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 .
Status of Claims
Currently claims 1-20 are pending.
Claim Objections
Claim 7 objected to because of the following informalities: The word “faxing” should read “facing” in line 2. 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:
Fluid discharge mechanism in claim 1.
Fastening structure in claim 1.
Counter fastening structure in claim 1.
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 § 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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1-8, 12-14, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bach (U.S. 2012/0260913).
With respect to claim 1, Bach discloses a fluid container (shown in figure 15, as #3) for a fluid dispensing device (the nebulizer 1, see figure 1), the fluid dispensing device comprising a fluid discharge mechanism (being the spring and piston shown in figures 4-5, paragraphs 0063 and 0067-0068 disclose pushing down on the housing and thus the spring causes a stroke to occur and resulting in the atomizing process), the fluid container comprising:
a flexible bag (figures 4-5 and 15, #4) and comprising a flexible sidewall (bag 4 being flexible such that it is collapsible, paragraph 0060), the flexible sidewall extends along a longitudinal direction (see figure 15, along the longitudinal direction shown), confines an interior volume to receive the fluid (volume within 4 having fluid 2 therein) and forms a bag outlet towards a distal end (outlet at the top end of 4 where 27 is inserter within); and
a rigid fastening adapter (figures 5 and 15, #27 and #28) sealingly engaged with the bag outlet (as shown in figure 15, with the noted seal pressed between the two) and comprising a hollow outlet shaft (the shaft of 27 along with that of 9) in fluid communication with the interior volume (as shown in figure 15);
wherein the rigid fastening adapter comprises a fastening structure (being the divot formed by 47 beneath the rim) for mechanical engagement with a corresponding counter fastening structure of the fluid dispensing device to establish (see below annotated figure taken from figure 5) a fluid-tight connection between the fluid discharge mechanism and the outlet shaft (as 47 is pressed between the fastening structure and counter fastening structure).
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With respect to claim 2, Bach discloses the hollow outlet shaft protrudes outwardly from the interior volume (as 9 extends up and out of the interior volume, figure 5).
With respect to claim 3, Bach discloses the rigid fastening adapter comprises a shoulder portion adjacent to the distal end of the flexible bag (being the shoulder shown in figure 15, adjacent where 47 is indicated) and wherein the fastening structure is provided on at least one of an outside surfaces of the shoulder portion (as the inner surface forms the shoulder and the outer surface forms the fastening structure shown above) and an outside surface of the outlet shaft (as the noted fastening structure is on an outside surface of the shaft, see figure 15).
With respect to claim 4, Bach discloses the hollow outlet shaft protrudes from the shoulder portion in longitudinal distal direction (as shown, 9 is protruding up in a longitudinal distal direction) and wherein the shoulder portion comprises a through recess merging with an interior of the hollow outlet shaft (being the recess within the shoulder that the upper part of 4 is located within).
With respect to claim 5, Bach discloses the shoulder portion (being the shoulder between 47 and 27, against that of 26) comprises a distally facing abutment face (the face against 26) to longitudinally abut with the counter fastening structure of the fluid dispensing device (which would be the element of the device above 26, when figure 15’s #3 is inserted as shown in figure 15).
With respect to claim 6, Bach discloses the fastening structure comprises at least one snap element to mechanically engage in a form fitting manner with a complementary-shaped counter snap element of the counter fastening structure (being the faces of the fastening adapter and counter fastening structure that snap together as shown in the above annotated figure).
With respect to claim 7, Bach discloses the snap element comprises a beveled flank adjoining a proximally faxing abutment face (as shown in figure 5 and 15, there being a beveled flank adjoining a proximally facing abutment face).
With respect to claim 8, Bach discloses an outer rigid casing (paragraph 0060, where the container 3 has a rigid stricture, understood being that of 46) sized to accommodate the flexible bag, wherein the outer rigid casing is fixedly connected to the rigid fastening adapter or wherein the rigid fastening adapter is integrated into the outer rigid casing (as shown in figures 5 and 15, where the bag is fixed within that of 46 where the fastening adapter is integrated (being a part of and attached) to that of 46).
With respect to claim 12, Bach discloses the bag outlet (see the outlet of bag 4) is sealingly engaged with the rigid fastening adapter (the rigid adapter above it) through at least one of a clamping (as shown being clamped together with the shown snap connection, see figures 5 and 15), a bonding, a welding, an extrusion, a blow molding, or an injection molding.
With respect to claim 13, Bach discloses an outside surface section of the bag outlet is sealingly engaged with an inside surface of the hollow outlet shaft (figure 15, showing a seal between the upper part of 15 and that of the hallow outlet shafts upper side).
With respect to claim 14, Bach discloses the hollow outlet shaft comprises a cylindrical receptacle at a distal end to receive a complementary shaped valve insert of the fluid discharge mechanism (figure 5. Where 9 terminates at 10, taking 10 and the body about it as part of the fluid discharge mechanism that has a shaped valve insert to which 9 goes within).
