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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 05/07/2026 has been entered.
DETAILED ACTION
Claims 1-20 are pending in the Claim Set filed 5/07/2026.
Applicants elected without traverse Group I: claims 1-14 in the reply filed on 10/29/2025. Further, Applicants elected species without traverse a combination of physiological changes: i, ii and iii and a carrier that is Lactose.
Claims 1, 8, 9 and 18 have been amended.
Claims 7 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Species election was made without traverse in the reply filed on 10/29/2025.
Herein, claims 1-6 and 8-14 are for examination to the extent that they read on the elected species.
This Office Action contains New Grounds of Rejection.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 8-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
There is lack of written description for claims 1 and 9.
Claim 1 (Currently Amended) recites:
A method for intranasal administration of a dry powder pharmaceutical composition comprising: intranasally administering to a human a single dose of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof; wherein the single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof; and wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 at least at least 35
Claim 9 (Currently Amended) recites:
A method for intranasal administration of a dry powder pharmaceutical composition comprising: intranasally administering to a human a single dose of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof and a carrier; wherein the single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof; and wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 at least for a duration of at least 35
A complete search of Instant Specification did not provide support for the limitation(s):
Claim 1, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 at least at least 35 .
Claim Interpretation
Regarding claim 1:
The phrase: ‘at least 50 minutes’ would encompass an increase in systolic blood pressure by at least 10 mm Hg for 50 minutes and longer, i.e., 50 minutes and any value larger than 50 minutes.
The phrase ‘at least 50 minutes’ would encompass an increased heart rate of at least 10 beats per minute for a duration of 50 minutes and longer, i.e., 50 minutes any value larger than 50 minutes.
The phrase: ‘at least 35 minutes’ would encompass an increased diastolic blood pressure by at least 10 mm Hg for a duration of 35 minutes and longer, i.e., 35 minutes and any value larger than 35 minutes.
Claim 9, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35
Claim Interpretation
Regarding claim 9:
The phrase: ‘at least 50 minutes’ would encompass an increase in systolic blood pressure by at least 10 mm Hg for 50 minutes and longer, i.e., 50 minutes and any value larger than 50 minutes.
The phrase ‘at least 50 minutes’ would encompass an increased heart rate of at least 10 beats per minute for a duration of 50 minutes and longer, i.e., 50 minutes any value larger than 50 minutes.
The phrase: ‘at least 35 minutes’ would encompass an increased diastolic blood pressure by at least 10 mm Hg for a duration of 35 minutes and longer, i.e., 35 minutes and any value larger than 35 minutes.
Applicants’ arguments presented in the reply filed 5/7/2026:
Support for Amendments to the Claims
Applicants argue: Claim 1 has been amended to recite, in part, "wherein the intranasal administration of the single dose produces ... an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose." Support for this amendment, and an analogous amendment to claim 9, can be found, inter alia, in original Figure 64 as filed and in paragraphs [00182], [00309], [00311], [00327], and [00336] as filed.
[00182] The dry powder epinephrine compositions, methods of intranasal delivery, and drug products for the intranasal delivery of epinephrine disclosed herein can also produce advantageous pharmacodynamic (PD) results. Specifically, the pharmacodynamic response to intranasal delivery of the dry powder epinephrine compositions described herein show a desired increase in blood pressure and/or heart rate, while also maintaining these parameters with a desired range. For example, in some embodiments, the intranasal administration of a dose of epinephrine produces at
least one of an increase in systolic blood pressure by at least 10 mm Hg for a duration of up to 50 minutes after administration of the single dose or an increased heart rate of at least 10 beats per minute for a duration of up to 50 minutes after administration of the single dose.
Examiner Remarks: The phrase ‘systolic blood pressure by at least 10 mm Hg for a duration of up to 50 minutes, fails to provide support for an increase in systolic blood pressure by at least 10 mm Hg for 50 minutes and longer, i.e., 50 minutes and any value larger than 50 minutes.
[00311] Heart rate and blood pressure analysis was conducted using change from baseline values for each individual subject. All treatments had effects on increasing heart rate, systolic blood pressure, and mean arterial pressure (MAP) with minimal effects on diastolic blood pressure. Greater effects were observed on heart rate and blood pressure for IN versus IM dosing, suggesting IN BBP0l may provide greater efficacy at concentrations that are not much higher than IM dosing.
