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 .
Status of Claims
Claims 1-20 have been examined.
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 1, 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 of U.S. Patent No. 12,217,837. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a system/method for digitization of tissue slides based on associations among serial sections. The claims differ in that claim 1 and 11 of the current application recite retrieving a first, a second map, whereas claim 1, 11 of US Patent No. 12,217,837 recite retrieving a candidate tissue map and retrieve a reference tissue map associated with a reference tissue section.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claim(s) 1-10 recite(s) a system, which is within the four statutory categories (i.e. machine). Claims 11-20 recite a method, which is within the four statutory categories (i.e. process)..
Step 2A | Prong One
Claim 1 recites
A system for digitization of tissue slides based on associations among serial sections, wherein the system is comprised of:
at least a computing device, wherein the computing device is comprised of:
a memory, wherein the memory stores instructions; and
a processor, communicatively connected to the memory, wherein the processor is configured to:
retrieve a first map;
retrieve a second map, wherein the second map comprises a slide that is digitized using a scanner;
align, using a registration module, the second map;
generate a regenerated second map as a function of the first map, wherein the regenerated second map is digital; and
select a scan parameter as a function of the regenerated second map, wherein the scan parameter is configured to instruct the scanner; and
the scanner, wherein the scanner is configured to:
scan at least a slide as a function of the scan parameter; and
send a digitized image of the at least a slide to the at least a computing device
The above underlined limitations, under the broadest reasonable interpretation constitutes (b) certain methods of organizing human activity (e.g. fundamental economic principles or practice including hedging, insurance, mitigating risk; etc., commercial or legal interactions including agreements in the form of contracts, etc., managing personal behavior or relationships or interactions between people including social activities, teaching, following rules or instruction, etc.) because these limitation could be performed by the user to monitor, to establish the recirculation in the dialysis liquid through the dialysis. Accordingly, the claim is directed toward at least one abstract idea.
Furthermore, the abstract idea for claim 11 is identical as the abstract idea for claim 9, because the only difference between claim 1 and claim 11 is that claim 1 recites a system, whereas claim 11 recites a method.
Furthermore, the following depending claims further define the at least one abstract idea, and thus fail to make the abstract idea any less abstract.
Dependent claim 3 recites the stained tissue, claims 9-10, 19-20 recite scan parameters of the slides with magnification, resolution levels. Claims 6-7, 16-17 recite t, as being part of the abstract idea, and thus part of certain methods of organizing human activity.
Step 2A | Prong Two
Claim 1 recites
A system for digitization of tissue slides based on associations among serial sections, wherein the system is comprised of:
at least a computing device, wherein the computing device is comprised of:
a memory, wherein the memory stores instructions; and
a processor, communicatively connected to the memory, wherein the processor is configured to:
retrieve a first map;
retrieve a second map, wherein the second map comprises a slide that is digitized using a scanner;
align, using a registration module, the second map;
generate a regenerated second map as a function of the first map, wherein the regenerated second map is digital; and
select a scan parameter as a function of the regenerated second map, wherein the scan parameter is configured to instruct the scanner; and
the scanner, wherein the scanner is configured to:
scan at least a slide as a function of the scan parameter; and
send a digitized image of the at least a slide to the at least a computing device
Furthermore, claims 1-20 are not integrated into a practical application because there is no application or use of the abstract idea in any meaningful way. In particular, the claims recite the additional elements, using a scanner, a processor, a memory, …; (Spec., Para 0014,) for scanning a slide, The specification’s written description describes these mere generic components. These components encompass any number of suitable computer architectures. And thus, these components are recited at a high-level of generality. The specification does not provide any specific information of how to digitize tissue slides from serial section, how to regenerate tissue map as function of the reference tissue map. Furthermore, the use of a computing device to retrieve, to align to compare “add nothing when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
And thus, it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect step 2A, Prong One, the additional elements are recited at a high level of generality, and the written description describes these elements such as the computing device, a scanner are generic computer components, (Spec.; Para 0014). The Examiner submits that these limitations amount to merely using these computer devices as well-understood, routine, conventional activity (Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018).), and MPEP 2106.05(d)(I)(2). Further the use of generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patient-ineligible abstract idea into a patent-eligible invention”). Thus, claims 1-20 have been held as patent ineligible under 35 USC 101.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: registration module in claims 1 and 11.
