DETAILED ACTION
Response to Amendment
The amendment filed July 2, 2026 has been entered. Claims 1 and 11 have been amended. Claims 1-13 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
Claim Objections
Claims 2, 6, 8, and 13 are objected to because of the following informalities: the claims depend from “claim 0”. Appropriate correction is required. For the purposes of examination, all claims referencing claim 0 will be considered to depend from claim 1.
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) 1-3, 6-9, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al. (US 2005/0010203) in view of Desai (US 2003/0073908).
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). Edwards fails to explicitly disclose the axial location indicator which includes a first marking denoting a distal position of the two or more needles, and a second marking denoting a proximal position of the two or more hypodermic needles relative to the handle.
Desai teaches a catheter device (Figure 3) comprising a handle (28), and the use of an axial location indicator (markings 42 depicted on handle in Figure 3; ¶ [0055] discloses the scale 42 as being used to determine the depth of insertion of the needle (the extent of axial movement).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Edwards to utilize a scale depicting the depth of needle insertion, as taught by Desai, so as to provide a means for determining the needle distance from a specific point during a procedure as taught by Desai. In addition, the use of the scale provides at least two clear indications of proximal and distal locations of the needle (e.g., at a first insertion depth, and after the needles have been moved axially, the scale will read larger value as the depth of penetration has increased).
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/Desai teach the markings as se forth above for claim 1, but fail to explicitly disclose the use of millimeters for the scale. However, Desai clearly teaches that any known scale would be usable as the graded scale 42 and one of ordinary skill in the art at the time of filing would have found it obvious to chose a known scale such as millimeters for the depth of penetration of a needle during a medical procedure. There is no evidence of record that establishes that changing the units of the scale would result in a difference in function of the ability to track the depth of needle penetration. Further, a person having ordinary skill in the art, being faced with modifying the graded scale of Edwards/Desai, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed units of millimeters. Lastly, applicant has not disclosed that the scale in millimeters solves any stated problem apart from the general function of measurement, and therefore there appears to be no criticality placed on the use of millimeters as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the graded scale of Edwards/Desai as an obvious matter of design choice within the skill of the art.
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, 4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 9,320,850) in view of Desai.
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). Fischell fails to explicitly disclose the axial location indicator as claimed.
Desai teaches a catheter device (Figure 3) comprising a handle (28), and the use of an axial location indicator (markings 42 depicted on handle in Figure 3; ¶ [0055] discloses the scale 42 as being used to determine the depth of insertion of the needle (the extent of axial movement).
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 utilize a scale depicting the depth of needle insertion, as taught by Desai, so as to provide a means for determining the needle distance from a specific point during a procedure as taught by Desai. In addition, the use of the scale provides at least two clear indications of proximal and distal locations of the needle (e.g., at a first insertion depth, and after the needles have been moved axially, the scale will read larger value as the depth of penetration has increased).
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).
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) 1, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swift (US 2017/0035990) in view of Desai.
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). Swift fails to explicitly disclose the axial indicator as claimed.
Desai teaches a catheter device (Figure 3) comprising a handle (28), and the use of an axial location indicator (markings 42 depicted on handle in Figure 3; ¶ [0055] discloses the scale 42 as being used to determine the depth of insertion of the needle (the extent of axial movement).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Swift to utilize a scale depicting the depth of needle insertion, as taught by Desai, so as to provide a means for determining the needle distance from a specific point during a procedure as taught by Desai. In addition, the use of the scale provides at least two clear indications of proximal and distal locations of the needle (e.g., at a first insertion depth, and after the needles have been moved axially, the scale will read larger value as the depth of penetration has increased).
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(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Desai, and further in view of McRae (US 2006/0293647).
Regarding claim 13, Edwards/Desai teach 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/Desai 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
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 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
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