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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 May 2026 has been entered.
Claims 1-30 are pending in the application. Claims 1, 27 and 30 are currently amended. Applicant’s amendment to the Claims have overcome each and every 35 U.S.C. 112 rejection previously set forth in the Final Office Action mailed 05 Dec 2025.
Response to Arguments
Applicant's arguments filed 05 May 2026 have been fully considered but they are not fully persuasive.
Regarding the 35 U.S.C. 102(a)(1) rejection of claims 1 and 27 applicant argues Kobayashi et al. (U.S. Pub. 2010/0154793) does not disclose the flexible ampoule is a self-contained container physically separate from the hard shell and disposed entirely within the hard shell (Pg. 7-8).
As an initial note, upon review of the specification of the instant application there is not found to be sufficient written description support in the application as originally filed for the claimed specificity that the flexible ampoule is “disposed entirely within the hard shell”. While Fig. 13 shows drug ampoule 1302 as nested within hard shell structure 1304 it is not evidently clear, nor is it discussed in the specification, that drug ampoule 1302 might not extend outward beyond hard shell structure 1304 and into the space defined by lid closure 1306. Additionally written description issues have also been found in the pending claims.
In regards to Kobayashi applicant argues that reservoir 7 is not physically separate from and disposed entirely within ejection head portion 8 (Pg. 7-8). However, applicant correctly cites a portion of Kobayashi which states reservoir 7 is not connected to ejection head portion 8 before the medicine ejection unit is attached to the inhaler (Pg. 8). Applicant thus admits that the reservoir 7 is physically separate from ejection head portion 8. It is noted that applicant has not indicated the language “physically separate from” must mean the flexible ampoule and the hard shell can never be in contact (and there is doubt applicant would have sufficiently written description support for such language). And it is respectfully submitted that the combined views of Figs. 3-4 of Kobayashi show reservoir 7 as disposed entirely within ejection head portion 8 (in Fig. 3 note the bottom end of reservoir 7 as shown, which is fully within ejection head portion 8, and in Fig. 4 the top end of reservoir 7 is shown and is discussed in ¶0040 as a thin film of aluminum foil).
Applicant’s arguments against Kobayashi are thus not understood to distinguish over clear teachings in Kobayashi. It appears applicant’s comments about the fluid transfer function of ejection head portion 8 of Kobayashi may seem to indicate applicant is intending to somehow want to specify the flexible ampoule as delivering its fluid without any interaction from the hard shell. However, at present there is not found to be any claim language aimed at that concept.
Applicant comments briefly in regards to Kobayashi and the cited teaching of an electronically actuated aperture plate (Pg. 8). It is respectfully submitted that the language electronically actuated aperture plate is broad and is not limited to the use of a piezoelectric actuator, against which Kobayashi has not been cited in regard to various dependent claims.
The rejections based on Kobayashi are thus maintained.
Regarding the 35 U.S.C. 103 rejection of claims 1, 27 and 30 applicant argues the pierce-and-drain feed system of Loeffler et al. (U.S. Pub. 2002/0134372) does not teach a flexible ampoule and that the teachings of a squeezable ampoule in Kern (U.S. Pub. 2019/0388627) are different from Loeffler and the claimed invention (Pg. 9-12).
Upon review Examiner concurs with applicant’s arguments against the combination of Loeffler and Kern and withdraws the prior 35 U.S.C. 103 rejection. However, the claims are still rejected based upon an alternate interpretation. Specifically, the previously cited Loeffler reference discusses in ¶¶0026, 0040 that it may use the same ampoules as described in a co-pending application filed on the same date. That other reference is Loeffler et al. (U.S. Pub. 2002/0134377) which teaches in ¶0025 certain types of materials which may be used to construct the ampoule, among which are low density polyethylene. The further prior art of Armstrong et al. (U.S. Patent 5411175) then teaches that low density polyethylene would be considered as a flexible material. (See also the attached Bing search print-out regarding low density polyethylene being known as a flexible material.)
Applicant’s arguments regarding the 35 U.S.C. 103 rejection of claims 18-23 appears solely drawn to the considerations of amended claim 1 (Pg. 12-13) and is thus not considered to need any direct response.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the [flexible] ampoule is … disposed entirely within the [hard] shell” (claims 1, 27 and 30) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-30 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 27 and 30 each recite “the [flexible] ampoule is … disposed entirely within the [hard] shell”. While Fig. 13 shows drug ampoule 1302 as nested within hard shell structure 1304 it is not evidently clear, nor is it discussed in the specification (e.g. ¶00152), that drug ampoule 1302 might not extend outward beyond hard shell structure 1304 and into the space defined by lid closure 1306. There is thus lack of sufficient written description support in the application as originally filed for the particular claiming of the ampoule as “disposed entirely within the [hard] shell”.
