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 .
Election/Restrictions
Claims 7-8, 14, and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
Applicant’s election without traverse of Species A2, B1, and C1 in the reply filed on 11/10/2025 is acknowledged.
Examiner notes claims 7-8 and 14 are being withdrawn as they are drawn to the nonelected Species A1 of a hand-holding device that is formed by the outer housing of the pressure accumulator and thus comprises a shooting button 71 fixed on the outer surface of said pressure accumulator (see at least Fig. 2-3, 5, and 7 and para. 0063). Claims 7 and 14 discloses the shooting button fixed on the outer surface of said pressure accumulator and thus is drawn to the nonelected Species A1. Claim 8 discloses the shooting button as an image control key on the display of the control panel which is illustrated in Fig. 10 where the hand-holding device is formed by the outer housing of the pressure accumulator, and thus is drawn to the nonelected Species A1. The elected species A2 is drawn to a hand-holding device in the shape of a handle and fixed to the bottom of the pressure accumulator with the shooting button 71 is arranged on the hand-holding device (see Fig. 6 and para. 0066). Examiner further notes for consistency, claim 13 should be amended to remove the limitation “or an image shooting key in said display” as this limitation is drawn to the nonelected Species A1 as discussed above.
Drawings
The drawings are objected to because Fig. 1-2, 4, 7-10, and 12 contain reference numbers such as “511” in Fig. 2 which are difficult to identify. Examiner requests these triple-digit reference numbers be corrected such that they are illustrated as those shown in Fig. 11. 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
Claims 1-2, 6, and 13 are objected to because of the following informalities:
Regarding claim 1, the phrase “said connecting convex portion” in line 8 should read “said at least one connecting convex portion” for proper antecedent basis,
Regarding claim 1, the phrase “said engaging groove“ in line 13 should read “said at least one engaging groove” for proper antecedent basis,
Regarding claim 1, the phrase “said first connection end” in line 14 should read “said first connecting end” for proper antecedent basis,
Regarding claim 1, the phrase “said connection port” in line 15 should read “said connecting port” for proper antecedent basis,
Regarding claim 1, the phrase “said second connection end” in line 16 should read “said second connecting end” for proper antecedent basis,
Regarding claim 1, the phrase “said connecting convex portion” in line 17 should read “said at least one connecting convex portion” for proper antecedent basis,
Regarding claim 1, the phrase “said engaging groove” in lines 17-18 should read “said at least one engaging groove” for proper antecedent basis,
Regarding claim 2, the phrase “said output tube” in line 2 should read “said output pipe” for proper antecedent basis,
Regarding claim 2, the phrase “said first surface having a convex shape faces said connection port” in lines 2-3 should read “said first surface having a convex shape facing said connecting port” for proper grammar and antecedent basis,
Regarding claim 2, the phrase “said second surface faces” in line 3 should read “said second surface facing” for consistency,
Regarding claim 2, the phrase “said inner wall” in line 4 should read “said inner wall of said output pipe” for clarity,
Regarding claim 2, the phrase “said connection port” in line 5 should read “said connecting port” for proper antecedent basis,
Regarding claim 2, the phrase “the distance between said second surface and said inner wall are gradually increases from said connection port” in lines 5-6 should read “the distance between said second surface and said inner wall is gradually increased from said connecting port” for proper grammar and antecedent basis,
Regarding claim 6, the phrase “and communicated with” in line 13 should read “and communicates with” for proper grammar,
Regarding claim 6, the phrase “said material storage member is used for placing a proliferating agent or delivery material” in lines 14-15 should read “said material storage member is used for storing a proliferating agent or delivery material” for clarity,
Regarding claim 6, the phrase “thereby pushes” in line 16 should read “thereby pushing” for proper grammar,
Regarding claim 6, the phrase “said accommodation space” in line 17-18 should read “said accommodating space” for proper antecedent basis,
Regarding claim 6, the phrase “a control panel, has a display” in line 21 should read “a control panel comprising a display” for proper grammar,
Regarding claim 13, the phrase “said control key” in line 2 should read “said at least one control key” for proper antecedent basis,
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a dividing unit” in claim 1,
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “a dividing unit” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (unit), (ii) it is coupled with functional language (dividing), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 4 and para. 0050 disclose the dividing unit of the output pipe as conical-shaped, spindle-shaped, or olive-shaped object that divides the accommodating space of the output pipe into two connected spaces. Examiner is interpreting the limitations as this structure and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 9-13, and 15-18 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.
