DETAILED ACTION - FINAL
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not persuasive.
Applicant argues that Armstrong and/or Safa does not teach a lumen “connected to an exterior of the shaft and an exterior of the handle” since the terms “non-concentric” and “in a side wall” are distinguishable from the claimed language. See the response filed 01/08/2026 on page 7 stating,
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However, applicant is arguing that which is not claimed. The claim language of “connected to an exterior of the shaft and an exterior of the handle” does not require that the lumen be outside of the side wall as argued. Nothing about the term connected requires specific placement of a structure but rather a general location that has a connection to another element. Stating that the lumen is connected to an exterior of the shaft does not require that the lumen comprise a portion of the outside surface of the shaft or an outside of the lumen be fused to the exterior surface of the shaft. The term “connected,” without other modifiers, is a general term and has been interpreted as such. Therefore, the prior art merely has to show some connection between the lumen and the exterior of the shaft and exterior of the handle.
In this case, Safa clearly shows a connection via the material of the sidewall itself between the lumen and an exterior of the shaft and an exterior of the handle. As shown below, the lumen is connected to an exterior of the shaft and an exterior of the handle through the material of the shaft.
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It is noted that applicant did not provide arguments against the rejection of the claims in light of the combinations of Armstrong with Hopman, Tran, Entabi, Guzman or Savvouras.
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 8 is 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. Independent claim 1 now recites “a guidewire lumen connected to an exterior of the shaft and an exterior of the handle.” Further, applicant argues that this connection requires the lumen to be outside of the sidewall of the shaft. See remarks filed 01/08/2026, pp. 7-8. However, claim 8 which depends from claim 1 recites “wherein the guidewire lumen is positioned inside the shaft and the handle.” These recitations are contradictory as presented by applicant’s arguments filed 01/08/2026.
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.
Claims 1-3, 8, 11, 21-27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2019/0247090 A1 to Armstrong (“Armstrong”) in view of WO2013/173617 to Hopman et al. (“Hopman”) and in view of WO 2021/026641 to Safa (“Safa”).
Regarding claims 1 and 8, Armstrong discloses a safety needle apparatus (10) for insertion of a peritoneal dialysis catheter (see Title, Field of the Invention and para. [0038]), the apparatus (see Fig. 1) comprising: a shaft (12) including a first end (16) and a second end (18), the first end including a sharp bevel (see para. [0031] stating, “a first end 16 which is sharpened to form a pointed tip”); a handle (20) connected to the second end (18) of the shaft (see Fig. 1), a guidewire lumen (38/46) including a first end and a second end (see Fig. 3), the first end being aligned with the first end of the shaft (see Figs. 2 and 6-7), the guidewire lumen configured to receive a guidewire (48 and see para. [0036] stating, “The interior diameter of the fluid passage 38 and the central opening 46 are suitably sized to allow passage of a guide wire 48 therethrough in which the guide wire is of the type used for peritoneal dialysis catheter insertion.”) for placement of the peritoneal dialysis catheter (see paras. [0038] stating, “the peritoneal dialysis catheter 58 can then be inserted over the guide wire to allow the guide wire 48 to be subsequently withdrawn from the patient.”); and a blunt tip (30) located within the shaft (12) at the first end (16). Armstrong also discloses that the guidewire lumen may be non-concentric and “even in a side wall of the inner tube 14.” See para. [0037].
Regarding claims 2-3, Armstrong also includes a spring (35) that causes the blunt tip to extend past the sharp bevel (see Figs. 7-8 and para. [0034] stating, “helical spring 35 is received under compression between the annular collar 36 and the inner end of the end cap 34 to create a biasing force which urges the inner tube 14 into a first position relative to the hollow needle in which the first end of the inner tube protrudes beyond and shields the pointed tip at the first end 16 of the hollow needle”).
Regarding claim 11, Armstrong discloses the apparatus of claim 1 and also that the blunt tip (30) includes a blunt obturator or an inner shaft (14) and the sharp bevel includes a sharp cannula or an outer shaft (12). See Figs. 6-8.
