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 .
Applicant’s filing of claims 1-20 on 8/8/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/22/23 was acknowledged. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first hollow flexible tubing is in fluid communication with the fluid routing system (claim 1); the second hollow flexible tubing is in fluid communication with the fluid routing system (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
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 1-14 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 is rejected because the “first hollow flexible tubing is in fluid communication with the fluid routing system” is unclear in light of [0062] of applicant’s PG Pub. Because the “fluid routing system” includes tubing segments according to [0062], it is unclear whether the claimed “first hollow flexible tubing” is a separate structural feature from the tubing segments of the fluid routing system.
Claim 1 is rejected because the structural relationship between the biological analyzer, fluid routing system and first linear peristaltic pump is unclear. What structural features perform the “configured to” claim language associated with the biological analyzer, fluid routing system and first linear peristaltic pump.
Claim Interpretation under 35 U.S.C. 112(f)
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: fluid routing system configured to direct the biological sample into the biological analyzer in claim 1; a first tubing compression member configured to move relative to the first hollow flexible tubing in claim 1; a first end configured to move relative to the first actuation assembly in response to an input from the first actuation assembly, and (B) a second end configured to move along the cam in response to movement of the first end in claim 13.
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 Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wanders et al. (“Wanders,” US Pub. No. 2018/0143182) in view of Phallen et al. (“Phallen,” US 6213739).
As to claim 1, Wanders discloses in figs. 1-4J et seq., a biological analyzer system comprising: (a) a biological analyzer (e.g., flow cell such as 22 in 1-3 et seq. and [0070] et seq.; also see [0349] et seq. for analyzer) configured to analyze a biological sample; (b) a fluid routing system (e.g., tube, tubing, channel, flow channel and/or flowpath connected to the “biological analyzer”) configured to direct the biological sample into the biological analyzer; and (c) a first pump (one of the precision metering pumps in [0071] et seq.) configured to move the biological sample in the fluid routing system through the biological analyzer.
Regarding claim 1, Wanders does not specifically disclose a linear peristaltic pump comprising: a first hollow flexible tubing extending along a first longitudinal axis, wherein the first hollow flexible tubing is in fluid communication with the fluid routing system, (ii) a first actuation assembly, and (iii) a first tubing compression member. Phallen discloses in e.g., col. 6, line 40 et seq., a linear or in-line three element peristaltic pump, indicated generally at 10 in FIGS. 1-4, the peristaltic pump also being known as a tube pump or hose pump. In general, the pump consists of a pump liquid flow tube 12 which is suitably acted upon to create flow, the inlet end of the pump tube 12 being connected to an inlet tube (not shown) via an inlet hose barb 14 which is held in place by a clamp 16 (12 and/or 14 can be flexible tubing; also see col. 22, line 13 et seq.). The three element pump includes three principal active or actuating assemblies (or elements) which act upon the pump tube 12 in col. 6, line 56 for “first actuation assembly”. The second principal or active element in the hose pump of the present invention is the displacement assembly, indicated generally at 36. (It is also referred to as the pumping element or the displacement element, the pumping section, or the compression section) in e.g., col. 7, line 25 et seq. for “first tubing compression member”. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include specifically a linear peristaltic pump because linear peristaltic pumps, or in-line designs, are unlike the rotary types in that the flow tube is acted upon only at right angles to the direction of flow of liquid through the tube, and thus, this single compressive motion eliminates the stretching and torquing forces of the rotary approach (col. 1, lines 42-46 of Phallen).
As to claims 2 and 3, the combination of Wanders and Phallen disclose the first linear peristaltic pump is positioned upstream and/or upstream of the biological analyzer and is configured to push the biological sample through the biological analyzer in e.g., fig. 1 of Phallen (upstream of the biological analyzer); and/or in e.g., [0071] et seq., and [0244] of Wanders (upstream and/or downstream of the biological analyzer because the particulars of sample preparation apparatus and methods for sample dilution, permeabilizing and histological staining, generally are accomplished using precision pumps and valves. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the pumps at particular locations of the analyzer system to promote efficient flow throughout the system.
