Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application
The Remarks and Amendments filed on 10/10/24 are acknowledged.
Claims 1-61 were previously cancelled.
There were no claim amendments.
Claims 62-69 are pending and are included in the prosecution.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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.
Claims 62-69 are again rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baichwal et al. (US 2003/0129234 A1), or alternatively over Sackler et al. (US 5,478,577), or Maloney (WO 01/08661 A2), each in view of Reitberg (US 2002/0032581 A1).
Instant claim 62 is drawn to a method of treating pain in a renally impaired patient with a creatinine clearance rate being less than about 80 mL/min, comprising the steps of:
(a) providing the patient with a therapeutically effective amount of an oral dosage form of a pharmaceutical composition comprising from about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix;
(b) informing the patient or the patient's prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment;
(c) orally administering the composition to the patient in a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment wherein the dose depends on the creatinine clearance rate of the patient; and
(d) the administration of the composition to said renally impaired patient results in a comparable bioavailability of the oxymorphone to that of a healthy person.
Baichwal et al. disclose methods of treating pain through oral administration of sustained release compositions containing oxymorphone (Abstract, Page 1, [0009] and [0013]). Oxymorphone is provided in an amount of about 1 mg to about 200 mg and more preferably, about 5 mg to about 80 mg (Page 2, [0015]). This range of about 5 mg to about 80 mg disclosed by Baichwal directly reads on the instant range of about 5 mg to about 80 mg oxymorphone of claim 62. The sustained release delivery system comprises at least one hydrophilic compound that forms a gel matrix that releases the oxymorphone or the pharmaceutically acceptable salt thereof at a sustained rate upon exposure to liquids (Page 2, [0017], [0019] & [0022]; Page 3, [0025]; and Page 5, [0042]). Baichwal et al. disclose that their target patient population is suffering from pain (Abstract, Page 1, [0013], Pages 4-5, [0041]); i.e., a generic patient population that does not exclude the renally impaired patient population recited in instant claim 62.
Sackler et al. disclose teach a method for treating pain by oral administration of an analgesically effective amount of an opioid analgesic, provided in a controlled release dosage form (Abstract, Col. 1, line 4 – Col. 4, line 41, Col. 6, lines 11-25, Col. 7, lines 51-59). Suitable opioid analgesic compounds disclosed include oxymorphone (Col. 7, line 10). The reference discloses opioid formulations, which provide an extended duration of effect for once-a-day administration in order to ensure bioavailability of the opioid drug (Col. 1, line 43 – Col. 2, line 7 and Col. 6, lines 26-61). A controlled release matrix which incorporates the opioid is disclosed (Col. 6, lines 45-48). Sackler et al. disclose that their target patient population is suffering from moderate to severe pain (Col. 3, lines 49-53); i.e., a generic patient population that does not exclude the renally impaired patient population recited in instant claim 62.
Maloney teaches methods for reducing the range in daily dosage dosages required to control pain in a human using a controlled release dosage form comprising an opioid analgesic – oxymorphone, a matrix-forming polymer and an ionic exchange resin, whereby the composition can be taken orally (Abstract, Pages 7-10 and Pages 12 and 14). The dosage form may comprise from about 0.1 - 500 mg of the opioid compound (Page 11, lines 18-19). This range reads on, encompasses and overlaps with the instant range of about 5 mg to about 80 mg oxymorphone of instant claim 82. 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). Maloney discloses that the target patient population is suffering from pain (Pages 12 and 14); i.e., a generic patient population that does not exclude the renally impaired patient population recited in instant claim 62.
Baichwal et al., Sackler et al. and Maloney do not expressly disclose a patient population that is renally impaired, and wherein the renally impaired patient is administered a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment.
