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
Claims 20, 21, 24 and 25 are objected to because of the following informalities:
Regarding claim 20, in line 1, “the oocytes” should be rewritten as “the one or more oocytes”.
Regarding claim 21, in line 2, “the identified oocytes” should be rewritten as “the one or more identified oocytes”.
Regarding claim 24, in line 7, “a ML model” at the first instance should be rewritten as “a machine learning (ML) model”. “a ML model” can be used after that.
Regarding claim 25, in line 2, “each depicting” should be rewritten as “each image depicting”.
Appropriate correction is required.
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:
In claim 9, "sorting unit" → defined as a plurality of controllable valves (“controller may control a sorting unit, comprising a plurality of controllable valves, to fill an oocytes container”, paragraph [0040] in specification)
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.
Claim 1-7, 9-12, 23 and 25 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.
Regarding claim 1, it recites the limitation "the suction unit" at line 9. There is insufficient antecedent basis for this limitation in the claim. Claims 2-7 and 9-12 are also rejected due to its dependency on claim 1.
Regarding claim 2, in line 2, it is unclear if “suction unit” is the same as or different from “the suction unit” recited at line 9 of claim 1. Claim 2 also recites the limitations "the suction" and “the suction velocity”. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 5, it recites the limitation “controlling the suction unit”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 23, it recites the limitation “the fluid flowing in the oocytes retrieval tube”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 25, it recites the limitation “the extracted features”. There is insufficient antecedent basis for this limitation in the claim.
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 19-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2016.04, claims 19-22 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claim 19-22 recites a series of steps or acts for oocytes retrieval through image analysis. Thus, the claims are directed to a mental process, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of claims 19-22 recites at least one step or instruction for oocytes retrieval through image analysis, which is grouped as a mental process under the 2019 PEG. The claimed steps of addressing oocytes retrieval in patients by receiving one or more images and analyzing them can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. It would be practically performable in a human’s mind, or with pen and paper, to analyze brain network data as well to make decisions whether the data changes over time. Analyzing information and making a determination based on information is akin to an observation, evaluation or judgement that defines the mental process grouping.
Accordingly, each of claims 19-22 recites an abstract idea.
Specifically, Claim 19 recites a method of oocytes retrieval, comprising:
Receiving one or more images of a fluid in a retrieval tube (construed as receiving images on printed matter); and
Analyzing the one or more images for identifying one or more oocytes in the fluid (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
Further, dependent claims 20-22 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims does not recite any additional elements outside of the abstract idea.
Step 2A, Prong 2
Claims 19-22 do not recite additional elements that integrate the judicial exception into a practical application. Claims 19-22 recite the following additional steps: “receiving one or more images”, “analyzing the one or more images”, “identifying one or more oocytes”, and “assigning a score”. These steps are recited at a high level of generality. Further mere instructions or commands to apply judicial exception using a mental process does not impose meaningful limits on practicing the abstract idea.
Most notably, none of the additional elements recited in these claims apply or use the judicial exception to affect the method of oocytes retrieval.
Thus claims 19-22 do not integrate the abstract idea into a practical application.
Step 2B
When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of claims 20-22 further define mental process steps.
Therefore, these elements are demonstrated to be generic, well understood components that are commonly recited in the art.
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.
Claims 1-7, 9-12, and 19-23 are rejected under 35 U.S.C. 103 as being obvious over Hodgson (KR 20160030487 A) in view of Ang Wei (WO 2018063098 A1).
Regarding claim 1, Hodgson teaches a system for oocytes retrieval (“purpose…to collect oocytes during the egg collection process”, page 13, paragraph 2), comprising:
A holder (egg chamber 1, Fig. 7e) configured to hold an oocytes retrieval tube (“egg chamber 1 is configured to attach the chamber 1 through the ports to the tubing attaching the egg collecting needle”, page 7, paragraph 7; tubing 12, needle 114) and there is a transparent portion of the oocytes retrieval tube (“chamber 1 comprises a transparent and/or translucent material”, page 7, paragraph 1); and
A controller (“controller…may also be operably coupled to any sensors”, page 17, page 6)
Wherein the transparent portion is transparent to visible light (“lower wall 3 of the container is also transparent…ensures that light will enter through”, page 6, paragraph 7), and the suction unit is configured to suction oocytes in the oocytes retrieval tube (“suction pump is used to draw the liquid…through the needle 13 and tubing 12 into the egg chamber 1”, page 8, paragraph 5).
Hodgson does not teach a camera or a control that is configured to control a camera.
However, Ang Wei teaches a system for oocyte retrieval (“system may be able to detect the ICM and rotate the cell…oocyte”, paragraph [00070]), comprising:
At least one camera (“image capturing device 110 may include a camera 112”, paragraph [00017]);
A holder configured to hold the camera (incubation unit 240), such that a transparent portion is within the field of view (FOV) of the at least one camera (“imaging device 212, such as a camera, and an objective lens 214”, paragraph [00041]; camera 212, transparent portion 214, Fig. 2); and
A controller (“processor”, paragraph [000103]) configured to:
Control the at least one camera to capture images of fluid flowing in the transparent portion (“apparatus may further include a processor configured to receive the captured image from the embryo image capturing mechanism”, paragraph [000103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Hodgson with the system of Ang Wei and implement a camera into the holder of the system in order to capture images of the fluid flowing within the oocyte retrieval tube in order to allow the operator to visualize the oocytes retrieved from the patient.