Claim 1 recites the limitation "the bottom end of said pressure accumulator" in lines 19-20. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the phrase “the bottom end of said pressure accumulator” in lines 19-20 renders the claim indefinite because it is unclear. Claim 1, line 2 recites “a pressure accumulator, one end of which is provided with an output portion”, and thus the limitation of lines 19-20 is unclear whether the bottom end of said pressure accumulator is an opposite end to the output portion, a bottom surface of the output portion end, a bottom surface of an opposite end to the output portion, or another structure. From Fig. 6, examiner is interpreting this limitation as the hand-holding device is fixed on the bottom surface of the pressure accumulator.
Regarding claim 3, the phrase “a pressure trimmer” in line 2 renders the claim indefinite because it is unclear. The scope of a pressure trimmer is unclear. Para. 0065 discloses “The pressure trimmer 47 is convenient for the user to adjust the input speed and/or the input quantity of the high- pressure gas A at any time, thereby improving the convenience and safety of the operation.” However, in Fig. 5, the system already comprises a solenoid valve 49, a pressure regulator 83, and in other embodiments a control panel 90; thus, it is unclear what structure would be interpreted as a pressure trimmer. Examiner is interpreting a pressure trimmer as any structure that adjusts the pressure by decreasing it.
Regarding claim 4, the phrase “a fixing hole corresponding to the position of said fixing groove” in line 3 renders the claim indefinite because it is unclear. It is unclear whether there is at least one fixing hole in the adapter tube to correspond with at least one fixing groove of the pressure accumulator, or if the fixing groove of the pressure accumulator is being limited to only one fixing groove that corresponds with a fixing hole of the adapter tube. Examiner is interpreting this limitation as the former and suggests amending to recite “said adapter tube is provided with at least one fixing hole corresponding to the position of said at least one fixing groove.” The remainder of the claim should be amended accordingly for proper antecedent basis.
Claim 6 recites the limitation "the top side of said pressure accumulator" in line 11 There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the bottom end of said pressure accumulator" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the phrase “the bottom end of said pressure accumulator” in line 2 renders the claim indefinite because it is unclear. Claim 6, lines 2-3 recites “said output portion is arranged at one end of said pressure accumulator”, and thus the limitation of claim 9 is unclear whether the bottom end of said pressure accumulator is an opposite end to the output portion, a bottom surface of the output portion end, a bottom surface of an opposite end to the output portion, or another structure. From Fig. 6, examiner is interpreting this limitation as the hand-holding device is fixed on the bottom surface of the pressure accumulator.
Claim 15 recites the limitation "the bottom end of said pressure accumulator" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, the phrase “the bottom end of said pressure accumulator” in line 2 renders the claim indefinite because it is unclear. Claim 12, line 2 recites “a pressure accumulator, one end of which is provided with an output portion, and thus the limitation of claim 15 is unclear whether the bottom end of said pressure accumulator is an opposite end to the output portion, a bottom surface of the output portion end, a bottom surface of an opposite end to the output portion, or another structure. From Fig. 6, examiner is interpreting this limitation as the hand-holding device is fixed on the bottom surface of the pressure accumulator.
Regarding claims 2, 5, 10-13, and 16-18, these claims are rejected due to their dependency upon a rejected base 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.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Menassa (U.S Patent Pub. No. 20120253272 A1) in view of Zhuang (CN Patent No. 111850049 A) in view of Pritz et al. (U.S Patent No. 3945379, “Pritz”).
