DETAILED ACTION
This Office Action is in response to the filing of amendments to the claims on 4/13/2026. As per the amendments therein, claims 2-4 and 19-20 have been amended, and no claims have been added or cancelled. Thus, claims 2-6, 11-13, and 16-20 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 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 2-6, 11-13, and 16-20 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.
Claims 2-4 and 19-20 all recite the limitation at the end of the claim: “when the preparation and removal methods for the metallocene catalyst and the non-metallocene catalyst are performed using the same techniques and conditions.” However, the limitation is indefinite as it is unclear how the techniques and conditions can be the exact “same” between the removing of the different catalysts.
Any remaining claims are rejected for being dependent on a rejected claim.
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 2-6, 11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US Pat. 7,828,150) in view of Merical et al. (US Pub. 2003/0235664) in view of Hekal (US Pat. 5,911,937).
Regarding claim 2 Taylor discloses an inhaler (dry powder inhaler 420 in Fig. 5) comprising: a body portion (body 421 in Fig. 5) defining a flow path for an administration of a medicament to a patient (flow path within body 421 from reservoir 423 to dosing member 432 and out passage 433 to mouthpiece 435 in Fig. 5); and an entrained polymer located in the flow path and secured to or integral with the body portion (see Col. 5 lines 7-20 where the container is made of a polymer entrained with a desiccant), wherein the entrained polymer comprises a monolithic material comprising a polypropylene base polymer prepared using a metallocene catalyst (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, where the use of a metallocene catalyst is a product-by-process limitation such that the end result of a polypropylene polymer is the same and the method of making it via a metallocene catalyst does not patentably distinguish the polypropylene from any other polypropylene), an active agent comprising a molecular sieve desiccant (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, and see Col. 10 lines 38-65 where the desiccant can include a molecular sieve), a hydrophilic zeolite odor adsorbing material (see Col. 10 lines 38-65 where the desiccant can include a hydrophilic zeolite odor adsorbing material; see also Col. 4 lines 52-55 where a zeolite can be combined with a molecular sieve as a mixed desiccant), and a channeling agent (see Col. 5 lines 13-20 where the thermoplastic can be a combination of different thermoplastic materials, including polyurethane which is a channeling agent (see Applicant’s specification [0038])), and further wherein the entrained polymer is substantially odor free (where the entrained polymer of Taylor has the same polymer (see [0037] of the applicant’s specification and Col. 5 lines 13-20 of Taylor, where there is multiple overlapping polymers in common) and desiccant composition (see [0040]-[0044] of the applicant’s specification and Col. 4 lines 52-55 of Taylor, where there is multiple overlapping desiccants in common) as the claimed invention, and thus is equally as odor free. Further, there is no agreed upon standard for “odor free.” Some people are more or less sensitive to odors, as are certain animals. Additionally, it is understood that everything (or almost everything) has some odor, whether or not it is perceptible to an average human. Hence, the entrained polymer of Taylor is made of the same material, and is equally as odorless as the claimed invention).
In the alternative that Taylor does not have the polypropylene made by a metallocene catalyst, and wherein the entrained polymer prepared using the metallocene catalyst is cleaner than a comparable entrained polymer prepared using a non-metallocene catalyst, resulting from ease, and amount, of removal of the metallocene catalyst from the entrained polymer as compared to removal of the non-metallocene catalyst, when the preparation and removal methods for the metallocene catalyst are the non-metallocene catalyst are performed using the same techniques and conditions, then it is taught by Merical.
Merical teaches a similar desiccant impregnated material, where a thermoplastic, including polypropylene, can be made by metallocene catalyst, which is a known method of production (see [0035]). It is then understood that preparation via a metallocene catalyst can be as clean as the manufacturer desires, and thus can be cleaner than preparation with a non-metallocene catalyst.
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 method of making the polypropylene of Taylor to be made via metallocene catalyst as taught by Merical, as it would be using a known method of creating a thermoplastic with a desiccant, to produce the same polypropylene, and would further be a simple matter of design choice for a person of ordinary skill in the art to choose a different method of production. As both the modified Taylor device (via the teachings of Merical) and the claimed invention use a metallocene catalyst for preparation of the entrained polymer, both are equally as capable of being as clean as desired by the manufacturer, such as cleaner than a non-metallocene catalyst preparation. The limitation thus amounts to nothing more than a preference for the quality of the prepared polymer, using the same production technique. Furthermore, the claimed invention and modified Taylor device appear to be using the same system and method for preparation of the polymer, and thus is equally as capable of meeting the desired “cleanliness.”
