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 .
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11954926. Although the claims at issue are not identical, they are not patentably distinct from each other because they recited substantially the same limitations.
Claim Rejections - 35 USC § 101
3. 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 1-18 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims 2 and 10 recite,
(c) computationally align said first sequence of time-stamped images with said second sequence of time stamped images such that said first sequence of time- stamped images and said second sequence of time-stamped images are development- time matched; and(d) computationally process each image of said first and said second sequences of time-stamped images in order to identify and track unique features of successfully implanted embryos for use as predictors of successful IVF implantation..”,
which can all reasonably be construed as mental processes, i.e. the phrases “computationally align” and “computationally process” the alignment of time-stamped images that are development time matched and to identify and track unique features of successfully implanted embryos are processes which can be performed by a trained human using their brain to do to the computation as stated in the specification, Pg 2, line 13, as a skilled observer i.e. embryologist can perform these computations.
This shows that a person can perform these steps by viewing the image.
This judicial exception is not integrated into a practical application because additional limitations of “(a) obtain a first sequence of time-stamped images tracking development of a pre-implantation embryo that has been qualified as being successfully implanted; “
“(b) obtain a second sequence of time-stamped images tracking development of a pre-implantation embryo that has been qualified as being non-successfully implanted;”
are data gathering steps, that do not add a meaningful limitation to the abstract idea as they are insignificant extra-solution activities.
Listed depending claims do not remedy these deficiencies.
Claims 2 and 11 also pertain to identifying details in the gathered images albeit in more detail. But can still be construed as mental processes where a person makes these determinations.
Claims 3-4 and 12-13 define the nature of the data collected which does not add a meaningful limitation or practical application.
Claim 5 and 14 further defines the unique features in the data collected, which does not add a meaningful limitation or practical application.
Claim 6 and 15 recites an additional element recited at a high level of generality akin to a processor, which does not add a meaningful limitation or a practical application.
Claim 7-8, 16 and 17 are image processing steps which merely alter the appearance of the data collected and does not add a meaningful limitation or practical application.
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 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.
Claims 1-2, 4, 7, 10-11, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell, (“Retrospective analysis of outcomes after IVF using an aneuploidy risk model derived from time-lapse imaging without PGS, Alison Campbell a,*, Simon Fishel a, Natalie Bowman b, Samantha Duffy b, Mark Sedler b, Simon Thornton”, hereinafter referred to as “Campbell”).
Regarding Claim 1,
Campbell teaches A system for identifying predictors of successful IVF implantation, wherein the system comprises: a memory; and a processor configured to:(a) is configured to:
obtain a first sequence of time-stamped images tracking development of a pre-implantation embryo that has been qualified as being successfully implanted;
obtain a second sequence of time-stamped images tracking development of a pre-implantation embryo that has been qualified as being non-successfully implanted;
(Campbell, section – Outcome measures, 2nd paragraph, lines 5 – 13, “
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Additionally, Campbell, Pg. 142, Left Col, 1st paragraph, lines 5 – 10,
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Time-lapse images obtained corresponding to KID value of “1” and the images corresponding to a KID value of “0” are equivalent to obtaining a first sequence of time-stamped images tracking development of a pre-implantation embryo that has been qualified as being successfully implanted and a second sequence of time-stamped images tracking development of a pre-implantation embryo that has been qualified as being non-successfully implanted.)
(c) computationally align said first sequence of time-stamped images with said second sequence of time stamped images such that said first sequence of time-stamped images and said second sequence of time-stamped images are development-time matched; and (Campbell, Pg. 144, Fig. 2,
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In Fig.2. the outcomes of successful implantations are illustrated by blue “+” and unsuccessful implantation is red “-” which correspond to the first and second time stamped sequence of images, they are plotted along tB = time from insemination to the formation of a “full blastocyst” and tSB = time from insemination to the start of blastulation which shows that they are development time matched time stamped images.)
( d ) computationally process (Campbell, Pg. 142, left col, 2nd paragraph, line 1, “aneuploidy risk classification model”) each image of said first and said second sequences of time-stamped images in order to identify and track unique features of successfully implanted embryos thereby identifying predictors (tSB and tB) of successful IVF implantation (Campbell, Pg. 142, left col, 1st paragraph,lines 10 – 19 and 2nd paragraph, lines 7 – 16, “
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“All times were recorded in hours post insemination by ICSI and the ‘annotations’
(detailed recordings of embryo development) were completed prior to embryo transfer”
in combination with
“(i) tSB, the time from insemination to the start of blastulation, when the first sign of a blastocoele cavity forming was visible; and (ii) tB, the time from insemination to the formation of a ‘full blastocyst’, when the blastocoele cavity filled the embryo, the inner cell mass and trophectoderm tissues were distinguishable from each other and there was no more than 10% increase in the outer diameter of the zona pellucida.”
and
“ tSB and tB were not used as selection criteria but were studied retrospectively in relation to the outcome of the embryo transfer.”
