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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “actuator means to make it possible actuate the device” in claims 4-5.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 4-7 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 pre-AIA the applicant regards as the invention.
Regarding Claims 4-5, the recitation(s) of ranges, followed by “in particular” a single value (e.g. less than 0.2N, in particular equal to 0.019N; and between 80μm and 100μm, in particular equal to 90μm), renders the claim indefinite because it is unclear whether the scope of the claim is the full range, or only the recited value.
Dependent Claims 6-7 are also rejected for relying on at least one rejected claim above.
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 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng 10188811 in view of Trows1 and Hartman 20190282497.
1 Trows et al., Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S., 11 April 2014, Pharmaceutics 2014, 6, 195-219, doi: 10.3390/pharmaceutics6020195, ISSN1999-4923
Regarding Claims 4-5, Zeng teaches a device for nasal delivery of fluid product (Figs 1-4; Title), comprising:
a reservoir (inside 4) containing a dose of fluid product (col.6 ll.4-6);
a nasal delivery head (17, Fig 4) provided with a delivery orifice (19) comprises an axial cylinder having an axial height and a radial diameter (Fig 4), and
actuator means (incl. outside of 4, 2, 10, 5, 6, 8) to make it possible to actuate the device, said actuator means comprising an actuator body (any of outside of 4, 10, 5, 6) that is movable relative to the nasal delivery head (Fig 1; col.6 ll.12-49), said actuator body engaging during actuation with said reservoir so as to move it axially relative to the nasal delivery head towards the delivery orifice (Fig 1; col.6 ll.12-49; all the potential actuator body parts engage the reservoir during all phases of use – either directly or indirectly – and cooperate to move the reservoir toward the delivery orifice during actuation – to open the valve and deliver the product),
characterised in that
the axial height is equal to 0.6mm (col.8 ll.20-32),
the dose volume is 50μL (col.10 ll.9-25 teaches example including 0.08mg beclomethasone dipropionate, 4.8mg ethanol, and 55.1mg of P134a, giving a total of ≈ 50μL based on respective densities of 1.26mg/μL, 0.789 mg/μL, and 1.21 mg/μL) and
the radial diameter is equal to (claim 4) 0.4mm, or (claim 5) 0.5mm (col.8 ll.20-32), and
in that, for an actuation speed of 70mm/s (col.10 ll.1-3; Table 2), the force of the impact of the spray measured at a distance of 3cm from said delivery orifice is less than (claim 4) 0.03N, or (claim 5) 0.02N, in particular equal to (claim 4) 0.026N, or (claim 5) 0.019N (col.8 ll.55-end).
Zeng does not teach the distribution of the droplet sizes is of between (claim 4) 50μm and 70μm, in particular equal to 60μm, or (claim 5) 80μm and 100μm, in particular equal to 90μm.
However, Trows teaches the desirability of droplet sizes in the range of 30-120μm, because droplets greater than 120μm deposit mostly on the anterior part of the nose, and droplet sizes smaller than 10μm are possibly inhaled into the lungs (section 3.1 titled Droplet Size Distribution beginning on p.200 and cont. to p.201). Trows further teaches droplet size distribution being dependent on both the design/handling of the device and the formulation of the medicament (section 3.1 titled Droplet Size Distribution beginning on p.200 and cont. to p.201). Furthermore, quantification of the droplet size distribution may use various statistics including D10, D50, D90 and span
D
90
-
D
10
D
50
.
Furthermore, Hartman teaches various achievable droplet size ranges including the claimed ranges/values for D50, D90 in [0253-0256]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least the medicament formulation of Zeng to achieve some quantification statistic of the distribution of particles to be in the claimed ranges of 50-70 or 80-100 microns, because Trows teaches medicament formulation as a result-effective variable, i.e., a variable which achieves a recognized result, in the prior art, in this case the droplet size distribution depending on medicament formulation (section 3.1 titled Droplet Size Distribution beginning on p.200 and cont. to p.201), such that the determination of the optimum or workable ranges of said variable, in this case 50-70 or 80-100, which are both in the range of 30-120 microns as taught by Trows and are exemplary ranges in Hartman, may have been characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977); MPEP 2144.05(II)(B). Where the general conditions of a claim are disclosed in the prior art, in this case Zeng teaching all the structures and operating conditions of the claim, it has been held that the discovery of optimum or workable ranges, by experimentation requiring only routine skill in the art, in this case the ability to modify the formulation, would have been an obvious extension of prior art teachings, in order to ensure medicament is delivered to the desired area (instead of the anterior part of the nose, or into the lungs; section 3.1 titled Droplet Size Distribution beginning on p.200 and cont. to p.201). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05(II)(A).
Claims 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartman in view of Zeng.
Regarding Claims 4-5, Hartman teaches a device for nasal delivery of fluid product ([0073-74]), comprising:
a reservoir (1705) containing a dose of fluid product ([360]);
a nasal delivery head (1701) provided with a delivery orifice ([0359]) comprises an axial cylinder having an axial height and a radial diameter, and
actuator means (incl. a piston) to make it possible to actuate the device ([0359]), said actuator means comprising an actuator body (piston) that is movable relative to the nasal delivery head ([0359]), said actuator body engaging during actuation with said reservoir so as to move it axially relative to the nasal delivery head towards the delivery orifice ([0359]; Fig 17),
characterised in that the dose volume is 50μL ([0332, 361]) and
the distribution of the droplet sizes is (claim 4) of between 50μm and 70μm, in particular equal to 60μm, or (claim 5) of between 80-100μm, in particular 90μm ([0253-255]).