Regarding claim 1, Menassa discloses the limitations of (Claim 1) a needle-free injection system (1 in Fig. 1-4, see Abstract), comprising:
a pressure accumulator (3 and 4 in Fig. 2, examiner notes a pressure accumulator is being interpreted as a structure that allows pressure to accumulate therein, see para. 0053-0054 – the combined structure of upper cylinder 3 and lower cylinder 4 form a structure that allows pressure from the compressed gas to accumulate therein), one end (distal end of 3 in Fig. 4) of which is provided with an output portion examiner notes the distal end is being interpreted as the end closest to the body of the patient, see Fig. 4 and para. 0054 – distal end of upper cylinder 3 forms an output portion oriented in the direction of the injected drug);
an output pipe (36 in Fig. 4), includes a connecting port (35 in Fig. 4 and para. 0042), an ejection port (104 in Fig. 4) and at least one connecting convex portion (external threads of 35, see Fig. 4 and para. 0048 and 0054 – front end 104 of output pipe 36 forms ejection port as the drug is ejected from this end, see para. 0042 – external threads on connecting port 35 form the at least one connecting convex portion as external threads are convex connections), wherein said connecting port (35 in Fig. 4) and said ejection port (104 in Fig. 4) are respectively located at two ends of said output pipe (36, see Fig. 4), and an accommodating space is formed between said connecting port (35 in Fig. 4) and said ejection port (104 in Fig. 4, see Fig. 4), said connecting convex portion (threads of 35 in Fig. 4) is located on the outer surface of said output pipe (36, see Fig. 4 and para. 0042), the outer surface of said output pipe (36 in Fig. 4) is provided with a charging hole (79 in Fig. 1, see Fig. 1 and 3 and para. 0045 – the outer surface of output pipe 36 comprises an inlet 79 forming a hole as a fluid inlet for the drug), which can be connected to said accommodating space (see Fig. 3-4 and para. 0045 and 0047);
an adapter tube (25 in Fig. 4), includes a first connecting end (24 in Fig. 4, see para. 0041), a second connecting end (distal end of 25 in Fig. 2) and at least one engaging groove (internal threads of 24 in Fig. 4, see para. 0042 – the internal threads of first connecting end 24 of adapter tube 25 are interpreted as the at least one engaging groove as the internal threads are formed by helical grooves), said first connecting end (24 in Fig. 2) and said second connecting end (distal end of 25 in Fig. 2) are respectively located at two ends of said adapter tube (25, see Fig. 2), said engaging groove (internal threads of 24 in Fig. 4) is located on said adapter tube (25, see Fig. 4 and para. 0042), said first connection end (24 in Fig. 2) can be sleeved on said output portion (distal end of 3) of said pressure accumulator (3, see Fig. 2 and para. 0041 – external threads 24 sleeve internally within the distal end of upper cylinder 3), said connection port (35 in Fig. 4) of said output pipe (36 in Fig. 4) can enter said adapter tube (25 in Fig. 4) from said second connection end (distal end of 25) and be connected to said output portion (distal end of 3) of said pressure accumulator (3, see Fig. 2 and para. 0041-0042 – connection port 35 of output pipe 26 enter through distal end of adapter 25 and is indirectly connected to the distal end of pressure accumulator 3 through the adapter tube 25), said connecting convex portion (external threads of 35 in Fig. 4) of said output pipe (36) can be engaged with said engaging groove (internal threads of 24) of said adapter tube (25, see Fig.2 and para. 0042);
and a hand-holding device (2 in Fig. 1-2, see para. 0038), fixed on the bottom end of said pressure accumulator (3 and 4, see Fig. 2 – handle 2 is fixed to the bottom surface of the lower cylinder 4), includes a shooting trigger (31 in Fig. 1-2) for controlling a high-pressure gas entering or leaving said pressure accumulator (3 and 4, see para. 0053 – trigger 31 controls the compressed gas entering upper cylinder 3 and lower cylinder 4).
However, Menassa fails to disclose the limitations of (Claim 1) a dividing unit is arranged in said accommodating space, and at least one neck channel is arranged inside said dividing unit or between said dividing unit and an inner wall of said output pipe; and a shooting button.
