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 .
Priority
This application is a national stage entry of PCT/EP2022/071125 filed on 07/27/2022. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in ITALY on 07/28/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Applicant’s amendment filed on June 26, 2026 amending claim 10 has been entered. Claims 1 and 5 are canceled. Claims 2-4 and 6-10 are currently pending and presented for examination.
Response to Arguments
Due to Applicant’s amendment to claim 10, the previous rejection under 35 USC 112 (b) is hereby withdrawn.
Applicant's arguments filed June 26, 2026 with respect to the rejections under 35 USC 103 have been fully considered but they are not persuasive. Applicant argues that Vita does not teach oral LT4 solutions that are ethanol-free and teaches that ethanol contributes to levothyroxine absorption. Applicant argues that the formulation tested contained ethanol and glycerol, and thus the results are tied to an ethanol-containing oral solution, not to an ethanol-free glycerol solution as presently claimed.
Applicant further argues that Fossati does not cure the deficiencies of Vita because Fossati discloses ethanol-free glycerol solutions of T4 having enhanced stability, including reduced conversion of T4 to undesired species during storage. Thus Applicant argues that Fossati is therefore concerned with the chemical stability of packaged levothyroxine solutions and not with a patient undergoing proton pump inhibitor treatment and whether an ethanol-free solution maintains effective levothyroxine absorption under conditions in which proton pump inhibitor therapy would otherwise be expected to impair absorption.
Thus, Applicant argues that the cited references do not provide a reasoned basis for expecting that replacement of Vita's ethanol-containing formulation with Fossati's ethanol-free glycerol solution would preserve the absorption benefit reported by Vita in patients undergoing orally administered proton pump inhibitor treatment.
These arguments are found not persuasive since Vita does not provide any evidence that the improvements in LT4 solutions are due to the ethanol contained in it for the reasons detailed below.
Vita et al. teaches that an acid gastric pH is required to permit dissolution of LT4 and its arrival in the intestine, where LT4 is absorbed (page 4482). Vita et al. teaches that the dissolution of the LT4 tablet is impaired upon progressive increases in the ambient pH (page 4482). Vita et al. teaches that the intestinal absorption of LT4 can be impaired by beverages, by a number of gastrointestinal diseases or surgical interventions, and by drugs that either physically sequester the hormone or increase the gastric pH (page 4482). Among the most prescribed drugs that interfere with the intestinal absorption of LT4 are the proton-pump inhibitors (PPIs) which increases the gastric pH (page 4482). Thus in view of these teachings, PPIs interfere with the dissolution of the LT4 tablet due to increases in the ambient pH.
Vita states that for the oral solution, LT4 is solubilized in 95% ethanol and 86% glycerol (page 4482 2nd column). Vita further states that LT4 in the oral solution needs no dissolution and, therefore, is absorbed faster than tablet LT4, and consequently, this liquid formulation should be resistant to the interference exerted by drugs or beverages (page 4482 2nd column). Thus Vita teaches that the ethanol is used to solubilize the LT4 and does not teach or suggest that the ethanol has any benefit in terms of the absorption of LT4. Rather, Vita suggests that better absorption is due to the liquid form which needs no dissolution, over the tablet form which requires dissolution, and thus the better absorption would apply to other liquid forms of LT4 due to the form and not what it is solubilized in. Furthermore, Vita merely mentions that another reference may suggest ethanol as a facilitating role but provides no further evidence demonstrating that ethanol has any benefit in terms of absorption.
In fact, the reference referred to by Vita, Cappelli et al. (Cappelli C, Pirola I, Gandossi E, Formenti A, Castellano M. Oral liquid levothyroxine treatment at breakfast: a mistake? Eur J Endocrinol. 2014;170:95–99) merely speculates that their observations may be due to the possible different molecular properties, stability, and absorption of liquid L-T4 compared with the tablet form (see page 97 2nd column). Cappelli et al. hypothesizes that the differences between tablet and liquid LT4 may be due to the increased absorption of the liquid formulation possibly due to the alcohol present or possibly due to the drug being absorbed through the oral mucosa directly into the systemic circulation bypassing the GI tract (pages 97-98). Cappelli et al. further hypothesizes that the differences might be related to the greater stability of liquid formulations compared with tablet formulations (page 98). Cappelli et al. further clearly states that additional studies are needed to clarify these issues. Thus, these teachings do not provide any direct evidence between increased absorption of liquid LT4 and ethanol.
