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 .
Response to Amendment
This office action is responsive to the amendment filed on 18 November 2025. As directed by the amendment: claims 1 and 7 have been amended, claims 45-50 have been added, claims 6, 16, 18-22, 24-25, 28, and 34-41 have been or remain canceled. Thus claims 1-5, 7-15, 17, 23, 26-27, 29-33, and 42-50 are presently pending in this application. Applicant’s amendments to the Claims have overcome the 35 U.S.C. 112(a) rejection previously set forth in the Non-Final Office Action mailed 18 June 2025, however, a new 35 U.S.C. 112(a) rejection is made, required by the amendments.
Response to Arguments
The applicant argues that the amendments overcome the written description rejection. The examiner agrees that the previously applied rejection is overcome, however, the new claims fail to satisfy the written description requirement. As outlined further in the 112(a) rejection below, the inclusion of a gas layer that does not interfere with administration to the object region would require some modification to the embodiment shown in Figs 1 and 2A, it would require more than simply putting an amount of gas in the chamber along with the dosing liquid, so claims directed to the embodiment that includes the gas layer cannot also be directed to structures specific to the embodiment of the device in Figs 1 and 2A.
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.
Claims 45-50 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.
The specification describes the gas layer “may be included in the dosing liquid insofar as the gas layer does not interfere with the administration to the object region” [0094]. How the gas layer is incorporated is not described. Simply including gas within the liquid, such as in the form of a bubble, with no changes or additions to the structure of the embodiment depicted in Figs 1 and 2A would interfere with the injection to the object region. The gas layer could break up into smaller bubbles, it could dissolve into the liquid, changing its injection properties, the gas could enter the nozzle before all of the liquid is expelled, it could interfere with a predictable flow path, and possibly prevent all of the liquid from being injected. The inclusion of the gas layer was not described enough to reasonably convey to one skilled in the art that it would be included in the embodiment depicted in Figs 1 and 2A, as such, because the new limitations require a storage chamber with only one compartment and a single plunger, this is specifically directed to the embodiment shown in Figs 1 and 2A and not directed to an embodiment that includes the gas layer incorporated in a way which would not interfere with the administration to the object region.
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.
Claim 50 is 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.
Claim 50 recites the limitation "an injection port”. There is already antecedent basis given for this limitation in claim 1. It is unclear if these are intended to be the same or different injection ports. For the purpose of examination, the injection ports are being interpreted as the same component.
Claim 50 recites “the administration object”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-5, 7-15, 17, 23, 26-27, 29-33, 42, and 44-50 are rejected under 35 U.S.C. 103 as being unpatentable over Oda (US 2013/0237951 A1) in view of Hjertman (US 2004/0087897 A1).
Regarding claim 1, Oda discloses an administration apparatus (Fig 1(a)) for administering a dosing liquid to an object region ([0001] “an injection target area”), the administration apparatus comprising: a storage chamber (14 Fig 1(a)) storing the dosing liquid prior to the dosing liquid being injected, the dosing liquid comprising a liquid medium ([0055] “injection solution ML”, ML Fig 1(a)); a drive unit (20 Fig 1(a)) configured to generate administration energy ([0052] “explosive charge”, “a high pressure is generated during the combustion immediately after the ignition”, [0053] “a gas generating agent 30”); a pressurization unit (6, 7 Fig 1(a)) configured to pressurize the dosing liquid stored in the storage chamber with the administration energy generated by the drive unit ([0003] “applying a large force to a piston by the combustion of the high speed combustion powder.”, “a pressure is continuously applied to such an extent that the injection solution can be diffused in the skin by the combustion of the low speed combustion powder.”); and an injection unit (13 Fig 1(a), (c)) configured to inject the pressurized dosing liquid stored in the storage chamber to the object region through an injection port (4 Fig 1(a), (c)), the pressurization unit configured to pressurize the dosing liquid([0056] “Accordingly, when the pressure is applied to the piston 6, and the injection solution ML is moved to the forward end side of the syringe 1 together with the sealing members 7, 8, then the sealing member 8 can be accommodated in the recess 10. When the sealing member 8 is accommodated in the recess 10, the pressurized injection solution ML is released.”, [0066] “pressure transition applied to the injection solution enclosed in the through-hole 14 by the aid of the piston 6”) such that the dosing liquid in the storage chamber has a pressure configured to rise and vibrate in a damped manner such that the dosing liquid has an injection pressure at the injection port during an initial period, the initial period comprising