DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on June 25, 2026. As directed by the amendment: claims 1, 2, 4, 5, 7, and 8 have been amended, claims 3 and 6 have been canceled, and no new claims have been added. Thus, claims 1, 2, 4, 5, 7, and 8 are presently pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, lines 11-12, it is suggested that “central rigid disc” be amended to read --central rigid disk-- for consistency.
In claim 1, line 18, it is suggested that “central rigid disc” be amended to read --central rigid disk-- for consistency.
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.
In claim 1, “interlocking means” is interpreted according to page 3 lines 19-21 of the Specification as “one or more grooves or cavities”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(b) as being anticipated by Holroyd (US 2004/0025867).
As to claim 1, Holroyd discloses a breath actuated inhaler device (Fig. 1) comprising:
an actuator housing 400;
a canister 25 containing a dose; and
a pneumatic force holding unit (Fig. 8) for triggering the dose in response to a breath;
wherein pneumatic force holding unit comprises a compression spring 460 (Fig. 8, paragraph [0033]), a lower cap 420 that engages the canister 25 (see Fig. 1), a diaphragm 640 (Figs. 4-8) attached to an upper surface of the lower cap 420 (Fig. 8, paragraph [0056]), and a flap (valve seal/flap 540) to seal a valve port 695 located in the diaphragm 640 (paragraph [0057]),
wherein the diaphragm 640 includes a central rigid disk 641 and a peripheral flexible polymer ring 647 for triggering the dose in response to the breath (Figs. 4-8, paragraph [0056]),
wherein the central rigid disk 641 of the diaphragm 640 is provided with an interlocking means (axial grooves 708) to firmly secure and bound the peripheral flexible polymer ring 647 with the central rigid disc 641 of the diaphragm 640 (see Figs. 6-7, paragraphs [0054]-[0055]; see also applicant’s specification on page 3, lines 19-21, which describes “interlocking means” as “one or more grooves or cavities”), and
wherein the central rigid disk 641 and the peripheral flexible polymer ring 647 of the diaphragm 640 is formed by two shot injection molding process, wherein the central rigid disk 641 is prepared having the interlocking means (grooves 708) in first shot (paragraph [0054]: rigid disc-like section 641 is portion "A" of the diaphragm 640, molded in a first step; paragraph [0055]: axial grooves 708 are part of central rigid disc-like section 641) and the peripheral flexible polymer ring 647 is prepared in second shot (paragraph [0054]: peripheral attachment ring 647 is part of portion "B" of the diaphragm 640, along with central portion 700 and annular flexure 645, which is molded in a second step; paragraph [0054]: part "B" is an optimally flexible thermoplastic elastomer material (TPE)) during which a flexible polymer (optimally flexible thermoplastic elastomer material (TPE) forming part "B", which includes ring 647, central portion 700, and annular flexure 645) is allowed to flow through the interlocking means of the central rigid disk 641 (paragraph [0054]-[0055]: since part "B" is bonded to part "A" during the molding of part "B" in the second step/shot, when the TPE material is injected into the mold during the second shot, it will flow through the interlocking means/grooves 708 of central rigid disc 641) and solidify to form the projections/walls 706 within the grooves 708 which forms the bond between the parts "A" and "B") to form a continuous uninterrupted part on either side of the central rigid disc 641 of the diaphragm 640 (the resulting molded part (diaphragm 640) is continuous and uninterrupted on each side (no other components are attached through the diaphragm 640 that would "interrupt" its surface on either side, the only opening in either surface of the resultant diaphragm 640 is that of valve port 690/695, which is the same as applicant's valve port 204 present on the continuous "uninterrupted" surface of diaphragm 33 It is further noted that the diaphragm 33 of Applicant's allows for projections such as baffle 202, boss 204, and radial rib 205 on the "uninterrupted" surface of the diaphragm 33 (see Fig. 3 and page 6, the last paragraph continuing to page 7 of the instant specification).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Holroyd (US 2004/0025867), in view of Stenzler et al. (US 2018/0093051).
