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 .
Election/Restrictions
Applicant’s request for reconsideration of the restriction requirement mailed 08/11/2025 is acknowledged. As all the pending claims require at least the device of Claim 1, the inventions are not separate and distinct under US restriction practice. The restriction requirement mailed 08/11/2025 is withdrawn.
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.
Claim 16 is 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.
Claim 16 recites the limitation "applying a force on the device with the clamp". There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from Claim 15, but Claim 15 does not recite a clamp. Only Claim 14, a separate system of Claim 1, accounts for the clamp. Applicant may wish to amend Claim 16 to recite “a clamp” so as to obviate the issue.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 sets forth the replicating enzyme and NTPs, however, claim 20 recites an alternative-type choosing of “replicating enzyme and a plurality of NTPS” or “oligonucleotides,” wherein the claim does not necessitate the choosing of replicating enzyme and a plurality of NTPS. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant may intend to recite “…the fluid comprising the replicating enzyme and a plurality of NTPS and wherein the replicating enzyme…”
Claim Rejections - 35 USC § 102
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 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.
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 1-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Detusch (US 2011/0034348 A1), hereinafter “Detusch”.
Regarding Claim 1, Detusch teaches a device comprising a first layer 14 and a second layer 12 (Fig. 1a), wherein first layer 14 comprises a window having a thickness of about 1 μm to about 1000 μm ([0008]: “a planar conduit defining layer, including a conduit cut out of the layer” – [0122]: “The spacers are optionally about 0.5 mm thick” – See further Fig. 1A showing the spacers 14a/b forming a conduit between a cover 18 and base 12.), and wherein the first and second layers reversibly seal to form a flow path having an inlet and an outlet and bounded in part by the window ([0179]: “In exemplary embodiments of the invention, spacers and inlet reservoir components allow liquids to pass through device 10 by capillary action.” – Thus, fluid flows through the compartment formed by the spacers and the top/bottom layers.), as in Claim 1.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein a thickness of the first layer bounding the window is greater than the thickness of the window (See Fig. 1A wherein when assembled, the window borders sit above/below the thickness of the spacer as they are formed in part by the upper and lower layers separated by a layer of adhesive on the top/bottom of the spacer. Further, such a qualitative “greater than” recitation is broad so as to encompass even minute differences, wherein even a microscopic thickness difference attributable to mere manufacturing variation provides for the “greater than” aspect.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the thickness of the first layer bounding the window is from about 1 pm to about 1 mm ([0122]: “The spacers are optionally about 0.5 mm thick”), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the thickness of the window is about 0.17 mm ([0223]: “FIG. 6H shows a cover layer 616, with air hole 624. This layer is optionally formed of 0.175 mm thickness.”), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the flow path comprises a void in a surface of the first or second layer (See Fig. 7 showing the capillary flow path 712 formed by the void in the spacer layer.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the first layer and the second layer are configured to seal via an adhesive, conformal contact, or capillary force ([0018, 0021]), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the first layer comprises a plurality of windows having a thickness of about 1 pm to about 1000 pm that are physically separated (See Fig. 10C, for example, showing an embodiment of the device comprising multiple of the windows having a thickness of about 1 pm to about 1000 pm, as discussed in Claim 1, and being physically separated.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, Detusch teaches the device discussed above wherein each of the plurality of windows is separated by a region of the first layer having a greater thickness than each window (Similarly as above, the region of the first layer separating the windows must have a greater thickness than the windows so as to contact with the opposing layer. Further, such a qualitative “a greater” recitation is broad so as to encompass even minute differences, wherein even a microscopic thickness difference attributable to mere manufacturing variation provides for the “a greater” aspect.), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 7 as discussed above. Further, Detusch teaches the device discussed above wherein each of the plurality of windows is separated by a region of the first layer comprising a hydrophobic pattern ([0150]: “In FIG. 5D is depicted a device where a flow regulator 28 d is 2 mm across and 1 mm long, but is coated with a very thin layer of a hydrophobic material. The hydrophobic material reduces the rate of flow of aqueous liquids through flow regulator 28 d.”), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the flow path is bounded in part by a hydrophobic pattern on the first and/or second layer ([0150]: “In FIG. 5D is depicted a device where a flow regulator 28 d is 2 mm across and 1 mm long, but is coated with a very thin layer of a hydrophobic material. The hydrophobic material reduces the rate of flow of aqueous liquids through flow regulator 28 d.”), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 10 as discussed above. Further, Detusch teaches the device discussed above wherein the second layer comprises a hydrophobic surface texture or surface pattern opposite the window ([0150]: “the same flow conduit is made of Teflon, the hydrophobicity of Teflon could result in there being no capillary flow at all”), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the first and/or second layer comprises an elastomer ([0208]), as in Claim 12.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, Detusch teaches the device discussed above wherein the second layer comprises the inlet and/or the outlet ([0221]: “FIG. 6F shows a conduit layer 610, with exemplary dimensions for reservoir (e.g., 300 micro liters) and inlet conduit. Optionally, this layer is formed of a sandwich (e.g., by laminating) of double sided tape, 175 micron thick spacer and a third layer of 1522 above.”), as in Claim 13.
