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 .
Priority
This application was filed 10/13/2023. This application does not claim benefit to any provisional or foreign priority; hence, the effective filing date is 10/13/2023. Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement submitted on 2/13/2025 has been considered by the examiner.
The specification lists 16 references on pp. 1-2 which are not listed on the IDS nor provided to the Office. These references have not been considered. The references should be listed on an IDS and provided to the Office for consideration.
Drawings
The drawings are objected to for the following reason:
37 CFR 1.84(i) states "Words must appear in a horizontal, left-to-right fashion when the page is either upright or turned so that the top becomes the right side, except for graphs utilizing standard scientific convention to denote the axis of abscissas (of X) and the axis of ordinates (of Y)." In the instant application, words appear in Figs. 2A, 8, 9, 10A, 10D, 11A, 11D, 12A, 13, 14A, 14B, 15, 16A, 16C, 17A, 17D, 18A, 18B, 18C, 19A and 20A which are not in a left-to-right hand fashion.
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 Objections
Claims 7, 11 and 18-20 are objected to because of the following informalities:
Claim 7 recites “wherein the culture model is a three-dimensional multicellular structures” in lines 1-2 which should be “wherein the culture model is a three-dimensional multicellular structure” to be grammatically correct.
Additionally, claim 7 recites “comprising microbial biofilms and mammalian cell spheroids” in line 2 which should be “comprising microbial biofilms and/or mammalian cell spheroids” because the methods of claims 18 and 19 only recite microbial biofilms and not mammalian spheroids.
Claim 11 recites “providing a second layer dispoed on the first layer” in line 6, which should be “providing a second layer disposed on the first layer”.
Claim 11 also recites “the graident generator” in line 12 which should be “the gradient generator”.
Claim 18 recites “observing any cellular, molecular, genetic, morphological, chemical and behavioral changes of the biological agent” in lines 11-12 which should be “observing any cellular, molecular, genetic, morphological, chemical and/or behavioral changes of the biological agent” because the term “any” indicates that the observation is of cellular, molecular, genetic, morphological, chemical or behavioral changes of the biological agent not only observation when a cellular change, a molecular change, a genetic change, a chemical change AND a behavioral change occurs together.
Claim 19 recites “quantifying any cellular, molecular, genetic, morphological, chemical and behavioral changes in the biological agent” in lines 11-12 which should be “quantifying any cellular, molecular, genetic, morphological, chemical and/or behavioral changes in the biological agent” because the term “any” indicates that the observation is of cellular, molecular, genetic, morphological, chemical or behavioral changes of the biological agent not only observation when a cellular change, a molecular change, a genetic change, a chemical change AND a behavioral change occurs together.
Claim 20 recites “observing any cellular, molecular, genetic, morphological, chemical and behavioral changes of the first biological agent” in lines 10-11 which should be “observing any cellular, molecular, genetic, morphological, chemical and/or behavioral changes of the first biological agent” because the term “any” indicates that the observation is of cellular, molecular, genetic, morphological, chemical or behavioral changes of the biological agent not only observation when a cellular change, a molecular change, a genetic change, a chemical change AND a behavioral change occurs together.
Claim 20 also recites “any cellular, molecular, genetic, morphological, chemical and behavioral changes of the second biological agent” in lines 13-14 which should be “any cellular, molecular, genetic, morphological, chemical and/or behavioral changes of the second biological agent” because the term “any” indicates that the observation is of cellular, molecular, genetic, morphological, chemical or behavioral changes of the biological agent not only observation when a cellular change, a molecular change, a genetic change, a chemical change AND a behavioral change occurs together.
Appropriate correction is required for all the objections.
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 1-10, 15 and 18-19 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 1 recites the limitation "the flow of the biological agent" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a flow of the biological agent; hence, antecedent basis is lacking and claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 1 also recites the limitation "the analyte" in line 10. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite an analyte; hence, antecedent basis is lacking and claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 2-10 depend from claim 1 and do not resolve the indefiniteness; hence, claims 1-10 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 18 recites the limitation "the first chamber" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Claim 18 refers to claim 1, but neither claim 18 nor claim 1 disclose a first chamber; hence, the limitation lacks antecedent basis and claim 18 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 19 recites the limitation "the first chamber" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Claim 19 refers to claim 1, but neither claim 19 nor claim 1 disclose a first chamber; hence, the limitation lacks antecedent basis and claim 19 is rejected under 35 U.S.C. 112(b) as being indefinite.