Zhuang discloses a needleless delivery device (10 in Fig. 1) using a gas to accelerate a solution for penetrating the skin (see para. 03), wherein the needleless delivery device (10) comprises an output pipe (11) defining an accommodating space (12, see Fig. 1 and para. 040). Zhuang teaches (Claim 1) a dividing unit (13 in Fig. 1) is arranged in said accommodating space (12 in Fig. 1, examiner notes a dividing unit is being interpreted under 112(f) as a conical-shaped, spindle-shaped, or olive-shaped object that divides the accommodating space of the output pipe into two connected spaces or equivalent structures thereof, see para. 040 and 044 – dividing unit 13 may be a cone, spun pendant or olive shaped object that divides the output pipe 11 into two connected spaces), and at least one neck channel (14 in Fig. 1-2) is arranged between said dividing unit (13) and an inner wall (112) of said output pipe (11, see Fig. 1-2 and para. 049).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the output pipe taught by Menassa to incorporate the dividing unit taught by Zhuang. Zhuang provides motivation for this modification as the dividing unit within the output pipe allows the gas to increase in velocity as it enters the constricted neck channel and allows the high-speed gas to inject the drug solution into the patient (see para. 025 and 051). In combination, a dividing unit would be incorporated into Menassa in the distal end of the chamber (66 in Fig. 2) of the output pipe (36) such that when plunger (53 in Fig. 2) is accelerated by the compressed gas to translate distally within chamber (66), the drug solution is further accelerated by the dividing unit at the distal end of the chamber (66, see Menassa Fig. 2 and para. 0043). Examiner notes the stroke of the plunger (53) is adjustable and limited by the shoulder (60 in Fig. 4) such that the dividing unit can be placed in the distal end of the chamber (66) without interfering with the stroke of the plunger (53, see para. 0043).
Pritz discloses a pressure operated injection device (see Fig. 1) comprising a button (20) triggering opening of a valve (10) to allow gas flow to the pressure accumulator (2, see Fig. 1 and Col.3, lines 7-29).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shooting trigger taught by modified Menassa to be substituted for a shooting button as taught by Pritz. The trigger (31) of Menassa is depressed which translates stem (152) and further translates stem (158) which opens rear valve (151) to allow gas flow into the injector (1, see para. 0053) is being substituted with the button (20) of Pritz which operates in a similar manner as the button (20) is depressed which translates stem (14) to open the valve (10) allowing gas flow into the injector (see Col.3, lines 7-29). Both a trigger and button actuators are known actuators in the art, and one of ordinary skill could have substituted one known actuator for another with the results of said substitution being predictable.
Regarding claim 2, modified Menassa discloses the needle-free injection system of claim 1, as discussed above. In modified Menassa, Zhuang discloses (Claim 2) wherein said dividing unit (13 in Fig. 1) of said output tube (11 in Fig. 1) has a first surface (132 in Fig. 1) and a second surface (134 in Fig. 1), said first surface (132) having a convex shape faces said connection port (111, see Fig. 1 and para. 042), and said second surface (134) faces said ejection port (113, see Fig. 1 and para. 042), the distance between said first surface (132) and said inner wall (112) is gradually reduced from said connection port (111) to said ejection port (113, see Fig. 1 and para. 043), the distance between said second surface (134) and said inner wall (112) are gradually increases from said connection port (111) to said ejection port (113, see Fig. 1 and para. 043).
Regarding claim 3, modified Menassa discloses the needle-free injection system of claim 1, as discussed above. In modified Menassa, Menassa discloses the limitations of (Claim 3) wherein said pressure accumulator (3 and 4) includes a pressure trimmer (178, examiner notes the pressure trimmer is being interpreted as any structure that adjusts the pressure by decreasing it, see para. 0055 – venting passageway 178 runs through the lower cylinder 4 as seen in Fig. 2 acts as a pressure trimmer as it adjusts the pressure of the chamber 176 by allowing the gas to vent out of the chamber 176 when a user releases the trigger 31), said pressure accumulator (3) can be connected to a fluid supply device (see para. 0053), said fluid supply device provides said high-pressure gas and leads said high-pressure gas into said pressure accumulator (3, see para. 0053).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Menassa in view of Zhuang in view of Pritz as applied to claim 1 above, and further in view of Bednarek et al. (U.S Patent Pub. No. 20060142694 A1, “Bednarek”) in view of Budyansky et al. (U.S Patent Pub. No. 20180147071 A1, “Budyansky”).
Regarding claim 4, modified Menassa discloses the needle-free injection system of claim 1, as discussed above.
