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 .
Response to Amendment
The amendment filed 8/13/2025 has been entered. Claims 3, 15, and 18 have been cancelled. Claims 1, 2, 4-14, 16, 17, and 19-21 remain pending in the application. Examiner withdraws the objection to the Specification and 112(b) rejections set forth in the Non-Final Office Action mailed 2/14/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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, 2, and 4-7 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the limitation "the inhalation device further comprises a release actuator" in lines 6 and 7, and claim 7 recites the limitation “a release actuator of the inhalation device”. There is insufficient support for this limitation in the specification and drawings of the claimed invention. The specification of the claimed invention does not disclose the release actuator 160 being part of the inhalation device, and rather suggests that the release actuator 160 is part of filling machine 200. Description regarding the release actuator 160 can be found in [0093]. Fig. 5 reflects that release actuator 160 is part of filing machine 200. For purposes of examination, Examiner will interpret claim 1 to read “a filing machine further comprises a release actuator”, and claim 7 to read “a release actuator of a filing machine”. Claims 2 and 4-6 are rejected as depending on claim 1.
Claim Rejections - 35 USC § 103
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 8-14, 16, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Michihisa Yokouchi et al. (WO 2013039102 A1) in view of Ryoo Ki Taek (KR 101469055 B1).
Regarding claim 8, Yokouchi teaches a manufacturing apparatus comprising: a first
plate (Fig. 1b, Chamber 23) that defines an axis (Fig. 1b, Chamber 23; examiner interprets that
the opening of Chamber 23 inherently defines an axis) and is configured for disposal of a
medicament carrier (Fig. 1b, Chamber 23; examiner interprets that chamber 23 is fit for disposal
of a medicament carrier and that this disposal would not impact the intended use and proper
functioning of the apparatus depicted); a second plate (Fig. 1b, Die 11) being aligned and
engageable with the first plate to support a layer (Fig. 1b, Plate-like Material 1) therebetween,
the carrier being connected to the layer (Fig. 1b, Plate-like Material 1; examiner interprets that
the layer is capable of being connected to the layer and that this connection would not impact the
intended use and proper functioning of the apparatus depicted) and at least one of the plates
including a cutting surface (Fig. 1b, Edge 11e); and an actuator (Fig. 1b, Fluid 21) being
engageable with the carrier such that the carrier translates along the axis and cuts the layer about the carrier (Fig. 1b, Plate-like Material 1; examiner interprets that if said carrier were to be
attached to Plate-like Material 1 and disposed inside of Chamber 23, Fluid 21 would be
engageable with the carrier and would cause the carrier to translate along the axis in order to cut
the Plate-like Material 1 around said carrier), and the first plate (Fig. 1b, Chamber 23) includes at least one opening (Fig. 1b, opening of Chamber 23) for disposal of the actuator (Fig. 1b, Fluid 21 exists in and passes through the opening) and the second plate (Fig. 1b, Die 11) includes at least one opening (Fig. 1b, opening defined by Edge 11e). Yokouchi does not need to disclose the medicament carrier itself, including the limitation that the carrier includes a disk having a plurality of spaced apart pockets, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
Yokouchi does not teach that there is a release actuator disposed in the opening of the second plate that expels the carrier from the second plate.
However, Taek teaches expelling a cut piece (Fig. 11, Chip 60) from a cavity (Fig. 11, cavity defined as space between Blades 132) with a release actuator (Fig. 11, Ejector Pin 200).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify CKD Corporation’s method for fabricating to include the limitation of claim 1 as taught by Taek. Doing so is beneficial as it allows for a cut piece to be selectively discharged (Taek, Page 7 Para 1).
Regarding claim 9, Yokouchi teaches the manufacturing apparatus according to claim 8,
wherein the cutting surface (Fig. 1b, Die 11) has a blunt edge (Fig. 1b, Edge 11e; examiner
interprets the edge to be blunt as it is not described as sharp, and is defined by surfaces which
clearly have a greater than 45 degree angle between them).
Regarding claim 10, Yokouchi teaches the manufacturing apparatus according to claim
8, wherein each of the plates (Fig. 1b, Chamber 23 and Die 11) include an inner surface (Fig. 1b,
inside surfaces of Chamber 23 and Die 11) and a central guide (Fig. 1b, the smaller
circumference portions of Chamber 23 and Die 11 are interpreted by the examiner to be central
guides) that define a cavity (Fig. 1b, inside surfaces and smaller circumference portions of
Chamber 23 and Die 11 are interpreted by the examiner to define a cavity).
Regarding claim 11, Yokouchi teaches the manufacturing apparatus according to claim
8, wherein at least one of the plates (Fig. 1b, Die 11) includes a central guide (Fig. 1b, the
smaller circumference portion of Die 11; examiner interprets that a carrier attached to Plate-like
Material 1 would pass through and therefore engage with said guide) engageable with the carrier.
