DETAILED ACTION
The office action is in response to applicant’s filling dated December 12, 2023.
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 .
Claim Objections
Claims 2-15 and 20 are objected to because of the following informalities:
In claims 2-15, “is present in” should read “is present in the solution in a concentration of.”
In claim 20, line 1, “a human subject major depressive disorder” should read “a human subject with major depressive disorder.”
In claim 20, line 2, “affective amount” should read “effective amount.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is 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.
The term “substantially free” in claim 16 is a relative term which renders the claim indefinite. The term “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the case of the oral solution, it is unclear as to what level of visible particulate matters is impermissible by the claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Calisti et al. (WO 2021058810 A1), in view of Rowe et al. (U1, Rowe, R. C., Sheskey, P. J., Quinn, M. E., Handbook of Pharmaceutical Excipients. 2009. Pharmaceutical Press, 6th Edition, pp. 61-63, 242-244, 441-445, 627-629, 679-682), Marchetti et al. (WO 2009016069 A2), Meeks (V1, Meeks, S. “Saccharin: What to Know” Medical News Today (2021) pp. 1-3), FDA Staff (W1, FDA STAFF. “Food Ingredients & Colors” FDA.gov (2010) pp. 2-4), and Sharma et al (X1, SHARMA, A. V. et al. “Flavoring Agents in Pharmaceutical Formulations” Ancient Science of Life, Vol. VIII, No. 1, (July 1988) pp. 39).
Calisti et al. teaches of multiple orally administered trazodone solutions. Calisti emphasizes that sweeter formulations of trazodone are needed due to trazodone’s bitter taste (pp. 6, Paragraph 4). Calisti claims multiple solutions which contain multiple of the following:
trazodone hydrochloride (pg. 16, Paragraph 1)
citric acid (pg. 16, Table 4)
sorbitol (pg. 21, Table 8)
sodium benzoate (pg. 22, Table 8)
methylparaben (pg. 22, Table 8)
disodium edetate (pg. 21, Table 8)
sucralose (pg. 21, Table 8)
water (pg. 21, Table 8)
However, Calisti fails to teach a trazodone solution containing: disodium edetate dehydrate, sodium saccharin, FD & C Red No. 40, and cherry flavor.
Rowe et al. teaches disodium edetate has multiple forms including anhydrous and dihydrate forms (pp. 242-244).
Marchetti teaches a liquid formulation containing trazodone containing saccharin at a concentration of 0.8 mg/mL (0.08 g of sodium saccharin in a 100 mL solution; pp. 11, Example 8). Marchetti also teaches that Trazodone targets serotonin receptors which allows it to help treat insomnia and major depressive disorder (pp. 14, Paragraph 47).
Meeks teaches that sodium saccharin is most commonly used as an artificial sweetener (pp. 1-3).
FDA Staff teaches of color additives which are used to improve the appearance of food, drugs, and cosmetics. The reference specifically teaches that colors, such as Red 40, help to offset color loss due to environmental conditions, correct and enhance color variations, and provide color to colorless food (pp. 2-3, Table 1; pp.4, Paragraphs 4-6).
Sharma teaches of different flavoring agents which can be used to make pharmaceutical formulations more palatable. Specifically, Sharma teaches that cherry flavoring is particularly well suited to mask bitter flavors (pg. 39, Table II).
Regarding claim 1, since Calisti teaches of an oral solution comprising trazodone hydrochloride, citric acid, sorbitol, sodium benzoate, methylparaben, edetate disodium dihydrate, and water, Rowe teaches that there are two finite hydrate forms of disodium edetate with analogous properties in solution, Marchetti teaches a trazodone oral solution containing sodium saccharin, Meeks teaches that Sodium Saccharin is a common sweetener, FDA Staff teaches of adding FD & C Red No. 40 to generic pharmaceutical compositions, and since Sharma teaches that cherry flavoring can be added to generic bitter pharmaceutical compositions, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to develop an oral solution comprising the components of claim 1 with an expectation of success. Since Rowe teaches that there are two possible disodium edetate hydrate forms, as such a person of ordinary skill before the effective filing date, knowing there are a finite number of ways to implement disodium edetate, would have pursued using disodium edetate dihydrate and incorporating it into the composition with a reasonable expectation of success. The prior art also establishes that both sucralose and sodium saccharin are considered common excipient sweeteners shown to be compatible with Trazodone oral solutions, it would have been prima facie obvious to substitute one sweetener for another. Furthermore, FDA Staff teaches that FD & C Red No. 40 is rigorously certified to be safe and helps to make pharmaceutical products more appealing, while Sharma teaches that cherry flavoring can help mask bitter flavors and is safe for use in pharmaceutical products. As such a person of ordinary skill in the art would have had reasonable expectation of success adding those excipients to the pharmaceutical solution.
Claims 2-15 are all directed to specific concentrations of particular excipients in the trazodone solution.
