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 . 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 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.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/569,811 application filed on December 13, 2023. Claims 46-69 are pending and have been fully considered. The examined claims are directed to an apparatus, where claims 46 and 68 are interpreted as independent.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 46-67, in the reply filed on August 17, 2026 is acknowledged. Claims 68 and 69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 12/13/2023 and 6/02/2026. Please refer to the signed copy of the PTO-1449 form attached herewith.
Claim Interpretation
The examined claims are apparatus claims requiring only the positively recited structural components, although structured with physical features that can perform the stated functions or accomplish the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, in the patentability analysis of these apparatus/system claims, functional features are considered/not ignored and Applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
The recited sample solution, for example, is considered a material potentially contained within, transient or passing through, generated or produced, or otherwise worked upon by the apparatus rather than a structural component of the apparatus.
According to the MPEP §2115 [R-2], a material or article worked upon does not limit apparatus claims: Expressions relating an apparatus to contents thereof during an intended operation are of no significance in determining patentability of apparatus claims. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I. Unless otherwise specified, any citation to Applicant’s specification will generally refer to the original and any substitute or amended specification rather than a published application.
Examiner interprets limitations such as ‘configured,’ ‘configured to’ and/or ‘configured for’ as similar or equivalent to ‘set up to,’ ‘designed to,’ ‘capable of,’ or simply ‘can,’ in the context of an appropriate reference.
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 46-69 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 pre-AIA the applicant regards as the invention.
Claim 46 recites that "each of the components of the mixture is at least partially dissolvable or dispersible in the at least one water-based sample solution to mix with the at least one water-based sample solution." However, the claim also states that the "luminescent chemical sensor [is] configured to emit an emission spectrum dependent on conditions of the extracellular environment..." It is unclear whether the sensor stays anchored and operational as a local sensor within the culture chamber in the event the matrix and the sensor completely dissolves or disperses away upon exposure to the liquid flowing from the first end to the second end.
Also, with the language “at least one luminescent chemical sensor configured to emit an emission spectrum dependent on conditions of the extracellular environment in the at least one water-based sample solution in the microstructure” it is unclear what specific features or conditions would cause an emission spectrum.
In claim 48, the recitation “at least 40% or 50% dissolvable or dispersible” is unclear since this appears to be a moving boundary. For example, it would be unclear if a mixture that is 45% dissolvable will meet the limitation or whether the threshold will shift based on a certain context.
Claim 49 states "substantially entirely or almost diffused," which are terms of degree that lack an objective baseline or metric within the claim or the specification to inform one of ordinary skill where the structural boundary lies.
Claim 53 recites three distinct options but it mixes operational modes ("selected to move freely") with physical structures ("disposed inside an entity"). In the context of an “at least one of” list this is an improper Markush group construction since it creates overlapping, ambiguous permutations that confuses the intended metes and bounds of the claim.
Claim 54 states: "the at least one culture chamber comprises a plurality of culture chambers respectively associated with the plurality of chambers." The latter underlined phrase "the plurality of chambers" lacks antecedent basis, making it unclear whether it refers to the channels or another unrecited structural element.
Claim 64 references "respective substructures along the associated channels," however, no specific channels were structurally mapped or associated earlier within that same clause, thereby creating an antecedent basis issue.
Claims 47-67 depend on claim 46.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. The inventive entity for a particular application is based on some contribution to at least one of the claims made by each of the named inventors. MPEP §2137.01.
Claims 46-57, 59-62, 66 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Kahlman et al. (US20090105087, Kahlman)(IDS of 06/02/2026) in view of Super et al. (US20150064703, Super).
Note that these are apparatus claims. In the patentability analysis below, the italicized portions represent functional aspects, whereas the bolded portions represent structure.
