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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (GB2115132.9) filed on the October 21, 2021.
Response to Amendment
This office action is responsive to the amendment filed on January 16, 2026. As directed by the amendment: claims 1, 7, and 11 have been amended, no claims have been canceled, and claim 20 has been added. Thus, claims 1-20 are presently pending in the application.
Response to Arguments
Applicant argues on page 6 of the remarks that the objection made to drawings should be withdrawn. Applicant response is persuasive and replacement drawings have been filed; the previous drawing objections has been hereby withdrawn.
Applicant argues on page 6 of the remarks that the objection made on claim 1 should be withdrawn. Applicant response is persuasive and previous claim objections has been hereby withdrawn.
Applicant argues on page 6 of the remarks that the objection made on the specification should be withdrawn. Applicant response is persuasive and previous specification objections has been hereby withdrawn.
Applicant argues on page 6-7 of the of the remarks that the 112(b) and 112(d)-rejections made on Claims 7-13 and their dependences should be withdrawn. Previously, examiner stated that claim indefinite issue with the ranges and the dependencies . Applicant has amended the claims and response is persuasive; the previous 112(b)and (d)-rejections has been hereby withdrawn.
Applicant argues on page 7-8 of the remarks that the 102-rejection made on the claims are improper. However, Applicant amended the claim to add new limitation “wherein the nozzle bore has a first constant diameter, and the funnel-shaped nozzle includes a first section coupled to the nozzle bore and having a first varying diameter, a second section coupled to the first section and having a second constant diameter greater than the first constant diameter, and a third section coupled to the second section and having a second varying diameter” , that was not previously considered. Applicant has amended the claims and a new 103 rejection stated below addresses the new limitations of the claim.
Applicant argues on page 8-9 of the remarks that the 103 rejections are improper. However, Applicant amended the claim to add new limitation in the independent claim that was not previously considered; therefore, the arguments are moot because the new ground of rejection is given.
Claim 20 is added and rejected below.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US 20040144798 A1), hereafter as Ouyang in view of Howlett (US 6062214 A).
Regarding Claim 1, Ouyang discloses an actuator for a metered-dose inhaler (Fig. 1, para. 0011-0015),
the actuator comprising a body for receiving a canister (Fig. 1; 21) and a metering valve (Fig. 1; 22), and a mouthpiece (Fig. 1; 3) through which aerosolised canister content can be dispensed (para. 0011, 0015),
the body comprises a support block (Fig. 1; 24) which comprises a metering valve stem receptacle (Fig.1, 12) and a sump (Fig. 1; 11) which leads, via a nozzle bore (Fig. 1; 10), to a funnel-shape nozzle opening leading to the mouthpiece (Fig. 1; para. 0026),
the sump has a generally triangular cross section (Fig. 1), with a proximal end of an inclined face (examiner notes: the face of the sump is inclined) extending immediately adjacent the metering valve stem receptacle and from which the nozzle bore extends generally centrally and towards, but not at, a distal end of the inclined face (Fig. 1; para. 0026), wherein the nozzle bore (10) has a first constant diameter (Fig. 1), and the funnel-shaped nozzle (at the end of 10 Fig. 1) includes a first section coupled to the nozzle bore and having a first varying diameter (Fig. 1), a second section coupled to the first section and having a second constant diameter greater than the first constant diameter (Fig. 1),
Ouyang does not disclose and a third section coupled to the second section and having a second varying diameter.
However, Howlett teaches wherein the nozzle bore (Fig. 1; coming out of duct 16) has a first constant diameter (Fig. 1), and the funnel-shaped nozzle (Fig. 1; 19) includes a first section coupled to the nozzle bore and having a first varying diameter (Fig. 1; the funnel shaped 19 has varying diameter as it goes to 24), a second section coupled to the first section and having a second constant diameter greater than the first constant diameter (Fig. 1; 24), and a third section coupled to the second section and having a second varying diameter (Fig. 1; 20, 24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mouthpiece and the sump connection to the funnel of Ouyang to include a third section coupled to the second section and having a second varying diameter as taught by Howlett for the purpose of the spray pattern is much wider and more upwardly angled as the product is dispersed with a greater volume of air. Thus, the inhaler is more effective and more comfortable to use (Col. 3 lines 49-61).
Regarding Claim 2, Modified Ouyang discloses the actuator of claim 1, in which the axis of the nozzle bore (Fig. 1; 10) is generally perpendicular to the inclined face (Fig. 1).
Regarding Claim 11, Modified Ouyang discloses the actuator of claim 1,
Modified Ouyang does not specifically disclose in which a dimension measured from the top of the support block (Fig. 1; 24) to the bottom of the sump (Fig. 1; bottom of 11) is between 8.05mm and 9.9 mm.
However, due to an absence of the limitations of a dimension measured from the top of the support block (Fig. 1; 24) to the bottom of the sump (Fig. 1; bottom of 11) is between 8.05mm and 9.9 mm, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that duct of Ouyang would encompass a such dimensions.
