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 .
DETAILED ACTION
Claims 1-26 are currently pending in the instant application and are subject to a lack of unity requirement.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
WHEN CLAIMS ARE DIRECTED TO MULTIPLE CATEGORIES OF INVENTIONS
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
1. Group 1: Claims 1-19 are drawn to a method for treating a cancer in a subject in need thereof, the method comprising administering to the subject an effective amount of a first agent that inhibits cellular nucleus export and an effective amount of a second agent that inhibits Protein kinase B (Akt).
Further election of species is required as described below
2. Group 2: Claims 20-26 are drawn to a composition and Kit comprising a first agent that inhibits cellular nucleus export and an effective amount of a second agent that inhibits Protein kinase B (Akt) and one or more pharmaceutically acceptable excipients.. Further election of species is required as described below.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
An international application should relate to only one invention or, if there is more than one invention, the inclusion of those inventions in one international application is only permitted if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1). With respect to a group of inventions claimed in an international application, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The claims herein lack unity of invention under PCT rule 13.1 and 13.2 since, under 37 CFR 1.475(a).
Where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups 1-2 lack unity of invention because even though the inventions of these groups require the technical feature of a first agent that inhibits cellular nucleus export and an effective amount of a second agent that inhibits Protein kinase B (Akt) ,Tthis technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kutok (WO 2017/223422 A1, already of record ) as Kutok discloses a method for treating a cancer in a subject in need thereof, the method comprising administering to the subject an effective amount of a first agent that inhibits cellular nucleus export and an effective amount of a second agent that inhibits Protein kinase B (Akt) (para [0008], the second agent is... an XPO I inhibitor"; para [0052] which is Selinexor (para 0035). As such the instantly combination and treatment of Cancer has been known in the prior art, prior to the effective filing date of the instant application. Under PCT Rule 13.2 this element cannot be a special technical feature since it is shown in the prior art.
As a result, no special technical features exist among the different groups because the inventions in Groups 1-2 fail to make a contribution over the prior art. In conclusion, Groups 1-2 are not so linked by the same or a corresponding special technical feature as to form a single general inventive concept, and therefore, restriction for examination purposes as indicated is proper.
Election of species
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1. Applicant is required to elect single disclosed specie from each of the election of specie requirement detailed below.
1. Specie Election 1: This specie election is required upon electing any of the Groups 1-2 set forth in the above restriction.
Applicant is required to specify a single disclosed specie of the first agent that inhibits cellular nucleus export , for e.g. Selinexor and an effective amount of a second agent that inhibits Protein kinase B (Akt) such as Ipatasertib . Claims 1-26 are generic to this specie
During a telephone conversation with Bernard Brown on 02/04/2026 a provisional election was made without traverse to prosecute the invention 1 listed below claim 1-19. Applicants provisional election of the species Selinexor as the first agent and Ipatasertib as the second agent is also acknowledged.
Upon further consideration, the restriction requirement is withdrawn and the entire set of claims 1-26 will be examined.
During the search for the elected specie, PI3K inhibitor Idelalisib was found, therefore the examination was expanded to include the following Idelalisib as the second agent.
Claims 1-26 have been examined to the extent to which they are readable on the elected embodiment and the above identified nonelected species. Since art was found on a nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-26 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/2024 and 04/16/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This patent application is the U.S. national stage entry under 35 U.S.C. $ 371 of International Application Number PCT/US2022/027659, filed May 4, 2022, which claims priority to U.S. Provisional Patent Application No. 63/183,806, filed May 4, 2021.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 8-26 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Kutok (WO 2017/223422, referenced in the instant IDS)
Instant claims are drawn to a method for treating a cancer in a subject in need thereof, the method comprising administering to the subject an effective amount of a first agent that inhibits cellular nucleus export and an effective amount of a second agent that inhibits Protein kinase B (Akt)., wherein the first agent is Selinexor and the second agent is Ipatasertib or Idelalisib.
