DETAILED ACTION
This Office Action is in response to the filing of amendments to the claim language filed 9/08/2025. As per the amendments therein, claims 12-13 have been added, and no claims have been cancelled. Thus, claims 1-6 and 8-13 are pending in the application.
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
Claim 12 is objected to because of the following informalities:
Claim 12 recites the language “the element is non-movable manner relative to the reservoir” in lines 16-17. Examiner suggests changing to read --the element is non-movable relative to the reservoir-- in order to fix a typographical error.
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: “protective element” in claims 1, 4, and 12-13 “blocking element” in claim 6, and “trigger element” in claim 6.
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 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 1-6 and 8-11 and 13 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 lines 18-19 recite the limitation “said spring is compressed, so as to transmit an axial force directly to said reservoir.” However, in light of the specification and drawings, it would appear that the axial force is not directly transmitted to the reservoir as claimed, but rather through some intermediary member. As seen in the specification, page 12 lines 9-14, as well as Fig. 1 of the drawings, where upon compression of actuator member 800, the spring 850 is compressed, which then transfers force via hoop 950. Hence, as neither of the ends of spring 850 are pressed against the reservoir 100, and it instead presses against hoop 950, it is understood that the claimed invention does not have where the axial force of the spring is directly transmitted to the reservoir, but rather is indirect through some member (e.g. hoop 950). At best, the specification mentions on page 4 line 23 to page 5 line 6 “Advantageously, an actuator member is mounted to move axially, in particular slidingly, in said body between a rest position and a primed position, a spring being arranged between said actuator member and said reservoir or an element integral with said reservoir, so that when said actuator member moves towards its primed position, said spring is compressed, so as to transmit an axial force to said reservoir.” This disclosure in the specification does not 1) make any mention of the spring actually touching the reservoir (as between is a relative location and can be anywhere in the middle of the recited end points), and 2) does not directly impart its axial force on the reservoir. As such, the limitation constitutes new matter. For the purposes of examination, the spring transmitting its force through an intermediary (similar to how the claimed invention works) will be understood to be a direct transmission of force.
Claim 13, similar to claim 1, recites that the spring “transmits an axial force to the reservoir through direct contact” in line 17. For the same reasons as in the above rejection of claim 1, it is understood that the disclosure lacks any detail whereby the spring is in direct contact with the reservoir such that the force is directly imparted from the spring to the reservoir. Hence, the limitation is likewise considered new matter in claim 13.
Any remaining claims are rejected for being dependent on a rejected claim.
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 12 is 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 12 recites the limitation "the element" in both lines 16 and 18. There is insufficient antecedent basis for this limitation in the claim, as it is unclear if it refers back to the “element that is fixedly secured to said reservoir” or the “protective element.” For the purposes of examination, it will be understood to refer to the element that is fixedly secured to said reservoir.
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.
Claims 1, 5-6, 8-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rich et al. (US Pat. 5,060,643) in view of Shahaf et al. (US Pat. 10,549,052).
Regarding claim 1, Rich discloses an inhalation-synchronized fluid product dispenser device (see breath-actuated inhalation device 10 in Fig. 2) comprising a body (the outer casing of the inhaler in Fig. 2, particularly housing 12) provided with a mouthpiece (the distal end of lateral extension 14 in Fig. 2), at least one fluid reservoir containing fluid (medicament-dispensing container 70 in Fig. 2), and dispenser means for dispensing a dose of fluid on each actuation (dispensing orifice 112 and bore 66 in Fig. 2, through which medicament is dispensed through), said device comprising blocking means for said dispenser means (collar 42 with flange 62 in Fig. 2), said device comprising an inhalation-controlled trigger system comprising an inhalation-sensitive member that is deformable and/or movable under the effect of inhaling (see flexible diaphragm-type valve 18 in Fig. 2), said inhalation-sensitive member co-operating with said blocking means so that, when said inhalation-sensitive member is deformed and/or moved under the effect of inhaling, it enables said dispenser means to be actuated (see Figs. 2 and 4 where during inhalation, valve 18 moves to allow air in, and collar 42 presses against the assembly around valve stem 68, the two working in cooperative fashion