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 .
This office action is in response to the amendment filed 2/23/26. As directed by the amendment, claims 1-9, 11-16, 18-29, 31-36, 38-40, 42-55, 57, and 59 have been amended and no claims have been added nor cancelled. Claims 2-3, 12, 23-26, 29-30, 36, 38, and 51-54 remain withdrawn as being directed towards non-elected subject matter and claims 1, 4-11, 13-22, 27-28, 31-35, 37, 39-50, and 55-59 are examined below.
Drawings
The drawings are objected to because Figs. 10-12 are objected to as these figures include lead lines but no reference characters. 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 Objections
The following claims are objected to because of the following informalities:
Regarding claim 1, the language “second end of at least one hollow puncturing member” (line 19-20 is objected to for a formatting/grammatical error; Examiner suggests amending to read –second end of said at least one hollow puncturing member--.
Regarding claim 1, the language “and deliver the same” (line 22) is objected to for potentially vague language. While it is clear that the ‘at least one substance’ is what is being delivered, examiner suggests amending to read –and deliver said at least one substance--.
Regarding claim 5, the claim is objected as it does not end with a period punctuation mark. MPEP 608.01(m) states that the form of the claims is such that each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.
Regarding claim 7, the language “nosepiece said is reversible” (line 2) is objected to for a typographical/grammatical error; Examiner suggests amending to read –nosepiece is reversible--.
Regarding claim 8, the language “throughout which” (line 2) is objected to for a grammatical error; Examiner suggests amending to read –through which--.
Regarding claim 10, the language “pressured fluid” (line 2) is objected to for a grammatical/typographical error; Examiner suggests amending to read –pressurized fluid--.
Regarding claim 15, the language “at least one said at least one” (section d) and e)) is objected to for a grammatical/typographical error; Examiner suggests amending to read –said at least one substance--.
Regarding claim 20, the language “said ends” (line 2) is objected to for consistency in claim terminology to match the language in claim 19 line 2; Examiner suggests amending to read –said at least two ends--.
Regarding claim 21, the language “said ends” (line 2) is objected to for consistency in claim terminology to match the language in claim 19 line 2; Examiner suggests amending to read –said at least two ends--.
Regarding claim 32, the language “and deliver the same” (line 22) is objected to for potentially vague language. While it is clear that the ‘at least one substance’ is what is being delivered, examiner suggests amending to read –and deliver said at least one substance--.
Regarding claim 39, the language “throughout which” (line 2) is objected to for a grammatical error; Examiner suggests amending to read –through which--.
Regarding claim 41, the language “pressured fluid” (line 2) is objected to for a grammatical/typographical error; Examiner suggests amending to read –pressurized fluid--.
Regarding claim 44, the language “at least one said at least one” (section e)) is objected to for a grammatical/typographical error; Examiner suggests amending to read –said at least one substance--.
Regarding claim 48, the language “said ends” (line 2) is objected to for consistency in claim terminology to match the language in claim 47 line 2; Examiner suggests amending to read –said at least two ends--.
Regarding claim 49, the language “said ends” (line 2) is objected to for consistency in claim terminology to match the language in claim 47 line 2; Examiner suggests amending to read –said at least two ends--.
Appropriate correction is required.
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.
The following claims 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the language “said one end” (line 16-17) is unclear as it is not known if this is referring to the at least one first end or the second end (lines 12-13). It appears Applicant is intending to refer to the at least one first end and examiner suggests amending to read –said at least one first end--.
Regarding claim 1, the language “said hollow puncturing member” (line 21) is unclear as the language “at least one hollow puncturing member” (line 11) sets forth the possibility of plural puncturing members and it is therefore unclear if the language in line 21 is referring back to each of, or a particular one/subset of, the potential plural puncturing members. Examiner suggests amending to read –said at least one hollow puncturing member--.
