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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The “automated means for manipulating a tube weld” of claim 1 is interpreted to refer to the “tube welder on a robotic arm” described at line 21 of Page 13 of the specification.
The “automated means for transferring a first fluid” of claim 1 is interpreted to refer to the pumping arrangement described in lines 19-24 of Page 26 of the specification.
The “automated means for determining quantity of fluid” of claim 1 is interpreted to refer to the weight sensor described in line 34 of Page 27 of the specification.
The “automated means for sealing” of claim 3 is interpreted to refer to the heat sealer described at line 11 of page 27 of the specification.
The “automated means for mixing” of claim 9 is interpreted to refer to the mixing zone described at line 5 of Page 22 of the specification.
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(s) 1-6, 8-10, 13, 19, 20, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 11,541,222 (Konrad) in view of WO 2019/106207 (GB) (provided by the applicant.
In Re claim 1 Konrad discloses a closed system for mixing fluids, comprising: a means for connecting a first tube fluidly connected to a first consumable (container 4b) and another tube fluidly connected to a mixing consumable (container 4a), said connection a closed fluid connection between the first consumable and the mixing consumable; a means for transferring a first fluid contained by the first consumable to the mixing consumable via the fluid connection (pump 40); and a means for determining a quantity of fluid transferred to or from the mixing consumable (scale 71), wherein the system is further configured to manipulate a connection between a second tube fluidly connected to a second consumable (second container 4b) and said another tube fluidly connected to the mixing consumable, and transfer a second fluid therebetween to be mixed with the first fluid in the mixing consumable (Column 20, line 46 – Column 21, line 57).
Konrad fails to disclose the use of an automated means for manipulating a tube weld to connect the consumables to the mixing consumable.
GB discloses a sterile fluid handling apparatus which makes use of a means for manipulating a tube weld (Paragraph 130), and which further teaches the automation of the fluid handling function (Paragraph 113).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify he Konrad apparatus by adding an automated means for manipulating a tube weld, in order to guarantee a sterile connection between the various containers.
In Re claim 2 Konrad discloses a system which forms a connection between a mixing consumable (container 4a) and an output consumable (Bag 80) to transfer at least some of a mixture to the output consumable. It would have been obvious, in light of the teaching of GB described above, to use a means for manipulating a tube weld to form this connection, in order to ensure a sterile connection.
In Re claim 3 Konrad in view of GB discloses many limitations, but fails to disclose an automated means for sealing and disconnecting a tube once a transfer of consumables is complete.
GB discloses a sealing means (Paragraph 130, cutting line at a sealed junction to separate two closed lines).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the Konrad apparatus by using the means for manipulating a tube weld from GB to also act as a sealing means, as taught by GB, in order to permit a user to remove consumable containers without exposing their contents to air.
In Re claim 4 Konrad discloses an automated processing station (element 1 in Figure 1).
In Re claim 5 Konrad discloses a means for transferring fluid (pump 40), located on the processing station.
In Re claim 6 Konrad in view of GB discloses many limitations, but fails to disclose a means for manipulating a tube weld, a means for transferring fluid, or a means for sealing provided on a separate mobile unit.
It would have been an obvious matter of design choice whether to assemble the components of the Konrad system on a single station or on separate stations, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179.
In Re claim 8 Konrad discloses a pumping arrangement configured to apply pumping action to said tubes (pump 40).
In Re claim 9 Konrad discloses automated means for mixing the first and second fluids within the mixing consumable (mixing junction 60).
In Re claim 10 Konrad discloses a mixing zone in which the mixing consumable is positioned to receive the first and second fluids (mixing junction 60).
In Re claim 13 Konrad discloses a station comprising a plurality of slots configured to retain the first consumable, second consumable (holders for containers 4b in Figure 1), and output consumable (tray 70).
In Re claim 19 Konrad discloses an identifying mark on the consumables (801 in Figure 1).
In Re claim 20 Konrad discloses one or more sensors configured to measure one or more parameters of the consumables (weight sensor 71).
Konrad in view of GB as applied to claim 1 above performs the method of claims 22 and 23 during ordinary use and operation.
Allowable Subject Matter
Claim 7, 12, and 15-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent 9,883,987 discloses an apparatus for mixing consumables which connects consumable containers with a mixing consumable to produce an output consumable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON KAROL NIESZ whose telephone number is (571)270-3920. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig Schneider can be reached at 571 272 3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON K NIESZ/Primary Examiner, Art Unit 3753
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