The modified Taylor device lacks a detailed description of the channeling agent being different from the polypropylene base polymer, wherein the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent.
However, Hekal teaches a desiccant entrained polymer (see abstract), where the desiccant entrained polymer includes a channeling agent that has been blended together with the polymer to form a monolithic material (see channeling agent 35 in Figs. 1-10; see also Col. 6 line 51 to Col. 7 line 5), the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent (see Figs. 1-10 where channeling agent 35 of the polymer base 25 forms a plurality of interconnected passages 45; see also Col. 12 line to Col. 13 line 20 and Col. 15 lines 7-18).
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 entrained polymer of the modified Taylor device to include a channeling agent mixed into the base polymer to form interconnected passages as taught by Hekal, as it would provide channels in the polymer that increase the rate that moisture can travel, thus improving the absorption rate of the desiccant (Hekal; see Col. 6 lines 25-35).
Regarding claim 3, Taylor discloses an inhaler (dry powder inhaler 420 in Fig. 5) comprising: a body portion (body 421 in Fig. 5) defining a flow path for an administration of a medicament to a patient (flow path within body 421 from reservoir 423 to dosing member 432 and out passage 433 to mouthpiece 435 in Fig. 5); and an entrained polymer located in the flow path and secured to or integral with the body portion (see Col. 5 lines 7-20 where the container is made of a polymer entrained with a desiccant), wherein the entrained polymer comprises a monolithic material comprising a polypropylene base polymer prepared using a metallocene catalyst (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, where the use of a metallocene catalyst is a product-by-process limitation such that the end result of a polypropylene polymer is the same and the method of making it via a metallocene catalyst does not patentably distinguish the polypropylene from any other polypropylene), an active agent comprising a molecular sieve desiccant (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, and see Col. 10 lines 38-65 where the desiccant can include a molecular sieve), a hydrophilic zeolite odor adsorbing material (see Col. 10 lines 38-65 where the desiccant can include a hydrophilic zeolite odor adsorbing material; see also Col. 4 lines 52-55 where a zeolite can be combined with a molecular sieve as a mixed desiccant), and a channeling agent (see Col. 5 lines 13-20 where the thermoplastic can be a combination of different thermoplastic materials, including polyurethane which is a channeling agent (see Applicant’s specification [0038])), and further wherein the entrained polymer in a 16 gram quantity releases less than 4 ppm volatile organic compounds after heating at 60 C for up to 72 hours (this is understood to be an inherent material property of the entrained polymer. As the entrained polymer of Taylor has the same composition of polymer and desiccant as the claimed invention, it has the same material properties as the broadly claimed entrained polymer. Additionally, it appears that the claimed invention does not positively need to include volatile organic compounds, and thus a system without them would release no ppm of volatile organic compounds), wherein the entrained polymer is disposed in, or is in fluid communication with, a compartment of the body portion that houses the medicament and is located in the flow path of the medicament (see Col. 5 lines 7-20 where the any part of the inhaler, including the reservoir 423 which is a compartment, is made of a polymer entrained with a desiccant; see also Col. 2 lines 48-50, Col. 6 line 62 to Col. 7 line 13 where the desiccant material is intended to line parts of the body which contact the medicament powder, more specifically desiccant material 403 in Fig. 5 being both in the reservoir housing the medicament and in fluid communication with the medicament, such that the reservoir 423 as well as the walls of passage 433 and material around the metering valve can have the desiccant and are part of the flow path of the medicament as it leaves the reservoir).
In the alternative that Taylor does not have the polypropylene made by a metallocene catalyst, and wherein the entrained polymer prepared using the metallocene catalyst is cleaner than a comparable entrained polymer prepared using a non-metallocene catalyst, resulting from ease, and amount, of removal of the metallocene catalyst from the entrained polymer as compared to removal of the non-metallocene catalyst, when the preparation and removal methods for the metallocene catalyst are the non-metallocene catalyst are performed using the same techniques and conditions, then it is taught by Merical.
Merical teaches a similar desiccant impregnated material, where a thermoplastic, including polypropylene, can be made by metallocene catalyst, which is a known method of production (see [0035]). It is then understood that preparation via a metallocene catalyst can be as clean as the manufacturer desires, and thus can be cleaner than preparation with a non-metallocene catalyst.
