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 .
Response to Amendment
This action is responsive to the amendment dated 2/16/2026. The previous claim objections have been withdrawn due to applicant’s amendment. Some of the previous 112 rejections have been withdrawn. However, some remain and are presented below. Claims 1-9 and 11-17 remain pending. Any new ground(s) of rejection below have been made due to applicant’s amendment. This action is Final.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: there is no description in the specification for the opposing outer walls of the compressor elements extending parallel to each other and the sealable barrier conforming to a shape of the opposite outer wall portions of the compressor elements when in the position to prevent flow.
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 1-9 and 11-17 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 1, it is unclear what is meant by the internals channels of the single piece block being “configured as an embedded sealable barrier” as a channel is a lack of structure. It is believed the applicant is intending to claim the channels are defined by embedded sealable barriers.
Claim 3, it is unclear if the recitation of “a compressor element” is introducing an additional compressor element or if this feature is intending to refer back to the “one or more compressor elements” recited in claim 1.
Claim 3, it is unclear how the sealable barrier can be “in one of the internal channels” when, per claim 1, the internal channel is configured as the embedded sealable barrier. In other words, how can the sealable barrier be in the internal channel when, per claim 1, the sealable barrier is the internal channel.
Claims 4-6 are further rejected for reasoning similar to that directly above in claim 3.
Claim 11 is rejected as the claim depends from a canceled claim, making the claim indefinite. For the purposes of examination, claim 11 will be interpreted to depend from claim 1.
Claim 17, it is unclear how the embedded sealable barrier is formed external to the respective one or more internal channels and movable into the one or more internal channels when, per claim 1, the internal channels are configured as an embedded sealable barrier. In other words, how is the embedded sealable barrier formed external to the channels when the channels are formed by the sealable barriers?
Claims 2, 7-9, and 12-16 are rejected due to their dependency on a claim rejected above.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code 103 not included in this action can be found in a prior Office action.
Claim(s) 1-6, 9, 12, and 16-17, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes (U.S. 6,554,589) in view of Kneen (U.S. 2020/0049288).
Grapes discloses a pinch valve assembly comprising: a single piece block (11) comprising one or more internal channels providing a fluid path within the block (the void space of the block at tube tunnel 14), each of the one or more internal channels of the single piece block configured as an embedded sealable barrier (12); the single piece block further comprising one or more outlets (at the right end of the block in fig. 2) for connection of one or more fluid conduits to the channels; and one or more compressor elements (13a, 16) attached to the single piece block, each of the one or more compressor elements corresponding to a respective one of the one or more internal channels (figs. 1-3), each of the one or more compressor elements having opposing outer wall portions extending parallel to each other (the walls at the left and right end of 16 in fig. 2), wherein when the one or more compressor elements are in a position that prevents fluid flow in the respective one or more channels the embedded sealable barrier of the respective internal channel conforms to a shape of the opposing outer wall portions of the respective one or more compressor elements (fig. 2, notice how 12 extends along the sidewalls of 16 at the left and right end and conforms to the shape of 16 at these ends).
Grapes does not appear to disclose the block being a single piece or the channels being for the sterile distribution of fluids (i.e. some implicit structure/material/coating to maintain a sterile environment for the fluids flowing through).
Kneen teaches it was known in the art to have a similar compressible tube (12, 14) made of silicone material (para. 29) and pre-sterilization of the entire pinch valve assembly (see abstract and para. 29).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Grapes by having the embedded barrier be made of silicone that is pre-sterilized as taught by Kneen in order to be able to use the device in a medical application where contamination avoidance is of high importance or required if so desired by a user and especially as it has been held that selection of a known material on the basis of its suitability for an intended use involves only routine skill in the art. See MPEP2144.07.
Regarding claim 2, Grapes as modified further discloses one or more openings for connection of one or more compressor elements to the internal channels (the opening at 15 which leads to 14).
Regarding claim 3, Grapes as modified further discloses a compressor element (13a, 16) connected to one of the one or more openings is moveable towards and through the opening for compression of the embedded sealable barrier in one of the internal channels to seal the internal channel (as best understood, fig. 2).
Regarding claim 4, Grapes as modified further discloses wherein the embedded sealable barrier is a compressible surface internal to the assembly and the compressor element is configured to push the compressible surface into the internal channel to seal the internal channel (as best understood, fig. 2).
Regarding claim 5, Grapes as modified further discloses wherein the embedded sealable barrier is a compressible fluid conduit internal to the assembly and the compressor element is configured to push directly onto the surface of the compressible fluid conduit to seal the internal channel (as best understood, fig. 2).
Regarding claim 6, Grapes as modified further discloses wherein, in use, the compressor element is moveable between an open position wherein the embedded sealable barrier in one of the one or more channels is uncompressed to allow for fluid flow in the channel (when 13a is retracted to allow fluid flow therethrough, see col. 2, ll. 12-16) and a closed position wherein the embedded sealable barrier in one of the one or more channels is compressed to prevent fluid flow in the channel (fig. 2).
Regarding claim 9, Grapes as modified further discloses the embedded sealable barrier being comprised of silicone material (claim 2 of Grapes and the teaching above).
Regarding claim 12, Grapes as modified further discloses wherein the single piece block is further configured to be connectable to an additional single piece block (the block is at least capable of being connectable to another block, especially via the threaded ports).
Regarding claim 16, Grapes as modified further discloses wherein the one or more compressor elements comprise at least one of a pin or a piston (piston 13a, 16).