Regarding claim 2, Hodgson in view of Ang Wei teaches the controller (“controller”, ) further being capable of controlling a suction unit based on an analysis of the captured images and wherein controlling the suction unit comprises at least one of: terminating the suction, reinitiating the suction and changing the suction velocity (“controller…may also be operably coupled to any sensors incorporated within the fluid pump system 100…determine physical properties within the fluid pump system 100, such as, for example, fluid flow rate”, page 17, paragraph 6; Hodgson).
Regarding claim 3, Hodgson in view of Ang Wei teaches all the limitations of claim 1.
Furthermore, Ang Wei teaches the controller being further configured to identify oocytes in the captured images (“processor configured to receive the captured image from the embryo image capturing mechanism…to determine a development stage of the embryo”, paragraph [000103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Hodgson in view of the system of Ang Wei and configure the controller to identify the oocytes from the captured images in order to allow the operator to inspect the characteristics of the oocytes detected.
Regarding claim 4, Hodgson in view of Ang Wei teaches all the limitations of claim 3.
Furthermore, Ang Wei teaches wherein identifying the oocytes comprises identifying at least one of: number of oocytes, size of an oocyte, shape of an oocyte, morphology of an oocyte (“method may include…processing the planar images to monitor the morphology of the embryo, so as to identify the number/volume/size”, paragraph [00012]), cytoplasm of an oocyte, ooplasm characteristics of an oocyte, structure of the perivitelline space, corona radiata quality, zona pellucida, clarity and uniformity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Hodgson in view of the system of Ang Wei and identify the oocytes by viewing the number, size, shape, and morphology, in order to ensure that the operator gathers all necessary feedback for fertility preservation (“identifying genetic defects within embryos created through in vitro fertilization”, paragraph [0003]).
Regarding claim 5, Hodgson in view of Ang Wei teaches controlling the suction unit based on the identification of the oocytes (“oocyte-sediment complex is pulled…suction is controlled by suction through the foot pedal….observed through a microscope to identify the eggs”, page 3, paragraph 1; suction unit can be controlled depending on the identification of the oocytes; Hodgson).
Regarding claims 6 and 7, Hodgson in view of Ang Wei teaches all the limitations of claim 3.
Furthermore, Ang Wei teaches the controller further configured to assign a score to at least some of the identified oocytes, and wherein the score of an identified oocyte is based on at least one of: size of the identified oocyte, shape of the identified oocyte, morphology of the identified oocyte (“method may include…processing the planar images to monitor the morphology of the embryo, so as to identify the number/volume/size”, paragraph [00012]), cytoplasm of the identified oocyte, ooplasm characteristics of the identified oocyte, structure of the perivitelline space, corona radiata quality, zona pellucida, clarity and uniformity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Hodgson in view of the system of Ang Wei and identify the oocytes by assigning a score of the number, size, shape, and morphology, in order to ensure that the operator gathers all necessary feedback for fertility preservation (“identifying genetic defects within embryos created through in vitro fertilization”, paragraph [0003]).
Regarding claim 9, Hodgson in view of Ang Wei teaches a sorting unit (fluid pump system 100) for sorting the fluid flowing in the oocytes retrieval tube between at least two different chambers (“filter…arranged in the vessel between the first inlet and the first outlet and configured to separate the vessel into a first inner chamber and a second inner chamber”, abstract; Hodgson).
Regarding claims 10 and 11, Hodgson in view of Ang Wei teaches the controller (“controller”, page 18, paragraph 4) being capable of controlling the sorting unit based on identification and controlling the sorting unit based on analysis of the images captured by the camera (“the fluid pump system…initiated automatically by the controller”, page 18, paragraph 4; Hodgson).
Regarding claim 12, Hodgson in view of Ang Wei teaches a light source positioned to provide light to the transparent portion (“lower wall 3 allows the light to enter…light source is located below the egg chamber…when using a microscope with a transparent, lower positioned light source”, page 10, paragraph 1; Hodgson).
Regarding claim 19, Hodgson teaches a method of oocytes retrieval (“purpose…to collect oocytes during the egg collection process”, page 13, paragraph 2), and utilizing a retrieval tube (tubing 12, needle 114), but does not teach the method of receiving one or more images of a fluid in a retrieval tube and analyzing the one or more images for identifying one or more oocytes in the fluid.
