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 .
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 notch 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.
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.
Claim 34 and 37 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. Claim 34 now recites “a curvature comprising notch..” which does not appears to be supported by the specification and is being considered new matter. A similar limitation was added to claim 37 in the previous claim set as well. It appears the curvature refers to the embodiment of Fig. 4a and 4b and the curvature is shown as element 450. However, a notch that is part of the curvature on a first side of the stylet hub next to and spaced radially inward from one of the clasp arms is not shown in the drawing nor described in the specification. This is considered new matter as the notch was not initially disclosed in the original claim set or specification. Applicant is asked to either point to support for the claimed structure or to remove the structure from the claim limitations.
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) 21- 25, 27, 29, 31-33 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2008/0262430 A1) in view of Snow (US 2015/0201963 A1).
With regard to claim 21, Anderson discloses A medical device assembly (Fig. 2a, 3a and 14), comprising: a stylet (Fig. 2a, element 20) having a stylet body (22) and a stylet hub (at 26), wherein the stylet hub includes two clasp arms (formed by 29 and 27), wherein each clasp arm curves outward at a proximal portion of the clasp arm relative to a longitudinal axis of the stylet (at 29), and wherein each clasp arm includes an anchor (at 27); and a cannula (Fig. 3a) having a cannula body (30) and a cannula hub (at 32), wherein the cannula hub includes a proximal portion (generally where 45 is pointing), a distal portion (generally where 39 is pointing), and a locking protrusion (37), wherein the locking protrusion forms a continuous ring around an outer surface of the cannula hub (as can be seen in Fig. 1), and wherein a width of the locking protrusion is greater than a width of the proximal portion (37 has a width greater than the neck portion at 45); wherein a proximal surface of each anchor of the clasp arms is in contact with the locking protrusion in a locked configuration of the stylet and the cannula (as seen in Fig. 14), to restrict withdrawal of one of the stylet hub or the cannula hub from the other of the stylet hub or the cannula hub.
Anderson discloses suggesting that any outer lipped surface can be used as the locking protrusion, however it shows the luer lip as being the locking protrusion ([0058]).
Anderson therefore does not explicitly disclose the locking protrusion being between the proximal portion and the distal portion.
Snow teaches a similar assembly (Fig. 4) having a stylet (Fig. 4, element 240) and a cannula (220), where calping arms have an anchor (244) designed to claps onto a locking protrusion (224) which is located between a proximal portion of the cannula (at 218) and a distal portion (where 220) is pointing. Because Anderson teaches that other lipped surfaces other than the luer can be used as the locking protrusion it would be prima facie obvious to have a separate locking ring that is located other than at the proximal end. Anderson shows the locking protrusion as a ring, while Snow does not teach the ring, Snow is simply being used to teach that a locking protrusion can be located at a location other than the proximal end of the cannula.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson with the locking protrusion that is located between a proximal portion and distal portion of the cannula as taught by Snow for the purpose of providing an alternate way of connecting the stylet and cannula ([0038]).
With regard to claim 22, Anderson discloses wherein the proximal surface of each anchor of the clasp arms is not in contact with the locking protrusion in an unlocked configuration of the stylet and the cannula (as shown in Fig. 2a).
With regard to claim 23, Anderson discloses wherein each clasp arm is coupled to a hinge ([0051]).
With regard to claim 25, Anderson discloses wherein each clasp arm is biased in a radially inward direction towards the longitudinal axis of the stylet ([0058]).
With regard to claim 27, Anderson discloses wherein each clasp arm includes gripping ridges (as can best be seen in Fig. 1, 29 is a button type piece that extends outwards and therefore creates a gripping ridge on its edge) on the proximal portion of the clasp arm.
With regard to claim 29, Anderson discloses wherein the proximal portion of the cannula hub is within the stylet hub when the medical device assembly is in the locked configuration (as can be seen in Fig. 14).
With regard to claim 31, Anderson discloses wherein each clasp arm includes a recess (see annotated drawing below).
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With regard to claim 32, Anderson discloses wherein the recesses are configured to receive the locking protrusion (see Fig. 14).
With regard to claim 33, Anderson discloses wherein the recesses are proximal the anchors (as can be see the protrusions on 27 that form the anchors are distal to the recesses).
With regard to claim 42, Anderson discloses wherein the ring of the locking protrusion includes a tapered sidewall between the proximal portion and the distal potion (the ring as shown as 37 in Fig. 3a, is tapered at its top end), each of the proximal and distal portions having a cylindrical shape (Fig. 3a).
Claim(s) 25, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2008/0262430 A1) in view of Snow (US 2015/0201963 A1) and in further view of Davis et al. (US 5,466,225).
With regard to claim 25 and 28, Anderson/Snow teach the claimed invention except for the clasp arms being the most distal and proximal part of the stylet hub.
Davis teaches a similar device (fig. 9, 10) where a stylet having clasp arms (76) that curve outward (as can be seen in Fig. 9) and an anchor (84) for attaching to a locking protrusion (formed surrounding the recess 86). Davis further teaches the clasp arms as being the most distal part (Fig. 9, 10) and the most proximal part of the stylet (Fig. 9 and 10).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Snow with the clasp arms that are most distal and proximal as taught by Davis for the purpose of allowing for easy squeezing the clasp arms (Col 6, line 67 to Col 7, line 10).
Allowable Subject Matter
Claim 34 and 37 and all dependents potentially recite allowable subject matter by reciting the curvature with a notch. However, the 112(a) rejection must be overcome before the claims are allowable.
Response to Arguments
Applicant’s arguments with respect to claim(s)21-23, 25-29, 31-34, 36-38, 40-42 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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