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 method of making the polypropylene of Taylor to be made via metallocene catalyst as taught by Merical, as it would be using a known method of creating a thermoplastic with a desiccant, to produce the same polypropylene, and would further be a simple matter of design choice for a person of ordinary skill in the art to choose a different method of production. As both the modified Taylor device (via the teachings of Merical) and the claimed invention use a metallocene catalyst for preparation of the entrained polymer, both are equally as capable of being as clean as desired by the manufacturer, such as cleaner than a non-metallocene catalyst preparation. The limitation thus amounts to nothing more than a preference for the quality of the prepared polymer, using the same production technique. Furthermore, the claimed invention and modified Taylor device appear to be using the same system and method for preparation of the polymer, and thus is equally as capable of meeting the desired “cleanliness.”
The modified Taylor device lacks a detailed description of the channeling agent being different from the polypropylene base polymer, wherein the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent.
However, Hekal teaches a desiccant entrained polymer (see abstract), where the desiccant entrained polymer includes a channeling agent that has been blended together with the polymer to form a monolithic material (see channeling agent 35 in Figs. 1-10; see also Col. 6 line 51 to Col. 7 line 5), the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent (see Figs. 1-10 where channeling agent 35 of the polymer base 25 forms a plurality of interconnected passages 45; see also Col. 12 line to Col. 13 line 20 and Col. 15 lines 7-18).
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 entrained polymer of the modified Taylor device to include a channeling agent mixed into the base polymer to form interconnected passages as taught by Hekal, as it would provide channels in the polymer that increase the rate that moisture can travel, thus improving the absorption rate of the desiccant (Hekal; see Col. 6 lines 25-35).
Regarding claim 4, Taylor discloses an inhaler (dry powder inhaler 420 in Fig. 5) comprising: a body portion (body 421 in Fig. 5) defining a flow path for an administration of a medicament to a patient (flow path within body 421 from reservoir 423 to dosing member 432 and out passage 433 to mouthpiece 435 in Fig. 5); and an entrained polymer located in the flow path and secured to or integral with the body portion (see Col. 5 lines 7-20 where the container is made of a polymer entrained with a desiccant), wherein the entrained polymer comprises a monolithic material comprising a polypropylene base polymer prepared using a metallocene catalyst (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, where the use of a metallocene catalyst is a product-by-process limitation such that the end result of a polypropylene polymer is the same and the method of making it via a metallocene catalyst does not patentably distinguish the polypropylene from any other polypropylene), an active agent comprising a molecular sieve desiccant (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, and see Col. 10 lines 38-65 where the desiccant can include a molecular sieve), a hydrophilic zeolite odor adsorbing material (see Col. 10 lines 38-65 where the desiccant can include a hydrophilic zeolite odor adsorbing material; see also Col. 4 lines 52-55 where a zeolite can be combined with a molecular sieve as a mixed desiccant), and a channeling agent (see Col. 5 lines 13-20 where the thermoplastic can be a combination of different thermoplastic materials, including polyurethane which is a channeling agent (see Applicant’s specification [0038])), and further wherein the entrained polymer in a 16 gram quantity releases 0 ppm volatile organic compounds after heating at 60 C for up to 72 hours (this is understood to be an inherent material property of the entrained polymer. As the entrained polymer of Taylor has the same composition of polymer and desiccant as the claimed invention, it has the same material properties as the broadly claimed entrained polymer. Additionally, it appears that the claimed invention does not positively need to include volatile organic compounds, and thus a system without them would release no ppm of volatile organic compounds), wherein the entrained polymer is disposed in, or is in fluid communication with, a single compartment of the body portion that houses the medicament and is located in the flow path of the medicament (see Col. 5 lines 7-20 where the any part of the inhaler, including the reservoir 423 is a single compartment, and is made of a polymer entrained with a desiccant; see also Col. 2 lines 48-50, Col. 5 line 62 to Col. 6 line 13 where the desiccant material is intended to line parts of the body which contact the medicament powder, more specifically desiccant material 403 in Fig. 5 being both in the reservoir housing the medicament and in fluid communication with the medicament, such that the reservoir 423 as well as the walls of passage 433 and material around the metering valve can have the desiccant and are part of the flow path of the medicament as it leaves the reservoir).