a first period, a second period and a third period in this order, the injection pressure at the injection port configured to be substantially constant at a first pressure during the first period at which the pressure of the dosing liquid in the storage chamber is configured to begin to rise, the injection pressure at the injection port configured to increase from the first pressure and vibrate in a damped manner to have a plurality of damped vibration cycles represented by a damped sinusoidal wave such that the injection pressure repeatedly increases and decreases while peak values of the plurality of damped vibration cycles gradually decrease during the second period, the third period configured to begin when the injection pressure vibrating in the damped manner converges to a second pressure greater than the first pressure, the injection pressure configured to rise and drop in each of the plurality of damped vibration cycles, the plurality of damped vibration cycles comprising a first damped vibration cycle occurring first among the plurality of damped vibration cycles, the plurality of damped vibration cycles further comprising one or more subsequent damped vibration cycles immediately following the first damped vibration cycle, the injection pressure configured to reach a first peak value at a first rate in the first damped vibration cycle and to reach a second peak value at a second rate in the one or more subsequent damped vibration cycles, a ratio of the first peak value to the second peak value being higher than 1,wherein a total amplitude of the one or more subsequent damped vibration cycles is equal to or lower than a reference amplitude value such that an unnecessary dynamic action on a cell membrane in the object region is avoided, wherein the pressurization unit is configured to begin pressurizing the dosing liquid at a first point of time, wherein the injection pressure is configured to reach the first peak value at a second point of time that comes after the first point of time, wherein the injection pressure is configured to increase from the second pressure and reach a third peak value greater than the second pressure at a third point of time that comes after the initial period ends, wherein the injection pressure has an injection pressure transition period that is configured to start at the first point of time and end at a fourth point of time that comes after the third point of time, wherein the third peak value is between the second pressure and the first peak value, wherein the injection pressure comprises an end pressure at the fourth point of time, wherein the end pressure is lower than the second pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid as claimed, the pressurization unit is slidable within the through-hole 14 and the pressure it applies can be modified by “appropriately adjusting the combination of the ignition charge 22 and the gas generating agent 30 contained in the syringe 1” along with many other factors, including the viscosity of the fluid, the size of the injection port, the size of the storage unit etc. Because the pressure profile is a functional limitation, something the pressurization unit is configured to generate, the pressurization unit of the prior art does not need to be taught explicitly performing the function, it only needs to be fully capable of performing the function, the piston and sealing member of Oda is fully capable of providing all sorts of pressure profiles to the fluid including the pressure profile claimed), wherein the administration energy is configured to be generated based on a combustion gas ([0053] “a gas generating agent 30”), and wherein the pressurization unit is configured to pressurize of the dosing liquid such that the injection pressure vibrates in the damped manner based at least in part on an elastic compressive deformation of the gas layer in the dosing liquid stored in the storage chamber, caused by combustion of a high-energy substance (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid comprising a gas layer as claimed).
However, Oda fails to teach the dosing liquid comprising a gas layer.
Hjertman teaches a storage chamber (100 Fig 10) storing the dosing liquid prior to the dosing liquid being injected, the dosing liquid comprising a liquid medium (106 Fig 10) and a gas layer (114 Fig 10). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the injection liquid to comprise a gas layer as taught by Hjertman as it “amplifies dampening and makes it more reliable” [0068].
Regarding claim 2, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the drive unit includes at least the high-energy substance (ignition charge 22 Fig 2) and is configured to generate the administration energy by burning the high-energy substance ([0051] “combustion product, which is produced by the combustion of the ignition charge 22”).
Regarding claim 3, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the second peak value is greater than the first pressure and the second pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed peak pressures).
Regarding claim 4, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the first rate is faster than the second rate (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed rates).
Regarding claim 5, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the plurality of damped vibration cycles are in a prescribed frequency range (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed frequency).