Examiner’s remarks: Thus, para. [00311] fails to provide support for: an increase in systolic blood pressure by at least 10 mm Hg for 50 minutes and longer, i.e., 50 minutes and any value larger than 50 minutes; an increased heart rate of at least 10 beats per minute for a duration of 50 minutes and longer, i.e., 50 minutes any value larger than 50 minutes; an increased diastolic blood pressure by at least 10 mm Hg for a duration of 35 minutes and longer, i.e., 30 minutes and any value larger than 35 minutes.
[00327] FIGS. 81 and 82 show comparisons of heart rate of patients over time after treatment with both intramuscular doses and intranasal doses of the composition of the present invention. Similar to the effects on systolic blood pressure, the intranasal doses produced a more pronounced increase in heart rate in patients relative to the intramuscular doses, while still being within a safe range of physiological effects. However, the timing of the peak heart rate effects of the intranasal doses appears to be comparable to the timing of the peak heart rate effects of the intramuscular doses.
Additionally, both the high and low intranasal doses according to the present invention cause a sustained increase in heart rate compared to either intramuscular dose. A low or no dose response was observed between both the high and low intranasal doses according to the present invention.
Examiner’s remarks: claim 1 recites: an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose. Thus, the phrase ‘at least 50 minutes’ would encompass an increased heart rate of at least 10 beats per minute for a duration of greater than 50 minutes. Fig. 81 show increased in heart rate of at least 10 beats per minute for a duration of about 90 minutes but not longer than this. Further, Fig. 82 shows a heart rate of less than 10 beats per minute for a duration interval of 20-30 minutes. Therefore, para. [00327] fails to provide support for an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose. Moreover, Fig. 82 fails to show an increased in heart rate beyond 60 minutes.
[00336] FIGS. 94 and 95 show comparisons of heart rate of patients over time after treatment with the intramuscular dose and intranasal doses of the composition of the present invention. Similar to the effects on systolic blood pressure, the intranasal doses produced a more pronounced increase in heart rate in patients relative to the intramuscular doses, while still being within a safe range of physiological effects. However, the timing of the peak heart rate effects of the intranasal doses appears to be comparable to the timing of the peak heart rate effects of the intramuscular doses.
Additionally, both the high and low intranasal doses according to the present invention cause a sustained increase in heart rate compared to the intramuscular dose. These results confirm the results of Study 101. A low or no dose response was observed between both the high and low intranasal doses according to the present invention.
Examiner’s remarks: claim 1 recites: an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose. Thus, the phrase ‘at least 50 minutes’ would encompass an increased heart rate of at least 10 beats per minute for a duration of greater than 50 minutes. Fig. 94 shows increased in heart rate of at least 10 beats per minute at a duration of about 10 minutes, about 35 minutes and about 60-150 minutes. But Fig. 94 fails to shows an increased heart rate of at least 10 beats per minute for the entire duration of at least 50 minutes after administration of the single dose. Moreover, Fig. 94 fails to show an increased in heart rate beyond about 150 minutes. Similarly, Fig. 95 fails to show an increased heart rate of at least 10 beats per minute for the entire duration of at least 50 minutes after administration of the single dose. Fig. 95 fails to show an increased in heart rate beyond about 60 minutes. Moreover, Fig. 82 fails to show an increased in heart rate beyond 60 minutes. Therefore, Fig. 94 and Fig. 95 fail to provide support for an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose. Moreover, Fig. 82 fails to show an increased in heart rate beyond 60 minutes.
Applicants argue: Claim 1 has been amended to recite, in part, "wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose." Support for this amendment, and an analogous amendment to claim 9, can be found, inter alia, in original Figure 65 and in paragraphs [00182], [00310], [00326], and [00335] of the specification as filed.
[00182] The dry powder epinephrine compositions, methods of intranasal delivery, and drug products for the intranasal delivery of epinephrine disclosed herein can also produce advantageous pharmacodynamic (PD) results. Specifically, the pharmacodynamic response to intranasal delivery of the dry powder epinephrine compositions described herein show a desired increase in blood pressure and/or heart rate, while also maintaining these parameters with a desired range. For example, in some embodiments, the intranasal administration of a dose of epinephrine produces at least one of an increase in systolic blood pressure by at least 10 mm Hg for a duration of up to 50 minutes after administration of the single dose or an increased heart rate of at least 10 beats per minute for a duration of up to 50 minutes after administration of the single dose.
