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
This application is a 371 of PCT/CN2021/079901, filed 3/11/2020. This application claims benefit to foreign applications PCT/CN2020/078752, filed 3/11/2020; CHINA 202020863635.5, filed 5/17/2020; CHINA 202021122240.6, filed 6/17/2020; CHINA 202021122914.2, filed 6/17/2020; and CHINA 202010919863.4, filed 9/04/2020. Claims 60-75 are pending.
Certified copies of 202021122240.6, 202021122914.2 and 202010919863.4 have been received; however, certified copies of PCT/CN2020/078752 and 202020863635.5 have not been received from the International Bureau nor from Applicant. Until the foreign priority is perfected, the effective filing date of the instant application is the filing date, 3/11/2020 because 202021122240.6, 202021122914.2 and 202010919863.4 alone or in combination do not appear to disclose the entire claimed invention.
Election/Restrictions
Applicant's election with traverse of Group II, claims 70-75, in the reply filed on 8/29/2025 is acknowledged. The timely traversal is on the ground that there is no undue search burden to the Examiner (Remarks, 8/29/2025, p. 6). This is not found persuasive because the instant application is a 371, i.e., National stage application, of an international application and the restriction requirement was based on a lack of unity, see MPEP 1875 for Unity of Invention of international applications. Search burden is not a criterion when determining unity of invention or lack of unity of invention; hence, Applicant’s argument is moot.
Claims 60-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement submitted on 8/30/22 has been considered by the examiner.
Drawings
The drawings are objected to for the informality detailed below.
37 C.F.R. 1.84(t) drawn to the numbering of sheets of drawings states “Numbering of sheets of drawings. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking.” The sheets of drawings received 8/26/2022 are not numbered with two Arabic numerals placed on either side of an oblique line, i.e., 1/9 through 9/9.
Appropriate correction is required.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 70-75 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 70, lines 8-9, recites “wherein the reagent carousel is configured to rotate on a d axis of rotation” which constitutes new matter because the original disclosure does not disclose that the reagent carousel is configured to rotate on a “d axis of rotation” as a “d axis of rotation” is not mentioned in the original disclosure nor in the drawings. Claims 71-75 depend from claim 70 and also constitute the new matter; hence, claims 70-75 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for constituting new matter.
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 70-75 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 70, lines 8-9, recites “wherein the reagent carousel is configured to rotate on a d axis of rotation” which renders the claim indefinite because the original disclosure does not disclose the metes and bounds of a “d axis of rotation” as a “d axis of rotation” is not mentioned in the original disclosure nor in the drawings. Claims 71-75 depend from claim 70 and do not resolve the indefiniteness; hence, claims 70-75 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 74, lines 1-2, recites “wherein the method further comprises a microscope slide mounting method” but no method steps of said microscope slide mounting method are disclosed. A method which does not recite any method steps is indefinite because one skilled in the art would not know how to practice a method with no defined method steps.
Claim 75 recites the limitation "the common liquid dispenser" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 75 depends from claim 70 and neither claim 70 nor claim 75 disclose a common liquid dispenser; hence, the limitation lacks antecedent basis; therefore, claim 75 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 75 also recites the limitation "the waste removal outlet" in line 9. There is insufficient antecedent basis for this limitation in the claim. Claim 75 depends from claim 70 and neither claim 70 nor claim 75 disclose a waste removal outlet; hence, the limitation lacks antecedent basis; therefore, claim 75 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 75 recites the limitation "the waste flow element" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Claim 75 depends from claim 70 and neither claim 70 nor claim 75 disclose a waste flow element; hence, the limitation lacks antecedent basis; therefore, claim 75 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 70-74 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Copeland et al., US 5595707 (cite A, attached PTO-892; herein “Copeland”).