Claims 3 and 4 each recite “the flexible ampoule has an airtight seal and puncturable material”. In the discussion of Fig. 13 in ¶00152 O-ring 1312 and foil lidding 1308 are described as separate structures of the fluid reservoir from drug ampoule 1302. That is also supported by the view of Fig. 13. There is thus lack of sufficient written description support in the application as originally filed for the claiming of the ampoule as having an airtight seal and puncturable material, as opposed to the disclosure of the airtight seal and the puncturable material being separate parts of the fluid reservoir.
Claim 28 recites “the flexible ampoule is puncturable”. In the discussion of Fig. 13 in ¶00152 drug ampoule 1302 itself is not puncturable. Instead what is puncturable is foil lidding 1308 which is described as a separate structure of the fluid reservoir from drug ampoule 1302. That is also supported by the view of Fig. 13. There is thus lack of sufficient written description support in the application as originally filed for the claiming of the ampoule as puncturable, as opposed to the disclosure of a separate part of the fluid reservoir (i.e. foil lidding 1308) which is puncturable.
Claim 30 recites “the ampoule has a puncturable material”. In the discussion of Fig. 13 in ¶00152 drug ampoule 1302 itself is not puncturable. Instead what is puncturable is foil lidding 1308 which is described as a separate structure of the fluid reservoir from drug ampoule 1302. That is also supported by the view of Fig. 13. There is thus lack of sufficient written description support in the application as originally filed for the claiming of the ampoule as having a puncturable material, as opposed to the disclosure of a separate part of the fluid reservoir (i.e. foil lidding 1308) which is puncturable.
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(s) 1-4, 14-17, 19-22 and 25-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi et al. (U.S. Pub. 2010/0154793).
Regarding claim 1, Kobayashi discloses a droplet delivery device (Fig. 1; ¶¶0028, 0038) comprising: a housing (Fig. 1 #1; ¶0028) including an airflow exit at a mouthpiece (Fig. 1 #4; ¶0028); and a fluid reservoir (Figs. 2-3 #6; ¶0031) having a hard shell (Fig. 3 #8; ¶0040 – stainless steel) coupled to the housing (Fig. 4) in fluid communication with an electronically actuated aperture plate including openings (¶¶0004, 0033, 0040, 0081 – orifices of ejection head which can use piezoelectric energy); and a flexible ampoule (Fig. 4 #7; ¶0031) including a fluid (¶0031 – medicine) and contained within the hard shell of the reservoir (Fig. 4), wherein the flexible ampoule is a self-contained container physically separate from the hard shell (Figs. 3-4 #7 & #8 are separate components) and disposed entirely within the hard shell (Figs. 3 & 5 – #7 fully within #6, 8; ¶¶0040-0041). The language “physically separate” is not understood to imply that the flexible ampoule and the hard shell can never be in contact. The claim is afforded an effective filing date of 05 Mar 2017 based upon its particular recitations in regard to the fluid reservoir.
Regarding claim 2, Kobayashi discloses the fluid comprises a drug (¶0031 – medicine).
Regarding claim 3, Kobayashi discloses the flexible ampoule has an airtight seal and puncturable material (¶0040 – aluminum foil film).
Regarding claim 4, Kobayashi discloses the flexible ampoule has an airtight seal and puncturable material (¶0040 – aluminum foil film).
Regarding claim 14, Kobayashi discloses a piezoelectric actuator operably coupled to the aperture plate (¶¶0033, 0081).
Regarding claim 15, Kobayashi discloses a piezoelectric actuator operably coupled to the aperture plate (¶¶0033, 0081).
Regarding claim 16, Kobayashi discloses a piezoelectric actuator operably coupled to the aperture plate (¶¶0033, 0081).
Regarding claim 17, Kobayashi discloses a piezoelectric actuator operably coupled to the aperture plate (¶¶0033, 0081).
Regarding claim 19, Kobayashi discloses the puncturable material includes foil (¶0040).
Regarding claim 20, Kobayashi discloses the puncturable material includes foil (¶0040).
Regarding claim 21, Kobayashi discloses the hard shell includes a puncture element (Fig. 4 #8b; ¶0040) positioned to puncture the puncturable material.
Regarding claim 22, Kobayashi discloses the hard shell includes a puncture element (Fig. 4 #8b; ¶0040) positioned to puncture the puncturable material.
Regarding claim 25, Kobayashi discloses the hard shell includes a puncture element (Fig. 4 #8b; ¶0040) positioned to puncture the puncturable material.
