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 .
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. 120 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. 17/931,927, 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 one or more claims of this application. Specifically, the 17/931,927 application does not provide support for the elevator being used to transport the cell culture vessels from the storage area to the imager unit. Furthermore, while the 17/931,927 application includes support for windows, the prior application does not provide support for windows that filter UV light.
Accordingly, claims 1-8 have an effective priority date of 05/31/2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the elevator for moving the culture vessels from the storage area to the imager (claims 1 and 5) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Regarding the related applications in paragraph [0001], the status of these applications need to be updated.
Appropriate correction is required.
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.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard (US 2021/0222110 A1 – hereafter ‘110) in views of Houjou et al. (US 2013/0156287 A1 – hereafter ‘287) and Reiserer et al. (US 2022/0135925 A1 – hereafter ‘925).
Note: ‘110 is prior art only due to the features of the instant application not being supported in the parent application as discussed above as the prior art was published more than a year before the effective filing date of the claimed invention.
‘110 discloses an incubator with a robot for moving culture vessels from station to station (Abstract) that includes the following limitations for claim 1:
“A method of incubation for in vitro fertilization”: ‘110 discloses a method of incubating that can be used for in vitro fertilization ([0006]).
“placing at least one of sperm, eggs, and embryos in at least one cell culture vessel in an incubator chamber having windows with filters to filter out ultraviolet light”:’110 discloses the step of placing cells within a culture vessel contained within the incubator ([0183]) and where the chamber includes windows ([0110]).
“wherein interior surfaces of the chamber comprises material that prevents the growth of fungus”: ‘110 discloses that the interior surface of the incubator can be coated with copper or silver which are anti-microbial, but also inhibit fungal growth ([0198]).
“wherein the chamber includes sensors for regulating the levels of oxygen, carbon dioxide and nitrogen in the chamber”: ‘110 includes sensors that are used to regulate the levels of oxygen, nitrogen and carbon dioxide in the incubator ([0012]).
“transporting the at least one cell culture vessel from a storage location in the chamber to an imager at an imaging location in the chamber using an elevator”: ‘110 discloses using a robotic element ([0034]) to move the culture vessel around the incubator and includes using an elevator to lift the transport in the Z direction at the storage station ([0262]; Fig. 24).
“repeatedly imaging at least one of the sperm, eggs and the embryos in the imager while maintaining the levels of oxygen, carbon dioxide and nitrogen throughout the chamber.”: ‘110 discloses the step of monitoring and maintaining the levels of oxygen, carbon dioxide and nitrogen within the incubator via sensors ([0110]) where this is cone during the entire process and is being interpreted as being done during image capture. The imager of ‘110 takes one or more images of the cells ([0037]) where this is being interpreted as repeatedly taking images of the cells.
While ‘110 does not explicitly disclose using the elevator for lifting the sample to the imager, this would be an obvious design choice for one of ordinary skill in the art in order to have the sample vessel at the desired level for optical analysis of the cells.
‘110 does not disclose a window with a filter that blocks UV light.
‘287 discloses an observation system ([0060]; Fig. 1) that includes an illumination window (window 14) that is coated with a film that functions as a filter to transmit visible light, but cut radiations of wavelengths in the ultraviolet and infrared ranges ([0068]). This cutting of the ultraviolet wavelengths helps alleviate the damage it inflicts on the cells ([0068]).
Therefore, it would have been obvious to one of ordinary skill in the art to employ the coating of ‘287 within ‘110 in order to block ultraviolet light. The suggestion for doing so at the time would have been in order to alleviate the damage ultraviolet light causes cells ([0068]).
‘110 does not specify that the system cultures an embryo, but it would have been obvious to one of ordinary skill in the art to employ the method of ‘110 to culture embryos baring evidence to the contrary.
‘925 discloses a perfusion culture system (Abstract) that for claim 1 includes culturing zebrafish embryos ([0117]). Zebrafish embryos have the advantage of being uses in physiological studies due to their small size, transparency and the ease with which they can be genetically altered ([0283]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the zebrafish embryos of ‘925 within ‘110 in order to perform physiological recapitulation of the cellular microenvironment ([0131]). The suggestion for doing so at the time would have been in order to use a sample that has the advantage of being small, transparent and easy to genetically alter ([0283]).
‘110 discloses an incubator with a robot for moving culture vessels from station to station (Abstract) that includes the following limitations for claim 5:
“An apparatus for incubating at least one of sperm, eggs and embryos for in vitro fertilization”: ‘110 discloses a method and apparatus of incubating that can be used for in vitro fertilization ([0006]). Moreover, the device of ‘110 is fully capable of incubating a sperm, eggs or embryos.