Fig. 65: See Drawings filed 6/19/2025.
[00310] FIG. 65 is a graph of the mean baseline-corrected systolic blood pressure by treatment. FIG. 66 is a graph of the mean baseline-corrected diastolic blood pressure by treatment. FIG. 67 is a graph of the mean baseline-corrected mean arterial blood pressure by treatment.
Examiner’s remarks: Claim 1 recites, in part: the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose. However, Fig. [0065] fails to provide support for the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose. The phrase ‘at least 50 minutes’ would encompass the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of greater than 50 minutes after administration of the single dose. Further, para. [00182] fails to provide support the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose. Figure [065] extends only to about 250 minutes, wherein at about 85 minutes fails to show a single dose produces an increase in systolic blood pressure by at least 10 mm Hg.
Specification at page 12:
[00109] FIG. 66 illustrates a graph of the mean baseline-corrected diastolic blood pressure by treatment in humans.
[00110] FIG. 67 illustrates a graph of the mean baseline-corrected mean arterial blood pressure by treatment in humans.
Fig. 65 and 67 fail to show a single dose produces an increase in systolic blood pressure by at least 10 mm Hg.
[00326] FIGS. 79 and 80 show comparisons of systolic blood pressure of patients over time after treatment with both intramuscular doses and intranasal doses of the composition of the present invention. As shown in FIGS. 79 and 80, both the high and low intranasal doses according to the present invention caused a more pronounced and earlier onset increase in systolic blood pressure compared to either intramuscular dose, while still being within a safe range of physiological effects.
Additionally, both the high and low intranasal doses according to the present invention cause a sustained increase in systolic blood pressure compared to either intramuscular dose. A low or no dose response was observed between both the high and low intranasal doses according to the present invention. These results indicate that the intranasal doses act faster and longer in providing relief than comparable intramuscular doses.
Examiner’s remarks: Figures 79 and 80 fail to show the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for the entire duration of at least 50 minutes after administration of the single dose, i.e., greater than 50 minutes.
[00335] FIGS. 92 and 93 show comparisons of systolic blood pressure of patients over time after treatment with both the intramuscular dose and intranasal doses of the composition of the present invention. As shown in FIGS. 92 and 93, both the high and low intranasal doses according to the present invention caused a more pronounced and earlier onset increase in systolic blood pressure compared to either intramuscular dose, while still being within a safe range of physiological effects.
Additionally, both the high and low intranasal doses according to the present invention cause a sustained increase in systolic blood pressure compared to the intramuscular dose. These results indicate that the intranasal doses act faster and longer in providing relief than comparable.
Examiner’s remarks: Figures 92 fails to show the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for the duration of at least 50 minutes after administration of the single dose, i.e., greater than 50 minutes. Figure 92 is below 10 mm Hg after about 90 minutes. Figures 93 shows a systolic blood pressure that is less than 10 mm Hg for a 5.5 mg dose IN at about 30 minutes. Moreover, Fig. 93 fails to show an increased in systolic blood pressure that is less than 10 mm Hg beyond 60 minutes.
Applicants argue: Claim 1 has been amended to recite, in part, "wherein the intranasal administration of the single dose produces ... an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose." Support for this amendment, and an analogous amendment to claim 9, can be found, inter alia, in original Figure 84 as filed, and in paragraph [00328] of the specification as filed.
Examiner’s remarks: Figure 84 fails to show an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose. The phrase ‘at least 35 minutes’ would encompass an increased diastolic blood pressure by at least 10 mm Hg for a duration greater than at least 35 minutes. Moreover, doses at 3.5 mg and 5.5 mg IN have lower than diastolic blood pressure by at least 10 mm Hg at about up to 10 minutes.
Applicants argue in the reply filed 5/7/2026 that support for this amendment, and an analogous amendment to claim 9, can be found, inter alia, in original Figure 84 as filed, and in paragraph [00328] of the specification as filed.
Examiners remarks: Figure 84 fails to show an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose. Thus, the phrase ‘at least 35 minutes’ would encompass an increased diastolic blood pressure by at least 10 mm Hg for a duration greater than at least 35 minutes. Moreover, doses at 3.5 mg and 5.5 mg IN have lower than diastolic blood pressure by at least 10 mm Hg at about up to 10 minutes.