Reitberg teaches a method of evaluating and/or optimizing clinical outcomes and providing rational pharmacotherapy in an individual or animal requiring chronic drug therapy (Abstract). The method also entails conducting drug trials of a drug substance, comparing information accumulated from a pre-assembled patient population and optimizing treatment for new patients (Page 2, [0024] and Page 1, [0010]). At Page 3, [0029], the reference discusses the theory of determining the maximum amount of drug that would prove to be effective. Reitberg teaches that numerous drugs and indications can be evaluated using the methods of their invention. Suitable drugs to be evaluated include opiates such as oxymorphone and agents used for treatment of the central nervous system, urinary tract, musculoskeletal, psychiatric, renal and neurological systems, for example (Page 9, [0109]-[0110] and [0170]). According to Reitberg, the invention has many uses that include: using it to test, confirm or verify a particular therapy’s safety and effectiveness. It can also provide professional usage information and be used in bioavailability single dose studies (Page 10, [0132]). The invention of Reitberg includes demonstrating the effectiveness of the specific treatment for the specific individual, that is, to document the probability that the medication is beneficial without causing unacceptable side effects. The system consists of a clinical evaluation kit which generates definitive guidance regarding the safety and effectiveness of drug therapy in each individual patient. The kit contains a full supply of medication to be evaluated and/or placebo, as well as all instructions and evaluation instruments for professionals, patients and if appropriate, caretakers (Page 11, [0157]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the teachings of Reitberg within the controlled release matrix formulations comprising oxymorphone of Baichwal et al., or alternatively Sackler et al., or Maloney, and arrive at the instant invention.
One of ordinary skill in the art would have found it obvious to do so with a reasonable expectation of success because Reitberg teaches methods and kits for evaluating and optimizing clinical outcomes. The clinical evaluation kit generates definitive guidance regarding the safety and effectiveness of drug therapy in each individual patient and contains a full supply of medication to be evaluated and all instructions and evaluation instruments for professionals, patients and caretakers. The reference further teaches that drugs to be evaluated include opiates such as oxymorphone. The expected result would be optimization of clinical outcomes and determining maximum drug safety and effectiveness levels for an individual.
Moreover, one of ordinary skill in the art recognizing the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain. Furthermore, it is not necessary that the prior art recognize a relationship of the ratio of the performance enhancing amounts for renally-impaired patients and to the amounts conventionally used in healthy patients; merely that there be present in the art a suggestion that under controlled release conditions the drug oxymorphone relieves pain.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Therefore, the limitations of claims 62-69 would have been obvious over the combination of Baichwal et al., alternatively Sackler et al., or Maloney, each in view of Reitberg.
Response to Arguments
Applicant’s arguments (Pages 5-8, filed 10/10/24) with respect to the rejection of claims 62-69 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baichwal et al. (US 2003/0129234 A1), or alternatively over Sackler et al. (US 5,478,577), or Maloney (WO 01/08661 A2), each in view of Reitberg (US 2002/0032581 A1) have been fully considered but are not persuasive.
Applicant argues that Reitberg relates to evaluating efficacy and side effects of pharmaceuticals in individual patients, but the evaluation criteria fails to include an assessment of renal impairment. Applicant argues that [0110] cited by the Examiner refers to “agents” that may be “used for the treatment of … renal, … conditions …” and that the claimed invention, however, is directed to treating pain, not renal conditions.
This is not persuasive because Reitberg not only teaches agents used for the treatment of renal disorders in [0110], but also that drugs for illnesses and conditions including pain can be evaluated ([0108], [0179]-[0181]). Reitberg discloses drugs which may be habit forming and possess a high abuse potential including pain medications and narcotic analgesics ([0169]) including oxymorphone ([0170]), which is the same drug recited in the instant claims.
Applicant argues that Reitberg’s evaluation proceeds in one of three ways: against a placebo, against an alternative drug, or against a different dose. Applicant argues that the only evaluation of an analgesic (codeine) occurs in Example 11 at page 21 where the evaluation is by means of a questionnaire, that there is a single recital of the word “bioavailability” in [0132], and it provides no guidance whatsoever to a POSA relevant to the claimed invention.
This is not persuasive because the invention of Reitberg includes demonstrating the effectiveness of the specific treatment for the specific individual, that is, to document the probability that the medication is beneficial without causing unacceptable side effects. The clinical evaluation kit taught by Reitberg generates definitive guidance regarding the safety and effectiveness of drug therapy in each individual patient and contains a full supply of medication to be evaluated and all instructions and evaluation instruments for professionals, patients and caretakers. As explained above, Reitberg clearly includes that the drugs to be evaluated include opiates such as oxymorphone. The expected result would be optimization of clinical outcomes and determining maximum drug safety and effectiveness levels for an individual.