In the alternative that Taylor does not have the polypropylene made by a metallocene catalyst, and wherein the entrained polymer prepared using the metallocene catalyst is cleaner than a comparable entrained polymer prepared using a non-metallocene catalyst, resulting from ease, and amount, of removal of the metallocene catalyst from the entrained polymer as compared to removal of the non-metallocene catalyst, when the preparation and removal methods for the metallocene catalyst are the non-metallocene catalyst are performed using the same techniques and conditions, then it is taught by Merical.
Merical teaches a similar desiccant impregnated material, where a thermoplastic, including polypropylene, can be made by metallocene catalyst, which is a known method of production (see [0035]). It is then understood that preparation via a metallocene catalyst can be as clean as the manufacturer desires, and thus can be cleaner than preparation with a non-metallocene catalyst.
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 method of making the polypropylene of Taylor to be made via metallocene catalyst as taught by Merical, as it would be using a known method of creating a thermoplastic with a desiccant, to produce the same polypropylene, and would further be a simple matter of design choice for a person of ordinary skill in the art to choose a different method of production. As both the modified Taylor device (via the teachings of Merical) and the claimed invention use a metallocene catalyst for preparation of the entrained polymer, both are equally as capable of being as clean as desired by the manufacturer, such as cleaner than a non-metallocene catalyst preparation. The limitation thus amounts to nothing more than a preference for the quality of the prepared polymer, using the same production technique. Furthermore, the claimed invention and modified Taylor device appear to be using the same system and method for preparation of the polymer, and thus is equally as capable of meeting the desired “cleanliness.”
The modified Taylor device lacks a detailed description of the channeling agent being different from the polypropylene base polymer, wherein the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent.
However, Hekal teaches a desiccant entrained polymer (see abstract), where the desiccant entrained polymer includes a channeling agent that has been blended together with the polymer to form a monolithic material (see channeling agent 35 in Figs. 1-10; see also Col. 6 line 51 to Col. 7 line 5), the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent (see Figs. 1-10 where channeling agent 35 of the polymer base 25 forms a plurality of interconnected passages 45; see also Col. 12 line to Col. 13 line 20 and Col. 15 lines 7-18).
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 entrained polymer of the modified Taylor device to include a channeling agent mixed into the base polymer to form interconnected passages as taught by Hekal, as it would provide channels in the polymer that increase the rate that moisture can travel, thus improving the absorption rate of the desiccant (Hekal; see Col. 6 lines 25-35).
Regarding claim 5, the modified Taylor device has wherein the entrained polymer releases no volatile organic compounds at room temperature (this is understood to be an inherent material property of the entrained polymer. As the entrained polymer of Taylor has the same composition of polymer and desiccant as the claimed invention, it has the same material properties as the broadly claimed entrained polymer. Additionally, it appears that the claimed invention does not positively need to include volatile organic compounds, and thus a system without them would release no ppm of volatile organic compounds).
Regarding claim 6, the modified Taylor device has wherein the entrained polymer in a 16 gram quantity releases less than 4 ppm volatile organic compounds after heating at 60 C for up to 72 hours (this is understood to be an inherent material property of the entrained polymer. As the entrained polymer of Taylor has the same composition of polymer and desiccant as the claimed invention, it has the same material properties as the broadly claimed entrained polymer. Additionally, it appears that the claimed invention does not positively need to include volatile organic compounds, and thus a system without them would release no ppm of volatile organic compounds).
Regarding claim 11, the modified Taylor device has wherein the inhaler is a dry powder inhaler (Taylor; dry powder inhaler 420 in Fig. 5).
Regarding claim 16, the modified Taylor device has wherein the active agent comprises a desiccant and is from 30% to 80% by weight of the entrained polymer (Taylor; see Col. 5 lines 21-28).
Regarding claim 17, the modified Taylor device has wherein the desiccant is from 30% to 70% by weight of the entrained polymer (Taylor; see Col. 5 lines 21-28).
