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 in the reply filed on 06/01/2026 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim Status
Claims 1-20 are pending with claims 1-10 being examined, claims 11-20 are deemed withdrawn.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Appropriate correction is required.
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 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 line 1 of claim 1, the “device” is unclear what element the applicant refers to as there is no drawing that illustrates the “device” element. Applicant is encouraged to clarify if the recited “device” is it the concentrating pipette tip (CPT) disclosed in [0023] that comprises housing 2002 as disclosed in [0139].
Claims 2-10 are rejected based on dependency on a rejected base claim.
As to line 1 of claim 2, the “permeate chamber” lacks antecedent basis.
Examiner will interpret the “permeate chamber” in accord with Applicant’s disclosure [0091], as the permeate side of the filter.
Appropriate action is required
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 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (US 20210215583 A1; hereinafter “Page”) in view of Liu et al (US 20060281143 A1; hereinafter “Liu”).
Regarding claim 1, Page teaches a device (Page; [0024]), comprising:
a housing (Page; [0057] “wall of CPT 100”) having a top end (Page; fig. 1A 113) and a bottom end (Page; fig. 1A. 103);
a filter (Page; fig. 1A. 101) enclosed within the housing (Page; [0057] “filter forms a permeate chamber between the wall of CPT 100”), the filter being vertically oriented and spanning a length of the housing (Page; fig. 1A. 101), the filter having a retentate surface (Page; [0063] “retentate side of filter”) and an opposing permeate surface (Page; fig. 1A. 109);
a retentate port positioned adjacent the top end of the housing (Page; fig. 12. 1217);
a permeate port positioned adjacent the top end of the housing (Page; fig. 1B. 119);
a sample port positioned adjacent the bottom end of the housing (Page; fig. 1A. 105).
Page fails to teach a device that includes a rotary distribution valve connected to the retentate port; a syringe pump connected to the rotary distribution valve, wherein the syringe pump is adapted to push a volume of fluid that is equivalent to a known internal volume of a retentate portion of the tip; and a source of addition fluid, a source of blocking fluid, a source of wash fluid; and a source of lysis fluid; wherein all sources of fluid are connected to separate and distinct ports on the rotary distribution valve.
However, Liu teaches the analogous art of an apparatus (Liu; Title) that includes a rotary distribution valve (Liu; fig. 4. 222) connected to the retentate port (Liu; [0071]); a syringe pump (Liu; fig. 4. 220 and [0058]) connected to the rotary distribution valve (Liu; fig. 5. 220, 222), wherein the syringe pump is adapted to push a volume of fluid that is equivalent to a known internal volume of a retentate portion of the tip (Liu; [0042] “inject a known volume of fluid…”); and a source of addition fluid (Liu; fig. 2. 208), a source of blocking fluid (Liu; fig. 2. 204 and [0064] “PBS”), a source of wash fluid (Liu; fig. 2. 202); and a source of lysis fluid (Liu; fig. 2. 206); wherein all sources of fluid are connected to separate and distinct ports on the rotary distribution valve (Liu; fig. 2. 202, 204, 206, 208, 222).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Page’s device to include a rotary distribution valve connected to the retentate port; a syringe pump connected to the rotary distribution valve, wherein the syringe pump is adapted to push a volume of fluid that is equivalent to a known internal volume of a retentate portion of the tip; and a source of addition fluid, a source of blocking fluid, a source of wash fluid; and a source of lysis fluid; wherein all sources of fluid are connected to separate and distinct ports on the rotary distribution valve as taught by Liu because Liu teaches an apparatus (Liu; Title) that includes a rotary distribution valve (Liu; fig. 4. 222) connected to the retentate port (Liu; [0071]); a syringe pump (Liu; fig. 4. 220 and [0058]) connected to the rotary distribution valve (Liu; fig. 5. 220, 222), wherein the syringe pump is adapted to push a volume of fluid that is equivalent to a known internal volume of a retentate portion of the tip (Liu; [0042] “inject a known volume of fluid…”); and a source of addition fluid (Liu; fig. 2. 208), a source of blocking fluid (Liu; fig. 2. 204 and [0064] “PBS”), a source of wash fluid (Liu; fig. 2. 202);and a source of lysis fluid (Liu; fig. 2. 206) ;wherein all sources of fluid are connected to separate and distinct ports on the rotary distribution valve (Liu; fig. 2. 202, 204, 206, 208, 222).
