DETAILED ACTION
Applicant’s amendment and response to the restriction requirement received on 6/1/26 has been entered. Claims 1, 3-9, 11, 14, 22-24, 26-28, 35, and 54-56 are pending in this application. Applicant’s election of Group I, claims 1, 3-9, 11, 14, 22-24, 26-28 and 35 is acknowledged. As applicant did not indict whether the election was made with or without traverse, and further did not include any arguments traversing the grounds for restriction, the election of Group I is considered to have been made without traverse.
Claims 54-56 are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/26.
Claims 1, 3-9, 11, 14, 22-24, 26-28 and 35 are currently under examination. An action on the merits follows. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/18/23, 12/30/24, and 8/26/25 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statements have been considered by the examiner, and initialed and signed copies of the 1449s are attached to this action.
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, 3-9, 11, 14, 22-24, 26-28 and 35 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.
Claim 1 recites certain claim elements which are confusing and indefinite. Claim 1 recites a sensor element and an output element of a biosensor each of which include a “stem sequence” and a “stem target sequence”, and which in alternative embodiments may include an “overhang sequence” and an “overhang target sequence” or a “linker sequence” and a “linker target sequence”. It is unclear what constitutes a nucleotide sequence which a “stem sequence” vs a “stem target sequence” vs a “linker sequence” vs a “linker target sequence” vs an “overhang” sequence vs and “overhang target sequence” other than an indication of the relative position of these required or alternative sequence elements in relation to the sensor element and the output element. It is noted that it is proper to interpret claim limitations in view of the specification as long as such interpretation does not unnecessarily import limitations from the specification into the claims. The specification does not provide a specific definition for any of these nucleotide sequence elements. The specification does teach that each of these nucleotide sequence elements is between 0-15 nucleotides in length, and in some embodiments the overhang sequence is the reverse complement of at least a portion of the overhang target sequence, the stem sequence is the reverse complement of at least a portion of the stem target sequence, and the linker sequence is the reverse complement of at least a portion of the linker target sequence (specification, pages 2-3). These aspects are also recited in dependent claims 3 and 8. However, the specification does not define what makes a “stem” sequence different from a “linker” sequence, or from an “overhang” sequence. Likewise, the specification does not define what makes a “stem target” sequence different from a “linker target” sequence or an “overhang target sequence”. Each of these sequences appear to encompass any nucleotide sequence such that the demarcation between these sequence elements in a larger sequence cannot be determined. For example, claim 1 recites that “if the sensor domain comprises a linker sequence, the aptamer domain comprises a linker target sequence between the stem sequence and the aptamer subsequence”. Since there appears to be no way to define what constitutes a linker sequence vs a stem sequence or the linker target sequence or stem target sequence for which they may be in part a reverse complement, it is unclear what nucleotide sequence may meet this claim limitation. The same goes for the limitation, “if the sensor domain comprises an overhang sequence, the output domain comprises an overhang target sequence between the stem target sequence and the output subsequence”. Since there appears to be no way to define what constitutes a overhang sequence vs a stem sequence or an overhang target sequence vs a stem target sequence for which they may be in part a reverse complement, it is unclear what nucleotide sequence may meet this claim limitation. Furthermore, in view of the uncertainty with which nucleotides of the RNA qualify as “linker”, “stem”, “stem target”, “linker target”, “overhang” and “overhang target”, and the lack of a definition for what sequence qualifies as “aptamer subsequence” or “output” subsequence, I is unclear what nucleotides qualify as an “aptamer sequence” or an “output subsequence”. In addition, claim 1 recites that the output domain “when transcribed” folds into different conformations based on ligand binding to the sensor domain. The phrase “when transcribed” is confusing in the context of this RNA biosensor construct. Transcription occurs when an RNA polymerase copies a DNA sequence into complementary RNA sequence. Since the construct is claimed as an “RNA” construct, it is unclear how any portion of this RNA sequence is to be “transcribed”. Thus, for the reasons set forth above, the metes and bounds of the RNA construct and the sequence elements discussed above cannot be determined. Claims 3-9, 11-14, 22-24, 26-28 and 35 depend on claim 1 and thus are included in this rejection.