Regarding claim 19, Taylor discloses a method of manufacturing a low odor inhaler (providing dry powder inhaler 420 in Fig. 5), comprising the step of providing a body portion (body 421 in Fig. 5) defining a flow path for an administration of a medicament to a patient (flow path within body 421 from reservoir 423 to dosing member 432 and out passage 433 to mouthpiece 435 in Fig. 5), and an entrained polymer located in the flow path and being secured to or integral with the body portion (see Col. 5 lines 7-20 where the container is made of a polymer entrained with a desiccant), wherein the entrained polymer comprises a monolithic material that includes a polypropylene base polymer prepared using a metallocene catalyst (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, where the use of a metallocene catalyst is a product-by-process limitation such that the end result of a polypropylene polymer is the same and the method of making it via a metallocene catalyst does not patentably distinguish the polypropylene from any other polypropylene), an active agent comprising a molecular sieve desiccant (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, and see Col. 10 lines 38-65 where the desiccant can include a molecular sieve), a hydrophilic zeolite odor adsorbing material (see Col. 10 lines 38-65 where the desiccant can include a hydrophilic zeolite odor adsorbing material; see also Col. 4 lines 52-55 where a zeolite can be combined with a molecular sieve as a mixed desiccant), and a channeling agent (see Col. 5 lines 13-20 where the thermoplastic can be a combination of different thermoplastic materials, including polyurethane which is a channeling agent (see Applicant’s specification [0038])), and further wherein the entrained polymer is substantially odor free (where the entrained polymer of Taylor has the same polymer (see [0037] of the applicant’s specification and Col. 5 lines 13-20 of Taylor, where there is multiple overlapping polymers in common) and desiccant composition (see [0040]-[0044] of the applicant’s specification and Col. 4 lines 52-55 of Taylor, where there is multiple overlapping desiccants in common) as the claimed invention, and thus is equally as odor free. Further, there is no agreed upon standard for “odor free.” Some people are more or less sensitive to odors, as are certain animals. Additionally, it is understood that everything (or almost everything) has some odor, whether or not it is perceptible to an average human. Hence, the entrained polymer of Taylor is made of the same material, and is equally as odorless as the claimed invention).
In the alternative that Taylor does not have the polypropylene made by a metallocene catalyst, and wherein the entrained polymer prepared using the metallocene catalyst is cleaner than a comparable entrained polymer prepared using a non-metallocene catalyst, resulting from ease, and amount, of removal of the metallocene catalyst from the entrained polymer as compared to removal of the non-metallocene catalyst, when the preparation and removal methods for the metallocene catalyst are the non-metallocene catalyst are performed using the same techniques and conditions, then it is taught by Merical.
Merical teaches a similar desiccant impregnated material, where a thermoplastic, including polypropylene, can be made by metallocene catalyst, which is a known method of production (see [0035]). It is then understood that preparation via a metallocene catalyst can be as clean as the manufacturer desires, and thus can be cleaner than preparation with a non-metallocene catalyst.
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 method of making the polypropylene of Taylor to be made via metallocene catalyst as taught by Merical, as it would be using a known method of creating a thermoplastic with a desiccant, to produce the same polypropylene, and would further be a simple matter of design choice for a person of ordinary skill in the art to choose a different method of production. As both the modified Taylor device (via the teachings of Merical) and the claimed invention use a metallocene catalyst for preparation of the entrained polymer, both are equally as capable of being as clean as desired by the manufacturer, such as cleaner than a non-metallocene catalyst preparation. The limitation thus amounts to nothing more than a preference for the quality of the prepared polymer, using the same production technique. Furthermore, the claimed invention and modified Taylor device appear to be using the same system and method for preparation of the polymer, and thus is equally as capable of meeting the desired “cleanliness.”
The modified Taylor device lacks a detailed description of the channeling agent being different from the polypropylene base polymer, wherein the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent.
However, Hekal teaches a desiccant entrained polymer (see abstract), where the desiccant entrained polymer includes a channeling agent that has been blended together with the polymer to form a monolithic material (see channeling agent 35 in Figs. 1-10; see also Col. 6 line 51 to Col. 7 line 5), the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent (see Figs. 1-10 where channeling agent 35 of the polymer base 25 forms a plurality of interconnected passages 45; see also Col. 12 line to Col. 13 line 20 and Col. 15 lines 7-18).
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 entrained polymer of the modified Taylor device to include a channeling agent mixed into the base polymer to form interconnected passages as taught by Hekal, as it would provide channels in the polymer that increase the rate that moisture can travel, thus improving the absorption rate of the desiccant (Hekal; see Col. 6 lines 25-35).
