DETAILED ACTION
Response to Amendments
The amendment filed on 3/26/2026 has been entered.
Claims 1-16 remain pending in the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
Reference character “6” does not point to/designate any element in figs. 1, 3A, 3B, 4A, 4B, and 5B.
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. No new matter should be added.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, and 10-11 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by USPGP# 20050051453 of Schuler (henceforth Schuler).
Regarding claim 1, Schuler teaches
A device (100) for manually sealing a multiwell plate (130, fig. 11B and para 0030, especially “a lower layer 130 with a preformed cavity 135 prefilled with the pharmaceutical formulation may be positioned onto the surface 115”), the device comprising:
a multiwell plate holder (300);
a frame (105 in fig. 11B) movably arranged and configured to frame the multiwell plate (using cavities 140), for holding and centering a precut adhesive foil (150) placed on the multiwell plate (105 at least indirectly hold and centers the foil 150), wherein the frame is configured for transmitting a pressure force onto the adhesive foil (105 is used to space the roller 110 relative to the adhesive foil 150 and apply pressure force onto the adhesive foil during sealing-see fig. 3A and para 0042-0043); and
a handle portion (110, 320) comprising a roller (110) moveable across the frame and the adhesive foil, for applying manual pressure onto the adhesive foil to thereby seal the multiwell plate (para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”);
wherein the device is configured to hermetically seal the multiwell plate using only manual force applied by a user without the assistance of machine power (para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”).
Regarding claim 2, as shown in claim 1, Schuler teaches
wherein the device is configured such that the handle portion can be manually moved from an initial position along the whole length of the multiwell plate to a stopping position and back to the initial position (para 0042-0043, the initial position being one end of the multiwell plate 130 and the other end being the stopping position, see para 0044 for manual operation especially part “the roller 110 may be translated relative to the platform 105 by hand”).
Regarding claim 3, as shown in claim 2, Schuler teaches
wherein the device is configured such that the handle portion mechanically blocks the frame from moving to an open position (para 0042, especially “the platform 105 may be pivotably connected to the stage 300 so that the platform 105 may pivot about an axis parallel to its longitudinal axis. In this way, misalignment between the roller 110 and the platform 105 may be accommodated”.) when the handle portion is in a position other than the initial position such that the frame is only removable from the multiwell plate, and the multiwell plate is only removable from the multiwell plate holder, when the handle portion is in its initial position (see fig. 10, when the roller is being moved above the multiwell plates, it will mechanically block the removal of the multiwell plate 130 and the multiwell plate holder 300).
Regarding claim 4, as shown in claim 1, Schuler teaches
wherein the frame is movably attached to the multiwell plate holder by means of a hinge (para 0042, especially “the platform 105 may be pivotably connected to the stage 300 so that the platform 105 may pivot about an axis parallel to its longitudinal axis. In this way, misalignment between the roller 110 and the platform 105 may be accommodated”. Please note that merriam-webster dictionary defines “hinge” as “a jointed or flexible device on which a door, lid, or other swinging part turns”. Therefore, Examiner is interpreting the hinge as the location at which the platform 105 pivots. See https://www.merriam-webster.com/dictionary/hinge accessed 6/2/2026), such that the frame can be folded onto the adhesive foil placed on the multiwell plate, and opened again (para 0042).
Regarding claim 6, as shown in claim 1, Schuler teaches
wherein the roller comprises a soft material, wherein, a hardness of the soft material at 20°C ranges between 55 and 65 shore A in accordance with DIN 53505 (para 0043, i.e. “the surface may be made of a material having a durometer of from about 10 to about 100. In one version, the surface comprises a fluoroelastomer, such as Viton.TM. available from E.I. Dupont de Nemours”), and wherein, the soft material is a polymer (para 0043, the surface comprises a fluoroelastomer, such as Viton.TM. available from E.I. Dupont de Nemours).
Regarding claim 10, as shown in claim 1, Schuler teaches
wherein the roller is biased away from the handle portion by means of a biasing mechanism (“springs” in para 0042), for evenly applying a force onto the frame and onto the adhesive foil placed on the multiwell plate (para 0042, especially “Accordingly, when a multi-layer package is positioned on the surface 115 of the platform 105 and when the platform 105 is positioned on the stage 300, the roller surface 120 contacts the multi-layered package to seal the layers, as discussed above. This contact may be provided by positioning the roller 110 a predetermined distance above the top surface 305 of the stage 300 or above the surface 115 of the platform 105. Alternatively, the contact may be provided by providing a mechanism, such as a spring, that biases the platform 105 toward the roller 110 or that biases the roller 110 toward the stage 300. The spring may be sized and shaped to provide a predetermined amount of pressure to be applied to the package.”).
