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 27-41 in the reply filed on August 29, 2025 is acknowledged.
Claims 42-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 collection matrix in a flow-through unit (claim 29); a centrifuge integrated into the apparatus (claim 32); at least one interface and at least one sensor (claim 34); temperature sensor (claim 35); a GPS receiver (claim 36); and electronic control system (claim 40) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The prior do not appear to be represent by any reference numerals nor labeling in the specification and drawings.
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 claimed apparatus 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 apparatus. However, the claims mention a sample liquid, sampling station (not defined by any specific structure(s)), body of water, container, at least one analyte, collection matrix identifier, identifier (not defined as any structure), at least one sensor, measurements, data, operating device (not defined as being any specific structure), server, and non-transitory computer medium (not defined as being any specific structure). None of the prior are positively claimed as elements of the apparatus, but are materials and/or articles intended to or can be worked upon, used with the apparatus. The claims are replete with language directed to intended use with further unclaimed articles and materials. There is no requirement for the apparatus to be used to perform any steps including transporting/pumping any liquid samples. However, there is no indication as to what is required of “a sample liquid” to be in a form “a liquid sample”. The phrases appear to be similar and redundant.
The apparatus of claim 1 is only structurally defined by a sample line, a pump device, at least one sample container, and an electronic control system.
It is noted that the positively claimed elements are not required to be fluidically connected because claim 27 only requires that the elements be capable of being connected as indicated by the phrase “can be fluidically connected”.
It is noted that the electronic control system is defined in the claims as being any specific structure(s).
It is noted that the “configured to” clauses recited in the claims do not provide for any further structural elements.
It is noted that the term “or” provides for alternative, options not requirements.
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 27-41 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 27 recites the limitation "the qualitative or quantitative determination" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
As to claims 27, 29, 38, and 43, it is unclear what/which sample container is being referenced by the phrase “the sample container” because claims 27 and 38 previously recites “at least one sample container”.
Claims 27 and 38 recites the limitation "the analyte present in the liquid sample" in the last line and 3rd from last paragraph, respectively. There is insufficient antecedent basis for this limitation in the claim. Although not positively claimed as an element of the apparatus it is noted that the preamble of the claim recites “at least one analyte contained in the sample liquid”. No liquid sample is previously claimed as containing an analyte.
It is noted that the claim also previously recites “liquid samples” of “a sample liquid”. Therefore, it is unclear what is the nexus of “the analyte” to the “at least one analyte” (claims 27-28, 31, 38, and 41).
Furthermore, it is unclear what is the nexus of “the liquid sample” to the prior “liquid samples” and what/which liquid sample is being referenced by the phrase “the liquid sample” (in claims 27-28, 33-36, and 38).
As to claims 27 and 38, how an electronic control system which is configured to fluidically connect the sample line to the at least one sample container because the control system is not defined as comprising any mechanical structure that can move the sample line and at least one sample container (nor any other structure) to provide any structural connection (fluidic connection). The electronic control system appears to be a computer or similar device. Therefore, it is unclear how the electronic control system can provide such a fluid connection and what is required of the electronic control system by the “configured to” clause because the claim does not clearly recite such.
Dependent claims 28-37 and 39-41 are rejected via dependency upon a rejected claim.
Claims 28 and 32 recites the limitation "the concentration or extraction" in line 2. There is insufficient antecedent basis for this limitation in the claim. Concentration and extraction are not structural elements. If the claim is intended to refer to the last line of claim 27, it is noted that such is directed to what the apparatus can do. There is no requirement of method steps to be performed including any concentrating or extracting of any analyte.
Since concentration and extraction are not structures that the apparatus can comprise and appear to be referring to acts/process steps, it is unclear how such can include a collection matrix (structure).
The term “substantially selectively binds” in claim 28 is a relative term which renders the claim indefinite. The term “substantially selectively binds” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although binding is required to be performed, the claim nor specification provides for any definition as to what is considered as substantially selectively binding. See also prior rejections above directed to claim 28.
As to claim 29, it is unclear if applicant intends for the apparatus to comprise a flow-though unit (not defined as specific structure) because the claim does not clearly recite such. Reciting that a flow-through unit is fluidically connected to the sample container does not require such unit to be an element of the instant apparatus/invention. Furthermore, it is unclear which/what sample container is being referenced by “the sample container”.