Regarding claim 7, Oda discloses an administration apparatus (Fig 1(a)) for administering a dosing liquid to an object region ([0001] “an injection target area”), the administration apparatus comprising: a storage chamber (14 Fig 1(a)) storing the dosing liquid prior to the dosing liquid being injected, the dosing liquid comprising a liquid medium ([0055] “injection solution ML”, ML Fig 1(a)); a drive unit (20 Fig 1(a)) configured to generate administration energy ([0052] “explosive charge”, “a high pressure is generated during the combustion immediately after the ignition”, [0053] “a gas generating agent 30”); a pressurization unit (6, 7 Fig 1(a)) configured to pressurize storage chamber with the administration energy generated by the drive unit ([0003] “applying a large force to a piston by the combustion of the high speed combustion powder.”, “a pressure is continuously applied to such an extent that the injection solution can be diffused in the skin by the combustion of the low speed combustion powder.”); and an injection unit (13 Fig 1(a), (c)) configured to inject the pressurized dosing liquid stored in the storage chamber to the object region through an injection port (4 Fig 1(a), (c)), the pressurization unit configured to pressurize the dosing liquid ([0056] “Accordingly, when the pressure is applied to the piston 6, and the injection solution ML is moved to the forward end side of the syringe 1 together with the sealing members 7, 8, then the sealing member 8 can be accommodated in the recess 10. When the sealing member 8 is accommodated in the recess 10, the pressurized injection solution ML is released.”, [0066] “pressure transition applied to the injection solution enclosed in the through-hole 14 by the aid of the piston 6”) such that the dosing liquid in the storage chamber has a pressure configured to rise and vibrate in a damped manner such that the dosing liquid has an injection pressure at the injection port during an initial period, the initial period comprising a first period, a second period and a third period in this order, the injection pressure at the injection port configured to be substantially constant at a first pressure during the first period at which the pressure of the dosing liquid in the storage chamber is configured to begin to rise, the injection pressure at the injection port configured to increase from the first pressure and vibrate in a damped manner to have a plurality of damped vibration cycles represented by a damped sinusoidal wave such that the injection pressure repeatedly increases and decreases while peak values of the plurality of damped vibration cycles gradually decrease during the second period, the third period configured to begin when the injection pressure vibrating in the damped manner converges to a second pressure greater than the first pressure, wherein the injection pressure is configured to rise and drop in each of the plurality of damped vibration cycles, the plurality of damped vibration cycles comprising a first damped vibration cycle occurring first among the plurality of damped vibration cycles, the plurality of damped vibration cycles further comprising one or more subsequent damped vibration cycles immediately following the first damped vibration cycle, wherein a total amplitude of the one or more subsequent damped vibration cycles is equal to or lower than a reference amplitude value, wherein the injection pressure is configured to reach a first peak value at a first rate in the first damped vibration cycle and to reach a second peak value at a second rate in the one or more subsequent damped vibration cycles, wherein the pressurization unit is configured to begin pressurizing the dosing liquid at a first point of time, wherein the injection pressure is configured to reach the first peak value at a second point of time that comes after the first point of time, wherein the injection pressure is configured to increase from the second pressure and reach a third peak value greater than the second pressure at a third point of time that comes after the initial period ends, wherein the injection pressure has an injection pressure transition period that is configured to start at the first point of time and end at a fourth point of time that comes after the third point of time, wherein the third peak value is between the second pressure and the first peak value, wherein the injection pressure comprises an end pressure at the fourth point of time, and wherein the end pressure is lower than the second pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid as claimed, the pressurization unit is slidable within the through-hole 14 and the pressure it applies can be modified by “appropriately adjusting the combination of the ignition charge 22 and the gas generating agent 30 contained in the syringe 1” along with many other factors, including the viscosity of the fluid, the size of the injection port, the size of the storage unit etc. Because the pressure profile is a functional limitation, something the pressurization unit is configured to generate, the pressurization unit of the prior art does not need to be taught explicitly performing the function, it only needs to be fully capable of performing the function, the piston and sealing member of Oda is fully capable of providing all sorts of pressure profiles to the fluid including the pressure profile claimed), wherein the administration energy is configured to be generated based on a combustion gas ([0053] “a gas generating agent 30”), and wherein the pressurization unit is configured to pressurize of the dosing liquid such that the injection pressure vibrates in the damped manner based at least in part on an elastic compressive deformation of the gas layer in the dosing liquid stored in the storage chamber, caused by combustion of a high-energy substance (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid comprising a gas layer as claimed).
