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
Applicant’s arguments and amendment have persuasively overcome the 112b rejections.
The remaining issues are addressed below.
101
Applicant argues:
It is respectfully submitted that any concept performed in the human mind cannot physically control a light source to generate light which passes through designated regions as amended claim 1
requires.
Examiner responds:
MPEP 2106.04(a)(2)(III)(A) identifies “displaying certain results of the collection and analysis” as a mental step. Because the display in Electric Power Group produced light while being a mental process, this computer controlled light display is also understood as a mental process.
Applicant argues:
It is respectfully submitted that the human mind cannot generate electrical "control signals" to operate an object lens to obtain one or more images.
Examiner responds:
This is a mental process for the above reasons.
Applicant argues:
Amended claim 1 recites a specific electro- mechanical control mechanism of a cytology imaging system without suffering the hardware burden of scanning the entire glass slide at high magnification.
Examiner responds:
This is merely automating the previously manual process. Specification, [0005].
Applicant argues:
Additionally, claim 1 has been further amended to recite the elements of "wherein...the target cells are distributed in a first space defined by the first subregion and the first depth of field" to ensure that the claimed computing device generates control signals to obtain images of only subregions including target cells, instead of subregions not including target cells.
Examiner responds:
The examiner disagrees that the claim limits where images are obtained.
Double Patenting
Applicant argues:
The references cited in the Office action fail to cure the deficiencies of the claims of Chen I and the claims of Chen Il, which will be further discussed below with respect to 35 U.S.C. § 102 and § 103 rejections.
Examiner responds:
The prior art rejections have been updated and maintained.
Prior Art
Applicant argues:
To anticipate claims 1 - 16 and 19, any of GBI article and Cancer article must teach each and every element of claims 1 - 16 and 19.
Examiner responds:
The examiner notes that the Office Action has shifted the burden to Applicant because the public use and/or on sale bar activities are substantially identical to the presently claimed invention.
Applicant argues:
It is respectfully submitted that none of GBI article, Cancer article, and Ascierto teaches at least these elements.
Examiner responds:
This lacks any explanation. See, e.g., In re Lovin, 652 F.3d 1349, 99 U.S.P.Q.2d 1373 (Fed. Cir. 2011)
Applicant argues:
GBI article discloses an image of software on a computer screen and nothing more.
Examiner responds:
The examiner disagrees.
Applicant argues:
Cancer article does not teach comparing the number of high-risk atypical cells to a threshold number of target cells
Examiner responds:
The Cancer article, p. 878, right column, discusses thresholds for risk levels. Also, the work of the scientists/doctors in the Cancer article is also part of the teaching (e.g., even if the software only counted cells and then the doctors decided if the count was above a threshold, that still meets the claims).
Applicant argues:
As clearly illustrated, the image in GBI article and Figure 1(A) of Cancer article are different images.
Examiner responds:
Yes, but they are of the same software.
Applicant argues:
Ascierto does not teach comparing a number of target cells to a threshold of the target cells as amended claim 1 requires
Examiner responds:
Ascierto, claim 3’s “rules” teach this.
Applicant argues:
Ascierto discloses an imaging system that "may include... other optical system having one or more objective lenses" but does not teach how its objective lenses are used.
Examiner responds:
One of ordinary skill in the art understands how to use an objective lens.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/403,660, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the claims of this application. For example, Application No. 63/403,660 does not disclose the claimed “wherein the second object lens is different from the first object lens,” because it is silent regarding the lenses. (For context, the current specification is 22 pages, whereas the provisional is three pages.)
Additionally, Applicant admitted that 63/403,660 lacks priority, see remarks of January 16, 2026, page 5.
Therefore, none of the claims are entitled to the priority date of Application No. 63/403,660.
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 and 3-15 (all claims) are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) without significantly more.
Step 1: Claim 1 (and its dependents) recite a method, and processes are eligible subject matter.