Regarding Claim 15, Detusch teaches method for assembling a device comprising: (a) providing the device of Claim 1 (see Claim 1 above as anticipated by Detusch); (b) applying a sample to the window (See Fig. 8 and [0237]: “before cover closure, the cells are allowed to settle in wells”); and (c) reversibly contacting the first layer and the second layer and forming a fluid tight seal and the flow path through which fluid can flow (See Fig. 8 step 816 occurring after the step 812 of adding the cell sample.), as in Claim 15.
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.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Detusch in view of Achneck et al. (US 2014/0370593 A1), hereinafter “Achneck”. Detusch has been discussed above.
Regarding Claim 14, Detusch provides for “comprising the device of claim 1”, as discussed above regarding Claim 1. However, Detusch does not specifically teach “a clamp configured to apply a force on the device [of Claim 1] to maintain the seal”, as in Claim 14.
However, Achneck teaches a respective flow chamber assembly (Title, Abstract) wherein layers of the device comprise an upper layer and a lower layer separated by a channel forming layer similarly as in Detusch, and wherein a snap seal closure mechanism maintains compression of the channel at all times ([0088]: “This closure mechanism functions as a snap seal, which keeps the gasket fully compressed between top and bottom plates. The height of the flow path inside the wells is constant and predetermined by the height of the bottom plate rim and bumpers touching the top plate undersurface.” – See also [0070-0072] discussing construction of the snap seal, wherein such arrangement provides for improved sealing of the device, thereby reducing errors and contamination due to leaks.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the device of Claim 1 as system comprising said device and a clamp configured to apply a force on the device to maintain a seal, such as suggested by Achneck, so as to provide for improved sealing of the device, thereby reducing errors and contamination due to leaks.
Regarding Claim 16, the prior art meets the limitations of Claim 15 as discussed above. Further, Detusch does not specifically teach the method discussed above wherein step (c) comprises applying a force on the device with the clamp, as in Claim 16.
However, Achneck teaches a respective flow chamber assembly (Title, Abstract) wherein layers of the device comprise an upper layer and a lower layer separated by a channel forming layer similarly as in Detusch, and wherein a snap seal closure mechanism maintains compression of the channel at all times ([0088]: “This closure mechanism functions as a snap seal, which keeps the gasket fully compressed between top and bottom plates. The height of the flow path inside the wells is constant and predetermined by the height of the bottom plate rim and bumpers touching the top plate undersurface.” – See also [0070-0072] discussing construction of the snap seal.), wherein such arrangement provides for improved sealing of the device, thereby reducing errors and contamination due to leaks.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Detusch wherein step (c) comprises applying a force on the device with the clamp, such as suggested by Achneck, so as to provide for improved sealing of the device, thereby reducing errors and contamination due to leaks.
Claims 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Detusch in view of Cai et al. (US 2015/0267251 A1), hereinafter “Cai” ab. Detusch has been discussed above.
Regarding Claim 17, Deutsch teaches a method comprising: (a) providing the device of Claim 1 (See Claim 1 above as anticipated by Detusch.); (b) applying a sample to the window (See Fig. 8 and [0237]: “before cover closure, the cells are allowed to settle in wells”), as in Claim 17.
