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 .
Response to Amendment
The amendment filed on August 22, 2025 is acknowledged. Claims 34 and 46-55 remain pending wherein claims 47, 49 and 53-55 remain withdrawn but subject to rejoinder. Applicant amended claim 34.
Response to Arguments
The amendment necessitated the new grounds of rejection set forth in this Office action, rendering moot Applicant’s arguments with respect to the patentability of the claims.
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 34, 46, 48 and 50-52 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claim 34 has been amended to recite, inter alia,
a semi-permeable membrane AND a SEPARATE substrate positioned on a first side of the membrane,
wherein the claimed apparatus comprises a plurality of interaction sites, wherein EACH interaction site comprises a semi-permeable membrane (i.e. the claimed apparatus comprises a plurality of separate and distinct semi-permeable membranes).
The specification fails to provide support for the amendment. According to Applicant, paragraphs [0012] and [0059] of the specification provide support for the amendment. However, paragraph [0012] explicitly discloses that the “substrate could be a semi-permeable membrane”, and paragraph [0059] discloses that the interaction sites lie on a single semi-permeable membrane.
In other words, the specification provides support for a substrate in the form of a semi-permeable membrane wherein a plurality of interaction sites lie on said semi-permeable membrane, which is patentably distinct from what is conveyed by the amended claim language. For the foregoing reason, the subject matter of the amended claims constitute new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 34, 46, 48 and 50-52 are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (“Charest”) (US 2015/0301027 A1) in view of Rollins et al. (“Rollins”) (US 2003/0137669).
With respect to claim 34, Charest teaches an apparatus comprising (see Figs. 2-3):
a platform (layers 208, 224 and 226), a fluid delivery system (210a/b, 212a/b) and an activity-detector 220 (see [0024] and [0037] disclosing sensors in the form of electrodes 220),
wherein the fluid delivery system is coupled to the platform for providing an environment conducive to cell growth and maintenance on said platform (see Fig. 3),
wherein the platform comprises interaction sites (individual cells) that are separate and distinct from each other (see [0024] disclosing that cells are cultured on membrane 208; see also [0031] disclosing that cells do not clump together, meaning the cells constitute separate and distinct interaction sites), wherein each interaction site comprises a section of a semi-permeable membrane 208 having a first side (upper side) and a second side (lower side), and a substrate 226 supportive of cell culture positioned on the first side of the semi-permeable membrane 208 (see [0031] disclosing that the cells are “seeded into” channel 204, which is formed in substrate 226).
wherein said activity detector 220 is coupled to said platform (see Fig. 2), and
wherein said activity detector 220 detects evidence of an interaction between a biological agent and a pathogen (e.g. a toxin, see [0048]) at said interaction sites, said evidence comprising a change in structure or a change in composition of a medium (see [0037] disclosing determining integrity of the cells using electrodes).
The apparatus taught by Charest differs from the claimed invention in that Charest does not teach that the activity detector includes an interferometer. However, it would have been obvious to one of ordinary skill in the art to utilize other forms of activity detectors for measuring properties other than barrier function of cells (see [0037]). That said, Rollins discloses an optical system comprising an interferometer (see abstract) for gathering data related to properties of particles (e.g. biological tissue) (see [0096]). One property that can be quantified using the optical system is particle size (see [0096]). In light of the disclosure, it would have been obvious to one of ordinary skill in the art to provide the apparatus taught by Charest with an interferometer for optically measuring various properties (e.g. size) of cells cultured in the platform.
With respect to claim 46, if the apparatus taught by Charest is modified as discussed above, then the interferometer would carry out interferometric measurements of an amplitude of a scattered light field from the interaction sites (see [0004] of Rollins).
With respect to claim 48, it is evident that the apparatus taught by Charest comprises a processor that receives data from the activity detector 220 (electrodes). That said, it would have been obvious to one of ordinary skill in the art to configure the processor to receive data from the interferometer as well, wherein the data comprises information representative of angular distribution of light that has been back-scattered (see [0091] and [0110] of Rollins).
With respect to claims 50-52, Charest discloses measuring the concentration of agents (e.g. tracer molecules) added to the cells (see [0011]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art to configure the interferometer to measure a change in a concentration of a metabolite (e.g. glucose) caused by the interaction (see [0051] and [0066] of Rollins disclosing how the interferometer can be used to measure concentration of analytes in a medium, for example glucose in aqueous humor of an eye).
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 PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796