Regarding claim 1, the language “the first end” (line 22) is unclear as it is not known if this is referring to the at least one first end or the second end (lines 12-13). It appears Applicant is intending to refer to the at least one first end and examiner suggests amending to read –the at least one first end--.
Regarding claim 6, the language “said nosepiece cover” (line 1) is unclear as claim 5 line 2 sets forth the possibility of plural nosepiece covers with the language “at least one nosepiece cover” and it is therefore unclear if the language in claim 6 is referring back to each of, or a particular one/subset of, the potential nosepiece covers. Examiner suggests amending to read –said at least one nosepiece cover--.
Regarding claim 7, the language “nosepiece cover” (line 2) is unclear as claim 5 line 2 sets forth the possibility of plural nosepiece covers with the language “at least one nosepiece cover” and it is therefore unclear if the language in claim 7 is referring back to each of, or a particular one/subset of, the potential nosepiece covers. Examiner suggests amending to read –said at least one nosepiece cover--.
Regarding claim 8, the language “said nosepiece cover” (line 1) is unclear as claim 5 line 2 sets forth the possibility of plural nosepiece covers with the language “at least one nosepiece cover” and it is therefore unclear if the language in claim 8 is referring back to each of, or a particular one/subset of, the potential nosepiece covers. Examiner suggests amending to read –said at least one nosepiece cover--.
Claim 14 recites the limitations: “said volume rate” in section g), and “said volume rate” in section i). There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "said predetermined volume Vsub" in section c), “said predetermined pressure” in section c), and “said at least one orifice” in section c). There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the language “said nosepiece cover” (line 1) is unclear as claim 5 line 2 sets forth the possibility of plural nosepiece covers with the language “at least one nosepiece cover” and it is therefore unclear if the language in claim 16 is referring back to each of, or a particular one/subset of, the potential nosepiece covers. Examiner suggests amending to read –said at least one nosepiece cover--.
Regarding claim 28, the language “said first end” (line 15) is unclear as it is not known if this is referring to a particular one or each of the potential plural first ends set forth by the language “at least one first end” (line 13); Examiner suggests amending to read –said at least one first end--.
Regarding claim 28, the language “said one end” (line 17) is unclear as it is not known if this is referring to the at least one first end or the second end (lines 13-14). It appears Applicant is intending to refer to the at least one first end and examiner suggests amending to read –said at least one first end--.
Regarding claim 28, the language “the first end” (line 19) is unclear as it is not known if this is referring to the at least one first end or the second end (lines 13-14). It appears Applicant is intending to refer to the at least one first end and examiner suggests amending to read –the at least one first end--.
Claim 35 recites the limitations “said coupling” in line 1 and "nosepiece cover" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "said nosepiece cover" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "said nosepiece cover" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation “said volume rate” in section j. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitations: “said predetermined volume Vsub” in section c, “said at least one orifice” in section c. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 56, the language “said hollow puncturing member” (line 2-3) is unclear as the language “at least one hollow puncturing member” in claim 1 line 11 sets forth the possibility of plural puncturing members and it is therefore unclear if the language in claim 56 is referring back to each of, or a particular one/subset of, the potential plural puncturing members. Examiner suggests amending to read –said at least one hollow puncturing member--.
Regarding claim 57, the language “said hollow puncturing member” (line 2-3) is unclear as the language “at least one hollow puncturing member” in claim 1 line 11 sets forth the possibility of plural puncturing members and it is therefore unclear if the language in claim 57 is referring back to each of, or a particular one/subset of, the potential plural puncturing members. Examiner suggests amending to read –said at least one hollow puncturing member--.
Regarding claim 58, the language “said hollow puncturing member” (line 2-3) is unclear as the language “at least one hollow puncturing member” in claim 28 line 12 sets forth the possibility of plural puncturing members and it is therefore unclear if the language in claim 58 is referring back to each of, or a particular one/subset of, the potential plural puncturing members. Examiner suggests amending to read –said at least one hollow puncturing member--.
