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 .
In view of the amendment filed by applicant on May 20, 2026, previous 112(b) rejection on claims 1-15 is hereby withdrawn. Therefore, previous 103 rejection over Lyman et al (US 2022/0395457 A1) is being reinstated (before the amendment of May 20, 2026, the prior art did not teach or suggest the previous limitation “wherein the Tmax is greater than a Tmax of a first reference dose and less than a Tmax of a second reference dose, wherein . . . delivered intramuscularly via an autoinjector”) because the prior art now teaches or renders obvious instant limitation (as amended in the amendment of May 20, 2026) “wherein the Tmax is earlier than a Tmax of a first reference dose and later than a Tmax of a second reference dose, wherein . . . delivered intramuscularly via an autoinjector.” as discussed below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lyman et al (US 2022/0395457 A1) (with Casale et al (“Pharmacokinetics/pharmacodynamics of epinephrine after single and repeat administration of neffy, EpiPen, and manual intramuscular injection”, Journal of Allergy and Clinical Immunology (December 2023), pg. 1587-1596, as obtained from the website: https://www.jacionline.org/article/S0091-6749(23)01059-X/pdf), which is being cited here merely to support the Examiner’s assertion that median Tmax for a 0.3 mg of epinephrine delivered intramuscularly via a manual injection (Epinephrine 1M) is 45 min and median Tmax for a 0.3 mg of epinephrine delivered intramuscularly via an autoinjector (EpiPen) is 7.50 min).
Lyman teaches (claim 20 and [0217]) a device for intranasal administration of a dry powder pharmaceutical composition, wherein the composition comprises epinephrine or its pharmaceutically acceptable salt and a carrier, which includes lactose (such as lactose monohydrate) and/or sodium carboxymethylcellulose. Lyman teaches that the dry powder pharmaceutical composition provides a (single) dose of about 0.5 mg to about 8 mg of the epinephrine or its salt. Such range overlaps with instant range about 3.5 mg to about 5.5 mg for the amount of epinephrine or its salt, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Lyman also teaches (abstract and [0256]) a method of treating a patient who is experiencing the symptoms of anaphylaxis by intranasally administering the dry powder formulation comprising epinephrine by using a delivery device (such as the device of its claim 20).
With respect to instant Tmax limitations of claims 1, 4, 9 and 15, Lyman teaches ([0174] and [0266]) that its dry powder formulation, when administered to a patient, reaches a maximal blood concentration (Tmax) of epinephrine in less than 60, 50, 40, 30, 20, 15, 10, 5, 3 or 1 minute(s) after administration. The ranges less than 60, 50, 40, 30 or 20 overlaps with instant Tmax ranges of claims 1 and 9 (about 15 minutes to about 30 minutes) and instant Tmax ranges of claims 4 and 15 (about 18 minutes to about 28 minutes), thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Alternatively, under the guideline (i.e., Tmax of less than 60, 50, 40, 30, 20, 15, 10, 5, 3 or 1 minute(s) after administration) given by Lyman, instant ranges of claims 1, 4, 9 and 15 would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to instant limitation of claims 1 and 9 “wherein the Tmax is earlier than a Tmax of a first reference dose and later than a Tmax of a second reference dose, wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector”, Lyman does not explicitly teach such limitation. However, as evidenced by Casale et al, median Tmax for a first reference dose (0.3 mg) of epinephrine that is delivered intramuscularly via a manual injection (Epinephrine IM) is 45 min, and median Tmax for a second reference dose (0.3 mg) of epinephrine that is delivered intramuscularly via an autoinjector (EpiPen) is 7.50 min (see Table I on pg.1589 and “Abbreviation used” on pg.1588). The Examiner already established above that Lyman’s teaching of Tmax values render obvious instant Tmax ranges of claims 1 and 9 (about 15 minutes to about 30 minutes) as well as instant Tmax ranges of claims 4 and 15 (about 18 minutes to about 28 minutes). Since the Tmax range about 15 minutes to about 30 minutes is earlier than 45 min (i.e., the Tmax of the first reference dose) and later than 7.5 min (i.e., the Tmax of the second reference dose), this means that Lyman’s Tmax values would naturally render obvious instant limitation quoted above as well.
