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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/04/2025 has been entered.
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 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, 15, 16 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Albrecht et al. (US 2019/0078985).
Regarding claims 1 & 2, Albrecht et al. teach:
1. A nematode trap plate comprising:
a container (e.g., glass slide base 12 and spacers 18, 384 multi-well plate); and
a solid phase (e.g., hydrogel, ¶ 0051-0054+) in the container (see Figs. 1, 12 & ¶ 0046-0050, 0071+ for example),
the solid phase capable of allowing nematodes (nematodes, C. elegans, see ¶ 0051+) to move over an upper surface (see discussion below) of the solid phase (see, for example, the bottom images in Fig. 1A showing C. elegans on an upper surface of PEG hydrogel (left) and agarose pad (right); and i.e., FIGS. 1A-1F show mounting live C. elegans 16 in hydrogels 10 and on agarose pads for microscopy. FIG. 1A shows the schematic of worm mounting procedures by PEG hydrogel encapsulation (left) or on agarose pads (right). FIG. 1B-FIG. 1D show images taken over 9 hrs [...] Solid vertical lines 20, 22, 24 indicates pharynx landmark position at t=0, dashed lines 26, 28, 30 indicate landmark position at each time point, and the arrows indicates displacement relative to t=0, with a scale bar of 10 μm. [...] FIG. 1E shows multiple larval and adults stages embedded in the same hydrogel. [...] FIG. 1F shows worms embedded in 20% PEG hydrogel that were imaged immediately after crosslinking and after release 12 hr later. Arrowheads indicate the cavity (recess) of the worm in the hydrogel (scale bars of 200 μm and 100 μm for the inset). ¶ 0132; The flexibility of animals and the hydrogel enabled some movement within this confined space (recesses for each C. elegans to be embedded and move) during contraction of body wall muscles, ¶ 0133; Movement of animals embedded in 20% PEG hydrogels averaged 39 μm over 3 minutes (16 μm-68 μm) ¶ 0143; swelling animals before crosslinking in hypo-osmotic solutions could expand the hydrogel space, thereby providing more space for movement ¶ 0145; FIGS. 19A-19E show an exemplary embodiment of an immobilization of C. elegans in one well of a 384 well plate using the hydrogel, and successful recovery of embedded animals to standard NGM plates. FIG. 19A shows the first frame of a 30 second bright-field video demonstrating different z-depth positions of ~40 animals in the liquid phase of the hydrogel before the crosslinking of the hydrogel, which allows the organisms to thrash in the hydrogel. A frame 5 seconds after the first, demonstrating relative animal movement to the overlaid grid lines to the time point above. ¶ 0160; see also Hydrogel structures can be formed with any micron-scale geometry, including external and internal structures. Hydrogel molds can be created using micropatterned molds, embedding 3D channel structures ¶ 0065; Hollow micron diameter channels at mm to cm lengths can also be created within the hydrogel material ¶ 0066), and
the upper surface of the solid phase having at least two recesses, each having a size that allows one or some of the nematodes to enter into said at least two recesses (see i.e., FIGS. 1A-1F show mounting live C. elegans 16 in hydrogels 10 and on agarose pads for microscopy. FIG. 1A shows the schematic of worm mounting procedures by PEG hydrogel encapsulation (left) or on agarose pads (right). FIG. 1B-FIG. 1D show images taken over 9 hrs [...] Solid vertical lines 20, 22, 24 indicates pharynx landmark position at t=0, dashed lines 26, 28, 30 indicate landmark position at each time point, and the arrows indicates displacement relative to t=0, with a scale bar of 10 μm. [...] FIG. 1E shows multiple larval and adults stages embedded in the same hydrogel. [...] FIG. 1F shows worms embedded in 20% PEG hydrogel that were imaged immediately after crosslinking and after release 12 hr later. Arrowheads indicate the cavity (recess) of the worm in the hydrogel (scale bars of 200 μm and 100 μm for the inset). ¶ 0132; The flexibility of animals and the hydrogel enabled some movement within this confined space (recesses for each C. elegans to be embedded and move) during contraction of body wall muscles, ¶ 0133; Movement of animals embedded in 20% PEG hydrogels averaged 39 μm over 3 minutes (16 μm-68 μm) ¶ 0143; swelling animals before crosslinking in hypo-osmotic solutions could expand the hydrogel space, thereby providing more space for movement ¶ 0145; FIGS. 19A-19E show an exemplary embodiment of an immobilization of C. elegans in one well of a 384 well plate using the hydrogel, and successful recovery of embedded animals to standard NGM plates. FIG. 19A shows the first frame of a 30 second bright-field video demonstrating different z-depth positions of ~40 animals in the liquid phase of the hydrogel before the crosslinking of the hydrogel, which allows the organisms to thrash in the hydrogel. A frame 5 seconds after the first, demonstrating relative animal movement to the overlaid grid lines to the time point above. ¶ 0160; see also Hydrogel structures can be formed with any micron-scale geometry, including external and internal structures. Hydrogel molds can be created using micropatterned molds, embedding 3D channel structures ¶ 0065; Hollow micron diameter channels at mm to cm lengths can also be created within the hydrogel material ¶ 0066).