However, Oda fails to teach the dosing liquid comprising a gas layer.
Hjertman teaches a storage chamber (100 Fig 10) storing the dosing liquid prior to the dosing liquid being injected, the dosing liquid comprising a liquid medium (106 Fig 10) and a gas layer (114 Fig 10). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the injection liquid to comprise a gas layer as taught by Hjertman as it “amplifies dampening and makes it more reliable” [0068].
Regarding claim 8, modified Oda discloses the administration apparatus according to claim 7. Modified Oda further discloses wherein the drive unit includes at least the high-energy substance (ignition charge 22 Fig 2) and is configured to generate the administration energy by burning the high-energy substance ([0051] “combustion product, which is produced by the combustion of the ignition charge 22”).
Regarding claim 9, modified Oda discloses the administration apparatus according to claim 7. Modified Oda further discloses wherein the plurality of damped vibration cycles are in a prescribed frequency range (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed frequency).
Regarding claim 10, modified Oda discloses the administration apparatus according to claim 7. Modified Oda further discloses wherein a ratio of the first peak value to the second peak value being higher than 1 (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed ratio).
Regarding claim 11, modified Oda discloses the administration apparatus according to claim 10. Modified Oda further discloses wherein the second peak value is greater than the first pressure and the second pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed peak value).
Regarding claim 12, modified Oda discloses the administration apparatus according to claim 10. Modified Oda further discloses wherein all of the peak values of the plurality of damped vibration cycles are greater than the first pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed peak values).
Regarding claim 13, modified Oda discloses the administration apparatus according to claim 10. Modified Oda further discloses wherein the first rate is faster than the second rate (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed rates).
Regarding claim 14, modified Oda discloses the administration apparatus according to claim 10. Modified Oda further discloses wherein at least two of the peak values of the plurality of damped vibration cycles are greater than the second pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed peak values).
Regarding claim 15, modified Oda discloses the administration apparatus according to claim 2. Modified Oda further discloses further comprising: a gas generating agent ([0034] “gas generating agent”) configured to generate combustion products generated by the combustion of the high-energy substance ([0053] “a gas generating agent 30 having a columnar shape, which is combusted by the combustion product produced by the combustion of the ignition charge 22 to produce the gas”).
Regarding claim 17, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the administration apparatus is a needleless injector ([0001] “The present invention relates to a syringe (injector) with which an injection objective substance is injected into an injection target area of a living body without using any injection needle.”) and configured to administer the dosing liquid to the object region from the injection port (4 Fig 1) without involving a structure that contacts an inside of the object region (the nozzle does not contact an inside of the object region, See Fig 5(a) showing the syringe 1 on the outside of the skin).
Regarding claim 23, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the one or more subsequent damped vibration cycles comprise a second damped vibration cycle having an amplitude less than that of the first damped vibration cycle, a third damped vibration cycle having an amplitude less than that of the second damped vibration cycle, and a fourth damped vibration cycle having an amplitude less than that of the third damped vibration cycle (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vibration cycles and amplitudes).
Regarding claim 26, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the second period is longer than the first period, and the third period is longer than the second period (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed periods).
Regarding claim 27, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the second pressure is less than the first peak value (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed peaks).
Regarding claim 29, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein a minimum value of the first damped vibration cycle is less than a peak value of each of the one or more subsequent damped vibration cycles (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vibration cycles).
Regarding claim 30, modified Oda discloses the administration apparatus according to claim 29. Modified Oda further discloses wherein the minimum value of the first damped vibration cycle is less than the second pressure wherein a minimum value of the first damped vibration cycle is less than a peak value of each of the one or more subsequent damped vibration cycles (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vibration cycle values).
Regarding claim 31, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the one or more subsequent damped vibration cycles comprise a second damped vibration cycle immediately following the first damped vibration cycle, and wherein a minimum value of the second damped vibration cycle is less than the second pressure (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vibration cycles).
