DETAILED ACTION
Notice of AIA Status
The present application, filed on 11/13/2023, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are rejected.
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 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” are being interpreted under 35 U.S.C. 112(f). Conversely, claim limitations in this application that do not use the word “means” 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.
Claim 1 recites “c) a means for conveying a first fluid through the first channel (1161) between the first chamber (1210) and the binding chamber (1120)”. The corresponding structure described in the instant specification as performing the claimed functions is a first of an actuator, a flexible vessel, tube, or vial (see [0006] of the instant disclosure) and tubes, channels, valves, or pumps (see [0013]); and equivalents thereof.
Claim 1 recites “e) a means for conveying a second fluid through the second channel (1162) between the second chamber (1220) and the binding chamber (1120)”. The corresponding structure described in the instant specification as performing the claimed functions is a second of an actuator, a flexible vessel, tube, or vial (see [0006] of the instant disclosure) and tubes, channels, valves, or pumps (see [0013]); and equivalents thereof.
Claim 13 recites “a means for preventing access to the first chamber (1210) through the first coupler (1140 a)”. The corresponding structure is a cap, a seal, a plug, a film, valve, or a vial (see [0007] of the instant disclosure).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(d)
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.
Claim 9 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Claim 9 recites “the device (1100) of claim 7, wherein the first channel (1161) is fluidly connected to a first side (1121) of the binding chamber (1120); and the second channel (1162) if fluidly connected to a second side (1122) of the binding chamber (1120)” and claim 7 recites “The device (1100) of claim 1, wherein the first channel (1161) is fluidly connected to a first side (1121) of the binding chamber (1120); and the second channel (1162) if fluidly connected to a second side (1122) of the binding chamber (1120)”. As a result, claim 9 doesn’t further limit claim 7.
Applicant may cancel the claim, amend the claim placing the claim in proper dependent form (e.g. consider amending the dependency such that claim 9 depends from claim 8), rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirement. The U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. §112 (d) are related to matters of form, non-compliance with U.S.C. §112 (d) renders the claim unpatentable just as non-compliance with other sections of 35 U.S.C. 112 would. See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006) (holding a dependent claim in a patent invalid for failure to comply with pre-AIA 35 U.S.C. §112, 4th paragraph).
Claim Rejections under 35 U.S.C. § 112(b)
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.
Claims 10-12 rejected under 35 U.S.C. §112 (b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 10 recites “the first actuator”. There is insufficient antecedent basis for the limitation in the claims. Consider rephrasing to ‘further comprising a first actuator’ or amending the dependency such that claim 9 depends from claim 8.
Claim 10 recites “the second actuator”. There is insufficient antecedent basis for the limitation in the claims.
Claim 11 recites “the first actuator”. There is insufficient antecedent basis for the limitation in the claims.
Claim 12 recites “the second actuator”. There is insufficient antecedent basis for the limitation in the claims.
Claim Objections
Claims 7 and 9 are objected to because of the following informalities: Appropriate correction is required.
Claim 7 recites “the second channel (1162) if fluidly connected to side (1122) of the binding chamber (1120)”. For the sake of clarity, consider rephrasing to ‘the second channel (1162) is fluidly connected to side (1122) of the binding chamber (1120)”.
Claim 9 recites ““the second channel (1162) if fluidly connected to side (1122) of the binding chamber (1120)”. For the sake of clarity, consider rephrasing to ‘the second channel (1162) is fluidly connected to side (1122) of the binding chamber (1120)”.
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.
Claims 1, 3-13 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Battrell (US20090148933).
