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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/17/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 08/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The amendment to the specification filed on 07/17/2023 has been considered and entered for the record.
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: the culture unit, the imaging unit, the storage unit, the determination unit and the display unit of claim 1, the correction unit of claim 3, acceptance unit in claim 6 and the relearning unit of claim 8.
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 3, 4, 6 and 8 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 limitation the “correction unit (claim 3 & 4)”, “acceptance unit (claim 6)” and the “relearning unit (claim 8)” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not provide the corresponding structure to perform these acts and it appears that these structures are basically a button on a screen and a computer. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
It should be further noted that in light of the specification, it is unclear what structure or element of the display is the acceptance unit or what structure or element is the relearning unit. At best, it appears to be a button on the screen of the display and that is how this limitation will be interpreted for purposes of examination (see paragraphs 66 and 70 of the instant application). The correction unit appears to be a software operation, but the specification does not provide an explanation of the corresponding structure. For purposes of examination, if a process or element corrects either the image or the position of an embryo based on the image, this will be interpreted as meeting this claim limitation.
Appropriate corrective action is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5, 6, 8 and 9 are rejected under 35 U.S.C. 102a1 as being anticipated by Fukunaga (JP 2018093795 A – hereafter ‘795 and reference will be made to the enclosed machine translation; both submitted with the IDS of 07/17/2023).
‘795 discloses a large number of trays holding treated eggs and implements time lapse processing of the eggs (Abstract) that includes the following limitations for claim 1:
“An embryo culture device that keeps in a culture environment a treatment egg having been subjected to insemination treatment”: ‘795 discloses an embryo culture device (device 10) that is for culturing an egg subjected to treatment for in vitro fertilization ([0022]) that keeps the egg in a culture environment.
“a culture unit that accommodates a plurality of recess parts that can each accommodate a treatment egg, and keeps the recess parts in the culture environment”: ‘795 discloses that the apparatus (apparatus 10; Fig. 1; [0023]) includes twelve culture units (units 11-22) that include a culture chamber (chamber R11-R22; Fig. 3; [0024]) that include a recess portion (recess 40; [0026]). These units accommodate an egg for treatment.
“an imaging unit that continuously or intermittently captures an image including the treatment egg accommodated in the recess part without relatively moving the recess part”: ‘795 discloses a time lapse part (part 50; Fig. 1) that includes a camera module (camera 51; Fig. 2; [0023]; [0024]) that capture the images continuously or intermittently (Abstract; claim 3; [0054]; [0055]).
“a storage unit that stores per treatment egg an egg image that is an image including the imaged treatment egg”: ‘795 disclose a storage unit such as a hard disk or memory card (card 59; [0046]) that stores an image of the treated egg.
“a determination unit that applies a learned model generated in advance by supervised learning to the egg image of each treatment egg, and makes determination of growth of the treatment egg”: ‘795 discloses a control unit (unit 60A; Fig. 13) that executes a time-lapse control process ([0058]). This is done through a machine-learned in advance that determines whether fertilization is possible. This process can be realized in real time by using a high-speed calculation ([0049]) and the capture image may be displayed to determine whether fertilization is possible. While not specifying that this process is a machine-learned model, this is being interpreted as the model of the instant application since it is machine-learned in advance in the same manner as the model of the instant application.
“a display unit that reads from the storage unit an egg image of a treatment egg having been determined to satisfy a condition set in advance according to a result of the determination to display”: ‘795 discloses a display module (module 52; Fig. 2; [0024]) that is connected to the memory by a display interface ([0033]; Fig. 7; display interface 82). This interface performs and output of an image signal to be displayed on the display module ([0034]). This display is fully capable of displaying an image that has satisfied a condition based on the determination process.
For claim 2, ‘795 discloses that the determination process makes this based on images stored within the storage unit ([0049]).
For claim 5, ‘795 discloses a control unit (unit 60A; Fig. 13) that executes a time-lapse control process ([0058]). This is done through a machine-learned in advance that determines whether fertilization is possible. This process can be realized in real time by using a high-speed calculation ([0049]) and the capture image may be displayed to determine whether fertilization is possible. The controller determines if the egg is fertilized or if it is not fertilized.
For claim 6, ‘795 discloses using an end button (button 78; [0050]; Fig. 9) that is on the display and is being interpreted as the acceptance unit which displays the determination and image of the egg and accepts the decision of the operator.
For claim 8, ‘795 does not explicitly disclose a relearning unit, however, ‘795 would have a relearning unit as a machine-learned determination device is used to determine whether fertilization is possible ([0049]). Furthermore, all machine learning models or units employ an iterative process for learning and optimizing a process which means that a relearning unit or process is an inherent feature of machine-learned device.
‘795 discloses a large number of trays holding treated eggs and implements time lapse processing of the eggs (Abstract) that includes the following limitations for claim 9:
“A method for displaying a treatment egg kept in a culture environment and having been subjected to insemination treatment”: ‘795 discloses an embryo culture device (device 10) and method that is for culturing an egg subjected to treatment for in vitro fertilization ([0022]) that keeps the egg in a culture environment.
“a accommodating a plurality of recess parts that can accommodate a treatment egg and keeping the recess parts in the culture environment”: ‘795 discloses the step where the apparatus (apparatus 10; Fig. 1; [0023]) includes twelve culture units (units 11-22) that include a culture chamber (chamber R11-R22; Fig. 3; [0024]) that include a recess portion (recess 40; [0026]). These units accommodate an egg for treatment.
