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
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that although the claims 1-11, 13, and 15 mention cells, a vacuum source, and fluid. However, such are not positively claimed as structural elements of the microfluidic device and system. The prior are considered as materials and/or articles intended to be worked upon, used with the claimed device. It is noted that claims are directed to a device not a process of use. There is no requirement for the device to be used to perform any method steps including isolating, processing, washing, and analyzing cells; applying any vacuum pressure, perfusing of anything etc. as may be intended by applicant.
It is noted that the term “plurality” only requires 2.
It is noted that the phrase “one or more” only requires 1.
It is noted that the term “or” provide for alternatives, not requirements. The term “and/or” minimally means “or”.
It is noted that the terms “pneumatic” and “perfusion” do not provide for any further structure of the microchannels. The terms are directed to intended use.
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 1-15 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.
As to claims 1-4, 11, and 13, it is unclear which/what microwell molds are being referenced by the respective phrases “each microwell mold”; “said microwell mold”; “the microwell molds”; “the microwell mold”; “each of the microwell molds”; and “each individual microwell mold”. It is presumed that such are intended to refer to each of the plurality of microwell molds. If so, the claims should clearly recite such.
Claim 1 recites the limitation "the microwells" in the first paragraph. There is insufficient antecedent basis for this limitation in the claim.
It is unclear if the “an inlet” is an element of the microfluidic device because the claim as presently drafted, the claim does not provide for such. The claim does not preclude the inlet from being a separate element or an element of the vacuum source.
As to claim 1, it is unclear what/which pneumatic microchannel is being referenced “a said pneumatic microchannel” in the last paragraph because the claim does not provide such.
As to claim 1, it is unclear what/which “a said pneumatic microchannel” in the second paragraph because the claim does not provide such.
As to claim 1, it is unclear what is further structurally required by the phrase “thereby forming a microwell… because such appears to be directed to a process step of forming a microwell. It does not appear that the device actually comprises a microwell, but the existence of such microwell is dependent, conditioned upon a vacuum pressure being applied to the elastic membrane. As noted above, the claims are directed to a device defined by the positively claimed structural elements not by any conditional process step that is never required to be performed.
Claims 2-15 are rejected via dependency upon a rejected claim.
As to claim 2, in addition to the above applicable rejection, it is unclear what is the nexus of “rows and columns of microwell molds” to the plurality of microwell molds of claim 1 because the claim does not clearly recite such.
The term “unique” in claims 2 and 4 is a relative term which renders the claim indefinite. The term “unique” 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. There is no indication as what is structurally required for a pneumatic microchannel and a perfusion microchannel to be considered as “unique”. What may be considered as unique to one person may not be considered as such to another and vice versa.
As to claim 3-4, in addition to the above applicable rejections, it is unclear what is the structural connectivity of the one or more perfusion channels to the prior positively claimed elements of claim 1 because the claim does not provide for such. It is noted that list of structures that are not required to be structurally connected do not define a single device, but is just a list of parts that can possibly be used together. The “configured for” clause directed to how such channels can possibly be conditionally used relative to unclaimed cells as evidenced by the “when” clauses. No washing of any cells is ever required to be performed. The channels themselves cannot perform any washing. The phrase “disposed above” does not provide for nor require any structural connectivity. See also claim 13.
As to claim 4, in the last 2 lines, it is unclear what/which perfusing microchannels and pneumatic microchannels are being reference by the phrases “the perfusion microchannels” and “the pneumatic microchannels” because the claims previously recite “one or more perfusion microchannels”, “a plurality of perfusion channels”, “one or more pneumatic microchannels”, “said pneumatic microchannel”, and “the pneumatic microchannel”.
As to claim 5, it is unclear what is the structural connectivity of the cell pooling chamber to the prior positively claimed elements of claim 1 because the claim does not provide for such. It is noted that list of structures that are not required to be structurally connected do not define a single device, but is just a list of parts that can possibly be used together.
Furthermore, it is noted that the phrase “cell pooling” does not provide for any further structure of the chamber. The phrase is directed to intended use of the chamber.
The term “about” in claims 7 and 11 is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, 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. It is unclear what values other than the exact recited values in the claims are considered as “about” the exact values because the claims do not provide for such. What values that may be considered as about the recited values to one person may not be considered as such to another and vice versa.
Claim 8 recites the limitation "said microwells" in the last line. There is insufficient antecedent basis for this limitation in the claim. The microfluidic device has not been claimed as comprising any microwells.
It is unclear what is further structurally required by claim 10 because the claim does not provide for any further structure of the one or more pneumatic channels. Instead, the configured to clause is directed to the intended possible use of such channels with the unclaimed controllable vacuum source that is not claimed as a structural element of the device.
As to claim 12, it is unclear what is the nexus of “a controllable vacuum source” to “a controllable vacuum source” recited in claim 1; if such are the same or different because the claim does not provide for such.
As to claim 12, it is unclear what/which pneumatic channels are being referenced by “the pneumatic microchannels” because claim previously recites “one or more pneumatic microchannels”.
It is noted that recited in the “optionally” clause is not further structurally limiting of the analysis system because options are not requirements. There is no requirement for the system to comprise a controller. However, it is unclear if the controller is a programmed controller because the phrase “for programmed operation” is directed to intended, possible use.
Furthermore, it is unclear what is the nexus/relationship of the “one or more selected pneumatic channels” to the prior recited “one or more pneumatic microchannels” and “the pneumatic microchannels” because the claim does not provide for such.
