Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 61/733117 filed on 12/04/2012.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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 1 – 30 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.
Regarding claims 1, 2, 14, 22, and dependents therein, the limitation “an annular puncture region situated at no less than 0.4r” (claim 1) and “between about 0.4r and about 0.8r” (claim 2) is recited. However, it is unclear as to what the ratio of r is supposed to be located and whether 0.4r or 0.8r is supposed to be the distance from the center or from the circumference of the capsule, as currently claimed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim recites “between about 0.4r and about 0.8r”, which includes a range of tolerance less than 0.4r, yet depends on claim 1 requiring the annular puncture region situated “at no less than 0.4r”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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: “a mechanism for puncturing” in claims 1 – 11 and 13.
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 § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-5, 7, 9-17, 19, 21-26, 28, and 30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Edwards (2003/0150453).
Regarding claim 1, Edwards discloses a device for puncturing a capsule to release a powdered medicament therefrom (Inhalation device also includes an improved implement for puncturing the receptacle) (abstract, line 5-10). The device comprises a chamber 210 for receiving a capsule 219 (para. 0090) comprising opposing domes and a cylindrical wall portion defined by a capsule wall radius r as shown in Edwards's FIG. 2 (capsule shown has opposing domes matching hemispheric region 222 and cylindrical walls, see also para. 0090) and FIG. 8 (capsule has a radius). Edwards also discloses a mechanism for puncturing 230 (means for puncturing, para. 0094) at least one hole in at least one dome (two prongs).
Edwards does not specifically disclose that a total surface area of all puncture holes is between about 0.5% and about 2.2% of a total surface area. It is known that the aerodynamic properties of a capsule are partially determined by the surface area of the holes relative to the total surface area of the holes. The prior art recognizes the total surface area of the puncture holes as a result effective variable. In particular, Edwards explicitly recognizes that "larger longitudinal prongs of the present invention can create larger openings in the receptacles than conventional piercing devices, which allows for higher emitted doses at low peak inspiratory flow rates, low volumes, and high dosage quantities" and that increasing the size of the holes in the receptacle improves the powder flow from the receptacle. Edwards, paras. 44, 45. Edwards furthermore discloses a puncture apparatus for use with large capsules, see Edwards, para. 91 (describing capsules of size 0 (volume of 0.67 cm³) and size 00 (volume of 0.95 cm³)), paras. 116-117 (describing experiments performed using size 00 capsules), and Spec. Fig. 3 (chart of standard capsule sizes). Edwards, as a non-limiting example, discloses a single fixed capsule hole surface area of 0.013 square inches, which translates to approximately 1.325% of a total surface area of a size 00 capsule, and furthermore discloses that the surface area encompasses other capsule hole areas, especially when used with different sized capsules, see para. 117. Therefore, the total surface area of the puncture holes is considered to be a result effective variable that determines the requirement for the aerodynamic properties of the aerosolization of medicaments in the capsule. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the capsule of the Edwards reference with a suitable size and dimension in order to optimize the inhalation of the medicament in the capsule in order to suit the requirements of different powders of different particles sizes and aerodynamic properties. In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 198).
The Edwards reference appears to disclose the puncturing mechanism being configured such that a center of each hole is located within an annular puncture region situated no less than 0.4r as shown in FIG. 8, but does not specifically disclose such a region being situated at no less than 0.4r. Edwards clearly discloses a pair of prongs for puncturing a single capsule dome (as seen in FIG. 8 and 9b of Edwards) and also provides that the device as disclosed is able to accommodate capsules of differing sizes (capsule size 2, 1, 0, 00, or 000) (Edwards, para. 0091). With such evidence that the chamber of the device of Edwards is able to accommodate capsules of differing sizes, one of ordinary skill in the art at the time the invention was made would have found the optimization of the location through routine experimentation. Edwards additionally discloses testing of various off-center staple designs to discern the effort required to puncture the capsule, recognizing the possibility of crushing the capsule during puncture, see para. 0140. Since the device of Edwards has the same structure as claimed, it would have been a matter of routine optimization for a person having ordinary skill in the art at the time the invention was made that situating the annular puncture region at no less than 0.4r would be dependent upon the capsule size and dimensions, and avoid crushing the capsule during puncturing.
Regarding claim 2, Edwards reference appears to disclose the puncturing mechanism being configured such that the center of each hole is located within an annular puncture region bounded and defined in the at least one dome by 0.4r and 0.8r as shown in FIG. 8, but does not specifically disclose such a region being between about 0.4r and 0.8r. However, since the device of Edwards has the same structure as claimed, it would have been a matter of routine optimization for a person having ordinary skill in the art at the time the invention was made that situating the annular puncture region between 0.4r and 0.8r would be dependent upon the capsule size and dimensions, and avoid crushing the capsule during puncturing.