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.
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 § 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 1-20 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.
Claims 1 and 11 recite ”retrieving a first map.., retrieving a second map”. The specification merely describes the regeneration of a candidate tissue map and reference tissue map. There is no disclosure of any structure to perform the retrieval of a first map, second map. Therefore, the claims render indefinite.
Claims 1 and 11 recite ”generate a regenerated second map as a function of the first map”. The specification merely describes the regeneration of a candidate tissue map and reference tissue map. The specification is devoid of adequate structure to perform the claimed function. There is no disclosure of any structure to perform the generating a regenerated second map as a function of the first map. Therefore, the claims render indefinite.
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 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 ahrens et al. (EP2783716A1 hereinafter Ahrens)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.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US 20220156930A1 hereinafter Barnes) in view of Yip et al. (US20220101519A1 hereinafter Yip).
With respect to claim 1, Barnes teaches a system for digitization of tissue slides based on associations among serial sections (‘930; Para 0064: Once the image data is received (S401), an image in a series of images corresponding to slides comprising serial tissue sections may be displayed on a user interface for field-of-view (FOV) selection and annotation), wherein the system is comprised of:
at least a computing device, wherein the computing device is comprised of:
a memory, wherein the memory stores instructions; and
a processor, communicatively connected to the memory, wherein the processor is configured to:
retrieve a first map (‘930; Para 0077: in the automated mode, either an Area of Interest (AoI) detector finds or identifies a tissue region in the whole slide image or the tissue annotations are automatically generated by some other image analysis algorithm, such as image registration algorithm which maps annotations from the adjacent serial section to the IHC tissue slide);
retrieve a second map, wherein the second map comprises a slide that is digitized using a scanner (‘930; Para 0035: a series of histopathological simplex and/or multiplex tissue slides from serial sections of cancerous tissue block corresponding to each patient and stained with H&E and multiple IHC tumor and immune markers (such as tumor markers ER, PR, Ki67, HER2, etc. and/or immune markers such as CD3, CD8, CD4 etc.) are digitized using a digital pathology scanning system, for example, on a whole slide scanner or a digital microscope; Para 0077: after detecting candidate nuclei, algorithms can be used automatically to provide a score or information about the entire analyzed image. The selection criteria can be modified or determined based at least in part on reference images. For example, reference images of stained breast tissue can be used to determine selection criteria used to select nuclei of an image of breast tissue from a subject. In some embodiments, the user can delete any areas of interest on a slide-by-slide basis);
align, using a registration module, the second map (‘930; Para 0042: Annotation and Registration module 112 annotates the FOV on the first slide and maps the annotations across the remainder of the slides. As described herein, several methods for annotation and registration are possible, depending on the defined FOV. For example, a whole tumor region annotated on a Hematoxylin and Eosin (H&E) slide from among the plurality of serial slides may be selected automatically or by a pathologist on an interface such as VIRTUOSO/VERSO™ or similar);
generate a regenerated second map as a function of the first map, wherein the regenerated second map is digital (‘930; Para 0076: a set of reference slides is used. For example, the reference slide images can be images of the same type of tissue as the tissue to be analyzed. The system learns about characteristics of the observed variability in the digitized image because of data variability in tissue, staining protocols, image scanning and artifacts sources based at least in part on the known information associated with the reference images. The system can receive at least one classification method and train a classifier using the digitized images of tissue samples. The classifier can be modified using additional reference slides); and
Yip teaches
select a scan parameter as a function of the regenerated second map (‘519; Para 0123), wherein the scan parameter is configured to instruct the scanner; and
the scanner, wherein the scanner is configured to:
scan at least a slide as a function of the scan parameter (‘519; Para 0050: a computing device configured to identifying biomarkers in digital image of a Hematoxylin and eosin (H&E) stained slide of target tissue, the computing device comprises: one or more memories; and one or more processors configured to, receive the digital image; perform an image tiling process on the digital image by separating the digital image into a plurality of tile images, where each of the plurality of tile images contains a different portion of the digital image; apply the plurality of tile images to a multiscale deep learning framework comprising one or more trained deep learning multiscale classifier models; Para 0094: ), and
send a digitized image of the at least a slide to the at least a computing device (‘519; Para 0123: The imaging-based biomarker prediction system 102 may further send generated reports to a computer system 120 of the patient's primary care provider and to a physician clinical records system 122 for databasing the patients report with previously generated reports on the patient and/or with databases of generated reports on other patients for use in future patient analyses, including deep learning analyses ) (‘288; Para 0192: enabling customers to view data through a web browser, store de-identified patient information associated with the tissue and digitized whole slide images that the tissue repository scans, and slide digitization for creating a training data set for automated diagnostic algorithms.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the histopathological tissue slide analysis of Barnes with the technique of determining biomarkers from histopathology slide image as taught by Yip in order to provide a digitized image in tissue repository.