As to claim 2, Holroyd discloses the breath actuated inhaler device according to claim 1, but lacks detailed description as to the limitation that the flap (valve seal/flap 540) comprises a soft elastomer component to form an air tight lock with the valve port of the diaphragm. However, Stenzler discloses a valve seal/flap 142 which is formed of a soft elastomer material to form an air tight lock with a valve port 140 (Figs. 6A-6C, 7A-7B, paragraph [0042]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Holroyd so that the flap/valve seal 540 is made of a soft elastomer, as taught by Stenzler, in order to provide a suitable material choice for the flap that allows it to seal the valve port when closed and to flex and open upon a suitable inhalation pressure.
As to claim 5, Holroyd discloses the breath actuated inhaler device according to claim 2, wherein the hardness of the soft elastomer component is between 5-20 Shore A (see Stenzler, paragraph [0042]: valve 142 material may be silicone rubber or similar hyper-elastic material having a durometer between 5 and 80, preferably between 10 and 40).
As to claim 7, Holroyd discloses a breath actuated inhaler device (Fig. 1) comprising:
an actuator housing 400;
a canister 25 containing a dose; and
a pneumatic force holding unit (Fig. 8) for triggering the dose in response to a breath;
wherein pneumatic force holding unit comprises a compression spring 460 (Fig. 8, paragraph [0033]), a lower cap 420 that engages the canister 25 (see Fig. 1), a diaphragm 640 (Figs. 4-8) attached to an upper surface of the lower cap 420 (Fig. 8, paragraph [0056]), and a flap (valve seal/flap 540) to seal a valve port 695 located in the diaphragm 640 (paragraph [0057]), and
wherein the flap forms an air tight lock with the valve port of the diaphragm (paragraph [0057]: valve seal/flap 540 seals the valve port when closed).
Holroyd does not expressly disclose that the flap comprises a soft elastomer component. However, Stenzler discloses an inhaler device having a valve seal/flap 142 which is formed of a soft elastomer material to form a seal with a valve port 140 (Figs. 6A-6C, 7A-7B, paragraph [0042]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Holroyd so that the flap/valve seal 540 is made of a soft elastomer, as taught by Stenzler, in order to provide a suitable material choice for the flap that allows it to seal the valve port when closed and to flex and open upon a suitable inhalation pressure.
As to claim 8, modified Holroyd discloses the breath actuated inhaler device according to claim 7, wherein a hardness of the soft elastomer component is between 5-20 Shore A (see Stenzler, paragraph [0042]: valve 142 material may be silicone rubber or similar hyper-elastic material having a durometer between 5 and 80, preferably between 10 and 40).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holroyd (US 2004/0025867), in view of Gilbert et al. (US 2014/0053835).
As to claim 4, Holroyd discloses the breath actuated inhaler device according to claim 1, but does not expressly disclose that a hardness of the flexible polymer ring (portion 647 of diaphragm 640) is between 55-75 Shore A. However, Gilbert teaches a gas dispenser having a diaphragm 206 (Fig. 5) made of elastomer material having a hardness between 40-50 (paragraph [0061]: silicone material having a Shore A hardness ranging from 40-90 or from about 50 to 80). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Holroyd so that the flexible polymer ring of the diaphragm is made of a material having a hardness within the claim range, as taught by Gilbert, in order to provide a suitable material choice allowing flexure of the material upon increased pressure.
Response to Arguments
Applicant's arguments filed June 25, 2026 have been fully considered but they are not persuasive.