Copeland teaches an automated immunostaining apparatus and methods of use for the apparatus (Abst.) wherein the apparatus comprises a microscope slide carousel (24 in Fig. 1; col. 6, l. 20 - col. 7, l. 9), wherein the microscope slide carousel is configured to rotate on a first axis of rotation (Fig. 1; col. 6, l. 20 - col. 7, l. 9), and wherein the microscope slide carousel comprises at least one microscope slide cartridge stall (26 in Fig. 1); a reagent assembly comprising: (i) a reagent carousel (10 in Fig. 1; col. 6, l. 20 - col. 7, l. 9), wherein the reagent carousel is configured to rotate on a second axis of rotation (Fig. 1; col. 6, l. 20 - col. 7, l. 9), and wherein the reagent carousel comprises at least one reagent holder (holes in 10 in Fig. 1), (ii) a dispensing actuator (18 in Fig. 1), and wherein the reagent carousel is positioned above the microscope slide carousel, and where the reagent carousel and the microscope slide carousel are positioned such that when a reagent is placed in the reagent carousel the reagent can flow from the reagent carousel to the microscope slide carousel (Fig. 1; col. 6, l. 20 - col. 7, l. 9), wherein the microscope slide cartridge assembly is interfaced with a microscope slide comprising the tissue sample (26 in Fig. 1; col. 6, l. 20 - col. 7, l. 9; Fig. 5; col. 7, l. 55 - col. 8, l. 19). Copeland teaches methods of staining a tissue sample comprising placing a microscope slide cartridge assembly (26) in a microscope slide stall of a tissue staining device (Fig. 1; col. 6, l. 20 - col. 7, l. 9; Fig. 5; col. 7, l. 55 - col. 8, l. 19) and initiating the tissue staining device to perform a tissue staining protocol thereby staining the tissue sample (col. 6, ll. 20-32; col. 2, l. 66 - col. 3, l. 7; col. 19, l. 49 - col. 21, l. 11) anticipating claim 70.
Copeland teaches that the staining protocol is selected (col. 6, ll. 20-32; col. 2, l. 66 - col. 3, l. 7) anticipating claim 71.
Copeland teaches that the tissue staining protocol can comprise a chemical staining protocol or an immunohistochemical staining protocol (col. 2, ll. 28-38; col. 6, ll. 20-32) anticipating claims 72-73.
Copeland teaches that the method further comprises a microscope slide mounting method (col. 7, l. 55 - col. 8, l. 19) anticipating claim 74.
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 70-75 are rejected under 35 U.S.C. 103 as being unpatentable over Copeland in view of Zhang et al., CN208092056 (Foreign Patent Document cite 6, IDS, 8/30/2022; English language translation from Espacenet (cite U, attached PTO-892; herein “Zhang”) is referenced in the cites below).
The discussion of Copeland regarding claims 70-74 set forth in the rejection above is incorporated herein.
Copeland clearly teaches that the tissue staining protocol comprises dispensing a reagent from the reagent carousel to the microscope slide, followed by vortex mixing stations to ensure the reagent fully coats the tissue sample, followed by rinsing the slide with rinse solution, i.e., washing with wash solution, in the rinse station (Fig. 12; col. 9, l. 57 - col. 10, l. 40), i.e., from a common liquid dispenser, and removing the wash solution by a jet drain (col. 19, l. 49 - col. 21, l. 11; col. 24, ll. 31-46) wherein the wash solution is evacuated through a waste removal outlet of the microscope slide carousel via a waste flow element (Fig. 13; col. 9, l. 57 - col. 10, l. 40) wherein the wash solution can comprise a buffer (col. 24, ll. 43-46).
Hence, Copeland’s method differs from claim 75 in that Copeland does not rotate the microscope slide carousel such that the reagent fully coats the tissue sample nor rotate the microscope slide carousel to remove the wash solution; however, a person of ordinary skill in the art at the time of filing would have found it obvious to practice Copeland’s method wherein the liquids are distributed and removed from the slides by rotation of the slide carousel in view of Zhang.
Zhang teaches a slide immunostaining apparatus comprising a slide carousel wherein the reagent is tiled across the slide, i.e., coats the slide, by centrifugally rotating the carousel (Abst.; “DETAILED DESCRIPTION OF THE EMBODIMENTS”, ¶2) and cleaning solution, i.e., wash solution, is distributed across the slide and into a waste liquid port by centrifugal rotation (pdf p. 6, “Working Principle”).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious that Copeland’s method could utilize rotating the microscope slide carousel to coat reagent on the slide and to wash the slide; therefore, claim 75 is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 70-75 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 76, 110, 112-113 and 115 of copending Application No. 17198058 (herein “’058”) in view of Copeland.