2. The nematode trap plate as set forth in claim 1, wherein the container has a bottom surface having a transmittance of not less than 70% for light having a wavelength of 360 nm to 1500 nm (see line 46 in Fig. 2B & Fig. 3A for example).
Regarding the limitation “upper surface” in claim 1 is sufficiently broad to have read on the disclosure of Albrecht et al., because any surface positioned above a lower surface falls within the scope of this limitation.
With regard to limitations in claims 1, 15, 16 (e.g., “[...] allowing nematodes to move over an upper surface of the solid phase, and [...] each having a size that allows one or some of the nematodes to enter into said at least two recesses”, “…for maintaining an environment on the solid phase so as to be fixed”, “nematodes to be used in a test”), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 15 & 16, Albrecht et al. teach:
15. A nematode trap test kit comprising:
the nematode trap plate recited in claim 1; and
a cover (e.g., cover slip) capable of maintaining an environment on the solid phase so as to be fixed (¶ 0085, 0118+),
the cover having a transmittance of not less than 70% for light having a wavelength of 360 nm to 1500 nm (see line 46 in Fig. 2B & Fig. 3A for example).
16. The nematode trap test kit as set forth in claim 15, further comprising nematodes to be used in a test (throughout the reference).
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
In response to the Applicant's argument that “[...] Albrecht does not describe, teach, or suggest, at least, the hydrogel allowing nematodes to move over an upper surface of the hydrogel or an upper surface of the hydrogel having at least two recesses each having a size that allows one or some of the nematodes to enter into the at least two recesses. Rather, Albrecht describes placing an animal into a hydrogel liquid which is then cured such that it's solidified to restrict the movement of the organism within the confined space within the gel. See e.g., Albrecht, para. [0133]. This results in the animals being "fully encapsulated in the hydrogel, preventing large movements beyond their encapsulated space." See id. In Albrecht, the animals cannot move on an upper surface of the hydrogel, which the Office Action identifies as the claimed "solid phase". Instead, the animals are placed within the hydrogel liquid while the gelation of the hydrogel proceeds around and over them to encapsulate them, and then the animals are constrained to move within the encapsulated confined space of the hydrogel in Albrecht. Thus, Albrecht does not disclose teach or suggest at least, "the solid phase allowing nematodes to move over an upper surface of the solid phase," as recited in amended claim 1.”, Examiner disagrees.
Albrecht et al. teach, among other things: the solid phase capable of allowing nematodes (nematodes, C. elegans, see ¶ 0051+) to move over an upper surface of the solid phase (see, for example, the bottom images in Fig. 1A showing C. elegans on an upper surface of PEG hydrogel (left) and agarose pad (right); and i.e., FIGS. 1A-1F show mounting live C. elegans 16 in hydrogels 10 and on agarose pads for microscopy. FIG. 1A shows the schematic of worm mounting procedures by PEG hydrogel encapsulation (left) or on agarose pads (right). FIG. 1B-FIG. 1D show images taken over 9 hrs [...] Solid vertical lines 20, 22, 24 indicates pharynx landmark position at t=0, dashed lines 26, 28, 30 indicate landmark position at each time point, and the arrows indicates displacement relative to t=0, with a scale bar of 10 μm. [...] FIG. 1E shows multiple larval and adults stages embedded in the same hydrogel. [...] FIG. 1F shows worms embedded in 20% PEG hydrogel that were imaged immediately after crosslinking and after release 12 hr later. Arrowheads indicate the cavity (recess) of the worm in the hydrogel (scale bars of 200 μm and 100 μm for the inset). ¶ 0132; The flexibility of animals and the hydrogel enabled some movement within this confined space (recesses for each C. elegans to be embedded and move) during contraction of body wall muscles, ¶ 0133; Movement of animals embedded in 20% PEG hydrogels averaged 39 μm over 3 minutes (16 μm-68 μm) ¶ 0143; swelling animals before crosslinking in hypo-osmotic solutions could expand the hydrogel space, thereby providing more space for movement ¶ 0145; FIGS. 19A-19E show an exemplary embodiment of an immobilization of C. elegans in one well of a 384 well plate using the hydrogel, and successful recovery of embedded animals to standard NGM plates. FIG. 19A shows the first frame of a 30 second bright-field video demonstrating different z-depth positions of ~40 animals in the liquid phase of the hydrogel before the crosslinking of the hydrogel, which allows the organisms to thrash in the hydrogel. A frame 5 seconds after the first, demonstrating relative animal movement to the overlaid grid lines to the time point above. ¶ 0160; see also Hydrogel structures can be formed with any micron-scale geometry, including external and internal structures. Hydrogel molds can be created using micropatterned molds, embedding 3D channel structures ¶ 0065; Hollow micron diameter channels at mm to cm lengths can also be created within the hydrogel material ¶ 0066).