Applicant argues, on pages 6-8 of the remarks:
“Conversely, Holroyd requires axial walls (706) which are received within and bonded to axial grooves (708) of the rigid disc-like section (641), providing bonding surfaces substantially parallel with the central axis of the diaphragm (640). See para. [0055]. Thus, the two surfaces are merely in close vicinity of one another and not locked mechanically. Applicant asserts that this type of bonding is fragile, leading to the peeling off of the peripheral flexible polymer ring from the central rigid disc while the vacuum is being retained…Holroyd does not teach "wherein the central rigid disk is prepared having the interlocking means in first shot and the peripheral flexible polymer ring is prepared in second shot during which a flexible polymer is allowed to flow through the interlocking means of the central rigid disk to form a continuous uninterrupted part on either side of the central rigid disc of the diaphragm"
However, the argument is not well taken, because, as described in the above rejection, Holroyd does actually disclose the two part injection mold process as claimed (see paragraph [0054]) where the central disc 641 (rigid disc-like section 641 is portion "A" of the diaphragm 640) is molded in a first step and the peripheral ring 647 (peripheral attachment ) is molded in a second step, at which point it is bonded to the central disc/first portion "A". As to the limitation that the polymer material is allowed to flow through the interlocking means of the central disk to form a “continuous uninterrupted part on either side of the central rigid disc, it is noted that the claim language only "either side" can be interpreted as one of the two sides of the disk. The flexible polymer of part "B" in Holroyd is continuous and uninterrupted on at least the bottom side of central disk 641/part "A" (no components of part A extend entirely through part "B" or are exposed on the bottom side, as shown in Fig. 6 of Holroyd, see also Holroyd paragraph [0018], "the disk, the annular flexure and the peripheral ring form a contiguous assembly"). Thus, the limitation is met and the rejection stands.
Applicant further argues on pages 8-10 of the remarks:
“Stenzler does not teach a generic elastomeric valve seal, but a disc-shaped, slit-based valve (142, 144) formed of hyperelastic material specifically to achieve threshold-triggered snap-through behavior. The valve remains closed during an initial inhalation phase and then snaps open at a defined negative pressure, with flaps that recess and partially obstruct airflow, producing a bi-stable, two-stage inhalation profile. See Stenzler, para. [0042]. Thus, the material selection is inseparably tied to this specialized structure and function, not merely generic sealing or flexure.
Furthermore, Stenzler fails to teach or suggest the flap comprising a soft elastomer component "to form an air tight lock with the valve port of the diaphragm," as required by claim 7. Stenzler discloses an integral elastomeric valve structure that seals via deformation, rather than a discrete flap cooperating with a valve port of a diaphragm. See Stenzler, Figs. 6c and 7b. In contrast,9
Applicant's valve seal (see Fig. 6, 372) provides a predictable sealing interface with continuous opening under inhalation, without slit geometry, snap action, or bi-stable airflow. Applicant respectfully asserts that one of ordinary skill in the art would not be motivated to extract only the "soft elastomer" aspect from Stenzler absent its associated structure and function, as this would alter the principle of operation and introduce unintended nonlinear behavior.”
However, the argument is not well taken. Though the structure of Holroyd's valve is different than Stenzler, they both include a flexible material designed to move to open a port/opening upon a threshold inhalation pressure being reached. Thus, Stenzler's teaching of a soft elastomer as a material choice for a valve flap is relevant to the valve design of Holroyd's. Further, the functions of the inhaler and/or valve disclosed by Holroyd would not be prevented or inhibited by the use of Stenzler's soft elastomer material choice for the flap part since it would still function to seal the valve port when closed and move to open the port when inhalation pressure achieved. Thus, one of ordinary skill in the art, lacking a particular material for the valve of Holroyd, upon seeing the soft elastomer material taught by Stenzler, would be motivated to try it as a suitable material choice for a valve member meant to move/open under inhalation while maintaining enough resilience to return to its sealed position upon release of said pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cecka et al. (US 2007/0083677) discloses a valve for use in endobronchial therapy comprising a flexible flap material with a hardness as low as Shore A 20 designed to open at relatively low pressure drops (paragraph [0114]).
DiCastri et al. (US 2025/0065059) discloses a powder inhaler having a sealing element with a hardness between 1A Shore A and 60 Shore A (paragraph [0030]).
THIS ACTION IS MADE FINAL. 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 VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
