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
Applicant’s election without traverse of Groups A4, B5, C1, and D1 in the reply filed on 10/17/2025 is acknowledged.
Currently, no claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as all the claims appear to be drawn to the elected species. Election was made without traverse in the reply filed on 10/17/2025.
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 two openings in the needle hub in claims 5, 15, and 21, and the button housing in claim 17 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.
The drawings are objected to because of the following informalities:
In Fig. 5, reference numeral 204 does not appear to point to a “metal wedge” as set forth in the original specification in paragraph [0076].
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 disclosure is objected to because of the following informalities:
Paragraph [0079] recites references numerals such as 402, 404, 412, and 414 which are not present in any of figures 1, 34, or 35. Clarification is required.
Examiner notes that it appears that several extraneous paragraphs appear to be present in the current specification. Applicant is suggested to review the current specification and make the appropriate adjustments, especially in reference to Figs. 34+.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities:
In line 1, “forming the the” should be changed to “forming the.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 15, and 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 5, 15, and 21 recite “the needle hub comprises two openings through which the button may move,” however such a limitation is not described in the original specification and is considered new matter. For examination purposes, a single opening will be assumed.
Claim 17 recites “a button housing comprising at least one release window,” however such a limitation is not described in the original specification and is considered new matter. For examination purposes, a “housing” will be assumed.
Claim 18-21 are rejected under 35 U.S.C. 112(a) by virtue of being dependent on a rejected base claim.
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 1-10, 12, 13, and 17-21 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, lines 10-11, recites “engaging the catheter hub to the needle hub the compressed state.” The phrase appears to be missing language, in any case, it is unclear how the compressed state is related to the engagement of the catheter hub to the needle hub. For examination purposes and until the language is corrected, the term “the compressed state” will not be considered.
The term “substantially” in claims 2, 12, and 18 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the degree to which the needle hub surrounds the button and the housing cannot be ascertained with certainty. The term will be interpreted given the broadest reasonable interpretation.
Claim 13 recites “forming at least one opening,” However, it unclear where the opening is being formed.
Claim 17 recites “a button slidable within the housing.” However, assuming a “button housing,” it is unclear how the button may slide within itself.
Claims 3-10 and 19-21 are rejected under 35 U.S.C. 112(a) by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 10-12, 14, 17, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2017/0021137 to Cole.
Regarding claim 1, Cole teaches an insertion mechanism comprising a housing (106) comprising at least one release window (112) at a distal portion of the housing, a flexible firing arm (230), a button (200) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 8), a catheter hub (Fig. 7, portion above 220) fixed to a catheter, a needle hub (206) fixed to an insertion needle (204), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (212) being larger than an inside of the housing in a relaxed state (Fig. 12) and being compressed within the inside of the housing and engaging the catheter hub to the needle hub the
Regarding claim 2, Cole teaches the insertion mechanism of claim 1 as shown above, Cole further teaching the needle hub substantially surrounds the button (206 surrounds at least a portion of 200, see Figs. 3 and 5) and the housing (206/210 surrounds a portion of the upstanding portion of the housing to the left of 210 in Figs. 11, 13, and 14).
Regarding claim 4, Cole teaches the insertion mechanism of claim 1 as shown above, Cole further teaching the housing comprises two firing arms on opposite sides of the housing (230 are disposed in both instances of 214, Fig. 3).
Regarding claim 10, Cole teaches the insertion mechanism of claim 1 as shown above, Cole further teaching when the engagement and release clip is in the relaxed state and aligned with the release window the engagement and release clip prevents the catheter hub from moving in a proximal direction (Fig. 12).
Regarding claim 11, Cole teaches a method of inserting a catheter comprising the steps of providing a housing (106) comprising at least one release window (112) at a distal portion of the housing, providing a button (200) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 8), fixing a catheter hub (Fig. 7, portion above 220) to a catheter (Fig. 7), fixing a needle hub (206) to an insertion needle (204), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), inserting an engagement and release clip into inside of the housing in a compressed state (Fig. 7), engaging the catheter hub to the needle hub with the engagement and release clip in the compressed state (Fig. 7), providing a return spring (202) to bias the needle hub in the proximal direction (Fig. 13), the return spring being compressed as the button moves distally (Fig. 11), providing a firing arm (230) that interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0062]), permitting the engagement and release clip to expand toward its relaxed configuration when the button is pressed distally (Fig. 10) and the release and engagement clip becomes aligned with the release window (Fig. 12), and moving the needle hub to a final proximal position with the return spring when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 13).