Thus, Lyman renders obvious instant claims 1, 4, 6, 7, 9 and 13-15.
With respect to instant claims 2 and 10, Lyman teaches ([0179]) that its dry powder formulation further includes a second vasodilator in addition to epinephrine and teaches that such vasodilator is preferably not an alpha-adrenergic blocker because using alpha-adrenergic antagonists is problematic since these agents act to widen blood vessels in smooth muscle and counteract the intended therapeutic action of epinephrine itself. For such reason, it would be obvious to one skilled in the art not to include an alpha-adrenergic blocker in Lyman’s dry powder formulation. Thus, Lyman renders obvious instant claims 2 and 10.
With respect to instant claims 3 and 11, Lyman teaches ([0267]) that its dry powder formulation when administered increases the blood concentration of epinephrine by about 0.01 - 0.04 mg/mL (which is a baseline-corrected epinephrine concentration) in about less than 1 minute to about 15 minutes. Since the blood concentration of epinephrine already can increase by about 0.01-0.04 mg/mL (i.e., 10,000-40,000 pg/ml) in less than 1 minute, this surely would meet instant limitation of at least 100 pg/ml about 5 minutes after delivery of the single dose. Thus, Lyman renders obvious instant claims 3 and 11.
With respect to instant claims 5 and 12, in Table 3 (see [0397]), Lyman shows four batches of its epinephrine dry powder formulation, and Lyman’s Fig. 124 shows the particle size distribution of the sprayed out or actuated out (emitted) formulations of each batch (see [0400] and Fig.124). According to the figure, the Dv(50) for those four batches ranges from 19 mm to 184 mm. Such range overlaps with instant range of about 25 microns to 200 microns, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Lyman renders obvious instant claims 5 and 12.
With respect to instant claim 8, Lyman determines (see [0401] including Table 4) the moisture content of each of the four batches of its epinephrine dry powder formulation shown in Table 3. Table 4 shows that the moisture content ranges from 4.34% to 13.09%. Such range overlaps with instant range of about 3% to 6%, thus rendering instant moisture content range prima facie obvious. In re Wertheim, supra. Thus Lyman renders obvious instant claim 8.
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.
Claim 9-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 19/243,303 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 1 of App.’303 states the following:
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Furthermore, claim 3 of App.’303 teaches that the Tmax for the epinephrine is between about 18-28 minutes, and such Tmax range overlaps with instant range of about 15-30 minutes, thus rendering instant range prima facie obvious. In re Wertheim, supra. Also, the Tmax range about 18-28 minutes is earlier than the Tmax (45 min as discussed above) of a first reference dose and later than a Tmax (7.5 min as discussed above) of a second reference dose. Also, claim 6 of App.’303 teaches the use of a carrier, which is lactose. Thus, claims 1, 3 and 6 of App.’303 renders obvious instant claims 9, 13 and 15. Also, Claims 4, 2 and 5 of App.’303 teach or render obvious instant claims 10, 11 and 12, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4 and 6-8 of copending Application No. 19/242,195 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 1 of App.’195 teaches the following:
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Thus, Claim 1 of App.’195 teaches instant method of claim 9 except for instant limitation as to the Tmax of epinephrine being about 15-30 minutes. However, since claim 1 teaches that the Tmax of epinephrine is earlier than Tmax (45 min as discussed above) of the first reference dose and later than Tmax (7.5 min as discussed above) of the second reference dose, this means that the Tmax of epinephrine would range from greater than 7.5 min to less than 45 min. Such range overlaps with instant Tmax range (about 15-30 minutes), thus rendering instant range prima facie obvious. In re Wertheim, supra. Claims 6 and 7 of App.’195 teach the use of lactose and lactose monohydrate as the carrier of its claim 1. Thus, claims 1, 6 and 7 of App.’195 render obvious instant claims 9 and 13-15. Furthermore, claim 8 of App.’195 teaches or renders obvious instant claim 10; claim 4 of App.’195 teaches or renders obvious instant claim 11; and claim 2 of App.’195 teaches or renders obvious instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
August 22, 2026
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