[00328] FIGS. 83 and 84 show comparisons of diastolic blood pressure of patients over time after treatment with both intramuscular doses and intranasal doses of the composition of the present invention. As shown in FIGS. 83 and 84, both the high and low intranasal doses according to the present invention caused a more pronounced and earlier onset increase in diastolic blood pressure compared to either intramuscular dose, while still being within a safe range of physiological effects.
Additionally, both the high and low intranasal doses according to the present invention cause a sustained increase in diastolic blood pressure compared to either intramuscular dose. These results indicate that the intranasal doses act faster and longer in providing relief than comparable intramuscular doses. A low or no dose response was observed between both the high and low intranasal doses according to the present invention.
Examiners remarks: Figure 84 fails to show an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose. Fig.84 fails to show support for an increased diastolic blood pressure by at least 10 mm Hg after about 60 minutes.
‘at least 35 minutes’ would encompass an increased diastolic blood pressure by at least 10 mm Hg for a duration of 35 minutes and longer, i.e., 35 minutes and any value larger than 35 minutes.
Therefore, the disclosure fails to provide support for: Claim 1, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose.
Therefore, the disclosure fails to provide support for: Claim 9, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose.
M.P.E.P. §2163 states that amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g. In re Lukach 442 F.2d 967, 169 USPQ (CCPA 1971).
Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter.
The remaining claims do not resolve the issues with claim 1 and 2. Therefore, the remaining claim are rejected as depending from a rejected claim.
Claim Rejections - 35 USC § 103
(rejection is reformulated in view of claim amendments)
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 of this title, 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 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 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 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lyman et al (US 2022/0395457, of record) [Lyman].
Regarding claims 1-6 and 8-14,
Lyman teaches a method of administering intranasal administration of a dry powder formulations comprising epinephrine alone or in combination with at least one carrier, suitable for nasal application, wherein the dry powder formulations is sprayed in the human nasal passage (Abstract; [0011]; See entire document). Lyman teaches the dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof ([0012], [00170]). Lyman teaches the carrier is lactose (([0014]; [028-0040]; [0149]; [0151]; [0217]; [0217]). Lyman teaches that provided herein are pharmaceutical formulations comprising a single dose of dry powder epinephrine in an amount of 3.0 to 4.5 mg [0170]; [0177]; [0180]; [0264]) and at least one dry powder enabling agent, i.e., carrier, that have optimized systemic delivery of epinephrine through the nasal passages, wherein the agent/carrier is lactose ([0169] / [0217]; [0233]). (lactose is elected carrier). Moreover, Lyman teaches that lactose optimizes the systemic delivery of epinephrine through the nasal passage and affects the transport of epinephrine across the nasal mucosa [0293].
Lyman teaches a baseline-corrected epinephrine concentration present in the body is at least 100 pg/mL after about 5 minutes after delivery of the dose ([0174]-[0176]). Further, Lyman teaches that Tmax ranged from 10 to 30 minutes for lactose [0349].
In addition, Lyman teaches one of the primary therapeutic goals of administering epinephrine during anaphylactic events is to counteract the drop in peripheral circulatory blood pressure, so the use of alpha-adrenergic antagonists is problematic because these agents act to widen blood vessels in smooth muscle and counteract the intended therapeutic action of epinephrine itself [0166]. Thus, Lyman makes obvious no alpha-adrenergic antagonists is included in the composition.
Lyman teaches the dry powder pharmaceutical composition is formulated such that delivery of the dose of the dry powder pharmaceutical composition via a delivery aperture produces a spray having an emitted particle size distribution characterized by a Dv50 of between about 25 microns and about 200 microns ([0298-0299]).
Lyman teaches the dry powder pharmaceutical composition has a moisture content of between about 3% and about 6% (see para [0401] and figure 123). Particularly, Lyman teaches the epinephrine composition is hygroscopic having a water content of about 4% water (moisture content) ([0401]; Table 4).
Furthermore, Lyman teaches in some embodiments, the method of treating a subject includes the intranasal administration of the dry powder composition disclosed herein, wherein the method of treating a subject by increasing the heart rate of the subject includes the intranasal administration of the dry powder composition disclosed herein [0464].
