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 .
Claim Objections
Claim 25 is objected to because of the following informalities: line 1, “farther” should read “further”. Appropriate correction is required.
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.
Claim(s) 1-4, 7 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stefanovic et al., Romanowsky-Giemsa as a counterstain for immunohistochemistry: optimizing a traditional reagent; Informa Healthcare, The Biological Stain Commission; Biotechnic & Histochemistry, 2-13, Vol. 88, No. 6, pp. 329-335, hereinafter Stefanovic.
Regarding claim 1, Stefanovic teaches a method for detecting a biomarker and morphology in a cell sample (abstract), the method comprising: contacting a cell sample with one or more biomarker-specific reagents that specifically binds to a biomarker in the cell sample (page 331, column 1, steps 1-7); depositing the biomarker-stained cell sample on a solid support (pages 330-331, columns 2-1, paragraphs 8-1); analyzing the biomarker-stained cell sample for one or more biomarker (page 332, column 1, paragraph 1); staining the biomarker-stained cell sample with a Romanowsky-type stain to obtain a Romanowsky-type stained cell sample (page 331, column 2, step 3); and analyzing the Romanowsky-type stained cell sample to determine morphology of at least one cell in the Romanowsky-type stained cell sample (page 332, column 2, paragraph 1).
Regarding claim 2, Stefanovic teaches wherein the one or more biomarker-specific reagents comprises a fluorescent label, a brightfield label, a nanoparticle label, a dye, and combinations thereof. (page 331, column 1, step 7).
Regarding claim 3, Stefanovic teaches further comprising contacting the cell sample with one or more detection reagents that specifically binds the one or more biomarker-specific reagents (page 331, column 1, step 6).
Regarding claim 4, Stefanovic teaches wherein the one or more detection reagents comprises a fluorescent label, a brightfield label, a nanoparticle label, a dye, and combinations thereof (page 331, column 1, step 7).
Regarding claim 7, Stefanovic teaches wherein the biomarker is selected from an extracellular biomarker, an intracellular biomarker, and combinations thereof (page 331, column 1, steps 1-7).
Regarding claim 8, Stefanovic teaches wherein the solid support is selected from a microscope slide, a coverslip, a plate, a tray, a cup, a tube, a vial, and combinations thereof (pages 330-331, columns 2-1, paragraphs 8-1).
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.
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.
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic in view of United States Application Publication No. 2014/0004561, hereinafter Lapen.
Regarding claim 6, Stefanovic teaches all limitations of claim 1; however, Stefanovic fails to teach the sample is a body fluid sample.
Lapen teaches an automated system for preparing biological specimens which uses a blood sample or epithelial tissue for the sample (Lapen, paragraph [0003]).
Examiner further finds that the prior art contained a device/method/product (i.e., a body fluid sample (blood)) which differed from the claimed device by the substitution of component(s) (i.e., epithelial tissue) with other component(s) (i.e., a body fluid sample), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., samples for analysis), and the results of the substitution (i.e., analyzing the sample) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the epithelial sample of reference Stefanovic with a body fluid sample of reference Lapen, since the result would have been predictable.
Regarding claim 11, Stefanovic teaches all limitations of claim 1; however, Stefanovic fails to teach the method is performed on an automated staining platform.
Lapen teaches an automated system for preparing biological specimens which provides a fast efficient and highly uniform specimen processing using minimal quantities of fluid (Lapen, abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have implemented the method on an automated staining platform because it would provide a fast efficient and highly uniform specimen processing using minimal quantities of fluid (Lapen, abstract).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic in view of United States Application Publication No. 2020/0300750, hereinafter Eshell.
Regarding claim 9, Stefanovic teaches all limitations of claim 1; however, Stefanovic fails to teach rein the cell sample is deposited on the solid support in a monolayer.
Eshell teaches a blood sample staining process in which the sample is prepared in a monolayer of cells which allow for examination of the majority of cells in any field of vision (Eshell, paragraph [0005]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have deposited the cell sample on the solid support in a monolayer because it would allow for examination of the majority of cells in any field of vision (Eshell, paragraph [0005]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic in view of United States Application Publication No. 2019/0025281, hereinafter Lee.
Regarding claim 10, Stefanovic teaches all limitations of claim 1; however, Stefanovic fails to teach the cell sample is deposited on the solid support by printing the cell sample on the solid support.
Lee teaches a device for detecting circulating tumor cells in which the sample is printed onto the solid support so that adjustment to the discharge speed or position can be made to provide the sample in a single layer (Lee, paragraph [0370]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have printed the cell sample on the solid support because it would allow for adjustments of the discharge speed or position to be made to provide the sample in a single layer (Lee, paragraph [0370]).
Claim(s) 23-26, 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic in view of United States Application Publication No. 2008/0026366, hereinafter Harkins.
