DETAILED ACTION
This is the first office action on the merits with reference to the above identified patent application filed on 30 April 2025. Claims 1 – 9 and 20 – 23 are pending and currently being examined.
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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1 – 9 and 20 – 23, drawn to a method of isolating discrete fluid portions in a peristaltic consumable, classified in F04B 43/1276.
II. Claims 10 – 19 and 24, drawn to a fluid isolating pump and a single use reactor consumable, classified in F04B 43/1253.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the product can be used to practice the materially different process of delivering fluid from a source to its destination.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
There is a search and/or examination burden for the different inventions as set forth above because they may require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one invention would not likely be applicable to the other invention; and/or the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. In addition, examination burden is not limited exclusively to a prior art search but also includes the effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions such as those in the present application normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jae Yeon Baek on 2/8/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1 – 9 and 20 – 23. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10 – 19 and 24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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: The specification needs to be corrected to provide proper antecedent basis for the subject matter of claims 21 – 23, because currently, there is none.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “thermal element” in claim 7, “first routing feature” in claim 9 and “second routing feature” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claim(s) 1, 2, 5, 6, 8 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuccelli (PG Pub US 20200172568 A1).
In Re Claim 1, Tuccelli discloses a method of isolating discrete fluid portions (MPEP 2112.02 – I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”; paragraph [0052] discloses an apparatus that anticipates the claimed method) in a peristaltic consumable (paragraph [0052]; Figure 6; note that label 5 is not in Figure 6 but Figure 5 shows label “tubing wrapped around a central mandrel”, the label 5 corresponds to “central mandrel”; the “tubing” is label 10 but the label is not shown in Figure 6; the “tubing”/10 plus the “mandrel”/5 is being designated the claimed peristaltic consumable), comprising: inserting a consumable (5, 10) into a roller assembly (15; paragraph [0052]; Figure 5; note that label 15 is not in the figure but it shows label “roller compressing the tubing”) comprising one or more rollers (15; at least two rollers are visible), wherein the consumable (5, 10) comprises a cylindrical core (5) having a length of tubing (10) helically wrapped (paragraph [0052]: “peristaltic helix”) around the cylindrical core (as best seen in Figure 6); loading fluid in an inlet (the “one end” in paragraph [0051]: “Sample introduced as a pulse at one end of a flow channel”) of the tubing (10); compressing the tubing with the one or more rollers (15) to isolate one or more fluid portions (paragraph [0032]: “an individually defined volume”) within the tubing (“paragraph [0049]: “the different or discrete zones or packets of fluid are achieved by applying compressive forces to the exterior of the fluid flow channel”; paragraph [0032]: “an individually defined volume separated from adjoining volumes by an intervening barrier”), preventing fluid communication between adjacent fluid portions (paragraph [0048]: “maintain the separation between packets”); triggering relative peristaltic movement of the tubing to move each of the one or more fluid portions across the tubing (paragraph [0049]: “essentially mimicking a peristaltic pump”); and outputting at least a part of the fluid from an outlet of the tubing (paragraph [0050]: “channel outlet”; paragraph [0051]: “exit the flow channel”).
In Re Claim 2, Tuccelli discloses that the relative peristaltic movement is achieved by (b) moving the one or more rollers around the cylindrical core (paragraph [0052]: “One or more rollers 15 rotate around the mandrel 5”).
In Re Claim 5, Tuccelli discloses determining a time (paragraph [0051]: “known time”; paragraph [0056]: “target a particular residence time”) for incubation of the fluid (paragraph [0013]: “The flow channel may function as an incubation chamber”) and mechanically encapsulating the fluid in the tubing (10) with the one or more rollers (15) for the determined time (“residence time”) for incubation (by selecting the appropriate flow rate and tubing length - paragraph [0056]), wherein an amount of time from when a portion of the fluid is loaded into the inlet to when the portion of the fluid is output from the outlet corresponds to the determined time for incubation (paragraph [0051]: “Sample introduced as a pulse at one end of a flow channel will exit the flow channel in a sharp, well-defined peak at a known time”).
In Re Claim 6, Tuccelli discloses that the tubing (10) is flexible (the tubing must be flexible for the apparatus to function as disclosed).