Regarding claim 20, Taylor discloses a method of administering a medicament to a patient in need thereof (via dry powder inhaler 420 in Fig. 5), comprising the step of delivering the medicament in an inhaler (see Fig. 5 where medicament flows out of mouthpiece 435 to a patient), wherein the inhaler comprises: a body portion (body 421 in Fig. 5) defining a flow path for an administration of a medicament to a patient (flow path within body 421 from reservoir 423 to dosing member 432 and out passage 433 to mouthpiece 435 in Fig. 5); and an entrained polymer located in the flow path and being secured to or integral with the body portion (see Col. 5 lines 7-20 where the container is made of a polymer entrained with a desiccant), wherein the entrained polymer comprises a monolithic material that includes a polypropylene base polymer prepared using a metallocene catalyst (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, where the use of a metallocene catalyst is a product-by-process limitation such that the end result of a polypropylene polymer is the same and the method of making it via a metallocene catalyst does not patentably distinguish the polypropylene from any other polypropylene), an active agent comprising a molecular sieve desiccant (see Col. 5 lines 7-40 where the container is made of a base polymer that can be polypropylene entrained with an active agent desiccant, and see Col. 10 lines 38-65 where the desiccant can include a molecular sieve), a hydrophilic zeolite odor adsorbing material (see Col. 10 lines 38-65 where the desiccant can include a hydrophilic zeolite odor adsorbing material; see also Col. 4 lines 52-55 where a zeolite can be combined with a molecular sieve as a mixed desiccant), and a channeling agent (see Col. 5 lines 13-20 where the thermoplastic can be a combination of different thermoplastic materials, including polyurethane which is a channeling agent (see Applicant’s specification [0038])), and further wherein the entrained polymer is substantially odor free (where the entrained polymer of Taylor has the same polymer (see [0037] of the applicant’s specification and Col. 5 lines 13-20 of Taylor, where there is multiple overlapping polymers in common) and desiccant composition (see [0040]-[0044] of the applicant’s specification and Col. 4 lines 52-55 of Taylor, where there is multiple overlapping desiccants in common) as the claimed invention, and thus is equally as odor free. Further, there is no agreed upon standard for “odor free.” Some people are more or less sensitive to odors, as are certain animals. Additionally, it is understood that everything (or almost everything) has some odor, whether or not it is perceptible to an average human. Hence, the entrained polymer of Taylor is made of the same material, and is equally as odorless as the claimed invention), wherein the entrained polymer is disposed in, or is in fluid communication with, a compartment of the body portion that houses the medicament (see Col. 5 lines 7-20 where the any part of the inhaler, including the reservoir 423, is made of a polymer entrained with a desiccant; see also Col. 2 lines 48-50, Col. 6 line 62 to Col. 7 line 13 where the desiccant material is intended to line parts of the body which contact the medicament powder, more specifically desiccant material 403 in Fig. 5 being both in the reservoir housing the medicament and in fluid communication with the medicament).
In the alternative that Taylor does not have the polypropylene made by a metallocene catalyst, and wherein the entrained polymer prepared using the metallocene catalyst is cleaner than a comparable entrained polymer prepared using a non-metallocene catalyst, resulting from ease, and amount, of removal of the metallocene catalyst from the entrained polymer as compared to removal of the non-metallocene catalyst, when the preparation and removal methods for the metallocene catalyst are the non-metallocene catalyst are performed using the same techniques and conditions, then it is taught by Merical.
Merical teaches a similar desiccant impregnated material, where a thermoplastic, including polypropylene, can be made by metallocene catalyst, which is a known method of production (see [0035]). It is then understood that preparation via a metallocene catalyst can be as clean as the manufacturer desires, and thus can be cleaner than preparation with a non-metallocene catalyst.
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 method of making the polypropylene of Taylor to be made via metallocene catalyst as taught by Merical, as it would be using a known method of creating a thermoplastic with a desiccant, to produce the same polypropylene, and would further be a simple matter of design choice for a person of ordinary skill in the art to choose a different method of production. As both the modified Taylor device (via the teachings of Merical) and the claimed invention use a metallocene catalyst for preparation of the entrained polymer, both are equally as capable of being as clean as desired by the manufacturer, such as cleaner than a non-metallocene catalyst preparation. The limitation thus amounts to nothing more than a preference for the quality of the prepared polymer, using the same production technique. Furthermore, the claimed invention and modified Taylor device appear to be using the same system and method for preparation of the polymer, and thus is equally as capable of meeting the desired “cleanliness.”
The modified Taylor device lacks a detailed description of the channeling agent being different from the polypropylene base polymer, wherein the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent.
