DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “a rotary crank mechanism” in claim 1; the limitation “a rotation axis” in claim 5 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the limitation “rotary crank mechanism” should be defined to equivalent element in the drug delivery infusion set.
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 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.
In claim 1, the term “a rotary crank mechanism” is vague. It is unclear to Examiner that which element is referring to “a rotary crank mechanism”.
It appears to Examiner that the limitation “a rotary crank mechanism” is equivalent to a linking arm. However, in claim 3 further requires that a rotating a linking arm together with the rotary crank mechanism. In other words, the linking arm and the rotary crank mechanism are two separate components.
In para [0080] of the PGPub 2024/0100251 (equivalent to the current application), it states that: The pre-loaded torsion spring 181, when released by the button 161, performs both the insertion and retraction of the introducer needle 134. Torsion springs can store a large amount of energy within a small and flat profile. This is facilitated by the 360 degree rotation of the disc 171 driven by the torsion spring 181. The first 180 degree rotation of the disc 171 inserts the introducer needle 134, and the second 180 degree rotation of the disc retracts the introducer needle completely into the base 121...
Does Applicant mean that the limitation “a rotary crank mechanism” being referred to a disc 171?
According to the definition, “crank” defines a part of an axle or shaft bent out at right angles, for converting reciprocal to circular motion. Although the disc 171 is rotatable; however, the disc 171 shows as a plate, but not axle (rod) nor a shaft. The Examiner cannot determine which element is being equivalent to the claimed “rotary crank mechanism”. Therefore, Applicant is requested to point out the equivalent element being referred to the claimed “rotary crank mechanism”.
Having said the reasons above, Examiner cannot determine which element is being referred to the “rotary crank mechanism”.
Claims 2-6 are being rejected due to their dependency.
Claim 1 recites the limitation "the infusion set" in line 4. There is insufficient antecedent basis for this limitation in the claim. It should be changed to --- an infusion set ---.
In claim 5, the limitation: rotating a first member about a rotation axis and link a second member to the first member at a location offset from the rotation axis” is vague. The limitations, i.e., fist member, second member are generic term. In the drug delivery device, there are plurality of rotatable members, i.e., torsion spring 281/381, a linking arm 151/251/351/361, a disc 271, a drive gear 303, a slave gears304. The Fig. 2 shows that the torsion spring 181 is linking/connecting to the disc 171. Does Applicant mean that torsion spring and the disc being referred to a first member and second member? Or In Fig. 26, all the components, i.e., linking arms 351 & 361, torsion spring 381, gears 303 & 304 are rotatable and linking together. It appears to Examiner that these components have same rotation axis. Therefore, it is unclear to Examiner that which element is being referred to the first member, the second member; and the second member links to the first member at a location offset from the rotation axis, as recited in claim 5.
In claim 6, the limitation “linking the first member to the second member in a manner that permits relative rotation between the first member and the second member” is vague. Same question as mentioned in the claim 5 above, it is unclear to Examiner that which element is being rotated in between the first and second members?
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bikovsky (US 2008/0051730).
Regarding claim 1, Bikovsky discloses a method for inserting a flexible catheter/cannula 48, in Figs. 1-3 & 24-25 comprising:
Note: the term “catheter” and “cannula” are interchangeable and could be used in same manner as inserting into a patient. In addition, it is well-known in the art that the catheter/cannula can be made in flexible material.
disposing a medicine delivery device 12 on a skin surface at an injection site;
inserting an introducer needle 758 and the flexible catheter/cannula (para [0150]) through the skin surface upon activation of a torsion spring 756 disposed within an infusion set 712 (in Figs. 24-25) and coupled to the introducer needle 758 via a rotary crank mechanism 750;
retracting the inserted introducer needle 758 through the catheter (see similar Fig. 6 & para [0156] states that: the insertion device shown in Figs. 24-25 employed to insert a needle and cannula into a patient’s kin and withdrawn the needle, leaving the cannula in place) by continued movement of the spring 758 and the rotary crank mechanism 750 (see Fig. 24); and
storing the retracted introducer needle 758 substantially entirely within a body of the medicine delivery device, see Fig. 24.