Regarding claim 59, the language “said hollow puncturing member” (line 2-3) is unclear as the language “at least one hollow puncturing member” in claim 28 line 12 sets forth the possibility of plural puncturing members and it is therefore unclear if the language in claim 59 is referring back to each of, or a particular one/subset of, the potential plural puncturing members. Examiner suggests amending to read –said at least one hollow puncturing member--.
Claims dependent on the above mentioned claims are also rejected due to dependency on a rejected claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-6, 8, 9-10, 13-15, 18-19, 27, 56-57, 28, 31-34, 39-41, 43-47, 55, and 58-59 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Shahaf et al. (2016/199135).
Note: the earliest effective filing date for the claims is 3/5/20.
Regarding claim 1, Shahaf discloses a device for delivering at least one substance within at least one body cavity (see Fig. 9-10 and abstract, pg. 99 discloses delivery of substance to the nose) including (i) at least one nosepiece including at least one capsule including Vsub of the substance with the capsule having at least one fluid inlet port with diameter Din and at least one fluid discharging outlet of diameter Dout, the nosepiece configured for placement in proximity to the body cavity (see pg. 99 disclosing delivery of substance to the nose, nosepiece 1240, see Figs. 9-10 and pg. 104-105; substance capsule disclosed in pg. 103 and shown in Figs. 4-8 for example, pg. 104 discloses that in Figs. 9-10 no substance capsule is shown for clarity, capsule would include fluid inlet at a lower portion when located in nosepiece 1240 at a substance compartment 1242 per pg. 105 and a fluid discharging outlet at an upper portion of the capsule, having diameters); (ii) at least one base in communication with the nosepiece and including at least one chamber configured to confine compressed and pressurized fluid a volume Vpf and pressure Ppf (see Fig. 9-10, base defined by elements 1210 and 1230, see pg. 104-105, “pressurized-gas capsule” 1212 within 1210); (iii) at least one hollow puncturing member characterized by at least one first end in direct fluid communication with the capsule in the nosepiece and a second end in direct fluid communication with the base and the ends fluidly interconnected by a hollow tube and the fluid inlet port of the capsule configured by means of size and shape to interface in a sealable manner with the first end of the puncturing member (see Fig. 10A-C in particular showing puncture member 1220 with first, upper end in direct fluid communication with the capsule (not shown) in the nosepiece 1240 and second, lower end 1223 fluidly interconnected by hollow tube 1221, see pg. 104-105); wherein actuation of the base enables piercing of the chamber by the second end of the puncturing member to enable pressurized fluid to exit the chamber and entrain through the hollow tube to the capsule entrain the substance and deliver it to the body cavity (see pg. 103-105, abstract, Figs. 9-10 and in particular Fig. 10C showing actuation position), wherein the first end of the puncturing member is substantially flat (see Fig. 9-10, in particular 10A showing the upper first end of 1220 being substantially flat).
Regarding claim 4, the Shahaf device’s actuation of the base includes pressing on the base (see pg. 104-105).
Regarding claim 5, the Shahaf device’s nosepiece includes a cover configured by means of size and shape to cover, in a sealable manner, at least partially the nosepiece (see Fig. 9-10, nosepiece cover 1250, see pg. 104-105).
Regarding claim 6, the Shahaf device’s nosepiece cover and nosepiece are coupled to each other (see Fig. 9-10 showing nosepiece cover 1250 coupled to nosepiece 1240).
Regarding claim 8, the Shahaf device’s nosepiece includes at least one port through which the substance exits the device and the nosepiece cover seals the port and removal thereof removes the seal (see Fig. 9-10, nosepiece cover 1250 covering at least one port, the upper discharge port of nosepiece 1240, and sealing the port until removal, pg. 104-105).
Regarding claim 9, the Shahaf device’s capsule is selected from the claimed group (see pg. 94-95, pierceable container).
Regarding claim 10, the Shahaf device’s chamber is a container adapted to hold the pressurized fluid at the Ppf for prolong periods of time (see pg. 103-105).
