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 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 1-7, 11, 14, and 15 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.
Amended claim 1 recites “wherein the auxiliary resilient component is used to release the base, therefore under an action of a resilient force of the elastic member, the base returns to the intermediate position or the initial position form the working position.” As claimed, it appears as though the limitation of the base returning to the intermediate or initial position under the action of the elastic member from the working position is a result of the auxiliary resilient component releasing the base. However, the auxiliary resilient component cannot be attached to the device in the working position and the fastening component is already used to fastening the base at the intermediate or initial position, so there is no reason to “release” the base back to the same intermediate or initial position, i.e., the base can only be in the initial or intermediate position via the fastening component/auxiliary resilient component, why would it be “released” again into the initial or intermediate position. It is noted that such an interpretation appears to be argued in the latest remarks by Applicant. For the purpose of examination, it will be assumed that the “therefore” limitation is strictly related to the limitation pertaining to the elastic member and not a direct result of the action of the auxiliary resilient component being used to release the base. Examiner suggests moving the “therefore” limitation to follow the limitations of the elastic member for further clarification.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over CN 106110445 to Yang,
(“Yang1”), in view of U.S. Patent Publication No. 2019/0117881 to Yang, (“Yang2”), and U.S. Patent Publication No. 2003/0199825 to Flaherty.
Regarding claim 1, Yang1 teaches a patch-type drug infusion device (Fig. 11b) comprising an
infusion unit (Fig. 2) comprising a drug storage unit (6) provided with an opening (61) for drug flowing,
a housing (1), where the infusion unit is provided, comprising a cavity (10, Fig. 7a) providing with a first
opening (left end of 10, Fig. 7a) and a second opening (upright portion 10), wherein the second opening
is surrounded by an elastic seal (103), an infusion tube structure (Figs. 8a-8b), which comprises a base
(2) and an infusion needle (52) fixedly arranged on the base, and the base comprises an initial position
(Fig. 8b), a working position (Fig. 8c), and an intermediate position set between the initial position and
the working position ([0057], lines 424+, the “slightly downward” position of the base 2 when top shell
81 is pressed), wherein the base comprises a guide post (22, Fig. 8c), when the base is at the initial
position, the base is fastened to the housing at a first position (Fig. 8b) along the guide post, when the base is at the intermediate position, the base is fastened to the housing at a second position (“slightly downward” position of the base as previously defined) along the guide post, and when the base is at the working position, the base is fastened to the housing at a third position (Fig. 8c) of the base, an elastic member (42) arranged on the base or the housing, and when the base is in the working position, the elastic member is compressed (Fig. 7b), a fastening component (8, Fig. 11a), which comprises a first fastener (8/82/83) and an auxiliary resilient component (81), wherein the first fastener is used to fasten the base to the housing at the first position (Fig. 11b), wherein the auxiliary resilient component is used to release the base (81 can be used to release 8), therefore under an action of a resilient force of the elastic member, the base returns to the intermediate position or the initial position from the working position ([0052]), and a second fastener (3) is provided on the housing, after sliding the fastening component backward to release the base, the second fastener fastens the base at the third position (once 8 is removed, button 3 locks the base in the working position), the infusion needle comprising a front end (51) and a subcutaneous end (52), both the front end and the subcutaneous end extend out of the base (Fig. 8a), wherein when the base is at the initial position, the front end is not communicated with the second opening (Fig. 8b), when the base reaches the working position, the front end pierces the elastic seal to communicate with the second opening, and the drug, along the cavity, flows from the drug storage unit to the subcutaneous end, to exhaust air in the cavity of the infusion needle ([0057], lines 427-430), but does not teach the details of the infusion unit.
Yang2 teaches an infusion unit (Fig. 3) comprising a screw (7) connected to a piston (9) and a
driving wheel (4) provided with wheel teeth, respectively, the driving wheel drives the screw to move by
rotation to push the piston in the drug storage unit to move forward ([0091]), a driving unit (2)
cooperated with the driving wheel, the driving unit comprises at least two driving portions (limbs of
swinging part 2), the driving unit pivots around a pivot shaft (circle in middle of 2 in Fig. 1) to drive
different driving portions of the at least two driving portions in different directions, thus pushing the
wheel teeth located on different driving wheel respectively, and rotating the driving wheel ([0091]-
[0092]), and a power unit (10 & 6) connected to the driving unit, outputs two forces in two directions on
the driving unit to make the driving unit pivot in two directions around the pivot shaft ([0091]-[0092]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the
claimed invention to have modified to Yang1 to have substituted the infusion unit of Yang1 with the
infusion unit of Yang2 because both infusion units are considered art-recognized alternative infusion
units that yield the predictable result of providing fluid for infusion into the body of a patient without
any unexpected results.