Regarding claims 46-57, 59-62, 66 and 67, Kahlman discloses a monitoring device (Abstract, Figs. 1 & 2)) comprising:
a substrate comprising at least one microstructure formed therein, the at least one microstructure ([0012], [0041]) comprising:
at least one channel 5 with a first end and a second end, and at least one culture chamber that opens to the at least one channel (Figs 1 & 2); and
an opening coupled to said first end of the at least one channel, the opening being configured to load at least one water-based sample solution into the at least one microstructure through the first end of the at least one channel to flow along the channel from the first end to the second end of the at least one channel into the at least one culture chamber to form an extracellular environment,
wherein one or more of the at least one channel and the at least one culture chamber comprises a part which is coated with a mixture comprising at least the following components:
a matrix element ([0004], [0031]), and
at least one luminescent chemical sensor 100 configured to emit an emission spectrum dependent on conditions of the extracellular environment in the at least one water-based sample solution in the microstructure ([0020], [0021], [0041], [0067; where any fluorescent or luminescent tag will emit a different emission spectrum dependent on extracellular environmental conditions in the microstructure), and
wherein each of the components of the mixture is at least partially dissolvable or dispersible in the at least one water-based sample solution to mix with the at least one water-based sample solution ([0031], [0064], where the dissolvability and dispersibility of the components depends on the nature of the solution).
Therefore, Kahlman discloses the claimed invention, except for certain implied features along with the microfluidic extracellular environment.
Super discloses methods, compositions, kits and systems for rapid determination of antibiotic susceptibility of a microbe within hours after a sample is collected (Abstract, Fig. 1). In one embodiment, one or more of the preprocessing, processing, capture, microbe separation, detection, and antibiotic sensitivity can be performed in a microfluidic device ([0032]). In some embodiments, one or more of the microbe capture or separation, microbe incubation, and microbe detection, or the modules or systems performing these processes, can be included in a microfluidic device and can comprise a microfluidic channel (Id.). Use of a microfluidic device can automate the process and/or allow processing of multiple samples at the same time (Id.).
Generally, the method comprises: (i) extraction and concentration of microbes from a biological fluid ([0027]). The microbe can be extracted from the test sample using a microbe-targeting substrate, i.e., a solid substrate coated with microbe-binding molecules (Id.). The sample mixture may be subjected to a microbe separation process ([0085]). Depending on types of microbe labeling methods, for example, a detection component, device or system can be used to optionally detect the presence of the separated microbe ([0107]).
In some embodiments, one can employ the methods to determine the antibiotic susceptibility of a bacteria present in a biofilm, which can be broadly defined as microbial cells attached to a surface, and which are embedded in a matrix of extracellular polymeric substances produced by the microorganisms ([0321]). The mass spectrometric analysis is performed on intracellular or extracellular substances ([0332]).
When the claimed invention was effectively filed, it would have been obvious to one of ordinary skill in the art to employ the monitoring device in any suitable environment including a microfluidic extracellular environment such as Super to facilitate efficient and automated processing such as allow processing of multiple samples at the same time.
Additional Disclosures Included: Claim 47: Said at least one luminescent chemical sensor comprised in said mixture is incorporated in at least one bead (Kahlman, [0043]); Claim 48: The components of the mixture are selected such that the mixture is at least 40% or 50% dissolvable or dispersible in the at least one water-based sample solution (Kahlman, [0031], [0055], [0070], where this is viewed as implicit if it is dissolvable or dispersable); Claim 49: The mixture is configured to be substantially entirely or almost diffused to the at least one water-based sample solution within 10 minutes after loading of the at least one water- based sample solution into the microstructure (this depends on the unclaimed nature and quantity of the solution and other conditions such as temperature); Claim 50: The at least one water-based sample solution is a body fluid or fluid derived from a body fluid (Kahlman, [0007]); Claim 51: The mixture comprises a further component that is a microbial growth agent that is dissolvable in the at least one water-based sample solution (Super, [0130], [0143]); Claim 52: The mixture comprises a further component that is a predetermined drug that is dissolvable or dispersible in the sample solution (Super, [0031], claim 46 analysis); Claim 53: The at least one luminescent chemical sensor is at least one of: selected to move freely relative to microbes present in the sample solution when dissolved or dispersed in the sample solution, disposed inside an entity or at a wall of an entity to not directly contact microbes present in the at least one water-based sample solution when dissolved in the at least one water-based sample solution, and selected to not penetrate microbes present in the at least one water-based sample solution (this is a purely functional limitation and does not appear to limit the structure); Claim 54: The at least one channel comprises a plurality of channels and the at least one culture chamber comprises a plurality of culture chambers respectively associated with the plurality of chambers, each of the channels having a first end in fluid connection with a respective opening configured to load the at least one water-based sample solution and a second