Regarding claims 2 and 3, the concentrations of trazodone hydrochloride listened in claims 2 and 3 would have been prima facia obvious to one of ordinary skill in the art to utilize trazodone hydrochloride concentrations of 15 mg/mL to 30 mg/mL taught by Calisti (pp. 16 (Paragraph 1) for a Trazodone solution of claim 1.
Regarding claims 4 and 5, the concentrations of citric acid listened in claims 4 and 5 would have been prima facia obvious to one of ordinary skill in the art to utilize the citric acid concentrations of 5.0 mg/mL taught by Calisti (pp. 16, Table 4) as a starting point for optimizing the amount of citric acid for the solution. This is as Calisti teaches pharmaceutically effective oral trazodone which incorporate concentrations of citric acid analogous to those in claims 4 and 5 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 6 and 7, the concentrations of sorbitol listened in claims 6 and 7 would have been prima facia obvious to one of ordinary skill in the art to utilize the sorbitol concentrations of 100 mg/mL taught by Calisti (pp. 21, Table 8) as a starting point for optimizing the amount of sorbitol in the solution. This is as Calisti teaches pharmaceutically effective oral trazodone solutions which incorporate concentrations of sorbitol analogous to those in claims 6 and 7 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 8 and 9, the concentrations of sodium saccharin listened in claims 8 and 9 would have been prima facia obvious to one of ordinary skill in the art to utilize the sodium saccharin concentrations of 0.8 mg/mL taught by Marchetti (pp. 11, Example 8) as a starting point for optimizing the amount of sodium saccharin in the solution. This is as Marchetti teaches pharmaceutically effective oral trazodone solutions which incorporate concentrations of sodium saccharin analogous to those in claims 8 and 9 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 10 and 11, the concentrations of sodium benzoate listened in claims 10 and 11 would have been prima facia obvious to one of ordinary skill in the art to utilize the sodium benzoate concentrations of 5.0 mg/mL taught by Calisti (pp. 22, Table 8) as a starting point for optimizing the amount of sodium benzoate in the solution. This is as Calisti teaches pharmaceutically effective oral trazodone solutions which incorporate concentrations of sodium benzoate analogous to those in claims 10 and 11 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 12 and 13, the concentrations of methylparaben listened in claims 12 and 13 would have been prima facia obvious to one of ordinary skill in the art to utilize the methylparaben concentrations of 1.30 mg/mL taught by Calisti (pp. 22, Table 8) as a starting point for optimizing the amount of methylparaben in the solution. This is as Calisti teaches pharmaceutically effective oral trazodone solutions which incorporate concentrations of methylparaben analogous to those in claims 12 and 13 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 14 and 15, the concentrations of edetate disodium dihydrate listened in claims 14 and 15 would have been prima facia obvious to one of ordinary skill in the art to utilize the edetate disodium dihydrate concentrations of 5.0 mg/mL taught by Calisti (pp. 21, Table 8) as a starting point for optimizing the amount of edetate disodium dihydrate in the solution of claim 1. This is as Calisti teaches of pharmaceutically active oral trazodone solutions which incorporate concentrations of edetate disodium dihydrate analogous to those in claims 14 and 15 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 16-19 are drawn to physical and chemical properties of the trazodone solution. C
Regarding claim 17, claim 17 is rendered obvious because Calisti recites a set of trazodone formulations with pH values of approximately 4.5 (pg. 22, Paragraph 1).
Regarding claims 16, 18, and 19, the prior art does not explicitly teach the disclosed composition is free from visible particular matters, has a specific gravity of 1.055 g/mL, and has a viscosity less than 10 cP as required in claims 16, 18, and 19. However, the above physical and chemical parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulations will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claims 1-5, 8-9, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Marchetti et al. (WO 2009016069 A2), in view of Promises Behavioral Health Editorial Team (U2, Promises Behavioral Health Editorial Team, “Medications for Depression: Trazodone in Brief” Promises Behavioral Health. (2012) pp. 2), Rowe et al. (U1, Rowe, R. C., Sheskey, P. J., Quinn, M. E., Handbook of Pharmaceutical Excipients. 2009. Pharmaceutical Press, 6th Edition, pp. 242-244), FDA Staff (W1, FDA STAFF. “Food Ingredients & Colors” FDA.gov (2010) pp. 2-4), and Sharma et al (X1, SHARMA, A. V. et al. “Flavoring Agents in Pharmaceutical Formulations” Ancient Science of Life, Vol. VIII, No. 1, (July 1988) pp. 39).
Marchetti teaches of multiple trazodone hydrochloride oral solutions containing Trazodone HCl capable of treating depression and Major Depressive Disorder (pp. 14, Paragraph 47) as well as the following excipients being compatible with trazodone being:
Citric acid (pp. 12, Example 10)
Sodium Saccharin (pp. 11, Example 8)
Benzoic Acid (pp. 11, Example 8)
Disodium Edetate (pp. 12, Example 10)
Water (pp. 12, Example 10)
However, Marchetti fails to teach a trazodone solution containing: sorbitol, sodium benzoate, methylparaben, sodium edetate dihydrate, FD & C Red No. 40, and cherry flavor.