Additionally, the infusion of unit of Yang2 uses a single shape-memory wire with a spring to provide the reciprocating motion as the power unit instead of utilizing 2 separate shape-memory wires without a spring. Flaherty teaches a first alternative power unit embodiment using a single shape-memory wire (268, Figs. 10-12) with a spring (270) and a second alternative power unit using two separate shape-memory wires (290/268, Figs. 13-15), both embodiments being used to provide the identical type of reciprocating motion in the power unit of an infusion unit. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the power unit of Yang2 with the power unit of Flaherty because both power units are considered art-recognized alternative power units that yield the predictable result of providing reciprocating motion to power an infusion unit, absent any unexpected results. Once combined, the device of Yang1, Yang2, and Flaherty teach a bilateral-driven patch-type drug infusion device.
Regarding claim 2, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug infusion device of claim 1 as shown above, Yang2 further teaching the driving wheel comprising at least
two sub-wheels (4, Fig. 3).
Regarding claim 3, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug infusion device of claim 2 as shown above, Yang2 further teaching the driving wheel comprising two sub-
wheels, and the pivot shaft (circle in middle of 2, Fig. 3) is disposed between the two sub-wheels (Fig. 3),
one or more of the driving portions are provided on both sides of the driving unit (Fig. 3), and each sub-
wheel is cooperated with each driving portion (Fig. 3).
Regarding claim 4, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug
infusion device of claim 3 as shown above, Yang2 further teaching two driving portions (limbs of swinging part 2) are respectively provided on both sides of the driving unit (2, Fig. 3), and the two
driving portions on one side of the driving unit are disposed up and down or left and right (left and right
in Fig. 3, depending on point of view).
Regarding claim 5, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug infusion device of claim 1, Flaherty further teaching the power unit comprising an electric-heated linear
actuator or an electric- driven linear actuator ([0058]).
Regarding claim 6, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug
infusion device of claim 1, Yang2 further teaching the driving unit having a variety of different pivot
amplitudes or pivot rates, and the infusion unit have a variety of different infusion increments or
infusion rates ([0031]).
Regarding claim 7, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug
infusion device of claim 1, Yang1 further teaching the type of the first fastener comprising a block or slot
(Fig. 11a, any rectangular portion is considered a “block” and there appear to be slots as well).
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yang1, Yang2,
and Flaherty as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2011/0306929 to Levesque et al. (“Levesque”).
Regarding claim 11, Yang1, Yang2, and Flaherty teach the bilateral-driven patch-type drug
infusion device of claim 1 as shown above, Yang1 further teaching the elastic member being a spring
(42) arranged on the housing but do not teach the claimed position of the spring relative to the
guidepost.
Levesque teaches a part of a guide post (280a, Fig. 2 & Figs. 5A-5B) is located in a hollow cavity
of a spring (284), where the guidepost is part of an analogous base (280) having an infusion needle
(212). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed
invention to have modified the spring of Yang1 to be positioned on the guidepost as taught by Levesque
to yield the predictable result of providing a biasing force to withdraw an infusion needle after
medicament has been delivered. Both Yang1 and Levesque use U-shaped infusion needles having one
end that pierces a septum to receive medicament and another end that enters the patient skin, and
both references use a spring to provide withdrawal of the needle from the patient, the position of the
spring on the guidepost would be considered an art-recognized alternative spring position to accomplish
the same result.
Regarding claim 15, Yang1, Yang2, Flaherty, and Levesque teach the bilateral-driven patch-type
drug infusion device of claim 1 as shown above, Yang 1 further teaching the fastening component comprising at least one fastening arm (83), and the first fastener (8) is provided on the fastening arm.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yang1, Yang2, and
Flaherty as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2020/0147312 to Gregory et al. (“Gregory”).
Regarding claim 14, Yang1, Yang2, Flaherty, and Levesque teach the bilateral-driven patch-type
drug infusion device of claim 1, Yang1 further teaching a sliding block (83) is provided on the fastening
component, but do not teach the groove.
Gregory teaches a sliding block (44, Fig. 6) provided on a fastening component (42) while a
housing (Fig. 2) is provided with a groove (46), the sliding block is arranged in the groove, and the sliding
block can slide along the groove. It would be obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified the fastening component and housing of
Yang1 to have a tab/groove configuration as taught by Gregory, in order to provide at least temporary
coupling between two components until intentionally released by the user ([0045]). Once modified, the
fastening component would fasten or release the base.
Response to Arguments
Applicant’s arguments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn. However, new 112 rejections have been issued in response to new amendments as shown above.
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Yang1, Yang2, and Flaherty in response to Applicant’s new amendments.
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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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783