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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of PCT/CN21/99749 filed 06/11/2021 is acknowledged.
Claim Status
Claims 10, 17-20, 23, 26 and 28-48 are cancelled.
Claims 1-9, 11-16, 21-22, 24-25 and 27 are pending and are examined on the merits.
Claim Objections
Claims 1, 21 and 27 are objected to because of the following informalities:
claim 1 recites “regent” at step (a), (e),
claim 21 recites “regent” at step (a), (e),
claim 27 recites “regent” at step (a), (e),
which should read as “reagent” in all above cases.
Claim 6 is objected to because of the following informalities: claim 6 recites “wherein the first slide count S1 equal 0.8*S2”, which should read as “wherein the first slide count S1 equals 0.8*S2.”
Claim 27 recites “,;” at the end of step (a), which should read as “;”.
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 1-9, 11-16, 21-22, 24-25 and 27 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 recites the limitation "the regent" in steps (a, e). There is insufficient antecedent basis for this limitation in the claim. Claim 27 has identical problems at steps (a, e). Claim 21 does not have this problem.
Claim 21 recites the limitation "the reagent system" in steps (b, f). There is insufficient antecedent basis for this limitation in the claim.
The term “about one minute” and “about 5 seconds” in claim 15 is a relative term which renders the claim indefinite. The term “about” 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. An ordinary skilled person does not know the tolerance for “about” time. Claim 15 is hence indefinite. Similar problems exist in claims 16 and 25.
Claim 1 recites:
“in response to the cumulative count being less than a first slide count S1” at step (b);
“in response to the cumulative slide count being greater than the first slide count S1” at step (c);
“in response to the cumulative count being less than a second slide count S2” at step (f); and
“in response to the cumulative slide count being greater than the second slide count S2” at step (g).
In the above situations, what happens when the slide count equals to the threshold S1 or S2 is not defined, which left the ordinary skilled person wondering what to do. Claim 1 is hence indefinite. Claims 21 and 27 have similar problems of indefinite.
Claim 1, 21 and 27 each has a transition “after staining of the in-progress slides has been completed:” after step (c) and before step (d). It also marks the counting of slides shifted from S1 to S2. However, the claims do not explain how “count S1” is shifted to “count S2”. Whether there is reset operation to reset the slide count, or S1 becomes part of S2 is not defined. Claims 1, 21 and 27 hence are indefinite in this regard.
Regarding the 35 U.S.C. 101
The claims are eligible under 35 U.S.C. 101, as the claims, although recite abstract idea of data analysis (“(a) determine a cumulative count of a set of received slides since the regent system was installed, each set of slides having one or more slides;”) at Step 2A/Prong one, integrate the judicial exceptions into additional elements of experimental operations (in response to the cumulative count being … stain (staining) …) at Step 2A/Prong two. The claims hence are eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Berezhna et al. (“Assessment and Control of Reagents in Automated Slide Preparation”, US20180143111A1, Priority October 25, 2016; publication May 24, 2018), in view of Ikuta et al. (“Smear preparation apparatus and smear preparation method”. US20200408653A1. Priority June 26, 2019; publication December 31, 2020).
Claim 1 is interpreted as automatic slide staining apparatus. Regarding claim 1, Berezhna provides ([004]) “aspects of the methods include automated assessments of reagent amounts, quality and performance as well as automated adjustments of reagents based on such assessments, including the adjustment of reagent amounts, e.g., as present in reagent baths, the adjustment of reagent compositions and the replacement of reagents”, which teaches (preamble) automated reagent control.
Berezhna does not teach parallel handing of slides. Ikuta provides ([146]) “the number of glass slides 10 that can be simultaneously held can be thereby adjusted by adjusting the number of staining tanks 21 to be used”, which teaches (preamble) parallel handing supported in the smear-staining context.
Berezhna provides ([007]) “an automated method of determining the number of slides held by a slide carrier”, which teaches (“a slide counter”) automated counts of slides in a carrier.
Berezhna provides ([166]) “components of the subject devices and systems may be connected to or otherwise in communication with one or more processors”, which teaches (“a controller”) processor connection.
Berezhna provides ([009]) “determining the number of slides held by a slide carrier; calculating a predicted liquid level for the reagent bath expected when the determined number of slides are inserted into the reagent bath”, which teaches (step a) batch count for predicted bath level, which also suggests a cumulative count.
However, Berezhna does not teach timed automated staining steps and multi-slide handling.
Ikuta provides ([003]) “The glass slides 901 are transferred to the tanks in order, starting from the first staining tank 902 a and are processed by being immersed in a staining solution accommodated in each tank for predetermined setting time”. Ikuta supports (step b) timed sequence of automated staining.
Berezhna provides ([142]) “Hematoxylin and Eosin (H&E) stains”, which teaches (step b) the eosin staining. Alcohol at the last step would be obvious for dehydration in staining operation.
Berezhna does not teach withholding un-started slides. Ikuta provides ([147]) “the controller 50 controls the transfer unit 30 such that the transfer unit 30 does not transfer the glass slides 10 to the staining tank(s) not used for the staining processing and transfers the glass slides 10 to the staining tank(s) used for the staining processing.” Ikuta suggests (step c) holding un-started slide transfer, before complete in-progress slides.
Berezhna provides ([007]) “an automated method of determining the number of slides held by a slide carrier”, which teaches (step d-e) batch slide determination.
Berezhna does not teach condition-responsive staining configuration. Ikuta provides ([068]) “the controller 50 determines the staining tank(s) used for the staining processing and the staining tank(s) not used for the staining processing by calculating the staining time C corresponding to the staining concentration”, Ikuta teaches (step f) time linked to user-provided staining concentration.
Berezhna does not teaches completing in-progress second-protocol slides and hold un-started slides. Ikuta provides ([147]) “the controller 50 controls the transfer unit 30 such that the transfer unit 30 does not transfer the glass slides 10 to the staining tank(s) not used for the staining processing and transfers the glass slides 10 to the staining tank(s) used for the staining processing.” Ikuta suggests (step g) holding un-started slide transfer, before complete in-progress slides.
Claim 21 is the CRM version of the claim 1 apparatus. Since Berezhna provides ([166]) “components of the subject devices and systems may be connected to or otherwise in communication with one or more processors”, which teaches a processor connection, that suggests a CRM. The art applied to claim 1 also teaches claim 21.
Claim 27 is the method version of the claim 1 apparatus. The art applied to claim 1 also teaches claim 27.
Berezhna teaches automated slide preparation control, reagent assessment, and automated determination of the number of slides. Ikuta teaches a controller that processes slides in staining tanks for predetermined settings, controls which tanks receive slides, and adjusts tank use in response to staining concentration.
It would have been prima facie obvious to combine Berezhna’s reagent-quality/adjustment control with Ikuta’s controller-directed timed staining architecture because both Berezhna and Ikuta concern automated slide preparation and the combination predictably permits a stainer to manage quality and throughput in response to operating conditions. A PHOSITA would have had a reasonable expectation of integrating known controller inputs and timed-transfer outputs in one instrument. Because this is a classic example of “combining prior art elements according to known methods to yield predictable results” (MPEP §2141.III.(A)).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUOZHEN LIU whose telephone number is (571)272-0224. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D Riggs can be reached at (571) 270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635