Step 2A, prong one: All of the elements of claims 1-16 and 19 are a mental process because a person can look at a glass slide and identify regions based on what they see. See, e.g., Specification [0005] describing this as potentially manual, and not identifying advantages to doing this digitally other than benefits that flow from this being done on a computer. As noted in the mapping of claim 8, the claimed wavelengths are in the visible color spectrum.
MPEP 2106.04(a)(2)(III)(C) explains that use of a generic computer or in a computer environment is still a mental process. In particular, this section begins by citing Gottschalk v. Benson, 409 US 63 (1972). “The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea.” In Benson the Supreme Court did not separately analyze the computer hardware at issue; the specifics of what hardware was claimed is only included in an appendix to the decision.
Because there are no additional elements, no further analysis is required for Step 2A, prong two or Step 2B.
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 and 3-15 (all claims) are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent Nos. US 11416990 and US 12412267 in view of the prior art as applied below.
Both the pending claims and the conflicting patent claims are all directed to imaging for cytology. Therefore, the conflicting patent is directed to the same problem as the present application. Therefore, all of the conflicting patents are directed to the same problem as the present application. Further, any differences between the present claims and the claims in any of the conflicting patents are obvious in view of the prior art as applied below. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to combine the below prior art with any of the conflicting patents for implementation details (especially as the patent claims lack implementation details). Based on the findings herein, this is an example of “(A) Combining prior art elements according to known methods to yield predictable results.” MPEP 2143.
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 and 3-15 (all claims) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites various “spaces” that are “defined” by various “subregions,” but the subregions are not themselves defined beyond being in a region through which light passes. Because the various spaces, regions and subregions lack definite boundaries, it is unclear how to determine if a space is defined by a subregion or not.
Claim 1 also recites that the various “spaces” are defined by various “depths of field.” Because “depth of field” is defined based on an acceptable focus (e.g., https://en.wikipedia.org/wiki/Depth_of_field), this is relative terminology that lacks sufficient guidance because the specification does not provide an objective measure or sufficient examples of what is and is not within the depth of field. MPEP 2173.05(b).
Dependent claims are also rejected.
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 1 and 3-15 (all claims) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by public use and/or on sale bar activities.
The examiner has previously attached (see the February 18, 2026 office action) a machine translation of an article from Global Bio & Investment Monthly titled “Medical Intelligence Must-Have Digital Cytology Directly Targets the US Market,” dated December 28, 2021, by Wu Pei’an, retrieved from https://news.gbimonthly.com/tw/magazine/article_show.php?num=45614 (“GBI article”).
The examiner has also previously attached (see the February 18, 2026 office action) a copy of:
Ou YC, Tsao TY, Chang MC, Lin YS, Yang WL, Hang JF, Li CB, Lee CM, Yeh CH, Liu TJ. Evaluation of an artificial intelligence algorithm for assisting the Paris System in reporting urinary cytology: a pilot study. Cancer cytopathology. 2022 Nov;130(11):872-80, retrieved from https://doi.org/10.1002%2Fcncy.22615 (“Cancer article”)
As an overview, the GBI article is available as prior art, and shows that AIxMED’s AIxURO software was in public use and on sale. The Cancer article also shows AIxMED’s AIxURO and is similar enough to the AIxURO software from the GBI article that the examiner is inferring that the AIxURO software described in the Cancer article (which was submitted within one year of Applicant’s priority date) is the same software as the AIxURO software from the GBI article. An affidavit or declaration detailing the differences may be successful in rebutting this inference.
The GBI article shows that the AIxURO software was ready for patenting. See the below image from the article, and note what is shown on the computer screen:
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The software shown in the above figure appears to be from the same AIxURO software as that from Fig. 1(A) of the Cancer article:
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The Cancer article was submitted in March of 2022, shortly after the GBI article came out in December 2021, and the closeness in time supports the idea that these two images are of the same AIxURO software.