Furthermore, although no one or more pneumatic channels are positively claimed, it is unclear what structurally required of such a channel to be considered as “selected” because the claim does not provide for such.
As to claim 13, as noted above, the “configured for” clause is directed to intended possible use. No washing of any cells is ever required to be performed.
Furthermore, it is noted that the controller has not been positively claimed, required to be an element of the system. See rejection/remarks directed to claim 12. What the controller is capable of performing is not a structural element.
As to claim 14, it is unclear what is structurally required for the system to comprise imaging processing software because software is not structure. Software is data, information, code etc.
It is unclear what is further structurally required by claim 15 because the claim does not provide for any further structural element nor any further structure of any prior positively claimed structural element. As noted above, the claims are directed to an apparatus/device, not any process of use. There is no requirement for any analysis, isolation, and processing of any cells to be performed. No cells are claimed as elements of the invention. However, anything done to cells can be considered as “processing”. Reciting how any of prior can possibly be performed does not further structurally limit the system. It is noted that there is no structure claimed that can perform any analysis and there is no structural element positively claimed that can perform and provide for any semi-automated or fully automated performance of any of such processes.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7, 10, 12-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Mansky, US 6,439,036.
Mansky discloses a microfluidic device comprising:
a microwell substrate 22 comprising a plurality of microwell molds 40 having an opening at an upper surface of the substrate 22;
an elastic membrane 50 on the top of the substrate 22 that is capable deforming in each microwell mold 40 when a vacuum is applied through the pneumatic channels 42 to individual microwell molds 40. (See figures 1A-5 and corresponding descriptions).
As to claim 2, the microwell molds 40 are arranged in a rectangular array having rows and columns. See for example figure 1.
As to claims 3-4, the device comprises perfusion channels 52, 54 above the elastic membrane that can be employed to wash the membrane. See Figure 2A.
As to claim 5, any of the chambers 52, 54 can be referenced as a cell pooling chamber.
As to claim 6-7, the membrane 50 may be formed from silicone, latex, or nitrite and have a thickness of 0.004-0.010 inches (considered as being about 1 μm to about 20 μm). (column 8, lines 34-36).
As to claims 12-13 and 15, FIG. 5 illustrates an example of a pneumatic circuit 100 (vacuum source) that may be used to apply pressure and vacuum to the apparatus. The circuit includes three solenoid valves 102, 104, 106, air pressure regulators 108, 110, a vacuum generator 112, and an electronic controller (controller), generally indicated at 113. The electronic controller 113 includes a cycle timer 114, which controls the solenoid valves 102, 104, 106 and an event timer 116. (column 8, lines 47-54). The cycle timer 114 is preferably programmed (software) to first energize the vacuum solenoid valve 104 and place the control solenoid valve 106 in its vacuum position (connecting ports 128 and 130) while deenergizing the pressure solenoid valve 102.
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.
Claim(s) 8-9, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansky, US 6,439,036 as applied above.
As to claims 8-9, Mansky does not specify that the membrane comprises one or more selected cell binding moieties disposed on a surface of the membrane.
As to claims 11 and 14, Mansky does not specify that each of the microwell molds have a length or a diameter in the range from about 5 μm to about 100 μm and that the system comprises
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
As to claims 8-9, Mansky discloses the fabric in combination with various treatment agents (e.g. coatings, adsorbed moieties, bonded moieties (e.g., covalently bonded moieties, ionically bonded moieties)), etc.). Typically, treatment agents can be employed in a fabric composition to effect a change in one or more properties of the particular fabric, including without limitation, color fastness, polymer adsorption, soil release, stain release, dye retention, dye transfer, soil redeposition, abrasion resistance, fiber building, wrinkle reduction or prevention, static reduction or prevention, and texture. (column 16, lines 29-41).
It would have been obvious to and within the common sense, knowledge, and skill of one ordinary skill in the art before the effective filing date of the invention to treat the membrane 50 with moieties to modify the properties of the membrane as desired as taught by Mansky.
As to claim 11, it would have been obvious to and within the common sense, knowledge, and skill of one ordinary skill in the art before the effective filing date of the invention to manufacture the microwell molds 40 of Mansky to any size as desired including to have a length or a diameter in the range from about 5 μm to about 100 μm because such would not require any skill and knowledge beyond that of one of ordinary skill in the art.
It would have been an obvious matter of design choice since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 14 Mansky discloses the use of spectroscopic techniques (e.g., absorbance techniques, reflectance techniques, etc.), imaging techniques (e.g., digital camera) (column 17, lines 52-54); a camera (e.g., a digital camera, CCD camera, etc.), a flatbed scanner, or a scanning reflectance probe of some type. The data (software) are preferably stored for use later in a comparative step. (column 20, lines 6-10); samples may be analyzed using for example a scanning reflectance spectrophotometer or a color imaging device such as a camera or scanner (column 21, lines 12-15); and an analysis program (software) is employed. (column 27, line 15).
It would have been obvious to and within the common sense, knowledge, and skill of one ordinary skill in the art before the effective filing date of the invention to recognize that a conventionally known microscope may be employed for imaging and analyzing fabric/the membrane because a microscope is conventionally known device that can be used for such.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Battrell; C. Frederick et al.; Amorese; Douglas A. et al.; Amorese; Douglas A.; Clemmens; John et al.; Hoummady, Moussa; and Song; Gu-Young et al. disclose devices including substrates and membranes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
