scope of claims and as a result, the 103 rejection of claims as stated in the final office action mailed 7/2/2025 is withdrawn.
Applicants’ amendments to claims 1 and 16 has overcome all but one of the claim 112b rejections in Claim 16 set forth in the final office action dated 7/2/2025. Additional, 112b rejections have been made.
Response to Arguments
Applicant's arguments filed 10/8/2025 have been fully considered.
Applicant disagrees that Imamura does not teach the alleged deficiency of Favaloro. Applicant argues the even if Favaloro and Imamura were combined the combination fails to teach all of the elements of the claimed invention.
Applicant argues that Favaloro does not teach the recited cleaning compositions, the resultant pHs of the different dispensed cleaning compositions after they are mixed with a hematoxylin waste solution, or the effect of the cleaning compositions on the hematoxylin waste system components after dispensing. Examiner agrees that Imamura and Favaloro do not teach the amended cleaning compositions and the effect of the cleaning compositions on the hematoxylin waste system. Therefore, the examiner has withdrawn the 103 rejection and the obviousness rejection has been withdrawn.
Applicant further submits that Imamura does not teach dispensing a cleaning composition without the cleaning composition contacting a sample. Rather, Imamura teaches the opposite, namely the intentional introduction of a dye and a cleaning composition to a biological sample. Therefore, the Patent Office's assertion that Imamura discloses the recitation "without the cleaning composition contacting the biological sample" is incorrect. Examiner disagrees and maintains that Imamura teaches “and do not come in contact with the biological sample” within Paras 14 and 18, FIG. 1 in that the biological sample can be dried on the spot after the discharging the cleaning liquid. However, based on other claim amendments the 103 rejection has been withdrawn.
Applicant disagrees and submits that in view of the amendments to claim 1 and the arguments set forth above, the combination the cited art for claims 8, 9, 12, 13, and 18 cannot teach all of the limitations of the claims. Accordingly, the obviousness rejection should be withdrawn. Examiner agrees that the cited art does not teach all of the claims amendments and withdraws the obviousness rejection for claims 8, 9, and 12, 13, and 18.
Applicant stated that the patent office rejected claims 13 and 18 under 35 U.S.C. 103 as allegedly unpatentable over Favaloro and in view of Barnes (JP2014505248) and the applicant disagrees, in view of the cancellation of claim 20, and the rejection should be moot and should be withdrawn. Examiner believes the recited “Claim 13 and 18” are typos in the remarks and should read –claim 20—as claim 20 was the only one rejected using Barnes. If applicant is referring to claim 20 examiner agrees and the claim has been cancelled and argument has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden can be reached on 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.E.H./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798