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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Non-Provisional App. No. 16/638,534 filed February 12, 2020 now Patent No. 11,969,547; to PCT No. GB2018/052453 filed August 30, 2018; and to Foreign App. No. GB 1713899.1 filed August 30, 2017.
Status of claims
Claims 1-31, filed March 29, 2024, are presently pending in this application, with claims 34-35 being withdrawn from consideration.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "27" and "17", have both been used to designate “shuttle valve” (Para. 0112). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 6, 7, 17, 25, and 28 are objected to because of the following informalities:
Claim 6 recites “the closed position”, ln 2 should read --a closed position--;
Claim 7 recites “when a device is primed”, ln 2 should read --when the device is primed --;
Claim 17 recites “the closed (protective) position”, ln 3 should read --the closed position--;
Claim 25 recites “for the nasal delivery of an emergency therapy”, ln 2 should read --for a nasal delivery of the emergency therapy--;
Claim 28 recites “the closed position”, ln 2 should read --a closed position--;
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “latch mechanism” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 2-4, 8-10, 15, 21, and 30, and claims 16, 17, and 22 by dependency, 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 2 recites “a medicament container (or carrier)”, ln 2-3 the recitation of “(or carrier)” renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of this office action “a medicament container (or carrier)” has been interpreted as --a medicament container--.
Claim 3 recites “the foil cover”, ln 2 it is unclear whether the limitation “foil cover” is intended to reference the foil cover introduced in claim 2 or introduce a new limitation. For the purpose of this Office Action claim 3 has been interpreted as depending from claim 2.
Claim 4 recites “wherein the foil cover is positioned over one or both ends of the sleeve.”, ln 2 there is insufficient antecedent basis for the “foil cover” and the “sleeve” limitation. The limitations “foil cover” and the “sleeve” were initially introduced in claim 2, while claim 4 depends from claim 1. For the purpose of this Office Action claim 4 has been interpreted as depending from claim 2.
Claim 8 recites “wherein the pair of orifices comprise”, ln 2 there is insufficient antecedent basis for the “pair of orifices” limitation. The limitation “pair of orifices” was initially introduced in claim 7, while claim 8 depends from claim 6. For the purpose of this Office Action claim 8 has been interpreted as depending from claim 7.
Claim 9 recites “A multi-unit dose dry powder medicament delivery device according to claim 1 in conjunction with a cartridge comprising a dry powder medicament.”, ln 1-2 it is unclear whether the limitation “cartridge” is intended to reference the replacable cartridge of claim 1 or introduce a new limitation. For the purpose of this Office Action claim 9 has been interpreted as --A multi-unit dose dry powder medicament delivery device according to claim 1 wherein the replacable cartridge comprises a dry powder medicament.--.
Claim 10 recites “wherein the medicament cartridge”, ln 1-2 it is unclear whether the limitation “medicament cartridge” is intended to reference the replacable cartridge of claim 1 or introduce a new limitation. For the purpose of this Office Action claim 10 has been interpreted as --wherein the replacable cartridge--.
Claim 15 recites “held in the closed (protective) position”, ln 2 there is insufficient antecedent basis for the “the closed (protective) position” limitation and the recitation of “(protective)” renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis are part of the claimed invention See MPEP § 2173.05(d). For the purpose of this office action “held in the closed (protective) position” has been interpreted as --held in a closed position--.
Claim 21 recites “the entrance orifice”, ln 2-3 it is unclear whether the limitation “the entrance orifice” is intended to reference the entrance orifice cartridge of claim 8 or introduce a new limitation. For the purpose of this Office Action claim 21 has been interpreted as --an entrance orifice --.
Claim 30 recites “A method of delivering a medicament to a patient which comprises the use of a dry powder medicament delivery device according to claim 1.”, ln 1-2 which fails to claim a process without setting forth any steps. Specifically, claim 30 merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
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, 5-7, 11-12, 23, and 27-28 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,969,547 (hereinafter: “Patent’547”).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the instant application independent claims 1 and 27 are found in Patent’547 claims 1 and 27, respectively. Since the instant application independent claims 1 and 13 are fully encompassed by Patent’547 claims 1 and 27, respectively, the difference between the application claims and the Patent’547 claims lies in the fact that the Patent’547 claim includes more elements and is thus more specific. Accordingly, the invention of Patent’547 claim is a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. Since the application claims are anticipated by the Patent’547 claims, it is not patentably distinct from the patent claim
Furthermore:
Instant claim 5 is unpatentable over claim 1 of Patent’547 because they recite the same limitations.