Claim 8 is further rejected for indefiniteness for the recitation that the overhang sequence is between 0-15 nucleotides in length, the stem sequence is between 0-15 nucleotides in length, and/or the linker sequence is between 0-15 nucleotides in length. If the stem sequence is 0 nucleotides in length, it is not present, which contradicts the limitation in claim 1 upon which it depends that the sensor comprises a stem sequence. Likewise, if the linker sequence is 0 nucleotides in length, or the overhang sequence is 0 nucleotides in length then those elements are not present and such conflict with the alternative embodiments in claim 1 where a linker is present or an overhang is present. As such, claim 8 is confusing such that the metes and bounds of the claim cannot be determined.
Claim 24 is further indefinite in the recitation of the phrase “and the like”. The phrase "and the like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claim Interpretation
In the interests of compact prosecution, the following claim interpretation has been applied to claims 1, 3-9, 11, 14, 22-24, 26-28 and 35. The “RNA biosensor construct” has been given its broadest reasonable interpretation of encompassing an RNA molecule. Further, since as discussed above, there appears to be no way to differentiate between what may be stem vs. linker vs. overhang sequence, or stem target vs. overhang target sequence vs linker target sequence, the claims have been given their broadest reasonable interpretation as encompassing any sequence present either 5’ of an aptamer ligand binding site or 3’ of the aptamer through to the output functional sequence with the proviso that the sequence exhibits any structural or functional features recited by the claim, such as acting as a reverse complement to another sequence, or being capable of forming a helix stem structure. Further, as it is unclear what sequence may be “aptamer subsequence” or “output subsequence”, these sequences have been given their broadest reasonable interpretation and including any sequence present in the aptamer or output sequence.
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.
Claims 1, 3-8, 14, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt et al. (2019) Cold Spring Harbor Perspect Biol, Vol. 11:032532; doi:10.1101/cshperpect.a032532, pages 1-13. Schmidt et al. teaches a conformational/kinetic RNA biosensor which is an RNA bioswitch which comprises a “sensor” sequence which is an aptamer sequence that binds to a ligand and an “output” sequence which is referred to by Schmidt et al. as the actuator domain which encodes a gene modulation switch activity (Schmidt et al., pages 2-3). Schmidt et al. teaches that the aptamer and actuator domains are connected with a “linker sequence” in such a way that the secondary structure of the sensor domain affects the secondary structure of the actuator domain (Schmidt et al., page 3). More specifically, Schmidt et l. teaches that binding of the ligand to the aptamer stabilizes the ligand-bound conformation of the aptamer and thus the conformation of the gene regulatory element associated with that aptamer conformation (Schmidt et al., page 3). Schmidt et al. teaches that for gene expression “on” switches, ligand binding stabilizes a conformation that results in increased gene expression from the actuator whereas for “off” switches, ligand binding stabilizes a conformation that results in decreased gene expression (Schmidt et al., pages 3-4). More specifically, Schmidt et al. teaches that linker sequences are selected based on their ability to form a set of structures with desired folding patterns and provides an example where sequences are identified that can adopt two structures, one in which the aptamer domain is not in the correct conformation for ligand binding and the RBS is obstructed and a second structure with inverse properties which exhibits correct conformation for ligand binding and an unobstructed RBS (Schmidt et al., page 4). Schmidt et al. provides a diagram of this type of biosensor in Figure 1, which is reproduced below.
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In this example, it can be seen that the aptamer portion depicted as “A” has a structure which forms a hairpin loop comprises a 5’ stem sequence, the ligand binding sequence of the aptamer, and a 3’ reverse complement stem sequence which can bind to the 5’ stem sequence, and the actuator portion also comprises a hairpin loop structure connected to the actuator subsequence which comprises 5’-3’ a sequence that can form a stem sequence, a loop sequence, a 3’ sequence that can also form a stem sequence and the output sequence/actuator sequence comprising the ribosome binding site (Schmidt et al., Figure 1). The RNA sequence also includes a “connecting” sequence between the aptamer and the actuator. In the “off” state, a portion of the sequence 3’ of the ligand binding site of the aptamer is the reverse complement of a portion of 5’ stem sequence of the aptamer, and in the “on” state, a portion of the sequence 3’ of the aptamer ligand binding site is a reverse complement of a portion of the sequence 5’ to the actuator subsequence (Schmidt et al., Figure 1). While Schmidt et al. does not use the same phrases to describe the sequences between the aptamer ligand binding site and the actuator ribosome binding site, the functional properties of the nucleotides in this region appear to correspond to sequences identified as 3’ stem target sequence, linker sequence, and linker target sequence. It is also noted that in total, the sequence between the aptamer ligand binding site and the actuator ribosome binding site is between 15-16 nucleotides depending on the “off” or “on” state of the RNA and individual elements which participate in forming a stem structure in the “off” or “on” state are between 2-4 nucleotides in length which appears to correspond to lengths recited in instant claim 8. It is also noted that pairing between RNA sequence and reverse complement of an RNA sequence forms an RNA duplex which is inherently helical in structure, i.e. forms an RNA helix. Thus, by teaching all the limitations of the claims as written, Schmidt et al. anticipates the instant invention as claimed.