As to claims 30-31, it is unclear if the collection matrix is actually structural element of the invention. See prior rejection of claim 28.
The term “roughened or structured” in claim 30 is a relative term which renders the claim indefinite. The term “roughened or structured” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication to what value of surface roughness a surface is required to have to be considered as roughened. Furthermore, it is noted that any surface is a structure. Therefore, any surface is structured. Furthermore is unclear what is meant by the collection matrix has a functionalized nonwoven and a chromatographic separation column because the claim does not clearly provide for such.
As to claim 31, it is unclear which/what particles are being referenced by “the particles” because claim 30 previously recites “a plurality of particles”. It is unclear if such are the same or different. Furthermore, it is noted that a plurality of particles of one of the alternatives provided for in claim 30. Furthermore, although no surface is required, it is unclear what surface is being referenced by “the surface”.
It is unclear what is further structurally required by claim 32 because the claim is directed to process steps. See prior rejection of claim 28. Furthermore, it is unclear what is meant by the phrase “integrated into the apparatus” because the entire apparatus is what being currently defined. The phrase does not provide for any clearly and definitive structural connection to any prior positively claimed element so as to determine what is required by the phrase.
As to claims 33-36, it is unclear what/which liquid sample is being referenced by the phrase “the liquid sample”. See prior rejection above. Furthermore, it is unclear what is considered as an “identifier” because such is not defined in the claim and how a time stamp (or anything see also claims 35-36) can be saved to an identifier because the claim does not clearly recite such.
Claim 33 recites the limitation "the time at which the liquid sample is taken" in last 2 lines. There is insufficient antecedent basis for this limitation in the claim.
As to claim 34 see prior applicable rejections above. Furthermore, it is noted that the at least one sensor is not positively claimed as an element of the apparatus. The “which” clauses are directed to intended use of the at least one sensor.
As to claim 35, it is unclear what is the nexus of “a liquid sample” to the prior recited “the liquid sample” in claim 33 and “liquid samples” recited in claim 27 because the claim does not provide for such. Furthermore, it is unclear which/what liquid sample is being referenced by “the liquid sample” in the last line. It is noted that the “which is” clause is directed to intended use of the temperature sensor. However it is unclear what values are being referenced by “these values” and what is “a measured value profile” because such are clearly provided for in the claim.
As to claim 37, it is unclear what the term “it” references. It presumed to refer to “the data”. If so, the claim should clearly recite such. It is noted that no operating device, server, and non-transitory computer readable medium are positively claimed as elements of the apparatus.
Claim 38 employs the same or similar language as claim 27. Therefore, applicant should see applicable rejections of claim 27 above. It is noted that there is no indication as to from where/what and to where/what the transfer device provides a sample.
Claims 39-40 recite the limitation " the concentrated or extracted analyte". There is insufficient antecedent basis for this limitation in the claim. The last paragraph of claim 38 recites “a sample of the at least one analyte, which is concentrated or extracted….” Although, no sample is positively claimed and no concentrating or extracting of any analyte is required to be performed, it is unclear what is the nexus (if the same or different) of the sample (claim 39), a sample (claim 40) and the concentrated or extracted analyte to a sample and at least one analyte previously recited in claim 38 because the claims do not clearly recite such. As to claim 40, it is presumed that an electronic control system is different from that previously recited in claim 38 because claim 40 does not indicate that such are the same.
As to claim 41, although, no qualitative or quantitative determination is required to be performed, it is unclear what is the nexus (if the same or different) of “the qualitative or quantitative determination of the analyte” to “the qualitative or quantitative determination of at least one analyte in a sample liquid” previously recited in claim 38 because the claim does not clearly recite such. Furthermore, it is unclear what is required to be done by the analytical instrument to carry out such determination what is considered as such determination, what about the analyte is required to determined because the claim does not recite such.
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) 27-31 and 33-41 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Davison et al., US 2008/0235081.
Davison discloses an automatic sampling apparatus (the "chromatographic system", paragraph [0109], comprising the "waste water sampler system", paragraph [0154], figure 12, 166, comprising a "control system" 168.