Instant claim 6 is unpatentable over claim 1 of Patent’547 because they recite the same limitations.
Instant claim 7 is unpatentable over claim 4 of Patent’547 because they recite the same limitations.
Instant claim 11 is unpatentable over claim 1 of Patent’547 because they recite the same limitations.
Instant claim 12 is unpatentable over claim 8 of Patent’547 because they recite the same limitations.
Instant claim 23 is unpatentable over claim 11 of Patent’547 because they recite the same limitations.
Instant claim 28 is unpatentable over claim 13 of Patent’547 because they recite the same limitations.
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 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.
Claim(s) 1-12 and 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over Boyes et al. (U.S. Pub. No. 2014/0364837; hereinafter: “Boyes”) in view of 二塚 由紀子 (JP 4986192 B2; a machine translation accessed June 12, 2026 relied upon herein; hereinafter: “Futatsuka”).
Regarding Claim 1, Boyes discloses a multi-unit dose dry powder medicament delivery device comprising: a first element (3; Fig. 1a-1c) comprising a single use nozzle (6; Fig. 1a-2c) located in a body (5; Fig. 1a-1c) which is at least partially lined with an inner sleeve (7, 8, area to receive 2 and 9; Fig. 1a-2c), said inner sleeve comprising an airway (7; Fig. 1a-2c) and a cartridge seat (area to receive 2 and 9; Fig. 1a-2c; ¶¶ 0113-0123); and a second element (4, 31, 32, 33; Fig. 1a-6b; ¶¶ 0113-0123), said second element comprising an actuator (4, 31, 32, 33; Fig. 1a-3) provided with an air source (31; Fig. 3) and a valve (32; Fig. 3; ¶¶ 0041-0043, 0048, 0117; Claim 13).
Boyes does not specifically disclose the dry powder medicament delivery device wherein the second element is adapted to be releasably attached to the first element.
Futatsuka teaches a medication device comprising a first element (13, 13a, 13b, 13c, 13d; Fig. 1-2) releasable attached to a second element (11, 11a, 11b, 11c; Fig. 1-2) by a releasable attachment (11b, 13c; ¶¶ 0023-0024) for the purpose of providing repeatable releasable hermetically sealed attachment of the first element to the second element (¶¶ 0023-0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dry powder medicament delivery device of Boyes to include the second element being releasably attached to the first element as taught by Futatsuka for the purpose of providing repeatable releasable hermetically sealed attachment of the first element to the second element (See Futatsuka: ¶¶ 0023-0024).
Regarding Claim 2, the modified device of Boyes discloses the dry powder medicament delivery device wherein the replaceable medicament cartridge comprises three components; a medicament container (See Boyes: 10; Fig. 2b, 2c), a sleeve (11; Fig. 1b, 2a-2c) and a foil cover (See Boyes: ¶¶ 0008, 0036, See Futatsuka: ¶ 0054 ).
Regarding Claim 3, the modified device of Boyes discloses the dry powder medicament delivery device wherein the valve comprises the foil cover (See Boyes: ¶¶ 0008, 0036, See Futatsuka: ¶ 0054 ).
Regarding Claim 4, the modified device of Boyes discloses the dry powder medicament delivery device wherein herein the foil cover is positioned over one or both ends of the sleeve (See Boyes: ¶¶ 0008, 0036, See Futatsuka: ¶ 0054 ).
Regarding Claim 5, the modified device of Boyes discloses the dry powder medicament delivery device wherein the inner sleeve is provided with a shuttle valve (A, Fig. A annotated below and A, Fig. B annotated below; See Boyes: ¶¶ 0113-0118, 0126-0130; Examiner notes: 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). In this case, Boyes discloses a shuttle valve as defined by Applicant’s disclosure (the shuttle valve 27, 27a, 27b; Fig. 5-6; Pg. 20, ln 20 to Pg. 21, ln 19).].