However, Menassa fails to disclose (Claim 4) wherein said output portion of said pressure accumulator is provided with at least one fixing groove, said adapter tube is provided with a fixing hole corresponding to the position of said fixing groove, and a fixing member can pass through said fixing hole, so that said pressure accumulator is fixed on said adapter tube, said pressure accumulator is provided with a second locking hole adjacent to said output portion, said adapter tube is provided with a first locking hole corresponding to said second locking hole, and a locking piece can pass through said first locking hole and be fixed to said second locking hole.
Bednarek discloses a steerable catheter control handle comprising a dowel-pin for connecting two concentric tubular members (see Fig. 23 and para. 0064); however, the pinned connection between the two concentric tubular members would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of pinned connections between the adapter tube and pressure accumulator. Bednarek teaches (Claim 4) wherein said distal portion of said first tubular member (10 in Fig. 23) is provided with at least one fixing groove (22 in Fig. 23 and para. 0063), said second tubular member (16 in Fig. 23) is provided with a fixing hole (20 in Fig. 23) corresponding to the position of said fixing groove (22 in Fig. 23, see para. 0063), and a fixing member (18 in Fig. 23) can pass through said fixing hole (22, see Fig. 23 and para. 0063), so that said first tubular member (10) is fixed on said second tubular member (16, see para. 0063).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure accumulator and adapter tube taught by modified Menassa to incorporate a fixing groove, fixing hole, and fixing member as taught by Bednarek according to known methods to yield predictable results. Bednarek discloses a dowel pin for two concentric tubular members which is a known connection mechanism. One of ordinary skill in the art could have combined the dowel pin connection as claimed by known methods, and that in combination, the dowel pin connection would be incorporated into the adapter tube and pressure accumulator in addition to the threaded connection to ensure proper alignment between the two structures and prevent longitudinal movement. Thus, in combination the output portion (distal portion of 3) of the pressure accumulator (3) of modified Menassa would incorporate a fixing groove and the adapter tube (25) would incorporate a fixing hole corresponding to the position of the fixing groove and wherein a dowel pin may pass through the fixing hole.
However, modified Menassa fails to disclose (Claim 4) said pressure accumulator is provided with a second locking hole adjacent to said output portion, said adapter tube is provided with a first locking hole corresponding to said second locking hole, and a locking piece can pass through said first locking hole and be fixed to said second locking hole.
Examiner notes the invention of Budyansky is a connection between a shaft and suction cannister for use in bone harvesting (see para. 0002, 0004); however, the pressure-tight connection between the shaft and suction cannister would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of pressure-tight connections between the adapter tube and pressure accumulator. Budyansky teaches a pressure cannister is provided with one or more second locking holes adjacent its distal end and a tubular shaft is provided with one or more first locking holes corresponding to the one or more second locking holes, and cross pin can pass through each first locking hole and be fixed to said second locking hole (see Fig. 15a and para. 0101).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure accumulator and adapter tube taught by modified Menassa to incorporate an additional locking mechanism with a first locking hole, second locking hole, and locking piece as taught by Budyansky. Budyansky teaches that a pinned connection between a tubular member and a pressure cannister may consist of one or more cross pins to provide a sealed, permanent or temporary attachment (see para. 0101). Thus, in combination the output portion (distal portion of 3) of the pressure accumulator (3) of modified Menassa would further incorporate a first and second fixing hole, respectively, and a cross pin therethrough.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Menassa in view of Zhuang in view of Pritz as applied to claim 1 above, and further in view of McCabe (U.S Patent No. 5584807) in view of Edwards (U.S Patent Pub. No. 20170340424 A1).
Regarding claim 5, modified Menassa discloses the needle-free injection system of claim 1, as discussed above. In modified Menassa, Menassa discloses the limitations of (Claim 5) wherein said pressure accumulator (3 and 4) contains a valve (151, see para. 0053).
However, modified Menassa fails to disclose (Claim 5) wherein said pressure accumulator contains a solenoid valve, which is electrically connected to said shooting button and a power supply device, said pressure accumulator is connected to a control panel, which has a display and at least one control key.
