Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The claims are objected to because of the following informalities:
Claim 72-76 should recite “the” dihydroergotamine.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 57-78 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.
It is unclear if the therapeutic formulation in claim 57 is being positively recited or not since it is functionally recited in the preamble and then referred to again in the body of the claim. It is unclear if the reservoir just has to be capable of holding the therapeutic compound of if the reservoir has to contain that specific compound. For purposes of examination it has been interpreted as the latter.
All dependent claims are rejected due to their dependency on claim 57.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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.
Claim(s) 61-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki et al. (EP 0796628 B1) in view of Armer et al. (US 2014/0179706 A1).
Regarding claim 57, Ohki discloses: A device for delivering a therapeutic formulation (figure 2 of figure 5), wherein the device comprises:
a reservoir (K) comprising an interior volume (volume within K), the therapeutic formulation in the interior volume [0024], and
a tray (5) arranged to trap the therapeutic formulation fallen from said reservoir (figure 3),
Ohki does not disclose: wherein the therapeutic formulation comprises dihydroergotamine or a pharmaceutically acceptable salt thereof.
However, Armer teaches it is known to deliver a therapeutic formulation comprising dihydroergotamine or a pharmaceutically acceptable salt thereof with a dry powder inhaler [0022].
It would have been obvious to have modified Ohki such that the therapeutic formulation comprises dihydroergotamine or a pharmaceutically acceptable salt thereof in order to treating, preventing or ameliorating symptoms of medical disorders as set forth in [0022].
Regarding claim 58, Ohki further discloses the device comprising a valve (10, 39 regulate flow), wherein the valve comprises an opening (10, 39).
Regarding claim 59, Ohki further discloses the device further comprising a valve (10, 39 regulate flow) that is stationary during activation of the device (10, 39 do not move as shown in figure 3 for example).
Regarding claim 60, Ohki further discloses the device further comprising a valve (50), a nozzle (49), and a retainer (45), wherein the valve contacts the nozzle and the retainer simultaneously (see figure 6).
Regarding claim 61, Ohki further discloses the device further comprising an air-intake hole (46) that allows outside air to enter the device [0057].
Regarding claim 62, Ohki further discloses wherein the air-intake hole comprises two air intake holes [0057].
Regarding claim 63, Ohki further discloses further comprising a retainer comprising the air-intake hole (42; see figure 7).
Regarding claim 64, Ohki as modified further discloses wherein the therapeutic formulation further comprises microcrystalline cellulose (Armer: [0105]).
Claim(s) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki et al. (EP 0796628 B1) in view of Armer et al. (US 2014/0179706 A1) in further view of Ngheim et al. (US 2009/0004281 A1).
Regarding claim 65, Ohki as modified does not explicitly disclose wherein the therapeutic formulation comprises at least about 40% w/w of microcrystalline cellulose.
However Ngheim teaches dihydroergotamine delivery [0178] via inhalation [0156] wherein the therapeutic formulation comprises at least about 40% w/w of microcrystalline cellulose [0241].
It would have been obvious to have modified Ohki wherein the therapeutic formulation comprises at least about 40% w/w of microcrystalline cellulose in order to appropriately deliver the therapeutic substance.
Claim(s) 57, 69-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki et al. (EP 0796628 B1) in view of Dickens (GB 2400565 A).
Regarding claim 57, Ohki discloses: A device for delivering a therapeutic formulation (figure 2 of figure 5), wherein the device comprises:
a reservoir (K) comprising an interior volume (volume within K), the therapeutic formulation in the interior volume [0024], and
a tray (5) arranged to trap the therapeutic formulation fallen from said reservoir (figure 3),
Ohki does not disclose: wherein the therapeutic formulation comprises dihydroergotamine or a pharmaceutically acceptable salt thereof.
However, Dickens teaches it is known to deliver a therapeutic formulation comprising dihydroergotamine or a pharmaceutically acceptable salt thereof with a dry powder inhaler (page 11 describes the therapeutic formulation which includes mixtures thereof as the paragraph ends on page 13, line 16 on page 11 specifically states dihydroergotamine).
It would have been obvious to have modified Ohki such that the therapeutic formulation comprises dihydroergotamine or a pharmaceutically acceptable salt thereof in order to treat migraines (Page 13, second paragraph).