Claims 1, 3, 8, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chau et al. (2020) Int. J. Mol. Sci., Vol. 21, 3192; doi:10.3390/ijms21093192, pages 1-20.
Chau et al. teaches a biosensor which is an RNA riboswitch comprising a sensory domain such as an aptamer and regulatory domain such an expression domain, which the binding of a ligand to the aptamer causes a conformational change that triggers a desired readout from the expression platform (Chau et al., pages 1-3). Chau et al. teaches that the binding of a metabolite to the aptamer leads to a shift in the structure of the expression platform which activates or represses the expression of a gene typically through accessibility of ribosomes to a ribosome binding site and start codon in the expression platform (Chau et al., page 3). Chau et al. identifies a number of different aptamers which bind to various ligands such s theophylline, L-lysine, and guanine (Chau et al., page 10, Table I). Chau et al. provides an example of a riboswitch which when bound to ligand represses the expression of a gene which is depicted in Figure 1A reproduced below (Chau et al., page 4, Figure 1A).
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Chau et al. depicts an RNA riboswitch comprising an aptamer domain which in the “on” position comprises a 5’ overhang sequence and aptamer ligand binding sequence which comprises two stem loop formations each comprising stem sequence and stem target sequence where the stem target sequence is a reverse complement of at least a portion of the stem target sequence and a 3’ sequence connected to an expression platform which in the “on” position comprises a sequence which forms a hairpin loop which allows access to the ribosome binding site (Chau et al., page 4, Figure 1A). In the “off” position, the sequence 3’ of the aptamer ligand binding site forms a stem structure with the 5’ overhang and the formation of a different hairpin loop structure in the output domain which blocks access to the ribosome binding site (Chau et al., Figure 1A). From the diagram, it is clear that the 5’ overhang of sensor domain comprises a portion which is the reverse complement of sequence 3’ to the aptamer binding site and 5’ to the ribosome binding site which appears to correspond to the “overhang target sequence” of the output domain as recited in the instant claims. It is further noted that a portion of the 5’ overhang can also be considered as a stem sequence which hybridizes and forms a stem structure with sequence 5’ of the output expression sequence which is the reverse complement of the stem sequence and appears to correspond to stem target sequence. From Figure 1A, the 5’ sequence of the sensor which when in the “off” position hybridizes with sequence 5’ of the output sequence comprising the ribosome binding site is 9 nucleotides in length, and as it encompasses sequence which can be considered overhang sequence or portions of overhang sequence and stem sequence, this 9 nucleotide sequence meets the limitation of instant claim 8. Thus, by teaching all the limitations of the claims as written, Chau et al. anticipates the instant invention as claimed.
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.
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 26-28 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. (2019) Cold Spring Harbor Perspect Biol, Vol. 11:032532; doi:10.1101/ cshperpect.a032532, pages 1-13, in view of Litke et al. (2019) Nat. Biotech., Vol. 37, 667-675.
Schmidt et al. teaches a conformational/kinetic RNA biosensor which is an RNA bioswitch which comprises a “sensor” sequence which is an aptamer sequence that binds to a ligand and an “output” sequence which is referred to by Schmidt et al. as the actuator domain which encodes a gene modulation switch activity (Schmidt et al., pages 2-3). Schmidt et al. teaches that the aptamer and actuator domains are connected with a “linker sequence” in such a way that the secondary structure of the sensor domain affects the secondary structure of the actuator domain (Schmidt et al., page 3). More specifically, Schmidt et l. teaches that binding of the ligand to the aptamer stabilizes the ligand-bound conformation of the aptamer and thus the conformation of the gene regulatory element associated with that aptamer conformation (Schmidt et al., page 3). Schmidt et al. teaches that for gene expression “on” switches, ligand binding stabilizes a conformation that results in increased gene expression from the actuator whereas for “off” switches, ligand binding stabilizes a conformation that results in decreased gene expression (Schmidt et al., pages 3-4). More specifically, Schmidt et al. teaches that linker sequences are selected based on their ability to form a set of structures with desired folding patterns and provides an example where sequences are identified that can adopt two structures, one in which the aptamer domain is not in the correct conformation for ligand binding and the RBS is obstructed and a second structure with inverse properties which exhibits correct conformation for ligand binding and an unobstructed RBS (Schmidt et al., page 4). Schmidt et al. provides a diagram of this type of biosensor in Figure 1, which is reproduced below.