However, Hekal teaches a desiccant entrained polymer (see abstract), where the desiccant entrained polymer includes a channeling agent that has been blended together with the polymer to form a monolithic material (see channeling agent 35 in Figs. 1-10; see also Col. 6 line 51 to Col. 7 line 5), the monolithic material comprises passages interconnected with each other through the entrained polymer formed of the channeling agent (see Figs. 1-10 where channeling agent 35 of the polymer base 25 forms a plurality of interconnected passages 45; see also Col. 12 line to Col. 13 line 20 and Col. 15 lines 7-18).
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 entrained polymer of the modified Taylor device to include a channeling agent mixed into the base polymer to form interconnected passages as taught by Hekal, as it would provide channels in the polymer that increase the rate that moisture can travel, thus improving the absorption rate of the desiccant (Hekal; see Col. 6 lines 25-35).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Merical in view of Hekal as applied to claim 3 above, and further in view of Trill et al. (US Pub. 2012/0180785).
Regarding claim 12, the modified Taylor device has the inhaler.
The modified Taylor device lacks a detailed description of wherein the inhaler is an aerosol inhaler.
However, Trill teaches a similar polymer inhaler which is an aerosol inhaler (see [0007]] where the expelled pressurized drug is vaporized into a cloud of particles entrained in the air).
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 polymer inhaler of the modified Taylor device to be an aerosol inhaler as taught by Trill, as it would be a simple substitution of one type of inhaler for another, while using the same entrained polymer body.
Regarding claim 13, the modified Taylor device has the inhaler. It is noted that Taylor does disclose blister packs of medicament, which could be considered a metered dose.
The modified Taylor device lacks a detailed description of wherein the inhaler is a metered dose inhaler.
However, Trill teaches a similar polymer inhaler wherein the inhaler is a metered dose inhaler (see [0007]] where the inhaler has a metering valve and metering chamber for metering a specified dose amount; further see [0001]).
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 polymer inhaler of the modified Taylor device to be metered dose inhaler as taught by Trill, as it would be a simple substitution of one type of inhaler for another, while using the same entrained polymer body.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Merical in view of Hekal as applied to claim 3 above, and further in view of Sauro et al. (US Pat. 6,112,888).
Regarding claim 18, the modified Taylor device has wherein the odor adsorbing material is from 1% to 8% by weight of the entrained polymer.
The modified Taylor device lacks a detailed description of where an odor absorbing material is less than 10% by weight of the desiccant.
However, Sauro teaches a similar entrained polymer with a desiccant, where an odor absorbing material is less than 10% by weight of the desiccant (see Col. 3 lines 53-67).
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 weight percentage of the odor absorbing material of the modified Taylor device to be less than 10% by weight as taught by Sauro, as it would be a simple matter of design choice for one of ordinary skill in the art to choose a relatively small percentage value of weight for the odor absorbing material, so as to not significantly interfere with other material properties of the polymer. Further, there is a lack of criticality in the claimed range of weights, and one of ordinary skill in the art would recognize that less than 10% is reasonably the same as 1-8% such that a value such as 7% could be chosen.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 10-11 of the remarks that a person would not be motivated to use a metallocene catalyst by Merical as 1) it is expensive, 2) it is complex, and 3) it is more difficult than other traditional methods. The arguments are not well-taken. The use of metallocene catalysts for making polymers has been well-known for decades. See Razavi (US Pat. 5,117,020) which is from 1992, and states that using a metallocene can provide control over stereospecificity of polypropylene (Col. 1 lines 14-20), and the metallocene itself being of sufficient purity (abstract). This is evidence that the process has been known for decades, and that a person of ordinary skill in the art would both 1) be aware of the process, and 2) when making a polypropylene, be motivated by the known control over the stereospecificity. Furthermore, a person of ordinary skill in the art can readily choose what known production process to use, and it is known that there are certain advantages and disadvantages to each choice. Thus, even knowing about the supposed expensive, complex, and difficult nature of the metallocene catalyst usage, it would be an obvious option for a person of ordinary skill in the art.
Furthermore, the limitation of each independent claim requiring that the metallocene catalyst usage is cleaner than the comparable non- metallocene catalyst usage under the same conditions amounts to nothing more than hypothetical functional language. Absent any specific structure or steps, then any prior art device that uses a metallocene catalyst is understood to be just as capable of creating the same entrained polymer as the claimed invention
Thus, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
