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 .
Response to Arguments
a. In response to U.S.C 112 rejection, Applicant notes that claims 1 and 10 (the independent claims for claims 8 and 16) have been amended to simply recite that those claims' respective staining modules comprise "two or more chambers," and that the language which was seen as indefinite has been removed.
a. (Examiner’s response) Applicant’s arguments with respect to claims 8, 9 , & 16 have been fully considered and are persuasive. The 35 U.S.C 112 rejection of claims 8, 9, & 16 has been withdrawn.
b. In regards to the 35 U.S.C 103 rejection, Applicant notes that, as amended, that claim recites a staining module comprising two or more chambers, and a heater "linked to all of the two or more chambers." In its rejections, the Office Action asserted that those features, which were originally recited in claim 8, were covered by the "independent stations" of Sakura.¹ However, this is incorrect, as Sakura explicitly states that its stations are "[c]ompletely independent staining stations," and that "[e]ach individual staining station has a built-in temperature controlling system for fast and efficient temperature change."2 Thus, Sakura cannot be treated as covering a heater "linked to all of the two or more chambers.
b. (Examiner’s response) Applicant’s arguments with respect to the rejection(s) of claim(s) 1 & 10 under TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051. Further explanation is shown in the action below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a lighting module configured to illuminate” “an imaging module” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Applicant teaches the lighting module comprises light emitters (0016).
Applicant recites the imaging module comprises a camera in claim 3.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 10, & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051.
With respect to claim 1, Takahashi teaches a biological imaging analyzer comprising:
a staining module (fig 1, 204) configured to produce stained cells, the staining module comprising:
a heater (fig 1, 204) configured to heat the biological sample and the staining composition;
a lighting module (fig 15, 321) configured to illuminate the stained cells (fig 15, 311); and
an imaging module (fig 15, 354) configured to capture images of the stained cells.
Takashi does not teach one or more chambers configured to receive a biological sample and a staining composition.
Diagnostic Biosystems, in the same field of endeavor as Takashi of staining, teaches a staining unit (fig 3) comprising chambers configured to receive biological samples and a staining composition (fig 1 & 2). At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine Diagnostic Biosystem’s chambers with Takashi staining unit as a means to hold both the sample and stain during staining.
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The combination does not teach the heater is linked to all of the one or more chambers.
Sakura, in the same field of endeavor as Takashi of temperature control staining, controlling the temperature of all the chambers (fig 1) in order to heat individual samples (pg. 2, 30 independent stations).
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Sakura does not specifically teach a heater.
McCampbell, in the same field of endeavor as Takashi of temperature control staining (0025, lines 9-15 McCampbell), teaches a heater may comprise a plurality of circumferentially spaced (relative to the longitudinal axis of the container support 492) heating elements positioned close to a sample (0135, lines 10-14). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Sakura’s controller and McCampbell’s heater with the combination’s chambers to enable efficient temperature change for each chamber.
With respect to claim 2 according to claim 1, the combination teaches the biological imaging analyzer further comprising a flow cell (fig 15,13 Takashi) configured to flow the stained cells therethrough, the flow cell further comprising an imaging region (fig 15 Takashi) where the images are captured.
With respect to claim 3 according to claim 1, the combination teaches the biological imaging analyzer
wherein the imaging module comprises a camera (TDI) camera (0164, lines 1-2 Takashi).
With respect to claim 10, the Takashi does not teach a staining module in a biological imaging analyzer comprising:
a heater (fig 1, 204) configured to heat a biological sample.
Takashi does not teach one or more chambers configured to receive a biological sample and a staining composition.
Diagnostic Biosystems, in the same field of endeavor as Takashi of staining, teaches a staining unit (fig 3) comprising chambers configured to receive biological samples and a staining composition (fig 1 & 2). At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine Diagnostic Biosystem’s chambers with Takashi staining unit as a means to hold both the sample and stain during staining.
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The combination does not teach the heater is linked to all of the one or more chambers.