Regarding claim 11, as shown in claim 1, Schuler teaches
wherein the multiwell plate holder comprises a plurality of support structures (310) arranged in a fixed manner, for supporting and holding in place the multiwell plate (para 0042).
Claims 1 and 11-12 are rejected under 35 U.S.C. 102 (a)(1/2) as being anticipated by an alternate interpretation of Schuler.
Regarding claim 1, alternate interpretation of Schuler teaches
A device (100) for manually sealing a multiwell plate (130, fig. 11B and para 0030, especially “a lower layer 130 with a preformed cavity 135 prefilled with the pharmaceutical formulation may be positioned onto the surface 115”), the device comprising:
a multiwell plate holder (105);
a frame (300) movably arranged and configured to frame the multiwell plate (using 315), for holding and centering a precut adhesive foil (150) placed on the multiwell plate, wherein the frame is configured for transmitting a pressure force onto the adhesive foil (315 is used to space the roller 110 relative to the adhesive foil 150 and apply pressure force onto the adhesive foil during sealing-see para 0042-0043); and
a handle portion (110, 320) comprising a roller (110) moveable across the frame and the adhesive foil, for applying manual pressure onto the adhesive foil to thereby seal the multiwell plate (para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”);
wherein the device is configured to hermetically seal the multiwell plate using only manual force applied by a user without the assistance of machine power (para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”).
Regarding claim 11, as shown in claim 1, alternate interpretation of Schuler teaches
wherein the multiwell plate holder comprises a plurality of support structures (140) arranged in a fixed manner, for supporting and holding in place the multiwell plate (para 0030, 0043).
Regarding claim 12, as shown in claim 11, alternate interpretation of Schuler teaches
wherein the support structures are formed to correspond to a plurality of recesses (recesses between various 130 cavities of the multiwell plate) on the bottom side of a respective multiwell plate (see fig. 11B), wherein the support structures are formed for accommodating different types of multiwell plates in the multiwell plate holder (the support structures can at least accommodate 1-6 well multiwell plates), and for preventing a deformation of the multiwell plate by directing a force applied by the roller to collars of the respective wells of the multiwell plate, as well as to edge regions of the multiwell plate (see fig. 3A-3B and para 0031-0032).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Schuler in view of USPGP# 20250066762 of Man et al. (henceforth Man).
Regarding claim 5, as shown in claim 1, Schuler does not teach
wherein the frame comprises a hinge (para 0042, especially “the platform 105 may be pivotably connected to the stage 300 so that the platform 105 may pivot about an axis parallel to its longitudinal axis. In this way, misalignment between the roller 110 and the platform 105 may be accommodated”. Please note that merriam-webster dictionary defines “hinge” as “a jointed or flexible device on which a door, lid, or other swinging part turns”. Therefore, Examiner is interpreting the hinge as the location at which the platform 105 pivots. See https://www.merriam-webster.com/dictionary/hinge accessed 6/2/2026).
Schuler does not teach
wherein the hinge is one of a friction and torque hinge for preventing the frame from folding by itself.
Man teaches
a hinge (5305) for connecting two frame elements (5310, 5315, fig. 53), wherein the hinge is a friction hinge (para 0380) for preventing the frame from folding by itself (para 0380).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the hinge of Schuler with a friction hinge as taught by Man in order to provide assistance when opening and closing the two elements (i.e. the frame relative to the multiwell plate holder of Schuler) and to prevent uncontrolled movement between the two elements (Man: para 0380). This makes the device easier and safer to use.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schuler in view of USPGP# 20130247521 of May et al. (henceforth May).
Regarding claim 7, as shown in claim 6, Schuler does not teach
wherein the soft material is polyurethane.
May teaches
a roller (127r) comprising a soft material (para 0110, 0146), wherein, in particular, a hardness of the soft material at 20°C ranges between 55 and 65 shore A (para 0110, 0146) and wherein the soft material is polyurethane (para 0110, 0146)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the roller material of Schuler with polyurethane as taught by May in order to ensure the roller is made from food/medical safe material (May: para 0110, 0146). Additionally, It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to make the soft material out of polyurethane, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schuler in view of WO2021101334 of Kim et al. (henceforth Kim).