Thus an ordinary skilled artisan can only conclude from the teachings of Vita that PPI-induced LT4 tablet malabsorption is corrected by an oral LT4 solution because the solution needs no dissolution as compared to the tablet. Vita teaches that the data shows that patients in whom tablet LT4 fails to normalize or suppress serum TSH because of the concomitant ingestion of PPI benefit from the switch from the tablet to the oral solution, and that the absorption of LT4 is much better reflecting better pharmacokinetics of the oral solution than of the tablet LT4 (page 4485). One cannot conclude that ethanol contributes to the improved absorption of liquid LT4.
In addition, Fossati is specifically directed to highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, which can be used in a method of treating patients whose gastric pH is altered and thus have absorption problems or whose absorption problems may be caused by intake of food [0042]. The inventive T4 solution of Fossati can be administered to such patients having altered gastric pH or altered absorption related to food intake for treatment of their respective conditions [0042]. Claim 21 of Fossati claims a method of treating patients who undergo bariatric surgery, patients whose gastric pH is altered and have absorption problems, or patients having absorption problems caused by intake of food, the method comprising administering the highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity to a patient in need thereof. Thus the teachings of Fossati specifically teach and suggest that the alcohol-free, water-glycerol solutions of T4 can be advantageously administered to patients whose gastric pH is altered and have absorption problems, which include those patients being treated with PPIs as taught by Vita et al. whose gastric pH is altered by PPI administration and thus have absorption problems.
Therefore, in view of the combination of teachings, it would have been obvious to a person of ordinary skill in the art to administer the alcohol-free, water-glycerol solutions of T4 taught in Fossati, for the treatment of patients in need of T4 therapy and also taking PPIs with a reasonable expectation that the liquid formulation of Fossati would correct PPI-induced LT4 tablet malabsorption because the solution of Fossati would need no dissolution as compared to the tablet. Furthermore, an ordinary skilled artisan would have been motivated to administer the solution of Fossati since Fossati teaches that the ethanol-free solution has less T3 impurities and improved properties as compared to ethanol-containing solutions.
Applicant argues that their invention is surprising and unexpected since the claimed ethanol-free glycerol solution maintained favorable levothyroxine absorption notwithstanding established proton pump inhibitor therapy and notwithstanding the removal of ethanol, an ingredient identified in Vita as potentially facilitating absorption.
This argument is found not persuasive for the same reasons as detailed above. In view of the teachings of Vita and Fossati, a person of ordinary skill in the art would not have found Applicant’s findings surprising or unexpected since Applicant’s claims are drawn to the use of a T4 solution which would not need dissolution as compared to a tablet form. Thus, similar to the teachings of Vita, one would expect that patients whom tablet LT4 fails to normalize or suppress serum TSH because of the concomitant ingestion of PPI would benefit from the switch from the tablet to the oral solution, and that the absorption of LT4 would be much better reflecting better pharmacokinetics of the oral solution than of the tablet LT4 since the solution needs no dissolution as compared to the tablet. “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (resultant decrease of dental enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a process of sterilizing a polyolefinic composition which contains an antioxidant with high-energy radiation. Although evidence was presented in appellant’s specification showing that particular antioxidants are effective, the Board concluded that these beneficial results would have been expected because one of the references taught a claimed antioxidant is very efficient and provides better results compared with other prior art antioxidants.).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s remaining arguments with respect to the CG184 and Ronchi references are found not persuasive for the same reasons as detailed above since Applicant did not provide any additional arguments not addressed above.
Thus, for these reasons, the previous rejections under 35 USC 103 are hereby maintained and reproduced below. This action is FINAL.
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.