Sakura, in the same field of endeavor as Takashi of temperature control staining, controlling the temperature of all the chambers (fig 1) in order to heat individual samples (pg. 2, 30 independent stations).
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Sakura does not specifically teach a heater.
McCampbell, in the same field of endeavor as Takashi of temperature control staining (0025, lines 9-15 McCampbell), teaches a heater may comprise a plurality of circumferentially spaced (relative to the longitudinal axis of the container support 492) heating elements positioned close to a sample (0135, lines 10-14). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Sakura’s controller and McCampbell’s heater with the combination’s chambers to enable efficient temperature change for each chamber.
With respect to claim 13 according to claim 10, the combination teaches the staining module wherein biological sample includes a blood sample (0031Takahashi).
Claim(s) 4, 5, 11, & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051 in further view of QI US 20210041361.
With respect to claim 4 according to claim 1, the combination does not teach a lysing composition.
Qi, in the same field of endeavor as Takashi of lysing and staining of blood cells (fig 2 Takahashi) (0052, lines 31-32 Takahashi), teaches a staining composition comprising a lysing compound (0008). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to try to combine Qi’s staining composition to simultaneously stain and dye red blood cells in a more efficient manner.
With respect to claim 5 according to claim 1, the combination does not teach the staining composition further comprises a lysing compound.
Qi, in the same field of endeavor as Takashi of lysing and staining of blood cells (fig 2) (0052, lines 31-32 Takashi), teaches staining composition comprising a lysing compound (0008). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Qi’s staining composition with the combination’s chamber to efficiently identify red blood cells by simultaneously staining and dying blood samples.
With respect to claim 11 according to claim 10, the combination does not teach a lysing composition.
Qi, in the same field of endeavor as Takashi of lysing and staining of blood cells (fig 2) (0052, lines 31-32 Takashi), teaches staining composition comprising a lysing compound (0008). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Qi’s staining composition with the combination’s chamber to efficiently identify red blood cells by simultaneously staining and dying blood samples.
With respect to claim 12 according to claim 10, the combination does not teach the staining composition further comprises a lysing compound.
Qi, in the same field of endeavor as Takashi of lysing and staining of blood cells (fig 2) (0052, lines 31-32 Takashi), teaches staining composition comprising a lysing compound (0008). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Qi’s staining composition with the combination’s chamber to efficiently identify red blood cells by simultaneously staining and dying blood samples.
Claim(s) 6 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051 in further view of SOMMER EP 1500932.
With respect to claim 6 according to claim 1, the combination teaches the biological imaging analyzer wherein the stained cells are white blood cells (fig 8 Takashi).
The combination does not teach a stained nuclear region.
Sommer, in the same field of endeavor as Takashi of lysing and staining of blood cells and flow cytometry, teaches staining the nuclei of permeabilized white blood cells in lysed blood products allows the white blood cells to be identified based on their light absorption or light scattering characteristics (0027, lines 35-40). At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to try to stain nuclear region of white blood cells within the combination’s chambers to enable concentration measurements of white blood cells.
With respect to claim 14 according to claim 13, the combination teaches the staining module wherein the staining composition is configured to provide white blood cells (fig 8 Takashi).
The combination does not teach a stained nuclear region.
Sommer, in the same field of endeavor as Takashi of lysing and staining of blood cells and flow cytometry, teaches staining the nuclei of permeabilized white blood cells in lysed blood products allows the white blood cells to be identified based on their light absorption or light scattering characteristics (0027, lines 35-40). At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to try to stain nuclear region of white blood cells within the combination’s chambers to enable concentration measurements of white blood cells.
Claim(s) 7 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051 in further view of LIU CN 110794889.
With respect to claim 7 according to claim 1, the combination does not teach the heater comprises an induction coil.
Liu, in the same field of endeavor as Takashi of temperature control staining, teaches a heater comprising an induction coil ( pg. 2, ¶ 7, lines 1-3). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Lui’s induction coil with the combination’s heater to precisely heat a sample for a desired staining (abstract, lines 10-13 Liu).
