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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitations are: “media replacement means” in Claim 31. Examiner reviewed the specification and page 33, lines 12-13 describe a media replacement storage.
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.
Claim 31 is 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. The written description does not recite “media replacement means” as required in Claim 31 and thus this is considered new matter. Correction is required.
Claim 33 is 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. The written description does not have support for the “sampling space is not a multi microwell plate” as required by the claim limitation in Claim 33. Correction is required.
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 22-33 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.
Regarding Claim 22, while the device could be configured to collect samples, it is unclear which part of the claimed microfluidic device is capable and configured for collecting samples from the living organism. Further clarification and correction are required.
Claims 23-33 are further rejected as they depend on Claim 22.
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.
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 22-33 are rejected under 35 U.S.C. 103 as being unpatentable over Ludlam et al. (WO2018213357A1) in view of Li et al. (CN106145187A).
Regarding Claim 22, Ludlam teaches the following:
A cell culture system comprising… a microfluidic enabled multiwell plate (para 36)(a microfluidics device)
The microfluidic layer may itself comprise a plurality of sublayers including a well layer 302 (sampling chambers layer), a fluid routing layer 304 (payload plumbing layer), pneumatic membrane layer 306 (flexible membrane), and pneumatic layer 308 (control valves layer, where the well layer 302 may comprise the plurality of wells themselves, while fluid routing layer 304 may comprise microfluidic channels through which fluid may flow to and/or from the channels, pneumatic membrane layer 306 and pneumatic layer 308 may work together to use pneumatic force to cause the opening and/or closing of microvalves and/or the actuation of micropumps to control the flow of fluid through the microfluidic channels of layer 304 and into and/or out of the wells of layers 302 (para 77 and 78) and the layers included in microfluidics layer 300 may be stacked with well layer 302 on one side (e.g., the bottom of microfluidics layer 300), followed by fluid routing layer 304, then pneumatic membrane layer 306, then pneumatic layer 308 on the opposite side (e.g., the top of microfluidics layer 300) as well layer 302 (para 79) and the pneumatic layers discussed herein may be used in order to enable each of a large number of wells (e.g., 48 wells, 96 wells, or more) to be individually addressable (para 234)(a control valves layer, a flexible membrane beneath the control valve layer, a payload plumbing layer with configurable addressable ports beneath the flexible membrane, and a sampling chamber lay beneath the payload plumbing layer)(also see
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Fig. 3A above)
A middle tier of the device comprises a multiplexer associated with signal processing (para 385). The multiplexer being used for fluid control is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The multiplexer of Ludlam would be capable of fluid control and therefore meets the claim.
Ludlam does not teach an integrated analysis chip for sample analysis.
Li, in the same field of endeavor, teaches a microfluidic chip for gene detection (Abstract). Li further teaches the cell screening, capture, identification step (analysis) is integrated on a micro-fluidic chip (integrated analysis chip)(para 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an integrated analysis chip to the device of Ludlam as taught by Li. One would have been motivated to make this modification as it greatly reduces the number of operation steps thereby improving the success rate and reliability of experiments (para 34).
The device configured and dimensioned to be inserted or implanted into a living organism for collecting samples from the living organism in vivo is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). Since there are no limitations to the specific size of the device other than being implanted into a living organism and a living organism is broad and has a large range of sizes, the device of Ludlam in view of Li would be capable of being implanted into an unspecified living organism absent clear evidence otherwise and therefore meets the claim.
Regarding Claim 23, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches one or more of the layers 304, 306, 308 may be permanently bonded to one another, such as pressed, and/or heated and melted together (para 80). This would require the layers to be independently prepared and the joined together with the flexible membrane.
Regarding Claim 24, Ludlam in view of Li teaches all the limitations of Claim 23 (see above). The limitations of Claim 24 are product-by-process. The patentability of a product is independent of how it was made. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
Regarding Claim 25, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches one or more of the layers 304, 306, 308 may be permanently bonded to one another, such as pressed, and/or heated and melted together and layer 302 may be bonded by adhesives (para 80)(the control valves layer, the payload plumbing layer, the sampling chambers layer, and the flexible membrane are joined together by a bonding method selected from a group consisting of chemical bonding, thermal bonding, pressure bonding, and combinations thereof).
Regarding Claim 26, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). The limitations of Claim 26 are product-by-process. The patentability of a product is independent of how it was made. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
Regarding Claim 27, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches a computer 1300 as a component of the microfluidics system as system 100 and any of its subcomponents. Computer 1300 is configured to execute live cell culture, assay and is configured to control, monitor, or otherwise send and/or receive electronic signals to and/or from any one or more of the devices described (para 248)(data processing unit configured to analyze data obtained from collected samples and a communication means for transmitting data to the data processing unit).
Regarding Claims 28 and 29, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches the system is a tabletop system configured to manipulate and monitor live cells for.. assays (para 36)(a plurality of chemical assays). The chemical assays for analyzing samples gather in vivo and for analyzing cranial bone defect-related properties is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The assays of Ludlam would be capable of being used in the manner claimed and therefore meet the claim.
Regarding Claim 30, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches the multiwell plate device may have a footprint that enables the device to be inserted into docking stations or other laboratory or field equipment (para 54)(the layers are integrated into a single portable system).
Regarding Claim 31, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches multiwell device 104 may comprise one or more reservoirs (media replacement storage) configured to be filled with reagent and/or other fluid by docking portion 109 such that multi well device 104 may be removed from docking station 102 (for example to be transported to another piece of laboratory equipment) without interrupting the continuous availability of media supply (para 43)(configured to provide replenishment media to the microfluidics device to maintain a substantially constant net amount of fluid in the microfluidics device).
Regarding Claim 32, Ludlam in view of Li teaches all the limitations of Claim 22 (see above). Ludlam further teaches fluid routing layer 304 (payload plumbing layer with configurable addressable ports) may comprise microfluidic channels through which fluid may flow to and/or from the channels and pneumatic membrane layer 306 and pneumatic layer 308 may work together to use pneumatic force to cause the opening and/or closing of microvalves and/or the actuation of micropumps to control the flow of fluid through the microfluidic channels of layer 304 and into and/or out of the wells of layers 302 (para 78)(the configurable addressable ports include a plurality of inlet ports that serve as access opening that allow fluid flow to and from different locations associated with a single sampling space).
Regarding Claim 33, Ludlam in view of Li teach all the limitations of Claim 32 (see above). Ludlam further teaches well layer 302 may comprise the plurality of wells themselves (para 78) and wells of well layer 302 may each have an input channel (e.g., inlet) and/or an output channel (e.g., outlet), which may open to a layer adjacent to well layer 302 (para 88)(the microfluidics device includes the single sampling space beneath the sampling chambers layer and is in fluid communication with at least two of the plurality of inlet ports of the configurable addressable ports included in the payload plumbing layer). Note: the output channel of Ludlam is capable of being used as an inlet and therefore meets the claim.
Response to Arguments
Applicant's arguments filed 06/17/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the device is open and directly interfaces with the implant site) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the device of Ludlam is not configured to be inserted or implanted into a living organism, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since there are no limitations to the specific size of the device other than being implanted into a living organism and a living organism is broad and has a large range of sizes, the device of Ludlam in view of Li would be capable of being implanted into an unspecified living organism absent clear evidence otherwise and therefore meets the claim.
The remainder of the applicants arguments are towards new or amended claims and have been addressed above.
The amendments to address the 112(b) rejections form the 03/20/2026 Office Action have been accepted and the 112(b) Rejections form the 03/20/2026 Office Action have been withdrawn, however, new 112(a) and (b) rejections have been made (see above).
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 JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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