DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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) 1-7, 9-17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 2065069 A1 to Sheridan et al. (Sheridan) in view of US 9636458 B2 to Hoffman et al. (Hoffman).
Regarding claim 1:
Sheridan discloses:
An injection instrument (figure 1) comprising:
a sleeve (2) defining a lumen (see the lumen within 2 as shown in figure 3);
a distal ring (6) disposed at a distal end (end of the sleeve that 6 is located) of the sleeve (2);
a plurality of needle tines (4) extending through the lumen of the sleeve (2) and movable through the lumen of the sleeve (2) (as shown in figure 1 where the needles tines 4 move and extend from the lumen), wherein the plurality of needle tines (4) is configured to dispense the therapeutic agent from the supply chamber (column 6, lines 50-55); and
a deflector (5) extending through the lumen of the sleeve (2) and movable through the lumen of the sleeve (2) (see the arrows in figure 1 which shows the movement of the deflector 5), wherein retraction of the deflector (5) relative to the sleeve (2) and the plurality of needle tines (4) causes the plurality of needle tines (4) to deflect away from a central longitudinal axis of the sleeve (2) against the distal ring (6) to change an angle between a trajectory of the plurality of needle tines (4) and the central longitudinal axis (as shown in figure 1 and 2).
Sheridan fails to disclose:
A supply chamber configured to store a therapeutic agent;
a handle assembly; and
the sleeve extending from the handle assembly.
Hoffman teaches:
A syringe injection system (figure 7) that includes a sleeve (40), a distal ring (56), and needle tines (44). The sleeve/distal ring/needle tines are supported by the handle assembly (166) and further a supply chamber (22) connected to the handle assembly to supply medication to the needle tines (44; column 6, line 63- column 7, line 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sheridan to further include a handle assembly and supply chambers as taught by Hoffman in order to supply the medicant form the supply chamber to the needle tines (Hoffman, column 14, lines 28-40). In regards to the needle tines and the deflector being movable through the lumen via the handle, the addition of the handle to the assembly in Sheridan allows for this movement to be possible since the handle supports the sleeve, needle tines and the deflector which reads on these limitation.
Regarding claim 2:
Sheridan discloses:
The injection instrument of claim 1, wherein the deflector (5) includes an anvil portion (see the anvil portion 5 as shown in figure 1) configured to abut the plurality of needle tines (4; as shown in figure 1) and apply a force to the plurality of needle tines (4) against the distal ring (6; as shown in figure 4).
Regarding claim 3:
Sheridan discloses:
The injection instrument of claim 1, wherein:
distal advancement of the plurality of needle tines (4) relative to the deflector (5) a first distance deflects the plurality of needle tines (4) at a first angle relative to the central longitudinal axis (as shown in figure 3 the needles 4 are moved toward the first distance relative to the deflector 5 and the needles 4 are only slightly displaced); and
distal advancement of the plurality of needle tines (4) relative to the deflector (5) a second distance deflects the plurality of needle tines (4) at a second angle relative to the central longitudinal axis (as shown in figure 4 the needles 4 are moved to the second distance toward the deflector 5 and the needles 4 are more displaced).
Regarding claim 4:
Sheridan discloses:
The injection instrument of claim 1, wherein:
retraction of the deflector (5) relative to the sleeve (2) and the plurality of needle tines (4) a first distance deflects the plurality of needle tines (4) at a first angle relative to the central longitudinal axis (as shown in figure 3 the deflector is moved toward the first distance relative to the needles 4 and the needles 4 are only slightly displaced); and
retraction of the deflector (5) relative to the sleeve (2) and the plurality of needle tines (4) a second distance deflects the plurality of needle tines (4) at a second angle relative to the central longitudinal axis (as shown in figure 4 the deflector is moved to the second distance toward the needles 4 and the needles 4 are more displaced).
Regarding claim 5:
Sheridan fails to disclose:
The injection instrument of claim 1, wherein a plurality of rounded grooves is defined along a length of an outer surface of the deflector and each needle tine of the plurality of needle tines is disposed within a respective rounded groove of the plurality of rounded grooves.
Hoffman teaches:
The injection instrument (figure 7) that includes a deflector (54) that includes a plurality of rounded grooves (64) on the outer surface of the deflector for each needle tine (see figure 12a).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sheridan to replace the angled surface of the deflector with the grooves of the deflector as taught by Hoffman. This is a simple substitution of one known element (angled surface of the deflector of Sheridan) for another (rounded grooves as taught by Hoffman) to obtain predictable results (to support and direct the needle tines of the injection instrument).
Regarding claim 6:
Sheridan discloses:
The injection instrument of claim 1, wherein the plurality of needle tines (4) is formed of a shape memory material (¶0022) possessing a predefined curvature (see the curvature of the needles 4 as shown in figure 3).
Regarding claim 7:
Sheridan discloses:
The injection instrument of claim 1, wherein a distal end of the deflector (5) includes a blunt dilator tip (see the blunt tip “A” in figure 1 below).
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Figure 1 – figure 4 of Sheridan, annotated by the examiner
Regarding claim 9:
Sheridan discloses:
The injection instrument of claim 1, wherein the sleeve (2) is formed of a flexible material (column 11, lines 5-10) and the distal ring (6) is formed of a rigid material (¶0042; rigid enough to collapse the needles).
Regarding claim 10:
Sheridan discloses:
The injection instrument of claim 1, wherein each needle tine (4) of the plurality of needle tines (4) is independently movable (moves outward and away from the other tines 4 as shown in figure 4) relative to other needle tines (4) of the plurality of needle tines (4).