With respect to claim 1, Battrell teaches a device (integrated device in [0049], which recites “FIG. 4 is a schematic of an integrated device, combining the microfluidic extraction, PCR amplification and detection subcircuits of FIGS. 1, 2, and 3”) for isolating nucleic acids from a sample (see [0174], which recites “FIG. 1 is a schematic of a microfluidic subcircuit 100 for sample processing and nucleic acid extraction. Sample, .., can be fluid”), the device (integrated device) comprising:
a) a housing (a single microfluidic card 400 in [0208]) comprising a binding chamber (nucleic acid target capture assembly in annotated Fig. 1), a first chamber (lysis chamber in Fig. 1), and a second chamber (solvent wash pouch in Fig. 1), wherein the binding chamber (nucleic acid target capture assembly) comprises a binding component (solid phase nucleic acid affinity binding substrate in [0145])) capable of binding nucleic acid therein (see [0145], which recites “Nucleic Acid Target Capture Assembly refers to a combination of a solid phase nucleic acid affinity binding substrate and a means for positioning the binding substrate in the fluid path of a microfluidic device”);
b) a first channel (see annotated Fig. 1) fluidly connecting the binding chamber (nucleic acid target capture assembly) and the first chamber (lysis chamber) (see annotated Fig. 1);
c) a means for conveying (which corresponds to the valve between the lysis chamber and the nucleic acid target capture assembly in annotated Fig. 1) a first fluid (a first material worked upon the device) through the first channel (see Fig. 1) between the first chamber (lysis chamber) and the binding chamber (nucleic acid target capture assembly);
d) a second channel (see Fig. 1) fluidly connecting the binding chamber (nucleic acid target capture assembly) and the second chamber (solvent wash pouch) (see annotated Fig. 1); and
e) a means for conveying (which corresponds to the valve between the solvent wash pouch and the nucleic acid target capture assembly in annotated Fig. 1) a second fluid (a second material worked upon the device) through the second channel (see annotated Fig. 1) between the second chamber (solvent wash pouch) and the binding chamber (nucleic acid target capture assembly).
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With respect to claim 3, Battrell teaches the device of claim 1, wherein the means for conveying (valve between the lysis chamber and the nucleic acid target capture assembly in Fig. 1) the first fluid through the first channel comprises a first actuator (electrostatic actuator flow controllers in [0128]) operatively connected to the first chamber (lysis chamber) (see [0128], which recites “Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers”) (each valve has a corresponding actuator in Battrell).
With respect to claim 4, Battrell teaches the device of claim 3, wherein the means for conveying (valve between the solvent wash pouch and the nucleic acid target capture assembly in annotated Fig. 1) the second fluid through the second channel (see annotated in Fig. 1) comprises a second actuator (electrostatic actuator flow controllers in [0128])) operatively connected to the second chamber (solvent wash pouch) (see [0128], which recites “Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers”)(each valve has a corresponding actuator in Battrell).
With respect to claim 5, Battrell teaches the device of claim 1, wherein the means for conveying (valve between the solvent wash pouch and the nucleic acid target capture assembly in annotated Fig. 1) a first fluid through the first channel comprises a flexible vial (lysis buffer pouch in annotated Fig. 1) operatively connected to the first chamber (lysis chamber).
With respect to claim 6, Battrell teaches the device of claim 5, wherein the means for conveying (valve between the lysis chamber and the nucleic acid target capture assembly in annotated Fig. 1) the second fluid through the second channel comprises a flexible vial (elution buffer pouch in annotated Fig. 1) operatively connected to the second chamber (solvent wash pouch).
With respect to claim 7, Battrell teaches the device of claim 1, wherein the first channel is fluidly connected to a first side (see annotated Fig. 1) of the binding chamber (nucleic acid target capture assembly); and the second channel if fluidly connected to a second side (see annotated Fig. 1) of the binding chamber (nucleic acid target capture assembly).