Regarding claim 3, Edwards also discloses that the mechanism 232 is configured to puncture only a single dome as shown in Edwards's FIG. 2.
Regarding claim 4, Edwards reference has everything as claimed including the puncturing mechanism being configured to puncture the single dome, but does not specifically disclose the total surface area of all punctured holes being between 3% and 15%. It is known that the aerodynamic properties of a capsule are partially determined by the surface area of the holes relative to the total surface area. See also discussion in claim 1 above. Therefore, the total surface area of the puncture holes is considered to be a result effective variable that determines the requirement for the aerodynamic properties of the aerosolization of medicaments in the capsule. Since the device of Edwards has the same structure as claimed, and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the capsule of Edwards with a suitable size and dimension in order to optimize the inhalation of the medicament in the capsule in order to suit the requirements of different powders of different particles sizes and aerodynamic properties. In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 198).
Regarding claim 5, Edwards also discloses that the capsule has a volume of at least 0.50 cm3 (the receptacles have a volume of at least 0.67 cm3) (para. 0091, lines 6-10).
Regarding claim 7, Edwards also discloses that the capsule houses a powdered medicament having a density below 0.10 g/cm3 (tap density of near to or less than about 0.1g/cm3) (para. 0093).
Regarding claim 9, Edwards discloses that the opposing domes and the cylindrical wall portions each comprise of the material gelatin (capsule material such as gelatin) (para. 0009, lines 15-20).
Regarding claim 10, Edwards discloses an inhalation portion 220 coupled to the chamber 210 (para. 0089, lines 1-10) as shown in Edwards’s FIG. 2, the inhalation portion 220 defining at least one aperture 224 for emitting the powdered medicament therethrough (inhalation portion comprises a hemispheric region that defines a plurality of apertures) (para. 0089, lines 1-10).
Regarding claim 11, Edwards discloses the chamber comprising a wall 212 (wall) defining a plurality of vents 218 (plurality of vents are defined by wall for introducing air into the chamber to disperse the powdered medicament released from the capsule (para. 0090).
Regarding claim 12, Edwards discloses the mechanism for puncturing the at least one hole in the at least one dome (means for puncturing that is used to puncture capsule) comprising a plurality of prongs 232 (two prongs) (para. 0094).
Regarding claim 13, Edwards discloses the mechanism for puncturing the at least one hole in the at least one dome (means for puncturing that is used to puncture the capsule) is movable between a non-puncturing position and a puncturing position (configured to be movable between a non-puncturing position and a puncturing position) (para. 0095).
Regarding claim 14, Edwards discloses a punctured capsule, comprising: opposing domes and a cylindrical wall portion defined by a capsule wall radius r as shown in Edwards's FIG. 2 (capsule shown has opposing domes and cylindrical walls) and FIG. 8 (capsule has a radius). Edwards also discloses a mechanism for puncturing 230 (means for puncturing) at least one hole in at least one dome (two prongs).
Edwards does not specifically disclose that a total surface area of all puncture holes is between about 0.5% and about 2.2% of a total surface area. It is known that the aerodynamic properties of a capsule are partially determined by the surface area of the holes relative to the total surface area of the holes. The prior art recognizes the total surface area of the puncture holes as a result effective variable. In particular, Edwards explicitly recognizes that "larger longitudinal prongs of the present invention can create larger openings in the receptacles than conventional piercing devices, which allows for higher emitted doses at low peak inspiratory flow rates, low volumes, and high dosage quantities" and that increasing the size of the holes in the receptacle improves the powder flow from the receptacle. Edwards, paras. 44, 45. Edwards furthermore discloses a puncture apparatus for use with large capsules, see Edwards, para. 91 (describing capsules of size 0 (volume of 0.67 cm³) and size 00 (volume of 0.95 cm³)), paras. 116-117 (describing experiments performed using size 00 capsules), and Spec. Fig. 3 (chart of standard capsule sizes). Edwards, as a non-limiting example, discloses a single fixed capsule hole surface area of 0.013 square inches, which translates to approximately 1.325% of a total surface area of a size 00 capsule, and furthermore discloses that the surface area encompasses other capsule hole areas, especially when used with different sized capsules, see para. 117. Therefore, the total surface area of the puncture holes is considered to be a result effective variable that determines the requirement for the aerodynamic properties of the aerosolization of medicaments in the capsule. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the capsule of the Edwards reference with a suitable size and dimension in order to optimize the inhalation of the medicament in the capsule in order to suit the requirements of different powders of different particles sizes and aerodynamic properties. In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 198).