Claim 76 of ‘058 recites a tissue staining device comprising: (a) a microscope slide carousel, wherein the microscope slide carousel is configured to rotate on a first axis of rotation controlled by a first rotary control mechanism, and wherein the microscope slide carousel comprises at least one microscope slide cartridge stall configured to hold a microscope slide cartridge assembly, and (b) a reagent assembly comprising: (i) a reagent carousel, wherein the reagent carousel is configured to rotate on a second axis of rotation that is not coaxial with the first axis of rotation, and wherein the reagent carousel comprises at least one reagent holder, (ii) a dispensing actuator, and wherein the reagent carousel is positioned above the microscope slide carousel, and wherein the reagent carousel and the microscope slide carousel are positioned such that when a reagent is placed in the reagent carousel the reagent can flow from the reagent carousel to the microscope slide carousel, wherein the reagent assembly further comprises a second rotary control mechanism comprising a stationary actuator positioned relative to the second axis of rotation, and wherein the first rotary control mechanism is configured to rotate the microscope slide carousel on the first axis of rotation at a speed sufficient to remove a fluid from a chamber of the microscope slide cartridge assembly; claim 110 of ‘058 recites the tissue staining device of claim 76, wherein the reagent assembly comprises at least one common liquid dispenser comprising a liquid dispenser output port and at least one liquid pump, wherein the liquid dispenser output port is positioned such that when a liquid is dispensed from the liquid dispenser output port the liquid can flow from the liquid dispenser output port to the input port of the microscope slide cartridge assembly on the microscope slide carousel, wherein the directionality of the flow of the liquid is based on that of gravitational force, wherein the liquid flow represents an imaginary liquid dispensing axis, and wherein the liquid dispensing axis, the first axis of rotation, and the second axis of rotation are substantially parallel; claim 112 of ‘058 recites the tissue staining device of claim 76, further comprising a control unit; claim 113 of ‘058 recites the tissue staining device of claim 112, wherein the control unit comprises one or more processors and memory storing one or more programs, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for: (i) positioning the reagent carousel and/or positioning the microscope slide carousel; (ii) enacting the dispensing actuator; and (iii) performing a tissue staining protocol and/or performing a tissue dehydration protocol; and claim 115 of ‘058 recites the tissue staining device of claim 76, wherein the microscope slide carousel is configured to control rotary motions back and forth to agitate fluid in microscope slide cartridges to achieve mixing reagents and thoroughly wash clean the tissues on the slides. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice a method of staining a tissue sample, the method comprising: (a) placing a microscope slide cartridge assembly in a microscope slide stall of the tissue staining device recited in ‘058, wherein the microscope slide cartridge assembly is interfaced with a microscope slide comprising the tissue sample; and (b) initiating the tissue staining device to perform a tissue staining protocol thereby staining the tissue sample wherein the method comprises mounting a microscope slide to the apparatus, dispensing a reagent from the reagent carousel to the microscope slide, rotating the microscope slide carousel such that the reagent fully coats the tissue sample, dispensing a wash buffer from the common liquid dispenser to the microscope slide; and rotating the microscope slide carousel such that a solution comprising the wash buffer is moved to the waste removal outlet of the microscope slide carousel via the waste flow element; therefore, instant claims 70 and 74-75 are prima facie obvious over the claims of ‘058.
The claims of ‘058 do not specifically teach selecting a tissue staining protocol wherein the tissue staining protocol comprises a chemical staining protocol or an immunohistochemical staining protocol; however, a person of ordinary skill in the art at the time of filing would have found it obvious to select a tissue staining protocol wherein the tissue staining protocol comprises a chemical staining protocol or an immunohistochemical staining protocol in view of the disclosure of Copeland.
Copeland teaches an automated immunostaining apparatus and methods of use for the apparatus (Abst.). Copeland teaches methods of staining a tissue sample comprising placing a microscope slide cartridge assembly (26) in a microscope slide stall of a tissue staining device (Fig. 1; col. 6, l. 20 - col. 7, l. 9; Fig. 5; col. 7, l. 55 - col. 8, l. 19) and initiating the tissue staining device to perform a tissue staining protocol thereby staining the tissue sample (col. 6, ll. 20-32; col. 2, l. 66 - col. 3, l. 7; col. 19, l. 49 - col. 21, l. 11). Copeland teaches that the staining protocol is selected (col. 6, ll. 20-32; col. 2, l. 66 - col. 3, l. 7). Copeland teaches that the tissue staining protocol can comprise a chemical staining protocol or an immunohistochemical staining protocol (col. 2, ll. 28-38; col. 6, ll. 20-32). Hence, instant claims 71-73 are prima facie obvious over the claims of ‘058 in view of Copeland.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651