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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on October 16th, 2025. Claims 1-16 are pending. Claims 1-11 are withdrawn from consideration.
Drawings
The drawings submitted 12/16/2022 have been reviewed and are accepted.
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.
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg et al. (US 2003/0017445), hereafter Berg, in view of Lipson (US 2012/0238520) and Hayes et al. (US 2014/0363883), hereafter Hayes.
Berg discloses assessing patient samples according to the physiological status of cells present in the sample (abstract). With regard to claim 12, Berg discloses a kit comprising a first container containing a tracer which is fluorescent, and a second container containing a positive control (pars.[0015,0024,0027,0063,0067,0091,0116], figs. 1B/2B). With regard to claim 13, Berg discloses that the positive control is at least one member selected from the group recited therein such as TNF-alpha or IFN-gamma (pars.[0098,0116]). With regard to claim 14, Berg discloses that kit comprises a third container containing a negative control (par.[0063], figs. 1B, 2B, for example, wherein the panel of assay combinations is provided in conjunction with positive and negative controls on culture plates implicitly provide the various containers). With regard to claim 16, Berg discloses that the kit further comprises epithelial cells (par[0043]).
With regard to claims 12 and 15, Berg does not specifically disclose that the tracer that is fluorescent is within 5 kDA of the molecular weight of human albumin, and as in a particular one of those recited in cl. 15, and a cell culture system comprising an apical compartment and a basolateral comparted as recited in cl. 12. With regard to claim 16, Berg does not specifically disclose airway epithelial cells.
Lipson discloses applications with inflammatory and non-inflammatory diseases and conditions therewith (abstract). Lipson discloses application in assessing bi-directional protein movement across the lung endothelium and the epithelial barrier of the lung utilizing FITC-labeled albumin, and utilizing a positive control as in LPS as in injury-inducing agent and without the injury-inducing positive control LPS agent (par.[0045], for example).
Hayes discloses a device for cell culture and assaying of cells, including that of human bronchial epithelial (HBE) culture and utilizing culture units including an apical compartment and a basolateral compartment below and lateral to the apical compartment, the basolateral compartment configured to contain a culture medium and the apical compartment configured to contain airway epithelial cells forming an epithelial cell barrier between the basolateral compartment and the apical compartment, and utilizing fluorescent tracers therewith the monitoring of the cells(pars.[0052,0054,0077-0079,0100], figs. 10A,B, 12A,B for example)
It would have been obvious to one of ordinary skill in the art to modify Berg so as to utilize a tracer that is fluorescent and within 5 kDa of the MW of human albumin such as in FITC conjugated albumin, and utilizing epithelial cells comprising airway epithelial cells as suggested by the analogous art of Lipson wherein Berg is likewise concerned with fluorescent labeling and assessment of therapeutic agents to inflammatory diseases, and including application with epithelial cells obtained from any organ or compartment of the body (pars.[0003,0043]) wherein utilizing FITC conjugated albumin provides a favorable fluorescent tracer that affords the ability to monitor bi-directional protein movement across the lung endothelium and the epithelial barrier of the lung in a clinically-relevant application that would be appreciated by and have a reasonable expectation of success in Berg.
Further, it would have been obvious to one of ordinary skill in the art to modify Berg to utilize a culture unit including an apical compartment and a basolateral compartment below and lateral to the apical compartment, the basolateral compartment configured to contain a culture medium and the apical compartment configured to contain airway epithelial cells forming an epithelial cell barrier between the basolateral compartment and the apical compartment such as suggested by the analogous art of Hayes to cell culturing and assessing functions thereof in which such a cell culture unit represents a suitable and well-known structure for simulating the cellular physiology that mimics the polarized nature of tissues, and wherein Berg likewise seeks to simulate cellular physiology and assess the cells with respect to various media and combinations of factors and agents (see par.[0027], for example).
Further, modified Berg by Lipson and Hayes provides commensurate structural components, as claimed, to the kit and is thus said to be fully capable of (herein, “configured to”) “upward translocation of the tracer from the basolateral compartment across the epithelia cell barrier into the apical compartment…in an amount proportional to a severity…” (i.e. such components are fully capable of being assembled and wherein the tracer may be added to the basolateral compartment to affect upward translocation thereof as claimed). The recitation is drawn to purely functional limitations and intended use thereof the kit that are met by the commensurately-provided structural components of the art of Berg/Lipson/Hayes, and wherein it is noted that the kit-type claims do not require any particular assay or active steps to be carried out in assessing epithelial cells.