Claims 2-4, 6-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vita et al. (J Clin Endocrinol Metab 99: 4481– 4486, 2014 Provided on IDS) in view of Fossati et al. U.S. Publication No. 2018/0104204 A1.
Claims 2-4, 6-7 and 10 of the instant application claim a method for the treatment or prevention of the abnormal functioning of the thyroid hormone in a patient undergoing treatment with an orally administered proton pump inhibitor, comprising orally administering an ethanol-free glycerol solution of thyroid hormone T4 to a patient in need thereof.
Vita et al. teaches that levothyroxine (LT4) is one of the most prescribed drugs worldwide for either replacement or suppressive purposes, wherein the classic formulation of LT4 is the tablet which contains a sodium salt of LT4 and a number of excipients (page 4482). Vita et al. teaches that an acid gastric pH is required to permit dissolution of LT4 and its arrival in the intestine, where LT4 is absorbed (page 4482). Vita et al. teaches that the dissolution of the LT4 tablet is impaired upon progressive increases in the ambient pH (page 4482). Vita et al. teaches that among the most prescribed drugs that interfere with the intestinal absorption of LT4 are the proton-pump inhibitors (PPIs), and the concomitant ingestion of LT4 and a PPI is relatively common (page 4482). Vita et al. teaches that therapy with PPIs neutralizes the TSH-suppressive effect of LT4, and thus to achieve a stable low level of TSH, the LT4 daily dose must be increased while taking a PPI (page 4482). Vita et al. teaches that new LT4 formulations, the soft gel capsule and the oral solution, have become available in some, but not all, countries, wherein the soft gel capsule contains LT4 dissolved in glycerin that is covered by a gelatin shell and this formulation is unaffected by changes in ambient pH (page 4482).
Vita et al. teaches that the aim of this study was to verify, in patients with PPI-induced tablet LT4 malabsorption (as proven by the failure of serum TSH to be normalized or suppressed), that switching from the tablet LT4 to the oral solution LT4 corrects the malabsorption problem (page 4482). Vita et al. teaches evaluating 24 patients, fourteen patients (58.3%) with primary hypothyroidism who take LT4 for replacement therapy, and 10 (41.7%) who take it for TSH suppression therapy (page 4482). All patients had impaired absorption of the LT4 tablet due to concomitant ingestion of PPIs (page 4482). The patients were taking the following PPIs for either gastroesophageal reflux disease or parietal cell antibody–negative gastritis: 9 patients taking omeprazole; 7 patients taking pantoprazole; 6 patients taking lansoprazole; and 2 patients taking esomeprazole (page 4482). Vita et al. teaches that while maintaining both the co-ingestion of LT4 at the same interval before the PPI and the LT4 daily dose, patients were switched from the tablet to the oral solution (pages 4482-4483). The liquid solution used was pre-dosed ampules of Tirosint soluzione orale (IBSA Italia s.r.l.) (page 4483). Vita et al. teaches that the LT4 daily dose in mg/kg for all patients treated was between 1.0 and 2.7 (Table 1 page 4483). Thus for an average size subject between 50 and 91 kg, the daily dosage for LT4 would be about 50 mg to about 250 mg.
Vita et al. teaches that these studies demonstrate that patients in whom tablet LT4 fails to normalize or suppress serum TSH because of the concomitant ingestion of PPI benefit from the switch from the tablet to the oral solution and that the absorption of LT4 is so much better that, in one sixth of patients, the daily dose has to be decreased (page 4485). This fact reflects better pharmacokinetics of the oral solution than of the tablet LT4 and the liquid formulation of LT4 has a greater area under the curve from 0 to 2 hours and a faster time to reach the maximal concentration in blood (~30 minutes) (page 4485).
Thus Vita et al. teaches a method for the treatment or prevention of the abnormal functioning of the thyroid hormone in a patient undergoing treatment with an orally administered proton pump inhibitor, comprising orally administering a solution of thyroid hormone T4 to a patient in need thereof.
Vita et al. does not teach that the T4 solution is an ethanol-free glycerol solution of T4. Vita et al. does not teach the specific amount of the dosage unit in 0.5 to 10 ml of solution as claimed.