Regarding claim 11:
Sheridan discloses:
A surgical intratumoral injection system (figures 1, 3 and 7) comprising:
a surgical intratumoral injection instrument (figure 1) configured to be inserted through the lumen of the guide catheter to access the target, the surgical intratumoral injection instrument including:
a sleeve (2) extending from the handle assembly and defining a lumen (see the lumen within 2 as shown in figure 3);
a distal ring (6) disposed at a distal end (end of the sleeve that 6 is located) of the sleeve (2);
a plurality of needle tines (4) extending through the lumen of the sleeve (2) and movable through the lumen of the sleeve (2) (as shown in figure 1 where the needles tines 4 move and extend from the lumen), wherein the plurality of needle tines (4) is configured to dispense the therapeutic agent from the supply chamber (column 6, lines 50-55); and
a deflector (5) extending through the lumen of the sleeve (2) and movable through the lumen of the sleeve (2) (see the arrows in figure 1 which shows the movement of the deflector 5), wherein retraction of the deflector (5) relative to the sleeve (2) and the plurality of needle tines (4) causes the plurality of needle tines (4) to deflect away from a central longitudinal axis of the sleeve (2) against the distal ring (6) to change an angle between a trajectory of the plurality of needle tines (4) and the central longitudinal axis (as shown in figure 1 and 2).
Sheridan fails to disclose:
A guide catheter defining a lumen and configured to be navigated to a target; and
a supply chamber configured to store a therapeutic agent;
a handle assembly.
Hoffman teaches:
A syringe injection system (figure 7) that includes a sleeve (40), a distal ring (56), and needle tines (44). The sleeve/distal ring/needle tines are supported by the handle assembly (166) and further a supply chamber (22) connected to the handle assembly to supply medication to the needle tines (44; column 6, line 63- column 7, line 8). The system further includes catheter (40) outside of the sleeve (51 as shown in figure 11a) for guiding the sleeve/tines/deflector into place (column 9, lines 39-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sheridan to further include a handle assembly and supply chambers as well as a catheter outside of the sleeve as taught by Hoffman in order to supply the medicant form the supply chamber to the needle tines and guide the assembly/sleeve into place (Hoffman, column 14, lines 28-40). In regards to the needle tines and the deflector being movable through the lumen via the handle, the addition of the handle to the assembly in Sheridan allows for this movement to be possible since the handle supports the sleeve, needle tines and the deflector which reads on these limitation.
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 2 by Sheridan and Hoffman.
Regarding claim 13:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 3 by Sheridan and Hoffman.
Regarding claim 14:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 4 by Sheridan and Hoffman.
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 5 by Sheridan and Hoffman.
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 6 by Sheridan and Hoffman.
Regarding claim 17:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 7 by Sheridan and Hoffman.
Regarding claim 19:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 9 by Sheridan and Hoffman.
Regarding claim 20:
Sheridan discloses:
A surgical intratumoral injection instrument (figure 1) comprising:
a sleeve (2) extending from the handle assembly and defining a lumen (see the lumen within 2 as shown in figure 3); and
a plurality of needle tines (4) extending through the lumen of the sleeve (2) and movable through the lumen of the sleeve (2) (as shown in figure 1 where the needles tines 4 move and extend from the lumen), wherein the plurality of needle tines (4) is configured to dispense the therapeutic agent from the supply chamber (column 6, lines 50-55) to a tumor (interpreted as intended use), and wherein the plurality of needle tines (4) is formed of a shape memory material (¶0022) configured to splay radially outward from a central longitudinal axis of the sleeve (2) when the plurality of needle tines (4) is deployed from the sleeve (2) (as shown in figure 4 the deflector is moved to the second distance toward the needles 4 and the needles 4 are more displaced) and configured to curve inward toward the central longitudinal axis of the sleeve (2) as the plurality of needle tines (4) is inserted into the tumor (interpreted as intended use which the structure in Sheridan is capable of).
Sheridan fails to disclose:
A supply chamber configured to store a therapeutic agent;
a handle assembly;
Hoffman teaches:
A syringe injection system (figure 7) that includes a sleeve (40), a distal ring (56), and needle tines (44). The sleeve/distal ring/needle tines are supported by the handle assembly (166) and further a supply chamber (22) connected to the handle assembly to supply medication to the needle tines (44; column 6, line 63- column 7, line 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sheridan to further include a handle assembly and supply chambers as taught by Hoffman in order to supply the medicant form the supply chamber to the needle tines (Hoffman, column 14, lines 28-40). In regards to the needle tines and the deflector being movable through the lumen via the handle, the addition of the handle to the assembly in Sheridan allows for this movement to be possible since the handle supports the sleeve, needle tines and the deflector which reads on these limitation.
Allowable Subject Matter
Claims 8 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20130053792-A1
FISCHELL
See the needle tines 19
US-20190070389-A1
JAYARAMAN
See the needle tines 26
US-7008411-B1
Mandrusov
See the needle tines 946
US-9149585-B2
Rodenberg
See the needle tines 41/43
US-6283947-B1
Mirzaee
See the needle tines 27
US-20100168713-A1
Tkebuchava
See the needle tines 310
WO-2010141837-A1
BUNCH
See the needle tines 80
WO-9408653-A1
HANSON
See the needle tines 26
WO-0040281-A1
MILLER
See the needle tines 58
WO-9635464-A1
PERKINS
See the needle tines 30
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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