so as to permit the actuation through the dispensing orifice 112), wherein said device comprises a protective element of said inhalation-controlled trigger system (see cover 16 for extension/mouthpiece 14 in Fig. 2, which is part of the triggering system as it allows for the negative pressure of inhalation to drive diaphragm valve 18; see Col. 4 lines 14-26); and wherein an actuator member is mounted to move axially in said body between a rest position and a primed position (see Figs. 1-2 where cap 82 with slides 88 moves axially by sliding along the up-down axis, with a rest position when the spring 79 is not compressed, and a primed position when the spring 79 is compressed), a spring being arranged between said actuator member and said reservoir (see spring 79 in Figs. 1-2, with at least a portion of the spring located below cap 82 and above container 70), so that when said actuator member moves towards its primed position, said spring is compressed, so as to transmit an axial force directly to said reservoir (see Figs. 1-3 and Col. 3 line 39 to Col. 4 line 13 where the compression of spring 79 transfers force through slides 88, to the wings 50/52 of collar 42, to then bias the coil spring 44, such that the spring 44 is in a compressed state and upon inhalation imparts its stored spring force in the axial direction towards container 70, the force being imparted onto collar 42, which has annular flange 60 that interacts with an annular flange 62 on movable nozzle 64, to push against valve stem 68, and thus against container 70. Hence, in light of the above 112(a) rejection of claim 1, it is understood that the transmitting of forces through an intermediary is a direct transmission of axial force, and thus the force from the compression of cap 82/ spring 79 leads to the corresponding axial compression of spring 44, which then imparts the transferred axial force to the reservoir via the collar and flanges).
Rich lacks a detailed description of the protective element being disposed inside the device between said mouthpiece and said inhalation-sensitive member, said protective element being made of a porous material that allows air to pass through it but blocks passage of water, dust and foreign bodies, wherein said protective element is configured and disposed to thereby avoid contamination of the inhalation-controlled trigger system.
However, Shahaf teaches a similar medicament inhaler device where a protective element being disposed inside the device between said mouthpiece and said inhalation-sensitive member (see Col. 63 lines 33-54 where the medicament device (Figs. 4A-10) can include a filter, the filter being able to be placed in a variety of locations, including within the charging mechanism around the piston so as to filter air as it enters the piston chamber), said protective element being made of a porous material that allows air to pass through it but blocks passage of water, dust and foreign bodies (see Col. 63 lines 33-54 where the filter can be designed for blocking particulates, bacteria, viruses, and moisture), wherein said protective element is configured and disposed to thereby avoid contamination of the inhalation-controlled trigger system (see Col. 63 lines 33-54 where the filter is to remove the wanted particles from the air, and the placement of the filter in the flow path upstream the charging mechanism will protect charging mechanism from the air that enters it).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve area of Rich to include a filter as taught by Shahaf, as it would help filter out unwanted particles and germs that enter the device to ensure the user receives clean, filtered air. It is understood that Shahaf discloses a plurality of locations where a filter could be placed (Shahaf; Col. 63 lines 33-54), including locations that are upstream of the piston mechanism that is creating the dispersal of the medicament. Hence, in the modified Rich device, the upstream location is somewhere between the valve 18 and the orifice 112, such that air entering the device to entrain the medicament is already filtered. One of ordinary skill in the art, upon reading Shahaf, would understand that there are a plurality of locations where a filter could be placed within the device to filter the air, and that placing it between an inhalation-sensitive member and a trigger mechanism amounts to a matter of design choice, as it would still ensure that the air passing through is filtered.
Regarding claim 5, the modified Rich device has wherein said product reservoir containing a fluid product and a propellant gas (Rich; see Fig. 2 where container 70 holds an aerosol, and it is understood that an aerosol within a container is a fluid held under pressure by a propellant gas) is mounted to slide axially relative to said body (Rich; see Figs. 2 and 4 where container 70 slides up and down during actuation strokes, along the axial length of housing 12), a metering valve (Rich; see Fig. 2 valve 68, which meters an amount of medicament), including a valve member (Rich; see Fig. 5 where the valve stem 68 includes the aerosol valve assembly 102), being assembled on said reservoir for selectively dispensing the fluid product (Rich; see Figs. 2 and 5 where valve stem 68 and valve assembly 102 are assembled on the container 70).