The modification to include a rotary valve allows to the valve to be rotated to allow fluid connection of any of the inlet ports (Liu; [0060]), adding a syringe pump allows pumping and transporting the fluid (Liu; [0057]).
Regarding claim 2, modified Page teaches the device in claim 1 (see above), further comprising: a backpressure system for applying backpressure to the filter permeate chamber (Page; [0069] “HFB creates a backpressure system on the permeate side of the hollow fibers 101” (which the fibers are in the chamber between impermeable walls of 100) (Page; [0057])).
Examiner will interpret the “permeate chamber” in accord with Applicant’s disclosure [0091], as the prior art’s permeate side of the hollow fibers of fiber filter 101 as disclosed in prior art applied to claim 2 [0057].
Regarding claim 3, modified Page teaches the device in claim 1 (see above), further comprising: a source of filter elution fluid (Page; [0058] “elution fluid line originates in the concentrator unit”, [0064] “a pump is contained within the concentrator unit”, [0087]); and a separate valve for controlling the flow of elution fluid through the filter housing and out the sample port (Page; [0096] “check valve causes elution fluid to pass though fiber filter”).
Regarding claim 4, modified Page teaches the device in claim 3 (see above), wherein the filter elution fluid source is pressurized with a soluble gas (Page; [0064] “sample is eluted using a gas, after the fluid is drawn the chamber is pressurized with positive pressure using a carbonated surfactant solution such as carbon dioxide”).
Regarding claim 5, modified Page teaches the device in claim 3 (see above), wherein the filter elution fluid contains a surfactant or detergent (Page; [0064] “sample is eluted using a gas, after the fluid is drawn the chamber is pressurized with positive pressure using a carbonated surfactant solution such as carbon dioxide”).
Regarding claim 6, modified Page teaches the device in claim 3 (see above), wherein the filter elution fluid contains a buffer (Page; [0063] “elution buffer”).
Regarding claim 7, modified Page teaches the device in claim 3 (see above), wherein the filter elution fluid contains a salt (Page; [0086] “sample is eluted using an elution buffer). It is well known in the art that elution buffers contain salts.
Regarding claim 8, modified Page teaches the device in claim 3 (see above), wherein the filter elution fluid contains a dispersant (Page; [0067] “Triton-X100”).
Regarding claim 10, modified Page teaches the device in claim 1 (see above), further comprising: a source of filter elution fluid (Page; [0056] “elution fluid line”).
Modified page fails to teach a source of filter elution fluid is connected to the rotary valve; wherein the rotary valve and syringe pump are used for dispensing the filter elution fluid.
However, Liu teaches the analogous art of an apparatus (Liu; Title) that includes a source of elution fluid (Liu; fig. 2. 204 and [0064]) connected to the rotary valve (Liu; fig. 2. 222); wherein the rotary valve and syringe pump (Liu; fig. 2. 220, 222) are used for dispensing the filter elution fluid (Liu; [0064] and [0057 “pump 220 can be a syringe pump”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Page’s source of elution fluid to be connected to the rotary valve; wherein the rotary valve and syringe pump are used for dispensing the filter elution fluid as taught by Liu because Liu teaches an apparatus (Liu; Title) that includes a source of elution fluid (Liu; fig. 2. 204 and [0064]) connected to the rotary valve (Liu; fig. 2. 222); wherein the rotary valve and syringe pump (Liu; fig. 2. 220, 222) are used for dispensing the filter elution fluid (Liu; [0064] and [0057 “pump 220 can be a syringe pump”).
The modification connect the source of elution fluid to a rotary valve allows to selectively choose when to connect the source of filter elution fluid to dispense filter elution fluid to the device.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (US 20210215583 A1; hereinafter “Page”) in view of Liu et al (US 20060281143 A1; hereinafter “Liu”) further in view of Qian (US 20170335313 A1; hereinafter “Qian”).
Regarding claim 9, modified Page teaches the device in claim 3 (see above) to include a filter elution fluid (see above).
Modified Page fails to teach the filter elution fluid contains a chelator.
However, Qian teaches the analogous art of a device (Qian; [0051) that includes a filter (Qian; [0047]) and an elution fluid that contains a chelator (Qian; [0046] EDTA).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Page’s filter elution fluid to contain a chelator as taught by Qian because Qian teaches a device (Qian; [0051) that includes a filter (Qian; [0047]) and an elution fluid that contains a chelator (Qian; [0046] EDTA).
The modification of adding a chelator to the filter elution fluid allows to sequester metal ions in the eluate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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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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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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