“providing an imaging unit at predetermined position with respect to the recess part”: ‘795 discloses providing a time lapse part (part 50; Fig. 1) that includes a camera module (camera 51; Fig. 2; [0023]; [0024]) that capture the images continuously or intermittently (Abstract; claim 3; [0054]; [0055]).
“continuously or intermittently capturing an image including the treatment egg accommodated in the recess part using the imaging unit”: ‘795 discloses the step of capturing the images continuously or intermittently (Abstract; claim 3; [0054]; [0055]).
“storing in a storage unit per treatment egg an egg image that is an image including the imaged treatment egg”: ‘795 disclose the step of using a storage unit such as a hard disk or memory card (card 59; [0046]) that stores an image of the treated egg.
“applying a learned model generated in advance by supervised machine learning to the egg image of the treatment egg, and making a determination of growth of the treatment egg”: ‘795 discloses using a control unit (unit 60A; Fig. 13) that executes a time-lapse control process ([0058]). This is done through a machine-learned in advance that determines whether fertilization is possible. This process can be realized in real time by using a high-speed calculation ([0049]) and the capture image may be displayed to determine whether fertilization is possible. While not specifying that this process is a machine-learned model, this is being interpreted as the model of the instant application since it is machine-learned in advance in the same manner as the model of the instant application.
“reading from the storage unit an egg image of a treatment egg having been determined to satisfy a condition set in advance according to a result of the determination to display on a display unit.”: ‘795 discloses using a display module (module 52; Fig. 2; [0024]) that is connected to the memory by a display interface ([0033]; Fig. 7; display interface 82). This interface performs and output of an image signal to be displayed on the display module ([0034]). This display is fully capable of displaying an image that has satisfied a condition based on the determination process.
Therefore, ‘795 meets the limitations of claims 1-2, 5, 6, 8 and 9.
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.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (JP 2018093795 A – hereafter ‘795 and reference will be made to the enclosed machine translation; both submitted with the IDS of 07/17/2023) in view of Wu et al. (US 2019/0162712 A1 – hereafter ‘712).
It should be noted that while ‘795 has a common inventor with the instant application the ‘795 reference was published more than a year before the earliest effective filing date of the instant application.
For claim 3, ‘795 (Fukunaga) discloses that the culture unit (unit 40) can hold a tray (tray 91; Fig. 10) within each recess where this tray has a plurality of wells ([0026]). The camera of ‘795 takes multiple images of the recesses ([0045]) where this is being interpreted as collectively taking images of the recesses. ‘795 further discloses that the images are divided per recess ([0046]) for each well and stored on the memory card.
However, ‘795 does not explicitly disclose a correction unit that corrects the image.
‘712 (Wu) discloses a system for culturing a fertilized egg of an organism in the field of animal husbandry ([0057]) that for claim 3 includes a correction image (image 69; Fig. 5; [0109]) that urges the operator to transfer a fertilized egg to the correct vessel. This is initiated by the notification unit (unit 34; Fig. 1; [0075]; it should be noted that this unit is labeled as element 33 in Fig. 1 and should be labeled as 34). This is being interpreted as the correction unit of the instant application since it corrects the image and position of the fertilized egg.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the notification/correction unit of ‘712 within ‘795 in order to position the fertilized egg. The suggestion for doing so at the time would have been in order to check the transfer condition of each embryo and to prevent mix-up of different fertilized embryos ([0140]).
712 (Wu) discloses a system for culturing a fertilized egg of an organism in the field of animal husbandry ([0057]) that for claim 4 includes a correction image (image 69; Fig. 5; [0109]) that urges the operator to transfer a fertilized egg to the correct vessel. This is initiated by the notification unit (unit 34; Fig. 1; [0075]; it should be noted that this unit is labeled as element 33 in Fig. 1 and should be labeled as 34). This is being interpreted as the correction unit of the instant application since it corrects the image and position of the fertilized egg.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the notification/correction unit of ‘712 within ‘795 in order to position the fertilized egg. The suggestion for doing so at the time would have been in order to check the transfer condition of each embryo and to prevent mix-up of different fertilized embryos ([0140]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (JP 2018093795 A – hereafter ‘795 and reference will be made to the enclosed machine translation; both submitted with the IDS of 07/17/2023) in view of Iwata et al. (JP 6414310 B1 – hereafter ‘310 and reference will be made to the enclosed machine translation).
For claim 7, ‘795 (Fukunaga) does not explicitly disclose determining whether or not a timing to take out the treatment egg or whether or not to exchange the culture medium. ‘795 does disclose a lid that is used to close the chambers ([0028]; [0038]; [0064]; [0065]; [0073]).
‘310 (Iwata) discloses a method for evaluating fertilized eggs (Abstract) that for claim 7 discloses an egg transplanter that transmits an acquisition request to a terminal in order to process the acquisition request. This transfer instruction that prompts the fertilized egg transplanter to take out the fertilized egg base on the fertilized egg analysis/evaluation report page 14, sixth paragraph). This is being interpreted as the equivalent to determining the timing to take out the fertilized egg.
Therefore, it would have been obvious to employ the removal step of j’310 within ‘795 in order to remove a fertilized egg from the culture chamber. The suggestion for doing so would have been in order to fulfil a request for the fertilized egg (page 14, sixth paragraph; page 15, fifth paragraph).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fukunaga (JP 2018061440 A) discloses a system for confirming whether an egg has undergone a fertilization treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799