“an incubator chamber for receiving at least one of sperm, eggs, and embryos in at least one cell culture vessel in an incubator chamber having windows with filters to filter out ultraviolet light”:’110 discloses the step of placing cells within a culture vessel contained within the incubator ([0183]) and where the chamber includes windows ([0110]). This chamber is fully capable of receiving a sperm, eggs or embryos.
“wherein interior surfaces of the chamber comprises material that prevents the growth of fungus”: ‘110 discloses that the interior surface of the incubator can be coated with copper or silver which are anti-microbial, but also inhibit fungal growth ([0198]).
“wherein the chamber includes sensors for regulating the levels of oxygen, carbon dioxide and nitrogen in the chamber”: ‘110 includes sensors that are used to regulate the levels of oxygen, nitrogen and carbon dioxide in the incubator ([0012]).
“an imager at an imaging location in the chamber”: ‘110 discloses an imager within the chamber (Fig. 1; imager 104; [0230]).
“a transport device in the chamber for transporting the at least one cell culture vessel from a storage location in the chamber to and from the imager using an elevator”: ‘110 discloses using a robotic element ([0034]) to move the culture vessel around the incubator and includes using an elevator to lift the transport in the Z direction at the storage station ([0262]; Fig. 24).
“wherein the imager is configured to repeatedly imaging at least one of the sperm, eggs and the embryos in the imager while maintaining the levels of oxygen, carbon dioxide and nitrogen throughout the chamber.”: ‘110 discloses the step of monitoring and maintaining the levels of oxygen, carbon dioxide and nitrogen within the incubator via sensors ([0110]) where this is cone during the entire process and is being interpreted as being done during image capture. The imager of ‘110 takes one or more images of the cells ([0037]) where this is being interpreted as repeatedly taking images of the cells.
While ‘110 does not explicitly disclose using the elevator for lifting the sample to the imager, this would be an obvious design choice for one of ordinary skill in the art in order to have the sample vessel at the desired level for optical analysis of the cells.
‘110 does not disclose a window with a filter that blocks UV light.
‘287 discloses an observation system ([0060]; Fig. 1) for claim 5 that includes an illumination window (window 14) that is coated with a film that functions as a filter to transmit visible light, but cut radiations of wavelengths in the ultraviolet and infrared ranges ([0068]). This cutting of the ultraviolet wavelengths helps alleviate the damage it inflicts on the cells ([0068]).
Therefore, it would have been obvious to one of ordinary skill in the art to employ the coating of ‘287 within ‘110 in order to block ultraviolet light. The suggestion for doing so at the time would have been in order to alleviate the damage ultraviolet light causes cells ([0068]).
‘110 does not specify that the system cultures an embryo, but it would have been obvious to one of ordinary skill in the art to employ the method of ‘110 to culture embryos baring evidence to the contrary.
‘925 discloses a perfusion culture system (Abstract) that for claim 5 includes culturing zebrafish embryos ([0117]). Zebrafish embryos have the advantage of being uses in physiological studies due to their small size, transparency and the ease with which they can be genetically altered ([0283]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the zebrafish embryos of ‘925 within ‘110 in order to perform physiological recapitulation of the cellular microenvironment ([0131]). The suggestion for doing so at the time would have been in order to use a sample that has the advantage of being small, transparent and easy to genetically alter ([0283]).
For claim 2, ‘110 discloses using LEDs and a UV light source within the chamber ([0106]; [0107]). While not specifying that the LEDs are ultraviolet, it would be an obvious substitution for one of ordinary skill in the art to replace a UV lamp with a UV LED in order to save on power consumption and space within the device.
For claim 3, ‘110 discloses monitoring the movement of the cells ([0053]) which would relate to viability. The use of an embryo within the method would have been obvious to one of ordinary skill in the art using the reasoning of claim 1.
For claim 4, ‘110 discloses a manipulator station [0056]; [0149]) that the transporter moves the culture vessel between the storage chamber, imager and manipulator station ([0243]; [0244]; fig. 19).
For claim 6, ‘110 discloses using LEDs and a UV light source within the chamber ([0106]; [0107]). While not specifying that the LEDs are ultraviolet, it would be an obvious substitution for one of ordinary skill in the art to replace a UV lamp with a UV LED in order to save on power consumption and space within the device.
For claim 7, ‘110 discloses monitoring the movement of the cells ([0053]) which would relate to viability. The use of an embryo within the method would have been obvious to one of ordinary skill in the art using the reasoning of claim 1.
For claim 8, ‘110 discloses a manipulator station [0056]; [0149]) that the transporter moves the culture vessel between the storage chamber, imager and manipulator station ([0243]; [0244]; fig. 19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shamah et al. (US 2006/0177922 A1) discloses an incubator system with a robot for placing and removing culture dishes from the incubator.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799