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Figure A, Adapted from Figure 2c of Boyes.
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Figure B, Adapted from Figure 11a of Boyes.
Regarding Claim 6, the modified device of Boyes discloses the dry powder medicament delivery device wherein the shuttle valve is dimensioned such that in the closed position it blocks the airway only until the device is primed by a user (See Boyes: Fig. 1c, 2b, 2c, 11a-11b; ¶¶ 0113-0116, 0121, 0126-0130).
Regarding Claim 7, the modified device of Boyes discloses the dry powder medicament delivery device wherein the shuttle valve is provided with a pair of orifices (See Boyes: 7 and 8; Fig. 2b, 2c and 27 and 28; Fig. 11b) which, when a device is primed, align with the airway of the device (See Boyes: ¶¶ 0113-0116, 0121, 0126-0130).
Regarding Claim 8, the modified device of Boyes discloses the dry powder medicament delivery device wherein the pair of orifices comprise an entrance orifice (8; Fig. 2c and 28; Fig. 11a, 11b), enabling air to be drawn into the device (See Boyes: ¶¶ 0113-0116, 0121, 0126-0130); and an exit orifice (7; Fig. 2c and 27; Fig. 11a, 11b), allowing air and the entrained medicament, to be drawn into the medicament carrier (See Boyes: ¶¶ 0113-0116, 0121, 0126-0130).
Regarding Claim 9, the modified device of Boyes discloses the dry powder medicament delivery device wherein the replacable cartridge comprises a dry powder medicament (See Boyes: ¶¶ 0058, 0067-0078, 0113-0123; Claim 33).
Regarding Claim 10, the modified device of Boyes discloses the dry powder medicament delivery device wherein the replacable cartridge comprises a unit dose of drug or medicament (See Boyes: ¶¶ 0058, 0067-0078, 0113-0123; Claim 33).
Regarding Claim 11, the modified device of Boyes discloses the dry powder medicament delivery device wherein the actuator in the second element comprises a spigot element (See Boyes: 4; Fig. 1a-2c) which, when inserted into the first element, pushes the medicament container into position for delivery of the medicament (See Boyes: ¶¶ 0114, 0122).
Regarding Claim 12, the modified device of Boyes discloses the dry powder medicament delivery device wherein the spigot element is provided with at least one aperture (B, Fig. A annotated above) to enable air to pass from the air source and valve through the spigot (See Boyes: Fig. 2c; ¶¶ 0098, 0117)
Regarding Claim 21, the modified device of Boyes discloses the dry powder medicament delivery device wherein the device comprises a dynamic relationship between the spigot, an entrance orifice (C, Fig. A annotated above) and the medicament carrier (See Boyes: ¶¶ 0113-0116, 0121, 0126-0130; Fig. 1c, 2b, 2c, 7a-7c).
Regarding Claim 22, the modified device of Boyes discloses the dry powder medicament delivery device wherein, in use, as the spigot progressively moves the carrier forward within the sleeve, the entrance orifice is progressively revealed (See Boyes: ¶¶ 0113-0116, 0121, 0126-0130; Fig. 1c, 2b, 2c, 7a-7c).
Regarding Claim 23, the modified device of Boyes discloses the dry powder medicament delivery device wherein the device is a nasal inhaler (See Boyes: ¶¶ 0006, 0035-0037, 0039, 0041, 0042, 0049, 0051, 0056-0061, 0080, 0114).
Regarding Claim 24, the modified device of Boyes discloses the dry powder medicament delivery device wherein the delivery device is suitable for the delivery of an emergency therapy. (See Boyes: ¶¶ 0002, 0006, 0050, 0076; Claim 39).
Regarding Claim 25, the modified device of Boyes discloses the dry powder medicament delivery device wherein the delivery device is for the nasal delivery of an emergency therapy (See Boyes: ¶¶ 0002, 0006, 0035-0037, 0039, 0041, 0042, 0049-0051, 0056-0061, 0076, 0080, 0114; Claim 39).
