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 with traverse of Invention II (claims 6-12) in the reply filed on 11/26/2025 is acknowledged. The traversal is on the ground(s) that it is believed the search of groups jointly would not impose a serious burden. This is not found persuasive because in addition to the different classification searches, specific symbols as well as distinct text searches in combination with the classification symbols would be required, and prior art identified in the separate searches would unlikely be relevant to the other inventions for purposes of considering and determining patentability. Further, there is a serious examination burden as issues relevant to one invention are not relevant to the other inventions. In particular, each invention can have a different broadest reasonable interpretation.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/26/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue."
These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant discloses a dialysate used to prepare samples, but flails to disclose the composition of the dialysate
The Breadth of the Claims
Applicant merely claims using a dialysate to prepare samples without describing the composition of the dialysate.
The Nature of the Invention
The nature of the invention requires the dialysate is used to “prepare” samples for electrospray atomization followed by differential mobility processing followed by particle counting.
The State of the Prior Art
A search of prior art dialysates indicates dialysates have different compositions that can be customized for a patient’s medical condition.
The Level of One of Ordinary Skill
One skilled in the art could envision different dialysate compositions without knowing the composition of dialysate applicant may have had in mind or used during the development of the invention.
The Level of Predictability in the Art
The level of predictability in the art would not lead one to determine the composition of the dialysate applicant may have had in mind or used during the course of the invention.
The Amount of Direction Provided by the Inventor
There is no guidance in applicant’s disclosure that would lead one of ordinary skill in the art to determine the composition of the dialysate that applicant may have had in mind or is needed to practice the claimed invention. Applicant’s disclosure does not provide any direction as to the composition of the dialysate.
The Existence of Working Examples
There are no working examples or references cited by applicant as to the composition of the dialysate.
Experimentation could well lead to a dialysate composition that applicant never conceived of.
The Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
No amount of experimentation would establish the composition of the dialysate applicant had in mind or used during the course of the invention. Attempting to determine the composition of a dialysate experimentally could well lead to a dialysate composition that was “inventive” over applicant’s invention and applicant’s disclosure and not conceived or disclosed or enabled by applicant.
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 6-12 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 6 recites “a sample prepared with dialysate” in line 5 and claim 9 recites “a sample prepared with dialysate” in line 2. It is unclear what is meant by the term “prepared”
Since the manner in which a sample is “prepared” with the dialysate, it is unclear how Beta2-microglobulin concentration is calculated by dividing the particle count be a “volume” of the dialysate entered per unit time as recited in claims 6 and 9.
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.
1. Claims 6-8 are rejected under 35USC 103 as being unpatentable over Bacher et al. (“Charge-reduced nano electrospray ionization combined with differential mobility analysis of peptides, proteins, glycoproteins, noncovalent protein complexes and viruses,” J. Mass Spectrom. 2001; 36: 1038–1052) (cited by applicant) in view of Applicant’s Admitted Prior Art as found in [0038] and Zhao et al. (“Direct preparation of dialysate from tap water via osmotic dilution,” Journal of Membrane Science 598 (2020)).
Bacher et al. teaches analyzing proteins using a combination of electrospray ionization and a differential mobility analyzer. (page 1038 opening paragraph)
Applicant’s Admitted Prior Art as found in [0038] discloses that TSI-3480 is a known electrospray atomizer and TSI-3080 is a known differential mobility analyzer.
It would have been obvious to modify Bacher et al. to use any known electrospray atomizer such as a TSI-3480 electrospray atomizer and any known differential mobility analyzer such as a TSI-3080 differential mobility analyzer disclosed in Applicant’s Admitted Prior Art to practice the analysis method taught by Becher et al.
Bacher et al. in view of Applicant’s Admitted Prior Art does not specifically teach beta2-microglobulin analysis; however, beta2-microglobulin is a protein rendering it suitable for analysis using electrospray ionization with differential mobility analysis.
It would have been obvious to modify Bacher et al. in view of Applicant’s Admitted Prior Art to analyze beta2-microglobulin based on Bacher et al. teaching analyzing proteins inasmuch as beta2-microglobulin is a protein.