Regarding claim 13, the Shahaf device is such that the volume Vpf of the pressurized fluid Ppf is released from the chamber within less than 500 ms (dT) via the fluid inlet port entrains the substance and erupts from the fluid discharging outlet port into the body cavity such that the release time of the substance and the pressurized fluid is less than 500 ms (see pg. 3, 14, and 105).
Regarding claim 14, the Shahaf device is configured to deliver the substance and pressurized fluid through the discharging outlet with at least one of the claimed list being held true (see pg. 3 and 14).
Regarding claim 15, the Shahaf device is such that at least one of the claimed conditions is true (see abstract, pg. 99 discloses delivery of substance to the nose and thus nasal cavity being the body cavity).
Regarding claim 18, the Shahaf device’s at least one substance is one of the claimed group (see pg. 8-10).
Regarding claim 19, the Shahaf device’s capsule is a hollow tube with two ends interconnected to each other one of which is positioned proximal to the chamber (see Figs. 4-8 showing capsule as hollow tube to hold substance, having two ends, see Fig. 9-10 and pg. 104-105, capsule provided to nosepiece 1240 at compartment 1242 and thus having end close to chamber 1212).
Regarding claim 27, the Shahaf device’s capsule includes at least one spherical element, membrane, uni-directional valve, duckbill valve, such that the substance is positioned therebetween (see pg. 10-11).
Regarding claim 56, the Shahaf device’s hollow puncturing member includes at least one orifice through which the pressurized fluid enters the puncturing member (see Fig. 10A-C and pg. 104-105).
Regarding claim 57, the Shahaf device is such that once actuated, the pressurized fluid exits the chamber and enters the hollow puncturing member through the at least one orifice (see Fig. 10A-C and pg. 104-105).
Regarding claim 28, the use of the Shahaf device inherently includes a method for delivering at least one substance within at least one body cavity (see Fig. 9-10 and abstract, pg. 99 discloses delivery of substance to the nose) including a) providing at least one nosepiece including at least one capsule including Vsub of the substance with the capsule having at least one fluid inlet port with diameter Din and at least one fluid discharging outlet of diameter Dout, the nosepiece configured for placement in proximity to the body cavity (see pg. 99 disclosing delivery of substance to the nose, nosepiece 1240, see Figs. 9-10 and pg. 104-105; substance capsule disclosed in pg. 103 and shown in Figs. 4-8 for example, pg. 104 discloses that in Figs. 9-10 no substance capsule is shown for clarity, capsule would include fluid inlet at a lower portion when located in nosepiece 1240 at a substance compartment 1242 per pg. 105 and a fluid discharging outlet at an upper portion of the capsule, having diameters); at least one base in communication with the nosepiece and including at least one chamber configured to confine compressed and pressurized fluid a volume Vpf and pressure Ppf (see Fig. 9-10, base defined by elements 1210 and 1230, see pg. 104-105, “pressurized-gas capsule” 1212 within 1210); (iii) at least one hollow puncturing member characterized by at least one first end in direct fluid communication with the capsule in the nosepiece and a second end in direct fluid communication with the base and the ends fluidly interconnected by a hollow tube and the fluid inlet port of the capsule configured by means of size and shape to interface in a sealable manner with the first end of the puncturing member (see Fig. 10A-C in particular showing puncture member 1220 with first, upper end in direct fluid communication with the capsule (not shown) in the nosepiece 1240 and second, lower end 1223 fluidly interconnected by hollow tube 1221, see pg. 104-105); b) actuating the base thereby piercing the chamber by the second end of the puncturing member (see pg. 103-105, abstract, Figs. 9-10 and in particular Fig. 10C showing actuation position), wherein the first end of the puncturing member is substantially flat (see Fig. 9-10, in particular 10A showing the upper first end of 1220 being substantially flat).
Regarding claim 31, the Shahaf use method’s step b) of actuating the base includes pressing the base (see pg. 104-105).
