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 .
Status of the Claims
Claims 1-13 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/KR2021/017842, filed on 11/30/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/06/2024, 11/12/2024, 05/03/2024, 04/12/2024, 10/03/2023 and 05/31/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-13 are 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.
Claim 1 is drawn to a stable oral formulation comprising an active pharmaceutical ingredient (API), which is 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid (also known as Tigulixostat) or a pharmaceutically acceptable salt thereof and one or more excipients, wherein the formulation does not contain a separate stabilizer as an excipient, and wherein 90% or more of the API content of the formulation remains stable (“is maintained”) under specific storage parameters:
40°C and 75% relative humidity for 6 months; or
80°C and 75% relative humidity for 12 days; or
25°C and 60% relative humidity for 1 year.
The claim is indefinite because a person of ordinary skill in the art would not be able to discern the metes and bounds of the claim in regard to what excipients can or cannot be included in a formulation that meets the limitations of the claim. The claim does not provide a definition of “stabilizer”. The instant Specification defines a stabilizer as any pharmaceutically acceptable additive (excipient) contained in the formulation to inhibit the formation of decomposition products that may be generated when the API is mixed and contacted with additives such as excipients (page 5, third paragraph). However, the Specification does not disclose what modes of decomposition can occur for Tigulixostat nor what decomposition products can be formed when the API is mixed and contacted with additives such as excipients, nor what excipients cannot be used in a formulation that meets the limitations of claim 1, either because a given excipient qualifies as a “stabilizer” or otherwise will cause the composition to fail the meet the required stability under the cited storage conditions. Additionally, the Specification does not define the meaning of “separate” in the context a “stabilizer” being included in a formulation as a “separate” excipient.
Prior art teaches the principles of drug degradation and excipient contributes toward and/or mitigations against such degradation – see, for example, Crowley (Crowley, P.J.; Pharmaceutical Science & Technology Today, v2, pp237-243; 1999). Crowley teaches that the potential for excipients to prevent or retard degradation will be determined by the factors that cause the molecular transformation of drug substances, including environmental components such as water and sunlight, stresses during conversion to the dosage form, such as size reduction, compaction or sterilizing processes, and interactions between adjacent molecules of a drug or between functional groups on the same molecule (page 237). Crowley further teaches that excipients with affinity for moisture might be expected to mitigate moisture sensitivity. Thus, formulation with a substance having a greater affinity for water compared with the drug could mean that moisture in the product is sequestrated by the excipient (page 238). Crowley shows that excipients such as mannitol, cellulose, lactose and talc can serve in this capacity and reduce hydrolytic degradation of nitrazepam (Figure 1, page 238), and further teaches that amorphous silica and microcrystalline cellulose are powerful sorbents that can sequester volatile residues such as lower alcohols and formaldehyde that may contribute to drug product degradation, and these excipients are provided as exemplary excipients for use with Tigulixostat in the instant Specification (pages 7-8). Crowley further teaches degradation by oxidation is a pathway for instability of drug products, and that while antioxidants such as tocopherol, butylated hydroxytoluene and hydroxyanisole are known as stabilizers for vitamins A and D, it is also known that magnesium stearate, listed as an exemplary excipient in the instant Specification, has been known to stabilize ascorbic acid (i.e., vitamin C). It is not clear whether the magnesium stearate effected the stabilization or whether the effect was produced by antioxidants that are usually present in stearates and other fatty acids (page 239). Thus, neither the instant disclosure nor the prior art, alone or in combination, provide a clear understanding of what excipients, or combinations of excipients, meet the limitation of providing a formulation of Tigulixostat that does not include a “separate stabilizer” and will provide the required stability under the cited storage conditions, and conversely, which excipients, or combinations of excipients, must be excluded.
Claims 2-4 further limit claim 1, each to a higher % content of the API that has been subjected to the claimed storage conditions, and each is indefinite in the same manner as claim 1.
Claims 5-13 depend directly or indirectly from claim 1 and do not resolve the ambiguity of whether the invention is directed to a composition of matter or a method of storage.