Regarding claim 6, the modified Rich device has a blocking element (Rich; see Figs. 2 and 4 links 32 and 34) that is movable and/or deformable between a blocking position in which said metering valve cannot be actuated (Rich; see configuration of links 32 and 34 in Fig. 2 where they are in a blocking position so as to prevent the actuation of the valve until they are moved), and an actuation position in which said metering valve is configured to be actuated (Rich; see Fig. 4 where links 32 and 34 are in an actuation position allowing the valve to actuate), a trigger element (Rich; see Figs. 2 and 4 lever 28) that is movable and/or deformable between a locking position in which it blocks said blocking element in its blocking position (Rich; see lever 28 in Fig. 2 where it is in a position where the links 32/ 34 remain in a blocking position), and a release position in which it does not block said blocking element (Rich; see Fig. 4 where the position of lever 28 does not block the links 32/34), and said inhalation-sensitive member co-operating with said trigger element (Rich; see Figs. 2 and 4 where valve 18 contacts and thus cooperates with lever 28), so that when said inhalation-sensitive member is deformed and/or moved, it moves and/or deforms said trigger element towards its release position (Rich; see Figs. 2 and 4 where the motion of valve 18 moves the lever 28 into the position of Fig. 4), thereby making it possible to move and/or deform said blocking element from its blocking position towards its actuation position (Rich; see Fig. 4 where the movement of the lever 28 in response to valve 18 opens up the blocking that was held by links 32/34).
Regarding claim 8, the modified Rich device has wherein a laterally-actuated pusher is mounted to move by pivoting and/or in translation on said body between a rest position and a working position (Rich; see lever 28 in Figs. 2 and 4, which moved in the lateral direction back and forth, and the actuation comes from the lateral motion of valve 18, thus make it laterally-actuated, being at work in Fig. 2 (by preventing motion) and at rest in Fig. 4 (by freely allowing motion)), a movement of said laterally-actuated pusher towards its working position moving said actuator member axially towards its primed position (Rich; see Fig. 2 where when lever 28 is moved into the work position, the links 32/34 and tabs 37 on the links allow for the bore 51 with spring 44 to compress back to a primed position as seen in Fig. 2).
Regarding claim 9, the modified Rich device has wherein said inhalation-sensitive member includes a deformable membrane that defines a deformable air chamber (Rich; see flexible diaphragm-type valve 18 in Figs. 2 and 4, where a diaphragm is a type of membrane, and is flexible and thus deforms as it moved, the valve 18 defining a wall of the empty air cavity within (see generally empty space substantially around lever 28), thus being an air chamber whose shape deforms with the movement of valve 18), said deformable membrane being fastened to said trigger element, said deformable membrane being deformed during inhaling (Rich; see Figs. 2 and 4 where valve 18 moves and deforms during the inhalation, and is fastened to lever 28 as valve 18 is held tightly by housing 12 at surfaces 20/22, and the lever 28 is directly connected to the housing through axle 30).
Regarding claim 11, the modified Rich device has wherein the actuator member is mounted to slide axially in said body between the rest position and the primed position (Rich; see Figs. 1-2 where slides 88 of cap 82 move axially by sliding along the up-down axis, with a rest position when the spring 79 is not compressed, and a primed position when the spring 79 is compressed).
