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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In lines 15-16 of claim 1, the limitation “wherein wherein” should read as “.
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.
Claims 1-20 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 imitation “the abutting plunger …the memory metal member contract … the reset elastic member ” in lines 5-12. It is unclear if referring to all plungers, all memory metal member and all reset elastic member in lines 5-6 it is referring to some of the these memory metal member. For the purpose of examination, the examiner will interpret that “each of the abutting plunger … each of the memory metal member is configured to contract … each of the reset elastic member ”.
Claim 9 recites the limitation "the medication output mechanism" in line 3. There is insufficient antecedent basis for this limitation in the claim.
In the last 10 lines of claim 10, “a memory metal member of the first valve mechanism … a memory metal member of the second valve mechanism… a memory metal member of the third valve mechanism…” it is unclear if it is referring to limitation of line 5-6 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation such as “the memory metal member of the first valve mechanism … the memory metal member of the second valve mechanism… the memory metal member of the third valve mechanism…”.
Claim 11 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the medication output mechanism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
In lines 2-8 lines of claim 18, “a memory metal member of the first valve mechanism … a memory metal member of the second valve mechanism… a memory metal member of the third valve mechanism…” it is unclear if it is referring to limitation of line 5-6 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation such as “the memory metal member of the first valve mechanism … the memory metal member of the second valve mechanism… the memory metal member of the third valve mechanism…”.
In lines 2-8 lines of claim 19, “a memory metal member of the first valve mechanism … a memory metal member of the second valve mechanism… a memory metal member of the third valve mechanism…” it is unclear if it is referring to limitation of line 5-6 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation such as “the memory metal member of the first valve mechanism … the memory metal member of the second valve mechanism… the memory metal member of the third valve mechanism…”.
In lines 3-8 lines of claim 20, “a memory metal member of the first valve mechanism … a memory metal member of the second valve mechanism… a memory metal member of the third valve mechanism…” it is unclear if it is referring to limitation of line 5-6 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation such as “the memory metal member of the first valve mechanism … the memory metal member of the second valve mechanism… the memory metal member of the third valve mechanism…”.
Claim Rejections - 35 USC § 103
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kiani et al. (US 20210236729 A1) (“Kiani”) in view of Rush et al. (US 20100114028A1) (“Rush”).
Re Claim 1, Kiani discloses a patch infusion pump (Fig. 1-14n, ¶0351, the pump is generally disclosed in Fig. 5b-1 and Fig, 14d and the plunger mechanism is disclosed in Fig, 14n) comprising: an infusion tube (4612, Fig. 14n) configured to deliver a liquid medication (¶0353); and an infusion assembly (Fig. 14n) comprising a plurality of valve mechanisms (4610) located at a side of the infusion tube (Fig. 14n) and arranged along a flow direction of the liquid medication with spacings (Fig. 14n), wherein each of the plurality of valve mechanisms comprises an abutting plunger (plunger head and rod 4610, ¶0353, Annotated a portion of Fig, 14n of Kiani), a memory metal member (muscle wire 4606), and a reset elastic member (spring 4608), wherein the abutting plunger is configured to abut against the infusion tube (Fig. 14n, ¶0353) to block a flow of the liquid medication in the infusion tube (¶0353), wherein wherein memory metal members of the plurality of valve mechanisms are energized and de-energized according to a preset sequence to enable deformation of the infusion tube (¶0353), the infusion tube is configured to, due to the deformation of the infusion tube (¶0353, suck the liquid medication from a liquid reservoir (¶0352-¶353) under a negative pressure in the infusion tube (¶0352,¶0353 as the tube is pressed and released, it will create a negative pressure that used to suck the fluid in the reservoir) and pump the liquid medication to a medication output mechanism (cannula) under the positive pressure in the infusion tube (as the plunger pushes the tube it will create a positive pressure towards the cannula) and further it disclose the memory metal member contracts and being energized and de-energized ( power on. Off, ¶0353) and drives the abutting plunger to move away from the infusion tube and the reset elastic member is configured to reset the abutting plunger (¶0353), but it fails to disclose that wherein the memory metal member contracts when being energized and drives the abutting plunger to move away from the infusion tube, and the reset elastic member is configured to reset the abutting plunger to a position for abutting against the infusion tube after the memory metal member is de-energized.
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Annotated a portion of Fig, 14n of Kiani
However, Rush discloses a plunger mechanism assembly (Fig. 1-2c) and wherein the memory metal member (215, ¶0035) contracts when being energized (with power, ¶0035) and drives the abutting plunger to move away from the infusion tube (202), and the reset elastic member (214) is configured to reset the abutting plunger (Fig. 2c) to a position for abutting against the infusion tube (¶0035) after the memory metal member is de-energized (no powered, ¶0035).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the memory metal member of Kiani so that the memory metal member contracts when being energized and drives the abutting plunger to move away from the infusion tube, and the reset elastic member is configured to reset the abutting plunger to a position for abutting against the infusion tube after the memory metal member is de-energized as taught by Rush for the purpose of using a programable generating power to control the plunger’s position (Rush, ¶0035).