In response to the Applicant's argument that “[...] in Albrecht, the animals are encapsulated in the hydrogel in a confined space is a closed space that is formed within the hydrogel, as shown in FIG. 1A. In contrast, a "recess" in an upper surface of a solid phase is necessarily an open structure with respect to the upper surface, not a closed encapsulated structure within a hydrogel. Applicant's particularly claimed recesses in an upper surface of the solid phase are configured to allow the nematodes to fall into the at least two recesses during movement along the upper surface of solid phase once the nematodes are supplied to the solid phase. Albrecht's closed confined spaces in a body of a hydrogel are not open recesses formed in an upper surface of the hydrogel. Thus, Albrecht does not disclose, teach, or suggest at least, "the upper surface of the solid phase having at least two recesses each having a size that allows one or some of the nematodes to enter into said at least two recesses," as recited in amended claim 1”, Examiner disagrees.
Albrecht et al. teach, among other things: the upper surface of the solid phase having at least two recesses, each having a size that allows one or some of the nematodes to enter into said at least two recesses (see i.e., FIGS. 1A-1F show mounting live C. elegans 16 in hydrogels 10 and on agarose pads for microscopy. FIG. 1A shows the schematic of worm mounting procedures by PEG hydrogel encapsulation (left) or on agarose pads (right). FIG. 1B-FIG. 1D show images taken over 9 hrs [...] Solid vertical lines 20, 22, 24 indicates pharynx landmark position at t=0, dashed lines 26, 28, 30 indicate landmark position at each time point, and the arrows indicates displacement relative to t=0, with a scale bar of 10 μm. [...] FIG. 1E shows multiple larval and adults stages embedded in the same hydrogel. [...] FIG. 1F shows worms embedded in 20% PEG hydrogel that were imaged immediately after crosslinking and after release 12 hr later. Arrowheads indicate the cavity (recess) of the worm in the hydrogel (scale bars of 200 μm and 100 μm for the inset). ¶ 0132; The flexibility of animals and the hydrogel enabled some movement within this confined space (recesses for each C. elegans to be embedded and move) during contraction of body wall muscles, ¶ 0133; Movement of animals embedded in 20% PEG hydrogels averaged 39 μm over 3 minutes (16 μm-68 μm) ¶ 0143; swelling animals before crosslinking in hypo-osmotic solutions could expand the hydrogel space, thereby providing more space for movement ¶ 0145; FIGS. 19A-19E show an exemplary embodiment of an immobilization of C. elegans in one well of a 384 well plate using the hydrogel, and successful recovery of embedded animals to standard NGM plates. FIG. 19A shows the first frame of a 30 second bright-field video demonstrating different z-depth positions of ~40 animals in the liquid phase of the hydrogel before the crosslinking of the hydrogel, which allows the organisms to thrash in the hydrogel. A frame 5 seconds after the first, demonstrating relative animal movement to the overlaid grid lines to the time point above. ¶ 0160; see also Hydrogel structures can be formed with any micron-scale geometry, including external and internal structures. Hydrogel molds can be created using micropatterned molds, embedding 3D channel structures ¶ 0065; Hollow micron diameter channels at mm to cm lengths can also be created within the hydrogel material ¶ 0066).
Regarding the limitation “upper surface” in claim 1 is sufficiently broad to have read on the disclosure of Albrecht et al., because any surface positioned above a lower surface falls within the scope of this limitation.
In response to the Applicant's arguments to the process or intended use limitations (e.g., [...] allowing nematodes to move over an upper surface of the solid phase, and [...] each having a size that allows one or some of the nematodes to enter into said at least two recesses), 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. The Courts have held that limitations regarding the contents, intended use or manner of operating an apparatus do not further limit the patentability of apparatus claims. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488,492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is encouraged to amend the claims to include additional structural elements of the trap plate.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798