With respect to claim 8, Battrell (US20090148933A1) teaches a device (integrated device in [0049], which recites “FIG. 4 is a schematic of an integrated device, combining the microfluidic extraction, PCR amplification and detection subcircuits of FIGS. 1, 2, and 3”) for isolating nucleic acids from a sample (see [0174], which recites “FIG. 1 is a schematic of a microfluidic subcircuit 100 for sample processing and nucleic acid extraction. Sample, .., can be fluid”), the device (integrated device) comprising:
a) a housing (a single microfluidic card 400 in [0208]) comprising a binding chamber (nucleic acid target capture assembly in annotated Fig. 1), a first chamber (lysis chamber in Fig. 1), and a second chamber (solvent wash pouch in annotated Fig. 1), wherein the binding chamber (nucleic acid target capture assembly) comprises a binding component capable (solid phase nucleic acid affinity binding substrate in [0145])) of binding nucleic acid (see [0145], which recites “Nucleic Acid Target Capture Assembly refers to a combination of a solid phase nucleic acid affinity binding substrate and a means for positioning the binding substrate in the fluid path of a microfluidic device”);
b) a first channel (see annotated Fig. 1) fluidly connecting the binding chamber (nucleic acid target capture assembly) and the first chamber (lysis chamber) (see annotated Fig. 1);
c) a second channel (see Fig. 1) fluidly connecting the binding chamber (nucleic acid target capture assembly) and the second chamber (solvent wash pouch) (see annotated Fig. 1);
d) a first actuator (which corresponds to a first actuator flow controller, see [0128], which recites “Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers”) (each valve has a corresponding actuator in Battrell) operatively connected to the first chamber (lysis chamber) and configured to affect fluid flow through the first channel between the first chamber (lysis chamber) and the binding chamber (nucleic acid target capture assembly); and
e) a second actuator (which corresponds to a second actuator flow controller, see [0128], which recites “Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers”) (each valve has a corresponding actuator in Battrell) operatively connected to the second chamber (solvent wash pouch) and configured to affect fluid flow through the second channel between the second chamber (solvent wash pouch) and the binding chamber (nucleic acid target capture assembly).
With respect to claim 9, Battrell teaches the device of claim 7, wherein the first channel is fluidly connected to a first side of the binding chamber (nucleic acid target capture assembly) (see annotated Fig. 1); and the second channel if fluidly connected to a second side (see annotated Fig. 1) of the binding chamber (nucleic acid target capture assembly, see annotated Fig. 1).
With respect to claim 10, Battrell teaches the device of claim 7, wherein the first actuator (1151) and the second actuator (1152) is a pressure pump (see [0041]) (see also [0128], which recites “Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers”) (each pneumatic microfluidic valve has a corresponding pressure pump actuator in Battrell).
With respect to claim 11, Battrell teaches the device of claim 7, wherein the first actuator is disposed at or near a second side of the first chamber (lysis chamber) (the first actuator is near the first chamber because the actuator is in communication with the first chamber and actuates the valve near the first chamber).
With respect to claim 12, Battrell teaches the device of claim 7, wherein the second actuator is disposed at or near a second side of the second chamber (solvent wash pouch) (the second actuator is near the first chamber because the actuator is in communication with the second chamber and actuates the valve near the second chamber).
With respect to claim 13, Battrell teaches the device of claim 7, wherein the housing (single microfluidic card 400) further comprises a first coupler (air port of pneumatic manifold with hydrophobic isolation filter, see Fig. 1 and 28) fluidly connected to the first chamber (lysis chamber), wherein the first coupler (air port of pneumatic manifold with hydrophobic isolation filter) comprises an opening (see annotated Fig. 1) to the first chamber (lysis chamber) and is configured to engage a means for preventing access (isolation filter) to the first chamber (lysis chamber) through the first coupler (air port of pneumatic manifold with hydrophobic isolation filter).
With respect to claim 18, Battrell teaches the device of claim 7 wherein the binding component (solid phase nucleic acid affinity binding substrate) is immobilized in the binding chamber (Nucleic Acid Target Capture Assembly) (see [0145], which recites “Nucleic Acid Target Capture Assembly refers to a combination of a solid phase nucleic acid affinity binding substrate and a means for positioning the binding substrate in the fluid path of a microfluidic device. Binding substrates include filters, beads, frits, fluidized beds, and solid surfaces in general. Materials include silica, derivatized silica, alumina, zirconia, treated latex beads, and the like. Means for positioning can be as simple as direct deposition of beads in a microfluidic channel, or more complex such as by mounting a filter membrane or frit in the fluid path of the channel. A filter membrane can be inserted in a cutout in a layer, can be glued in place”).
With respect to claim 19, Battrell teaches the device of claim 7, wherein the sample is a biological sample (the biological sample is a material worked upon and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935) (see also [0153], which recites “capturing target nucleic acids from a biological sample”).