The term “about 6 mm” in claim 15, line 2, is a relative term which renders the claim indefinite. The term “about” 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; hence, claim 15 is rejected under 35 U.S.C. 112(b) as being indefinite.
The term “a well-defined culture condition” in claim 18, lines 15-16, is a relative term which renders the claim indefinite. The term “well-defined” 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; hence, claim 18 is rejected under 35 U.S.C. 112(b) as being indefinite.
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.
(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.
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al., 2023 (NPL cite 1, IDS, 2/13/2025; herein “Ma”).
Note: Claims 1-10 are drawn to an integrated system, a composition. Intended use limitations in composition claims are met if the composition COULD be used for the intended use regardless of whether the prior art discloses the intended use or not.
Ma teaches 3D-bacterial “biofilm-dispersal-then-recolonization” (BDR) microfluidic model which comprises two separate chambers, each comprising 300 tapered microwells of 150 µm length, 250 µm width and 150 µm depth wherein the inner surface of the microwells is coated with exopolysaccharide, wherein the first chamber is upstream of the second chamber; a fluid flow control mechanism between the two chambers which is a valve; and, a gradient generator comprising two fluid inlets and eight fluid outlets; which is made by aligning and bonding together (bottom to top) a first polydimethylsiloxane (PDMS) layer with the first and second chambers wherein the first chamber is upstream of the second chamber, a second PDMS layer comprising multiple fluid channels and the valves and a third PDMS layer comprising the gradient generator upstream of the first chamber (pp. 1291-1292, “Establishment of the 3D-bacterial “biofilm dispersion-and-recolonization” (BDR) microfluidic model”; Fig. 1; p. 1298-1299, “Fabrication of device”; p. 1300, “Exogenous addition and coating of exopolysaccharides on microwells”) anticipating claims 1-2 and 4-17.
Ma teaches the method of instant claims 18 and 19 (pp. 1291-1294, “Establishment of the 3D-bacterial “biofilm dispersion-and-recolonization” (BDR) microfluidic model”, “CID induces rapid release of bacterial cells”,” EDA leads to the explosive release of bacterial aggregates”, “Bacteria undergo distinct spatiotemporal dynamics between CID and EDA”, “Bacteria generated from CID cannot recolonize fresh surfaces”, “Bacterial aggregates from biofilm disassembly slowly recolonized new areas”, “Similar dispersal and recolonization behavior adopted by P. aeruginosa clinical isolates”; Figs. 1-6 and 8) using the composition of claim 1 anticipating claims 18-19.
Ma teaches the method of instant claim 20 (pp. 1294-1296, “Unique characteristics of biofilm-released bacteria determine the fate of recolonization and dissemination of diseases in vivo”; Fig. 7) using the composition of claim 1 anticipating claim 20.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Khoo et al., US 2022/0113300 (cite A, attached PTO-892; herein “Khoo”).
The discussion of Ma regarding claims 1-2 and 4-20 set forth in the rejection above is incorporated herein.
Ma discloses the integrated system set forth in claims 1-2 and 4-11, as discussed in the rejection above. Ma discloses methods of culturing human lung 3D-spheroids with pathogens to investigate cell-cell interactions (pp. 1294-1296, “Unique characteristics of biofilm-released bacteria determine the fate of recolonization and dissemination of diseases in vivo”), but does not specifically disclose that the microwells comprise a cell culture surface with a plurality of micropores. However, a person of ordinary skill in the art at the time of filing would have found it obvious for the microwells to comprise a cell culture surface with a plurality of micropores in view of the disclosure of Khoo.
Khoo teaches microfluidic devices for preparing a cell model (Abst.) wherein the microfluidic device comprises three layers comprising wells, i.e., microwells; fluid channels; and a tree-like gradient generator comprising at least two fluid inlets [0006-10]. Khoo teaches methods of using the microfluidic device to predict a response to an agent comprising culturing cells and/or a pathogen to establish a cell model, detecting the presence of a bacterial biofilm wherein the agent can be a biofilm dispersal agent [0027-31]. Khoo teaches that the wells of the microfluidic device can comprise a cell culture surface with a plurality of micropores dimensioned to confine cancer or tumor-associated cells with pathogens to investigate cell-cell interactions [0059].
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious for the integrated system disclosed by Ma to further comprise a cell culture surface with a plurality of micropores, especially when practicing a method of culturing human lung 3D-spheroids with pathogens to investigate cell-cell interactions, because Khoo discloses that the micropores confine a three-dimensional inflammatory model of cancer cells with pathogens; therefore, instant claim 3 is prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651