Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment filed on 02/11/26 has been entered. Claims 1, 2, 4-8, 10, 12, and 26 remain pending and are examined herein.
Status of Application
New ground of rejection is necessitated by the Amendment.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Applicant’s argument is directed toward the term “continuous biocompatible media”. In particular, applicant interpreted the term “continuous” as “single-density” or “uniformity” in composition or properties of composition remaining constant. Though Examiner agrees uniformity is one interpretation of the term “continuous” in the context of describing fluidic media, uniformity is not the only definition for the term “continuous”. In particular, another interpretation of “continuous” is continuous system wherein fluidic media are constantly entering or exiting the system. This second interpretation has indeed been taught by Coombs (See the rejection of claim 1 below).
Even though applicant includes language of how the weight determination is being conducted using the device to further highlight the difference in operational and fluidic principle, the limitation is ultimately intended use recitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Examiner recommends applicant to incorporate language from para. [0052] of specification regarding containing a pressure seal to allow the media to be continuous form the top of the drop chamber to the collection pool in order to clarify the term “continuous” implies uniformity.
For the reason above, the rejection is maintained.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4-8, 10, 12, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coombs (A density gradient column for determining the specific gravity of fish eggs with particular reference to eggs of the mackerel scomber-scombrus”, 1981) as cited in previous Office Action.
Regarding claim 1, Coombs discloses a device for non-invasive selection and recovery of embryos having enhanced embryo development, comprising:
a drop chamber comprising a lumen (a graduated glass tube positioned inside a perspex housing) (interpreted as the inside/hollow side of the graduated glass tube) (Apparatus, Page 102) containing a continuous (System comprising circulator, peristaltic pump, passages for fluid transfer, reservoirs for more saline solution, Fig. 1; Lines 12-21, Apparatus, page 102) biocompatible media composition (sea water salt solution) (Abstract) extending vertically from a recovery pool (liquid in the clearing basket, Figure 1) (Operation of the Column) having fluid communication with the lumen of the drop chamber and having an outer surface designed to contain the biocompatible media (clearing basket, Figure 1);
a predetermined timing zone of said drop chamber having an upper and lower boundary of said predetermined timing zone capable of measurement of movement downward of each embryo through the biocompatible media composition in the drop chamber (Interpreted as the marks of graduated gradient tube); and
the biocompatible media composition of the drop chamber is a seawater salt solution, which contains the salinity level fit for living and breeding condition of mackerel scomber-scombrus and thus the solution does not reduce the viability of said embryos;
wherein non-invasive selection and recovery of said embryos is a qualitative assessment of embryo weight using specific gravity and/or density (Abstract).
The limitation of “identification of the descent time…wherein a faster descent time indicates a higher estimated weight” is recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, Coombs discloses the claimed manner of operation and therefore anticipates the claim limitation (Operation of the Column).
The limitation of “wherein the recovery pool is capable of receiving the embryos…allowing for embryo recovery” is interpreted as functional limitation. A functional limitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the feat conveyed by the functional limitation, then it meets the claim. Moreover, Coombs discloses the limitation and therefore anticipates the claim limitation (The experiments are carried out with the calibration floats suspended in the gradient and the clearing basket at the base of the tube…. The sample may be removed at any time by raising the clearing basket.) (Operation of the Column).
Regarding claim 2, The limitation of “wherein said predetermined timing zone of said drop chamber is capable of measuring descent time…”is interpreted as functional limitation. A functional limitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The graduated cylinder is transparent and contains markings and therefore is suitable for observing the content inside of the tube visually by taking the data on position of the fish egg relative to the column height visually (Figure 4).