Regarding claim 17, Grapes as modified further discloses wherein the embedded sealable barrier corresponding to each of the one or more internal channels is formed external to the respective one or more internal channels and movable into the respective one or more internal channels (as best understood, fig. 2).
Claim(s) 7, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes in view of Kneen as applied to claim 3 above, and further in view of White (U.S. 3,566,917).
Grapes as modified discloses the claimed invention and further discloses wherein the block is a rectangular cuboid shape (see fig. 1) but does not appear to disclose the block comprising the one or more outlets for connection of one or more fluid conduits to the internal channels on a first, second and third surface and the plurality of openings for connection of one or more compressor elements to the internal channels on a fourth surface.
White teaches it was known in the art to have a fluid manifold that is a rectangular cuboid shape comprising ports/openings on four surfaces of the manifold for connection to various components (see the rectangular cuboid 10 in fig. 1 and ports at the top surface for 28, ports on the side surfaces at 20, and also ports on the bottom surface for 25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Grapes such that the block has ports/openings on four surfaces of the block as taught by White in order to provide the block with the desired openings to connect to the various components.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes in view of Kneen as applied to claim 1 above, and further in view of Gilson (WO 00/68603)(supplied by the applicant in the IDS dated 2/7/2024).
Grapes as modified discloses the claimed invention but does not appear to disclose the block comprised of a disposable polymer block.
Gilson teaches it was known in the art to have a similar housing for a pinch valve that is made of a disposable polymer (tough plastic described on page 3, the third to last line or acetal plastic in the first two lines of the last full paragraph of page 5 are polymers, and the block is able to be disposed of).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Grapes such that the block is made of a disposable polymer as taught by Gilson in order to have the block be made of a relatively inexpensive material that is readily available and easily manufactured and especially as it has been held that selection of a material on the basis of its suitability for an intended use involves only routine skill in the art. See MPEP2144.07.
Claim(s) 11, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes in view of Kneen as applied to claim 1 above, and further in view of Mitsumori (U.S. 2006/0252992).
Grapes as modified discloses the claimed invention but is silent as to a sterilization being done by plasma coating.
Mitsumori teaches it was known in the art to sterilize tubing by coating the tubing with a plasma (para. 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the assembly of Grapes such that the channels are sterile via a plasma coating as taught by Mitsumori in order to achieve a pre-sterilized assembly if so desired by a user for a particular application via a known means to sterilize and prevent contaminants from being within the assembly.
Claim(s) 13, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes in view of Kneen as applied to claim 12 above, and further in view of Festo AG & Co (EP2674652)(supplied by the applicant with English translation in the IDS dated 2/7/2024).
Grapes as modified discloses the claimed invention but does not appear to disclose the block connected to one or more additional single piece blocks to form a modular assembly.
Festo teaches it was known in the art to have a pinch valve assembly that is modular and comprised of multiple blocks (see fig. 1 and blocks 5 totaling at least three and each block having a pinch valve 18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Grapes such that the block is modular and connected to additional blocks as taught by Festo in order to be able to control multiple fluid lines via the same pinch means in a compact and modular manner.
Claim(s) 14, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes in view of Kneen as applied to claim 3 above, and further in view of Gilson.
Grapes as modified discloses the claimed invention but does not appear to disclose the compressor element being configured to be manually actuated.
Gilson teaches it was known in the art to have a similar pinch valve that is manually actuated (via manual screwing of the cap 30, see pg. 5, the second full paragraph, beginning with “The plunger 36”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Grapes such that the actuation is manual as taught by Gilson in order to allow for an actuation of the valve that can be performed by a user and does not require additional components to be connected to the valve.
Claim(s) 15, as far as it is definite, is/are rejected under 35 U.S.C. 103 as being unpatentable over Grapes in view of Kneen as applied to claim 3 above, and further in view of Yusko, Jr. et al. (U.S. 4,877,053).
Grapes as modified discloses the claimed invention but does not appear to disclose the compressor element being pneumatically actuated.
Yusko teaches it was known to manually actuate (fig. 8) a pinch valve or alternatively have it pneumatically actuated (fig. 7)(see col. 8, ll. 21-34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the actuation of the compressor for the pinch valve of Grapes by having the actuation be pneumatic as taught by Yusko as the pneumatic actuation does not require the physical presence of a user to manually actuate the valve, making actuation easier and able to be remotely operated.
Response to Arguments
Applicant’s argues on page 5 that the 112 rejection should be withdrawn as the barrier is embedded within the channel of the block. However, applicant’s claim recites the internal channel “configured as” an embedded sealable barrier. It is unclear how the channel is “configured as” a sealable barrier as a channel is a lack of structure. This is further unclear in the dependent claims, such as claim 3 reciting the embedded sealable barrier is “in one of the internal channels” and claim 17 which recites the sealable barrier is external to the channel. How could the sealable barrier be in the channel or external to the channel when, per claim 1, the channel is configured as the sealable barrier?
Applicant’s arguments with respect to claim(s) 1-9 and 11-17 and the 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R REID whose telephone number is (313)446-4859. The examiner can normally be reached on Monday-Friday 9am-5pm est.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors can be reached by phone. Craig Schneider can be reached at 571-272-3607, or Ken Rinehart can be reached at 571-272-4881. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/MICHAEL R REID/ Primary Examiner, Art Unit 3753