Here, both the application and AIxURO are directed to counting cells from a Whole Slide Image to detect cancer using AI. Compare the “Background of the Invention” section of the current application to the GBI subheading “60 cells on a slide !? Target the most difficult exercises in urological cytopathology.” Further, compare how this section of the GBI article specifically states “cytopathology needs to examine individual cells scattered in liquid 3D space” to this specification stating “One reason is that the cytology specimen on the glass slide may contain single cells and cell groups distributed in a three-dimensional space.” Specification, [0005].
Claims 1 and 3-12 (all claims except those rejected under 103, below) are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by U.S. Pat. Pub. 20170270346 (“Ascierto”)
1. A method for a system having a computing device, a first object lens, and a second object lens to identify a cytology specimen including target cells, comprising: (Ascierto, [0175] “The imaging system may include, for example, a digital camera, a microscope or other optical system having one or more objective lenses … .” Fig. 1, computer 107.)
controlling, by the computing device, a light source to generate a first light which passes through a first region of the cytology specimen and the first object lens; (Ascierto, [0175] “The imaging system may include, for example, a digital camera, a microscope or other optical system having one or more objective lenses, and light sources, as well as a set of spectral filters.”)
generating, by the computinq device, a first set of control signals to obtain a first image of the first region through the first object lens having a first field of view, a first magnification and a first depth of field in the first field of view; (Ascierto, Fig. 11. Fig. 11 shows whole slide images, and these teach the claimed first and second images.)
controlling, by the computing device, the light source to generate a second light which passes through a first subregion within the first region and the second object lens; (Ascierto, [0175] “The imaging system may include, for example, a digital camera, a microscope or other optical system having one or more objective lenses, and light sources, as well as a set of spectral filters.”)
generating, by the computing device, a second set of control signals to obtain a second set of one or more images of the first subregion through the second object lens having a second field of view, a second magnification and a second depth of field in the second field of view, (Ascierto, Fig. 11. Fig. 11 shows whole slide images, and these teach the claimed first and second images.)
wherein the second object lens is different from the first lens and (Ascierto, [0175] “The imaging system may include, for example, a digital camera, a microscope or other optical system having one or more objective lenses … .” “More than one objective lens” teaches the claimed first and second lenses being different (in the sense that they are different instances, the claim does not require that the lenses magnify differently).)
the target cells are distributed in a first space defined by the first subregion and the first depth of field; (Ascierto, Fig. 11. The target cells can be chosen such that the claim is met.)
identifying, by the computing device, a first number of the target cells distributed in a space of the cytology specimen; (Ascierto, abstract, “An immune score and/or immune-related score may be generated based on the cells counted in each FOV.”)
comparing, by the computing device, the first number to a threshold number of target cells; (Ascierto, claim 3, “and applying cell-type and cancer-type specific rules on the cell count … for calculating the immune score.”)
generating, by the computing device and based on a result of the comparing, a third set of control signals to drive the second object lens to focus a second space defined by a second subregion within the first subregion and the first depth of field and to obtain a third set of one or more images of the second subregion through the second object lens and identifying, by the computing device, a second number of the target cells distributed in the second space, wherein the first subregion and the second subregion are different subregions within the first region. (Ascierto, abstract, “An immune score and/or immune-related score may be generated based on the cells counted in each FOV.” Ascierto’s “each” teaches the claimed “a third set of control signals to drive the second object lens …” See also, Figs. 14 and 15 (particularly steps 962 and 964).)
3. The method of claim 1, wherein the first field of view defines the first region. (Ascierto, Fig. 11.)
4. The method of claim 1, wherein the second field of view defines a part of the first subregion. (Ascierto, Fig. 11.)
5. The method of claim 1, wherein the second magnification is greater than the first magnification and the second depth of field is less than the first depth of field. (Ascierto, [0207] “a high resolution input image 631 from the image acquisition system 502,111, computing or receiving a low resolution version of the high resolution input image 631.” Moving closer to the image (i.e., moving to a lesser depth of field) results in greater magnification and lower resolution (similar to how zooming in on a digital image makes it grainier).)