"The invention is equally applicable to any chromatographic system including the single column system shown in FIG. 1 and any other multiple fraction instrument such as environmental waste water collection systems", (paragraph [0109]), and "FIG. 12 is a block diagram of a waste water sampling system in accordance with an embodiment of the invention", (paragraph [0105]) for taking liquid samples of a sample liquid, in particular water or wastewater, present at a sampling station of a body of water or of a container, for the qualitative or quantitative determination of at least one analyte (implicit for "samples", paragraph [0057]), in particular of a biopolymer, contained in the sample liquid, comprising:
a sample line that can be fluidically connected to the sampling station (between the "water source" 180, (paragraph [0155], figure 12), and the "pump station", 174);
a pump device ("pump station");
at least one sample container ("containers", paragraph [0155]) that can be fluidically connected to the sample line (via the "distributor", 178 paragraph [0155], figure 12,); and
an electronic control system (''control system", paragraph [0157]) which is configured to fluidically connect the sample line to the at least one sample container so that a fluid flow path extending from the sampling station through the sample line into the sample container is formed ("The control system 168 controls the operation to automatically fill a series of containers", paragraph [0157]), and
wherein the electronic control system is further configured to transport, by means of the pump device, a specifiable volume of the sample liquid, in the form of a liquid sample, along the fluid flow path into the sample container (see above),
the sampling apparatus collection matrix for concentrating and/or extracting the analyte present in the liquid sample ("at least one chromatographic column", 14 paragraph [0109], figure 1).
As to claim 29, the apparatus includes unit through which a flow can pass and which is fluidically connected to the sample container (see the "sample injector", 20 paragraph [0109], figure 1).
As to claims 30-31, the apparatus comprises a chromatographical separating column 14 (functionalized surface).
As to claim 33, an identifier and a time stamp and the associated saving as claimed, Davison discloses sample containers that may be identified as to the location where the water was drawn, the time the water was drawn, the customer for which the water was drawn, the source of the water, and the test steps to be performed on the water. (paragraph [0157]).
As to claim 34-35, the apparatus comprise an interface ("wireless communication device", paragraph [0154], figure 12, 188A), and a temperature a sensor as claimed (implicit for the "log of sample temperature from the time of sampling until analysis", paragraph [0156]) and the electronic control device as claimed (by means of the "nonvolatile memory", paragraph [0156]).
As to claim 36, the apparatus includes recording-transmitting devices for communication with global positioning systems to record conditions at certain locations where a measurement is to be made by an environmental device"( paragraph [0045]).
As to claim 37, the apparatus provides for wireless communication of environmental sampling apparatuses with other apparatuses. (paragraph [0012])
As to claim 38-41, refer to rejection of sampling apparatus of claim 27, in addition Davison discloses a system comprising an analytical instrument, "detector" 16 (paragraph [0109], figure 1); and a transfer device (paragraph [0113], the connection line between column and detector in figure 1). The system provides for automated operation (including fluid transfer and analysis). The supply of solvent is under the control of the controller 18. (paragraph [0110], figure 1).
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) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davison et al., US 2008/0235081as applied above, and further in view of Rule et al., US 2011/0306856.
Davison does not disclose the apparatus comprises a centrifuge.
Rule discloses systems for measuring analytes of a sample. The system includes a centrifuge for separating the components of sample (paragraphs 0080-81, 87, 96) before measurements are performed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to recognize that the system of Davison may incorporate a centrifuge to provide for separation of components of a sample as taught by Rule.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jovanovich; Stevan Bogdan et al.; Miyauchi; Yuki et al.; Sandstrom; Mark W. et al.
Higley; John Sanderson Wade et al.; Frosch; Robert A. Administrator of the National Aeronautics and Space et al.; Womack, II; Irving F. et al.; Koch; Dale M. et al.; YU; Hua et al.; OSCARSSON; Sven et al.; Stevens; Jed et al.; and Carpenter; Michael V. et al. disclose sampling devices.
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, Jill Warden can be reached at 571-272-1267. 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.
/BRIAN R GORDON/ Primary Examiner, Art Unit 1798