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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/11/2025 has been entered.
Claims Status
The amendments and remarks filed 09/11/2025 are acknowledged.
Claim 1 is amended.
Claims 2-8, 11-13, 15-17, 19-21, and 24-25 are canceled.
Claims 1, 9-10, 14, 18, and 22-23 are pending and under examination.
Withdrawn
The objections to the drawings are withdrawn. Applicant has submitted replacement drawings to overcome the objections.
The objection to claim 1 is withdrawn. Applicant has amended the claim to overcome the objection.
The previous rejections of claims 1, 9-10, 14, 18, and 22-23 under 35 U.S.C. 103 are withdrawn. Applicant has amended claim 1 to require that the pharmaceutical composition comprises no salt selected from the group consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, and calcium sulfate. However, upon further consideration, a new grounds of rejection is made in view of Goklen (US 20170174721; instant PTO-892). See below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/09/2025 and 05/02/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 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.
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, 9-10, 14, 18, and 22-23 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 the limitation “the pharmaceutical composition contains no salt selected from the group consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, and calcium sulfate.” The language of “contains no salt selected from the group consisting of” makes it unclear if only one of the listed salts must be absent from the composition or if all of the listed salts must be absent from the composition. Therefore, the scope of the claim is indefinite.
Claims 9-10, 14, 18, and 22-23, which depend from claim 1, are therefore indefinite for the reasons.
Note: If Applicant intended to limit the claim to mean that all of the listed salts must be absent from the composition, the Examiner recommends amending the claim to recite “the pharmaceutical composition contains no sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, and calcium sulfate” to overcome the rejection.
Claim Interpretation
In view of the rejection under 112(b) above, the Examiner is interpreting claim 1 to mean that all of the listed salts must be absent from the composition.
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 rejection has been modified solely to address the amendment to claim 1 requiring that the pharmaceutical composition comprise no salt selected from the group consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, and calcium sulfate.
Claims 1, 9-10, 14, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Fujino (WO 2015099175; 02/23/2024 PTO-892), Gillies (WO200279415; 08/14/2024 PTO-892), Presta (US 5,869,046; 08/14/2024 PTO-892), Janeway et al., 2001 (08/14/2024 PTO-892), Goklen (US 20170174721; instant PTO-892), Qi et al., 2008 (02/23/2024 PTO-892) and Lam (US 6,171,586; 02/23/2024 PTO-892).
Regarding claims 1, 9-10, 14, 18, and 22, Fujino teaches human anti-IL-33 neutralizing monoclonal antibodies [0001] and teaches a specific antibody clone named A10-1C04, which is disclosed as having the CDRs of C1 [0124], and C1 is disclosed as having an LCDR1 of SEQ ID NO: 1, an LCDR2 of SEQ ID NO: 11, an LCDR3 of SEQ ID NO:22, an HCDR1 of SEQ ID NO: 43, an HCDR2 of SEQ ID NO: 51, and an HCDR1 of SEQ ID NO: 65 [0011, Table 1].
SEQ ID NOs: 1, 11, 22, 43, 51, and 65 of Fujino have 100% sequence identity to SEQ ID NOs: 14-16 and 11-13 of the instant claim, respectively.
Further, Fujino teaches that the heavy chain and light chain variable regions of clone A10-1C04 is V1 [0124], which is disclosed as having SEQ ID NO: 105 for the heavy chain variable region and SEQ ID NO: 79 for the light chain variable region [0011, Table 2].
SEQ ID NO: 105 has 100% sequence identity to SEQ ID NO: 38 of the instant specification, and SEQ ID NO: 79 has 100% sequence identity to SEQ ID NO: 39 of the instant specification.
Fujino also teaches a composition comprising a monoclonal antibody of the invention [0099] and that the monoclonal antibodies can be separated and purified by any separation and purification method used in conventional proteins [0070].
However, Fujino does not specifically teach that the antibody heavy chain comprises SEQ ID NO: 1 and the antibody light chain comprises SEQ ID NO: 2, and also does not explicitly teach a specific formulation of the pharmaceutical composition comprising the antibody wherein the composition contains no salt, specifically no sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, and calcium sulfate, and contains specific concentrations of histidine, sorbitol, and polysorbate 80 at a specific pH.
It is noted that residues 1-116 of SEQ ID NO: 1 correspond to SEQ ID NO: 38 of the instant specification and residues 1-110 of SEQ ID NO: 2 correspond to SEQ ID NO: 39 of the instant invention. SEQ ID NOs: 38 and 39 are taught above by Fujino.
