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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15 in the reply filed on April 6, 2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The disclosure is objected to because of the following informalities: reference number 52 has been employed to designate both first half and microfluidic channels.
Appropriate correction is required.
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 syringe housing retainer; a single syringe pump comprising plural syringe pumps, stepper motor driver, microprocessor, and RF transceiver 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 Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims are directed to an apparatuses. Although the claims mention at least one microfluidic chip, a microfluidic chip, fluid, and information, none of such are positively claimed as structural elements of the apparatuses. The prior are considered as materials or articles intended be, can be worked upon, and used with the apparatuses.
The apparatuses are defined by the positively claimed structural elements listed in the body of the claims and are not required to be used in any processes including to perform delivering of a fluid at any flow rate values to a microfluidic chip nor any other process steps.
It is noted that there is no definitive structural nexus (structurally connectivity, relative locations) provided for each of the positively claimed structural elements. For example, the syringe plunger is not required to be connected to, located in the syringe housing.
It is noted that the capital “A”s employed in the body of claim 1 is unnecessary.
It is noted that the specification states at paragraph [0030] that “[s]”ubstantially” is intended to mean a quantity, property, or value that is present to a great or significant extent and less than, more than or equal to totally. For example, substantially vertical may be less than, greater than, or equal to completely vertical. Therefore, the term “substantially” is not limited to any specific values but encompasses all values.
It is noted that the syringe housing retainer, syringe plunger retainer, stepper motor driver are not defined in the claims by any specific structures. Furthermore, the examiner fails to understand which/which structures in the specification and drawings correspond to each of such is not clearly indicated.
As to claims 2-3, 5, and 8-9, it is noted that the phrase “in communication with” does not provide for any specific type of communication nor requires any structural connectivity between any positively claimed structures.
It is noted that the phrase “one or more” only requires 1.
The term “plural” and nouns ending with “s” only require 2.
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 1-15 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.
As to claims 1 and 8, it is unclear what the term “comprising” is directed to the syringe pump or at least microfluidic chip (in claim 1); and the system or one or syringe pumps (in claim 8).
Claims 1-7 appear to be only directed to a syringe pump. Therefore, it appears as if claim 1 should read as “… chip, the syringe pump comprising:” of if applicant intends to claim an apparatus that comprises at least one microfluidic chip and a syringe pump comprising…, then the claim should clearly recite such.
It appears as if claim 8 should read as “….pumps, the system comprising:” and after such applicant should list each structural element that defines the system.
As to claims 1 and 8, it is unclear if it is intended for each of the respective inventions to comprise at least one microfluidic chip and a microfluidic chip respectively. As presently drafted, neither of such are positively claimed, listed as elements on separate indented lines in the body of the claims after the transitional phrase comprising.
Furthermore, it is noted that claim 1 does not appear to be consistent with the specification and drawings because the specification at paragraph [0044] of the US Publication states:
“FIG. 1 illustrates an exemplary syringe pump assembly 10 in accordance with an embodiment of the present invention. Syringe pump assembly 10 includes a syringe housing 12, a syringe plunger 14, a mounting assembly 16 that secures the syringe housing 12 in a fixed position, the mounting assembly 12 also including guide rails 18 and a syringe plunger retainer 20 movably coupled to the guide rails 18 and fixedly coupled to the syringe plunger 14, and a stepper motor 22 that drives the syringe plunger retainer 20 in a linear and reciprocal fashion relative to the syringe housing 12.”
However, claim 1 does not require that syringe pump assembly to comprise the syringe housing and syringe plunger as disclosed in the specification.
As to claims 1 and 8, it is unclear what structure described in the specification and shown in the drawing is considered as a syringe housing retainer because such is not clearly identified by either.
Dependent claims 2-7 and 9-15 are rejected via dependency upon a rejected claim.
As to claims 2, 3, and 8, it is unclear what structure described in the specification and shown in the drawing is considered as a stepper motor driver because such is not clearly identified by either. It is unclear if such driver is an actual structure or a computer driver (software, coding).
As to claim 4, it is unclear how the (one single) syringe pump that is the invention being claimed comprises (is defined by more than one syringe pump). As indicated in claim 1, the invention is directed to “A syringe pump…” not a plurality of pumps. Therefore, claim 4 is confusing. Furthermore, it is unclear if each of such “plural syringe pumps” are required to be the same as the syringe pump defined in claim 1, comprise the same elements provided for in claim 1 because the claim does not recite such.
Claim 4 recites the limitation "the microprocessor". There is insufficient antecedent basis for this limitation in the claim. No microprocessor has been previously claimed as an element of the syringe pump, nor mentioned. Furthermore, it is noted that the phrase “under the control of the microprocessor” does not provide for any structural nexus (connectivity nor definitive relative structural locations) of the plural syringe pumps and microprocessor. See also the similar phrase in claim 10.
It is unclear what is further structurally required by claims 6-7 and 11-15 because the claims do not provide for any further structural elements nor any further structure of any previously positively claimed element, but the claims are directed to flow rate of the unclaimed fluid to the unclaimed at least one microfluidic chip and unclaimed microfluidic chip. No delivering of any fluid at any flow rate is ever required to occur. See also claim interpretations above.