McCabe discloses an automatic, gas-driven, gene delivery device (10 in Fig. 3), wherein McCabe teaches (Claim 5) wherein said pressure accumulator (34 in Fig. 3) contains a solenoid valve see Fig. 3 and Col.6, lines 40-45 – the pressure accumulator 34 is in the form of a solenoid valve where pressure is able to accumulate in its interior), which is electrically connected to said shooting button (30 in Fig. 3) and a power supply device (12 in Fig. 1, see Col.6, lines 33-34 and lines 40-56).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified valve and shooting button taught by modified Menassa to be a solenoid valve which is electrically connected to said shooting button and power supply device as taught by McCabe according to known methods to yield predictable results. McCabe discloses that an electrically-actuated solenoid piston valve operated by a valve trigger mechanism in the form of a button on the handle is a known valve and actuator mechanism, and that substituting any known valve and actuator mechanism would be recognized as obvious to one of ordinary skill in the art (see Col.6, lines 40-56). Further, examiner notes it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)).
Edwards discloses a hand-held drug delivery device (10 in Fig. 1) using a pressurized gas to drive the injection (see para. 0067), wherein Edwards teaches (Claim 5) said pressure accumulator (16 in Fig. 8) is connected to a control panel (38 in Fig. 1, see para. 0082 – drive section 16 comprises cylinder 100 which allows pressure accumulation, see para. 0103 and 0112 – display 38 connected to drive section 16 may be a touch screen adapted to receive user input), which has a display and at least one control key (see para. 0125-0126 – control panel 38 is in the form of a touch screen display which may be used as an input device where a user can select a medication type indicating at least one control key on the touch screen for user input).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menassa to incorporate a control panel connected to the pressure accumulator which has a display and at least one control key as taught by Edwards. Edwards teaches that a user interface comprising a display and user input touch screen allows for information to be displayed to a user such as text or images indicating the apparatus is operational and configured, and the selected or configured medication type (see para. 0109).
Claim(s) 6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (U.S Patent Pub. No. 20040180442 A1, “Lin”) in view of Zhuang in view of Lin et al. (U.S Patent No. 6436709 B1, “Lin 2”) in view of Edwards.
Regarding claim 6, Lin discloses the limitations of (Claim 6) a needle-free injection system (200 in Fig. 1-2, see para. 0034 – examiner notes system 200 is being interpreted as incorporating the biological material delivery device 108 of Fig. 1), comprising:
a pressure accumulator (202 and 206 in Fig. 2), comprising an output portion (distal portion of 202) and a power controller (224 in Fig. 2, examiner is interpreting a power controller as a structure able to control the power source, see para. 0034 – pressure accumulator 202 has a distal portion for output of the gas and a control valve 224 which controls the gas entry), said output portion (distal portion of 202) is arranged at one end of said pressure accumulator (see Fig. 2), said power controller (224) can control a power source to leave said pressure accumulator (202) from said output portion (distal portion of 202, see para. 0034 – control valve 224 controls gas entering and thus being output from the distal portion of the pressure accumulator 202);
an output pipe (204 in Fig. 2, see para. 0034), the two ends of said output pipe (204) are respectively a connection port (proximal end of 204) and an ejection port (distal end of 204, see Fig. 2 and para. 0034 – proximal end of output pipe 204 is connected to pressure accumulator 202 and distal end of output pipe 204 ejects the solution carried by the gas), an accommodating space is formed between said connection port (proximal end of 204) and said ejection port (distal end of 204, see Fig. 1 for exemplary output pipe showing the internal, accommodating space of the output pipe), said connection port (proximal end of 204) is connected to said output portion (distal end of 202) of said pressure accumulator (202, see Fig. 2), the outer surface of said output pipe (202) is provided with a charging hole that can communicate with said accommodating space (see Fig. 1 and para. 0031 – the incorporated material delivery system 108 indicates that the outer surface of output pipe 202 comprises a charging hole communicating with its internal space for the drug solution to enter);
a delivery device (108, in Fig. 1 and para. 0031), located at the top side of said pressure accumulator (202, see Fig. 1 – exemplary material delivery device 108 would be located at the top of said pressure accumulator 202), has a material storage member and a material delivery pipe (see para. 0031 – delivery device 108 comprises an inner cavity as the material storage member that holds the solution and comprises a channel that is connected to an outlet which is the material delivery pipe), said material delivery pipe is arranged at the front end of the material storage member and communicated with said charging hole of said output pipe (202, see Fig. 1 and para. 0031 – the channel and outlet pipe are on the bottom side of the interior cavity and communicate with the opening in the output pipe 202), said material storage member is used for placing a proliferating agent or a delivery material (see para. 0031 – the interior cavity is used for storing the sample drug solution);
a shooting button (226 in Fig. 2 and para. 0034 – trigger 226 is illustrated as button), connected to said power controller (224 in Fig. 2) of said pressure accumulator (202, see para. 0034 – trigger button 226 is electrically connected to valve 224);
a controller (see para. 0034 – system 200 is controlled by a controller that is not shown).