Regarding claim 4, Coombs discloses the claimed invention as discussed above in claim 1. Coombs discloses the one or more drop chambers emptying into one or more recovery pools (The experiments are carried out with the calibration floats suspended in the gradient and the clearing basket at the base of the tube. The sample of eggs, which may be up to 20 at least at one time, is placed by pipette immediately below the surface of the gradient; the eggs settle to their position of neutral buoyancy within approximately 1 h (Fig. 4), the time depending on the size and specific gravity of each egg. Specific gravity is determined for each specimen from its height in the column and by reference to the calibration curve. The sample may be removed at any time by raising the clearing basket.) (Operation of the Column).
Regarding claim 5, Coombs discloses the claimed invention as discussed above in claim 1. The claim is interpreted as recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). Currently, the only structural limitation claim 5 is drop chamber having an upper and lower boundary, which was taught in the parent claim (i.e. a drop chamber comprising a lumen containing a biocompatible media composition; a predetermined timing zone; a recovery pool). Therefore, Coombs teaches all the structural limitations of the claim.
Regarding claim 6, Coombs discloses the claimed invention as discussed above in claim 5. The limitation is interpreted as a recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). There are no structural limitations being claimed in claim 6. All the structures are being claimed in parent claim 1 (i.e. a drop chamber comprising a lumen containing a biocompatible media composition; a predetermined timing zone; a recovery pool). Therefore, Coombs teaches all the structural limitations of the claim.
Regarding claim 7, Coombs discloses the claimed invention as discussed above in claim 6. The claim is interpreted as a recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). There are no structural limitations being claimed in claim 7. All the structures are being claimed in parent claim 1 (i.e. a drop chamber comprising a lumen containing a biocompatible media composition; a predetermined timing zone; a recovery pool). Therefore, Coombs teaches all the structural limitations of the claim. Moreover, Coombs discloses the limitation of capable of comparing the identified descent time of each embryo in measuring step within a population mean (See Figure 4-6 and Table 1; population means is interpreted to be all the different data point taken) wherein a faster descent time indicates a higher estimated weight (The experiments are carried out with the calibration floats suspended in the gradient and the clearing basket at the base of the tube. The sample of eggs, which may be up to 20 at least at one time, is placed by pipette immediately below the surface of the gradient; the eggs settle to their position of neutral buoyancy within approximately 1 h (Fig. 4), the time depending on the size and specific gravity of each egg) (Operation of Columns) (Also see Result) (Figure 4-6) (Table 1).
Regarding claim 8, Coombs discloses the claimed invention as discussed above in claim 1. Coombs discloses the tube (outside of the graduated cylinder) is transparent (graduated glass tube is transparent).
Regarding claim 10, Coombs discloses the claimed invention as discussed above in claim 1. Coombs discloses the device comprises one drop chamber emptying into a collection pool (clearing basket, Figure 1) to allow assessment of multiple embryos having unique identification (The experiments are carried out with the calibration floats suspended in the gradient and the clearing basket at the base of the tube. The sample of eggs, which may be up to 20 at least at one time, is placed by pipette immediately below the surface of the gradient; the eggs settle to their position of neutral buoyancy within approximately 1 h (Fig. 4), the time depending on the size and specific gravity of each egg. Specific gravity is determined for each specimen from its height in the column and by reference to the calibration curve. The sample may be removed at any time by raising the clearing basket.) (Operation of the Column).
Regarding claim 12, Coombs discloses the claimed invention as discussed above in claim 1. The claim is interpreted as a recitation of intended use because the embryos are not positively recited elements of the claimed invention. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). Currently, claim 12 attempts to further limits the embryo. However, the embryo itself is not being positively recited in claim 1. All the structures are being claimed in parent claim 1 (i.e. a drop chamber comprising a lumen containing a biocompatible media composition; a predetermined timing zone; a recovery pool). Therefore, Coombs teaches all the structural limitations of the claim.
Regarding claim 26, Coombs discloses the claimed invention as discussed above in claim 1. Coombs a growth supportive media (sea water) which produces a “microfluidic effect” as intended by Applicant (descent in the growth support media inside the lumen).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.H./Examiner, Art Unit 1758 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797