Regarding claim 23, Stefanovic teaches a method for detecting a biomarker and morphology in a cell sample (abstract), the method comprising: contacting a cell sample with one or more biomarker-specific reagents that specifically binds to a biomarker in the cell sample (page 331, column 1, steps 1-7); depositing the biomarker-stained cell sample on a solid support (pages 330-331, columns 2-1, paragraphs 8-1); analyzing the biomarker-stained cell sample for one or more biomarker (page 332, column 1, paragraph 1); staining the biomarker-stained cell sample with a Romanowsky-type stain to obtain a Romanowsky-type stained cell sample (page 331, column 2, step 3); and analyzing the Romanowsky-type stained cell sample to determine morphology of at least one cell in the Romanowsky-type stained cell sample (page 332, column 2, paragraph 1).
Stefanovic fails to teach contacting the biomarker-stained cell sample on the solid support with one or more additional biomarker-specific reagents that specifically-bonds to a biomarker in the cell sample.
Harkins teaches a method in which multiple primary antibodies are utilized to mark different target antigens on a single sample (Harkins, paragraph [0101]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have contacted the biomarker-stained cell sample on the solid support with one or more additional biomarker-specific reagents because it would allow for multiple different target antigens to be identified on a single sample (Harkins, paragraph [0101]).
Regarding claim 24, Stefanovic teaches wherein the one or more biomarker-specific reagents comprises a fluorescent label, a brightfield label, a nanoparticle label, a dye, and combinations thereof (page 331, column 1, step 7).
Regarding claim 25, Stefanovic teaches further comprising contacting the cell sample with one or more detection reagents that specifically binds the one or more biomarker-specific reagents (page 331, column 1, step 6).
Regarding claim 26, Stefanovic teaches wherein the one or more detection reagents comprises a fluorescent label, a brightfield label, a nanoparticle label, a dye, and combinations thereof (page 331, column 1, step 7).
Regarding claim 29, Stefanovic teaches wherein the biomarker is selected from an extracellular biomarker, an intracellular biomarker, and combinations thereof (page 331, column 1, steps 1-7).
Regarding claim 30, Stefanovic teaches wherein the solid support is selected from a microscope slide, a coverslip, a plate, a tray, a cup, a tube, a vial, and combinations thereof (pages 330-331, columns 2-1, paragraphs 8-1).
Claim(s) 28 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic and Harkins as applied to claim 23 above, and further in view of Lapen.
Regarding claim 28, Stefanovic and Harkins teach all limitations of claim 23; however, they fail to teach the sample is a body fluid sample.
Lapen teaches an automated system for preparing biological specimens which uses a blood sample or epithelial tissue for the sample (Lapen, paragraph [0003]).
Examiner further finds that the prior art contained a device/method/product (i.e., a body fluid sample (blood)) which differed from the claimed device by the substitution of component(s) (i.e., epithelial tissue) with other component(s) (i.e., a body fluid sample), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., samples for analysis), and the results of the substitution (i.e., analyzing the sample) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the epithelial sample of reference Stefanovic with a body fluid sample of reference Lapen, since the result would have been predictable.
Regarding claim 33, Stefanovic and Harkins teach all limitations of claim 23; however, they fail to teach the method is performed on an automated staining platform.
Lapen teaches an automated system for preparing biological specimens which provides a fast efficient and highly uniform specimen processing using minimal quantities of fluid (Lapen, abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have implemented the method on an automated staining platform because it would provide a fast efficient and highly uniform specimen processing using minimal quantities of fluid (Lapen, abstract).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic and Harkins as applied to claim 23 above, and further in view of Eshell.
Regarding claim 31, Stefanovic and Harkins teach all limitations of claim 23; however, they fail to teach rein the cell sample is deposited on the solid support in a monolayer.
Eshell teaches a blood sample staining process in which the sample is prepared in a monolayer of cells which allow for examination of the majority of cells in any field of vision (Eshell, paragraph [0005]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have deposited the cell sample on the solid support in a monolayer because it would allow for examination of the majority of cells in any field of vision (Eshell, paragraph [0005]).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefanovic and Harkins as applied to claim 23 above, and further in view of Lee.
Regarding claim 32, Stefanovic and Harkins teach all limitations of claim 23; however, they fail to teach the cell sample is deposited on the solid support by printing the cell sample on the solid support.
Lee teaches a device for detecting circulating tumor cells in which the sample is printed onto the solid support so that adjustment to the discharge speed or position can be made to provide the sample in a single layer (Lee, paragraph [0370]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have printed the cell sample on the solid support because it would allow for adjustments of the discharge speed or position to be made to provide the sample in a single layer (Lee, paragraph [0370]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Petrovic, A. et al., Multicolor counterstaining for immunohistochemistry – a modified Movat’s pentachrome. Biotechnic & Histochemistry, 2010, 86(6), 429–435 which teaches analyzing in-between stainings of samples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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, Elizabeth Robinson can be reached at (571)272-7129. 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.
/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
Prosecution Insights