6. The method of claim 1, prior to generating the first set of control signals, further comprising:
obtaining images of other regions of the cytology specimen through the first object lens; (Ascierto, Fig. 11.)
determining a first layer of the cytology specimen that includes the target cells based on the images of the other regions, (Ascierto, claim 1 “or depicting a tissue section adjacent to one of the tissue sections depicted by the multiple marker images” Ascierto’s adjacency teaches the claimed “other regions.”)
and the first depth of field; and (Ascierto, Fig. 11.)
obtaining images of the first layer through the first object lens, wherein one of the images of the first layer is the first image. (Ascierto, Fig. 11.)
7. The method of claim 1, wherein image characteristics of the target cells include a contrast, a lightness, a shape and color information of the target cells. (Ascierto, [0111] “A “blob” or “pixel blob” as used herein is a region in a digital image that differs in properties, such as brightness or color, compared to surrounding regions.” [0048] “identifying pixel blobs in the tumor image whose intensity values are above a threshold; … the shape of the pixel blob.” Ascierto’s intensity teaches the claimed contrast.)
8. The method of claim 7, wherein the color information is obtained through a third light with a first range of wavelengths from 530 nm to 630 nm, a fourth light with a second range of wavelengths from 450 nm to 560 nm or a fifth light with a third range of wavelengths from 450 nm to 530 nm. (Ascierto, [0173] “an RGB image.” The claimed wavelengths correspond to red, green and blue light respectively.)
9. The method of claim 7, wherein the color information includes a range of R, G and B values in an RGB (Red, Green, Blue) domain or a range of Hue value in a HSV (Hue, Saturation, Value) domain. (Ascierto, [0173] “an RGB image.”)
10. The method of claim 1, further comprising, determining whether a sum of the first number and the second number is greater than the threshold number. (Ascierto, claim 3, “and applying cell-type and cancer-type specific rules on the cell count … for calculating the immune score.”)
11. The method of claim 10, in response to determining the sum not greater than the threshold number, obtaining a fourth set of one or more images of a third subregion within the first region through the second object lens or a fifth set of one or more images of a fourth subregion within a second region the cytology specimen, wherein the first region and the second region are different regions from each other. (Not invoked.)
12. The method of claim 1, wherein the second set of control signals are configured to drive the second object lens to focus a third space of the cytology specimen defined by the first subregion and the second depth of field and to obtain an image of the third space to be one of the second set of one or more images. (Ascierto, Fig. 11)
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.
Claims 13-15 (the claims other than those rejected under 102) are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Pat. Pub. 20170270346 (“Ascierto”) in view of legal precedent (MPEP 2144.04).
13. The method of claim 1, further comprising generating additional control signals to obtain additional images of other regions of the cytology specimen through the first object lens before generating the second set of control signals, wherein the identifying the first number of the target cells is before generating the second set of control signals but after generating the additional control signals. (Ascierto, Fig. 11.)
Ascierto is not relied on for the claim language regarding the order of the steps (e.g., “before”). MPEP 2144.04(IV)(C), “In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).” The examiner’s review of the specification has not identified any new or unexpected results, nor any criticality to this order. Specification, both [0047] and [0060] state “Although the blocks are illustrated in a sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein.”
14. The method of claim 13, wherein the first number of the target cells distributed in the first space are identified from the first image and the additional images. (Ascierto, Fig. 11.)
15. The method of claim 14, wherein the second set of one or more images consists of obtaining one single image. (Ascierto, Fig. 11. See also, Ascierto, [0089] “Alternatively, the method comprises generating the marker images by taking an image from each of a plurality of single stain slides respectively comprising one of multiple adjacent tumor tissue sections.”)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10489633, claim 1, “electronically generating a plurality of patches of different sub-regions of a region of interest (ROI) from a digital pathology or cytology whole slide image (WSI) image”
US 9159129, title, “Generating image-based diagnostic tests by optimizing image analysis and data mining of co-registered images”
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 DAVID ORANGE whose telephone number is (571)270-1799. The examiner can normally be reached Mon-Fri, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Morse can be reached at 571-272-3838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID ORANGE/Primary Examiner, Art Unit 2663
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