Kutok a method of treating, managing, or preventing a cancer in a subject. The method comprises administering to the subject a PI3K inhibitor (e.g., one or more PI3K inhibitors), or a pharmaceutically acceptable form thereof, in combination with a second agent (e.g., one or more second therapeutic agents), or pharmaceutically acceptable form thereof. In certain embodiments, the second agent is... an XPO I inhibitor"; [0008] [0051-0052] . They disclose wherein the XPO 1 inhibitor is Selinexor [0035] a and the PI3K inhibitor is a dual inhibitor of PI3K delta/gamma or a P13K inhibitor idelalisib [0056]. [00149] and discloses that Downstream mediators of the PI3K signal transduction pathway Include Akt and mammalian target of rapamycin (mTOR). Kutok further discloses wherein the second agent inhibits Akt via inhibiting a G-protein coupled receptor (GPCR), a phosphoinositide 3-kinase (PI3K), or a combination thereof (para [0035]; para [00156] Kutok discloses a compound described herein that selectively inhibits the gamma isoform over the alpha, beta, or delta isoform para [0095] , Kotok discloses wherein the cancer comprises leukemia, lymphoma, myeloproliferative neoplasms, myelodysplastic syndromes, amyloidosis, Waldenstrom's macroglobulinemia, aplastic anemia, myeloma, or solid cancers [00343] - "In one embodiment, the PI3K inhibitor is Compound 1, the XPO ] inhibitor is Selinexor, and the cancer is acute myeloid leukemia."). Kutok in addition discloses wherein the , the PI3K inhibitor can be administered concurrently with, prior to, or subsequent to, the second agent and they further disclose wherein the second agent is administered to the subject at least 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, or 16 weeks after the PI3K inhibitor (e.g. Compound 1), or a pharmaceutically acceptable form thereof, is administered [0009] [0070] [00524]. Kutok disclose that their P13K inhibitor idelalisib is used at a dosage of 150 mg BID [0066-0068] , and the first agent is administered at a dosage of 5-200 mg/day and the second agent can be administered to a patient in doses ranging from 0.001 to 100 mg/kg of body weight per day or per week in single or divided doses, or by continuous infusion [00526] [00575]. They disclose that the PI3K inhibitor and the second therapeutic agent can be present in a single dose form, or as two or more dose forms [0008] and that the subject is a mammal [0042]. Kutok further discloses composition and formulations comprising the PI3K inhibitor and the second agent which is an XPO I inhibitor such as Selinexor (section 4 page 110-126) which is formulated for administration to a subject , with a pharmaceutically acceptable excipients like carriers, lubricants, antioxidants, wetting agents etc, [00527-00528] [00539-00572]. They disclose the dosage wherein the first agent is administered at a dosage of 5-200 mg/day and the second agent can be administered to a patient in doses ranging from 0.001 to 100 mg/kg of body weight per day or per week in single or divided doses, or by continuous infusion [00526] [00575]. Kutok also discloses Kits which includes the pharmaceutical composition of the first and the second agent as previously disclosed, in suitable packageing and written materials that can include instructions for use, discussion of clinical setting, listing of side effects and the like [00581] (section 6. Kits, pages 126-128).
With regards to instant claim 16-19 and 25 these limitations are functional limitations of the combination when administered to the subject and will inherently occur absence of evidence to the contrary. Kutok explicitly discloses the instantly claimed combination of a exportin 1 inhibitor Selinexor with the PI3K inhibitor Idelalisib , administered to the same subject population which are cancer patients. As such the functional aspects claimed in claims 16-19 will inherently occur upon following the method of Kutok. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Therefore the method disclosed by Kutok. fully anticipates instant claims 1-5 and 8-26.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 6-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Kutok (WO 2017/223422, referenced in the instant IDS) as it applies to claims 1-5 and 19-26 rejected in the anticipation rejection above, further in view of Janku et al. (Nature Reviews, Clinical oncology, Volume 15, May 2018, pages 273-291) and Lenavski et al. (Science Advances, 2021;7, pages 1-16, 19th February 2021, referenced in the IDS).