However, Lin fails to disclose the limitations (Claim 6) a dividing unit is arranged in said accommodating space; a delivery device has a driving device, said driving device can move forward and backward, thereby pushes said proliferating agent or said delivery material in said material storage member through said material delivery pipe and said charging hole into said accommodation space; and a control panel, has a display and at least one control key, said control panel is electrically connected to the delivery device.
Zhuang discloses a needleless delivery device (10 in Fig. 1) using a gas to accelerate a solution for penetrating the skin (see para. 03), wherein the needleless delivery device (10) comprises an output pipe (11) defining an accommodating space (12, see Fig. 1 and para. 040). Zhuang teaches (Claim 6) a dividing unit (13 in Fig. 1) is arranged in said accommodating space (12 in Fig. 1, examiner notes a dividing unit is being interpreted under 112(f) as a conical-shaped, spindle-shaped, or olive-shaped object that divides the accommodating space of the output pipe into two connected spaces or equivalent structures thereof, see para. 040 and 044 – dividing unit 13 may be a cone, spun pendant or olive shaped object that divides the output pipe 11 into two connected spaces).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the output pipe taught by Lin to incorporate the dividing unit taught by Zhuang. Zhuang provides motivation for this modification as the dividing unit within the output pipe allows the gas to increase in velocity as it enters the constricted neck channel and allows the high-speed gas to inject the drug solution into the patient (see para. 025 and 051).
Lin 2 discloses a gas-accelerated particle gene gun system (300 in Fig. 3) comprising a material delivery device (108 in Fig. 1, see Col.5, lines 1-21), wherein Lin 2 teaches (Claim 6) a delivery device (108 in Fig. 1-2, see Fig. 3 – delivery device 108 and 308 are of the same design with 308 being integrated into the system 300) has a driving device (111 in Fig. 2), said driving device (111 in Fig. 2) can move forward and backward (see Col.4, lines 20-25 and Col. 5, lines 9-20 – clutch 111 can moved forward and back to its initial position when an electrical current is sent thereto), thereby pushes said proliferating agent or said delivery material (115 in Fig. 2) in said material storage member (116 in Fig. 2) through said material delivery pipe (112 in Fig. 2, see Col.4, lines 17-34 and Col.5, lines 9-20 – when clutch 11 receives an electrical current it moves downward thus pushing the feeding tube 110 and thus the delivery material 1115 through said material delivery pipe 112 and out of the delivery device 108); and a controller (326 in Fig. 4), the controller (326) electrically connected to the delivery device (108, see Fig. 3 – delivery device 108 and 308 are of the same design with 308 being integrated into the system 300, Col.5, lines 9-20).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device taught by modified Lin to incorporate the driving device and be electrically connected to said controller as taught by Lin 2. Lin 2 teaches a similar delivery device including a more detailed explanation of the function of said delivery device which comprises an electromagnetic clutch for driving the particles into the gene gun, wherein the electromagnetic clutch allows for the release of the drug solution into the gene gun to be automated rather than manually with the control device sending a signal to the electromagnetic clutch after the trigger is pressed (see Col.5, lines 1-21).