The method of administering intranasal administration of a dry powder formulations comprising epinephrine and the carrier lactose to a human in single dose as taught by Lyman is structurally and chemically indistinguishable from the claimed method of administration of a dry powder comprising epinephrine and the carrier lactose to a human in single dose, so that it would necessarily follow that the method of administering intranasal administration of a dry powder formulations as taught by Lyman would provide intranasal administration of a single dose that produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose. Inherency may supply a missing claim limitation in an obviousness analysis so long as the limitation at issue necessarily must be present, or is the natural result of the combination of elements disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms, Inc., 773 F, 3d 1186, 1196 (Fed. Cir. 2014). This property would be the natural result of the combination of the prior art elements. Inherency is appropriate in an obviousness analysis "when the limitation at issue is the 'natural result' of the combination of prior art elements." PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (quoting In re Oelrich, 666 F.2d 578, 581(CCPA 1981)).
Since Lyman teaches the dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof, it would necessarily follow that administering a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt would produce the following properties, as instantly claims:
Claim 1, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose.
Claim 9, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose.
Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
"The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004).
It would have been obvious to combine these known ingredients of epinephrine and the carrier lactose to a human in single because Lyman teaches their inclusion together in a dry powder formulation to a human in single dose. Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists. All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Accordingly, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Lyman.
Response to Arguments
Applicants argue that to advance prosecution, Applicant has amended claim 1 to recite, in part, "wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose." The sustained pharmacodynamic effects of the claimed composition, including the increase in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR), were unknown and unexpected properties based on the prior art, and thus, not inherent properties of the prior art. As disclosed in the specification as filed, the composition caused a surprising, sustained increase in systolic blood pressure (paras. [00326] and [00335]), heart rate (paras. [00327] and [00336]), and diastolic blood pressure (para. [00328]), as compared to either intramuscular dose (0.3 mg intramuscular injection (equivalent to the dosage and method of administration common in the art) and 0.5 mg intramuscular injection).
According to Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 773 F.3d 1186 (Fed. Cir. 2014), inherency "may supply a missing claim limitation in an obviousness analysis," however, "the use of inherency, a doctrine originally rooted in anticipation, must be carefully circumscribed in the context of obviousness". Id "The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency." Id "Obviousness cannot be predicated on what is unknown."
The Federal Circuit court has stated multiple times that inherency in the context of obviousness must be carefully limited because "that which may be inherent is not necessarily known and that which is unknown cannot be obvious." Honeywell Int 'l Inc. v. Mexichem Amanco Holding S.A. DEC. V (Fed. Cir. 2017). Further in Honeywell, the Federal Circuit court stated "[w]hat is important regarding properties that may be inherent, but unknown, is whether they are unexpected. All properties of a composition are inherent in that composition, but unexpected properties may cause what may appear to be an obvious composition to be nonobvious." Id (emphasis added). Thus, a property of a composition is not automatically inherent if such property was unexpected. Further, the court in Honeywell further urged that applying the inherency doctrine requires consideration "as to unpredictability and unexpectedness.
As applied to the present application, the sustained increases in heart rate and blood pressure (systolic and diastolic), were unexpected and surprising. While epinephrine is a neurotransmitter released in response to stress, thereby naturally causing an increase in heart rate and blood pressure, the known compositions and methods for delivering epinephrine in the art, primarily a 0.3 mg intramuscular injection, have not exhibited the surprising, sustained increase in heart rate and blood pressure caused by the present application. For example, group B (orange, 0.3 mg intramuscular (IM) epinephrine) shown in FIG. 64 as filed does not exhibit an increase in 10 beats per minute at all, let alone for the minimum duration of 50 minutes. Thus, one having ordinary skill in the art would not naturally expect a dry powder composition to provide such a drastic sustained increase in heart rate and blood pressure. Nor does the cited prior art (Lyman) disclose the sustained increase in heart rate and/or blood pressure. Nothing in Lyman would cause one having ordinary skill in the art to presume the sustained increase in pharmacodynamic effects of the present invention are inherent to Lyman, because of the surprising and unexpected nature of the sustained increase in pharmacodynamic effects.
Thus, when considering the unpredictability of and unexpectedness of the sustained pharmacodynamic effects of the present application, Applicant submits that the cited prior art does not teach "wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose." Claim 9: For at least the reasons recited with respect to claim 1, claim 9 is nonobvious in light of the cited prior art under 35 U.S.C. 103.
