DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
An amendment filed on 18 February 2026 is acknowledged. Claim 1 is amended, and claims 23-27 are newly canceled. Claims 1, 11, 12, 17, and 28-38 are pending, and claims 1, 11, 12, 17, 23, and 28-38 are examined herein on the merits.
In response to the amendment filed on 18 February 2026, an objection to the claims is added; rejections under 35 U.S.C. 112(a) are added; and rejections over the prior art are changed.
Claim Objections
Claim 1 is objected to because of the following informalities: a semicolon must be added after "Cu2+". Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 11, 12, 17, and 28-38 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The examiner respectfully reminds the Applicant that according to MPEP §2163:
"2163.02. Standard for Determining Compliance with Written Description Requirement:
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”).
Independent claim 1 has been amended to recite the following limitation:
a metal-organic framework structure, wherein the metal-organic framework structure comprises
(i) Cu2+[;]
(ii) a dicarboxylate formed from a dicarboxylic acid selected from the group consisting of:
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; and
(iii) a heteroaromatic ligand that is:
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,
wherein the dicarboxylate formed from the dicarboxylic acid and the heteroaromatic ligand are coordinated to Cu2+.
The original disclosure provides sufficient written description support for a MOF comprising either (i) and (ii) or (i) and (iii).
The recited combination of (ii) and (iii) in the same MOF, wherein the dicarboxylate formed from the dicarboxylic acid and the heteroaromatic ligand are coordinated to Cu2+, does not comply with the written description requirement.
In applicant's remarks filed on 18 February 2026, Applicant states that support for the amendment is found, for example, in paragraph [0053] of the specification. Paragraph [0053] is reproduced below, with added bolding:
In some embodiments, the MOP structure of the invention may include a plurality of different ligands and/or auxiliary counterions. The MOF structure may include multiple different polydentate ligands, as defined herein. For instance, the LIG group may include multiple different LIG groups each independently defined as herein described in relation to the LIG group. For example, the LIG group may be represented as [LIG1]y1[LIG2]y2 . . . [LIGn]yn such that the MOF structure is defined by the Formula [M]x[LIG1]y1[LIG2]y2. . . [LIGn]yn. In such embodiments, y is the sum of the individual ligand stoichiometries, i.e., y=y1+y2+ . . . +yn. The MOF structure may include other auxiliary ligands, such as monodentate ligands and the like. In this manner, the MOF structure may be considered “doped”, so as to affect the structure and/or pore sizes to provide the optimal MOF for a given circumstance.
Also relevant is the following disclosure of paragraph [0057] of the specification:
In some embodiments, the LIG group may include a plurality of different LIG groups. For example, LIG may be represented as [LIG1]y1[LIG2]y2 . . . [LIGn]yn.
The specification's broad original teaching that "The MOF structure may include multiple different polydentate ligands, as defined herein" fails to reasonably convey to the artisan that the inventor had possession at that time of the narrow subject matter claimed on 18 February 2026. The courts have found that a "laundry list" disclosure of every possible moiety for every possible position does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species. See MPEP 2163.05 II and Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996).
The original disclosure provides two distinct embodiments of "electron-deficient bidentate ligand": a dicarboxylic acid ligand of Formula 3 and a heteroaromatic ligand comprising at least two nitrogen atoms of Formula 4. The original disclosure does not disclose a MOF structure that comprises both disclosed categories of electron-deficient bidentate ligand (both a dicarboxylate and a heteroaromatic ligand comprising at least two nitrogen atoms). That is, the original disclosure does not disclose a MOF structure prepared by mixing a ligand of Formula 3 with a ligand of Formula 4.
Regarding claims 1 and 28, the original disclosure does not provide sufficient written description support for the combination of terephthalate (also known as 1,4-benzenedicarboxylate, bdc) and N,N′-di-(4-pyridyl)-1,4,5,8-naphthalenetetracarboxydiimide (DPNDI) in the same MOF.
Regarding claims 1 and 29, the original disclosure does not provide sufficient written description support for the combination of 2,6-naphthalenedicarboxylate and N,N′-di-(4-pyridyl)-1,4,5,8-naphthalenetetracarboxydiimide (DPNDI) in the same MOF.
Regarding claims 1 and 30, the original disclosure does not provide sufficient written description support for the combination of 4,4'-biphenyldicarboxylate and N,N′-di-(4-pyridyl)-1,4,5,8-naphthalenetetracarboxydiimide (DPNDI) in the same MOF.
Regarding claims 1 and 31, the original disclosure does not provide sufficient written description support for the combination of fumarate and N,N′-di-(4-pyridyl)-1,4,5,8-naphthalenetetracarboxydiimide (DPNDI) in the same MOF.