Re Claim 2, Kiani discloses wherein the infusion assembly further comprises a base (Annotated a portion of Fig, 14n of Kiani), the base comprises a plurality of channel plates arranged with spacing (Annotated a portion of Fig, 14n of Kiani), a valve channel is formed between two adjacent channel plates (Annotated a portion of Fig, 14n of Kiani) of the plurality of channel plates (Annotated a portion of Fig, 14n of Kiani), and each abutting plunger is movably disposed in a respective valve channel (Annotated a portion of Fig, 14n of Kiani).
Re Claim 3, Kiani discloses wherein the base (Annotated a portion of Fig, 14n of Kiani) further comprises a channel baffle (Annotated a portion of Fig, 14n of Kiani), the channel baffle is disposed on one side of the plurality of channel plates (Annotated a portion of Fig, 14n of Kiani) and the infusion tube is located between the channel baffle (Annotated a portion of Fig, 14n of Kiani) and the plurality of channel plates (Annotated a portion of Fig, 14n of Kiani).
Re Claim 4, Kiani discloses wherein the base further comprises a limiting plate (Annotated a portion of Fig, 14n of Kiani), the limiting plate is disposed on the other side of the plurality of channel plates (Annotated a portion of Fig, 14n of Kiani), and a plurality of limiting holes (Annotated a portion of Fig, 14n of Kiani) are formed on the limiting plate; and each abutment valve comprises a valve abutting head ( top end of 4610) and a valve guide rod (rod portion with the channel) that are connected to each other, wherein the valve abutting head (Annotated a portion of Fig, 14n of Kiani) is configured to abut against the infusion tube (Annotated a portion of Fig, 14n of Kiani), and the valve guide rod penetrates through one limiting hole of the plurality of limiting holes (Annotated a portion of Fig, 14n of Kiani).
Re Claim 5, Kiani discloses wherein each abutting plunger further comprises a valve connecting seat (Annotated a portion of Fig, 14n of Kiani) connected between the valve abutting head and the valve guide rod (Fig, 14n); and the reset elastic member is a coil spring sleeved on the valve guide rod (Fig, 14n), one end of the coil spring abuts against the valve connecting seat, and the other end of the coil spring abuts against the limiting plate (Annotated a portion of Fig, 14n of Kiani).
Re Claim 6, Kiani discloses wherein the infusion assembly further comprises an infusion cover plate (cover plate 920 on Fig. 14d) fixedly disposed on the base (Fig. 14d); and the memory metal member comprises a positive electrode elastic sheet (upper end of 4608, ¶0353, ¶0019 as it is connected with direct current power), a memory metal wire (4608), and a negative electrode elastic sheet (lower end of 4608) that are connected successively, one of the positive electrode elastic sheet and the negative electrode elastic sheet is connected to the abutting plunger (Fig. 14n), and the other of the positive electrode elastic sheet and the negative electrode elastic sheet is connected to the infusion cover plate ( lower end connected indirectly to the cover of 4601).
Re Claim 7, the embodiment of Fig, 14n of Kiani fails to disclose wherein the infusion assembly further comprises a guide post provided with limiting guide slots along a circumferential direction of the guide post; and wherein the infusion cover plate is located above the abutting plunger along a direction facing away from the base, the guide post is disposed at a same a side of the limiting plate, and the memory metal wire is disposed around the guide post and is positioned in a respective one of the limiting guide slots.
However, the embodiment of Fig, 14P of Kiani discloses wherein the infusion assembly further comprises a guide post provided with limiting guide slots (Annotated Fig, 14p of Kiani) along a circumferential direction of the guide post (Annotated Fig, 14p of Kiani); and wherein the infusion cover plate (4624) is located above the abutting plunger along a direction facing away from the base (right side of 4646), the guide post is disposed at a same side of the limiting plate (Annotated Fig, 14p of Kiani), and the memory metal wire (4624) is disposed around the guide post (Annotated Fig, 14p of Kiani) and is positioned in a respective one of the limiting guide slots (Annotated Fig, 14p of Kiani).
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Annotated Fig, 14p of Kiani
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the embodiment Fig. 14n of Kiani to include a guide post so that a guide post provided with limiting guide slots along a circumferential direction of the guide post; and wherein the infusion cover plate is located above the abutting plunger along a direction facing away from the base, the guide post is disposed at a same side of the limiting plate, and the memory metal wire is disposed around the guide post and is positioned in a respective one of the limiting guide slots as taught by the embodiment Fig. 14p of Kiani for the purpose of connecting memory metal with plunger in an art recognizable method of connecting (Kiani, ¶0354).