The Edwards reference appears to disclose the puncturing mechanism being configured such that a center of each hole is located within an annular puncture region situated no less than 0.4r as shown in FIG. 8, but does not specifically disclose such a region being situated at no less than 0.4r. Edwards clearly discloses a pair of prongs for puncturing a single capsule dome (as seen in FIG. 8 and 9b of Edwards) and also provides that the device as disclosed is able to accommodate capsules of differing sizes (capsule size 2, 1, 0, 00, or 000) (Edwards, para. 0091). With such evidence that the chamber of the device of Edwards is able to accommodate capsules of differing sizes, one of ordinary skill in the art at the time the invention was made would have found the optimization of the location through routine experimentation. Edwards additionally discloses testing of various off-center staple designs to discern the effort required to puncture the capsule, recognizing the possibility of crushing the capsule during puncture, see para. 0140. Since the device of Edwards has the same structure as claimed, it would have been a matter of routine optimization for a person having ordinary skill in the art at the time the invention was made that situating the annular puncture region at no less than 0.4r would be dependent upon the capsule size and dimensions, and avoid crushing the capsule during puncturing.
Regarding claim 15, Edwards also discloses that the mechanism 232 is configured to puncture only a single dome as shown in Edwards's FIG. 2.
Regarding claim 16, Edwards reference has everything as claimed including the puncturing mechanism being configured to puncture the single dome, but does not specifically disclose the total surface area of all punctured holes being between 3% and 15%. It is known that the aerodynamic properties of a capsule are partially determined by the surface area of the holes relative to the total surface area. See also discussion in claim 1 above. Therefore, the total surface area of the puncture holes is considered to be a result effective variable that determines the requirement for the aerodynamic properties of the aerosolization of medicaments in the capsule. Since the device of Edwards has the same structure as claimed it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the capsule of Edwards with a suitable size and dimension in order to optimize the inhalation of the medicament in the capsule in order to suit the requirements of different powders of different particles sizes and aerodynamic properties. In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 198).
Regarding claim 17, Edwards also discloses that the capsule has a volume of at least 0.50 cm3 (the receptacles have a volume of at least 0.67 cm3) (para. 0091, lines 6-10).
Regarding claim 19, Edwards also discloses that the capsule houses a powdered medicament having a density below 0.10 g/cm3 (tap density of near to or less than about 0.1g/cm3) (para. 0093).
Regarding claim 21, Edwards discloses that the opposing domes and the cylindrical wall portions each comprise of the material gelatin (capsule material such as gelatin) (para. 0009, lines 15-20).
Regarding claim 22, Edwards discloses a method for puncturing a capsule to release a powdered medicament therefrom (Inhalation device also includes an improved implement for puncturing the receptacle) (abstract, line 5-10) comprising: receiving, within a chamber 210, a capsule 219 (para. 0090) comprising opposing domes and a cylindrical wall portion defined by a capsule wall radius r as shown in Edwards's FIG. 2 (capsule shown has opposing domes and cylindrical walls) and FIG. 8 (capsule has a radius); puncturing at least one hole in at least one dome (via means for puncturing 230) in at least one dome (two prongs) (para. 0094).
Edwards does not specifically disclose that a total surface area of all puncture holes is between about 0.5% and about 2.2% of a total surface area. It is known that the aerodynamic properties of a capsule are partially determined by the surface area of the holes relative to the total surface area of the holes. The prior art recognizes the total surface area of the puncture holes as a result effective variable. In particular, Edwards explicitly recognizes that "larger longitudinal prongs of the present invention can create larger openings in the receptacles than conventional piercing devices, which allows for higher emitted doses at low peak inspiratory flow rates, low volumes, and high dosage quantities" and that increasing the size of the holes in the receptacle improves the powder flow from the receptacle. Edwards, paras. 44, 45. Edwards furthermore discloses a puncture apparatus for use with large capsules, see Edwards, para. 91 (describing capsules of size 0 (volume of 0.67 cm³) and size 00 (volume of 0.95 cm³)), paras. 116-117 (describing experiments performed using size 00 capsules), and Spec. Fig. 3 (chart of standard capsule sizes). Edwards, as a non-limiting example, discloses a single fixed capsule hole surface area of 0.013 square inches, which translates to approximately 1.325% of a total surface area of a size 00 capsule, and furthermore discloses that the surface area encompasses other capsule hole areas, especially when used with different sized capsules, see para. 117. Therefore, the total surface area of the puncture holes is considered to be a result effective variable that determines the requirement for the aerodynamic properties of the aerosolization of medicaments in the capsule. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the capsule of the Edwards reference with a suitable size and dimension in order to optimize the inhalation of the medicament in the capsule in order to suit the requirements of different powders of different particles sizes and aerodynamic properties. In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 198).