Applications’ arguments have been fully considered but they are not persuasive, because Lyman (single reference) explicitly teaches the dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof, dry powder pharmaceutical composition is formulated such that delivery of the dose of the dry powder pharmaceutical composition via a delivery aperture produces a spray having an emitted particle size distribution characterized by a Dv50 of between about 25 microns and about 200 microns , wherein the dry powder pharmaceutical composition has a moisture content of between about 3% and about 6%. Thus, it would necessarily follow that administering a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt would produce the following properties as instantly claims:
Claim 1, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose.
Claim 9, in part: wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose.
Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Inherency is appropriate in an obviousness analysis "when the limitation at issue is the 'natural result' of the combination of prior art elements." PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (quoting In re Oelrich, 666 F.2d 578, 581(CCPA 1981)). Thus, it would necessarily follow that the method of administering intranasal administration of a dry powder formulations comprising epinephrine alone or in combination with at least one carrier, suitable for nasal application, wherein the dry powder formulations is sprayed in the human nasal passage, as taught by Lyman, would provide a sustained pharmacodynamic effects comprising an increase in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)." Additionally, Par Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc. (Fed. Cir. 2014) even supports the Office's argument because the trial court found that claims drawn to a previously unknown function (e.g., sustained pharmacodynamic effect) were obvious because the structure of the composition considered to give rise to the effect, i.e., a baseline-corrected epinephrine concentration present in the body is at least 100 pg/mL after about 5 minutes after delivery of the dose and Tmax ranged from 10 to 30 minutes for lactose, was already known in the prior art of Lyman.
"When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. Applicants have failed to show that the Lyman disclosing administering a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt would not produce the following properties as instantly claims:
Furthermore, Applicants have failed to address the issue between the differences in dosage amounts of IM versus IN in group B (0.3 mg intramuscular (IM) epinephrine) shown in FIG. 64 and the dosage amounts of 3.5 and 5.5 mg Intranasal. (IN). Large dose differences between nasal administration (IN) and intramuscular administration (IM) do not always scale linearly due to how the body handles high drug amounts. Applicants have failed to discuss why a high nasal dose (IN), e.g., 3.5 mg, does not just equal ten times an intramuscular dose (IM), e.g. 0.3 mg.
Moreover, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004).
Regarding unexpected results:
MPEP 716.02(d) Unexpected Results Commensurate in Scope with Claimed Invention [R-08.2012]
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Thus, in the instant case, the unexpected results are not commensurate in scope with what is instantly claimed, because the scope of Instant Claims encompasses: Regarding claims 1 and 9: ‘at least 50 minutes’ would encompass an increase in systolic blood pressure by at least 10 mm Hg for 50 minutes and longer, i.e., 50 minutes and any value larger than 50 minutes; ‘at least 50 minutes’ would encompass an increased heart rate of at least 10 beats per minute for a duration of 50 minutes and longer, i.e., 50 minutes any value larger than 50 minutes; and, ‘at least 35 minutes’ would encompass an increased diastolic blood pressure by at least 10 mm Hg for a duration of 35 minutes and longer, i.e., 35 minutes and any value larger than 35 minutes.
That is, the method of intranasal administration of a dry powder that generated said alleged unexpected results are not commensurate in scope with cosmetic composition which is presently claimed (i.e., results generated by a single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof.
MPEP 716.02(d) II. DEMONSTRATING CRITICALITY OF A CLAIMED RANGE
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Applicants have not presented results demonstrating that the unexpected results lie inside the entire scope of the claimed invention compared to results that fall outside the claimed range. Applicants bear the burden to establish that the results are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
Therefore, in the absence of evidence to the contrary regarding Lyman, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Lyman.