However, Ang Wei teaches a method of receiving one or more images of a fluid in a retrieval tube (“image capturing device 110 may be used to collect images of the embryo…images may be used for embryo monitoring”, paragraph [00017]); and
Analyzing the one or more images for identifying one or more oocytes in the fluid (“to detect…oocyte”, paragraph [00070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Hodgson with the method of Ang Wei and utilize one or more images of a fluid from the retrieval tube and identify one or more oocytes using those images.
Regarding claim 20, Hodgson in view of Ang Wei teaches all the limitations of claim 19.
Furthermore, Ang Wei teaches wherein identifying the oocytes comprises identifying at least one of: number of oocytes, size of an oocyte, shape of an oocyte, morphology of an oocyte (“method may include…processing the planar images to monitor the morphology of the embryo, so as to identify the number/volume/size”, paragraph [00012]), cytoplasm of an oocyte, ooplasm characteristics of an oocyte, structure of the perivitelline space, corona radiata quality, zona pellucida, clarity and uniformity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Hodgson in view of the system of Ang Wei and identify the oocytes by viewing the number, size, shape, and morphology, in order to ensure that the operator gathers all necessary feedback for fertility preservation (“identifying genetic defects within embryos created through in vitro fertilization”, paragraph [0003]).
Regarding claims 21 and 22, Hodgson in view of Ang Wei teaches all the limitations of claim 19.
Furthermore, Ang Wei teaches the controller further configured to assign a score to at least some of the identified oocytes, and wherein the score of an identified oocyte is based on at least one of: size of the identified oocyte, shape of the identified oocyte, morphology of the identified oocyte (“method may include…processing the planar images to monitor the morphology of the embryo, so as to identify the number/volume/size”, paragraph [00012]), cytoplasm of the identified oocyte, ooplasm characteristics of the identified oocyte, structure of the perivitelline space, corona radiata quality, zona pellucida, clarity and uniformity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Hodgson in view of the system of Ang Wei and identify the oocytes by assigning a score of the number, size, shape, and morphology, in order to ensure that the operator gathers all necessary feedback for fertility preservation (“identifying genetic defects within embryos created through in vitro fertilization”, paragraph [0003]).
Regarding claim 23, Hodgson in view of Ang Wei teaches sorting the fluid flowing in the oocytes retrieval tube between at least two different containers (“filter…arranged in the vessel between the first inlet and the first outlet and configured to separate the vessel into a first inner chamber and a second inner chamber”, abstract; Hodgson).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being obvious over Hodgson in view of Ang Wei and further in view of Buxboim (WO 2020157761 A1).
Regarding claim 24, Hodgson teaches a method of classifying oocytes in a retrieved fluid (“purpose…to collect oocytes during the egg collection process”, page 13, paragraph 2; Hodgson), but does not teach a processor that comprises of at least one image of the retrieved fluid from at least one camera, detecting one or more oocytes from the at least one image, extracting from the at least one image, and applying a ML model.
However, Ang Wei teaches a method of receiving at least one image of the retrieved fluid from at least one camera (“image capturing device 110 may include a camera 112”, paragraph [00017]; Ang Wei);
Detecting one or more oocytes in the at least one image (“system may be able to detect the ICM and rotate the cell…oocyte”, paragraph [00070]; Ang Wei);
Extracting from the at least one image where at least one feature is related to the detected one or more oocyte (“capturing images…to monitor the morphology of the embryo so as to identify the number/volume/size”, paragraph [00012]; Ang Wei);
Hodgson in view of Ang Wei does not teach applying an ML model.
However, Buxboim teaches
Applying a ML model on the extracted at least one feature to classify the one or more; wherein said ML model is trained to classify oocytes based on oocytes quality (“machine learning model on a training set…associated with each of said corresponding embryos”, paragraph [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Hodgson with the method of Ang Wei in order to receive images from a camera from the retrieved fluid and detect the oocytes in the images, as well as further combining the method of Hodgson in view of Ang Wei with the method of Buxboim and implementing a ML model in order to train alongside the controller for identifying and/or classifying oocytes in the images received from the camera.
Regarding claim 25, the modified method teaches all the limitations of claim 24.
Furthermore, Buxboim teaches the ML model comprising:
Receiving a training dataset (“one or more machine learning models may be trained on the training dataset”, paragraph [0138]), comprising a plurality of images, each depicting at least one oocyte (“machine learning models, based…on training data comprising image data depicting at least a portion of a prenatal embryogenesis process”, paragraph [0052]);
Receiving a set of quality labels, corresponding to the plurality of images (“image data…with an indication of a developmental parameter of the depicted embryo”, paragraph [0058]);
Extracting from at least one image of the training dataset at least one respective feature of the depicted at least one oocyte (“machine learning model is trained to score at least one of the frames…based on…temporal features of the embryo depicted by the frame”, paragraph [0067]); and
Using the set of quality labels as supervisory data for training the ML model to classify at least one depicted oocyte based on the extracted features (“machine learning model is configured to output a sum of the scores of each frame”, paragraph [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified method with Buxboim and train the ML model based off a training dataset of images of the oocytes in order to help detect the characteristics of the retrieved oocytes more accurately.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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