Regarding claim 8, as shown in claim 1, Schuler teaches
wherein the handle portion is mounted onto the device by means of a roller mechanism (para 0042).
Schuler does not teach
wherein the handle portion is mounted onto the device by means of a ball bearing mechanism.
Kim teaches
a movement system (167, 169) comprising mounting a first part (157) to a second part (169) using a ball bearing mechanism (167).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the attachment mechanism of the handle portion of Schuler so that it uses ball bearing as taught by Kim in order to allow smooth movement of the handle during use (Kim: pg. 20 para 5 “The roller 167 according to embodiments of the present disclosure may include a ball bearing to smoothly move on the moving rail 169”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schuler in view of EP# 0774412 Rampp (henceforth Rampp).
Regarding claim 9, as shown in claim 1, Schuler does not teach
wherein the roller is mounted within the handle portion by means of a ball bearing mechanism.
Rampp teaches
mounting a roller (62) by means of a ball bearing mechanism (63)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mounting mechanism of the roller of Schuler so that it uses ball bearing as taught by Rampp in order to allow smooth movement of the roller during use. This makes the device easier to use.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the alternate interpretation of Schuler in view of USP# 6,015,534 of Atwood (henceforth Atwood).
Regarding claim 13, as shown in claim 11, alternate interpretation of Schuler teaches
wherein the support structures each protrude vertically from the multiwell plate holder (see fig. 11B, 140 protrude from bottom of the multiwell plate holder 105) and each have a cross-sectional area that is
Alternate interpretation of Schuler does not teach
the support structures each have a conical shape or a pyramid shape, respectively.
Atwood teaches
a multiwell plate holder (420) comprising a plurality of support structures (sloped walls as shown in fig. 43 and described in c. 43, l. 13-24) arranged in a fixed manner, for supporting and holding in place a multiwell plate (342, 376, 386); wherein the support structures each protrude vertically from the multiwell plate holder (see fig. 43); wherein the support structures are formed to correspond to a plurality of recesses on the bottom side of a respective multiwell plate (gaps between 376 as seen in fig. 45), wherein the support structures are formed for accommodating different types of multiwell plates in the multiwell plate holder (see fig. 45, support structures (as seen in fig. 43) can accommodate different multiwell plates that have few wells); wherein the support structures each protrude vertically from the multiwell plate holder (see fig. 43) and each have a cross-sectional area that is round (see fig. 43 and fig. 45), such that the support structures each have a conical shape (see fig. 43).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the shape of the support structure of Schuler such that it has a round cross section and a conical shape, as taught by Atwood, in order to produce the predictable result of firmly holding the multiwell plates firmly (Atwood: c. 43, l. 13-24). This prevents shifting of the multiwell plate during processing.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Schuler in view of USPGP# 20250229272 of Pedersen et al. (henceforth Pedersen).
Regarding claim 14, as shown in claim 1, Schuler does not teach
wherein the multiwell plate is a 96- or 384-well-plate.
Pedersen teaches
a multiwell plate (100) comprising a 96-well plate (para 0113) or a 384-well plate (para 0011).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the number of wells of the multiwell plate of Schuler such that it has either 96 or 384 wells as taught by Pedersen, in order to allow the device to seal greater number of wells simultaneously. This increases the efficiency and processing speed of the sealing device as greater number of wells can be sealed at the same time. Additionally, it would have been obvious to one having ordinary skill in the art, before the effective filling date of the invention, to increase the number of wells to 96 or 384, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Schuler in view of USPGP# 20150314927 of Warden et al. (henceforth Warden).
Regarding claim 15, Schuler teaches
A device (100) for manually sealing a multiwell plate (130, fig. 11B and para 0030, especially “a lower layer 130 with a preformed cavity 135 prefilled with the pharmaceutical formulation may be positioned onto the surface 115”), the device comprising:
a multiwell plate holder (300); and
a handle portion (110, 320) comprising a roller (110) moveable across multiwell plate holder and an adhesive foil (150), for applying manual pressure onto the adhesive foil to thereby seal the multiwell plate (para 0042-0043 and para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”);
wherein the sealing occurs without the assistance of machine power (para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”).
Schuler does not teach
a frame movably arranged and configured to frame the multiwell plate, for holding and centering the precut adhesive foil placed on the multiwell plate.