As to claim 4, the combination of Wanders and Phallen disclose comprising a sample fluid source containing sample fluid, wherein the sample fluid source is in fluid communication with the fluid routing system, wherein the first linear peristaltic pump is configured to push the sample fluid and the biological sample into the biological analyzer (see [0018] et seq. of Wanders; and col. 6, line 40 et seq. of Phallen.
As to claim 5, Wanders discloses a sheath fluid source containing sheath fluid, wherein the sheath fluid source is in fluid communication with the fluid routing system, wherein the sheath fluid is configured to generally surround the biological sample while traveling through at least a portion of the biological analyzer in e.g., [0022] et seq.
As to claim 6, the combination of Wanders and Phallen disclose a second linear peristaltic pump positioned upstream of the biological analyzer and configured to push the sheath fluid into the biological analyzer in e.g., in e.g., fig. 1 of Phallen (upstream of the biological analyzer); and/or in e.g., [0071] et seq., and [0244] of Wanders (upstream and/or downstream of the biological analyzer because the particulars of sample preparation apparatus and methods for sample dilution, permeabilizing and histological staining, generally are accomplished using precision pumps and valves. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the pumps at particular locations of the analyzer system to promote efficient flow throughout the system.
Regarding claim 7, While Wanders discloses having multiple pumps, Wanders does not specifically disclose each pump is a linear peristaltic pump comprising: a first hollow flexible tubing extending along a second longitudinal axis, wherein the second hollow flexible tubing is in fluid communication with the fluid routing system, (ii) a second actuation assembly, and (iii) a second tubing compression member. Phallen discloses in e.g., col. 6, line 40 et seq., a linear or in-line three element peristaltic pump, indicated generally at 10 in FIGS. 1-4, the peristaltic pump also being known as a tube pump or hose pump. In general, the pump consists of a pump liquid flow tube 12 which is suitably acted upon to create flow, the inlet end of the pump tube 12 being connected to an inlet tube (not shown) via an inlet hose barb 14 which is held in place by a clamp 16 (12 and/or 14 can be flexible tubing; also see col. 22, line 13 et seq.). The three element pump includes three principal active or actuating assemblies (or elements) which act upon the pump tube 12 in col. 6, line 56 for “first actuation assembly”. The second principal or active element in the hose pump of the present invention is the displacement assembly, indicated generally at 36. (It is also referred to as the pumping element or the displacement element, the pumping section, or the compression section) in e.g., col. 7, line 25 et seq. for “first tubing compression member”. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include specifically a linear peristaltic pump because linear peristaltic pumps, or in-line designs, are unlike the rotary types in that the flow tube is acted upon only at right angles to the direction of flow of liquid through the tube, and thus, this single compressive motion eliminates the stretching and torquing forces of the rotary approach (col. 1, lines 42-46 of Phallen).
As to claim 8, the combination of Wanders and Phallen disclose the first hollow flexible tubing has a first inner diameter, wherein the second hollow flexible tubing has a second inner diameter that is greater than the first inner diameter in e.g., col. 8, line 8 et seq. of Phallen.
As to claim 9, Wanders discloses the fluid routing system includes a plurality of tubing segments in fluid communication with the biological analyzer in e.g., [0358] et seq.
As to claim 10, Wanders discloses the biological analyzer includes a flow cell in e.g., [0088] et seq.
As to claim 11, Wanders discloses the biological analyzer includes an analysis region, the biological analyzer system further comprising an imaging device configured to capture at least one image of the biological sample within the analysis region in e.g., [0015] et seq.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wanders in view of Phallen, as applied to claim 1 above, and further in view of Kamen et al. (“Kamen,” US Pub. No. 2013/0177455).
See Wanders and Phallen above.