Bacher et al. in view of Applicant’s Admitted Prior Art does not teach preparing samples containing beta2-microglobulin with a dialysate before analysis.
Zhao et al. (“Direct preparation of dialysate from tap water via osmotic dilution,” Journal of Membrane Science 598 (2020)) teaches that dialysates are used connection with kidney function loss to remove toxins, wastes and excess fluids.
It would have been obvious to modify Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. to treat the beta2-microgloublin sample with a dialysate to remove toxins, wastes and/or excess fluids that might interfere with the analysis of beta2-microglobulin.
Bacher et al. teaches detecting the number of particles, but does not teach using a condensation particle counter. (page 1039, first full paragraph)
Applicant’s Admitted Prior Art discloses the use of a TSI-3776 condensation particle counter. [0038]
It would have been obvious to one of ordinary skill in the art to modify Bacher et al. in view of Zhao et al. to use any known particle counter such as a TSI-3776 for purposes of determining the number of beta2-Microglobulin particles.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. does not teach dividing the particle count by a volume of the dialysate entered per unit time to obtain a beta2-microglobulin concentration.
It would have been obvious to one of ordinary skill in the art to modify Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. to divide the particle count by a volume of the dialysate entered per unit time to obtain a beta2-microglobulin concentration in order to exclude extra volume contributed by the dialysate preparation of the sample.
I.) Regarding applicant’s claim 6, as noted above Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. teaches all the elements of claim 6.
Therefore, Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 6 obvious.
II.) Regarding applicant’s claim 7, as noted above Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 6 obvious from which claim 7 depends.
Claim 7 recites that a protein size of the screened particle sample ranges from 3.85 nm to 4.14 nm, a protein molecular weight of the screened particle sample is 11.8 kD.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. does not teach that that a protein size of the screened particle sample ranges from 3.85 nm to 4.14 nm, a protein molecular weight of the screened particle sample is 11.8 kD.
It would have been obvious to one of ordinary skill in the art that when concentrating and analyzing beta2-microglobulin using the system of Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. that a protein size of the screened particle sample would range from 3.85 nm to 4.14 nm, and a protein molecular weight of the screened particle sample would be 11.8 kD since the screened particles are obtained from the same equipment and method disclosed by applicant.
Therefore, Bacher et al. in view of Applicant’s Disclosed Prior Art and Zhao et al. renders claim 7 obvious.
III.) Regarding applicant’s claim 8, as noted above Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 6 obvious from which claim 7 depends.
Claim 8 recites that a laser wavelength of the condensation particle counter is 405 nm.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. does not teach that a laser wavelength of the condensation particle counter is 405 nm.
It would have been obvious to one of ordinary skill in the art to conduct routine engineering optimization experimentation to determine using the TSI-3776 condensation Particle counter disclosed by applicant at a laser wavelength of 405 nm would provide acceptable analysis results.
Therefore Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 8 obvious.
2. Claims 9-12 are rejected under 35 USC 103 as being unpatentable over Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al.
As noted above, Bacher et al. teaches analyzing proteins using a combination of electrospray ionization and a differential mobility analyzer. (page 1038 opening paragraph)
Applicant’s Admitted Prior Art as found in [0038] discloses that TSI-3480 is a known electrospray atomizer and TSI-3080 is a known differential mobility analyzer.
It would have been obvious to modify Bacher et al. to use any known electrospray atomizer such as a TSI-3480 electrospray atomizer and any known differential mobility analyzer such as a TSI-3080 differential mobility analyzer disclosed in Applicant’s Admitted Prior Art to practice the analysis method taught by Becher et al.
Bacher et al. in view of Applicant’s Admitted Prior Art does not specifically teach beta2-microglobulin analysis; however, beta2-microglobulin is a protein rendering it suitable for analysis using electrospray ionization with differential mobility analysis.
It would have been obvious to modify Bacher et al. in view of Applicant’s Admitted Prior Art to analyze beta2-microglobulin based on Bacher et al. teaching analyzing proteins, inasmuch as beta2-microglobulin is a protein.
Bacher et al. in view of Applicant’s Admitted Prior Art does not teach preparing samples containing beta2-microglobulin with a dialysate before analysis.
