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 .
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.
Claims 11-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for determining an effectivity of monoclonal antibodies as a treatment for cancer and infectious diseases (see paragraph [0038] of the specification), does not reasonably provide enablement for other fluid solutions as a treatment for cancer and infectious diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The examiner notes that claim 11 recites “f. determining an effectivity of the solution as a treatment for cancer and infectious diseases based on the viscosity of the solution”. The broadest reasonable interpretation of “the solution” includes both solutions that include monoclonal antibodies and solutions that do not include monoclonal antibodies. The examiner notes that the disclosed invention only provides the structure that allows the viscosity of the solution to be derived. The prior art of Patel (see the 102 rejections below) only provides an apparatus that could be used to derive the viscosity. However, Patel does not disclose how to derive the viscosity or how to use the viscosity to determine an effectivity of a solution as a treatment for cancer or infectious diseases. The examiner notes that the cancer and infectious disease treatment arts are not predictable, even though the microfluidic arts that evaluate viscosities are more predictable. The examiner notes that the instant specification only discloses that determining the effectivity of monoclonal antibodies can be performed using viscosity measurements. The instant specification does not disclose how other disease treatments (i.e. treatments that do not include monoclonal antibodies) can be evaluated. Based on the totality of the evidence, the examiner concludes that the entire scope of claim 11 would require undue experimentation for one having ordinary skill in the art.
Claims 12-18 depend on claim 11 and are rejected for inheriting the same problem.
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.
Claims 1-18 and 20 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 1 recites that “a viscosity of the fluid is derived from a velocity of the one or more objects in the plurality of microstreaming flow patterns” in lines 12-14. This limitation is unclear because it states a function (deriving a viscosity) without providing any indication about how the function is performed or what structure performs the function. The recited function does not follow from the structure recited in the claim (i.e. the main chamber, the plurality of CATs, the external acoustic source or the fluid), so it is unclear whether the function requires some other structure or is simply the result of operating the apparatus in a certain manner.
Claims 2-18 depend on claim 1 and inherit the same problem
Claim 20 recites a similar limitation as claim 1 and is rejected for the same reason.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 6-8, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 9,517,465 issued to Patel et al. (“Patel”).
As for claim 1, Patel discloses a microfluidic platform for measuring fluid viscosity, comprising:
a. a main chamber (12 and cylindrical inlet at left end of 10 in Fig. 1C) having a disc shape (see cylindrical inlet at left end of 10 in Fig. 1C) comprising an inlet (see Fig. 1C);
b. a plurality (see Fig. 2C) of cavity acoustic transducers (20), wherein the plurality of CATs (20) are dead-end channels coupled to the main chamber (see Figs. 2A-2C);
c. an external acoustic source (30) coupled to main chamber (see Fig. 1E); and
d. a fluid disposed through the inlet to the main chamber (Abstract),
said fluid comprising one or more objects (14), wherein the fluid intersects the CATs to form a plurality of interfaces (28) capable of generating a plurality of microstreaming flow patterns when actuated by the external acoustic source (see Fig. 1B), wherein a viscosity of the fluid is derived from a velocity of the one or more objects in the plurality of microstreaming flow patterns (this limitation describes the intended use of the platform and does not structurally distinguish the claimed invention over the prior art).
As for claim 2, Patel discloses that the external acoustic source (30) comprises a piezoelectric transducer (col. 4, lines 49-51).
As for claim 3, Patel discloses that the CATs (20) are positioned lateral to the main chamber (see Fig. 1C), above the main chamber, below the main chamber, or a combination thereof.
As for claim 4, Patel discloses that the plurality of interfaces (28) comprise a gas-liquid interface (28), a liquid-liquid interface, a lipid membrane, a polymer membrane, a nano-particle membrane, or a combination thereof.
As for claim 6, Patel discloses that the main chamber (12) comprises an outlet (16) for extracting the fluid.
As for claim 7, Patel discloses that the microstreaming flow patterns comprise bulk flow for direct flow velocity measurement (see Fig. 1B).
As for claim 8, Patel discloses that microstreaming flow patterns comprise a plurality of microvortices (see Fig. 1B).