The specification provides working examples of MOFs that comprise DPNDI and Zn2+. No working examples are provided of a MOF that comprises both DPNDI and a dicarboxylate ligand. No working examples are provided of a MOF that comprises Cu2+.
Therefore, the Applicants did not show possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention, by description of an actual reduction to practice, or by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention.
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, 17, and 28-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilmer (US 2013/0139686; newly cited).
Regarding claims 1, 17, and 28-31, Wilmer discloses a device comprising an article (abstract) comprising a solid support comprising a porous material, the porous material being impregnated with an indicator reagent comprising a metal-organic framework structure ("one or more embodiments of the inventive subject matter can be directed to compositions comprising MOFs of the sort disclosed herein…such compositions can be deposited or coated on or otherwise coupled to a substrate such as but not limited to a porous support," [0154]).
Wilmer teaches the following ([0150], bolding added):
The MOFs disclosed herein can be considered in the context of coordination of an inorganic metal center block component with one or more organic linker/ligand block components comprising terminal carboxy (e.g., via coordination with a carboxylate group, such group in the presence of a suitable counter ion such as but not limited to an alkaline or alkaline-earth metal ion) and/or analogous nitrogenous groups, such linker/ligand block components of the sort represented in FIGS. 3A-C.
Accordingly, Wilmer discloses MOFs comprising (i) an inorganic metal center block component, (ii) an organic linker/ligand block component comprising terminal carboxy groups, and (iii) a nitrogen-terminated linker/ligand block component, where (ii) and (iii) are represented in Figs. 3A-3C.
Wilmer's organic linker/ligand block components comprising terminal carboxy groups of Fig. 3A include organic building blocks 6, 7, 15, and 19 (portions of Fig. 3A reproduced below), which are the dicarboxylates formed from the dicarboxylic acids of claims 1 and 32-38. Wilmer's nitrogen-terminated linker/ligand block components of Fig. 3C include N,N′-di-(4-pyridyl)-1,4,5,8-naphthalenetetracarboxydiimide (DPNDI) (portion of Fig. 3C reproduced below).
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Accordingly, Wilmer discloses that the metal-organic framework structure comprises (i) Cu2+ ("Cu2+," [0150]), (ii) a dicarboxylate formed from a dicarboxylic acid selected from the claimed group ([0150], see above), and (iii) the claimed heteroaromatic ligand ([0150], see above), wherein the dicarboxylate formed from the dicarboxylic acid and the heteroaromatic ligand are coordinated to Cu2+ ([0150], see above).
Regarding claims 1, 17, and 28-38, Wilmer is silent as to whether the MOFs produce a detectable color change upon contact with the claimed opioid drug(s).
Regarding product claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP § 2114).
Because Wilmer discloses a metal-organic framework structure comprises the same components and therefore has the same structure as the claimed indicator reagent, it is presumed to be inherent that the MOFs of Wilmer are inherently capable of producing a detectable color change upon contact with the claimed opioid drug(s).
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 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 1, 11, 12, 17, 30, and 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa (JP 2011-256122 A; newly cited) in view of Sui ("Differentiable Detection of Volatile Amines with a Viologen-Derived Metal−Organic Material," ACS Appl. Mater. Interfaces; March 16, 2018; previously cited).
Claim 28 is not rejected under 35 U.S.C. 103 for the reason set forth in the next section.
Regarding claims 1, 17, 30, and 32-38, Kitagawa discloses a device comprising an article comprising an indicator reagent comprising a metal-organic framework structure (abstract), wherein the metal-organic framework structure comprises (i) Cu2+ (claim 3, [0007], [0012]; pages 2, 3, and 7 of translation;
(ii) a dicarboxylate formed from a dicarboxylic acid that is 4,4'-biphenyldicarboxylic acid (page 3 of translation, penultimate para.); and
(iii) the claimed heteroaromatic ligand (fluorogenic organic ligand including a naphthalene diimide moiety that is formula 1, illustrated on page 5 of original document and reproduced below; pages 3 and 5 of translation),
wherein the dicarboxylate formed from the dicarboxylic acid and the heteroaromatic ligand are coordinated to Cu2+ (claims 1 and 4; page 2 of translation, last para.; page 7 of translation).
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It is implicit to the disclosure of Kitagawa that the dicarboxylic acid synthetic precursor forms a dicarboxylate within the MOF, given that Kitagawa teaches that terephthalic acid (H2bdc) is converted to the dicarboxylate bdc in the synthesis of
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([0033]-[0034]; page 5 of translation).
Regarding claims 1, 17, 30, and 32-38, Kitagawa is silent as to whether the MOFs produce a detectable color change upon contact with the claimed opioid drug(s).
Regarding product claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP § 2114).
Because Kitagawa discloses a metal-organic framework structure comprises the same components and therefore has the same structure as the claimed indicator reagent, it is presumed to be inherent that the MOFs of Wilmer are inherently capable of producing a detectable color change upon contact with the claimed opioid drug(s).