Regarding claim 32, the Shahaf use method’s step b) of actuating the base enables piercing of the chamber by the second end of the puncturing member to enable pressurized fluid to exit the chamber and entrain through the hollow tube to the capsule entrain the substance and deliver it to the body cavity (see pg. 103-105, abstract, Figs. 9-10 and in particular Fig. 10C showing actuation position).
Regarding claim 33, the Shahaf use method’s step b) of actuating the base results in releasing the volume Vpf of the pressurized fluid Ppf is released from the chamber within less than 500 ms (dT) via the fluid inlet port entrains the substance and erupts from the fluid discharging outlet port into the body cavity such that the release time of the substance and the pressurized fluid is less than 500 ms (see pg. 3, 14, and 105).
Regarding claim 34, the Shahaf use method’s nosepiece includes a nosepiece cover coupled to the nosepiece (see Fig. 9-10, nosepiece cover 1250, see pg. 104-105).
Regarding claim 39, the Shahaf use method’s nosepiece includes at least one port through which the substance exits the device and the nosepiece cover seals the port and removal thereof removes the seal (see Fig. 9-10, nosepiece cover 1250 covering at least one port, the upper discharge port of nosepiece 1240, and sealing the port until removal, pg. 104-105).
Regarding claim 40, the Shahaf use method’s capsule is selected from the claimed group (see pg. 94-95, pierceable container).
Regarding claim 41, the Shahaf use method’s chamber is a container adapted to hold the pressurized fluid at the Ppf for prolong periods of time (see pg. 103-105).
Regarding claim 43, the Shahaf use method delivers the substance and pressurized fluid through the discharging outlet with at least one of the claimed list being held true (see pg. 3 and 14).
Regarding claim 44, the Shahaf use method is such that at least one of the claimed conditions is true (see abstract, pg. 99 discloses delivery of substance to the nose and thus nasal cavity being the body cavity).
Regarding claim 45, the Shahaf use method’s at least one substance is one of the claimed group (see pg. 8-10).
Regarding claim 46, the Shahaf use method’s hollow puncturing member includes a plurality of holes through which pressurized fluid exits the chamber and entrains the substance after activation (see Fig. 10A-C and pg. 104-105, top end of puncture member 1220 including a hole, and bottom end 1223 includes a hole 1222).
Regarding claim 47, the Shahaf use method’s capsule is a hollow tube with two ends interconnected to each other one of which is positioned proximal to the chamber (see Figs. 4-8 showing capsule as hollow tube to hold substance, having two ends, see Fig. 9-10 and pg. 104-105, capsule provided to nosepiece 1240 at compartment 1242 and thus having end close to chamber 1212).
Regarding claim 55, the Shahaf method’s capsule includes at least one spherical element, membrane, uni-directional valve, duckbill valve, such that the substance is positioned therebetween (see pg. 10-11).
Regarding claim 58, the Shahaf use method’s hollow puncturing member includes at least one orifice through which the pressurized fluid enters the puncturing member (see Fig. 10A-C and pg. 104-105).
Regarding claim 59, the Shahaf use method is such that once actuated, the pressurized fluid exits the chamber and enters the hollow puncturing member through the at least one orifice (see Fig. 10A-C and pg. 104-105).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7, 16, 35, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Riccio (4,017,007).
Regarding claim 7, the Shahaf device is silent as to including a nosepiece cover which is reversible; however, Riccio teaches a similar substance delivery device with a nozzle cover which is reversible (see Riccio Fig. 3-4, cover 39, col. 6 ln. 28-48). Thus 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 Shahaf device to include a reversible cover piece, as taught by Riccio, in order to provide a protective covering to prevent dust/dirt from clogging the nozzle outlet.