Promises Behavioral Health Editorial Team teaches that trazodone has an unpleasant taste (pp. 2).
Rowe et al. teaches that sorbitol is a common sweetener (pp. 441), and that benzoic acid (pp. 61), sodium benzoate (pp. 627), and methylparaben (pp. 441) are known anti-microbial preservatives. Rowe et al. also teaches disodium edetate has multiple forms including anhydrous and dihydrate forms (pp. 242-244).
FDA Staff teaches of color additives which are used to improve the appearance of food, drugs, and cosmetics. The reference specifically teaches that colors, such as Red 40, help to offset color loss due to environmental conditions, correct and enhance color variations, and provide color to colorless food (pp. 2-3, Table 1; pp.4, Paragraphs 4-6).
Sharma teaches of different flavoring agents which can be used to make pharmaceutical formulations more palatable. Specifically, Sharma teaches that cherry flavoring is particularly well suited to mask unpleasant and bitter flavors (pg. 39, Table II).
Regarding claims 1 and 20, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to develop a method of treating major depressive disorder with a solution comprising the components of claim 1 with an expectation of success. This is as Marchetti teaches that pharmaceutically effective amounts of trazodone may be particularly useful for treating a human suffering from depression or disorders associated with depression (pp. 14, Paragraph 47). Marchetti also teaches that citric acid, sodium saccharin, sodium benzoate, and sodium saccharin are compatible excipients with trazodone. Rowe et al. teaches that sorbitol and sodium saccharin are both sweeteners and that benzoic acid, sodium benzoate, and methylparaben are antimicrobial preservatives all of which are known excipients suitable for formulating an oral solution comprising trazodone, it would have been prima facie obvious to substitute one excipient for an equivalent one with a reasonable expectation of success. Furthermore, Rowe teaches that there are two possible disodium edetate hydrate forms, as such a person of ordinary skill before the effective filing date, knowing there are a finite number of ways to implement disodium edetate, would have pursued using disodium edetate dihydrate and incorporating it into the composition with a reasonable expectation of success. Furthermore, FDA Staff teaches that FD & C Red No. 40 is rigorously certified to be safe and helps to make pharmaceutical products more appealing, while Sharma teaches that cherry flavoring can help mask unpleasant flavors and is safe for use in pharmaceutical products. As such a person of ordinary skill in the art would have had reasonable expectation of success adding those excipients to a pharmaceutical solution to arrive at the solution of claim 1 and then using that solution to treat major depressive disorder following Marchetti et al.
Claims 2-5, 8-9, and 14-15 are all directed to specific concentrations of particular excipients in the trazodone solution.
Regarding claims 2 and 3, the concentrations of trazodone hydrochloride listened in claims 2 and 3 would have been prima facia obvious to one of ordinary skill in the art to utilize trazodone hydrochloride concentrations of 10 mg/mL to 60 mg/mL taught by Marchetti (pp. 11-12) for a Trazodone solution of claim 1.
Regarding claims 4 and 5, the concentrations of citric acid listened in claims 4 and 5 would have been prima facia obvious to one of ordinary skill in the art to utilize the citric acid concentrations of 1.0 mg/mL taught by Marchetti (pp. 12, Example 10) as a starting point for optimizing the amount of citric acid for the solution of claim 1. This is as Marchetti teaches pharmaceutically effective oral trazodone solutions which incorporate concentrations of citric acid analogous to those in claims 4 and 5 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 8 and 9, the concentrations of sodium saccharin listened in claims 8 and 9 would have been prima facia obvious to one of ordinary skill in the art to utilize the sodium saccharin concentrations of 0.8 mg/mL taught by Marchetti (pp. 11, Example 8) as a starting point for optimizing the amount of sodium saccharin in the solution of claim 1. This is as Marchetti teaches pharmaceutically effective oral trazodone solutions which incorporate concentrations of sodium saccharin analogous to those in claims 8 and 9 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 14 and 15, the concentrations of edetate disodium listened in claims 14 and 15 would have been prima facia obvious to one of ordinary skill in the art to utilize the edetate disodium concentrations of 1.0 mg/mL taught by Marchetti (pp. 12, Example 10) as a starting point for optimizing the amount of edetate disodium dihydrate in the solution of claim 1. This is as Marchetti teaches oral trazodone solutions which incorporate concentrations of edetate disodium dihydrate to those in claims 14 and 15 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 16-19 are drawn to physical and chemical properties of the trazodone solution. C
Regarding claim 17, claim 17 is rendered obvious because Marchetti recites a set of trazodone formulations with pH values of approximately 4.3-4.7 (pg. 3, Paragraph 2).
Regarding claims 16, 18, and 19, the prior art does not explicitly teach the disclosed composition is free from visible particular matters, has a specific gravity of 1.055 g/mL, and has a viscosity less than 10 cP as required in claims 16, 18, and 19. However, the above physical and chemical parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulations will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Conclusion
Claims 1-20 are rejected and no claim is allowed.
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/AARON RAFANAN ULLMAN/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628