As to claim 8, in addition to the above applicable remarks/rejections, it is unclear if it is intended for the system to comprise one or more syringe pumps. As presently, drafted such is not listed in the body of the claim after the transitional phrase “comprising”. Therefore, such is not claimed as an element of the system. Therefore, it is unclear what is further structurally required by references, recitations directed to the “one or more syringe pumps”. The same is applicable to the unclaimed microfluidic chip.
It is unclear what is the nexus of the one or more pumps and the syringe pump assembly and further elements recited in the claim because the claims do not clearly recite such.
Furthermore, although not structure, it is noted that the “flow volume information” is not defined in the claim as being any specific information. As such, it is unclear what is considered as, required to be considered as “flow volume information” and what is the difference between such and any flow rate (values).
Furthermore, although flow rate is not structure, it is unclear if “syringe flow rate”, “the flow rate”, “the pump flow rate”, and “substantially uniform flow rate” are all the same or different because the claim does not clearly indicate such. If the same, then the claims should employ clear, and consistent language to indicate such.
As to claim 9, it is unclear how the at least one feedback sensor is required to be operably coupled to the one or more syringe pumps because such one or more syringe pumps is not claimed as elements of the system. It is presumed that “and in communication with…” refers to the at least one feedback sensor.
As to claim 10, it is unclear what is the nexus of the “plural syringe pumps” to the previously recited “one or more syringe pumps” and “syringe pump assembly” because the claim does not clearly recite such. Furthermore, it is unclear what is structurally required by the phrase “in a network” because such is not structurally defined in the claim. The phrase does not provide for nor require any structural connectivity between any structural elements. Furthermore, although no controlling is required to be performed, it is unclear what is considered as under “common control” because such is not defined in the claim.
Claims 11-13 are directed to the unclaimed microfluidic chip.
As to claim 11, it is unclear what the terms “thereof” and “their” reference because the claim does not clearly recite such.
Claim 13 recites the limitation "the at least two microfluidic channels" in the last line. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-5 and 8-13 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Cote, US 10,821,434.
Cote discloses dispensing system including a plurality of syringe pumps (network) in pipettor (32), cylinder block assembly (31) (syringe housing) within a pipetting head (34) carried, supported, and retained by base tower (25) (syringe housing retainer), each of the syringe pumps include a pistons (42) (plungers) in their respective cylinders (38) (plunger retainers) is mounted to the piston drive plate (44) (plunger retainer, rail); (Figures 1, 3-4 and corresponding descriptions);
a displacement motor (29), stepper motor (29) to provide linear positioning of the piston drive assembly (27), and therefore the axial position of the pistons (42) within their respective cylinders (38); (Figure 6 and corresponding description);
each of the pistons (42) (plungers) are operable connected to a at least one guide rail that allows for displacement of the pistons, displacement of the pistons (42) within the cylinders (38) causes a decrease or increase in air pressure which either draws liquid into or drives liquid out of the pipette tips (26). (Figure 4; column 4, lines 45-48);
As to claim 2 and 8, various structures connected to the motor (29) the movable piston drive assembly (27) (can be considered as a stepper motor drive)r. The air displacement motor is responsive to air displacement motor commands from the remote controller (17) (microprocessor) in wireless communication (via radio waves, rf transceiver) with the controller processor board (30) shown in FIG. 5. The controller processor board (30) (microprocessor and/or stepper motor driver) is in direct wired communication with the air displacement motor (29). (column 4, lines 49-67).
As to claims 2-5, and 8, a remote computer system (17) (microprocessor including radio frequency transceiver) such as an Apple iPod is shown as the primary user interface through which a user programs (control software) and operates the instrument. An additional pipetting button (21) is provided for advancing through the pipetting steps programmed through the user interface (17). The remote computer system (17) communicates with a controller processor board (30) (microprocessor) discussed below with reference to FIG. 5. (column 4, lines 29-36)
As to claims 9-10, the system includes sensing technologies that include MEMS devices (accelerometer), optical sensors, micro-switches or other suitable sensor. (feedback sensor; column 10 line, 58 – column 11, line 2).
Claims 11-13 are directed to the unclaimed microfluidic chip that is not a structural element of the invention. Therefore, such claims are also rejected.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cote, US 10,821,434.
Cote does not specify a substantially uniform flow rate is characterized by not having substantial pulsatile flow variations and the substantially uniform flow rate is between 0.001 mL/min and 100 mL/min.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
It would have been obvious to and withing the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention recognize that the system of Cote may be programmed to provide for a flow rate for a desired, suitable purpose including to provide for a substantially uniform flow rate characterized by not having substantial pulsatile flow variations and the substantially uniform flow rate is between 0.001 mL/min and 100 mL/min because such does not require and specialized skills beyond that of one or ordinary skill in the art as such would yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sigler; Andrew et al.; Cote; Richard; And Mettier; Ivo et al. disclose dispensing systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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