Armstrong meets the claim limitations as described above for claim 1 but fails to teach “the handle including an engagement lever moveable between a lock position and an unlock position; the blunt tip connected to the engagement lever of the handle by a retraction mechanism, wherein the engagement lever of the handle is configured to prevent retraction of the blunt tip into the shaft when the engagement lever is moved to the lock position.”
However, Hopman teaches a handle (12) including an engagement lever (28) moveable between a lock position (Fig. 4) and an unlock position (Fig. 6); the blunt tip connected to the engagement lever (28) of the handle by a retraction mechanism (50), wherein the engagement lever (28) of the handle (12) is configured to prevent retraction of the blunt tip into the shaft when the engagement lever is moved to the lock position (see para. [0033] stating, “As shown in FIG. 4, the stylet pusher 50 is held in a lower or distal location within the interior of the housing or body 12 by a locking mechanism including a pair of arms 60 extending from the latch release button 28 and engaged with a retaining surface 62 within the transverse slot 26, which functions as a latch receptacle for the arms 60. With the stylet pusher 50 in that position, the spring 54 is compressed and urges the stylet pusher 50 toward the proximal end 22 of the body 12, keeping the arms 60 of the locking mechanism engaged against retaining surfaces 62 of the proximal side of the transverse slot 26.”
At the time of filing, it would have been obvious to one of ordinary skill in the art to incorporate the engagement lever moveable between a lock position and an unlock position; the blunt tip connected to the engagement lever of the handle by a retraction mechanism, wherein the engagement lever of the handle is configured to prevent retraction of the blunt tip into the shaft when the engagement lever is moved to the lock position as taught by Hopman into the invention of Armstrong. Armstrong and Hopman are analogous in the art of Veress style introducer needles; therefore, a combination is proper. Additionally, Hopman provides motivation for incorporating the lock into the invention of Armstrong in providing an improved safety feature for preventing further puncture of tissue once the needle is positioned in the chest wall. See Hopman para. [0008].
Armstrong meets the claim limitations as described above but fails to include “wherein the handle includes a sharp bevel indicator that is configured to provide a visual indication when the engagement lever is in a sharp bevel exposure position.”
However, Hopman teaches a Veress style needle that includes a handle having a sharp bevel indicator that is configured to provide a visual indication when the engagement lever is in a sharp bevel exposure position. See Fig. 10 element 92 and para. [0045] stating, “[a] colored washer-like collar, or bobber, 100, is securely attached to the tubular stylet 36 within the cavity 99 and functions as a stylet pusher, so that when the force of a helical compression spring 102, surrounding the stylet 36 and extending between the partition 98 and the stylet pusher bobber 100, is overcome, and the sharpened tip end 34 of the outer cannula 30 is exposed, the colored stylet pushing collar 100 is visible to the user through the window 92. The location and size of the window 92 may be designed to make the stylet pusher collar 100 visible with the blunt end 38 in a desired position or range of positions with respect to the sharpened tip 34 of the cannula 30.” It is noted that Fig. 11 includes a similar indicator toward the end of the housing and Hopman states at para. [0056] that “[i]t will be understood by the reader that a device similar to a combination of the devices 90 and 124 might include all of the colored collar 100, the viewing window 92, the viewing window 132, and the colored band or collar 130, so that the user might discern both that the inner tube or stylet 36 is free to move, as indicated by alignment of the colored band 130 with the viewing window 132, and that the inner tube or stylet 36 may have been forced into the bore of the outer cannula, if the collar 100 is seen to be aligned with the viewing window 92.”