Fossati et al. teaches highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, packaged via specific container arrangements (abstract). Fossati et al. teaches a pharmaceutical preparation of thyroid hormone T4 in an alcohol-free water-glycerol solution, suitable for oral administration and characterized by high physical, chemical and microbiological stability for use in the treatment of disorders caused by thyroid hormone deficiency [0002]. Fossati et al. teaches that T4 hormone is conveniently administered in the form of a solution, which allows a more precise dosing as compared to solid forms, however, the administration of T4 solutions presents some challenges including T4 solutions are reported to prematurely convert in part to T3 during storage [0010]. Due to the quite higher potency of T3 vs. T4, even a small amount of formed T3 may significantly increase the overall dosage of administered hormone, with potential consequences for the patient caused by over-dosing [0010]. Fossati et al. teaches that another difficulty derives from the low water solubility of thyroid hormones, causing them to partly precipitate from solutions during storage and/or in consequence of temperature changes [0011]. A partial improvement in this area occurs where the thyroid hormones are formulated in water-alcohol-glycerol solutions showing a good stability [0011]. However, a significant degree of instability was observed with regards to conversion of T4 into T3 [0011].
Fossati et al. teaches that it was unexpectedly found that the unwanted premature conversion of T4 to T3 in packaged solution can be significantly reduced if T4 is formulated in water-glycerol, alcohol-free solutions and thus the invention relates to highly stable alcohol-free water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, which are packaged in ready-to-use container arrangements suitable to maintain a general stability of the solution [0012]-[0013].
Fossati et al. teaches a single-dose unit form containing about 5 to about 350 μg T4 thyroid hormone, or about 5 to about 250 μg T4 thyroid hormone in 1 g of water-glycerol solution ([0016] and [0034]). Fossati et al. specifically teaches preparing dosage forms comprising alcohol-free water-glycerol solution wherein the following amounts of T4 hormone were dissolved in 1.222 g of glycerol 85%: 25 μg, 50 μg, 75 μg, and 100 μg, obtaining the respective final concentrations of: 25 μg/mL, 50 μg/mL, 75 μg/mL, and 100 μg/mL [0049]. Fossati et al. specifically demonstrates that their alcohol-free formulations are more stable and contain less T4 to T3 conversion than alcohol containing formulations (Examples on pages 4-5).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Vita et al. which teaches a method for the treatment or prevention of the abnormal functioning of the thyroid hormone in a patient undergoing treatment with an orally administered proton pump inhibitor, comprising orally administering a solution of thyroid hormone T4, with the teachings of Vita et al. which specifically teach a pharmaceutical preparation of thyroid hormone T4 in an alcohol-free water-glycerol solution, suitable for oral administration and characterized by high physical, chemical and microbiological stability for use in the treatment of disorders caused by thyroid hormone deficiency. Thus since Fossati et al. specifically teaches that their alcohol-free water-glycerol formulations are more stable and has less T4 to T3 conversion than formulations containing alcohol, an ordinary skilled artisan would have been motivated to use the T4 formulation of Fossati et al. in the method of Vita et al. to arrive at the instant invention with a reasonable expectation of improved results.
With respect to the concentrations of the unit dosage forms as claimed in claims 2-4 of the instant application which recite 10-800 mg or 500-800 mg of T4 in 0.5 to 10 ml which is a concentration range of 1 mg/ml to 1.6 mg/ml or 50 mg/ml to 1.6 mg/ml, Fossati et al. teaches unit dosages forms having the following concentrations 25 μg/mL, 50 μg/mL, 75 μg/mL, and 100 μg/mL. Thus the amounts taught in Fossati et al. are within the range as claimed in the instant claims.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vita et al. (J Clin Endocrinol Metab 99: 4481– 4486, 2014 Provided on IDS) in view of Fossati et al. U.S. Publication No. 2018/0104204 A1 as applied to claims 2-4, 6-7 and 10 above and further in view of “Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management” Clinical guideline, Reference number:CG184, Published: 03 September 2014, Last updated: 18 October 2019 (herein referred to as CG184)
Claim 9 of the instant application further claims that the proton pump inhibitor is administered between 5 and 100 mg daily.