The Edwards reference appears to disclose the puncturing mechanism being configured such that a center of each hole is located within an annular puncture region situated no less than 0.4r as shown in FIG. 8, but does not specifically disclose such a region being situated at no less than 0.4r. Edwards clearly discloses a pair of prongs for puncturing a single capsule dome (as seen in FIG. 8 and 9b of Edwards) and also provides that the device as disclosed is able to accommodate capsules of differing sizes (capsule size 2, 1, 0, 00, or 000) (Edwards, para. 0091). With such evidence that the chamber of the device of Edwards is able to accommodate capsules of differing sizes, one of ordinary skill in the art at the time the invention was made would have found the optimization of the location through routine experimentation. Edwards additionally discloses testing of various off-center staple designs to discern the effort required to puncture the capsule, recognizing the possibility of crushing the capsule during puncture, see para. 0140. Since the device of Edwards has the same structure as claimed, it would have been a matter of routine optimization for a person having ordinary skill in the art at the time the invention was made that situating the annular puncture region at no less than 0.4r would be dependent upon the capsule size and dimensions, and avoid crushing the capsule during puncturing.
Regarding claim 23, Edwards also discloses that the mechanism 232 is configured to puncture only a single dome as shown in Edwards's FIG. 2.
Regarding claim 24, Edwards reference has everything as claimed including the puncturing mechanism being configured to puncture the single dome, but does not specifically disclose the total surface area of all punctured holes being between 3% and 15%. It is known that the aerodynamic properties of a capsule are partially determined by the surface area of the holes relative to the total surface area. See also discussion in claim 1 above. Therefore, the total surface area of the puncture holes is considered to be a result effective variable that determines the requirement for the aerodynamic properties of the aerosolization of medicaments in the capsule. Since the device of Edwards has the same structure as claimed it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the capsule of Edwards with a suitable size and dimension in order to optimize the inhalation of the medicament in the capsule in order to suit the requirements of different powders of different particles sizes and aerodynamic properties. In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 198).
Regarding claim 25, Edwards also discloses that the capsule has a volume of at least 0.50 cm3 (the receptacles have a volume of at least 0.67 cm3) (para. 0091, lines 6-10).
Regarding claim 26, Edwards discloses wherein puncturing the at least one hole in the at least one dome causes the powdered medicament to be released from the capsule (puncture capsule to release powder contained therein) (para. 0094).
Regarding claim 28, Edwards also discloses that the capsule houses a powdered medicament having a density below 0.10 g/cm3 (tap density of near to or less than about 0.1g/cm3) (para. 0093).
Regarding claim 30, Edwards discloses that the opposing domes and the cylindrical wall portions each comprise of the material gelatin (capsule material such as gelatin) (para. 0009, lines 15-20).
Claims 6, 18, and 27 is rejected under 35 U.S.C. 103(a) as being unpatentable over Edwards (2003/0150453) further view of Drizen et al. (6,007,843).
Regarding claim 6, Edwards has everything as claimed in 1, including the capsule 219 housing a powdered medicament (disperse a powder released from capsule) (Edwards, para. 0090), but does not specifically disclose that the powdered medicament comprising levodopa as an active drug.
Drizen teaches levodopa as an active drug (Drizen, col. 5, lines 10-20).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the powdered medicament of Edwards to comprise levodopa as an active drug as taught by Drizen in order to treat the central nervous system (central nervous system drugs) (Drizen, col. 5, lines 10-20).
Regarding claim 18, Edwards in view of Drizen discloses the punctured capsule of claim 14 further comprising therein a powdered medicament comprising levodopa as an active drug (see claim 6 above).
Regarding claim 27, Edwards in view of Drizen discloses the method of claim 22, wherein the powdered medicament comprises levodopa as an active drug (see claim 6 above).
Claims 8, 20, and 29 are rejected under 35 U.S.C. 103(a) as being unpatentable over Edwards (2003/0150453) in view of Messora (3,927,195).
Regarding claim 8, 20, and 29, Edwards has everything as claimed in 1, 14, and 22, but does not specifically disclose that the thickness capsule has a thickness between 0.08 mm and 0.12 mm.
Messora teaches a capsule having a thickness between 0.08mm and 0.12 mm (0.10 to 0.20 mm) (Messora, col. 5, lines 25-30).
Therefore, one of ordinary skill in the art at the time the invention was made to modify the capsule of Edwards to have a thickness of between 0.08 mm and 0.12 mm as taught by Messora since it is well known for capsules to be manufactured with such a specific thickness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Valentini et al. (4,069,819), Valentini et al. (4,995,385), Niccolai (6,705,313), Edwards et al. (2004/0216738), Dunkley et al. (2005/0000518), Alston et al. (2005/0056280), Edward et al. (7,278,425), Ellwanger et al. (2009/0025721), Hrkach (7,954,491), and Hrkach (2012/0111325) all disclose dry powder inhalers with mechanisms for puncturing a capsule.
Shell et al. (6,340,475) teaches the different dimensional parameters of the number of differently sized standard capsules. Rangachari (2005/0081852) teaches a device for puncturing a capsule including chamber for receiving a capsule.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799