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 Group II in the reply filed on 3/23/2026 is acknowledged.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bourassa (US 6358217 B1) in view of Schied (US 3692020 A).
With respect to claim 9, Bourassa discloses a biopsy sample extraction device (see Fig. 5: biopsy needle #10) comprising:
an elongated housing (see Fig. 5 and col 6 lines 1-35: biopsy needle #10 comprises elongate housing #20 that defines a cavity #22 where cavity is shaped to contain a spring-loaded firing mechanism #48);
a sliding end coupled to a mating end of the elongated housing (see Fig. 5 and see col 6 lines 36-65: a stylet base #50 is attached to proximal end #34 of stylet #30 that is disposed in cavity #22 of housing #20 where both the stylet #30 and stylet base #50 are mounted for axial movement relative to hosing #20 and relative to a cannula #40 between a retracted and extended position where stylet base #50 is interpreted to be a sliding end);
a compression-based actuation system including a blade coupled to a spring disposed in the elongated housing (see Fig. 5 and col 7 lines 30-43: biopsy needle #10 includes a means for biasing a stylet base distally and the stylet biasing means is preferably a stylet coil spring that is disposed about a cannula coil spring #86 where the opposed winding of the coil springs prevent the two coil springs from becoming tangled; and see col 6 lines 20-25: cannula #40 is spring fired to sever a tissue sample where the cannula is interpreted to be a blade), the blade at least partially held in place by a trigger bar (see Figs. 1-3 and col 7 lines 1-30: a cannula base #70 is attached to proximal end #44 of cannula #40 and disposed in cavity #20 where the cannula base #70 has a safety cannula latch means #72 for retaining cannula base #70 in a first retracted position until it has been released), and configured such that a force against a front face of the sliding end causes the trigger bar to release the blade (see Figs. 1-3 and col 7 lines 1-30: cannula base #70 is retained in a first retracted position by safety cannula latch means #72 until it has been released where it is only released only after the stylet base #50 has moved to a second extended position that the safety cannula latch lever #72 is disengaged and the cannula #40 is fired); and
a dual-action locking system including one or more removable obstructions to prevent the trigger bar and the sliding end from moving (see Figs. 1-3 and col 7 lines 1-30: the cannula base #50 is mounted to a stylet base #50 and it has a safety cannula latch means #72 and a firing cannula latch means #76 that retains the cannula base #50 and stylet base #50 in a first retracted position until released which is interpreted to be a dual action locking system where the one or more removable obstructions are interpreted to be #72 and #76 as they can be engaged and disengaged).
Bourassa further teaches a mechanism for releasing the one or more removable obstructions where the trigger bar and the sliding end are prevented from moving until the one or more removeable obstructions are released (see Fig. 12 and col 9 lines 20-41: means for releasing the firing cannula latch means #126 to allow cannula base #70, interpreted to be a trigger bar, which is connected to stylet base #50 that is interpreted to be a sliding end, to move from first position to a second position where the means for releasing can be a cannula firing button).
Bourassa does not specifically disclose that the blade is a rotatable blade where the rotatable blade is held in place by a trigger bar.
Schied teaches a rotatable blade (see Fig. 1 and col 2 lines 4-35: cutting die #40 is rotated by pulling trigger on the stored torque in spring to collect a biopsy specimen) where the rotatable blade is held in place by a trigger bar (see Fig. 1 and col 2 lines 4-35: cutting die #40 is held in place by a spindle #14 to which when only when torque is applied via trigger #34 the cutting die moves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa with the teachings of Schied to have utilized a rotatable blade that is held in place because it would have resulted in the predictable result of only intentionally rotating a blade to collect a biopsy specimen when needed (Schied: see col 2 lines 4-35) as a controlling mechanism.
With respect to claim 18, all limitations of claim 9 apply in which Bourassa further discloses: one or more guide channels defined into a mating end of the elongated housing for slidably mating with the sliding end (see Fig. 5-7 and col 8 lines 48-59: the stylet base #50 and cannula base #70 are pushed into housing #20 though a stylet retracting hole #116 and cannula retracting hole #118 where in order to be pushed through they have to go via a guide channel defined for them to be pushed within the housing #20).
Claims 10-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bourassa in view of Schied as applied to claim 9 above, and further in view of Sarnoff (US 5085641 A).