Applicant argues that “… there is no teaching in Reitberg that would have motivated a POSA to test the blood levels of oxymorphone in patients with renal impairment who were taking an extended release oxymorphone formulation. Without such data, a POSA could draw no conclusions with regard to the impact of renal impairment on bioavailability and pharmacokinetics. And, there is nothing inherent in determining the appropriate dose for Reitberg' s individual patient that would lead to an observation on bioavailability in renally impaired patients.”
This is not persuasive because controlled release matrix formulations comprising oxymorphone are taught by Baichwal et al., Sackler et al., and Maloney. Baichwal et al. disclose that their target patient population is suffering from pain (Abstract, Page 1, [0013], Pages 4-5, [0041]); i.e., a generic patient population that does not exclude the claimed renally impaired patient population. Sackler et al. disclose that their target patient population is suffering from moderate to severe pain (Col. 3, lines 49-53); i.e., a generic patient population that does not exclude the claimed renally impaired patient population. Maloney discloses that the target patient population is suffering from pain (Pages 12 and 14); i.e., a generic patient population that does not exclude the claimed renally impaired patient population. Reitberg teaches testing the drug effect by using patients’ biological materials ([0026]) which include blood ([0027]). Reitberg also teaches individualization of therapy for the patient, decreased side effects, increased effectiveness, and decreased risk of treatment inter alia ([0134], [0157]). The patient populations taught by Baichwal, Sackler and Maloney overlap the patient population in need of pain medication and agents used for the treatment of renal disorders in ([0108], [0110], [0169], [0170], [0179]-[0181]) taught by Reitberg.
One of ordinary skill in the art recognizing the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain. Furthermore, it is not necessary that the prior art recognize a relationship of the ratio of the performance enhancing amounts for renally-impaired patients and to the amounts conventionally used in healthy patients; merely that there be present in the art a suggestion that under controlled release conditions the drug oxymorphone relieves pain.
Applicant argues that: “Given the imprecise relationship in opioids between blood levels and pain relief, prior to the present invention it was far from clear what a dose titration of an individual patient with renal impairment would give in terms of a difference in oral bioavailability compared to healthy patients. Dose titration is simply too imprecise a tool with which to detect differences in bioavailability between different classes of patients.”
This is not persuasive because Reitberg teaches that the invention can be used in dose titration ([0132]) and also teaches optimal or optimizing treatment which includes adjusting the time, manner or amount of a drug or therapy for maximum effect ([0084]). Moreover, Reitberg also teaches changing the dosage regimen in order to optimize the dosage regimen for a new patient ([0022]), changing the dosage regimen in order to minimize the abuse potential for a new patient ([0024]). Additionally, Reitberg teaches that: “When a patient is placed on or is already using a drug regimen which is believed to be particularly undesirable for chronic use, such as for addictive drugs, a modification of an approach referred to by statisticians as “adaptive allocation” or “play the winner” can be applied” ([0166]).
Therefore, the obviousness rejection of 04/11/24 is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 62-69 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,808,737 B2 (“the ‘737 Patent”) in view of Reitberg (US 2002/0032581 A1).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix.
The difference is that instant claims recite that the renally impaired patient is administered a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment, whereas claims of the ‘737 Patent do not recite this limitation.
Claims of the ‘737 Patent specifically recite measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 mL/min; and orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief; wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 ng·hr/mL, whereas instant claims recite that the renally impaired patient has a creatinine clearance rate of less than about 80 mL/min.
The teaching of Reitberg is discussed in detail above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the teachings of Reitberg within the method of treating pain in a renally impaired patient of the ‘737 Patent, and arrive at the instant invention. One of ordinary skill in the art would have found it obvious to do so with a reasonable expectation of success because Reitberg teaches methods and kits for evaluating and optimizing clinical outcomes. The clinical evaluation kit generates definitive guidance regarding the safety and effectiveness of drug therapy in each individual patient and contains a full supply of medication to be evaluated and all instructions and evaluation instruments for professionals, patients and caretakers. The reference further teaches that drugs to be evaluated include opiates such as oxymorphone. The expected result would be optimization of clinical outcomes and determining maximum drug safety and effectiveness levels for an individual.