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 1-4, 6, 9, 10, 11, 12, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9-14 of copending Application No. 19698256 (herein ‘256 claims).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claims are directed to a method for intranasal administration of a dry powder pharmaceutical composition comprising: intranasally administering to a human a single dose of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof; wherein the single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof; and wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose (claim 1); wherein a mean baseline-corrected epinephrine concentration present in the human is at least 100 pg/mL after between about 5 minutes to about 15 minutes after delivery of the single dose (claim 2); wherein the intranasal administration of the single dose produces plasma epinephrine concentrations in the human with the time to reach the maximum epinephrine plasma concentration (Tmax) between about 18 minutes and about 28 minutes (claim 3); wherein the dry powder pharmaceutical composition does not include an alpha-adrenergic blocker (claim 4); wherein the dry powder pharmaceutical composition further comprises a carrier, wherein the carrier is lactose (claim 6);
Further, Instant Claims are directed to a method for intranasal administration of a dry powder pharmaceutical composition comprising: intranasally administering to a human a single dose of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof and a carrier; wherein the single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof; and wherein the intranasal administration of the single dose produces an increase in systolic blood pressure by at least 10 mm Hg for a duration of at least 50 minutes after administration of the single dose, an increased heart rate of at least 10 beats per minute for a duration of at least 50 minutes after administration of the single dose, and an increased diastolic blood pressure by at least 10 mm Hg for a duration of at least 35 minutes after administration of the single dose (claim 9); wherein a mean baseline-corrected epinephrine concentration present in the human is at least 100 pg/mL after between about 5 minutes to about 15 minutes after delivery of the single dose (claim 10); wherein the intranasal administration of the single dose produces plasma epinephrine concentrations in the human with the time to reach the maximum epinephrine plasma concentration (Tmax) between about 18 minutes and about 28 minutes (claim 11); wherein the dry powder pharmaceutical composition does not include an alpha-adrenergic blocker (claim 12); wherein the carrier is lactose (claim 14).
‘256 claims are directed to a method for intranasal administration of a dry powder pharmaceutical composition comprising intranasally administering a dose of a dry powder pharmaceutical composition; wherein the dry powder pharmaceutical composition comprises a sole active ingredient a earner; wherein the sole active ingredient consists of epinephrine or a pharmaceutically acceptable salt thereof (claim 9); wherein the dose of the dry powder pharmaceutical composition provides about 0.01 mg to about 10 mg of the epinephrine or the pharmaceutically acceptable salt thereof (claim 10); wherein the carrier is lactose monohydrate (claim 11); wherein the dry powder pharmaceutical composition does not include a preservative (claim 12); wherein the dry powder pharmaceutical composition does not include an alpha-adrenergic blocker (claim 13); wherein the carrier includes mannitol, a cyclodextrin, citric acid, lactose, and/or sodium carboxymethylcellulose (claim 14).
The difference between ‘256 claims and instant claims is that the ‘256 do not recite the properties of instant claims 1-3 and 9-11. However, ‘256 claims recite a method for intranasal administration of a dry powder pharmaceutical composition comprising intranasally administering a dose of a dry powder pharmaceutical composition; wherein the dry powder pharmaceutical composition comprises a sole active ingredient a earner; wherein the sole active ingredient consists of epinephrine or a pharmaceutically acceptable salt thereof (claim 9); wherein the dose of the dry powder pharmaceutical composition provides about 0.01 mg to about 10 mg of the epinephrine or the pharmaceutically acceptable salt thereof (claim 10), which renders obvious the a method for intranasal administration of a dry powder pharmaceutical composition comprising: intranasally administering to a human a single dose of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof; wherein the single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt. Further, the range amounts of epinephrine as recited the ’256 claims encompassed the claimed range amounts. 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). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Inherency is appropriate in an obviousness analysis "when the limitation at issue is the 'natural result' of the combination of prior art elements." PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (quoting In re Oelrich, 666 F.2d 578, 581(CCPA 1981)). The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). Moreover, it would have been well within the purview of one of ordinary skill to optimize the dosage amounts recited in the ‘256 claim to provide the claimed range amount having a reasonable expectation of success. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. One would have been motivated to determine the optimal dosage range to best achieve the desired results of a method for the administration of epinephrine to necessarily provide the claimed properties. See Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955) & MPEP 2144.05.
Thus, Instant Claims and ‘5256 claims are obviously directed to common subject matter. Accordingly, it would have been prima facie obvious to one of skill in the art to provide a method for intranasal administration of a dry powder pharmaceutical composition comprising: intranasally administering to a human a single dose of a dry powder pharmaceutical composition comprising epinephrine or a pharmaceutically acceptable salt thereof; wherein the single dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of epinephrine or a pharmaceutically acceptable salt thereof in view of the ‘256 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-270-1307. Examiner can normally be reached Monday-Friday 11:00am-5:00pm EST.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
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