Regarding claim 12, Rich discloses an inhalation-synchronized fluid product dispenser device (see breath-actuated inhalation device 10 in Fig. 2) comprising a body (the outer casing of the inhaler in Fig. 2, particularly housing 12) provided with a mouthpiece (the distal end of lateral extension 14 in Fig. 2), at least one fluid reservoir containing fluid (medicament-dispensing container 70 in Fig. 2), and dispenser means for dispensing a dose of fluid on each actuation (dispensing orifice 112 and bore 66 in Fig. 2, through which medicament is dispensed through), said device comprising blocking means for said dispenser means (collar 42 with flange 62 in Fig. 2), said device comprising an inhalation-controlled trigger system comprising an inhalation-sensitive member that is deformable and/or movable under the effect of inhaling (see flexible diaphragm-type valve 18 in Fig. 2), said inhalation-sensitive member co-operating with said blocking means so that, when said inhalation-sensitive member is deformed and/or moved under the effect of inhaling, it enables said dispenser means to be actuated (see Figs. 2 and 4 where during inhalation, valve 18 moves to allow air in, and collar 42 presses against the assembly around valve stem 68, the two working in cooperative fashion so as to permit the actuation through the dispensing orifice 112), wherein said device comprises a protective element of said inhalation-controlled trigger system (see cover 16 for extension/mouthpiece 14 in Fig. 2, which is part of the triggering system as it allows for the negative pressure of inhalation to drive diaphragm valve 18; see Col. 4 lines 14-26); and wherein an actuator member is mounted to move axially in said body between a rest position and a primed position (see Figs. 1-2 where cap 82 with slides 88 moves axially by sliding along the up-down axis, with a rest position when the spring 79 is not compressed, and a primed position when the spring 79 is compressed), a spring being arranged between said actuator member and an element that is fixedly secured to said reservoir (see spring 79 in Figs. 1-2, with at least a portion of the spring located below cap 82 and above a top surface 75, the top surface 75 being part of upper portion 80 of cover 74, that remains in a fixed location about the container 70) so that the element is non-movable manner relative to the reservoir (see Fig. 2 where the top surface 75 or the upper portion 80 of cover 74 does not move during the use of the device, such that the top surface 75 does not move relative to the container 70), wherein, when said actuator member moves towards its primed position, said spring is compressed and directly transmits an axial force of the spring to the element (see Figs. 1-2 where the spring 79 is in contact with and presses against top surface 75, such that a compression of the spring results in additional spring force being directly applied to the top surface 75).
Rich lacks a detailed description of the protective element being disposed inside the device between said mouthpiece and said inhalation-sensitive member, said protective element being made of a porous material that allows air to pass through it but blocks passage of water, dust and foreign bodies, wherein said protective element is configured and disposed to thereby avoid contamination of the inhalation-controlled trigger system.
However, Shahaf teaches a similar medicament inhaler device where a protective element being disposed inside the device between said mouthpiece and said inhalation-sensitive member (see Col. 63 lines 33-54 where the medicament device (Figs. 4A-10) can include a filter, the filter being able to be placed in a variety of locations, including within the charging mechanism around the piston so as to filter air as it enters the piston chamber), said protective element being made of a porous material that allows air to pass through it but blocks passage of water, dust and foreign bodies (see Col. 63 lines 33-54 where the filter can be designed for blocking particulates, bacteria, viruses, and moisture), wherein said protective element is configured and disposed to thereby avoid contamination of the inhalation-controlled trigger system (see Col. 63 lines 33-54 where the filter is to remove the wanted particles from the air, and the placement of the filter in the flow path upstream the charging mechanism will protect charging mechanism from the air that enters it).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve area of Rich to include a filter as taught by Shahaf, as it would help filter out unwanted particles and germs that enter the device to ensure the user receives clean, filtered air. It is understood that Shahaf discloses a plurality of locations where a filter could be placed (Shahaf; Col. 63 lines 33-54), including locations that are upstream of the piston mechanism that is creating the dispersal of the medicament. Hence, in the modified Rich device, the upstream location is somewhere between the valve 18 and the orifice 112, such that air entering the device to entrain the medicament is already filtered. One of ordinary skill in the art, upon reading Shahaf, would understand that there are a plurality of locations where a filter could be placed within the device to filter the air, and that placing it between an inhalation-sensitive member and a trigger mechanism amounts to a matter of design choice, as it would still ensure that the air passing through is filtered.
Claims 2-3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rich in view of Shahaf as applied to claim 1 above, and further in view of Knopeck et al. (US Pat. 9,308,199).
Regarding claim 2, the modified Rich device has a porous protective element.
The modified Rich device lacks a detailed description of the protective element being made of open-pore sintered material.
However, Knopeck teaches a similar medicament inhaler device, where a porous filtering membrane in the mouthpiece is made from sintered polymers, such as polypropylene (see Col. 12 lines 34-50; where the material is porous and thus open-pore).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the porous filter of the modified Rich device to be a sintered polypropylene as taught by Knopeck, as it would be a simple substitution for one porous filter material for another, to yield the predictable result of still being able to filter out unwanted particles.
Regarding claim 3, the modified Rich device has wherein said open-pore sintered material comprises a polyolefin material (Knopeck; see Col. 12 lines 34-50 where polypropylene is understood to be a polyolefin material).