At the time of filing, it would have been obvious to one of ordinary skill in the art to incorporate the sharp bevel indicator that is configured to provide a visual indication when the engagement lever is in a sharp bevel exposure position as taught by Hopman into the invention of Armstrong. Armstrong and Hopman are analogous in the art of Veress style introducer needles; therefore, a combination is proper. Additionally, Hopman provides motivation for incorporating the sharp bevel indicator into the invention of Armstrong in providing an improved safety feature for preventing further puncture of tissue once the needle is positioned in the perineal cavity. See Hopman para. [0004] discussing unintended needle punctures and Hopman para. [0056] discussing the advantages of using the sharp bevel indicator in order to discern when the stylet is free to move and when it has been forced into the bore of the outer cannula, i.e. exposing the sharp tip.
Armstrong in view of Hopman meets the claim limitations as described above for claim 1; however, they fail to teach where the guidewire lumen is connected to an exterior of the shaft and an exterior of the handle and wherein the second lumen is parallel to the first lumen, these limitations are obvious in view of Safa.
Regarding claim 1 and 22, Safa discloses a tubular conduit with a primary lumen and a parallel secondary lumen. See Figs. 10A and 10D. As shown in 10A the second lumen is connected to the exterior of the shaft and exterior of the handle.
At the time of filing, one skilled in the art would have been motivated to provide the second lumen being a parallel lumen connected to an exterior of the shaft and handle as taught by Safa into the invention of Armstrong in view of Hopman. The motivation to provide the second lumen as a parallel lumen connected to an exterior of the shaft would have been in order to free the primary lumen to receive an additional instrument while also advancing the guidewire. By advancing two instruments at the same time, the total time of the procedure could be shortened thereby increasing the safety to the patient. See US Pub. No. 2007/0123840 for further evidence of advancing multiple instruments during a single procedure (Figs. 2B+).
Regarding claims 21 and 23-24, Armstrong discloses a guidewire lumen configured to receive a guidewire (48 and see para. [0036] stating, “[t]he interior diameter of the fluid passage 38 and the central opening 46 are suitably sized to allow passage of a guide wire 48 therethrough in which the guide wire is of the type used for peritoneal dialysis catheter insertion.”) Furthermore, as stated in para. [0031], “[t]he hollow needle 12 is typically a rigid, metal needle which is elongate in a longitudinal direction from a first end 16 which is sharpened to form a pointed tip to a second end 18 opposite the first end. An elongate hollow passage spans the full length of the needle between the first end and second end thereof.” As shown in Fig. 2, the hollow needle 12 accepts the blunt tip (14). As shown in Fig. 1, inner tube (14) has a lumen for the guidewire. See also Fig. 8. See Safa Figs. 10A and 10C.
Regarding claim 25, as shown in Fig. 4, the second end of the guidewire lumen is located at the second end of the handle (20).
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Regarding claims 26-27, the engagement lever (28) of Hopman is considered a click button and is located on the side of the handle (12). See para. [0012] and Figs. 1-11.
Regarding claim 29, the engagement lever (28) of Hopman includes a sliding pin with a detent (60). See Fig. 2.
Claims 1-3, 8, 11 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of US Pub. No. 2011/0218485 to Tran et al. (“Tran”) in view of Hopman and in further view of Safa.
Regarding claims 1 and 8, Armstrong discloses a safety needle apparatus (10) for insertion of a peritoneal dialysis catheter (see Title, Field of the Invention and para. [0038]), the apparatus (see Fig. 1) comprising: a shaft (12) including a first end (16) and a second end (18), the first end including a sharp bevel (see para. [0031] stating, “a first end 16 which is sharpened to form a pointed tip”); a handle (20) connected to the second end (18) of the shaft (see Fig. 1), a guidewire lumen (38/46) including a first end and a second end (see Fig. 3), the first end being aligned with the first end of the shaft (see Figs. 2 and 6-7), the guidewire lumen configured to receive a guidewire (48 and see para. [0036] stating, “The interior diameter of the fluid passage 38 and the central opening 46 are suitably sized to allow passage of a guide wire 48 therethrough in which the guide wire is of the type used for peritoneal dialysis catheter insertion.”) for placement of the peritoneal dialysis catheter (see paras. [0038] stating, “the peritoneal dialysis catheter 58 can then be inserted over the guide wire to allow the guide wire 48 to be subsequently withdrawn from the patient.”); and a blunt tip (30) located within the shaft (12) at the first end (16). Armstrong also discloses that the guidewire lumen may be non-concentric and “even in a side wall of the inner tube 14.” See para. [0037].