In Re Claim 8, Tuccelli discloses that the fluid is loaded in the inlet using a pump (paragraph [0075]: “main feed pump”).
In Re Claim 20, Tuccelli discloses a method of isolating discrete fluid portions (MPEP 2112.02 – I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”; paragraph [0052] discloses an apparatus that anticipates the claimed method) in a peristaltic consumable (paragraph [0052]; Figure 6; note that label 5 is not in Figure 6 but Figure 5 shows label “tubing wrapped around a central mandrel”, the label 5 corresponds to “central mandrel”; the “tubing” is label 10 but the label is not shown in Figure 6; the “tubing”/10 plus the “mandrel”/5 is being designated the claimed peristaltic consumable), comprising: providing a support body (5) having a length of flexible tubing (10) arranged around the support body (5); loading fluid into an inlet (the “one end” in paragraph [0051]: “Sample introduced as a pulse at one end of a flow channel”) of the tubing (10); compressing the tubing (10) with one or more rollers (15; paragraph [0052]; Figure 5; note that label 15 is not in the figure but it shows label “roller compressing the tubing”) to isolate discrete fluid portions (paragraph [0049]: “the different or discrete zones or packets of fluid are achieved by applying compressive forces to the exterior of the fluid flow channel”; paragraph [0032]: “an individually defined volume separated from adjoining volumes by an intervening barrier”), thereby preventing fluid communication between adjacent portions (paragraph [0048]: “maintain the separation between packets”); inducing relative peristaltic movement of the tubing (10) to advance each isolated portion along the tubing (paragraph [0049]: “essentially mimicking a peristaltic pump”); and delivering at least a part of the fluid from an outlet of the tubing (paragraph [0050]: “channel outlet”; paragraph [0051]: “exit the flow channel”), wherein the support body (5) is a cylindrical geometry (as shown in Figure 6).
Claim Rejections - 35 USC § 103
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 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) 3, 4, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuccelli (PG Pub US 20200172568 A1) in view of Mittelstein (PG Pub US 20020146338 A1).
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Annotated Figure 12 of Mittelstein
In Re Claims 3 and 4, Tuccelli discloses all the limitations of Claim 1, but it does not disclose that the wrapped portions are spaced apart and do not contact one another in the compressed state.
However, Mittelstein discloses a consumable (Figure 11) to be used in a fluid isolating pump (see title), comprises a cylindrical core (530) having a length of tubing (510) helically wrapped around the cylindrical core (530), wherein wrapped portions of the tubing around the cylindrical core (530) are spaced apart from each other (there is clearly a ridge in between), wherein when the wrapped portions of the tubing are compressed with one or more rollers (various embodiments show the roller: 320; Figure 6, 522; Figure 13), the wrapped portions in a compressed state do not contact one another (see annotated figure above) (paragraphs [0052],[0053]; Figures 11, 12).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to substitute the consumable (Figure 6) of Tuccelli with the consumable (Figure 11) of Mittelstein because the configuration provides an effective means to maintain or change the temperature of fluid being pumped (paragraph [0011] of Mittelstein).
In Re Claim 7, Tuccelli discloses all the limitations of Claim 1, but it does not disclose a thermal element.
However, Mittelstein discloses a consumable (Figure 11) to be used in a fluid isolating pump (see title), comprises a cylindrical core (530) having a length of tubing (510) helically wrapped around the cylindrical core (530), wherein the temperature of fluid inside the tubing (510) is controlled (“maintain or change temperature of fluid” - paragraph [0011]) using a thermal element (“heating or cooling elements”)(paragraphs [0011],[0013]; Figures 11, 12).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to substitute the consumable (Figure 6) of Tuccelli with the consumable (Figure 11) of Mittelstein (having the heating or cooling elements in the central core) because the configuration provides an effective means to maintain or change the temperature of fluid being pumped (paragraph [0011] of Mittelstein).
In Re Claim 9, Tuccelli discloses all the limitations of Claim 1, but it does not disclose an end cap.