For the purpose of examination, the claims will be examined as composition(s) of matter, with no weight given to the storage conditions as regards the structure of the composition.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “formulation” in claims 10-13 is used by the claim to mean “unit dose,” or “unit formulation” while the accepted meaning is “form under which a drug is presented as a medicinal product.”1 The term is indefinite because the specification does not clearly redefine the term. In contrast to claims 10-13, the specification discusses API loading, at various mg dosages, as “per unit formulation” (page 8).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are anticipated by Song.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Song (U.S. Patent No. 8,729,273 B2).
Claim 1 is drawn to a stable oral formulation comprising an active pharmaceutical ingredient (API), which is 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid (also known as Tigulixostat) or a pharmaceutically acceptable salt thereof and one or more excipients, wherein the formulation does not contain a separate stabilizer as an excipient, and wherein 90% or more of the API content of the formulation is stored according to particular parameters. As discussed in the rejection above, the claim is herein examined as a composition of matter, with no with no weight given to the storage conditions as regards the structure of the composition.
Song discloses a genus of indole compounds as inhibitors of xanthine oxidase, including Song’s “Example 1”, which is 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid (Col. 46, lines 1-32). Song further discloses pharmaceutical compositions comprising a compound disclosed therein and suitable carriers or excipients (Col. 15, lines 12-16), including for oral administration, without requiring a stabilizer as an excipient (Col. 12, lines 44-47).
Thus, claim 1 is anticipated by the disclosure of Song.
Claims 2-4 further limit claim 1 with regard to the weight % of the API content that has been subjected to the required treatment conditions. As no modification of the composition is attributed to these storage conditions, these claims are met by the rejection above.
Claim 5 further limits claim 1 to wherein the oral formulation comprises at least one excipient selected from a diluent, a disintegrant, a binder, a glidant and a lubricant. Song discloses a range of excipients suitable for use in formulations comprising the compounds disclosed therein, including fillers (i.e., diluents), disintegrants, and lubricants (Col. 15, lines 55-67, and Col. 16, lines 1-11).
Thus, claims 2-5 are anticipated by the disclosure of Song.
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 1-6 are unpatentable over Song in view of Gennaro.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Song (U.S. Patent No. 8,729,273 B2) in view of Gennaro (Gennaro, A. R.; Remington’s Pharmaceutical Sciences, Mack Publishing Co., Easton, PA; 1985).
The limitations of claims 1-5 and the disclosure of Song are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 6 further limits the formulation of claim 1 to wherein the oral formulation comprises a diluent, a disintegrant, a glidant and a lubricant. Song discloses that techniques for formulations of a compound can be found in Remington’s Pharmaceutical Sciences (i.e., Gennaro – see Col. 15, lines 16-19), and further discloses a range of excipients suitable for use in formulations comprising the compounds disclosed therein, including fillers (i.e., diluents), disintegrants, and lubricants (Col. 15, lines 55-67, and Col. 16, lines 1-11). While Song does not specifically describe any “glidant”, or specifically outline a singular formulation that includes each and all of the excipient categories of diluent, disintegrant, glidant and lubricant, a person of ordinary skill in the art would have a reasonable expectation of success in preparing a formulation comprising a compound disclosed by Song, including wherein the compound is Tigulixostat, along with excipients including a filler, disintegrant, glidant and lubricant, because Gennaro, a resource recommended by Song, explains the advantages of including each of these types of excipients in a solid oral formulation and further explains that talc, an excipient recommended by Song as a lubricant, is actually identifiable as both a glidant and a lubricant, thus simultaneously satisfying both categories.
Gennaro provides an encyclopedic review of pure and applied scientific topics relevant to the theory and practice of pharmacy, including the formulation of drug compounds. Gennaro teaches that a filler is used to give powder bulk so that an acceptable size tablet is produced (page 1425) and alternately defines “diluent” as an inert substance added to increase the bulk in order to make a tablet a practical size for compression (page 1605). Gennaro further teaches that a disintegrant is added to a tablet to facilitate its breakup or disintegration after administration (page 1606). Gennaro further teaches that lubricants have a number of functions in tablet manufacture: they prevent adhesion of the tablet material to the surface of dies and punches, reduce particle friction, facilitate the ejection of tablets from the die cavity, and may improve the rate of flow of the tablet granulation (page 1606). Gennaro further teaches that a glidant is a substance which improves the flow characteristics of a powder mixture, and are added in the dry state just prior to compression (i.e., during the lubrication step). Gennaro teaches that talc, a compound listed by Song as a suitable lubricant, may serve the dual purpose as lubricant/glidant (page 1606).