end in fluid connection with a respective one of the culture chambers, the openings of the plurality of channels forming a single common opening to lead the at least one water-based sample solution into each of the channels (Super, [0074], [0121], [0189]; alternately a duplication of an existing part is not patentably distinct unless it produces new and unexpected results); Claim 55: The coated parts of each of the channels and the culture chambers are coated by another mixture comprising a different predetermined drug (Super, [0027], [0029], [0075], [0242]; alternately, it would have been obvious to routinely experiment with and to apply one or more suitable alternate coatings to facilitate enhanced monitoring); Claim 56: One or more of the at least one channel and the at least one culture chamber has a first part coated with a first mixture and a second part coated with a second mixture, different from the first mixture (claim 55 analysis); Claim 57: In the microfluidic extracellular environment monitoring device one or more of: (i) only the first mixture comprises the chemical sensor material, and (ii) only the second mixture comprises one or more of a microbial growth agent and a predetermined drug (it would have been obvious to routinely experiment with the effectiveness of the chemical sensor and growth agent and to allocate the chemical sensor and growth agent to the different mixtures in any desired workable manner); Claim 59: The coated part is present only in the at least one channel (it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to routinely experiment with placement of the coating such that the coated part could be present only in the at least one channel; also see claim 57 analysis); Claim 60: The coated part comprises one of: (i) a plurality of droplets of the mixture and (ii) a layer of the mixture (Super, [0075]); Claim 61: The luminescent chemical sensor is configured to emit an emission spectrum dependent on conditions of the extracellular environment including at least one of pH, and the concentration of one or more of O2, CO2, ammonia, calcium, magnesium, metals, lactate, cortisol, glucose, extracellular Adenosine Triphosphate (eATP) and polymers (this is a functional limitation and does not further limit the claimed structural features); Claim 62: The at least one luminescent chemical sensor is selected from the group consisting of quenchable fluorophores, thiols, ruthenium(II), osmium(II), rhenium(I), iridium(III), platinum(II) and palladium(II), rhodamine-based dyes, indicators for Ca2+, indicators for Na+, indicators for K+, indicators for Cl-, potential-sensitive dyes, luciferase-based sensors and their mixtures (Super, [0159], [0162]); Claim 66: The opening comprises a filter configured to filter unwanted substances from the sample solution (Super, [0172]); and Claim 67: The microstructure is configured to induce a capillary flow in the at least one channel (this is an implied functional feature).
Claims 58 and 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Kahlman et al. (US20090105087) in view of Super et al. (US20150064703), as applied to claim 46 above, further in view of Moll et al. (US20140120556, Moll)(IDS of 12-13-2023).
Regarding claims 58 and 63-65, Kahlman and Super combined discloses the microfluidic extracellular environment monitoring device according to claim 46, except wherein the at least one culture chamber is at least partially transparent to the outside of the microstructure.
Moll discloses a particle identification system includes: a cartridge for containing a sample with fluorescently labeled particles; illumination for illuminating a region within the cartridge to stimulate emission from particles; imager for generating wavelength-filtered electronic images of the emission within at least one measurement field of the region; and particle identifier for processing the electronic images to determine a superset of particles of interest, and fluorescently labeled particles within the superset based on properties of the particles in the at least one measurement field (Abstract). Optical access to the sample is required, which one can facilitate with a transparent structure ([0122]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the at least one culture chamber at least partially transparent to the outside of the microstructure to facilitate observation of the process and ready access to the sample, as necessary
Additional Disclosures Included: Claim 63: The at least one channel comprises a primary channel and a secondary channel, the at least one culture chamber being opened to the first end of the secondary channel to enable a gas to exit the microfluidic extracellular environment monitoring device from the culture chamber and flow from the first end to the second end of the secondary channel, the secondary channel comprising a capillary stop disposed between the first end and second end of the secondary channel to prevent the at least one water-based sample solution from exiting the at least one culture chamber (Moll, [0232]-[0242], where different capillary configurations are contemplated and it would have been obvious to experiment with alternate capillary structures); Claim 64: The at least one microstructure comprises a plurality of substructures arranged in parallel, in series, or circularly, in the substrate to enable the at least one water-based sample solution to flow into respective substructures along the associated channels from the first end directly to the second end of each of the respective channels into each of the plurality of culture chambers (Moll, [0232] and claim 63 analysis); and Claim 65: The culture chambers of the plurality of substructures are arranged on one or more concentric imaginary circles with respect to the opening (Moll, [0232] and claim 63 analysis).
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via 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) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central 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.
/HAYDEN BREWSTER/Examiner, AU 1779
Prosecution Insights