Re Claim 8, Kiani discloses wherein the infusion assembly further comprises a ground elastic sheet (2614, Fig. 5b-1), the patch infusion pump further comprises a circuit board (2604, ¶0277), the positive electrode elastic sheet (positive electrode connected to the positive of battery) is electrically connected to the circuit board (Fig. 5b-1), and the negative electrode elastic sheet (negative electrode connected to the negative of battery) is electrically connected to the circuit board (Fig. 5b-1) through the ground elastic sheet (¶0277).
Re Claim 9, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 10, Kiani discloses an infusion method, being applied in the patch infusion pump of any one of claim 1 (see the rejection of claim 1) comprising: performing, by the infusion assembly, one infusion operation according to the following sequence: a memory metal member (4608) of the first valve mechanism (Fig. 14n, first 4601) is energized, a memory metal member (¶0353) of the second valve mechanism (Fig, 14n, second 4601) is energized, the memory metal member of the first valve mechanism is de- energized (¶0353), a memory metal member of the third valve mechanism ( a third 4601) is energized, the memory metal member (¶0353) of the second valve mechanism is de- energized (¶0353, and the memory metal member of the third valve mechanism is de- energized (¶0353), wherein the plurality of valve mechanisms comprise the first valve mechanism, the second valve mechanism, and the third valve mechanism along the flow direction of the liquid medication in the infusion tube (¶0353).
Re Claim 11, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 12, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 13, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 14, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 15, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 16, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 17, Kiani discloses a housing (Fig.14d), the liquid reservoir (904), a power supply mechanism (¶0015), and the medication output mechanism (cannula, ¶0166), wherein a mounting cavity is formed in the housing (Fig.14d), the infusion assembly, the liquid reservoir (), and the power supply mechanism are all disposed in the mounting cavity (Fig.14d), a liquid inlet end of the infusion tube ( upper end of 4612, Fig. 14n)) communicates with the liquid reservoir (¶0353), a liquid outlet end of the infusion tube (lower end of 4612, Fig. 14b) communicates with the medication output mechanism (¶0353), and the power supply mechanism is configured to supply power to the patch infusion pump (¶0353).
Re Claim 18, Kiani discloses an infusion method, being applied in the patch infusion pump of any one of claim 2 (see the rejection of claim 2) comprising: performing, by the infusion assembly, one infusion operation according to the following sequence: a memory metal member (4608) of the first valve mechanism (Fig. 14n, first 4601) is energized, a memory metal member (¶0353) of the second valve mechanism (Fig, 14n, second 4601) is energized, the memory metal member of the first valve mechanism is de- energized (¶0353), a memory metal member of the third valve mechanism ( a third 4601) is energized, the memory metal member (¶0353) of the second valve mechanism is de- energized (¶0353, and the memory metal member of the third valve mechanism is de- energized (¶0353), wherein the plurality of valve mechanisms comprise the first valve mechanism, the second valve mechanism, and the third valve mechanism along the flow direction of the liquid medication in the infusion tube (¶0353).
Re Claim 19, Kiani discloses an infusion method, being applied in the patch infusion pump of any one of claim 3 (see the rejection of claim 3) comprising: performing, by the infusion assembly, one infusion operation according to the following sequence: a memory metal member (4608) of the first valve mechanism (Fig. 14n, first 4601) is energized, a memory metal member (¶0353) of the second valve mechanism (Fig, 14n, second 4601) is energized, the memory metal member of the first valve mechanism is de- energized (¶0353), a memory metal member of the third valve mechanism ( a third 4601) is energized, the memory metal member (¶0353) of the second valve mechanism is de- energized (¶0353, and the memory metal member of the third valve mechanism is de- energized (¶0353), wherein the plurality of valve mechanisms comprise the first valve mechanism, the second valve mechanism, and the third valve mechanism along the flow direction of the liquid medication in the infusion tube (¶0353).
Re Claim 20, Kiani discloses an infusion method, being applied in the patch infusion pump of any one of claim 4 (see the rejection of claim 4) comprising: performing, by the infusion assembly, one infusion operation according to the following sequence: a memory metal member (4608) of the first valve mechanism (Fig. 14n, first 4601) is energized, a memory metal member (¶0353) of the second valve mechanism (Fig, 14n, second 4601) is energized, the memory metal member of the first valve mechanism is de- energized (¶0353), a memory metal member of the third valve mechanism ( a third 4601) is energized, the memory metal member (¶0353) of the second valve mechanism is de- energized (¶0353, and the memory metal member of the third valve mechanism is de- energized (¶0353), wherein the plurality of valve mechanisms comprise the first valve mechanism, the second valve mechanism, and the third valve mechanism along the flow direction of the liquid medication in the infusion tube (¶0353).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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