With respect to claim 15 according to claim 10, the combination does not teach the heater comprises an induction coil.
Liu, in the same field of endeavor as Takashi of temperature control staining, teaches a heater comprising an induction coil ( pg. 2, ¶ 7, lines 1-3). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Lui’s induction coil with the combination’s heater to precisely heat a sample for a desired staining (abstract, lines 10-13 Liu).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051 in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura.
With respect to claim 16 according to claim 10, the combination does not teach the heater is linked to all of the one or more chambers.
Sakura, in the same field of endeavor as Takashi of temperature control staining, teaches a heater is linked to one or more chambers (fig 1) in order to heat individual samples (pg. 2, 30 independent stations). At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Sakura’s heater with the combination’s chambers to enable efficient temperature change for each chamber.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051 in further view of Zhang CN 205761709.
With respect to claim 9 according to claim 1, the combination does not teach a mounting bracket connected to all of one or more chambers, and a heating element mounted to the mounting bracket.
Zhang, in the same field of endeavor as Takashi of mixing samples and reagents (pg. 12, ¶ 11, lines 1-2 Zhang), teaches a mounting bracket (fig 9, 608) connected to a chamber (fig 9, 604), configured to fix a heating element (fig 1, 602) to the chamber. At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Zhang’s mounting bracket with Takashi’s heater and chamber to keep the heater stationary during staining.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI EP 3663760 in view of Diagnostic Biosystems, “Diagnostic BioSystems HighLighter™ Automated Slide Stainer”, https://www.youtube.com/watch?v=uEReOEnllOQ, Jun 18, 2020 hereafter Diagnostic Biosystems in further view of paper of Sakura, “Tissue-Tek Genie Advanced Staining System” https://www.sakuraus.com/Products/Advanced-staining/Tissue-Tek-Genie-Advanced-Staining-System.html September 24, 2020 hereafter Sakura in further view of MCCAMPBELL WO 2022072051 in further view of Zhang CN 205761709.
With respect to claim 17 according to claim 10, the combination does not teach a mounting bracket
connected to all of the chambers, and a heating element mounted to the mounting bracket.
Zhang, in the same field of endeavor as Takashi of mixing samples and reagents (pg. 12, ¶ 11, lines 1-2 Zhang), teaches a mounting bracket (fig 9, 608) connected to a chamber (fig 9, 604), configured to fix a heating element (fig 1, 602) to the chamber. At the time prior to the effective filing date, it would have been obvious to one of ordinary skill in the art to combine Zhang’s mounting bracket with Takashi’s heater and chambers to keep the heater stationary during staining.
Allowable Subject Matter
Claims 8 & 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims or to include the limitation(s) and any intervening claims into the base claim. The following is a statement of reasons for the indication of allowable subject matter:
As to claim 8, the prior art of record, taken alone or in combination, fails to disclose or render obvious “staining module is a multi-chamber staining module, wherein each of the two or more chambers is disposed in an interior portion of the multi-chamber staining module and has a corresponding port adapted to allow the biological sample and the staining composition to be introduced into that chamber, and wherein the heater is linked to all of the two or more chambers by being configured to heat a closed area defining the interior portion of the multi-chamber staining module”, in combination with the rest of the limitations of claim 8.
As to claim 16, the prior art of record, taken alone or in combination, fails to disclose or render obvious “staining module is a multi-chamber staining module, wherein each of the two or more chambers is disposed in an interior portion of the multi-chamber staining module and has a corresponding port adapted to allow the biological sample and the staining composition to be introduced into that chamber, and wherein the heater is linked to all of the two or more chambers by being configured to heat a closed area defining the interior portion of the multi-chamber staining module”, in combination with the rest of the limitations of claim 16.
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 MAURICE C SMITH whose telephone number is (571)272-2526. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURICE C SMITH/Examiner, Art Unit 2877
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