The teachings of Kutok et al. is reiterated below:
Kutok a method of treating, managing, or preventing a cancer in a subject. The method comprises administering to the subject a PI3K inhibitor (e.g., one or more PI3K inhibitors), or a pharmaceutically acceptable form thereof, in combination with a second agent (e.g., one or more second therapeutic agents), or pharmaceutically acceptable form thereof. In certain embodiments, the second agent is... an XPO I inhibitor"; [0008] [0051-0052] . They disclose wherein the XPO 1 inhibitor is Selinexor [0035] a and the PI3K inhibitor is a dual inhibitor of PI3K delta/gamma or a P13K inhibitor idelalisib [0056]. [00149] and discloses that Downstream mediators of the PI3K signal transduction pathway Include Akt and mammalian target of rapamycin (mTOR). Kutok further discloses wherein the second agent inhibits Akt via inhibiting a G-protein coupled receptor (GPCR), a phosphoinositide 3-kinase (PI3K), or a combination thereof (para [0035]; para [00156] Kutok discloses a compound described herein that selectively inhibits the gamma isoform over the alpha, beta, or delta isoform para [0095] , Kotok discloses wherein the cancer comprises leukemia, lymphoma, myeloproliferative neoplasms, myelodysplastic syndromes, amyloidosis, Waldenstrom's macroglobulinemia, aplastic anemia, myeloma, or solid cancers [00343] - "In one embodiment, the PI3K inhibitor is Compound 1, the XPO ] inhibitor is Selinexor, and the cancer is acute myeloid leukemia."). Kutok in addition discloses wherein the , the PI3K inhibitor can be administered concurrently with, prior to, or subsequent to, the second agent and they further disclose wherein the second agent is administered to the subject at least 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, or 16 weeks after the PI3K inhibitor (e.g. Compound 1), or a pharmaceutically acceptable form thereof, is administered [0009] [0070] [00524]. Kutok disclose that their P13K inhibitor idelalisib is used at a dosage of 150 mg BID [0066-0068] , and the first agent is administered at a dosage of 5-200 mg/day and the second agent can be administered to a patient in doses ranging from 0.001 to 100 mg/kg of body weight per day or per week in single or divided doses, or by continuous infusion [00526] [00575]. They disclose that the PI3K inhibitor and the second therapeutic agent can be present in a single dose form, or as two or more dose forms [0008] and that the subject is a mammal [0042]. Kutok further discloses composition and formulations comprising the PI3K inhibitor and the second agent which is an XPO I inhibitor such as Selinexor (section 4 page 110-126) which is formulated for administration to a subject , with a pharmaceutically acceptable excipients like carriers, lubricants, antioxidants, wetting agents etc, [00527-00528] [00539-00572]. They disclose the dosage wherein the first agent is administered at a dosage of 5-200 mg/day and the second agent can be administered to a patient in doses ranging from 0.001 to 100 mg/kg of body weight per day or per week in single or divided doses, or by continuous infusion [00526] [00575]. Kutok also discloses Kits which includes the pharmaceutical composition of the first and the second agent as previously disclosed, in suitable packageing and written materials that can include instructions for use, discussion of clinical setting, listing of side effects and the like [00581] (section 6. Kits, pages 126-128).
With regards to instant claims 16-19 and 25 these limitations are functional limitations of the combination when administered to the subject and will inherently occur absence of evidence to the contrary. Kutok explicitly discloses the instantly claimed combination of a exportin 1 inhibitor Selinexor with the PI3K inhibitor Idelalisib , administered to the same subject population which are cancer patients. As such the functional aspects claimed in claims 16-19 will inherently occur upon following the method of Kutok. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Kotuk does not teach the instantly claimed second agent which is Ipatasertib.
However, Idellalisib and ipatasertib are both categorized as P13K/AKT pathway at different levels of the pathway.