Further, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative shape dimensions of the claimed device is that the dimension measured from the top of the support block to the bottom of the sump is between 8.05mm and 9.9 mm and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. [MPEP 2144.04, I. Aesthetic Design Changes].
It would have been obvious as to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between the top of the support block and the bottom of the sump of Modified Ouyang to be in between 8.05mm and 9.9 mm in distance. Applicant places no criticality on the particular distance. Modifying Ouyang to have the claimed shape dimensions would not have adverse effects on the performance of the device and thus the changing dimensions would not destroy the device. The courts have held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Regarding Claim 12, Modified Ouyang discloses the actuator of claim 11, in which the dimension is 9.70 mm +/- 0.20 mm (Fig. 1; Ouyang).
Regarding Claim 13, Modified Ouyang discloses the actuator of claim 11, in which the dimension is 8.25 mm +/- 0.20 mm (Fig. 1; Ouyang).
Regarding Claim 14, Modified Ouyang discloses the actuator of claim 1, in which the sump (Fig. 1; 11) has a generally wedge-shape section.
Regarding Claim 15, Modified Ouyang discloses the actuator of claim 1, in which the sump (Fig. 1; 11) is open at one end (Examiner notes; where it is connected to bore 12) and closed at the other end by a curved apex (Examiner notes: at the end of 11; para. 0012).
Regarding Claim 16, Modified Ouyang discloses the actuator of claim 15, in which the nozzle (Fig. 1, 10) bore extends laterally centrally from the inclined face (Fig. 1).
Regarding Claim 17, Ouyang discloses the actuator of claim 1,
Ouyang does not specifically disclose in which the inclined face is generally rectangular.
Ouyang does disclose a triangular shaped sump (Fig. 1; 11).
Therefore, due to an absence of the limitations of the inclined face is generally rectangular, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that duct of Ouyang would encompass a “generally” rectangular shape.
Further, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative shape dimensions of the claimed device (generally rectangular ), and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. [MPEP 2144.04, I. Aesthetic Design Changes].
It would have been obvious as to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sump shape of Ouyang to have a generally rectangular shape. Applicant places no criticality on one particular shape over the other. Modifying Ouyang to have the claimed shape would not have adverse effects on the performance of the device and thus the changing dimensions would not destroy the device. The courts have held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Regarding Claim 18, Modified Ouyang discloses a support block (Fig. 1; 9) for the inhaler of claim 1 (para. 0015, 0025-0026).
Regarding Claim 19, Modified Ouyang discloses a metered-dose inhaler (Fig. 1; 1, 2, 20-21) comprising the actuator of claim 1 (para. 0026).
Regarding Claim 20, Ouyang discloses an actuator for a metered-dose inhaler (Fig. 1, para. 0011-0015),
the actuator comprising a body for receiving a canister (Fig. 1; 21) and a metering valve (Fig. 1; 22), and a mouthpiece (Fig. 1; 3) through which aerosolised canister content can be dispensed (para. 0011, 0015),
the body comprises a support block which comprises a metering valve stem receptacle (Fig.1, 12) and a sump (Fig. 1; 11) which leads, via a nozzle bore (Fig. 1; 10), to a funnel-shape nozzle opening leading to the mouthpiece (Fig. 1; para. 0026),
the sump has a generally triangular cross section (Fig. 1), with a proximal end of an inclined face (examiner notes: the face of the sump is inclined) extending immediately adjacent the metering valve stem receptacle, wherein the nozzle bore (10) has a first constant diameter (Fig. 1), and the funnel-shaped nozzle (at the end of 10 Fig. 1) includes a first section coupled to the nozzle bore and having a first varying diameter (Fig. 1), a second section coupled to the first section and having a second constant diameter greater than the first constant diameter (Fig. 1),
Ouyang does not disclose and a third section coupled to the second section and having a second varying diameter.
However, Howlett teaches wherein the nozzle bore (Fig. 1; coming out of duct 16) has a first constant diameter (Fig. 1), and the funnel-shaped nozzle (Fig. 1; 19) includes a first section coupled to the nozzle bore and having a first varying diameter (Fig. 1; the funnel shaped 19 has varying diameter as it goes to 24), a second section coupled to the first section and having a second constant diameter greater than the first constant diameter (Fig. 1; 24), and a third section coupled to the second section and having a second varying diameter (Fig. 1; 20, 24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mouthpiece and the sump connection to the funnel of Ouyang to include a third section coupled to the second section and having a second varying diameter as taught by Howlett for the purpose of the spray pattern is much wider and more upwardly angled as the product is dispersed with a greater volume of air. Thus the inhaler is more effective and more comfortable to use (Col. 3 lines 49-61).
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang and Howlett , as applied to claim 1, in view of Berry et al. (US 20220257878 A1), hereafter as Berry.
Regarding Claim 3, Modified Ouyang discloses the actuator of claim 1,
Modified Ouyang does not disclose that a sump volume of approximately 12.6 mm3.