As for claim 19, Patel discloses a method of rapidly measuring a viscosity of an antibody solution (col. 8, lines 11-16), comprising:
a. providing a microfluidic platform comprising a main chamber (12 and cylindrical inlet at left end of 10 in Fig. 1C) having a disc shape (cylindrical inlet at left end of 10 in Fig. 1C), comprising an inlet (see Fig. 1C), and a plurality (see Fig. 2C) of cavity acoustic transducers (20), wherein the plurality of CATs (20) are dead-end channels coupled to the main chamber (see Figs. 2A-2C);
b. providing an external acoustic source (30) coupled to the main chamber (see Fig. 1E);
c. flowing the antibody solution through the inlet into the main chamber (see Fig. 1B), said antibody solution comprising one or more beads (14), wherein the antibody solution intersects the CATs to form a plurality of interfaces (28);
d. applying acoustic energy to the CATs via the external acoustic source (30) to oscillate the plurality of interfaces (col. 7, lines 45-59), wherein oscillating the plurality oof interfaces produces microstreaming flow patterns trapping the one or more beads therein (see Fig. 1B); and
e. measuring the maximum velocity of the one or more beads at the air-liquid interface in the microstreaming flow patterns (col. 8, lines 29-31), wherein the viscosity of the antibody solution is derived from the velocity of the one or more beads in the microstreaming flow patterns (this limitation describes the intended result of the previously recited step and does not distinguish the claimed method over the prior art);
wherein the viscosity of the antibody solution is used to determine an effectivity of the antibody solution as a treatment for cancer and infectious diseases (this limitation describes the intended result of the previously recited step and does not distinguish the claimed method over the prior art).
As for claim 20, Patel discloses a microfluidic platform for measuring fluid viscosity, comprising:
a. a main chamber (12 and cylindrical inlet at left end of 10 in Fig. 1C) having a disc shape (cylindrical inlet at left end of 10 in Fig. 1C) comprising an inlet (see Fig. 1C);
b. a plurality (see Fig. 2C) of cavity acoustic transducers (20), wherein the plurality of CATs (20) are dead-end channels fluidly coupled to the main chamber (see Figs. 2A-2C);
c. an external acoustic source (30) coupled to main chamber (see Fig. 1E); and
d. a fluid disposed through the inlet to the main chamber (Abstract), said fluid comprising one or more beads (14), wherein the fluid intersects the CATs to form a plurality of interfaces (28);
wherein the CATs are configured to oscillate, by the external acoustic source (30), the plurality of interfaces (col. 7, lines 45-59) to generate microstreaming flow patterns trapping the one or more beads therein (see Fig. 1B), wherein a viscosity of the fluid is derived from a velocity of the one or more beads in the microstreaming flow patterns (this limitation describes the intended use of the platform and does not structurally distinguish the claimed invention over the prior art).
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.
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 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 9,517,465 issued to Patel et al. (“Patel”) in view of U.S. Patent 9,797,862 issued to Lu et al. (“Lu”).
As for claim 5, Patel discloses the microfluidic platform of claim 1 (see the rejections of claim 1 above).
Patel does not disclose that the microfluidic platform further comprises a plurality of additional chambers.
However, Lu discloses a microfluidic platform (see Fig. 1) the comprises a plurality of additional chambers (12).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the microfluid platform of Patel to include the additional chambers as disclosed by Lu in order to analyze a sample in batch mode (Lu: col. 4, lines 10-12).
Patel as modified by Lu discloses a plurality of additional chambers (Patel: 12 and Lu: 12), each additional chamber comprising a corresponding inlet (Patel: see Fig. 1C), wherein the plurality of additional chambers are not fluidly connected to each other or to the main chamber (Lu: see Fig. 1).
As for claim 9, Patel as modified by Lu discloses the microfluidic platform of claim 5 (see the rejection of claim 5 above).
Patel as modified by Lu does not discloses that the plurality of additional chambers comprises 15 to 95 additional chambers.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to duplicate the additional chambers of Patel and Lu to achieve the predictable result of providing more chambers with which to analyze in a batch mode.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 9,517,465 issued to Patel et al. (“Patel”).
As for claim 10, Patel disclose the microfluidic platform of claim 1 (see the rejection of claim 1 above) and that the main chamber comprises a disc shape (see Fig. 1C).
Patel does not disclose that the microfluidic platform comprises about 8 to 24 CATs disposed around an exterior of the main chamber and fluidly coupled to the main chamber.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to duplicate the additional chambers of Patel to achieve the predictable result of providing more chambers with which to analyze in a batch mode.
Response to Arguments
Applicant's arguments filed 4/2/2026 have been fully considered but they are not persuasive. On pages 11-12 of the Remarks, Applicant argues that Patel does not disclose a main chamber that has a disc shape. The examiner respectfully disagrees. The examiner has broadly interpreted a main chamber having a disc shape to include the cylindrical inlet and passage 12 in Fig. 1 of Patel.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN N OLAMIT whose telephone number is (571)270-1969. The examiner can normally be reached M-F, 8 am - 5 pm (Pacific).
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, Stephen Meier can be reached at (571) 272-2149. 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.
/JUSTIN N OLAMIT/ Primary Examiner, Art Unit 2853
Prosecution Insights