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 .
Claim Interpretation
Per claim 8, the limitation “comprises a monolithic material”, it is interpreted to mean that a monolithic material is one continuous part or material, not multiple assembled or bonded parts.
Claim Objections
Claim 17 is objected to because of the following informalities: the recitation “the inhaler channel”, should read ---the channel---, to avoid any antecedent basis issues. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 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.
Regarding claim 17, with the limitation “wherein the membrane may comprise”, it is unclear as to whether the claim is intended to positively recite the structure proceeding the limitation, because of the use of may comprise. It is interpreted that the structure proceeding the limitation is required to be included.
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 1-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (WO 2021191606 A1) in view of Van Oort (US 5647347 A).
Regarding claim 1, Anderson discloses an inhaler device (Fig.1 below) comprising two flexible substrates (‘408,410’ Figure 1 below) and a membrane located between the two flexible substrates (‘402’ Figure 1 below), each of the two flexible substrates comprising at least one deformable element (pg. 2, lines 3-4);
the two flexible substrates being connected at two opposing edges and unconnected at two further opposing edges, (pg.2, lines 4-5);
wherein the device is configured to move between a first configuration where the two flexible substrates are substantially flat and in contact with one another (pg. 2, lines 6-7);
and a second configuration where the two flexible substrates are flexed such that a channel is formed between the two flexible substrates having a first opening at one end of the channel and a second opening at an opposed end of the channel (pg. 2, lines 7-15, see first opening and second opening and Figure 1 below);
wherein the membrane is configured to span the channel between the two flexible substrates when the device is in the second configuration, such that an active agent provided on the membrane may be inhaled by a user when the device is in the second configuration (pg.2, lines 9-12);
Anderson further discloses the membrane (‘402’ Figure 1) having a first zone facing the first opening and a second zone facing the second opening, where pores are configured to retain, prevent passage, or release the active agent (pg.9 lines 1-3, 24-27).
However, Anderson fails to explicitly disclose that the membrane comprises a first portion and a second portion configured as distinct elements wherein the first portion releasably retains the active agent and the second portion prevents the passage of the active agent through it.
Van Oort discloses an inhaler wherein:
the membrane comprises a first portion and a second portion (Van Oort Figure 5; ’14,12’, where ’14,16’ are optional enclosure screens within the edge ring – thereby having, one, both, or none of them [05]), wherein the portions have distinct active agent functions (Van Oort [04,08]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler device of Anderson to include two distinct portions of the membrane as taught by Van Oort with releasably retaining the agent on the first portion and prevent the passage of the agent through the second portion in Anderson’s device, since not only are two distinct portions of a membrane within an inhaler well known in the art (Van Oort [03]), but also because utilizing Van Oort’s two distinct membrane portions (Van Oort Figure 5; ’14,12’) would ensure that the active agent is efficiently entrained in the air when positioned within the inhaler device. By restricting the active agent to the first portion and blocking it with the second portion, the modified device helps to guide air flow to carry the exact intended dose through the inhaler to be inhaled by the patient (Van Oort [05]).
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Figure 1: annotated Figure 8A of Anderson.
Regarding claim 2, modified Anderson further discloses the inhaler device of claim 1, wherein the membrane comprises a first major surface and an opposed second major surface and the first portion of the membrane comprises the first major surface and the second portion of the membrane comprises the second major surface (as modified Van Oort Figure 5; ’14,12’ are the first and second portions of the membrane and they contain surfaces (first major surface and second major surface respectfully)).
Regarding claim 3, modified Anderson further discloses the inhaler device of claim 1 or claim 2, wherein the first portion of the membrane comprises a first plurality of apertures or pores (as modified Van Oort Figure 5; ‘14’ is the first portion of the membrane that has a plurality of apertures or pores).
Regarding claim 4, modified Anderson further discloses the inhaler device of claim 1, wherein the second portion of the membrane comprises a second plurality of apertures or pores (as modified Van Oort Figure 5; ‘12’ the second portion of the membrane comprises a plurality of apertures or pores).
Regarding claim 5, modified Anderson further discloses the inhaler device of claim 4 when dependent on claim 3, wherein the apertures or pores of the first plurality of apertures or pores are larger than the apertures or pores of the second plurality of apertures or pores (as modified Van Oort Figure 5; ‘14’ first portion of the membrane’s apertures or pores are larger than apertures or pores of the second portion ‘12’).
Regarding claim 6, modified Anderson further discloses the inhaler device of claim 1, wherein first portion of the membrane is substantially continuous (as modified Van Oort Figure 5; where the first portion of the membrane ‘14’ is substantially continuous where the active agent may be retained prior to use).
Regarding claim 7, modified Anderson further discloses the inhaler device of claim 1, wherein the second portion of the membrane is substantially continuous (as modified Van Oort Figure 5; where the second portion of the membrane ‘12’ is substantially continuous, such that an active agent can be mounted upon accordingly).
Regarding claim 8, modified Anderson further discloses the inhaler device of claim 1, wherein the first portion of the membrane and/or the second portion of the membrane comprises a monolithic material (as modified Van Oort Figure 5 provides the first portion ‘14’ and the second portion ‘16’, where the mesh material within the edge ring is a monolithic material – the same continuous material throughout, [015]; where the first and second portion ’14,12’ are made of stainless steel (one material) thereby being a monolithic material).
Regarding claim 9, modified Anderson further discloses the inhaler device of claim 1, wherein the first portion of the membrane comprises a mesh and/or the second portion of the membrane comprises a mesh (as modified Van Oort provides the first and second portion of the membrane ’14,12’, [015]; that are mesh screens).