Regarding claim 26, Kobayashi discloses the hard shell includes a puncture element (Fig. 4 #8b; ¶0040) positioned to puncture the puncturable material.
Regarding claim 27, Kobayashi discloses a fluid reservoir (Figs. 2-3 #6; ¶0031) comprising: a hard shell (Fig. 3 #8; ¶0040 – stainless steel) configured to couple to a base or housing of a droplet delivery device (e.g. Figs. 2-4); and a flexible ampoule
(Fig. 4 #7; ¶0031) including a fluid (¶0031 – medicine), wherein the ampoule is a self-contained container physically separate from the hard shell (Figs. 3-4 #7 & #8 are separate components) and disposed entirely within the hard shell (Figs. 3 & 5 – #7 fully within #6, 8; ¶¶0040-0041). The language “physically separate” is not understood to imply that the flexible ampoule and the hard shell can never be in contact. The claim is afforded an effective filing date of 05 Mar 2017 based upon its particular recitations in regard to the fluid reservoir.
Regarding claim 28, Kobayashi discloses the flexible ampoule is puncturable (¶0040).
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 of this title, 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 1-17 and 24-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loeffler et al. (U.S. Pub. 2002/0134372) in view of Loeffler et al. (U.S. Pub. 2002/0134377) and further in view of Armstrong et al. (U.S. Patent 5411175).
Regarding claim 1, Loeffler ‘372 discloses a droplet delivery device (Fig. 6; ¶¶0047-0050) comprising: a housing (Fig. 6 #90; ¶0049) including an airflow exit at a mouthpiece (Fig. 6 #82; ¶0049); and a fluid reservoir (Fig. 9 #120 as related to Fig. 6 #80; ¶¶0047, 0051) having a hard shell (Fig. 8 #122; e.g. ¶0034 – firm material) coupled to the housing (Figs. 6 & 9) in fluid communication with an electronically actuated aperture plate including openings (Fig. 6 #104 as relating to Fig. 9 #20; ¶¶0038, 0049); and an ampoule (Fig. 9 #132; ¶0052) including a fluid (¶0052 – liquid) and contained within the hard shell of the reservoir (Fig. 9), wherein the flexible ampoule is a self-contained container physically separate from the hard shell (Fig. 9 #132 separate from #122) and disposed entirely within the hard shell (Figs. 7 & 9; ¶¶051-0052, 0054-0055). The language “physically separate” is not understood to imply that the flexible ampoule and the hard shell can never be in contact. The claim is afforded an effective filing date of 05 Mar 2017 based upon its particular recitations in regard to the fluid reservoir.
Loeffler ‘372 is silent as to whether the ampoule is flexible.
Loeffler ‘372 discusses in ¶¶0026, 0040 that it may use the same ampoules as described in a co-pending application filed on the same date. That other reference is Loeffler ‘377 which teaches in ¶0025 certain types of materials which may be used to construct the ampoule, among which is low density polyethylene.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Loeffler ‘372 the ampoule is formed from low density polyethylene based upon teaching from common inventors to Loeffler ‘372 in Loeffler ‘377 that low density polyethylene is one material desirable for use in constructing an ampoule for an aerosolizer.
Armstrong teaches a liquid dispensing cartridge (e.g. Fig. 10) wherein a flexible container (#41; Col. 5, Ln. 34-49) may be formed from low density polyethylene (Col. 8, Ln. 57-60). Armstrong thus teaches that low density polyethylene is recognized in the medical arts as a flexible material.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Loeffler ‘372 the ampoule formed from low density polyethylene is flexible based the known use of low density polyethylene as a flexible material in the medical arts in view of Armstrong.
Regarding claim 2, Loeffler ‘372 teaches the invention as modified above and further suggests as obvious the fluid comprises a drug (¶0049 – aerosol delivered via mouthpiece will obviously include a drug).
Regarding claim 3, Loeffler ‘372 teaches the invention as modified above and further teaches the flexible ampoule has an airtight seal and puncturable material (¶0040 – only opened by piercing).
Regarding claim 4, Loeffler ‘372 teaches the invention as modified above and further teaches the flexible ampoule has an airtight seal and puncturable material (¶0040 – only opened by piercing).
Regarding claim 5, Loeffler ‘372 teaches the invention as modified above and further teaches the fluid reservoir includes a lid closure (Fig. 9 #144; ¶0054) coupled to the hard shell.
Regarding claim 6, Loeffler ‘372 teaches the invention as modified above and further teaches the fluid reservoir includes a lid closure (Fig. 9 #144; ¶0054) coupled to the hard shell.