Show that each image of said first and said second sequences of time-stamped images in order to identify and track unique features (such as tSB and tB) of successfully implanted embryos thereby identifying predictors (tSb and tB) of successful IVF implantation).
Regarding Claim 2,
Campbell teaches the system of claim 1, wherein (c) is effected by identifying a specific developmental feature ( tB and TSB, Campbell, Pg. 142, left col, 2nd paragraph, lines 7 – 16 “(i) tSB, the time from insemination to the start of blastulation, when the first sign of a blastocoele cavity forming was visible; and (ii) tB, the time from insemination to the formation of a ‘full blastocyst’, when the blastocoele cavity filled the embryo, the inner cell mass and trophectoderm tissues were distinguishable from each other and there was no more than 10% increase in the outer diameter of the zona pellucida.”)
in said first sequence of time-stamped images and said second sequence of time stamped images and setting a common development time based on said developmental feature.
(Campbell, Pg. 144, Fig. 2,
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In Fig.2. the outcomes of successful implantations are illustrated by blue “+” and unsuccessful implantation is red “-” which correspond to the first and second time stamped sequence of images, they are plotted along tB = time from insemination to the formation of a “full blastocyst” and tSB = time from insemination to the start of blastulation which shows that they are development time matched time stamped images.)
Regarding Claim 4,
Campbell teaches the system of claim 1, wherein said first sequence of time-stamped images and said second sequence of time-stamped images are time lapse sequences (Campbell, Pg. 142, Left Col, 1st paragraph, lines 5 – 10,
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The images acquired every 20 minutes is the sequence of time-stamped time lapse images)
Regarding Claim 7,
Campbell teaches the system of claim 1, wherein the system is further configured to modify each image (annotations) of said first and said second sequences of time-stamped images prior to (d) (Campbell, Pg. 142, left column, 1st paragraph, lines 5 – 19, The time lapse images were displayed on the EbryoViewer image analysis software to log and display the precise timing of developmental events. Embryologists assessed these events by studying the images and all the times were recorded and annotations i.e detailed recordings of embryo development were completed prior to transfer. This indicates that that some modification of each time – stamped image was performed during the steps mentioned above.
Since, the detailed annotations were performed while the embryologist was blind to the outcome indicates that the first and second sequences were included in the analysis mentioned above.
The modification of the images were performed prior to step (d) i.e. Campbell, Pg. 142, left col, 2nd paragraph, line 1 - 16, aneuploidy risk classification model using morphokineetic variables such as tSB and tB is equivalent to the teaching of step (d)).
Regarding claim 10, It recites the system of claim 1 as a method. Thus, the analyses in rejecting claim 1 are equally applicable to claim 10.
Regarding claim 11, The analyses in rejecting claim 2 are equally applicable to claim 11.
Regarding claim 13, The analyses in rejecting claim 3 are equally applicable to claim 13.
Regarding claim 16, The analyses in rejecting claim 7 are equally applicable to claim 16.
Claim Rejections - 35 USC § 103
5. 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 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.
Claims 3, 9, 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Khan (“Automated Monitoring of Early Stage Human Embryonic Cells in Time-lapse Microscopy Images, Aisha Sajjad Khan, A thesis submitted for the degree of Doctor of Philosophy at The Australian National University September 2016” hereinafter referred to as “Khan”)
Regarding claim 3,
Campbell teaches the system of claim 1,
Campbell fails to teach “ wherein said first sequence of time-stamped images and said second sequence of time-stamped images are video sequences”
Khan teaches wherein said first sequence of time-stamped images and said second sequence of time-stamped images are video sequences, (Khan, Pg. 20, lines 1 – 3, “After each experiment, the images were compiled into a time-lapse movie with well identification labels and timestamps that allowed manual measurement of the imaging parameters (see Fig. 2.3)”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to replace Campbells time-lapse images with Khan’s time-lapse video.
The motivation for doing so would have been to enable users to get a first look at important biological processes, (Khan, section 1.1.2, lines 1 – 4,
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Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Khan’s time lapse video with Campbell’ time-lapse images to obtain the invention as specified in claim 3.