Regarding Claim 26, the modified device of Boyes discloses the dry powder medicament delivery device wherein the dry powder medicament delivery device is for the delivery of a therapeutically effective amount of glucagon to a diabetic experiencing a hypoglycemic reaction (See Boyes: ¶¶ 0053, 0057, 0058, 0078).
Regarding Claim 27, Boyes discloses a multi-unit dose dry powder medicament delivery device kit comprising: a first element (3; Fig. 1a-1c) comprising a single use nozzle (6; Fig. 1a-2c) located in a body (5; Fig. 1a-1c) which is at least partially lined with an inner sleeve (7, 8, area to receive 2 and 9; Fig. 1a-2c), said inner sleeve comprising an airway (7; Fig. 1a-2c) and a cartridge seat (area to receive 2 and 9; Fig. 1a-2c; ¶¶ 0113-0123); and a second element (4, 31, 32, 33; Fig. 1a-6b; ¶¶ 0113-0123), said second element comprising an actuator (31, 32, 33; Fig. 3) provided with an air source (31; Fig. 3) and a valve (32; Fig. 3; ¶¶ 0041-0043, 0048, 0117; Claim 13) and at least one cartridge (9, 10, 11; Fig. 1a, 1b, 2b, 2c, 7a-7c) comprising a dry powder medicament (within 10; Fig. 2b, 2c, 7a-7c ; ¶¶ 0113-0123).
Boyes does not specifically disclose the dry powder medicament delivery device kit wherein the second element is adapted to be releasably attached to the first element.
Futatsuka teaches a medication device comprising a first element (13, 13a, 13b, 13c, 13d; Fig. 1-2) releasable attached to a second element (11, 11a, 11b, 11c; Fig. 1-2) by a releasable attachment (11b, 13c; ¶¶ 0023-0024) for the purpose of providing repeatable releasable hermetically sealed attachment of the first element to the second element (¶¶ 0023-0024).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dry powder medicament delivery device kit of Boyes to include the second element being releasably attached to the first element as taught by Futatsuka for the purpose of providing repeatable releasable hermetically sealed attachment of the first element to the second element (See Futatsuka: ¶¶ 0023-0024).
Regarding Claim 28, the modified device of Boyes discloses the dry powder medicament delivery device wherein the inner sleeve is provided with a shuttle valve (A, Fig. A annotated above and A, Fig. B annotated above; See Boyes: ¶¶ 0113-0118, 0126-0130; Examiner notes: 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). In this case, Boyes discloses a shuttle valve as defined by Applicant’s disclosure (the shuttle valve 27, 27a, 27b; Fig. 5-6; Pg. 20, ln 20 to Pg. 21, ln 19).].
Regarding Claim 29, the modified device of Boyes discloses the dry powder medicament delivery device of claim 27, shown above.
The modified device of Boyes does not specifically disclose the dry powder medicament delivery device which includes a plurality of medicament cartridges.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include a plurality of the medicament cartridges since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding Claim 30, the modified device of Boyes discloses a method of delivering a medicament to a patient (See Boyes: ¶¶ 0058, 0067-0078, 0113-0123; Claim 33) which comprises the use of a dry powder medicament delivery device according to claim 1 (shown above).
Regarding Claim 31, the modified device of Boyes discloses a method of treatment of a patient with a disorder or prevention of a disorder which comprises the administration to the patient a suitable medicament (the modified device of ¶¶ 0058, 0067-0078, 0113-0123; Claim 33) using a medicament delivery device according to claim 1 (shown above).
Allowable Subject Matter
Claims 13-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Prior art of Boyes and Futatsuka alone or in combination fail to disclose or render obvious the multi-unit dose dry powder medicament delivery device wherein the actuator comprises a plunger, such that, in use, a user presses or depresses the plunger in order to actuate the device and urge the spigot toward the cartridge assembly, as recited in dependent claim 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smutney et al. (U.S. Pub. No. 2014/0014106) discloses a dry powder drug delivery system and methods (Fig. 7-9).
Smutney et al. (U.S. 2009/0241949) discloses a dry powder inhalation system (Fig. 1-7).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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