Janku et al. discloses that The PI3K–AKT–mTOR pathway is one of the most frequently dysregulated pathways in cancer and, consequently, more than 40 compounds that target key components of this signaling network have been tested in clinical trials involving patients with a range of different cancers (abstract). They disclose that this pathway controls key cellular processes, such as metabolism, motility, growth, and proliferation, that support the survival, expansion and dissemination of cancer cells7; the pathway can be aberrantly activated in these cells through multiple mechanisms, including diverse genomic alterations involving PIK3CA, PIK3R1, PTEN, AKT, TSC1, TSC2, LKB1 (also known as STK11), MTOR, and other oncogenes or tumor suppressor genes8–18 (FIG. 1) and these alterations are frequently detected in a range of tumor types (Table 1). They disclose Idelalisib as the PI3K inhibitor and ipatasertib as he Akt inhibitor both acting on the same pathway (See under PI3Kδ inhibitors, and AKT inhibitors, page 286-287), It is noted that The PI3K/AKT pathway is a crucial intracellular cascade regulating cell survival, proliferation, and growth. Activated by growth factors, Phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) produces PIP3 at the membrane, which recruits and activates Akt (protein kinase B) and as such are targeted therapies designed to block the PI3K/Akt/mTOR pathway.
Further . lanevski discloses treating AML with a combination therapy including Ipatasertib (pg 3, col 1, para 2 col 2, para 1 "The predictive approach also identified the ruboxistaurin-ipataserib combination as synergistic in all but one sample (in the refractory AML3 sample, the combination was additive with ZIP = 2.3). This combination is likely to target multiple monotherapy-resistant AML subclones, as co- inhibition of protein kinase C (PKC) and AKT promotes blast cell death by down-regulation of antiapoptotic Bcl-2 family proteins in leukemic cells"). Since Infinity discloses treating AML using a combination therapy including an AKT inhibitor, and lanevski discloses treating AML with a combination therapy including the AKT inhibitor Ipatasertib.
it would have been obvious to one of ordinary skill in the art to modify the method, as disclosed by Infinity, to include or instead use Ipatasertib, since this would simply afford the use of an alternative AKT inhibitor, affording any improved performance of the combination therapy, and therefore any improved clinical outcome when used to treat a cancer patient, such as a patient with AML. Moreover, both Selinexor and Ipatasertib are individually known in the art as agents for treating cancer specifically acute myeloid leukemia, whose efficacy when administered alone is well established for the treatment of a large number of neoplasias and metastasis. It is generally obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. In re Kerkhoven, 205 U.S.P.Q. 1069 (CCPA 1980). The idea for combining said compositions flows logically from their having been individually taught in the prior art. In re Crockett, 126 U.S.P.Q. 186, 188 (CCPA 1960). Accordingly, to establish obviousness in such fact situations it is NOT necessary that the motivation come explicitly from the reference itself (although the Examiner believes it does, as discussed supra). The natural presumption that two individually known anticancer agents would, when combined, provide a third composition also useful for treating cancer flows logically from each having been individually taught in the prior art. Applicant has presented no evidence (e.g. unexpected results) to rebut this natural presumption. Further, it is clear from the prior art that Ipatasertib potentiates the antitumor effect of other chemotherapeutic agents.
An ordinarily skilled artisan would also be motivated from Janku et al. to utilize other Ipatasertib instead of Idelalisib as they both act on the in the PI3K/AKT in their treatment of cancer. The two agents both acting on the same pathway can be considered equivalents . Substituting equivalents, namely PI3K/ALT inhibitors , motivated by the reasonable expectation that the respective species will behave in a comparable manner or even provide comparable results in related circumstances, see In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) is prima facie obvious. Moreover, the express suggestion to substitute one equivalent for another need not be present to render the substitution obvious, see In re Font 213 USPQ 532
As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating all cancer with the instantly claimed combination, absence of evidence to the contrary.
Conclusion
Claims 1-26 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691