Regarding claim 12, Cole teaches the method of inserting a catheter of claim 11 as shown above, Cole further teaching substantially surrounding the housing (206/210 surrounds a portion of the upstanding portion of the housing to the left of 210 in Figs. 11, 13, and 14) and the button (206 surrounds at least a portion of 200, see Figs. 3 and 5) with the needle hub.
Regarding claim 14, Cole teaches the method of inserting a catheter of claim 11 as shown above, further comprising forming two firing arms on opposite sides of the housing (230 are disposed in both instances of 214, Fig. 3).
Regarding claim 17, Cole teaches a medicament infusion device comprising: a device housing comprising a medicament reservoir connected to a catheter; a button housing comprising at least one release window at a distal portion of the housing; a flexible firing arm; a button slidable within the housing from an initial proximal position to an inserted distal position; a catheter hub fixed to the catheter; a needle hub fixed to an insertion needle, the insertion needle being inserted into the catheter in an initial configuration; an engagement and release clip being larger than an inside of the housing in a relaxed stated and being compressed within the inside of the housing and engaging the catheter hub to the needle hub the compressed state; a return spring biasing the needle hub in the proximal direction and being compressed as the button moves distally; wherein the firing arm interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button; wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window; and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub.
Regarding claim 18, Cole teaches the medicament infusion device of claim 17 as shown above, Cole further teaching the needle hub substantially surrounds the button (206 surrounds at least a portion of 200, see Figs. 3 and 5) and the housing (206/210 surrounds a portion of the upstanding portion of the housing to the left of 210 in Figs. 11, 13, and 14).
Regarding claim 20, Cole teaches the medicament infusion device of claim 17, Cole further teaching the housing comprises two firing arms on opposite sides of the housing (230 are disposed in both instances of 214, Fig. 3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-8, 10, 11, 13-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2017/0119959 to Cole et al. (“Cole2”) in view of U.S. Patent Publication No. 2017/0290533 to Antonio et al. (“Antonio”).
Regarding claim 1, Cole2 teaches an insertion mechanism (Figs. 7-11) comprising a housing (12/14/100) comprising at least one release window (110) at a distal portion of the housing, a firing mechanism (84/76), a button (26) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 10), a catheter hub (52) fixed to a catheter (28), a needle hub (94) fixed to an insertion needle (at 89), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (105) being larger than an inside of the housing (outer portion of 105 is larger than an innermost portion of 100) in a relaxed stated and being compressed within the inside of the housing (105 is compressed when passed across 100) and engaging the catheter hub to the needle hub (36 keeps 56 and 94 together) mechanism interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0054]), wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 10), and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 11), but does not show an arm-type firing mechanism.
Antonio teaches a firing mechanism using a flexible firing arm (5142, [0425]). 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 detent-type firing mechanism of Cole2 with the arm-type firing mechanism of Antonio to yield the predictable result of providing releasable firing mechanism in a needle insertion device. Both firing mechanisms providing the same function and merely being art-recognized alternatives.
Regarding claim 3, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching the needle hub comprises at least one opening (opening formed by 94) through which the button may move.
Regarding claim 4, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Antonio further teaching a housing comprises two firing arms (5142 “A”, Fig. 52A) on opposite sides of the housing.
Regarding claim 5, Cole2 and Antonio teach the insertion mechanism of claim 3 as shown above, Cole2 further teaching the needle hub comprises an opening (opening formed by 94, see 112 rejection above for interpretation) through which the button may move.
Regarding claim 6, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching the engagement and release clip comprises two arms joined by a connecting member (100, [0052]).
Regarding claim 7, Cole2 and Antonio teach the insertion mechanism of claim 6 as shown above, Cole2 further teaching the connecting member comprises an opening that receives the insertion needle and the catheter (Fig. 7).
Regarding claim 8, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching a septum (62) and wedge (56) connected to the catheter, the insertion needle piercing the septum (Fig. 7).
Regarding claim 10, Cole2 and Antonio teach the insertion mechanism of claim 1 as shown above, Cole2 further teaching when the engagement and release clip (105) is in the relaxed state and aligned with the release window the engagement and release clip prevents the catheter hub from moving in a proximal direction (Fig. 10).