Hartman further teaches using a pressure point mechanism to secure reproducibility of the actuation force and emitted plume characteristics ([0359]).
Hartman does not teach details of the orifice such as it comprising an axial cylinder having an axial height and a radial diameter, the axial height equal to 0.6mm and the radial height equal to (claim 4) 0.4mm or (claim 5) 0.5mm; and in that, for an actuation speed of 70mm/s, the force of the impact of the spray measured at a distance of 3cm from said delivery orifice is (claim 4) less than 0.03N, in particular equal to 0.026N, or (claim 5) less than 0.02N, in particular equal to 0.019N.
However, Zeng teaches arranging the orifice of a nasal spray device with certain geometry in order to achieve soft spray characteristics (col.4 ll.10-17, col.8 l.55 – col.9 l.15); including an axial cylinder having an axial height and a radial diameter (at 19 in Fig 4), the axial height equal to 0.6mm and the radial height equal to 0.4mm (col.9 ll.1-15, col.8 ll.20-32); and in that, the force of the impact of the spray measured at a distance of 3cm from said delivery orifice is less than 0.03N, in particular equal to 0.026N (col.8 ll.55-end, Table 2). Note, the device of Zeng is a propellant MDI (metered dose inhaler) for nasal delivery of medicament. The actuation mechanism of propellant MDIs is different from manual nasal sprayers. For example, in manual nasal sprayers the user generates the force required to expel and atomize the liquid medicament. Thus, actuation factors affecting the resulting medicament plume include at least stroke length, actuation speed, actuation acceleration, and actuation force. For propellant based sprayers, the actuation of the device is merely to open and close a valve, and the propellant under pressure generates the force required to emit the medicament as it expands on release from the pressurized container. The actuation speed (and acceleration, stroke length, and actuation force) does not affect the resulting plume as long as the actuation is sufficient to open the valve. In any case, an actuation speed of 70mm/s is widely used for in vitro testing of manual nasal sprayers and was used to test both MDI and manual nasal sprayers in Zeng (Table 2). Thus, Zeng teaches arranging the outlet orifice of a nasal sprayer with specific geometry and dimensions in the claimed range to produce low impact force. Zeng further teaches testing the impact force of nasal sprayers using an actuation speed of 70mm/s and distance of 3cm (30mm). Finally, Zeng teaches a desirable impact force being 10-40mN, with specific examples including 29.3mN.
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 non-descript orifice of Hartman, to comprise the orifice geometry and dimensions of Zeng in order to achieve soft spray impact force (e.g. desirable impact forces of 10-40mN) when tested at 3cm distance and 70mm/s actuation speed. Furthermore, even though Zeng teaches a propellant based MDI nasal sprayer, Zeng attributes its soft spray results to the orifice geometry and dimensions (col.9 ll.1-15) and applying the orifice geometry of Zeng to the manual sprayer of Hartman achieves the same device as that claimed and disclosed by Applicant. Thus, in reference to the functional limitation of achieving a 0.03N impact force (at 3cm and 70mm/s) and droplet distribution of 50-70μm:
MPEP2112.01(I) provides: where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established; and when the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not
In this case, the nasal sprayer of Hartman in view of Zeng teaches all the structures of the claimed invention (including manual nasal sprayer actuator structures with ≥ 50μL reservoir and soft spray orifice geometry/dimensions of 0.4mm radius and 0.6mm length), and thus would perform the same (achieving 50-70μm droplet size distribution and 0.03N impact force), under the same conditions (testing impact force at 3cm distance and 70mm/s actuation speed with the same atmospheric conditions and medicament formula)
MPEP2114(I) provides: if an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus; the burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on
As discussed above, because Hartman in view of Zeng teaches all the structures of the claimed invention, the prior art structures inherently possess the same functionally defined limitations
MPEP2114(II) provides: apparatus claims cover what a device is, not what a device does; a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
Operating the nasal sprayer at 70mm/s actuation speed and testing impact force at 3cm are intended uses of the apparatus and do not differentiate the claimed nasal sprayer from that of Hartman in view of Zeng
Regarding claim 6, Hartman in view of Zeng teaches all the limitations of the claimed invention as discussed above. Hartman further teaches said reservoir comprises a stopper/piston (1704) to deliver at least some of said fluid product ([0360]), said reservoir being, before actuation, sealingly blocked by said stopper/piston (Fig 17; [0360]).
Regarding claim 7, Hartman in view of Zeng teaches all the limitations of the claimed invention as discussed above. Hartman further teaches a hollow insert (1702) inserted and fixed in said delivery head (Fig 17), said insert supporting a cannula (1703) to pierce said stopper/piston and thus connect said reservoir to said delivery orifice during actuation (Fig 17; [0360]).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741