With respect to claim 17, Bach discloses a fluid dispensing device (the nebulizer 1, see figure 1), comprising:
a housing to accommodate a fluid container according to claim 1 (figure 5, the housing of 1 that 3 is located within);
an outlet orifice (12);
a mechanical energy storage coupled to the discharge mechanism (the spring 7), reversibly transferable between a pre-loaded state and an unloaded state and configured to store mechanical energy in the pre-loaded state effective to produce the spray discharging of the fluid (as pressing the spring down brings fluid within the discharge pip and releasing causes the atomization, paragraph 0062-0068);
the discharge mechanism operable for spray discharging multiple doses of the fluid via the outlet orifice (as the discharge mechanism is operable for multiple doses to be sprayed one after the other by pressing and depressing the device over and over); and
the counter fastening structure to mechanically engage with the fastening structure of the rigid fastening adapter of the fluid container to establish the fluid-tight connection between the fluid discharge mechanism and the outlet shaft of the fluid container (as shown in the above rejection of claim 1, where the snap connecting within the housing is understood as the tight connection and being fluid tight being pressed against one another).
With respect to claim 18, Bach discloses the discharge mechanism comprises a driver (6) operatively coupled to the mechanical energy storage (the spring it pushed down)and movable relative to one of the housings and the outlet orifice to effectuate the spray discharging of the fluid (paragraph 0088), wherein the driver comprises the counter fastening structure to mechanically engage with the rigid fastening adapter of the fluid container (as shown in figures 4, 5 and 10).
With respect to claim 19, Bach discloses the discharge mechanism comprises:
an inlet valve (at 25) in fluid connection with the outlet shaft of the fluid container (See figure 15);
an outlet valve (10) in fluid connection with the outlet orifice;
a dispensing chamber located between the inlet valve and the outlet valve and sized to receive at least one dose of the fluid (being the amount of fluid within the device between 25 and 10); and
wherein for effectuating the spray discharging of the fluid a size of the dispensing chamber is reducible by moving at least one of the inlet valve and the outlet valve relative to the other one of the inlet valve and the outlet valve (as the sprayed fluid is pushed in past the seal that forms 25 and is stopped by 10, and when depressed sprays the fluid from within out, paragraph’s 0087-0088).
With respect to claim 20, Bach discloses the container filled with the fluid and connected to the outlet orifice in a fluid transferring manner (such that fluid transfers from the fluid to the outlet orifice to be atomized/sprayed).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 9-11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bach in view of Kato (U.S. 2023/0174283).
With respect to claim 9, Bach discloses the fluid container according to claim 8, but fails to disclose the outer rigid casing is made of a material or a material composition comprising at least one of a high density polyethylene and a polypropylene .
Kato discloses their outer rigid casing is formed of a high density polyethylene and a polypropylene, paragraphs 0030-0032.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize such known materials as disclosed by Kato for their outer shell (rigid casing) into the system of Bach, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
With respect to claim 10, Bach as modified discloses the outer rigid casing comprises a multilayer structure with a first layer made of a high-density polyethylene and a second layer made of a polypropylene (as shown by Kato, paragraph’s 0030-0032).
With respect to claim 11, Bach as modified discloses the flexible bag is blow-molded or injection molded into the outer rigid casing, or wherein the flexible bag and the outer rigid casing are co-extruded ( Kato discloses paragraph 0029, where the container 2 having the outer shell 20 and inner bag 21 is formed by blow-molding or injection molding, understood being done via a co-extruded together as container 2 discloses a single molding forming it, such blow molding process being obvious to be used in shaping the materials as disclosed by Kato using a known process to form the shell and inner bag).
With respect to claim 16, Bach discloses the flexible bag, but fails to disclose the flexible bag is made of a material or material composition comprising at least one of an ethylene vinyl alcohol, a low density polyethylene and a high density polyethylene.
Kato discloses the bag being formed of low density polyethylene or high density
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize such known materials as disclosed by Kato for their inner bag into the system of Bach, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bach in fire of Moretti (U.S. 2023/0008418).
With respect to claim 15, Bach discloses the hollow outlet shaft, but fails to disclose it comprises a tapered seal seat section to sealingly engage with the valve insert.
Moretti, figures 5 and 6a, discloses a tapered seal seat at the top of 11 that is within 6 (where its tapered and inserted) shown being sealing engaged with the valve inert of 6, being the valve side of pump 6. Though not disclosed such connected shows what is another snap connection between two elements holding the upwards protruding shafted connected to that of pump 6.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the tapered seal seat section of the shaft as disclosed by Moretti into the valve insert housing part of Bach, as such an insert would allow for another snap fit connection to occur to maintain the shaft in the desired location. Furthermore, such attachment to the device would allow for the shaft to be inserted and connected without the use of further materials (such as a weld or glue).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A GREENLUND whose telephone number is (571)272-0397. The examiner can normally be reached M-F 9am-5pm EST.
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/JOSEPH A GREENLUND/Primary Examiner, Art Unit 3752
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