Regarding claim 12, Yokouchi teaches the manufacturing apparatus according to claim
8, wherein the first plate (Fig. 1b, Chamber 23) includes at least one opening (Fig. 1b, opening at the top of Fig. 1b which allows Fluid 21 to pass through to contact Plate-like Material 21) for
disposal of the actuator (Fig. 1b, Fluid 21).
Regarding claim 13, Yokouchi teaches the manufacturing apparatus according to claim
8, wherein the actuator includes a fluid (Fig. 1b, Fluid 21).
Regarding claim 14, Yokouchi teaches the manufacturing apparatus according to claim
8, wherein the actuator includes a pin (Fig. 5, Second Auxiliary Solid 53).
Regarding claim 16, the combination of Yokouchi and Taek does not teach the manufacturing apparatus according to claim 8, wherein the layer includes a foil web, however the apparatus according to the rejection of claim 8 would be capable of working on a layer including a foil web. The apparatus of the aforementioned prior art does not need to specifically recite that the layer includes a foil web, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
Regarding claim 17, the combination of Yokouchi and Taek does not teach the manufacturing apparatus according to claim 8, wherein the layer includes a membrane cut to a profile of the carrier, however the apparatus according to the rejection of claim 8 would be capable of working on a layer including a membrane cut to a profile of the carrier. The apparatus of the aforementioned prior art does not need to specifically recite that the layer includes a membrane cut to a profile of the carrier, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
Regarding claim 19, the combination of Yokouchi and Taek does not teach the manufacturing apparatus according to claim 8, wherein the layer is sealed to the carrier, however the apparatus according to the rejection of claim 8 would be capable of working on the layer sealed to a carrier. The apparatus of the aforementioned prior art does not need to specifically recite that the layer is sealed to a carrier, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
Regarding claim 20, the combination of Yokouchi and Taek does not teach the manufacturing apparatus according to claim 8, wherein the carrier includes a disc having a plurality of spaced-apart dose pockets, however the apparatus according to the rejection of claim 8 would be capable of working on a carrier including a disc having a plurality of spaced-apart dose pockets. The apparatus as of the aforementioned prior art does not need to specifically recite that the carrier includes a disc having a plurality of spaced-apart dose pockets, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
Regarding claim 21, the combination of Yokouchi and Taek does not teach the manufacturing apparatus according to claim 8, further comprising a foil web sealed to a first planar surface of the carrier and the layer being sealed to a second planar surface of the carrier, however the apparatus according to the rejection of claim 8 would be capable of working on a foil web sealed to a first planar surface of the carrier and the layer being sealed to a second planar surface of the carrier. The apparatus of the aforementioned prior art does not need to specifically recite a foil web sealed to a first planar surface of the carrier and the layer being sealed to a second planar surface of the carrier, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
Claims 1, 2, 4, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over
CKD Corporation (U.S. PGPub 2018/0162618) in view of Michihisa Yokouchi et al. (WO
2013039102 A1) and Ryoo Ki Taek (KR 101469055 B1).
Regarding claim 1, CKD Corporation teaches a method for fabricating a container for
holding medicine, the method comprising the steps of: disposing a medicament carrier (Fig. 8,
Container Film 3) within a first member (Fig. 8, Receiving Plate 54), the carrier being connected
with a layer (Fig. 8, Cover Film 4); engaging a second member (Fig. 8, Cut Forming Blade 60) with the first member (Fig. 8, Receiving Plate 54) to support the layer (Fig. 8, Cover Film 4)
therebetween, the second member including a cutting surface (Fig. 8, the inner corners of Cut
Forming Blade 60) and defining a cavity (Fig. 8, the space between the right and left Cut
Forming Blades 60) and cutting the layer about the carrier [0077]. CKD Corporation does not need to disclose the particular details of the medicament carrier or inhalation device itself, including the limitation that the carrier comprises a disc having a plurality of pockets, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
CKD Corporation fails to teach translating the carrier relative to the members to dispose
the carrier within the cavity, and that there is a release actuator configured to expel the carrier from the cavity.
However, Yokouchi teaches translating a cut piece (Fig. 1b, cut out portion of Sheet-like
Material 1) relative to a first (Fig. 1b, Chamber 23) and second member (Fig. 1b, Die 11) to
dispose the cut piece within a cavity (Fig. 1b, inside surfaces and smaller circumference portions
of Die 11 are interpreted by the examiner to define a cavity) of the second member. Additionally, Taek teaches expelling a cut piece (Fig. 11, Chip 60) from a cavity (Fig. 11, cavity defined as space between Blades 132) with a release actuator (Fig. 11, Ejector Pin 200).