Moreover, one of ordinary skill in the art recognizing the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain.
Therefore, instant claims are obvious over claims of the ‘737 Patent in view of Reitberg and they are not patentably distinct over each other.
Claims 62-69 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-61 of U.S. Patent No. 9,789,103 B2 (“the ‘103 Patent”) in view of Reitberg (US 2002/0032581 A1).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix.
Claim 1 of the ‘103 Patent recites that the log transformed AUC of oxymorphone is about 1.05 to about 2.45 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose, whereas instant claim 63 recites that the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 0.86 to about 2.42 ng*hr/ml when administered equal doses.
Claim 2 of the ‘103 Patent specifically recites that the creatinine clearance rate of the patient is determined to be about 51 mL/min to about 80 mL/min, whereas instant claims recite that the renally impaired patient has a creatinine clearance rate of less than about 80 mL/min.
The teaching of Reitberg is discussed in detail above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the teachings of Reitberg within the method of treating pain in a renally impaired patient of the ‘103 Patent, and arrive at the instant invention. One of ordinary skill in the art would have found it obvious to do so with a reasonable expectation of success because Reitberg teaches methods and kits for evaluating and optimizing clinical outcomes. The clinical evaluation kit generates definitive guidance regarding the safety and effectiveness of drug therapy in each individual patient and contains a full supply of medication to be evaluated and all instructions and evaluation instruments for professionals, patients and caretakers. The reference further teaches that drugs to be evaluated include opiates such as oxymorphone. The expected result would be optimization of clinical outcomes and determining maximum drug safety and effectiveness levels for an individual.
Moreover, one of ordinary skill in the art recognizing the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain.
Therefore, instant claims are obvious over claims of the ‘103 Patent in view of Reitberg and they are not patentably distinct over each other.
Claims 62-69 are again rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,389,443 B2 (“the ‘443 Patent”) in view of Reitberg (US 2002/0032581 A1).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix.
Claim 1 of the ‘443 Patent recites that the log transformed AUC of oxymorphone is about 1.05 to about 2.45 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose, whereas instant claim 63 recites that the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 0.86 to about 2.42 ng*hr/ml when administered equal doses.
The teaching of Reitberg is discussed in detail above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the teachings of Reitberg within the method of treating pain in a renally impaired patient of the ‘443 Patent, and arrive at the instant invention. One of ordinary skill in the art would have found it obvious to do so with a reasonable expectation of success because Reitberg teaches methods and kits for evaluating and optimizing clinical outcomes. The clinical evaluation kit generates definitive guidance regarding the safety and effectiveness of drug therapy in each individual patient and contains a full supply of medication to be evaluated and all instructions and evaluation instruments for professionals, patients and caretakers. The reference further teaches that drugs to be evaluated include opiates such as oxymorphone. The expected result would be optimization of clinical outcomes and determining maximum drug safety and effectiveness levels for an individual.
Moreover, one of ordinary skill in the art recognizing the particular patient being treated through regular testing, would be fully capable of determining suitable amounts of drug as well as the time period of distribution. It would be standard procedure for one of ordinary skill in this art at the time of the invention, to determine the amount of drug that would not overdose a renal patient and yet also effectively provide relief from pain.
Therefore, instant claims are obvious over claims of the ‘443 Patent in view of Reitberg and they are not patentably distinct over each other.
Response to Arguments
Applicant’s arguments (Page 8, filed 10/10/24) with respect to the double patenting rejections over the ‘737 Patent; the ‘103 Patent; and the ‘443 Patent have been fully considered but are not persuasive.
Applicant requests that these rejections be held in abeyance until all other rejections have been overcome, and at that time Applicant will consider a terminal disclaimer if appropriate.
Until such time that terminal disclaimer(s) are filed, the double patenting rejections will be maintained.
Conclusion
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 extension fee 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.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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