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Annotated Figure 11 of Mittelstein
However, Mittelstein discloses a consumable (Figure 11) to be used in a fluid isolating pump (see title), comprises a cylindrical core (530) having a length of tubing (510) helically wrapped around the cylindrical core (530), the consumable further includes an endcap (the annotated larger diameter portion of 530 in the above figure is being designated as an endcap) coupled to an end of the cylindrical core (530), and wherein the endcap is formed with a first routing feature (where 542 is installed in the end cap; this is similar to port 342 in Figure 8) and a second routing feature (where 552 is installed in the end cap), wherein the inlet (this includes a portion of the tube 510 and connector 542) of the tubing (510) is routed through the first routing feature and the outlet (this includes a portion of the tube 510 and connector 552) of the tubing (510) is routed through the second routing feature (paragraphs [0011], [0013], [0041], [0052], [0053]; Figures 11, 12).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to modify the consumable of Tuccelli to incorporate a cap as taught by Mittelstein because the cap provides convenient fittings for connecting to the fluid source and destination.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuccelli (PG Pub US 20200172568 A1) in view of Corso (PG Pub US 20130266929 A1).
In Re Claim 21, Tuccelli discloses all the limitations of Claim 20, and paragraph [0076] discloses a rotational speed that achieves a target flow rate (to maintain a desired residence time as stated in paragraph [0056]), but it does not disclose adjusting speed based on a sensor feedback.
However, Corso discloses adjusting a speed of the one or more rollers in response to feedback from a sensor (paragraph [0029]) that detects a position of at least one fluid portion within the tubing (the claimed “position” is the exit of the tubing, a portion of the fluid is detected/measured when it exits the tubing, paragraph [0029]: “the fluid flow exiting the tubing being pinched by the rollers is measured”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to incorporate a feedback sensor as taught by Corso at the exit of the tubing of Tuccelli for the purpose of ensuring that the desired flow rate is established and maintained (paragraphs [0007] and [0018] of Corso).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuccelli (PG Pub US 20200172568 A1) in view of Corso (PG Pub US 20130266929 A1) and further in view of Karlin (PG Pub US 20210093983 A1).
In Re Claim 22, Tuccelli and Corso disclose all the limitations of Claim 21, and although paragraph [0005] of Tuccelli discloses exposure to radiation as part of known techniques, Tuccelli and Corso do not disclose gamma-radiation compatible materials.
However, paragraph [0044] of Karlin discloses tubing (21) and support body (“pump head”) from gamma-radiation compatible materials (“suitable for being gamma irradiated”), and are configured for single use (“materials suitable for being disposable”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to make the tubing and support body of Tuccelli / Corso from gamma-radiation compatible materials configured for single use as taught by Karlin because 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 (See MPEP 2144.07 In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuccelli (PG Pub US 20200172568 A1) in view of Corso (PG Pub US 20130266929 A1) and further in view of Thiers (US Patent 3,475,128 A).
In Re Claim 23, Tuccelli and Corso disclose all the limitations of Claim 21, and Tuccelli discloses introducing one or more formulation ingredients (“acid” in paragraph [0059]) as a side stream, but Tuccelli and Corso do not disclose introducing the formulation ingredients into the tubing through an injection port positioned between successive rollers.
However, Figure 1 of Thiers discloses introducing one or more formulation ingredients (“reagents 33””) into the tubing (30, 26, 34) through an injection port (junction between 26 and 32) positioned between successive rollers (41, 42)(Column 6, Lines 1 – 15; Figure 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed the invention to incorporating an injection port as taught by Thiers between successive rollers of Tuccelli / Corso because it is only a matter of substituting the broadly disclosed side stream injection/addition of Tuccelli with the specifically disclosed injection port of Thiers, therefore the results of the substitution are predictable – "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." KSR Intl. Co. v. Teleflex Inc. at 420, 82 USPQ2d at 1397; The rigid requirement of a teaching, suggestion, or motivation to combine known elements in order to show obviousness has been rejected. Id. At 398,419 (2007). This a rationale that can be used to support a conclusion of obviousness (MPEP 2141, Section III, Rationale B).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DNYANESH G KASTURE whose telephone number is (571)270-3928. The examiner can normally be reached Mon-Thu, 7:30 AM to 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Essama Omgba can be reached at 469-295-9278. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.G.K/Examiner, Art Unit 3746
/ESSAMA OMGBA/Supervisory Patent Examiner, Art Unit 3746