Regarding claim 32, modified Oda discloses the administration apparatus according to claim 31. Modified Oda further discloses wherein the second damped vibration cycle has the second peak value less than the first peak value, and wherein the difference between the first pressure and the first peak value is greater than the second peak value (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vibration cycles).
Regarding claim 33, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein each of the one or more subsequent damped vibration cycles has a peak value and a minimum value, and wherein the second pressure is greater than at least some of the minimum values of the one or more subsequent damped vibration cycles (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vibration cycles).
Regarding claim 42, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the fourth point of time at which the injection pressure has the end pressure is approximately 40 milliseconds from start of the combustion (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed timing).
Regarding claim 44, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the pressurization unit is configured to pressurize the dosing liquid such that an amount of a vertical vibration of the dosing liquid is generally constant in an injection direction of the dosing liquid (the pressurization unit (piston 6, and sealing member 7) of Oda is fully capable of pressurizing the dosing liquid to have the claimed vertical vibration).
Regarding claim 45, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the dosing liquid comprises a substance ([0054] “An injection solution ML”).
Regarding claim 46, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses wherein the storage chamber has only one compartment (14 Fig 1(a) is a single compartment, modified with Hjertman Fig 10 would still include one compartment, with the air in the same compartment separated with a membrane 115).
Regarding claim 47, modified Oda discloses the administration apparatus according to claim 1. Modified Oda further discloses further comprising a syringe section (2 Fig 1(a)) having a first end (The left side of 2 as depicted in Fig 1(a)) and a second end opposite the first end (The right side of 2 as depicted in Fig 1(a)) and a single plunger (7 Fig 1(a)), wherein the plunger is disposed at the first end of the syringe section and the storage chamber is formed within a body of the syringe section between the plunger and a second end of the syringe (14 is formed between 7 and the right side of 2 as depicted in Fig 1(a)).
Regarding claim 48, modified Oda discloses the administration apparatus according to claim 47. Modified Oda further discloses wherein, prior to the dosing liquid being injected, the dosing liquid is housed in the storage chamber and configured to contact the plunger proximate the first end (See the injection liquid “ML” contacting the plunger 7 in Fig 1(a)).
Regarding claim 49, modified Oda discloses the administration apparatus according to claim 47. Modified Oda further discloses wherein the plunger (7 Fig 1(a)) is slidably coupled to the syringe section (2 Fig 1(a), [0054] “the piston 6 is slidable in the axial direction in the through-hole 14”, 7 is coupled to 6 and would slide with it) such that, during administration of the dosing liquid, the plunger traverses the syringe section and can slide within the storage chamber to administer the dosing liquid ([00560 “when the pressure is applied to the piston 6, and the injection solution ML is moved to the forward end side of the syringe 1 together with the sealing members 7, 8”).
Regarding claim 50, modified Oda discloses the administration apparatus according to claim 47. Modified Oda further discloses wherein the syringe section further comprises a shield section (13 Fig 1) disposed around a periphery of an injection port (13 is disposed around 4 as shown in Fig 1(a) and (b)) proximate the second end (13 is proximate the right end as depicted in Fig 1(a)) to increase contactability between the syringe section and the administration object (Contactability is increased by preventing disengagement of the holder 5, [0055] “The holder cap 13 is formed to have a brim-shaped cross section so that the holder cap 13 fixes the holder 5, and the holder cap 13 is screw-fixed to the main syringe body 2. Accordingly, the holder 5 is prevented from being disengaged from the main syringe body 2 by the pressure applied to the injection solution ML when the injection solution ML is allowed to inject.”).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Oda (US 2013/0237951 A1) in view of Hjertman (US 2004/0087897 A1) and Ruben (US 2003/0105433 A1).
Regarding claim 43, modified Oda discloses the administration apparatus according to claim 1. However, modified Oda is silent to wherein the gas layer comprises air or inert gas.
Ruben teaches a gas layer comprises air or inert gas ([0037] “filled with a compressible gas such as air”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the gas layer of modified Oda to comprise the limitations as taught by Ruben so the gas is compressible [0037].
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.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783