Gillies teaches SEQ ID NO: 1, which is disclosed as a human IgG1 heavy chain Fc region [see pages 1, and 50-51].
SEQ ID NO: 1 of Gillies has 100% sequence identity to residues 117-446 of SEQ ID NO: 1 of the instant claim.
Presta teaches SEQ ID NO: 9, which is disclosed as the human lambda CL domain [see column 3, lines 51-52, and columns 57-58].
SEQ ID NO: 9 of Presta has 100% sequence identity to residues 111-215 of SEQ ID NO: 2 of the instant claim.
Janeway teaches that immunoglobulin heavy and light chains are composed of constant and variable regions [page 2, last paragraph – page 3, first-second paragraphs] and that the constant region determine the isotype, thus determining their functional properties [page 5, last paragraph – page 6, first paragraph].
Goklen teaches a multi component buffer system for the purification of proteins by a series of chromatography steps, comprising an organic acid, an alkaline metal or ammonium salt of the conjugate of the organic acid, and an organic base and wherein the modes of chromatography are performed using buffers that are made without the addition of NaCl [0003]. Goklen further teaches that this purification method using sodium acetate for the chromatography steps, along with acetic acid and tris base, offers advantages for monoclonal antibodies, including increasing ionic strength, maintaining constant pH through step changes, and avoiding pH transients that can lead to a loss of impurity clearance and step performance [0016]. Goklen also teaches that the elimination of sodium chloride ensures that the corrosive impact of high concentration chloride solutions on stainless steel processing equipment is managed and avoided all together [0016].
The purification method is described as using sodium acetate, acetic acid, and tris base, and therefore, meets the limitation of claim 1 in that the purified antibody contains none of the listed salts.
Qi teaches an antibody formulation comprising 100 mg/mL of an IgG protein (active ingredient) in a histidine, sorbitol (saccharide, sugar alcohol), and polysorbate 80 (nonionic surfactant), with a pH 5.5 solution [page 3120, left column, fifth paragraph].
The formulation is listed as not containing salt; therefore it meets the limitation of claim 1 in that it contains none of the listed salts.
Lam teaches a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, a buffer maintaining the pH in the range from about 4.5 to about 6.0, a surfactant, and a polyol [see Abstract]. Lam further teaches that the buffer can be histidine at a concentration of about 1 mM to about 50 mM, preferably from about 5 mM to about 30 mM [column 22, second paragraph], that the surfactant can be polysorbate 80, present in the formulation in an amount from about 0.001% to about 0.5% (w/v) [column 22, fourth paragraph], and the polyol can be sorbitol [column 6, sixth paragraph] with a suitable concentration of about 1% to about 15% w/v [column 22, third paragraph]. Lam further teaches that the therapeutically effective amount of antibody present in the formulation is determined by taking into account the desired dose volumes and dose of administration, with an exemplary antibody concentration in the formulation being from about 0.1 mg/mL to about 50 mg/mL [column 22, first paragraph], but that the appropriate dosage will depend on the condition to be treated, the severity and course of the condition, why the antibody is being administered, the patient’s clinical history, and response to the antibody, and other dosage regimens can be useful [column 23, fifth paragraph – sixth paragraph]. Lam also teaches that the formulation is prepared comprising the antibody in a pH-buffered solution, where the pH can range from about 4.5 to about 6.0, and histidine can control the pH within this range [column 22, second paragraph]. Lam further teaches that the formulation can be administered by way of known methods, inclusive of subcutaneous and intravenous administration [column 23, fourth paragraph] and also teaches that the formulation does not contain a tonicifying amount of a salt, such as sodium chloride, as it may cause the antibody to precipitate and/or may result in oxidation at a low pH [column 22, third paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heavy chain (i.e. residues 1-116 of instant SEQ ID NO: 1) and light chain variable regions (i.e. residues 1-110 of instant SEQ ID NO: 2) of clone A10-1C04 is V1, as taught by Fujino, to further comprise the human IgG1 heavy chain Fc region (i.e. residues 117-446 of instant SEQ ID NO: 1), as taught by Gillies, and the human lambda CL domain (i.e. residues 111-215 of instant SEQ ID NO: 2), as taught by Presta, to arrive at the heavy chain of SEQ ID NO: 1 and the light chain of SEQ ID NO: 2 as instantly claimed. One would have been motivated to make this modification because Janeway taches that immunoglobulin heavy and light chains are composed of both constant and variable regions, and the constant regions determine the antibodies functional properties. Thus, this is a known structure for an antibody.