Regarding claim 2, further comprising preloading the torsion spring, Fig. 24.
Regarding claim 3, further comprising rotating a linking arm 751 together with the rotary crank mechanism 750.
Regarding claim 4, further comprising pressing a button (a dome-shape button being attached to the cam member 750) to activate the torsion spring, para [0150]. In addition, Bikovsky states in para [0056] that: the disposable portion 20 may include a button or other operator 25 for operating a needle inserter device. It is noted that the needle inserter device 712 is a part of the disposable portion 20, also see paras [0154-0155].
Regarding claim 5, further comprising rotating a first member 751 about a rotation axis and linking a second member 746 and/or 748 to the first member 751 at a location offset from the rotation axis A5 (Fig. 24).
Regarding claim 6, as best as understood, further comprising linking the first member 751 to the second member 746 in a manner that permits relative rotation (e.g., the disc 750 being rotated) between the first member 751 and the second member 746.
Note: The Figs. 9-10 can be rejected over the claims 1-6 as well. For example: a needle 242, a cannula (similar a cannula 48 in Fig. 4, also see para [0105]), torsion spring
Claims 1-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chong et al. (US 2008/0269687) and incorporated with US Application No. 11/645,435 (equivalent to US 2008/0051730), see para [0132] in US’787.
Regarding claim 1, Chong discloses a method for inserting a flexible catheter, in Figs. 11-17, comprising:
Note: a needle inserter device 712 in Figs. 11-17 is incorporated or described with respect to Figs. 24-25 in US Application No. 11/645435 (equivalent to US 2008/0051730), see para [0127] in Chong’687.
disposing a medicine delivery device, i.e., infusion pump (in US 11/645,435; see paras [0127-0129] in Chong’687) on a skin surface at an injection site;
inserting an introducer needle 758 and the flexible catheter 759 through the skin surface upon activation of a torsion spring 754 disposed within the infusion set 712 and coupled to the introducer needle 758 via a rotary crank mechanism 750, see Fig. 15.
Note: it is well-known in the art that the cannula 359 can be made of flexible material and equivalent term to call as a flexible catheter.
retracting the inserted introducer needle 758 through the catheter 759 by continued movement of the spring 754 and the rotary crank mechanism 750, see Fig. 16 in Chong’787 and Fig. 24 in Bikovsky; and
storing the retracted introducer needle 758 substantially entirely within a body of the medicine delivery device, see Fig. 17 in Chong’787.
Regarding claim 2, further comprising preloading the torsion spring, Fig. 16 in Chong’687.
Regarding claim 3, further comprising rotating a linking arm 751 together with the rotary crank mechanism 750.
Regarding claim 4. The method for inserting a flexible catheter of claim 1, further comprising pressing a button (a dome-shape element of the cam member 750) to activate the torsion spring, see para [0153] in Bikovsky. Alternatively, Chong’687 further comprising pressing a button 744 (in Fig. 15) to activate the torsion spring.
Regarding claim 5, as best as understood, further comprising rotating a first member 751 about a rotation axis A5, see Fig. 24 in Bikovsky, and linking a second member 746 and/or 748 to the first member 751 at a location offset from the rotation axis, see Fig. 25 in Bikovsky.
Regarding claim 6, as best as understood, further comprising linking the first member 751 to the second member 746 in a manner that permits relative rotation (e.g., the disc 750 being rotated) between the first member 751 and the second member 746.
Examiner Notes
Applicant should be aware of this application contains multiple distinct species:
Figs. 1-8 2) Figs. 9-22 3) Figs. 23-35 4) Figs. 36-39
It appears to Examiner that the claims 1-4 can be read on all the species 1-4. Claims 5-6 involve 112, 1st & 2nd paragraph issues. The examiner cannot determine whether the claims 5-6 are best fitted in the above species. If the claims 5-6 (or other claims 1-4) are to be amended, then these claims 1-6 should be kept in the one of the species above. In the future, if the amendment contains more than one species, then applicant should be elected one of the species above. In other words, if the claims contain more than one species, then the Restriction/Election Requirement will be required in the next office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783