Regarding claim 10, the modified Rich device has wherein the polyolefin material is polypropylene (Knopeck; see Col. 12 lines 34-50 where polypropylene is understood to be a polyolefin material).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rich in view of Shahaf as applied to claim 1 above, and further in view of Loeser et al. (US Pub. 2009/0194107).
Regarding claim 4, the modified Rich device has a protective element for filtering germs.
The modified Rich device lacks a detailed description of said protective element is subjected to an antibacterial treatment.
However, Loeser teaches a similar respiratory device that delivers breathable gas to a patient, where a filter element includes a bioactive agent to resist germs and bacteria (see [0023]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the air filter of the modified Rich device to carry a bioactive agent to combat bacteria as taught by Loeser, as it would help in the air filter’s ability to capture germs and bacteria to purify the inhaled air.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rich in view of Shahaf in view of Wass (US Pat. 4,664,107).
Regarding claim 13, Rich discloses an inhalation-synchronized fluid product dispenser device (see breath-actuated inhalation device 10 in Fig. 2) comprising a body (the outer casing of the inhaler in Fig. 2, particularly housing 12) provided with a mouthpiece (the distal end of lateral extension 14 in Fig. 2), at least one fluid reservoir containing fluid (medicament-dispensing container 70 in Fig. 2), and dispenser means for dispensing a dose of fluid on each actuation (dispensing orifice 112 and bore 66 in Fig. 2, through which medicament is dispensed through), said device comprising blocking means for said dispenser means (collar 42 with flange 62 in Fig. 2), said device comprising an inhalation-controlled trigger system comprising an inhalation-sensitive member that is deformable and/or movable under the effect of inhaling (see flexible diaphragm-type valve 18 in Fig. 2), said inhalation-sensitive member co-operating with said blocking means so that, when said inhalation-sensitive member is deformed and/or moved under the effect of inhaling, it enables said dispenser means to be actuated (see Figs. 2 and 4 where during inhalation, valve 18 moves to allow air in, and collar 42 presses against the assembly around valve stem 68, the two working in cooperative fashion so as to permit the actuation through the dispensing orifice 112), wherein said device comprises a protective element of said inhalation-controlled trigger system (see cover 16 for extension/mouthpiece 14 in Fig. 2, which is part of the triggering system as it allows for the negative pressure of inhalation to drive diaphragm valve 18; see Col. 4 lines 14-26); and wherein an actuator member is mounted to move axially in said body between a rest position and a primed position (see Figs. 1-2 where spring 44 is an actuator member that has a rest position (Fig. 2) and a primed position (Fig. 4) where it pushes up nozzle 64/ bore 66 into the stem 68).
Rich lacks a detailed description of the protective element being disposed inside the device between said mouthpiece and said inhalation-sensitive member, said protective element being made of a porous material that allows air to pass through it but blocks passage of water, dust and foreign bodies, wherein said protective element is configured and disposed to thereby avoid contamination of the inhalation-controlled trigger system.
However, Shahaf teaches a similar medicament inhaler device where a protective element being disposed inside the device between said mouthpiece and said inhalation-sensitive member (see Col. 63 lines 33-54 where the medicament device (Figs. 4A-10) can include a filter, the filter being able to be placed in a variety of locations, including within the charging mechanism around the piston so as to filter air as it enters the piston chamber), said protective element being made of a porous material that allows air to pass through it but blocks passage of water, dust and foreign bodies (see Col. 63 lines 33-54 where the filter can be designed for blocking particulates, bacteria, viruses, and moisture), wherein said protective element is configured and disposed to thereby avoid contamination of the inhalation-controlled trigger system (see Col. 63 lines 33-54 where the filter is to remove the wanted particles from the air, and the placement of the filter in the flow path upstream the charging mechanism will protect charging mechanism from the air that enters it).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve area of Rich to include a filter as taught by Shahaf, as it would help filter out unwanted particles and germs that enter the device to ensure the user receives clean, filtered air. It is understood that Shahaf discloses a plurality of locations where a filter could be placed (Shahaf; Col. 63 lines 33-54), including locations that are upstream of the piston mechanism that is creating the dispersal of the medicament. Hence, in the modified Rich device, the upstream location is somewhere between the valve 18 and the orifice 112, such that air entering the device to entrain the medicament is already filtered. One of ordinary skill in the art, upon reading Shahaf, would understand that there are a plurality of locations where a filter could be placed within the device to filter the air, and that placing it between an inhalation-sensitive member and a trigger mechanism amounts to a matter of design choice, as it would still ensure that the air passing through is filtered.