Applicant’s invention is unpatentable over the disclosure of Song in view of the teaching of Gennaro, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation at preparing an oral formulation comprising Tigulixostat along with a diluent, disintegrant, lubricant and glidant, because Song provides Tigulixostat as a xanthine oxidase inhibitor and further provides for pharmaceutical compositions for oral administration comprising a range of suitable excipients, including diluents, disintegrants, and lubricants including talc, an excipient that Gennaro teaches is really both a lubricant and a glidant, and because Song recommends Gennaro as a resource for formulating pharmaceutical compositions and Gennaro teaches the various and distinct reasons for including excipients of each of the types known as diluents, disintegrants, lubricants and glidants in solid oral pharmaceutical compositions.
Thus, the invention was prima facie obvious at the time of filing.
Claims 1-6 and 10-13 are unpatentable over Song in view of Gennaro and further in view of Yoon.
Claims 1-6 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Gennaro and further in view of Yoon (Yoon, et al.; Drug Design, Development and Theory, v9, pp5033–5049; 2015)2.
The limitations of claims 1-6 and the disclosure of Song and the teaching of Gennaro are discussed in the rejections above and hereby incorporated into the instant rejection.
Claims 10-13 further limit claim 1, each to a specific dosage/strength of Tigulixostat, in amounts of 50, 100, 200 and 300 mg, respectively. Song discloses that the compounds disclosed therein as xanthine oxidase inhibitors can be administered in doses within the range of 0.1-1000 mg. While Song does not disclose specific dosing in the amounts of 50, 100, 200 and 300 mg, these claims pertain to the safe and effective dosing of the claimed compound, a xanthine oxidase inhibitor, which is a result-effective variable, and the determination of safe and effective dosing of a xanthine oxidase inhibitor was known in the art at the time of the instant application. See, for example, the teaching of Yoon.
Yoon teaches the design, implementation, and results of a clinical trial (NCT01361646) for the pharmacokinetics (PK), pharmacodynamics (PD) and tolerability of LC350189, a xanthine oxidase inhibitor, in comparison to placebo and another known xanthine oxidase inhibitor, febuxostat. Yoon teaches the eligibility criteria for human subjects, (page 5034, section “Methods: Study Participants”) as well as the study design for determining pharmacokinetic and pharmacodynamic properties of LC350189. The study was conducted using a randomized (in each dose group), double-blind, active and placebo-controlled, dose-escalation design after a single dose (part I) and multiple doses (part II). In part I, study participants randomly received a single oral dose of LC350189 or placebo in the fasted state after an overnight fast at a ratio of 6:2 (10 mg and 25 mg) or 8:2 (50 mg, 100 mg, 200 mg, 400 mg, and 600 mg). Furthermore, those assigned to 200 mg repeated the study in the fed state after a 7-day washout to assess the effect of a high-fat diet on the PK profile of LC350189. In part II, study participants randomly received multiple oral doses of LC350189, febuxostat at 80 mg, or placebo once daily for 7 days in the fasted state after an overnight fast at a ratio of 8:2:2 (100 mg, 200 mg, 400 mg, and 600 mg) or 6:2 (LC350189: placebo, 800 mg). Subjects were admitted to the Clinical Trials Center on 3 days before drug administration and discharged after finishing scheduled procedures. Each subject was administered placebo to evaluate baseline PD characteristics (day −1). During the confinement period, the subjects were provided with standardized meals (except for the high-fat diet on day 8 for the 200 mg dose group) to minimize the effect of food on PK/PD evaluations. In the single ascending dose (SAD) study, PK blood collections were scheduled right before drug administration (0 hour) and at 16 time points afterward. In the multiple ascending dose (MAD) study, blood samples were collected before and after the first dose (day 1), just prior to dosing on days 3, 4, 5, and 6 and after the last dose on day 7. Additional blood samples were collected on days −1 and 1 in part I to determine of the serum concentrations of uric acid, xanthine, and hypoxanthine and plasma concentrations, which were repeated on day 8 for the 200 mg food effect study. On the other hand, blood samples were collected daily from days -1 to 10 in part II. Urine samples were collected over the prespecified time intervals to evaluate PK and PD (page 5035). For PK data, serum and urine concentrations of LC350189 were determined by chromatographic analysis of samples obtained from trial subjects, using mass spectrometry detection, while for PD data, serum concentrations of uric acid, xanthine, and hypoxanthine were determined by a similar chromatographic/mass spectrometry method (page 5047). The data were plotted by timepoints for each dose of LC350189 and the results evaluated. Yoon teaches that the study found that LC350189 was well tolerated in the dose range of 10–800 mg. It lowered the serum and urine uric acid levels substantially in this dose range; the extent of the decrease in the serum uric acid level in the 200 mg dose group was similar or higher compared to that of febuxostat 80 mg group in the MAD study (Abstract, page 5033).