Further as in Claim 17, Deutsch does not specifically teach the method discussed above further comprising (c) flowing a fluid through the flow path, wherein the fluid comprises an oligonucleotide probe that hybridizes to a template nucleic acid in the sample; and (d) detecting the oligonucleotide probe, as in Claim 17.
However, Cai teaches a method for detection (Abstract), comprising: (b) applying a sample to a window ([0265]: “cells and tissues fixed on the bottom coverslip”); (c) flowing a fluid through flow path ([0265]: “push reagents into a 1 cm×1 cm well with cells and tissues fixed on the bottom coverslip”), wherein the fluid comprises an oligonucleotide probe that hybridizes to a template nucleic acid in the sample ([0007]: “contacting a cell comprising a plurality of nucleic acids with a first plurality of detectably labeled oligonucleotides, each of which targets a nucleic acid and is labeled with a detectable moiety”); and (d) detecting the oligonucleotide probe ([0007]: “(d) imaging the cell after the second contacting step so that interaction by oligonucleotides of the second plurality with their targets is detected”). Therein, such an arrangement of samples and reagents for selectively detecting particular gene sequence via a detectable oligonucleotide provides for the device to be used for genetic detection and thereby increase the utility of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Deutsch further comprising (c) flowing a fluid through the flow path, wherein the fluid comprises an oligonucleotide probe that hybridizes to a template nucleic acid in the sample; and (d) detecting the oligonucleotide probe, such as suggested by Cai, so as to increase the utility of the device by providing samples and reagents for genetic testing to the device.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, as discussed above regarding Claim 17, Detusch is modified in view of Cai to provide an oligonucleotide probe (“detectably labeled oligonucleotide” in Cai) so as to enable the device of Detusch for genetic detection. Further, Cai provides the detectably labeled oligonucleotide as an optical label ([0024]: “the detectably labeled oligonucleotides are labeled with fluorophore”), as in Claim 18.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Detusch in view of Cai, to provide the detectably labeled oligonucleotide as an optical label, such as suggested by Cai, so as to be commensurate with Cai requiring fluorescence imaging for detection of particular nucleotide sequences, and so as to provide a sufficient means for detection utilized extensively in genetic assays.
Regarding Claim 19, the prior art meets the limitations of Claim 18 as discussed above. Further, as discussed above regarding Claim 17, Detusch is modified in view of Cai to provide an oligonucleotide probe (“detectably labeled oligonucleotide” in Cai) so as to enable the device of Detusch for genetic detection. Further, Cai provides the detectably labeled oligonucleotide as a fluorescent label ([0024]: “the detectably labeled oligonucleotides are labeled with fluorophore”), as in Claim 19.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Detusch in view of Cai, to provide the detectably labeled oligonucleotide as a fluorescent label, such as suggested by Cai, so as to be commensurate with Cai requiring fluorescence imaging for detection of particular nucleotide sequences, and so as to provide a sufficient means for optical detection utilized extensively in genetic assays.
Regarding Claims 20-21, the prior art meets the limitations of Claim 17 as discussed above. Further, Detusch does not specifically teach the method of Claim 17 further comprising flowing a fluid comprising a replicating enzyme and a plurality of nucleotide triphosphates (NTPs) or oligonucleotides, wherein the replicating enzyme replicates the template nucleic acid with the NTPs, as in Claims 20-21.
However, the recitations above are merely drawn to a generic polymerase chain reaction (PCR), wherein each and every PCR reaction involves providing an “replicating enzyme” and NTPs to be used by said enzymes to synthesize new strands from the template nucleic acid. Therein, Cai discusses PCR being performed as an amplifying step prior to genetic analysis ([0193]: “an amplifying step comprises polymerase chain reaction (PCR)”), and wherein such an amplifying step of performing PCR is common practice in genetic analysis for obtaining a high enough concentration of the oligonucleotide to be analyzed so as to be detectable.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Detusch further comprising flowing a fluid comprising a replicating enzyme and a plurality of nucleotide triphosphates (NTPs) or oligonucleotides, wherein the replicating enzyme replicates the template nucleic acid with the NTPs, such as suggested by Cai, so as to provide for the device to be able to perform genetic amplification and subsequent analysis, thereby increasing the utility of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (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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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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