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
Applicant amendments filed 01/05/2026 have been entered. Applicant amendments overcomes the previous 112(a) and 112(b) rejections set forth in the Office Action mailed 09/04/2025, the previous 112(a) and 112(b) rejections are withdrawn.
Status of Claims
Claims 1, 4, 10, 33-35, 44, 46-47, 49-51 remain pending in the application, with claims 1, 4, 10, 33-35, 44, 49-51 being examined and claims 46-47 being withdrawn pursuant to the election of species made on 06/06/2024.
Claim Objections
Claim 51 is objected to because of the following informalities:
Claim 51 recites “the elastomeric diaphragm membrane” on line 1, where while claim 1 describes that the elastomeric membrane is a rolling diaphragm, it is suggested that the phrasing of the elastomeric membrane be kept consistent so that it is clear what is being referred to and to make clear that it is not a new membrane being referenced.
Therefore, it is suggested claim 51 recite “wherein the elastomeric
Appropriate correction is required.
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 1, 4, 10, 33-35, 44, 49-51 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 written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 now recites “A microfluidic device comprising a pump or valve comprising at least one elastomeric membrane, wherein the elastomeric membrane is a rolling diaphragm that rolls to experience displacement rather than undergoing elastic deformation during pneumatic actuation thereof with compressed gas and/or vacuum; and the microfluidic device further comprises an optically clear film,” on lines 1-5 where it is not seen in the specification where there is support for the microfluidic device including both a pump or valve comprising at least one elastomeric membrane, wherein the elastomeric membrane is a rolling diaphragm, as well as including an optically clear film.
In the remarks filed 01/05/2026, applicants point to the following in PG pub 2022/0105510-A1: [0025]-[0026], [0030]-[0031], [0070], [0144]-[0146], Figures 5A-B and 6A-D.
In particular, [0144]-[0146] are a part of a section describing on-chip control and sensing elements for microfluidic devices, where [0144] is directed to cyclic olefin copolymer elastomeric structures and [0145]-[0146] is directed to rolled elastomeric diaphragms, it is unclear if this is saying that they are two components that can be separately used in the microfluidic device or not. [0146] recites “The rolling diaphragms can also be made of other materials than thermoplastic elastomers…” where this seems to imply that the rolled elastomeric diaphragms are made of the thermoplastic elastomers, which is what the COC is as described in [0144] is understood to be.
Further, [0025]-[0026] describes the custom optical film developed to easily fabricate thermoplastic microfluidic chips with optical windows that has a high temperature grade of COC bonded to a thin layer of elastomeric COC, where the film is laminated in a roll lamination process or bonded using a thermal press or hot plate. Then [0030]-[0031] describes an elastomer diaphragm. It is not seen in these sections where there is support for both the optical film and the elastomer diaphragm being present in the same microfluidic device.
Further, [0137] describes a bonding procedure that involves thermoforming a membrane during the bonding process by vacuuming the material into a semi-porous material that defines a negative mold for the membrane to deform into, where they recite “Applications include pump diaphragm fabrication and valve development.”
The Figures pointed to in the remarks filed 01/05/2026 do show a rolling diaphragm, however they do not show a microfluidic device that includes both the rolling diaphragm and the optically clear film.
The specification does describe an optically clear film as well as an elastomeric diaphragm, however it does not appear from the provided sections that there is support for both of these components being used in the same microfluidic device. Rather, it appears that the specification is describing where the rolling diaphragm can be made out of the optically clear film.
Claims 4, 10, 33-35, 44, 49-51 are rejected by virtue of being dependent on a rejected claim.
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 6, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1, 4-5, 10, 42, 49 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 112(a), please see supra.
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.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796