With respect to claim 10, all limitations of claim 9 apply in which Bourassa and Schied do not specifically teach wherein the one or more removable obstructions include at least a locking clip and a protective cap.
Sarnoff teaches a locking clip and a protective cap (see col 7 lines 33-60: cap structure #18 and clip member #104 where the clip member has a protrusion #108 which extends radially inwardly which locks a surface).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have the one or more removable obstructions be a locking clip and a protective cap because it would have resulted in the predictable result of having two separate removable obstructions as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for a device which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 11, all limitations of claim 10 apply in which Bourassa and Schied do not specifically teach wherein the protective cap includes a locking post, extending from an inner surface of the protective cap, configured to occupy a space adjacent the trigger bar when the protective cap is disposed on the biopsy sample extraction device.
Sarnoff further teaches wherein the protective cap includes a locking post (see col 8 lines 47-67 – col 9 lines 1-22, the cap structure #18 includes an intermediate portion #18 and a thumb engaging portion #92 which prevents movement of a safety actuating pin #84), extending from an inner surface of the protective cap (see col 8 lines 47-67 – col 9 lines 1-22, a safety actuating pin #84 extends from housing body structure of cap structure #18), configured to occupy a space adjacent the trigger bar when the protective cap is disposed on the biopsy sample extraction device (see col 8 lines 47-67 – col 9 lines 1-22: safety actuating pin #84 occupies space next to the housing of cap structure #18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking post because it would have resulted in the predictable result retaining locking surfaces in engagement to prevent movement of a device (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-48) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 12, all limitations of claim 11 apply in which Bourassa and Schied do not specifically teach wherein the locking post includes a slanted end that faces inward with respect to a centerline of the elongated housing.
Sarnoff further teaches wherein the locking post includes a slanted end that faces inward with respect to a centerline of the elongated housing (see col 8 lines 47-67 – col 9 lines 1-22 and see Fig. 7-8: safety actuating pin #84 includes an intermediate portion #88 which extends towards the housing structure; and see col 6 lines 39-51: #88 has a reduced diameter with respect to a forward portion #86 thus interpreted as being slanted as it is seen to lean into #86 which is towards housing structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking post with a slanted end because it would have resulted in the predictable result retaining locking surfaces in engagement to prevent movement of a device (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-48) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 13, all limitations of claim 12 apply in which the combination of Bourassa in view of Schied and Sarnoff further teaches wherein the slanted end is a first slanted end (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22 and see Fig. 7-8: safety actuating pin #84 includes an intermediate portion #88 which extends towards the housing structure; see col 6 lines 39-51: #88 has a reduced diameter with respect to a forward portion #86 thus interpreted as being slanted as it is seen to lean into #86 which is towards housing structure); and the sliding end includes one or more actuation members with one or more second slanted ends, the one or more second slanted ends facing outward with respect to the centerline of the elongated housing (Bourassa: see col 6 lines 36-65 and col 7 lines 44-67: stylet base #50 also includes a wedge portion #60 where a finger #93 extends from a stop pad #90 towards style base #50 and contacts wedge portion #60).
With respect to claim 14, all limitations of claim 9 apply in which Bourassa and Schied do not specifically teach wherein the one or more removable obstructions include a locking clip having a first arm and a second arm.
Sarnoff teaches a locking clip having a first arm and a second arm (see col 7 lines 33-60: cap structure #18 includes clip member #104 where the clip member has first arcuate wall portion #112 and second arcuate wall portion #118).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking clip with two arms because it would have resulted in the predictable result of having removable obstructions as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) that connect to a tubular member (Sarnoff: see col 7 lines 33-67) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 15, all limitations of claim 14 apply in which Bourassa and Schied do not specifically teach wherein the first arm and the second arm are curved to correspond to a shape of the elongated housing.
Sarnoff teaches wherein the first arm and the second arm are curved to correspond to a shape of the elongated housing (see col 7 lines 33-70: cap structure #18 includes clip member #104 where the clip member has first arcuate wall portion #112 and second arcuate wall portion #118 where they hold a tubular member).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking clip with two arms because it would have resulted in the predictable result of having removable obstructions as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) that connect to a tubular member (Sarnoff: see col 7 lines 33-67) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 16, all limitations of claim 14 apply in which Bourassa and Schied do not specifically teach wherein the locking clip includes a pull tab coupled the first arm and the second arm.