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically purified the antibody of Fujino using the purification process taught by Goklen, thereby obtaining a purified antibody without any of the salts listed in instant claim 1. One would have been motivated to have purified the antibody of Fujino with the process of Goklen because Fujino teaches that the monoclonal antibodies can be separated and purified by any separation and purification method used in conventional proteins, and Goklen teaches that the purification method using sodium acetate for the chromatography steps, along with acetic acid and tris base, offers advantages for monoclonal antibodies, including increasing ionic strength, maintaining constant pH through step changes, and avoiding pH transients that can lead to a loss of impurity clearance and step performance, and that the elimination of sodium chloride ensures that the corrosive impact of high concentration chloride solutions on stainless steel processing equipment is managed and avoided all together.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the antibody as taught by Fujino, Gillies, Presta, Janeway, and Goklen in the pharmaceutical composition of Qi. One would have been motivated to use the pharmaceutical composition of Qi to have formulated a composition comprising the antibody taught by Fujino, Gillies, Presta, Janeway, and Goklen because Qi teaches that this formulation protects IgG antibodies from fragmentation with or without light exposure [page 3125, right column, first paragraph] and that the formulation was stable under normal light exposure encountered during manufacturing and handling [page 3129, left column, second-third paragraphs]. One of skill in the art would have a reasonable expectation that formulating the antibody taught by Fujino, Gillies, Presta, Janeway, and Goklen in the composition of Qi would produce a composition with superior stabilization properties.
It further would have been obvious to optimize the concentrations of the antibody, histidine, sorbitol, and polysorbate 80 of the composition of Qi using the teachings of Lam as a guide. One would have been motivated to optimize the composition to comprise 150 mg/mL of antibody (active ingredient), 10mM histidine, 4% (w/v) sorbitol, 0.02% (w/v) polysorbate 80, and has a pH adjusted to 5.5 to 6.5, because Lam teaches that these formulations are stable for antibody compositions. Further, MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Specifically regarding the concentration of the antibody at 150 mg/mL, as encompassed by claims 1, 10, and 18, it would have been obvious to formulate the composition at this concentration of antibody because Qi teaches a composition with an antibody at 100 mg/mL and Lam teaches that the composition can comprise the antibody in an exemplary range of 0.1 mg/mL to about 50 mg/mL but that the appropriate dosage will depend on the condition to be treated, the severity and course of the condition, why the antibody is being administered, the patient’s clinical history, and response to the antibody, and that other dosage regimens can be useful [column 23, fifth paragraph – sixth paragraph]. A prima facie case of obviousness exists where the claimed ranges do not overlap with the prior art but are merely close (see MPEP 2144.05(I). Therefore, this is recognized as a result effective variable and one of skill in the art would engage in routine optimization to find the best antibody concentration for creating compositions that allow for desired dosing, while also retaining composition stability.
Additionally, regarding the specific concentrations for all of the components of the composition (i.e. antibody, histidine, sorbitol, and polysorbate 80), these are art recognized variables and therefore, one would engage in routine optimization to obtain the desired result of a stable formulation for the composition, thus arriving at these specific concentrations as claimed. See MPEP 2144.05 (II). Further, it is the normal desire of scientists or artisans to improve upon what is already generally known. The MPEP states the following: generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller. 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson. 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc.. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). The determination of specific excipients at specific concentrations in the instant composition requires only routine experimentation for one of ordinary skill in the art. Therefore, given that the excipients and antibody are common to include in the formulation of antibody compositions, as taught in the art above, without specific evidence that the indicated concentrations are critical to the formulation, the identification of these properties will not render the subject matter patentable.
Claims 1, 9-10, 14, 18, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Fujino (WO 2015099175; 02/23/2024 PTO-892) in view of Gillies (WO200279415; 08/14/2024 PTO-892), Presta (US 5,869,046; 08/14/2024 PTO-892), Janeway et al., 2001 (08/14/2024 PTO-892), Goklen (US 20170174721; instant PTO-892), Qi et al., 2008 (02/23/2024 PTO-892) and Lam (US 6,171,586; 02/23/2024 PTO-892), as applied to claims 1, 9-10, 14, 18, and 22 above, and further in view of Terra Universal, 2015 (02/23/2024 PTO-892).
The teachings of Fujino, Gillies, Presta, Janeway, Goklen, Qi, and Lam are above.