As to claim 12, the combination of Wanders and Phallen disclose the first linear peristaltic pump further comprising: (i) a base, and (ii) a cam operatively coupled with the base, wherein the first hollow flexible tubing is at least partially supported by the base in e.g., col. 2, line 10 et seq. of Phallen, which discloses a base and cam, but Phallen does not specifically disclose the cam is part of the Phallen’s claimed invention. Kamen discloses in e.g., [0166] et seq., in FIG. 133 a cam-driven linear peristaltic pump having pinch valves and a plunger inside a variable volume in accordance with an embodiment of the present disclosure. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include a cam because it would be desirable to use a commonly known element that is easily combinable with a linear peristaltic pump.
As to claims 13 and 14, the combination of Wanders and Phallen disclose the first linear peristaltic pump further comprising a tubing compression assembly, the tubing compression assembly comprising: (A) a first end configured to move relative to the first actuation assembly in response to an input from the first actuation assembly, and (B) a second end configured to move along the cam in response to movement of the first end. The combination of Wanders and Phallen also disclose the tubing compression assembly comprising the first tubing compression member, wherein the first tubing compression member is configured to move relative to the hollow flexible tubing along the predetermined path in response to an input from the first actuation assembly to advance fluid linearly within the first hollow flexible tubing along the first longitudinal axis in response to movement of the second end. See e.g., col. 4, line 46 et seq. of Phallen; and e.g., [0166] et seq. of Kamen. For motivation statements, see above.
As to claims 15 and 20, Wanders discloses in figs. 1-4J et seq. of Wanders, a biological analyzer system comprising: (a) a biological analyzer configured to analyze a biological sample (e.g., flow cell such as 22 in 1-3 et seq. and [0070] et seq.; also see [0349] et seq. for analyzer of Wanders); (b) a fluid routing system configured to direct the biological sample into the biological analyzer (e.g., tube, tubing, channel, flow channel and/or flowpath connected to the “biological analyzer” of Wanders); and (c) a pump configured to move the biological sample in the fluid routing system through the biological analyzer (one of the precision metering pumps in [0071] et seq. of Wanders).
Regarding claims 15 and 20, while Wanders discloses a pump, as explained above, Wanders does not specifically disclose the linear peristaltic pump comprising: (i) a base, (ii) a cam operatively coupled with the base, (iii) an actuation assembly, (iv) a hollow flexible tubing at least partially supported by the base, and (v) a tubing compression assembly comprising: (A) a first end configured to move relative to the actuation assembly in response to an input from the actuation assembly, and (B) a second end disposed opposite the first end and configured to move along the cam in response to movement of the first end. See e.g., col. 4, line 46 et seq. of Phallen; and [0166] et seq. of Kamen for cam element. For motivation statements, see above.
As to claim 16, the combination of Wanders and Phallen disclose the hollow flexible tubing extends along a longitudinal axis in col. 6, line 40 et seq. of Phallen, the tubing compression assembly further comprising a tubing compression member configured to move relative to the hollow flexible tubing along a predetermined path to advance fluid linearly within the hollow flexible tubing along the longitudinal axis in response to movement of the second end in e.g., col. 4, line 46 et seq. of Phallen. For motivation statement, see above.
As to claim 17, the combination of Wanders, Phallen and Kamen disclose the tubing compression assembly further comprises: (i) a carriage disposed at the first end and configured to move along the actuation assembly, and (ii) a follower disposed at the second end and configured to move along the cam. See e.g., [0232] et seq. of Kamen, which discloses in FIG. 264 the door, a lever and a slide carriage of the peristaltic pump having L-shaped cam followers in an exploded view. For motivation statements, see above.
As to claim 18, the combination of Wanders, Phallen and Kamen disclose the tubing compression assembly further comprises a connecting arm coupling the follower and the tubing compression member with the carriage, wherein the connecting arm is pivotably coupled with the carriage in e.g., [0826] et seq. of Kamen. For motivation statements, see above.
As to claim 19, the combination of Wanders, Phallen and Kamen disclose the first linear peristaltic pump further comprises a guide spaced a distance from the cam and configured to contact the follower to direct the follower along a portion of the predetermined path in e.g., [0826] et seq. of Kamen. For motivation statements, see above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
3/21/2026