Edwards discloses a hand-held drug delivery device (10 in Fig. 1) using a pressurized gas to drive the injection (see para. 0067), wherein Edwards teaches (Claim 6) a control panel (38 in Fig. 1, see para. 0082 – drive section 16 comprises cylinder 100 which allows pressure accumulation, see para. 0103 and 0112 – display 38 connected to drive section 16 may be a touch screen adapted to receive user input), has a display and at least one control key (see para. 0125-0126 – control panel 38 is in the form of a touch screen display which may be used as an input device where a user can select a medication type indicating at least one control key on the touch screen for user input).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller taught by modified Lin to be in the form of a control panel which has a display and at least one control key as taught by Edwards. Edwards teaches that a user interface comprising a display and user input touch screen allows for information to be displayed to a user such as text or images indicating the apparatus is operational and configured, and the selected or configured medication type (see para. 0109).
Regarding claim 9, modified Lin discloses the needle-free injection system of claim 6, as discussed above. In modified Lin, Lin discloses (Claim 9) wherein the bottom end of said pressure accumulator (202 and 206) is fixedly provided with a hand-holding device (230, see Fig. 2 and para. 0034), said shooting button (226) is arranged on said hand-holding device (230, see Fig. 2 and para. 0034).
Regarding claim 11, modified Lin discloses the needle-free injection system of claim 6, as discussed above. In modified Lin, Zhuang discloses (Claim 11) wherein said output pipe (11) is a jet engine type output pipe (examiner is interpreting a jet engine type output pipe to be an output pipe that structured to create fluid jets, see Fig. 1 and para. 043 and 074 – the portion of the output pipe 11 distal to the dividing unit 13 is referred to as a jet space 123 as the dividing unit 13 accelerates the fluid creating fluid jets).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Zhuang in view of Lin 2 in view of Edwards as applied to claim 6 above, and further in view of McCabe.
Regarding claim 10, modified Lin discloses the needle-free injection system of claim 6, as discussed above. In modified Lin, Lin discloses the limitations of (Claim 10) wherein said pressure accumulator (202 and 206) further comprises a pressure accumulating chamber (interior of 202 and 206, see Fig. 1 for exemplary drawing of the interior pressure accumulating cavity of the combined cylinder 202 and connector 206), said pressure accumulator (202 and 206) is connected to a power supply device (220 in Fig. 2, see para. 0034 – power supply device is gas tank 220), said power supply device (220) provides said power (see para. 0034), said power controller (224) is a valve (see para. 0034).
However, modified Lin fails to disclose (Claim 10) said power controller is located in said pressure accumulating chamber, said power controller is a solenoid valve.
McCabe discloses an automatic, gas-driven, gene delivery device (10 in Fig. 3), wherein McCabe teaches (Claim 10) said power controller is located in said pressure accumulating chamber (34, see Fig. 3 and Col.6, lines 40-45 – pressure accumulator 34 is in the form of a solenoid valve wherein the valve components are located within the interior chamber of the pressure accumulator 34 seen in Fig. 3), said power controller is a solenoid valve (see Col.6, lines 40-45).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve taught by modified Lin to be a solenoid valve located in said pressure accumulating chamber as taught by McCabe according to known methods to yield predictable results. McCabe discloses that an electrically-actuated solenoid piston valve operated by a valve trigger mechanism in the form of a button on the handle is a known valve and actuator mechanism, and that substituting any known valve and actuator mechanism would be recognized as obvious to one of ordinary skill in the art (see Col.6, lines 40-56). Further, examiner notes it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)).
Claim(s) 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Lin 2 in view of Edwards.
Regarding claim 12, Lin discloses the limitations of (Claim 12) a needle-free injection system (200 in Fig. 1-2, see para. 0034 – examiner notes system 200 is being interpreted as incorporating the biological material delivery device 108 of Fig. 1), comprising:
a pressure accumulator (202 and 206 in Fig. 2), one end of which is provided with an output portion (distal portion of 202, see Fig. 2, see para. 0034 – pressure accumulator 202 has a distal portion for output of the gas);
an output pipe (204 in Fig. 2, see para. 0034), the two ends of which are respectively are respectively a connection port (proximal end of 204) and an ejection port (distal end of 204, see Fig. 2 and para. 0034 – proximal end of output pipe 204 is connected to pressure accumulator 202 and distal end of output pipe 204 ejects the solution carried by the gas), an accommodating space is formed between said connection port (proximal end of 204) and said ejection port (distal end of 204, see Fig. 1 for exemplary output pipe showing the internal, accommodating space of the output pipe), said connection port (proximal end of 204) is connected to