The modified Rich device lacks a detailed description of a spring being arranged between said actuator member and said reservoir so that when said actuator member moves towards its primed position, said spring is compressed and transmits an axial force to the reservoir through direct contact with said reservoir.
However, Wass teaches an inhalation-activated inhaler device, where a spring is placed between an actuator member and a reservoir (see Figs. 11-12 where spring 105 is placed between an actuating coil spring 100 and the container 23), such that when the actuator member is primed (see position in Fig. 12 and Col. 5 lines 64 to Col. 6 line 17), the spring is compressed and transmits an axial force to the reservoir through direct contact with said reservoir (see Col. 6 lines 7-17 and Figs. 11-12, where the spring 105 is overpowered and compressed by the coil spring 100, and the forces of the spring 105 act directly on and are transferred to the container 23). It is further noted that the spring 105 in Figs. 11-12 exists between the container 23, and a nozzle holder member 95.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the space between the container and nozzle of the modified Rich device to include a spring member as taught by Wass, as it would help maintain the container in a position separate from the nozzle when in a resting state, and allow for a wider range of nozzle stem lengths to be used by the dispenser (Wass; see Col. 6 lines 7-17).
Response to Arguments
Applicant's arguments filed 9/08/2025 have been fully considered but they are not persuasive. Further, new claim 13 is rejected including the newly applied teaching reference of Wass.
Applicant argues on page 7 of the remarks against the 112(a) rejection of claim 1 (which is understood to also apply to the new 112(a) rejection of claim 13). Applicant argues that the term “directly” is not ambiguous, and that a person of ordinary skill in the art would understand that the spring does not need to touch the reservoir in order to directly transmit the axial force. The arguments are not well-taken. First, it is held that the use of the term “direct” still constitutes a new matter issue, as the term is not used in the specification. Additionally, the specification at best just mentions the transmission of force (such as with an intermediate element (e.g. hoop 950)), and the drawings only show that arrangement. Rather, the applicant’s argument further illustrates the problem with the term “directly.” Applicant argues that whether a spring pushes on the reservoir via contact, or via an element between the spring and the reservoir, the result is the same and the axial force is directly transmitted to the reservoir. This creates confusion over how a “direct” transfer of force is different from a “indirect” or “not direct” transfer of force. For instance, if the claim recited “the axial force of the spring is transmitted to the reservoir” and omitted the term “directly,” then a person of ordinary skill in the art would understand that the breadth of that limitation includes both the spring touching the reservoir, and there being an element between the spring and reservoir. The term “directly” carries weight, and creates the presumption of the force being applied from one object to another without any intervening or additional steps/ structures. As such, due to a lack of any disclosure that points to specific structure and/or function whereby the spring has direct interaction with the reservoir, the limitation is considered new matter.
Applicant argues on pages 8-9 of the remarks that the spring 79 of Rich does not transfer an axial force to the reservoir, instead acting on the housing. The argument is not well-taken. The “transmission of force” is broader than the applicant is giving credit. Newton’s 3rd law states that for every action, there is an equal but opposite reaction. Hence, the force applied by the spring acts on the cap 82 and against the user’s fingers, the force then being part of the action/reaction forces that work through the chain of slides 88, wings 50/52 to collar 42 and so on to finally act on the reservoir. Additionally, the claim does not necessitate that it is the force of the spring which is providing the axial force. The claim recites “so that when said actuator member moves towards its primed position, said spring is compressed, so as to transmit an axial force directly to said reservoir.” This limitation can be read such that the actuator member moves to its primed position, that motion causes the spring to be compressed, the compression of the spring allowing for the transmission of axial force (e.g. an axial force provided by the user pressing down on the cap). In this way, the spring 79 of Rich compressing allows for the movement of the slides/ wings/ collar, and so on. There is no specific claim language that is connecting the spring tension to being the source of the axial force.
Examiner further notes that the “element” recited in the final lines of claim 12 has no claimed functionality, and does not need to relay its received axial force to the reservoir.
For the reasons above, the rejections hold.
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.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785