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 8 and 12-15 of U.S. Patent No. 8,729,273 B2 (hereafter referred to as “Song”). Although the claims at issue are not identical, they are not patentably distinct from each other, for the following reasons:
Song’s claim 1 claims a genus of compounds that encompasses Tigulixostat;
Song’s claims 3-6 further limit the generic formula of claim 1 in ways that continue to encompass Tigulixostat;
Song’s claim 8 distinctly claims Tigulixostat by IUPAC name in a Markush group of specific compounds (first named compound in list);
Song’s claims 12-15 claim a pharmaceutical composition for the inhibition xanthine oxidase comprising any compound from Song’s claim 1 (therefore including Tigulixostat) and a pharmaceutically acceptable carrier, diluent, an excipient, or combination thereof.
Claims 1-4 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18/251,646 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of 18/251,646 claims a pharmaceutical composition comprising crystalline particles of Tigulixostat or its methyl ester derivative, along with a pharmaceutically acceptable excipient, thereby anticipating instant claims 1-4;
Claims 2-4 of 18/251,646 further limit the composition to ranges of weight percent of the crystalline particles of the compound to 20-70, 30-60, or 40-50 wt%, respectively, corresponding to the limitations of instant claims 7-9, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/255,241 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of 18/255,241 claims an oral formulation comprising an active pharmaceutical ingredient (API) selected from 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazol-4-carboxylic acid or a pharmaceutically acceptable salt thereof; and a glidant, thereby anticipating instant claims 1-5;
Claims 2-5 of 18/255,241 further limit the formulation in ways that continue to anticipate instant claim 1;
Claims 6-7 of 18/255,241 further limits the formulation to ranges of API content by weight, to 30-55 or 40-50 wt %, thereby anticipating instant claims 7-9;
Claim 8 of 18/255,241 further limits the formulation to a Markush group of specific doses of 50, 100, 200, or 300 mg per unit dosage form, corresponding to instant claims 10-13;
Claim 9 of 18/255,241 further limits the formulation according to any of claims 1-8 of 18/255,241 with regard to the purity of the API, being 97% or higher, and therefore still anticipates instant claims 1-5 and 7-13;
Claim 10 of 18/255,241 is drawn to a method of preparing an oral formulation that combines Tigulixostat or pharmaceutically acceptable salt thereof with a glidant, and therefore results in a composition that meets the limitations of instant claims 1-5;
Claims 11-13 of 18/255,241 further limit the method of claim 10 in ways that continue to anticipate instant claims 1-5.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/555,226 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of 18/555,226 claims an oral formulation comprising Tigulixostat and one or more excipients selected from diluents, disintegrants, glidants and lubricants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of copending Application No. 18/705,502 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 7-8 of 18/705,502 claim a formulation for oral dosage comprising Tigulixostat as the API, wherein the API content, by weight, is within a range of 30-55 or 40-50 wt%, which requires that another ingredient, i.e., an excipient, is included in the composition, thereby anticipating instant claims 1-5 and 7-9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Nahler, G., Dictionary of Pharmaceutical Medicine, “Formulation” – page 76; Springer-Verlag, Wien; 2009.
2 Cited in Applicant’s Information Disclosure Sheet dated 05/03/2024.