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In this example, it can be seen that the aptamer portion depicted as “A” has a structure which forms a hairpin loop comprises a 5’ stem sequence, the ligand binding sequence of the aptamer, and a 3’ reverse complement stem sequence which can bind to the 5’ stem sequence, and the actuator portion also comprises a hairpin loop structure connected to the actuator subsequence which comprises 5’-3’ a sequence that can form a stem sequence, a loop sequence, a 3’ sequence that can also form a stem sequence and the output sequence/actuator sequence comprising the ribosome binding site (Schmidt et al., Figure 1). The RNA sequence also includes a “connecting” sequence between the aptamer and the actuator. In the “off” state, a portion of the sequence 3’ of the ligand binding site of the aptamer is the reverse complement of a portion of 5’ stem sequence of the aptamer, and in the “on” state, a portion of the sequence 3’ of the aptamer ligand binding site is a reverse complement of a portion of the sequence 5’ to the actuator subsequence (Schmidt et al., Figure 1). While Schmidt et al. does not use the same phrases to describe the sequences between the aptamer ligand binding site and the actuator ribosome binding site, the functional properties of the nucleotides in this region appear to correspond to sequences identified as 3’ stem target sequence, linker sequence, and linker target sequence.
Schmidt et al. differs from the instant products of claims 26-28 and 35 in the Schmidt et al. does not specifically teach how to make their described RNA bioswitch. Litke et al. supplements Schmidt et al. by teaching DNA constructs for generating an RNA bioswitch. Litke et al. teaches a method of producing RNA aptamers and RNA-based biosensors at high levels in mammalian cells comprising generating a DNA plasmid encoding the RNA device under operative control of a U6 promoter in HEK293T cells and other mammalian cells (Litke et al., pages 698-670). Litke et al. transfected cells with the plasmid and demonstrated production of RNA comprising diverse RNA aptamer sequences with functional folded conformations (Litke et al., page 698 and 670). Note that mammalian cells inherently comprise the machinery for generating RNA from DNA, including RNA polymerase and NTPs sufficient to facilitate synthesis of the RNA as evidenced by the generation of encoded RNA aptamer devices from cells transfected with plasmid encoding the RNA. Thus, the transfected cell is a system comprising a vector encoding an RNA device which comprises an RNA polymerase and NTPs.
Therefore, in view of the detailed teachings of Litke et al. for methods of generating high levels of an RNA device such as an RNA biosensor in a mammalian cell using a plasmid vector, and the further motivation provided by Litke et al. to use such as system to generate RNA devices since the cells produced RNA with functional folded conformations, it would have been prima facie obvious to the skilled artisan at the time of filing to utilize the methods of Litke et al. to produce RNA biosensor riboswitches of Schmidt et al. which include the production of a DNA plasmid encoding the RNA riboswitch under operative control of a U6 promoter, and transfecting mammalian cells with the vector in order to produce large amounts of the RNA riboswitch in the cell with a reasonable expectation of success.
Claims 1, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. (2019) Cold Spring Harbor Perspect Biol, Vol. 11:032532; doi:10.1101/ cshperpect.a032532, pages 1-13, in view of Garst et al. (2011) Cold Spring Harbor Perspect Biol, Vol. 3:a003533; doi:10.1101/cshperspect.a003533, pages 1-15, and Wickiser et al. (2005) Mol. Cell., Vol. 18, 49-60.