Regarding claim 7, Loeffler ‘372 teaches the invention as modified above and further teaches the fluid reservoir includes a lid closure (Fig. 9 #144; ¶0054) coupled to the hard shell.
Regarding claim 8, Loeffler ‘372 teaches the invention as modified above and further teaches the fluid reservoir includes a lid closure (Fig. 9 #144; ¶0054) coupled to the hard shell.
Regarding claim 9, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 10, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 11, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 12, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 13, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 14, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 15, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 16, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 17, Loeffler ‘372 teaches the invention as modified above and further teaches a piezoelectric actuator (Fig. 9 #22 as related to Fig. 6 #106; ¶¶0043, 0049) operably coupled to the aperture plate.
Regarding claim 24, Loeffler ‘372 teaches the invention as modified above and further teaches the hard shell includes a puncture element (Fig. 9 #140; ¶0052) positioned to puncture the puncturable material.
Regarding claim 25, Loeffler ‘372 teaches the invention as modified above and further teaches the hard shell includes a puncture element (Fig. 9 #140; ¶0052) positioned to puncture the puncturable material.
Regarding claim 26, Loeffler ‘372 teaches the invention as modified above and further teaches the hard shell includes a puncture element (Fig. 9 #140; ¶0052) positioned to puncture the puncturable material.
Regarding claim 27, Loeffler ‘372 discloses a fluid reservoir (Fig. 9 #120; ¶0051) comprising: a hard shell (Fig. 8 #122; e.g. ¶0034 – firm material) configured to couple to a base or housing of a droplet delivery device (e.g. Fig. 6; ¶¶0047-0050); and an ampoule (Fig. 9 #132; ¶0052) including a fluid (¶0052 – liquid), wherein the ampoule is a self-contained container physically separate from the hard shell (Fig. 9 #132 separate from #122) and disposed entirely within the hard shell (Figs. 7 & 9; ¶¶051-0052, 0054-0055). The language “physically separate” is not understood to imply that the flexible ampoule and the hard shell can never be in contact. The claim is afforded an effective filing date of 05 Mar 2017 based upon its particular recitations in regard to the fluid reservoir.
Loeffler ‘372 is silent as to whether the ampoule is flexible.
Loeffler ‘372 discusses in ¶¶0026, 0040 that it may use the same ampoules as described in a co-pending application filed on the same date. That other reference is Loeffler ‘377 which teaches in ¶0025 certain types of materials which may be used to construct the ampoule, among which is low density polyethylene.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Loeffler ‘372 the ampoule is formed from low density polyethylene based upon teaching from common inventors to Loeffler ‘372 in Loeffler ‘377 that low density polyethylene is one material desirable for use in constructing an ampoule for an aerosolizer.
Armstrong teaches a liquid dispensing cartridge (e.g. Fig. 10) wherein a flexible container (#41; Col. 5, Ln. 34-49) may be formed from low density polyethylene (Col. 8, Ln. 57-60). Armstrong thus teaches that low density polyethylene is recognized in the medical arts as a flexible material.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Loeffler ‘372 the ampoule formed from low density polyethylene is flexible based the known use of low density polyethylene as a flexible material in the medical arts in view of Armstrong.
Regarding claim 28, Loeffler ‘372 teaches the invention as modified above and further teaches the flexible ampoule is puncturable (Fig. 9; ¶0052).
Regarding claim 29, Loeffler ‘372 teaches the invention as modified above and further teaches an interior of the hard shell containing the flexible ampoule is enclosed by a lid closure (Fig. 9 #144; ¶0054) coupled to the hard shell.
Regarding claim 30, Loeffler ‘372 discloses a fluid reservoir (Fig. 9 #120; ¶0051) comprising: a shell (Fig. 8 #122) configured to couple to a base or housing of a droplet delivery device (e.g. Fig. 6; ¶¶0047-0050); a lid closure (Fig. 9 #144; ¶0054) coupled to the shell and enclosing an interior of the shell; and an ampoule (Fig. 9 #132; ¶0052) including a fluid (¶0052 – liquid), wherein the ampoule is a self-contained container physically separate from the shell (Fig. 9 #132 separate from #122) and disposed entirely within the shell (Figs. 7 & 9; ¶¶051-0052, 0054-0055), and wherein the ampoule has a puncturable material (Fig. 9; ¶0052). The language “physically separate” is not understood to imply that the flexible ampoule and the hard shell can never be in contact. The claim is afforded an effective filing date of 05 Mar 2017 based upon its particular recitations in regard to the fluid reservoir.
Loeffler ‘372 is silent as to whether the ampoule is flexible.