Vita et al. in view of Fossati et al. do not teach the daily dosage of the proton pump inhibitor administered.
However, Vita et al. teaches that the patients were taking the following PPIs for either gastroesophageal reflux disease or parietal cell antibody–negative gastritis: 9 patients taking omeprazole; 7 patients taking pantoprazole; 6 patients taking lansoprazole; and 2 patients taking esomeprazole (page 4482).
CG184 teaches interventions for the treatment of gastroesophageal reflux disease is found on Table 2 in appendix A (page 8) which is 40 mg once a day for esomeprazole, 30 mg once a day for lansoprazole, 40 mg once a day for omeprazole, and 40 mg once a day for pantoprazole (page 27).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat the patients of Vita et al. taking the following PPIs for gastroesophageal reflux disease (GERD): 9 patients taking omeprazole; 7 patients taking pantoprazole; 6 patients taking lansoprazole; and 2 patients taking esomeprazole; according to the recommended dosages as taught by CG184 which is 40 mg once a day for esomeprazole, 30 mg once a day for lansoprazole, 40 mg once a day for omeprazole, and 40 mg once a day for pantoprazole. Thus, a person of ordinary skill in the art would have been motivated to treat the patients of Vita et al. having GERD with proton pump inhibitors according to dosages well-known in the art with a reasonable expectation of predictable results. Thus, the dosages as taught in the prior art fall within the claimed range of between 5 and 100 mg daily and therefore claim 9 of the instant application is rendered obvious in view of the cited prior art teachings.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Vita et al. (J Clin Endocrinol Metab 99: 4481– 4486, 2014 Provided on IDS) in view of Fossati et al. U.S. Publication No. 2018/0104204 A1 as applied to claims 2-4, 6-7 and 10 above and further in view of Ronchi et al. (International Journal of Pharmaceutics, 567 (2019) 118416 pages 1-11).
Claims 8 of the instant application further claims that the proton pump inhibitor is administered in the form of a modified-release solution.
Vita et al. in view of Fossati et al. does not teach the proton pump inhibitor is administered in the form of a modified-release solution.
Ronchi et al. teaches that modified-release oral dosage forms are commonly used in pharmaceutics to delay or sustain the release of drugs, but they are only marketed as solid dosage forms such as capsules or tablets and therefore, the development of a liquid oral dosage form with modified-release properties has been keenly awaited to increase the compliance of patients with a swallowing impairment, such as pediatric, older or critically ill patients (abstract). Ronchi et al. teaches that a new technology has been developed that consists of multi-layered particles suspended extemporaneously in a syrup, using omeprazole as a model drug (abstract). This formulation utilizing polymers allowed stability and achieved the prevention of the early release of omeprazole when dispersed in the liquid carrier and when in the acidic environment of the stomach (abstract). It is able to protect omeprazole for 2 h in acidic medium at pH 1.2, while omeprazole was entirely released at pH 6.8 within 45 min (abstract). The oral delayed-release system based on a multi-layered particle technology, as described in Ronchi et al., has shown an innovative process that permitted reconstitutable omeprazole liquid dosage forms with modified-release properties to be obtained (page 11).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat patients according to the teachings of Vita et al. being treated with PPIs in any form known in the art and also in need of T4 therapy. Since modified release PPI formulations were known in the art as taught by Ronchi et al., it would have been obvious to a person of ordinary skill in the art to treat the patients of Vita et al. with T4 and also in need of a PPI with a modified-release solution of a PPI known in the art with a reasonable expectation of similar results. Thus since modified-release solutions of PPIs are suitable forms of treatment as taught by Ronchi, a person of ordinary skill in the art would have been motivated to combine the modified-release solutions of PPI with the oral solution of T4 with the same expectation that the PPI would not interfere with T4 absorption.
Thus claim 8 of the instant application is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1 and 5 are canceled. Claims 2-4 and 6-10 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