However, Fujino, Gillies, Presta, Janeway, Goklen, Qi, and Lam do not teach a lyophilized preparation of the pharmaceutical composition.
Terra Universal teaches that lyophilization, also known as freeze-drying, prevents sample contamination and promotes sample stability [see page 1, first paragraph]. Further, Terra Universal teaches that lyophilization also reduces sample weight and volume, remove the need to store samples on dry ice, as the samples are more stable at room temperature, and that overall lyophilization increases sample stability, purity, and increased shelf life [page 2, fifth paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have lyophilized the pharmaceutical composition, as taught by Fujino, Gillies, Presta, Janeway, Goklen, Qi, and Lam. One would have been motivated to lyophilize the pharmaceutical composition because Terra Universal teaches that lyophilization increases sample stability, purity, and increase shelf life. One of skill in the art would have a reasonable expectation that lyophilizing the antibody formulation of Fujino, Gillies, Presta, Janeway, Goklen, Qi, and Lam would produce a composition with superior stabilization, purity and shelf life. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person' s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Response to Arguments
The previous rejections of claims 1, 9-10, 14, 18, and 22-23 under 35 U.S.C. 103 are withdrawn. However, the arguments are addressed to the extent that they apply to the new rejections under 35 U.S.C. 103 set forth above. On page 10 of the remarks, Applicant argues that the inventors of the present application have discovered that salts are the major cause of clouding in five types of human anti-IL-33 monoclonal antibodies as recited in claim 1, pointing to Example 10 as displayed in Table 8 of the instant specification, and Example 2 as displayed in Table 4 of the specification, stating that compositions containing no NaCl and 10 mM NaCl had no clouding, whereas higher salt concentrations yielded clouding. Applicant further argues that the results support the unexpected results of the inhibition of clouding when no salt is present. This is not found persuasive because, to reiterate what was stated in the Office Action mailed 04/17/2025, Example 10 demonstrates that clouding was inhibited with 10 mM sodium chloride at pH 4 to 6 and clouding was only observed when sodium chloride exceeded 30 mM and Example 2 states that Kd value was negative (aggregation increased) with NaCl addition of 50 mM or greater, suggesting that NaCl addition of less than 50 mM is desirable in the formulation. Thus, the clouding does not appear to be due to the presence of salt (i.e. NaCl), which Applicant claims, but rather clouding is dependent on the specific concentration of NaCl. Applicant’s results explicitly state that there was no clouding when 10 mM NaCl at pH 4 to 6 was present in the formulation and only when sodium chloride exceeded 30 mM was clouding observed. Applicant argues this rebuttal stating that the inventors of the present application have discovered that it is particularly preferable that compositions containing the claimed antibodies “contain substantially no salt” and that even if there is evidence that 10 mM salt can also inhibit clouding, this evidence does not detract from the unexpected effect observed when no salt is present. This is not found persuasive because Applicants claim that it is “preferable” that compositions contain substantially no salt is a matter of routine optimization. The fact that these are variables that are recognized as needing to be optimized (i.e. in order to improve the composition) establishes that these conditions, when adjusted, lead to improved results. Optimizing conditions to obtain improved results is not equivalent to unexpected or unpredictable results. Additionally, the results of the instant application that Applicant relies upon to demonstrate unexpected results are not commensurate in scope with the instant claims. See MPEP 716.02(d). The instant claims are directed to the composition containing no salt selected from the group consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, and calcium sulfate, while the examples of the instant specification only pertain to the addition or absence of sodium chloride.
Further, it is well known in the art that salt causes protein aggregation. Bickel et al., 2016 (instant PTO-892) teaches that protein aggregation of a monoclonal antibody was induced by sodium chloride addition, but that aggregation could be reversed by dilution into salt-free buffer [see Abstract]. Arosio et al., 2012 (instant PTO-892) teaches that salt-induced aggregation of proteins in aqueous solutions is a major problem encountered often in pharmaceutical processes, and the production and purification of therapeutic peptides and proteins include multiple chromatography steps during which the product is exposed to changes in pH and salt concentration, which trigger protein aggregation [page 20, left column, sixth paragraph]. Arosio further teaches that drug formulation must guarantee the absence of even a small percentage of aggregates to avoid immunological reactions in patients, and that optimization of the purification and formulation process is important to eliminate aggregation [page 20, left column, sixth paragraph]. Thus, what Applicant claims as unexpected (i.e. clouding is inhibited in compositions without salt), would have been expected as supported by the art.
Conclusion
No claims are allowed.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675