Sarnoff teaches wherein the locking clip includes a pull tab coupled the first arm and the second arm (see col 7 lines 14-70 and Fig. 4: cap structure #18 includes clip member #104 where the clip member includes an elongated clip #106 having a forward end formed with a protrusion #18 where clip member #104 also includes wall portion #112 and #118 where it is interpreted that the elongated clip #106 is a pull tab).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking clip with a pull tab because it would have resulted in the predictable result of having removable obstructions as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) by retaining the clip in the housing structure (Sarnoff: see col 8 lines 43-46) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 17, all limitations of claim 16 apply in which Bourassa and Schied do not specifically teach wherein the locking clip is disposed adjacent to a lip wrapping at least partially circumferentially around the elongated housing when the locking clip is preventing motion of the sliding end.
Sarnoff teaches wherein the locking clip is disposed adjacent to a lip wrapping at least partially circumferentially around the elongated housing when the locking clip is preventing motion of the sliding end (see col 7 lines 14-70: the cap structure #18 includes clip member #104 which further includes a first arcuate wall portion #112 that terminates in a radially extending lug #114 where it is interpreted that the lip is the radially extending lug #114 seen in Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking clip because it would have resulted in the predictable result of having removable obstructions as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) that connect to a tubular member (Sarnoff: see col 7 lines 33-67) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 19, Bourassa discloses a method of forming a biopsy sample extraction device (see Fig. 5 and see col 6 lines 1-35: biopsy needle #10 for taking tissue samples from a patient), the method comprising:
securing a blade in a locked position in a housing of the biopsy sample extraction device, the blade being coupled to a compressed spring disposed in the housing (see Fig. 5 and col 7 lines 30-43: biopsy needle #10 includes a means for biasing a stylet base distally and the stylet biasing means is preferably a stylet coil spring that is disposed about a cannula coil spring #86 where the opposed winding of the coil springs prevent the two coil springs from becoming tangled; and see col 6 lines 20-25: cannula #40 is spring fired to sever a tissue sample where the cannula is interpreted to be a blade; and see Fig. 5 and col 6 lines 1-35: biopsy needle #10 comprises elongate housing #20 that defines a cavity #22 where cavity is shaped to contain a spring-loaded firing mechanism #48);
forming a slidable coupling between a sliding end and the housing (see Fig. 5 and see col 6 lines 36-65: a stylet base #50 is attached to proximal end #34 of stylet #30 that is disposed in cavity #22 of housing #20 where both the stylet #30 and stylet base #50 are mounted for axial movement relative to hosing #20 and relative to a cannula #40 between a retracted and extended position where stylet base #50 is interpreted to be a sliding end);
positioning as a first locking mechanism over at least a portion of the sliding end (see Figs. 1-3 and col 7 lines 1-30: the cannula base #50 is mounted to a stylet base #50 and it has a safety cannula latch means #72 and a firing cannula latch means #76 that retains the cannula base #50 and stylet base #50 in a first retracted position until released which is interpreted to be a dual action locking system where first locking mechanism is interpreted to be #72 as it can be engaged and disengaged); and
positioning a second locking mechanism between the sliding end and the housing (see Figs. 1-3 and col 7 lines 1-30: the cannula base #50 is mounted to a stylet base #50 and it has a safety cannula latch means #72 and a firing cannula latch means #76 that retains the cannula base #50 and stylet base #50 in a first retracted position until released which is interpreted to be a dual action locking system where the second locking mechanism interpreted to be #76 as it can be engaged and disengaged).
Bourassa further teaches a mechanism for releasing the one or more removable obstructions where the trigger bar and the sliding end are prevented from moving until the one or more removeable obstructions are released (see Fig. 12 and col 9 lines 20-41: means for releasing the firing cannula latch means #126 to allow cannula base #70, interpreted to be a trigger bar, which is connected to stylet base #50 that is interpreted to be a sliding end, to move from first position to a second position where the means for releasing can be a cannula firing button).
Bourassa does not specifically disclose that the blade is a rotatable blade and further that the rotatable blade is coupled to a compressed spring. Bourassa also does not disclose a protective cap as a first locking mechanism and a locking clip as a second locking mechanism.