Schmidt et al. teaches a conformational/kinetic RNA biosensor which is an RNA bioswitch which comprises a “sensor” sequence which is an aptamer sequence that binds to a ligand and an “output” sequence which is referred to by Schmidt et al. as the actuator domain which encodes a gene modulation switch activity (Schmidt et al., pages 2-3). Schmidt et al. teaches that the aptamer and actuator domains are connected with a “linker sequence” in such a way that the secondary structure of the sensor domain affects the secondary structure of the actuator domain (Schmidt et al., page 3). More specifically, Schmidt et l. teaches that binding of the ligand to the aptamer stabilizes the ligand-bound conformation of the aptamer and thus the conformation of the gene regulatory element associated with that aptamer conformation (Schmidt et al., page 3). Schmidt et al. teaches that for gene expression “on” switches, ligand binding stabilizes a conformation that results in increased gene expression from the actuator whereas for “off” switches, ligand binding stabilizes a conformation that results in decreased gene expression (Schmidt et al., pages 3-4). More specifically, Schmidt et al. teaches that linker sequences are selected based on their ability to form a set of structures with desired folding patterns and provides an example where sequences are identified that can adopt two structures, one in which the aptamer domain is not in the correct conformation for ligand binding and the RBS is obstructed and a second structure with inverse properties which exhibits correct conformation for ligand binding and an unobstructed RBS (Schmidt et al., page 4). Schmidt et al. provides a diagram of this type of biosensor in Figure 1, which is reproduced below.
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In this example, it can be seen that the aptamer portion depicted as “A” has a structure which forms a hairpin loop comprises a 5’ stem sequence, the ligand binding sequence of the aptamer, and a 3’ reverse complement stem sequence which can bind to the 5’ stem sequence, and the actuator portion also comprises a hairpin loop structure connected to the actuator subsequence which comprises 5’-3’ a sequence that can form a stem sequence, a loop sequence, a 3’ sequence that can also form a stem sequence and the output sequence/actuator sequence comprising the ribosome binding site (Schmidt et al., Figure 1). The RNA sequence also includes a “connecting” sequence between the aptamer and the actuator. In the “off” state, a portion of the sequence 3’ of the ligand binding site of the aptamer is the reverse complement of a portion of 5’ stem sequence of the aptamer, and in the “on” state, a portion of the sequence 3’ of the aptamer ligand binding site is a reverse complement of a portion of the sequence 5’ to the actuator subsequence (Schmidt et al., Figure 1). While Schmidt et al. does not use the same phrases to describe the sequences between the aptamer ligand binding site and the actuator ribosome binding site, the functional properties of the nucleotides in this region appear to correspond to sequences identified as 3’ stem target sequence, linker sequence, and linker target sequence.
Schmidt et al. differs from the instant products of claims 9 and 11 by not teaching to further include a “timer” domain which is between the aptamer domain and the “linker sequence” of the sensor domain, and where the timer domain comprises at least one transcriptional pause sequence. Garst et al. supplements Schmidt et al. by teaching that many riboswitches are kinetically controlled in that the time it takes for the aptamer portion of the RNA to bind its ligand during transcription affects the ability of the riboswitch to achieve and maintain a conformational state conducive to ligand binding and effectively regulate gene expression (Garst et al., pages 8 -9). Garst et al. teaches that the kinetics of ligand binding is slower than rate of transcription this limits the amount of riboswitch which can bind to ligand present at a particular concentration (Garst et al., page 9). Garst et al. teaches that the presence of one or more transcriptional pause sequences following the aptamer sequence can pause transcription and increase the time available for folding and ligand binding (Garst et al., page 9). Garst et al. teaches that the use of such transcriptional pause sequences in riboswitches may provide an important mechanism for tuning the response range of a riboswitch to ligand concentrations relevant for the cell (Garst et al., page 9). Wickiser et al. further supplements Gast et al. by teaching two transcriptional pause sequence, where the first transcriptional pause sequence PA is located 3’ of the aptamer and 5’ of the sequence comprising the terminator (the output sequence) (Wickiser et al., page 54, Figure 3A). The PA pause site is 12 nucleotides in length, which is less than 150 nucleotides as required by instant claim 9.
Therefore, in view of the teachings and motivation provided by Garst et al. to include a transcriptional pause sequence in a riboswitch in order to pause transcription at a point after transcription of the aptamer domain in order to compensate for slow kinetics of ligand binding, and the teachings of Wickiser et al. for a transcriptional pause sequence located between the aptamer sequence and the “output” sequence, it would have been prima facie obvious to the skilled artisan at the time of filing to include a transcriptional pause sequence such as the PA sequence disclosed by Wickiser in the riboswitches taught by Schmidt et al., where the PA sequence is placed after the aptamer sequence and before the output sequence, including before a sequence which is a “linker sequence”, with a reasonable expectation of success.
No claims are allowed.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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