Zhao et al. (“Direct preparation of dialysate from tap water via osmotic dilution,” Journal of Membrane Science 598 (2020)) teaches that dialysates are used connection with kidney function loss to remove toxins, wastes and excess fluids.
It would have been obvious to modify Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. to treat the beta2-microgloublin sample with a dialysate to remove toxins, wastes and/or excess fluids that might interfere with the analysis of beta2-microglobulin.
Bacher et al. teaches detecting the number of particles, but does not teach using a condensation particle counter. (page 1039, first full paragraph)
Applicant’s Admitted Prior Art discloses the use of a TSI-3776 condensation particle counter. [0038]
It would have been obvious to one of ordinary skill in the art to modify Bacher et al. in view of Zhao et al. to use any known particle counter such as a TSI-3776 for purposes of determining the number of beta2-Microglobulin particles.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. does not teach dividing the particle count by a volume of the dialysate entered per unit time to obtain a beta2-microglobulin concentration.
It would have been obvious to one of ordinary skill in the art to modify Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. to divide the particle count by a volume of the dialysate entered per unit time to obtain a beta2-microglobulin concentration in order to exclude extra volume contributed by the dialysate preparation of the sample.
I.) Regarding applicant’s claim 9, as noted above, Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. teaches all the limitations of claim 9.
Therefore, Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 9 obvious.
II.) Regarding applicant’s claim 10, as noted above Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites further comprising: a robotic arm; and a central controller connected to the electrospray atomizer, the differential mobility analyzer, the condensation particle counter and the robotic arm, the central controller configured to control the robotic arm to place the sample into the electrospray atomizer, move the aerosol sample from the electrospray atomizer to the differential mobility analyzer, and move the screened particle sample to the condensation particle counter.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. a robotic arm and a central controller connected to the electrospray atomizer, the differential mobility analyzer, the condensation particle counter and the robotic arm, the central controller configured to control the robotic arm to place the sample into the electrospray atomizer, move the aerosol sample from the electrospray atomizer to the differential mobility analyzer, and move the screened particle sample to the condensation particle counter.
It would have been obvious to one of ordinary skill in the art to modify Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. to provide a central controller and a robotic arm transfer mechanism to transfer the sample into the electrospray atomizer, move the aerosol sample from the electrospray atomizer to the differential mobility analyzer, and move the screened particle sample to the condensation particle counter, for purposes of automating the overall analysis procedure. Note providing an automatic or mechanical means to replace a manual activity which accomplished the same result is obvious. (MPEP 2144.04 (III)).
Therefore, Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 10 obvious.
III.) Regarding applicant’s claim 11, as noted above Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 9 obvious from which claim 11 depends.
Claim 11 recites that a protein size of the screened particle sample ranges from 3.85 nm to 4.14 nm, a protein molecular weight of the screened particle sample is 11.8 kD.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. that a protein size of the screened particle sample ranges from 3.85 nm to 4.14 nm, a protein molecular weight of the screened particle sample is 11.8 kD.
It would have been obvious to one of ordinary skill in the art that when concentrating and analyzing beta2-microglobulin using the system of Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. that a protein size of the screened particle sample would range from 3.85 nm to 4.14 nm, and a protein molecular weight of the screened particle sample would be 11.8 kD since the screened particles are obtained from the same equipment and method disclosed by applicant.
Therefore, Bacher et al. in view of Applicant’s Disclosed Prior Art and Zhao et al. renders claim 11 obvious.
IV.) Regarding applicant’s claim 12, as noted above Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 9 obvious from which claim 12 depends.
Claim 12 recites a laser wavelength of the condensation particle counter is 405 nm.
Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. that that a laser wavelength of the condensation particle counter is 405 nm.
It would have been obvious to one of ordinary skill in the art to conduct routine engineering optimization experimentation to determine using the TSI-3776 condensation Particle counter disclosed by applicant at a laser wavelength of 405 nm would provide acceptable analysis results.
Therefore, Bacher et al. in view of Applicant’s Admitted Prior Art and Zhao et al. renders claim 12 obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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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.
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798