Regarding claim 9,
Campbell teaches the system of claim 1,
Campbell fails to teach “wherein the identifying and tracking of features comprises the system being configured to: determine a plurality of characteristic values for each pixel or group of pixels within the image, wherein each of the plurality of characteristic values relates to a different characteristic of the feature; and, determine a confidence value for a target area of the image on the basis of the plurality of characteristic values of the pixels within the target area, wherein the confidence value is indicative of whether the feature is represented by the target area of the image.”
Khan teaches wherein the identifying and tracking of features comprises the system being configured to: determine a plurality of characteristic values for each pixel or group of pixels within the image, wherein each of the plurality of characteristic values relates to a different characteristic of the feature; (Khan, Section- 4.2.1.4 Features Description, 2nd paragraph, lines 1 - 3 and following table,
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and, determine a confidence value (Table, 4.2, overall %) for a target area of the image (Figure. 4.5,
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masked out intensity image is interpreted to be the target area of the image) on the basis of the plurality of characteristic values of the pixels within the target area (Khan, Section- 4.2.1.4 Features Description, 1st paragraph, lines 1 - 3 and following table
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Features derived from the pre-processed intensity image are interpreted to be the plurality of characteristic values of the pixels within the target area);
wherein the confidence value is indicative of whether the feature is represented by the target area of the image ( Khan, Table 4.2, Overall % is interpreted to be the confidence value that is indicative of the feature i.e. number of cells
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Additionally, Fig. 4.7 illustrates the target area of the image and the pixel intensity variation characteristics and comparison with ground truth cell transitions which is indicative of whether the feature is represented by the target area of the image.
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It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to add Khan’s method of generating features and confidence score to Campbell’s system for identifying predictors of successful IVF implantation.
The motivation for doing so would have been to have access to a rich set of tools such as methods of image preprocessing and feature extraction for automated monitoring of early stage human embryo development which would assist in increasing the accuracy of embryonic cell counting which is a critical factor in selecting viable embryos for IVF procedures (Khan, section- 8.3.1 CNN-based Embryonic Cell Counting, paragraphs 2 & 3, lines 1- 19,
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Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Khan’s method of generating features and confidence score with Campbell’s system for identifying predictors of successful IVF implantation to obtain the invention as specified in claim 34.
Regarding claim 12, The analyses in rejecting claim 3 are equally applicable to claim 12.
Regarding claim 18, The analyses in rejecting claim 9 are equally applicable to claim 18.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Bodri (“Blastocyst collapse is not an independent predictor of reduced live birth: a time-lapse study”, Daniel Bodri, M.D., M.Sc., Ph.D., Takeshi Sugimoto, M.Sc., Jazmina Yao Serna, M.Sc., Satoshi Kawachiya, M.D., Ryutaro Kato, B.Sc., and Tsunekazu Matsumoto, M.D., Ph.D. Kobe Motomachi Yume Clinic, Kobe, Japan.”, hereinafter referred to as “Bodri”)
Regarding Claim 5,
Campbell teaches the system of claim 1, wherein said unique features are characterized by morphology (morphokinetic variables) , appearance time ((i) tSB, the time from insemination to the start of blastulation,
when the first sign of a blastocoele cavity forming was visible), magnitude of morphological change over time (when the blastocoele cavity filled the
embryo, the inner cell mass and trophectoderm tissues were distinguishable from each other and there was no more than 10% increase in the outer diameter of the zona pellucida.), time length of appearance ((i) tSB, the time from insemination to the start of blastulation, when the first sign of a blastocoele cavity forming was visible), time length of morphological change and association with a genetic marker (The two morphokinetic variables used in the aneuploidy risk classification model that was retrospectively applied to the blastocysts in this study were defined as: (i) tSB,
the time from insemination to the start of blastulation, when the first sign of a blastocoele cavity forming was visible; and (ii) tB, the time from insemination to the formation
of a ‘full blastocyst’, when the blastocoele cavity filled the embryo, the inner cell mass and trophectoderm tissues were distinguishable from each other and there was no more than 10% increase in the outer diameter of the zona pellucida.).
Campbell does not teach “ wherein the unique features are characterized by disappearance time”
Bodri teaches wherein the unique features are characterized by disappearance time, (Bodri, Section - Time-lapse annotations, lines 8 -11, “Early (PNf, t2–t9) and late (start of blastulation and full blastocyst) morphokinetic time points were scored in accordance with recently published consensus criteria (25).” PNf = pronuclear fading (footnote under table 3), the fading time point is interpreted to be the disappearance time)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add Bodri’s method of collecting pronuclear fading time points from time-lapse images of embryos to analyze blastocyst collapse as a predictor of IVF viability to Campbell’s system for identifying predictors of successful IVF implantation.
