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
Claims 43, 65 and 106-111 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/24/2026.
The Applicant correctly pointed out the typographical error in the Restriction Requirement.
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.
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.
Claims 1, 5, 6, 10, 24, 28, and 100-104 are rejected under 35 U.S.C. 103 as being unpatentable over Richards, et al (EP 3301454 [IDS Reference]) and Lowery, et al (PGPub 2019/0032104). Richards provides for a device that appears consistent with the structural and functional elements claimed in the independent claim. It should be noted, though, that the claimed “needle” is not described in Richards, but it appears to consistent with Richards’ disposable pipette tip, as they serve identical functions. See paragraph [0003] [0061]. Richards indicates that the pipettor system provides for the same functional elements as that claimed, wherein sample can be taken into the pipette and distributed into the sample preparation cartridge. See paragraph [0059]-[0063]. Richards indicates that the pipettor system dispenses the samples into a plurality of aliquots for automated susceptibility testing (AST). See paragraph [0174]. After providing aliquots, Richards indicates that the samples are incubated. See paragraph [0248]. Richards indicates that an image is acquired, wherein antimicrobial susceptibly is determined. See paragraph [0004]. Although Richards does not include sample concentration as an explicitly described step, Richards does suggest sample concentration, and further indicates that the process should begin with the most concentrated specimen. See paragraph [0168] [0190].
Lowery provides for methods and devices for improving the speed of AST. See paragraph [0001] [0004]. Lowery provides for a pipetting device that is similar to that claimed and that of Richards. See paragraph [0208]. Lowery describes providing an aliquot, that was dispensed by pipette tip, into a centrifuge, which would concentrate the sample, followed by an incubation step. See paragraph [0007] [0010]. Although Lowery does determine the susceptibility of pathogens to the testing antimicrobial compounds, Lowery uses nuclear magnetic resonance (NMR) as a detecting means. See paragraph [0038].
Lowery and Richards are within the same field and would be known to the ordinary artisan that works in this field. Based upon this, it would be clear to the ordinary artisan that AST can be modified in manners to suit the ordinary artisan’s particular needs. For example, while NMRs are highly accurate and precise, they are large and expensive; therefore, it would be reasonable to expect the ordinary artisan to be capable of modifying a means of detection to suit their specific needs. It would further be clear to the ordinary artisan that a step of concentration would provide for the enrichment of microbes or elimination of unwanted cells, and cellular debris. See Lowery, paragraph [0165].
With respect to claim 1, Richards teaches all of the claimed structural limitations, and steps for performing the method on this device, including optical imaging of the sample; although Richards generally suggest enrichment, Richards does not explicitly describe this step. Lowery teaches all of the claimed structural limitations, including enrichment steps, but teaches a different means of acquiring the data. The ordinary artisan would find in obvious to apply Lowery’s enrichment step to the method of Richards, because Lowery indicates that this enrichment step helps eliminate unwanted cells and debris, thereby improving the signal-to-noise ratio.
With respect to claim 5, Lowery teaches the same centrifugation steps. See paragraph [0013].
With respect to claim 6, Lowery teaches “lysis centrifugation,” which fulfills the claimed limitation. See paragraph [0007].
With respect to claim 10, Lowery teaches magnetic particles that are configured to bind to the suspected pathogen. See paragraph [0009].
With respect to claim 24, Richards teaches the same steps of image acquisition. See paragraph [0032] [0064]. Although Richards does teach a reaction well, Richards does not describe structural elements that are inherent to a transparent reaction well. See paragraph [0003]
With respect to claim 28, Richards teaches that fluorophores can be added to the sample, and that these fluorescent dyes will stain the pathogens. See paragraph [0179].
With respect to claim 100, although not explicitly states, it would be reasonable to assume that Richards and Lowery used disposable pipette tips as they are designed to be used. This would necessarily accomplish the claimed step.
With respect to claim 101, although not explicitly stated, essentially all commercially available pipette tips are sold with aerosol filters. The prevention of contamination is obvious to the ordinary artisan.
With respect to claims 102-104, the claim provides for the general function of a micropipette, and it is likely included in the pipetting systems of both Richards and Lowery. See Richards, paragraph [0061]; Lowery, paragraph [0243]
With respect to claim 105, although neither Richards nor Lowery teach a septum, there is nothing non-obvious about providing airtight containers as a means of reducing the probability of contamination. See Richards, paragraph [0114]; Lowery, paragraph [0250] [0253] [0257].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
Prosecution Insights