Regarding claim 16, the Shahaf device is silent as to removal of a nosepiece obtained by the claimed group; however, Riccio teaches such a nozzle cover removed by the claimed action(s) (see Riccio Fig. 3-4, cover 39, col. 6 ln. 28-48). Thus 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 Shahaf device to include a reversible cover piece, as taught by Riccio, in order to provide a protective covering to prevent dust/dirt from clogging the nozzle outlet.
Regarding claim 35, the Shahaf use method is silent as to including a nosepiece cover which is reversible; however, Riccio teaches a similar substance delivery device with a nozzle cover which is reversible (see Riccio Fig. 3-4, cover 39, col. 6 ln. 28-48). Thus 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 Shahaf method to include a reversible cover piece, as taught by Riccio, in order to provide a protective covering to prevent dust/dirt from clogging the nozzle outlet.
Regarding claim 37, the Shahaf use method is silent as to removal of a nosepiece obtained by the claimed group; however, Riccio teaches such a nozzle cover removed by the claimed action(s) (see Riccio Fig. 3-4, cover 39, col. 6 ln. 28-48). Thus 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 Shahaf method to include a reversible cover piece, as taught by Riccio, in order to provide a protective covering to prevent dust/dirt from clogging the nozzle outlet.
Claim(s) 11 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Sullivan et al. (2005/0188985).
Regarding claim 11, the Shahaf device is silent as to the capsule explicitly being made of at least one material selected from the claimed group; however, Sullivan teaches a similar device/method which includes a capsule made of such a claimed material (see Sullivan para. 0030). Thus 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 Shahaf device’s capsule to be made of a material, such as taught by Sullivan, as this would have been obvious substitution of one known element/material for another and one would expect the modified Shahaf device to perform equally as well.
Regarding claim 42, the Shahaf use method is silent as to the capsule explicitly being made of at least one material selected from the claimed group; however, Sullivan teaches a similar device/method which includes a capsule made of such a claimed material (see Sullivan para. 0030). Thus 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 Shahaf method’s capsule to be made of a material, such as taught by Sullivan, as this would have been obvious substitution of one known element/material for another and one would expect the modified Shahaf method to perform equally as well.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Weston (6,135,979).
Regarding claim 17, the Shahaf device is silent as to including a safety latch shaped to prevent accidental operation; however, Weston teaches a similar substance delivery device including a safety latch as claimed (see Weston Fig. 2a-c, col. 3 ln. 55 through col. 4 ln. 18, safety latch 108). Thus 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 Shahaf device to include a safety latch, as taught by Weston, in order to prevent accidental firing of the device (see Weston col. 3 ln. 55 through col. 4 ln. 18).
Claim(s) 20 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Bruna et al. (WO 99/46055).
Regarding claims 20 and 48, the Shahaf device/method is silent as to the capsule including at least one spherical element positioned at at least one end to prevent leakage therefrom; however, Bruna teaches a similar substance delivery device/method which includes a capsule sealed at an end by at least one spherical element (see Bruna Fig. 1-5, spherical element 16, see also Fig. 6-8). Thus 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 Shahaf device/method to include a spherical element to close an end of the capsule, as taught by Bruna, as this would have been obvious substitution of one known element for another (spherical ball for a septum) and one would expect the modified Shahaf device to perform equally as well.
Claim(s) 21-22 and 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf and Bruna as applied to claim 20 above, and further in view of Jensen et al. (EP 2002856).
Regarding claims 21 and 49, the modified Shahaf device/method is silent as to the capsule including two spherical elements at each end as claimed; however, Jensen teaches a similar device which includes such a capsule having plural spherical elements (see Jensen Fig. 1-2, spherical elements 111). Thus 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 modified Shahaf device/method’s capsule to include plural spherical elements, as taught by Jensen, in order to provide the ability to have plural types of substances for mixing and delivery at the same time (Jensen abstract).
Regarding claims 22 and 50, the modified Shahaf device/method’s two spherical elements are adapted to mix substances therein (see Jensen Fig. 1-2 and abstract).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on the same reference(s) applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
Prosecution Insights