Loeffler ‘372 discusses in ¶¶0026, 0040 that it may use the same ampoules as described in a co-pending application filed on the same date. That other reference is Loeffler ‘377 which teaches in ¶0025 certain types of materials which may be used to construct the ampoule, among which is low density polyethylene.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Loeffler ‘372 the ampoule is formed from low density polyethylene based upon teaching from common inventors to Loeffler ‘372 in Loeffler ‘377 that low density polyethylene is one material desirable for use in constructing an ampoule for an aerosolizer.
Armstrong teaches a liquid dispensing cartridge (e.g. Fig. 10) wherein a flexible container (#41; Col. 5, Ln. 34-49) may be formed from low density polyethylene (Col. 8, Ln. 57-60). Armstrong thus teaches that low density polyethylene is recognized in the medical arts as a flexible material.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Loeffler ‘372 the ampoule formed from low density polyethylene is flexible based the known use of low density polyethylene as a flexible material in the medical arts in view of Armstrong.
Claim(s) 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loeffler et al. (U.S. Pub. 2002/0134372) in view of Loeffler et al. (U.S. Pub. 2002/0134377) and further in view of Armstrong et al. (U.S. Patent 5411175) and further in view of Kobayashi et al. (U.S. Pub. 2010/0154793).
Regarding claim 18, Loeffler teaches the invention as modified above but is silent as to whether the puncturable material includes foil.
Kobayashi teaches a medicine ejection device (Fig. 1; ¶¶0028, 0038) including a fluid reservoir (Figs. 2-3 #6; ¶0031) having a flexible ampoule (Fig. 4 #7; ¶0031) including a puncturable material including foil (¶0040). Kobayashi teaches a puncturable foil as providing the benefit of selecting a thin film of aluminum as a particular sealing material in the art known to prevent deterioration of a medication, prevent medicine from leaking, and being readily puncturable by a thin needle (¶0040).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in the modified Loeffler the puncturable material includes foil in order to provide the benefit of selecting a thin film of aluminum as a particular sealing material in the art known to prevent deterioration of a medication, prevent medicine from leaking, and being readily puncturable by a thin needle in view of Kobayashi.
Regarding claim 19, Loeffler teaches the invention as modified above but is silent as to whether the puncturable material includes foil.
Kobayashi teaches a medicine ejection device (Fig. 1; ¶¶0028, 0038) including a fluid reservoir (Figs. 2-3 #6; ¶0031) having a flexible ampoule (Fig. 4 #7; ¶0031) including a puncturable material including foil (¶0040). Kobayashi teaches a puncturable foil as providing the benefit of selecting a thin film of aluminum as a particular sealing material in the art known to prevent deterioration of a medication, prevent medicine from leaking, and being readily puncturable by a thin needle (¶0040).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in the modified Loeffler the puncturable material includes foil in order to provide the benefit of selecting a thin film of aluminum as a particular sealing material in the art known to prevent deterioration of a medication, prevent medicine from leaking, and being readily puncturable by a thin needle in view of Kobayashi.
Regarding claim 20, Loeffler teaches the invention as modified above but is silent as to whether the puncturable material includes foil.
Kobayashi teaches a medicine ejection device (Fig. 1; ¶¶0028, 0038) including a fluid reservoir (Figs. 2-3 #6; ¶0031) having a flexible ampoule (Fig. 4 #7; ¶0031) including a puncturable material including foil (¶0040). Kobayashi teaches a puncturable foil as providing the benefit of selecting a thin film of aluminum as a particular sealing material in the art known to prevent deterioration of a medication, prevent medicine from leaking, and being readily puncturable by a thin needle (¶0040).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in the modified Loeffler the puncturable material includes foil in order to provide the benefit of selecting a thin film of aluminum as a particular sealing material in the art known to prevent deterioration of a medication, prevent medicine from leaking, and being readily puncturable by a thin needle in view of Kobayashi.
Regarding claim 21, Loeffler teaches the invention as modified above and further teaches the hard shell includes a puncture element (Fig. 9 #140; ¶0052) positioned to puncture the puncturable material.
Regarding claim 22, Loeffler teaches the invention as modified above and further teaches the hard shell includes a puncture element (Fig. 9 #140; ¶0052) positioned to puncture the puncturable material.
Regarding claim 23, Loeffler teaches the invention as modified above and further teaches the hard shell includes a puncture element (Fig. 9 #140; ¶0052) positioned to puncture the puncturable material.
Conclusion
Note is again made of the previously cited prior art of Robertson et al. (U.S. Patent 5487378; Fig. 2 – solid vessel 12 around bag 10) and Gallem et al. (U.S. Pub. 2011/0146670; Fig. 9 ampoule 129 within cylindrical portion 15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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