Claim 11 is rejected as the same reason with claim 1.
With respect to claim 2, the combined art teaches the system of claim 1, Barnes discloses wherein: the first map is associated with a first section; and the second map is associated with a second section (‘930; FIGS. 2A & B).
Claim 12 is rejected as the same reason with claim 2.
With respect to claim 3, the combined art teaches the system of claim 2, Barnes discloses wherein: the first section comprises a Hematoxylin and Eosin (H&E)-stained slide; and the second section comprises a non-H&E-stained slide (‘930; Para 0042: a whole tumor region annotated on a Hematoxylin and Eosin (H&E) slide from among the plurality of serial slides may be selected automatically or by a pathologist on an interface such as VIRTUOSO/VERSO™ or similar).
Claim 13 is rejected as the same reason with claim 3.
With respect to claim 4, the combined art teaches the system of claim 2, Barnes discloses wherein retrieving the second map comprises identifying the second section as a function of stain information, wherein the stain information comprises a stain type (‘930; Para 0065).
Claim 14 is rejected as the same reason with claim 4.
With respect to claim 5, the combined art teaches the system of claim 2, Barnes discloses wherein retrieving the first map comprises identifying the first section as a function of an identification number and a block identification number (‘288; Paras 0155-0156: the take-up reels may be labeled as described above with section identifiers and/or sample block identifiers such that the correct take-up reels may be later retrieved.).
Claim 15 is rejected as the same reason with claim 5.
With respect to claim 6, the combined art teaches the system of claim 1, Barnes discloses wherein the registration module comprises an inline computing program (‘930; Para 0042).
Claim 16 is rejected as the same reason with claim 6.
With respect to claim 7, the combined art teaches the system of claim 1, Barnes discloses wherein aligning the second map comprises: receiving a user input from a user interface, wherein the user input indicates a location of a feature of the first map; and aligning, using the registration module, the second map to the first map as a function of the user input (‘930; Paras 0021-0022: The images are aligned in accordance with the image registration. In other words, the geometrical transformations that are generated by the image registration algorithm are applied to the images for aligning the images such as to display the aligned images on a display in a two-dimensional plane).
Claim 17 is rejected as the same reason with claim 7.
With respect to claim 8, the combined art teaches the system of claim 1, Barnes discloses wherein generating the regenerated second map is configured for avoiding untimely detection of errors (‘930; Paras 0008, 0043).
Claim 18 is rejected as the same reason with claim 8.
With respect to claim 9, the combined art teaches the system of claim 1, Yip discloses wherein the scan parameter comprises a magnification level (‘519; Paras 0116: The histopathology images may be images captured by any dedicated digital medical image scanners, e.g., any suitable optical histopathology slide scanner including 20× and 40× resolution magnification scanners).
Claim 19 is rejected as the same reason with claim 9.
With respect to claim 10, the combined art teaches the system of claim 1, Yip discloses wherein the scan parameter comprises a resolution level (‘519; Paras 0116, 0119: resolution).
Claim 20 is rejected as the same reason with claim 10.
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686