However, Berry teaches sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Modified Ouyang to include the sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3 as taught by Berry for the purpose of optimize the sump volume in the prior art within applicant’s claimed range for the benefit of improving medicament deposition, as well as accommodating the appropriate dose of aerosolized medicament. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. These sumps have angles and corners where the medicament being delivered can accumulate and/or deposit, giving rise to a reduction in the dose available and/or an increase in occurrence of blockage of a spray orifice (para. 0062).
Regarding Claim 4, Modified Ouyang discloses the actuator of claim 1, providing a sump volume of approximately 20.2 mm3.
Modified Ouyang does not disclose that a sump volume of approximately 20.2 mm3.
However, Berry teaches sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Ouyang to include the sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3 as taught by Berry for the purpose of optimize the sump volume in the prior art within applicant’s claimed range for the benefit of improving medicament deposition, as well as accommodating the appropriate dose of aerosolized medicament. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. These sumps have angles and corners where the medicament being delivered can accumulate and/or deposit, giving rise to a reduction in the dose available and/or an increase in occurrence of blockage of a spray orifice (para. 0062).
Regarding Claim 5, Modified Ouyang discloses the actuator of claim 1, providing a sump volume of approximately 12.7 mm3.
Modified Ouyang does not disclose that a sump volume of approximately 12.7 mm3.
However, Berry teaches sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Ouyang to include the sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3 as taught by Berry for the purpose of optimize the sump volume in the prior art within applicant’s claimed range for the benefit of improving medicament deposition, as well as accommodating the appropriate dose of aerosolized medicament. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. These sumps have angles and corners where the medicament being delivered can accumulate and/or deposit, giving rise to a reduction in the dose available and/or an increase in occurrence of blockage of a spray orifice (para. 0062).
Regarding Claim 6, Modified Ouyang discloses the actuator of claim 1, providing a sump volume of approximately 15.3 mm3.
Modified Ouyang does not disclose that a sump volume of approximately 15.3 mm3.
However, Berry teaches sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Ouyang to include the sump volume in the range of about 12 mm.sup.3 to about 20 mm.sup.3 as taught by Berry for the purpose of optimize the sump volume in the prior art within applicant’s claimed range for the benefit of improving medicament deposition, as well as accommodating the appropriate dose of aerosolized medicament. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. These sumps have angles and corners where the medicament being delivered can accumulate and/or deposit, giving rise to a reduction in the dose available and/or an increase in occurrence of blockage of a spray orifice (para. 0062).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang and Howlett, as applied to claim 1, in view of Wachtel et al. (US 20110186044 A1), hereafter as Wachtel.
Regarding Claim 7, Modified Ouyang discloses the actuator of claim 1,
Modified Ouyang does not disclose in which a dimension measured as the diameter or width at the mouth of the sump (Fig. 1; 12) is between 1.75mm and 2.25mm.
However, Wachtel teaches diameter or width at the inner channel valve stem that is connected to the sump mouth range between 1.68mm to 2.12mm and the outside diameter is between 2.76-3.19mm (examiner notes: the sump mouth is in-between these two ranges).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Ouyang to include the sump mouth diameter to be between 1.75mm and 2.25mm as taught by Wachtel for the purpose of wherein the diameter of the channel opening in the valve stem receptacle corresponds approximately to the internal diameter of the valve stem (claim 11, para. 0029-0030; Table 1).
Furthermore, 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 diameter of the sump mouth to be in-between 1.75mm and 2.25mm. Applicant has not disclosed that 1.75mm and 2.25mm provides criticality of this range as evidenced by the Applicant' s specification which recites an exemplary arrangement indicating that the diameter range is between 7.50-2.25 mm in paragraphs 0063-0064. Since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). One of ordinary skill in the art, furthermore, would have expected Modified Ouyang in view of Howlett’s inhaler and Applicant' s inhaler to perform equally well because these devices perform the same function of allows delivery of medicament to a user at reduced velocity without significantly increasing the size of the inhaler.
Therefore, it would have been prima facie obvious to modify the device taught by Modified Ouyang to incorporate the overall diameter of the sump mouth range taught by Wachtel to obtain the invention as specified in claim 7, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size for the delivery of the medicament, and thus fails to patentably distinguish over the prior art of Modified Ouyang.
Regarding Claim 8, Modified Ouyang discloses the actuator of claim 7, in which the dimension is 1.8 mm +/- 0.05 mm (Fig. 1; 11; Ouyang Fig. 1; para. 0029; Wachtel).
Regarding Claim 9, Modified Ouyang discloses the actuator of claim 7, in which the dimension is 2.20 mm +/- 0.05 mm(Fig. 1; 11; Ouyang Fig. 1; para. 0029; Wachtel).
Regarding Claim 10, Modified Ouyang discloses the actuator of claim 7, in which the dimension is 1.95 mm +/- 0.05 mm (Fig. 1; 11; Ouyang Fig. 1; para. 0029; Wachtel).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of particular note include: Genosar (US 6367471 B1; Fig. 1 ).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.
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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