Regarding claim 69, Ohki as modified further discloses wherein the therapeutic formulation further comprises a sugar alcohol (Dickens: mannitol on page 12, line 7).
Regarding claim 70, Ohki as modified further discloses wherein the sugar alcohol comprises mannitol (Dickens: page 12, line 7).
Claim(s) 57, 66-67, 72-78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki et al. (EP 0796628 B1) in view of Othmar (GB 2170407 A).
Regarding claim 57, Ohki discloses: A device for delivering a therapeutic formulation (figure 2 of figure 5), wherein the device comprises:
a reservoir (K) comprising an interior volume (volume within K), the therapeutic formulation in the interior volume [0024], and
a tray (5) arranged to trap the therapeutic formulation fallen from said reservoir (figure 3),
Ohki does not disclose: wherein the therapeutic formulation comprises dihydroergotamine or a pharmaceutically acceptable salt thereof.
However, Othmar teaches it is known to deliver a therapeutic formulation comprising dihydroergotamine or a pharmaceutically acceptable salt thereof (page 1, lines 30-33).
It would have been obvious to have modified Ohki such that the therapeutic formulation comprises dihydroergotamine or a pharmaceutically acceptable salt thereof in order to receive the therapeutic and pharmacological properties thereof (page 1, lines 30-33) like treating Herpes Zoster (page 1, line 39).
Regarding claim 66, Ohki as modified further discloses wherein the therapeutic formulation further comprises a thickening agent (Othmar: page 1, line 50).
Regarding claim 67, Ohki as modified further discloses wherein the thickening agent comprises hydroxypropyl methylcellulose (HPMC) (Othmar: page 1, line 50).
Regarding claim 72, Ohki as modified further discloses wherein the therapeutic formulation comprises about 0.1 mg to about 10 mg of dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: Page 1, line 40).
Regarding claim 73, Ohki as modified further discloses wherein the therapeutic formulation comprises about 1 mg to 10 mg of dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: Page 1, line 40).
Othmar does not explicitly disclose 5-7mg.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dosage from between 1-10mg to 5-7mg as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n 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).
Regarding claim 74, Ohki as modified further discloses wherein the therapeutic formulation comprises about 1 mg to 10 mg of dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: Page 1, line 40).
Othmar does not explicitly disclose 6-7mg.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dosage from between 1-10mg to 6-7mg as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n 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).
Regarding claim 75, Ohki as modified further discloses wherein the therapeutic formulation comprises about 1 mg to 10 mg of dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: Page 1, line 40).
Othmar does not explicitly disclose 5-6 mg.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dosage from between 1-10mg to 5-6 mg as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n 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).
Regarding claim 76, Ohki as modified further discloses wherein the therapeutic formulation comprises about 5 mg of dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: Page 3, line 26).
Regarding claim 77, Ohki as modified further discloses wherein the therapeutic formulation comprises about 15% w/w to about 25% w/w of the dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: page 3, lines 26-34; 5mg of dihydroergotamine, 20 mg of swelling substance, 2.5 mg of fatty materials, 10 mg other excipients are within the ratios set forth and this provides 15.38% w/w).
Regarding claim 78, Ohki as modified further discloses wherein the therapeutic formulation comprises about 16% w/w of the dihydroergotamine or a pharmaceutically acceptable salt thereof (Othmar: page 3, lines 26-34; 5mg of dihydroergotamine, 20 mg of swelling substance, 2.5 mg of fatty materials, 10 mg other excipients are within the ratios set forth and this provides 15.38% w/w which is about 16% w/w).
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki et al. (EP 0796628 B1) in view of Othmar (GB 2170407 A) in further view of Vandecruys et al. (US 6,667,060 B1)
Regarding claim 68, Ohki as modified does not explicitly disclose wherein the therapeutic formulation comprises about 0.1% w/w to about 5% w/w of HPMC.
However Vandecruys teaches it is known to have 0-16% w/w % of HPMC in a capsule (col. 15, line 58)
It would have been obvious to have modified Ohki wherein the therapeutic formulation comprises about 0.1% w/w to about 5% w/w of HPMC as taught by Lai as this is a known proportion of excipient in a capsule to control release (col. 1, lines 12-23).
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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