The motivation to do so would have been to achieve standardized results when using Time-lapse technology to monitor variables to perform univariate and multivariate analysis on the association between live birth and categorical TLM (time lapse monitoring) variables and other confounders which will improve the predictability of live birth from analysis of time-lapse images of embryos. (Bodri, section, Time-lapse annotations, last 6 lines, “
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Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Campbell’s system for identifying predictors of successful IVF implantation with Bodri’s method of collecting pronuclear fading time points from time-lapse images of embryos to analyze blastocyst collapse as a predictor of IVF viability to obtain the invention as specified in claim 30.
Regarding claim 14, The analyses in rejecting claim 5 are equally applicable to claim 14.
Claims 6, 8, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of “Patil” ( “Deep Learning Techniques for Automatic Classification and Analysis of Human in Vitro Fertilized (IVF) embryos. Prof. Sujata N Patil1, Dr. Uday Wali 2, Dr. M K Swamy 3, Nagaraj S P 4& Dr. Nandeshwar Patil 5 1 Research Scholar, KLE Academy of Higher Education & Research, Belagavi, India 2 Dept. of Electronics & Communication, KLEDr MSS College of Engineering & Technology, Belagavi, 3 J N Medical College, KLE Academy of Higher Education, Belagavi, India 4LIVFC & SSFC, Jayanagar, Bangalore, India Email:nagarajbgm@gmail.com 5KLE Dr Prabhakar Kore Hospital & MRC, Belagavi, India”, hereinafter referred to as “Patil”)
Regarding claim 8,
Campbell teaches the system of claim 7,
Campbell fails to teach “wherein said modifying is selected from the group consisting of colour shifting, colour filtering and embossing”.
Patil teaches wherein said modifying is selected from the group consisting of colour shifting, colour filtering and embossing (Patil, Section- III. Convolutional Neural Network, 1st paragraph, lines 2 and 7,
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The usage of an image filter to modify the colors in the input image to facilitate image interpretation such as object classification, region of interest detection, scene description etc is interpreted as the type of modification from the group consisting of colour shifting, colour filtering and embossing and this modification is helpful in achieving the goals of step (d) which is an identifying step).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add Patil’s CNN and including it prior to the annotation by embryologists of Campbell.
The motivation for doing so would have been to increase the quality of images in order to facilitate better quality annotations (Patil, Section- III. Convolutional Neural Network, 1st paragraph, lines 2 and 7 and 2nd paragraph lines 1 – 8.
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Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Patil’s CNN and including it prior to the annotation by embryologists of Campbell to obtain the invention as specified in claim 33.
Regarding claim 17, The analyses in rejecting claim 8 are equally applicable to claim 17.
Regarding claim 15,
Campbell teaches the method of claim 10,
Campbell fails to teach “wherein (d) is effected by a deep learning algorithm”
Patil teaches wherein computationally processing each image of the first and the second sequences of time-stamped images in order to identify and track unique features of successfully implanted embryos thereby identifying predictors of successful IVF implantation is effected by a deep learning algorithm (Patil, section- Feature extraction and Fig. 4
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The usage of a convolutional neural network is interpreted as using a deep learning algorithm to perform method of (d) where step (d) is an identifying step which is demonstrated by the feature extraction process.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add Patil’s deep learning techniques for analysis of human IVF embryos to Campbell’s system for identifying predictors of successful IVF implantation.
The motivation for doing so would have been to increase the accuracy of the prediction of the outcome of implantation by checking the viability of the embryo using deep learning models (Patil, Section 1. Introduction, 2nd paragraph. Lines 1 – 3,
“Convolutional Neural networks (CNNs) are a type of deep learning models that can act directly on the raw inputs, thus automating the process of feature construction. Machine learning algorithms are proving to be better in checking viability of embryo and prediction of the outcome of implantation”)
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Patil’s deep learning techniques for analysis of human IVF embryos with Campbell’s system for identifying predictors of successful IVF implantation to obtain the invention as specified in claim 40.
Regarding claim 6, The analyses in rejecting claim 15 are equally applicable to claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANDHI THIRUGNANAM whose telephone number is (571)270-3261. The examiner can normally be reached M-F 8:30-5PM.
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/GANDHI THIRUGNANAM/Primary Examiner, Art Unit 2672