Schied teaches a rotatable blade (see Fig. 1 and col 2 lines 4-35: cutting die #40 is rotated by pulling trigger on the stored torque in spring to collect a biopsy specimen) where the rotatable blade is coupled to a compressed spring (see Fig. 1 and col 2 lines 4-35: cutting die #40 is held in place by a spindle #14 to which when only when torque is applied via trigger #34 and torque spring #26 that the cutting die moves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa with the teachings of Schied to have utilized a rotatable blade that is held in place because it would have resulted in the predictable result of only intentionally rotating a blade to collect a biopsy specimen when needed (Schied: see col 2 lines 4-35) as a controlling mechanism.
Bourassa and Schied do not specifically teach a protective cap as a first locking mechanism and a locking clip as a second locking mechanism.
Sarnoff teaches a locking clip and a protective cap (see col 7 lines 33-60: cap structure #18 and clip member #104 where the clip member has a protrusion #108 which extends radially inwardly which locks a surface).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking clip and a protective cap because it would have resulted in the predictable result of having two separate removable obstructions (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
With respect to claim 20, all limitations of claim 19 apply in which Bourassa further discloses:
configuring the biopsy sample extraction device to create a biopsy sample (see Fig. 5 and see col 6 lines 1-35: biopsy needle #10 for taking tissue samples from a patient) by:
configuring the first locking mechanism to be pulled away by using a first force in a first direction (see Figs. 1-3 and col 7 lines 1-30: the cannula base #50 is mounted to a stylet base #50 and it has a safety cannula latch means #72 and a firing cannula latch means #76 that retains the cannula base #50 and stylet base #50 in a first retracted position until released which is interpreted to be a dual action locking system where first locking mechanism is interpreted to be #72 as it can be engaged and disengaged);
configuring the second locking mechanism to be pulled away by using a second force in a second direction (see Figs. 1-3 and col 7 lines 1-30: the cannula base #50 is mounted to a stylet base #50 and it has a safety cannula latch means #72 and a firing cannula latch means #76 that retains the cannula base #50 and stylet base #50 in a first retracted position until released which is interpreted to be a dual action locking system where the second locking mechanism interpreted to be #76 as it can be engaged and disengaged); and
configuring the sliding end to receive a force which causes a living hinge to release a detent on the sliding end (see Figs. 1-3 and col 7 lines 1-30: the cannula base #50 is mounted to a stylet base #50 and it has a safety cannula latch means #72 and a firing cannula latch means #76 that retains the cannula base #50 and stylet base #50 in a first retracted position until released where the safety cannula latch lever #72 is made of a resilient material biased towards a locking position which is functionally a hinge that releases from engagement from a safety cannula notch #74 interpreted to be a detent), thus releasing the compressed spring (see Figs. 1-3 and col 7 lines 1-30, releasing #72 from engagement from #74 releases the spring coil).
Bourassa does not specifically teach creating a biopsy sample with a rotational cut of the rotatable blade. Bourassa further does not teach a protective cap or a locking clip or that the rotatable blade rotates about a pin.
Schied teaches creating a biopsy sample with a rotational cut of the rotatable blade (see Fig. 1 and col 2 lines 4-35: cutting die #40 is rotated by pulling trigger on the stored torque in spring to collect a biopsy specimen) where the rotatable blade rotates about a pin (see Fig. 1 and col 2 lines 4-35: cutting die #40 is held in place by a spindle #14 to which when only when torque is applied via trigger #34 and torque spring #26 that the cutting die moves about a point).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa with the teachings of Schied to have utilized a rotatable blade creates a rotational cut about a point because it would have resulted in the predictable result of only intentionally rotating a blade to collect a biopsy specimen when needed (Schied: see col 2 lines 4-35) as a controlling mechanism.
Bourassa and Schied do not specifically disclose a protective cap or a locking clip.
Sarnoff teaches a locking clip and a protective cap (see col 7 lines 33-60: cap structure #18 and clip member #104 where the clip member has a protrusion #108 which extends radially inwardly which locks a surface).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bourassa and Schied with the teachings of Sarnoff to have added a locking clip and a protective cap because it would have resulted in the predictable result of having two separate removable obstructions (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) as part of a safety assembly (Sarnoff: see col 8 lines 47-67 – col 9 lines 1-22) for which when attached they lock a device to prevent it from actuating until needed (Sarnoff: see col 4 lines 7-26 and see col 10 lines 6-8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI PATEL whose telephone number is (571)272-2379. The examiner can normally be reached Mondays to Fridays 9AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791