Yokouchi and CKD Corporation are considered analogous to the claimed invention
because they are all in the same field of processing web materials. Therefore, it would have been
obvious to one of ordinary skill in the art at the time of filing to modify CKD Corporation’s
method for fabricating to include translating the carrier relative to the members to dispose the
carrier within the cavity as taught by Yokouchi as a matter of combining prior art elements
according to known methods to yield predictable results (see MPEP 2143). In this case, the
predictable result is CKD Corporation’s method for fabricating including translating the carrier
relative to the members to dispose the carrier within the cavity as taught by Yokouchi. Additionally, therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify CKD Corporation’s method for fabricating to include the limitation of claim 1 as taught by Taek. Doing so is beneficial as it allows for a cut piece to be selectively discharged (Taek, Page 7 Para 1).
Regarding claim 2, CKD Corporation further teaches wherein the first member includes
a guide (Fig. 8, protrusion between Hole 55) and the step of disposing includes aligning the
carrier with the guide [0077].
Regarding claim 4, the combination of Yokouchi, CKD Corporation, and Taek is described in the rejection of claim 1 above, including cutting the layer about the carrier.
CKD Corporation fails to teach the method according to claim 1, wherein the step of
translating includes engaging the carrier such that the carrier translates along an axis of the
members to cut the layer.
However, Yokouchi teaches the step of translating includes engaging the cut piece (Fig.
1b, cut portion Plate-like Material 1 is engaged with Fluid 21) such that the cut piece translates
along an axis (Fig. 1b, Chamber 23; examiner interprets that the opening of Chamber 23
inherently defines an axis) of the members (Fig. 1b, Chamber 23 and Die 11) to cut the layer
(Plate-like Material 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of
filing to modify the combination of CKD Corporation, Yokouchi, and Taek’s step of translating to include engaging the carrier such that the carrier translates along an axis of the members to cut
the layer as taught by Yokouchi as a matter of combining prior art elements according to known
methods to yield predictable results (see MPEP 2143). In this case, the predictable result is
combination of CKD Corporation, Yokouchi, and Taek’s step of translating including engaging the carrier such that the carrier translates along an axis of the members to cut the layer as taught by Yokouchi.
Regarding claim 5, the combination of Yokouchi, CKD Corporation, and Taek is described in the rejection of claim 1 above.
CKD Corporation fails to teach the method according to claim 4, wherein the step of
translating includes engaging the carrier with a fluid.
However, Yokouchi teaches wherein the step of translating includes engaging the cut
piece (Fig. 1b, Plate-like Material 1) with a fluid (Fig. 1b, Fluid 21).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of
filing to modify the combination of CKD Corporation, Yokouchi, and Taek’s step of translating to include engaging the with a fluid as taught by Yokouchi as a matter of combining prior art
elements according to known methods to yield predictable results (see MPEP 2143). In this case,
the predictable result is combination of CKD Corporation, Yokouchi, and Taek’s step of translating including engaging the carrier with a fluid as taught by Yokouchi.
Regarding claim 6, the combination of Yokouchi, CKD Corporation, and Taek is described in the rejection of claim 1 above.
The existing Yokouchi, CKD Corporation, and Taek combination fails to teach the method according to claim 1, further comprising the step of expelling the carrier from the cavity with a release actuator.
However, Taek teaches the step of expelling a cut piece (Fig. 11, Chip 60) from a cavity
(Fig. 11, cavity defined as space between Blades 132) with a release actuator (Fig. 11, Ejector
Pin 200).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of CKD Corporation, Yokouchi, and Taek’s method for fabricating to include the step of expelling the carrier from the cavity with a release actuator as taught by Taek as a matter of combining prior art elements according to known methods to yield predictable results (see MPEP 2143). In this case, the predictable result is combination of CKD Corporation, Yokouchi, and Taek’s method for fabricating including the step of expelling the carrier from the cavity with a release actuator as taught by Taek.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over CKD
Corporation (U.S. PGPub 2018/0162618) in view of Michihisa Yokouchi et al. (WO
2013039102 A1), Anthony James Hickey (US 20080197044 A1), and Ryoo Ki Taek (KR
101469055 B1).
Regarding claim 7, CKD Corporation teaches a method for fabricating a container for
holding medicine, the method comprising the steps of: disposing a medicament dose carrier (Fig.