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (“Pulmonary Permeability…” PLOS ONE, July 2014, Vol. 9, Issue 7, e101925), hereafter Chen, in view of Berg and Hayes.
With regard to claims 12 and 15, Chen discloses an assay involving a tracer which is fluorescent and has a mw within 5 kDa of the molecular weight of human albumin (particularly as in FITC-dextran as in cl. 15), and a positive control (and as in LPS w/cl. 13) (abstract, page 1, for example). With regard to claim 14, Chen discloses the assay involves a comparative negative control (control group that is without LPS; pages 4-5, fig. 3, for example) With regard to claim 16, Chen further discloses application with airway epithelial cells (page 3, fig. 1, for example).
With regard to claims 12-16, Chen discloses an in vivo assay and thus does not specifically provide a kit as claimed, and including a cell culture system comprising an apical compartment and a basolateral compartment as recited in cl. 12
Berg has been discussed above.
Hayes has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Chen to provide an in vitro form such as by a kit as suggested by Berg (see pars.[0028,0057,0084,0116]) in order to provide an obvious analogue to that of the in vivo assay in which the form of a kit and the cultured/sampled airway epithelial cells provides for a consumable that is both marketable for sale and allows for use at various sites when desired.
Further, it would have been obvious to one of ordinary skill in the art to modify Chen to utilize a culture unit including an apical compartment and a basolateral compartment below and lateral to the apical compartment, the basolateral compartment configured to contain a culture medium and the apical compartment configured to contain airway epithelial cells forming an epithelial cell barrier between the basolateral compartment and the apical compartment such as suggested by the analogous art of Hayes to cell culturing and assessing functions thereof in which such a cell culture unit represents a suitable and well-known structure for in-vitro practice of simulating the cellular physiology as in pulmonary permeability as would likewise be appreciated by Chen (see abstract, for example).
Further, modified Chen by Berg and Hayes provides commensurate structural components, as claimed, to the kit and is thus said to be fully capable of (herein, “configured to”) “upward translocation of the tracer from the basolateral compartment across the epithelia cell barrier into the apical compartment…in an amount proportional to a severity…” (i.e. such components are fully capable of being assembled and wherein the tracer may be added to the basolateral compartment to affect upward translocation thereof as claimed). The recitation is drawn to purely functional limitations and intended use thereof the kit that are met by the commensurately-provided structural components of the art of Chen/Berg/Hayes, and wherein it is noted that the kit-type claims do not require any particular assay or active steps to be carried out in assessing epithelial cells.
Response to Arguments
Applicant’s arguments with respect to claim(s) 12-16 have been considered but are moot because the new ground of rejection provided in view of the amendments made to the claims.
Further, Applicant’s arguments are not persuasive as they are not commensurate in scope with the claims.
Applicant’s arguments are drawn to purported differences in assaying/methodology wherein the claims are drawn to kit claims that does not require any such assay of particularly-necessitated active steps including steps to particular directionality therein as discussed by Applicant.
As discussed above, the prior art of Berg/Lipson/Hayes (newly-added herein as discussed above in the body of the action) discloses the commensurately-claimed structural components of the kit and is thereby fully capable of (herein, “configured”) in as much as claimed and required herein. The components of the kit are fully capable of being assembled and wherein the tracer may be added to the basolateral compartment to affect upward translocation thereof as claimed.
This is likewise seen with respect to the culture system wherein the apical compartment is “configured to contain…” as claimed and the basolateral compartment is “configured to contain a culture medium…” as claimed.
Likewise discussion is held with respect to Chen in view of Berg, wherein Examiner reasserts that the arguments are not commensurate in scope with the claims as Applicant’s arguments are drawn to purported differences in assaying/methodology wherein the claims are drawn to a kit that does not require any such assay of particularly-necessitated active steps including steps to particular directionality therein as discussed by Applicant.
Further, as discussed above, the prior art of Chen/Berg/Hayes discloses the commensurately-claimed structural components of the kit and is thereby fully capable of (herein, “configured”) in as much as claimed and required herein.
This is likewise seen with respect to the culture system wherein the apical compartment is “configured to contain…” as claimed and the basolateral compartment is “configured to contain a culture medium…” as claimed.
The claims are drawn to a kit and Applicant has failed to patentably distinguish the claimed kit from that of the prior art, and wherein, as discussed above, the kit of the prior art is fully capable of (herein “configured to”) the functionalities recited.
Herein, it appears from Applicant’s remarks and arguments that Applicant’s purported inventive intentions lie in a method-type claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798