Kitagawa discloses a "substrate" (page 4 of translation, seventh para.).
Kitagawa does not disclose a solid support comprising a porous material, the porous material being impregnated with the indicator reagent.
In the analogous art of a MOF sensor on a solid support, Sui discloses a solid support comprising a porous material (cellulose filter paper, Fig. 6; Test Paper Applications, page 11060; Preparation of 1-Paper, page 11061), the porous material being impregnated with an indicator reagent (1-paper, Fig. 6; Test Paper Applications, page 11060) comprising a metal-organic framework structure (1, [Cd2Cl(m-bpybdc)2(H2O)4](NO3)3·7H2O, page 11057, left col.; Fig. 1; Test Paper Applications, page 11060; Preparation of 1-Paper, page 11061), wherein the metal-organic framework structure comprises metal ions (Cd2+ ions, page 11057, left col.) and a plurality of dicarboxylate bidentate ligands [4,4′-bipyridinium-1,1′-bis(phenylene-3-carboxylate) (m-bpybdc), page 11057, left col.] coordinated to the metal ions.
Sui teaches that "1-paper can be easily prepared by spraying an aqueous solution of 1 onto the filter paper" (page 11060, left col., second para.) and that "the chromic process is not easily influenced by external factors such as the paper support" (page 11060, right col., first para.). As illustrated in Fig. 6 of Sui, the porous cellulose filter paper offers a high surface area to volume ratio for sensing.
For the benefit of a providing greater surface area to volume ratio by increasing the availability of MOF particles to the environment, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensor of Kitagawa by replacing the substrate with the (porous) cellulose filter paper taught by Sui, thereby providing a porous material impregnated with MOF.
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. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claim 11, Sui discloses that the solid support is cellulose filter paper (Preparation of 1-Paper, page 11061). The filter paper is comprised of fibers, as illustrated in Figs. 6(b) and 6(c), and cellulose is a polymer of glucose. Accordingly, Sui discloses that the solid support is a polymeric fiber.
Regarding claim 12, Sui discloses that the solid support is porous paper (cellulose filter paper, Fig. 6; Test Paper Applications, page 11060; Preparation of 1-Paper, page 11061).
Examiner's Comment on Claim 28
The declaration of Dr. Kelly Van Houten under 37 CFR 1.132 filed on 22 September 2025 provides sufficient evidence of unexpected results that is commensurate with the scope of claim 28. Accordingly, claim 28 is not rejected under 35 USC 103. The evidence of the declaration is not commensurate with the scope of claims 1, 11, 12, 17, and 29-38. See MPEP 716.02(d).
Claim 28 is rejected under 35 USC 112(a) and 35 USC 102.
Response to Arguments
Applicant's arguments filed on 18 February 2026 have been considered and are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chang (US 2018/0011010) discloses sensor devices comprising MOF materials as sensing components (abstract). Chang teaches that the MOF material can be prepared from precursor solutions comprising Cu(OAc)2 or (Cu(NO3)2∙2.5H2O ([0137]), which contain Cu2+. Regarding organic ligands used in the MOFs, Chang teaches the following ([0134], bolding added):
Exemplary ligands include, but are not limited to, oxalic acid, malonic acid, succinic acid, glutaric acid, phthalic acid, terephthalic acid, citric acid, trimesic acid, benzene-1,3,5-tricarboxylic acid (BTC), 4,6-dioxido-1,3-benzenedicarboxylate (DOBDC), 1,2,3-triazole, pyrrodizaole, squaric acid, 1,4-diazabicyclo[2.2.2]octane) (DABCO), 1,4-naphthalenedicarboxylate (NDC), 3,6-di(pyridin-4-yl)-1,2,4,5-tetrazine (DPTZ), N,N′-di(4-pyridyl)-1,4,5,8-naphthalenediimide (dpNDI), biphenyldicarboxylate, and combinations thereof.
Hupp (US 2009/0178558) discloses mixed-ligand, metal-organic framework (MOF) material having metal ions coordinated to carboxylate ligands and pyridyl ligands (abstract), including Zn(II) coordination to 2,6-naphthalenedicarboxylate (NDC) and N,N′-di-(4-pyridyl)-1,4,5,8-napthalene tetracarboxydiimide (DPNI) (Figs. 1a, 1b; [0011]).
Furukawa ("A block PCP crystal: anisotropic hybridization of porous coordination polymers by face-selective epitaxial growth," Chem. Commun., 2009) discloses porous frameworks of the general formula [M2(dicarboxylate)2(N ligand)]n (Fig. 1a):
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Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE ADAMS whose telephone number is (571)270-5043. The examiner can normally be reached M, T, Th, and F, 12-4 P.M.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE ADAMS/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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