8, Container Film 3) within a base plate (Fig. 8, Receiving Plate 54), the base plate including an
inner surface (Fig. 8, inner surface of Holes 55) and a central guide (Fig. 8, protrusion between
Hole 55) that define a base cavity (Fig. 8, space inside of Holes 55), the carrier being positioned
onto the guide and connected with a layer (Fig. 8, Cover Film 4); engaging a lid plate (Fig. 8,
Cut Forming Blade 60) including an inner surface (Fig. 8, surfaces of Cut Forming Blade 60 that
face inwards towards each other) and a central guide (Fig. 8, examiner interprets that upper
inside edges of Cut Forming Blade 60 act as a central guide) that define a lid cavity (Fig. 8,
examiner interprets that space between the two Cut Forming Blades 60 define a cavity) with the
base plate (Fig. 8, Receiving Plate 54) to support the layer therebetween, the lid plate (Fig. 8, Cut
Forming Blade 60) further including a cutting surface (Fig. 8, upper inside edges of Cut Forming
Blade 60) having a blunt edge (Fig. 8, upper inside edges of Cut Forming Blade 60; examiner
interprets the edge to be blunt as it is not described as sharp, and is defined by surfaces which
clearly have a greater than 45 degree angle between them). CKD Corporation also teaches cutting the layer (Fig. 8, Cover Film 4) about a perimeter of the carrier (Fig. 8, Container Film
3).
CKD Corporation does not teach that the carrier is connected to specifically a foil web,
that the carrier includes a disc, or that the disc has a plurality of pockets. CKD Corporation also does not teach engaging the carrier with an actuator such that the disc translates along the guide of the lid plate to cut the foil web; and expelling the carrier from the lid cavity with a release actuator. CKD Corporation does not need to teach that the disc has a plurality of pockets, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115.
However, Hickey teaches a medicament carrier for an inhalation device including a disc
(Fig. 1b, Rigid Spacer 17) which is connected to a foil web (Fig. 1b, Foil Seal 181), Yokouchi
teaches engaging a cut piece (Fig. 1b, cut out portion of Sheet-like Material 1) with an actuator
(Fig. 1b, Fluid 21) such that the cut piece translates along the guide (Fig. 1b, the smaller
circumference portion of Die 11 is interpreted by the examiner to be a central guide) of the lid
plate (Fig. 1b, Die 11) to cut a layer (Fig. 1b, Sheet-like Material 1), and Taek teaches expelling
a cut piece (Fig. 11, Chip 60) from a cavity (Fig. 11, cavity defined as space between Blades
132) with a release actuator (Fig. 11, Ejector Pin 200).
Hickey is considered analogous to the claimed invention as they are both in the same
field of inhalation devices. Therefore, it would have been obvious to one of ordinary skill in the
art at the time of filing to modify the layer of CKD Corporation to be a foil web, and the carrier
of CKD Corporation to include a disc as taught by Hickey as a matter of combining prior art
elements according to known methods to yield predictable results (see MPEP 2143). In this case,
the predictable result is CKD Corporation’s method for fabricating including a layer which is
specifically a foil web, and having a carrier which includes a disc, as taught by Hickey.
Therefore, it also would have been obvious to one of ordinary skill in the art at the time
of filing to modify the method for fabricating of the combination of CKD Corporation and Hickey to include engaging the carrier with an actuator such that the disk translates along the
guide of the lid plate to cut the foil web as taught by Yokouchi as a matter of combining prior art
elements according to known methods to yield predictable results (see MPEP 2143). In this case,
the predictable result is combination of CKD Corporation and Hickey’s method for fabricating
including engaging the carrier with an actuator such that the disk translates along the guide of the
lid plate to cut the foil web as taught by Yokouchi.
Therefore, it would have also been obvious to one of ordinary skill in the art at the time
of filing to modify the method for fabricating of the combination of CKD Corporation, Hickey,
and Yokouchi to include expelling the carrier from the lid cavity with a release actuator as taught
by Taek as a matter of combining prior art elements according to known methods to yield
predictable results (see MPEP 2143). In this case, the predictable result is the combination of
CKD Corporation, Hickey, and Yokouchi’s method for fabricating including expelling the
carrier from the lid cavity with a release actuator as taught by Taek.
Response to Arguments
Applicant's arguments filed 8/13/2025 have been fully considered but they are not persuasive.
Regarding claims 1, 7, and 8, Applicant asserts that the added limitations which define the carrier to comprise a disk having a plurality of pockets does impart patentability on the claims as the claims in their entirety include more than just a material or article being worked on. While the Examiner agrees that the claims as a whole do define both structure and materials/article being worked on, only the limitations of the claims which solely define characteristics of the workpiece in a way that does not impact the structure of the manufacturing apparatus are rejected with the use of In re Otto, as the inclusion of the material or article being worked upon by a structure does not impart patentability to the claims In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see MPEP 2115. For this reason, the rejection used in claims 1, 7, and 8 is found to be appropriate.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLA LORRAINE KEENA whose telephone number is (571)272-1806. The examiner can normally be reached 7:30am - 5:00 pm ET.
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/ELLA L KEENA/Examiner, Art Unit 3724
/ADAM J EISEMAN/Supervisory Patent Examiner, Art Unit 3724