Regarding claim 10, modified Anderson further discloses the inhaler device of claim 9, wherein the first portion of the membrane and the second portion of the membrane comprise a mesh, the mesh of the first portion of the membrane has larger gaps, holes or voids than the mesh of the second portion of the membrane (as modified Van Oort Figure 5; provides the first and second portion ’14,12’ that are mesh [015], and through Figure 5, it is seen that the first portion of the membrane ‘14’ has larger gaps/holes/voids than the mesh of the second portion ‘12’ gaps/holes/voids).
Regarding claim 11, modified Anderson further discloses the inhaler device of claim 1, wherein the active agent comprises particles of active agent and the second portion of the membrane is substantially impermeable to the particles of active agent (Anderson pg. 8, lines 31-33; active agent comprises particles of active agent, pg. 9, lines 25-27; impermeable to the particles of the active agent – as modified Van Oort provides the second portion ‘12’ of the membrane with the functionality of blocking the particles of the active agent of Anderson – making the modified device).
Regarding claim 12, modified Anderson further discloses the inhaler device of claim 1, wherein the first portion of the membrane comprises the same material as the second portion of the membrane (as modified Van Oort provides the first and second portion of the membrane ’14,12’ and they are the same material [015]; stainless steel mesh).
Regarding claim 17, Anderson discloses an inhaler device (Figure 1 above), comprising a membrane located within a channel having a first opening and an opposed second opening (Figure 1 above; membrane ‘402’ located within the channel ‘416’ with the first and second opening opposing each other), wherein the membrane is configured to span the inhaler channel such that an active agent provided on the membrane may be inhaled by a user through the channel (Figure 1 above; where the membrane ‘402’ spans the channel ‘416’ such that an active agent ‘414’ on the membrane ‘402’ may be inhaled by a user through the channel ‘416’);
Anderson further discloses the membrane (‘402’ Figure 1) having a first zone facing the first opening and a second zone facing the second opening, where pores are configured to retain, prevent passage, or release the active agent (pg.9 lines 1-3, 24-27).
However, Anderson fails to explicitly disclose that the membrane comprises a first portion and a second portion configured as distinct elements wherein the first portion releasably retains the active agent and the second portion prevents the passage of the active agent through it.
Van Oort discloses an inhaler wherein:
the membrane comprises a first portion and a second portion (Van Oort Figure 5; ’14,12’, where ’14,16’ are optional enclosure screens within the edge ring – thereby having, one, both, or none of them [05]), wherein the portions have distinct active agent functions (Van Oort [04,08]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler device of Anderson to include two distinct portions of the membrane as taught by Van Oort with releasably retaining the agent on the first portion and prevent the passage of the agent through the second portion in Anderson’s device, since not only are two distinct portions of a membrane within an inhaler well known in the art (Van Oort [03]), but also because utilizing Van Oort’s two distinct membrane portions (Van Oort Figure 5; ’14,12’) would ensure that the active agent is efficiently entrained in the air when positioned within the inhaler device. By restricting the active agent to the first portion and blocking it with the second portion, the modified device helps to guide air flow to carry the exact intended dose through the inhaler to be inhaled by the patient (Van Oort [05]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (WO 2021191606 A1) in view of Van Oort (US 5647347 A) and further in view of Kang (WO 2019004501 A1).
Regarding claim 13, modified Anderson further discloses the inhaler device of claim 1.
Modified Anderson is silent to whether the first portion of the membrane is less dense than the second portion of the membrane.
Kang discloses an inhaler device wherein:
the first portion of the membrane is less dense than the second portion of the membrane (Kang [0051]; where there are two mesh sections (first and second portion of the membrane), and the second one is denser than the first one – thereby the first portion is less dense than the second portion of the membrane).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler device of modified Anderson’s first and second portion of the membrane by having the first portion be less dense than the second portion of the membrane as taught by Kang, since it allows for the second portion of the membrane to act as a blocking membrane for the active agent, and increases the effective amount of the active agent delivered (Kang [0051]).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (WO 2021191606 A1) in view of Van Oort (US 5647347 A) and further in view of Rowland (CN 108348702 A).
Regarding claim 14, modified Anderson further discloses the inhaler device of claim 1.
Modified Anderson fails to disclose that the membrane is a laminated membrane comprising two or more layers laminated together.
Rowland discloses an inhalation device wherein:
the membrane is a laminated membrane comprising two or more layers laminated together (Rowland [0080]; where the membrane is laminated and comprises two or more layers laminated together).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler device of modified Anderson replacing the membrane with a laminated membrane comprising two or more layers as taught by Rowland with the first and second portion of the membrane, since it allows for the membrane layers to be sealed together, sealing the impermeable membrane, and/or sealing the membrane against the device (Rowland [0080]).
Regarding claim 15, modified Anderson in view of Rowland further discloses the inhaler device of claim 14, wherein the first portion of the membrane corresponds to one or more layers of the laminated membrane (as modified Rowland provides the first portion and the second portion of the membrane to be one or more layers of laminated membrane [0080]).
Regarding claim 16, modified Anderson in view of Rowland further discloses the inhaler device of claim 14, wherein the second portion of the membrane corresponds to one or more layers of the laminated membrane (as modified Rowland provides the first portion and the second portion of the membrane to be one or more layers of laminated membrane [0080]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Smith (WO 2019008336 A1): an inhaler with two separate holes in a channel, a membrane disposed between.
Britto (US 6098619 A): foldable/ collapsible inhaler mechanism.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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