With respect to claim 20, Battrell teaches the device of claim 7, wherein the sample is an environmental sample (the biological sample is a material worked upon and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935) (see also [0250], which recites “the design ensures a single-entry, disposable device for medical or environmental testing”).
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 2 and 17 is rejected under 35 U.S.C. 103 as being unpatentable over Battrell (US20090148933A1) in view Mauk (US20090186357).
With respect to claim 2, Battrell teaches the device of claim 1.
Battrel doesn’t teach that the binding component comprises cellulose.
In the analogous art of analytical devices, Mauk teaches a binding component comprising cellulose (see [0074], which recites “nucleic acid extraction and isolation, are implemented by way of the solid-phase nucleic acid binding media (Whatman FTA™ cellulose filter paper) that is included in the PCR chamber”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Battrel incorporating the cellulose disclosed Mauk such that the binding component comprises cellulose with a reasonable expectation of success because Mauk teaches cellulose as a known nucleic acid binding component and the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, B.).
With respect to claim 17, Battrell teaches the device of claim 7.
Battrell doesn’t teach that the binding component comprises cellulose.
In the analogous art of analytical devices, Mauk (US20090186357) teaches a binding component comprising cellulose (see [0074], which recites “nucleic acid extraction and isolation, are implemented by way of the solid-phase nucleic acid binding media (Whatman FTA™ cellulose filter paper) that is included in the PCR chamber”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Battrel incorporating the cellulose disclosed Mauk such that the binding component comprises cellulose with a reasonable expectation of success because Mauk teaches cellulose as a known nucleic acid binding component and the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, B.).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Battrell (US20090148933A1) in view Ching (US20120288897).
With respect to claim 14, Battrell teaches the device teaches the device of claim 13.
Battrell doesn’t teach that the means for preventing access to the first chamber through the first coupler comprises a cap, a seal, a plug, or a vial.
In the analogous art of providing analytical devices, Ching (US20120288897) teaches a cap (cap 6118 in [0187], which recites “a cap 6118 that is removably coupled to about the fill opening 6116. In use, a sample containing a target nucleic acid, such as, for example, urine, blood and/or other materials containing tissue samples can be conveyed into the lysing chamber 6114 via the fill opening 6116. The sample can be introduced into the lysing chamber 6114 via any suitable mechanism, including for example, by pipetting or injecting the sample into the first chamber 6114 via the fill opening 6116. In some embodiments, a sample filter can be disposed within the fill opening 6116 and/or the fill cap 6118”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Battrel incorporating the cap disclosed Ching such that the means for preventing access to the first chamber through the first coupler comprises the cap, with a reasonable expectation of success for the benefit of preventing contamination contents the chamber and the loss of contents therefrom.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell (US20090148933A1) in view Sakal (US20070140915).
With respect to claim 15, Battrell teaches the device of claim 7, wherein the housing (single microfluidic card) further comprises a second coupler (see annotated Fig. 1) fluidly connected to the second chamber (solvent wash pouch), wherein the second coupler (see annotated Fig. 1) comprises an opening (see annotated Fig. 1) to the second chamber (solvent wash pouch).
Battrell doesn’t teach that the second coupler is configured to engage a means for preventing access to the second chamber (1220) through the second coupler (1140b).
In the analogous art of providing analytical devices, Sakal teaches a means (vial cap 14 in [0036]) for preventing access to a chamber (collection chamber 20 in [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Battrel incorporating the means for preventing access to the chamber disclosed Sakal such that the second coupler is configured to engage a means for preventing access to the second chamber (1220) through the second coupler (1140b) with a reasonable expectation of success for the benefit of preventing contamination contents in the chamber and the loss of contents therefrom.
With respect to claim 16, Battrell in view of Sakal teaches the device of claim 15, wherein the means (vial cap 14 of Sakal) for preventing access to the second chamber (1220) through the second coupler (1140b) comprises a cap (vial cap 14 in [0036] of Sakai), a seal, a plug, or a via (see [0036] of Sakal).
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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