Regarding claim 11, Cole2 teaches a method of inserting a catheter comprising the steps of providing a housing (12/14/100) comprising at least one release window (110) at a distal portion of the housing, providing a button (26) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 10), fixing a catheter hub to a catheter (Fig. 7), fixing a needle hub to an insertion needle (Fig. 7), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), inserting an engagement and release clip into inside of the housing in a compressed state (105 is compressed when passed across 100), engaging the catheter hub to the needle hub with the engagement and release clip in the compressed state (36 keeps 56 and 94 together in Fig. 7), providing a return spring (106) to bias the needle hub in the proximal direction, the return spring being compressed as the button moves distally (Figs. 7-9), providing a firing mechanism that interferes with movement of the button in a distal direction until a predetermined force is applied to the button (84/76), permitting the engagement and release clip to expand toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 10), and moving the needle hub to a final proximal position with the return spring when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 11), but does not teach an arm-type firing mechanism.
Antonio teaches a firing mechanism using a flexible firing arm that flexes to release a button (5142, [0425]). 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 detent-type firing method of Cole2 with the arm-type firing method of Antonio to yield the predictable result of providing releasable firing mechanism in a needle insertion device. Both firing methods providing the same function and merely being art-recognized alternatives.
Regarding claim 13, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Cole2 further teaching the step of forming at least one opening (opening formed by 94) through which the button may move.
Regarding claim 14, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Antonio further teaching forming two firing arms (5142 “A”, Fig. 52A) on opposite sides of the housing.
Regarding claim 15, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Cole2 further teaching the step of forming an opening (opening formed by 94, see 112 rejection above for interpretation) through which the button may move in the needle hub.
Regarding claim 16, Cole2 and Antonio teach the method of inserting a catheter of claim 11 as shown above, Cole2 further teaching forming the
Regarding claim 17, Cole2 teaches medicament infusion device (Fig. 1) comprising a device housing (2) comprising a medicament reservoir (4) connected to a catheter (28), a mechanism (84/76), a button (26) slidable within the housing from an initial proximal position (Fig. 7) to an inserted distal position (Fig. 10), a catheter hub (52) fixed to the catheter, a needle hub (94) fixed to an insertion needle (at 89), the insertion needle being inserted into the catheter in an initial configuration (Fig. 7), an engagement and release clip (105) being larger than an inside of the housing (outer portion of 105 is larger than an innermost portion of 100) in a relaxed stated and being compressed within the inside of the housing (105 is compressed when passed across 100) and engaging the catheter hub to the needle hub (36 keeps 56 and 94 together) firing mechanism interferes with movement of the button in a distal direction until a predetermined force is applied to the button, causing the firing arm to flex and release the button ([0054]), wherein the engagement and release clip expands toward its relaxed configuration when the button is pressed distally and the release and engagement clip becomes aligned with the release window (Fig. 10), and wherein the return spring moves the needle hub to a final proximal position when the engagement and release clip expands and thereby releases the needle hub from the catheter hub (Fig. 11), but does not show an arm-type firing mechanism.
Antonio teaches a firing mechanism using a flexible firing arm (5142, [0425]). 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 detent-type firing mechanism of Cole2 with the arm-type firing mechanism of Antonio to yield the predictable result of providing releasable firing mechanism in a needle insertion device. Both firing mechanisms providing the same function and merely being art-recognized alternatives.
Regarding claim 19, Cole2 and Antonio teach the medicament infusion device of claim 17 as shown above, Cole2 further teaching the needle hub comprises at least one opening (opening formed by 94) through which the button may move.
Regarding claim 20, Cole2 and Antonio teach the medicament infusion device of claim 17 as shown above, Antonio further teaching the housing comprises two firing arms (5142 “A”, Fig. 52A) on opposite sides of the housing.
Regarding claim 21, Cole2 and Antonio teach the medicament infusion device of claim 19 as shown above, Cole2 further teaching the needle hub comprises an opening (opening formed by 94, see 112 rejection above for interpretation) through which the button may move.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cole2 and Antonio as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2018/0050155 to Avery et al. (“Avery”).
Regarding claim 9, Cole2 and Antonio teach the insertion mechanism of claim 1 as show above, but do not teach the translucent button.
Avery teaches a button comprising a translucent button face (70, [0165]). 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 button of Cole2 to be transparent as taught by Avery to yield the predictable result of allowing the user to see components beneath the button for confirmation of actuation of the device. Once modified, the button of Cole2, Antonio, and Avery would allow the needle hub to be visible when the insertion mechanism has deployed successfully.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783