Warden teaches
A device (device in fig. 3) for manually sealing a multiwell plate (101, para 0008), the device comprising:
a multiwell plate holder (120);
a frame (105a) movably arranged and configured to frame the multiwell plate (using 301a), for holding and centering a precut adhesive foil (105d, para 0019) placed on the multiwell plate (see fig. 3),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Schuler with the addition of a frame, as taught by Warden, in to provide the predictable result of providing additional protection to the material inside the wells of the multiwell plate (Warden: para 0017) while also allowing precise placement of the adhesive foil onto the multiwell plate.
The combination of Schuler and Warden teaches
wherein the frame is configured for transmitting a pressure force onto the adhesive foil (the frame 105a of Warden is placed on top of the adhesive foil 150 of Schuler after the modification. Therefore, when pressed with the roller 110 of Schuler, it will transmit pressure force onto the adhesive foil. see also para 0034 and 0044 of Schuler)
The combination of Schuler and Warden additionally teaches
A method for sealing a multiwell plate (Schuler: 130), the method comprising:
placing a multiwell plate (Schuler: 130) in the multiwell plate holder (Schuler: 300) of the device as shown above,
placing an adhesive foil (Schuler: 150) onto the multiwell plate,
placing the frame (Warden: 105a) of the device onto adhesive foil and multiwell plate, for centering and holding in place the adhesive foil (Warden: see fig. 3 and the features 301a that surround the foil 105d), and
sealing the multiwell plate by manually moving the handle portion from an initial position (Schuler: para 0042-0043) along the whole length of the multiwell plate to a stopping position (Schuler: para 0042-0043) and back to the initial position (Schuler: para 0042-0043), for applying pressure onto the adhesive foil by means of the roller of the device, wherein the sealing occurs without the assistance of machine power (Schuler: para 0044, “Alternatively, the roller 110 may be translated relative to the platform 105 by hand.” and para 0034, “Alternatively, the sealing material may comprise an adhesive or bonding material that does not require heat to activate. Accordingly, in this version, the roller 110 may be used to compress the layers and improve the sealing of the layers”).).
Regarding claim 16, as shown in claim 15, the combination of Schuler and Warden teaches
wherein the step of sealing the multiwell plate by manually moving the handle portion from an initial position along the whole length of the multiwell plate to a stopping position and back to the initial position (Schuler: para 0042-0044, see also figs. 2A-C).
The combination of Schuler and Warden does not teach
repeating at least once moving the handle portion from stopping position back to the initial position.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to repeat the step of moving the handle portion back to the initial position, since it has been held that mere duplication of the essential working steps involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Response to Arguments
Applicant’s arguments filed on 3/26/2026 have been fully considered:
Previous drawing objections have been overcome. However, new objections are made in view of the substitute drawings.
Amended claims have overcome all previous 112 (b) or second paragraph rejection/s.
Applicant’s arguments regarding claim 1, have been fully considered but are not persuasive.
Regarding claim 1, Applicant states Schuler teaches using “heated roller” for sealing which requires machine power.
As described in para 0034 of Schuler, the roller 110 can be used without heating by using an adhesive foil.
Regarding claim 1, Applicant states Schuler does not teach that “the frame is movable arranged and configured to framer the multiwell plates” because the invention requires “a distinct structural component that overlays the plate to center a precut foil and transmit pressure”
The claim, as recited, does not necessarily require that the frame overlays on top of the plate to center a precut foil and transmit pressure. Schuler teaches the claimed feature of a frame 105 movably arranged (para 0042, “the platform 105 is removably insertable onto a top surface 305 of the stage 300”) and configured to frame the multiwell plate (130), for holding (from below) and centering (center on top of the cavities 140) a precut adhesive foil (150) placed on the multiwell plate (130 figs. 3A-3B) and wherein the frame is configured for transmitting a pressure force onto the adhesive foil (provides pressure force to the bottom of the foil as shown in figs. 3A-3B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for the relevant art.
The above claims can also be rejected using Schuler in view of Warden which uses a frame 105a that overlays on top of the multiwell plate 101.
USPGP 20070251892 of Taike et al. also teaches support structures 120 as claimed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOBEEN AHMED whose telephone number is (571) 272-0356. The examiner can normally be reached on M-F (8:30 am to 5 pm).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached on 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A./
Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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