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
Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 22, 2026.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 6-9, 11, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards et al. (US 2005/0010203).
Regarding claim 1, Edwards et al. (henceforth Edwards) discloses (Figures 1-3 and 11) an injection device comprising: a handle (152; Figure 11); a shaft (14; 154) extending distally from the handle; and two or more hypodermic needles (36, Figures 1-3; ¶¶ [0070]-[0071]; a stylet with a sharpened end to enter tissue is considered analogous to a hypodermic needle) that can each be reconfigured between: (i) a first position that is fully within the shaft and (ii) a second position in which a distal tip portion of the hypodermic needles extends radially from the shaft (see e.g., ¶¶ [0079]-[0080] and [0097] which disclose using the tab 166 of handle 152 to advance and retract the stylets from the main catheter body).
Regarding claim 2, Edwards further discloses wherein the handle (152) has an actuator (switch 166) to control the radial movement of the needles between the first and second positions (see e.g., ¶¶ [0079]-[0080] and [0097] which disclose using the handle to orient the stylets during deployment).
Regarding claim 3, Edwards further discloses a ruled indicator showing radial extension positions of the hypodermic needles (see e.g., Figure 11 which depicts a graduated indicator above tab 166 which is linked to the deployment of the stylets).
Regarding claim 6, Edwards further discloses an expandable balloon (30) attached to the shaft (Figures 1-2; ¶¶ [0078]-[0079]).
Regarding claim 7, Edwards further discloses wherein the balloon is distal of the hypodermic needles (Figure 2, the balloon can be seen to be distal to the stylets).
Regarding claim 8, Edwards further discloses wherein the hypodermic needles (36) are manually translatable along a longitudinal axis of the shaft (Figure 11, ¶ [0097] discloses wherein the stylets are translatable via tab 166).
Regarding claim 9, Edwards further discloses wherein the handle has an actuator to control the translation of the hypodermic needles along the longitudinal axis of the shaft (166, Figure 11; ¶ [0097]).
Regarding claim 11, Edwards further discloses wherein the device further comprises an indicator that shows a position of the hypodermic needles along the longitudinal axis of the shaft (see e.g., Figure 11 which depicts a graduated indicator above tab 166 which is linked to the deployment of the stylets as per ¶ [0097]).
Regarding claim 12, Edwards further discloses wherein the hypodermic needles may be extended radially within a 0 mm to 5 mm radius from an outer surface of the sheath (¶ [0020] states that the needles may extend any desired radius up to 5 mm which meets the claimed range).
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell et al. (US 9,320,850).
Regarding claim 1, Fischell et al. (henceforth Fischell) discloses an injection device comprising: a handle (300; Figure 11); a shaft (102; Figure 2) extending distally from the handle; and two or more hypodermic needles (117, 119, Figure 2) that can each be reconfigured between: (i) a first position that is fully within the shaft (Figure 8; Col. 35, lines 3-26) and (ii) a second position in which a distal tip portion of the hypodermic needles extends radially from the shaft (Figure 10; Col. 36, line 53-Col. 37, line 8).
Regarding claim 4, Fischell further discloses wherein the device comprises four hypodermic needles (Figure 2; Col. 27, lines 2-7 set forth that there are four injectors).
Claim(s) 1, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swift (US 2017/0035990).
Regarding claim 1, Swift discloses an injection device comprising: a handle (155; Figure 10A); a shaft (120; Figures 10A-10B) extending distally from the handle; and two or more hypodermic needles (15, Figures 10A-11B) that can each be reconfigured between: (i) a first position that is fully within the shaft (¶ [0036] discloses thumb slide 8 is used for advancement and retraction of the needle from the catheter shaft) and (ii) a second position in which a distal tip portion of the hypodermic needles extends radially from the shaft (seen depicted in Figure 7).
Regarding claim 8, Swift further discloses wherein the hypodermic needles are manually translatable along the shaft (see e.g., Figures 1 and 7; ¶ [0036]; they are actuated via thumb slide 8).
Regarding claim 10, Swift further discloses wherein the hypodermic needles can be actuated to emerge radially from the shaft at multiple positions along the longitudinal axis of the shaft (Figures 10A-11B; ¶¶ [0067] and [0069], there are multiple exit holes as claimed).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell.
Regarding claim 5, Fischell discloses the claimed invention substantially as set forth above for claim 4, but fails to explicitly disclose the needles being radially extendable from the shaft to be in an envelope of less than 180 degrees. Fischell teaches that the catheter can be designed with a variety of angular offsets to deflect the needles at the desired angle relative to the catheter shaft (Col. 30, lines 3-25), but fails to explicitly disclose an envelope of less than 180 degrees. Furthermore, it appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the device of Fischell to have the needles extend in an envelope of less than 180 degrees as it involves only adjusting a dimension of a component disclosed to require adjustment (e.g., the angle of the guiding wall from which the needles extend. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Fischell to comprise extending the needles to a total envelope of less than 180 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of McRae (US 2006/0293647).
Regarding claim 13, Edwards discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose a measuring scale proximal of the needles.
McRae teaches (Figure 7) a shaft (200 or 210) for extendable needles (330) which comprises indexing marks (¶ [0078] discloses indexing marks on a proximal end of the shaft 220/210).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter shaft of Edwards to comprise the indexing marks of McRae to provide a means of determining the location or depth of the catheter shaft during a procedure as taught by McRae.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783