Regarding claims 2-3, Armstrong also includes a spring (35) that causes the blunt tip to extend past the sharp bevel (see Figs. 7-8 and para. [0034] stating, “helical spring 35 is received under compression between the annular collar 36 and the inner end of the end cap 34 to create a biasing force which urges the inner tube 14 into a first position relative to the hollow needle in which the first end of the inner tube protrudes beyond and shields the pointed tip at the first end 16 of the hollow needle”).
Regarding claim 11, Armstrong discloses the apparatus of claim 1 and also that the blunt tip (30) includes a blunt obturator or an inner shaft (14) and the sharp bevel includes a sharp cannula or an outer shaft (12). See Figs. 6-8.
Armstrong meets the claim limitations as described above for claim 1 but fails to teach “the handle including an engagement lever moveable between a lock position and an unlock position; the blunt tip connected to the engagement lever of the handle by a retraction mechanism, wherein the engagement lever of the handle is configured to prevent retraction of the blunt tip into the shaft when the engagement lever is moved to the lock position.”
However, Tran discloses a needle for insertion into a peritoneal cavity. The device (see Fig. 1) includes an outer hollow needle shaft and an inner blunt tip stylet with a needle handle. The device is designed to provide immediate indication that the peritoneal sac has been penetrated and to prevent further puncturing of tissue. Tran teaches that the handle (204) including an engagement lever (115 and cantilever, see Fig. 2A) moveable between a lock position and an unlock position (para. [0037]) stating, “the needle handle 204 includes a lock switch 115 that moves a cantilever into place, preventing the blunt tip from retracting” and para. [0056] disclosing unlocking); the blunt tip connected to the engagement lever of the handle by a retraction mechanism (see Fig. 2E and spring 252 (claim 2)), wherein the engagement lever of the handle is configured to prevent retraction of the blunt tip into the shaft when the engagement lever is moved to the lock position (see para. [0037]). As stated by Tran, “A lock is included in some embodiments, to prevent withdrawal of the protective blunt tip after the initial insertion, ensuring that vessels and organs beyond the peritoneal space are safeguarded.” See para. [0067].
At the time of filing, it would have been obvious to one of ordinary skill in the art to incorporate the engagement lever moveable between a lock position and an unlock position; the blunt tip connected to the engagement lever of the handle by a retraction mechanism, wherein the engagement lever of the handle is configured to prevent retraction of the blunt tip into the shaft when the engagement lever is moved to the lock position as taught by Tran into the invention of Armstrong. Armstrong and Tran are analogous in the art of Veress style introducer needles; therefore, a combination is proper. Additionally, Tran provides motivation for incorporating the lock into the invention of Armstrong in providing an improved safety feature for preventing further puncture of tissue once the needle is positioned in the perineal cavity. See Tran para. [0067].
Armstrong in view of Tran meet the claim limitations as described above but fail to include “wherein the handle includes a sharp bevel indicator that is configured to provide a visual indication when the engagement lever is in a sharp bevel exposure position.”
However, Hopman teaches a Veress style needle that includes a handle having a sharp bevel indicator that is configured to provide a visual indication when the engagement lever is in a sharp bevel exposure position. See Fig. 10 element 92 and para. [0045] stating, “A colored washer-like collar, or bobber, 100, is securely attached to the tubular stylet 36 within the cavity 99 and functions as a stylet pusher, so that when the force of a helical compression spring 102, surrounding the stylet 36 and extending between the partition 98 and the stylet pusher bobber 100, is overcome, and the sharpened tip end 34 of the outer cannula 30 is exposed, the colored stylet pushing collar 100 is visible to the user through the window 92. The location and size of the window 92 may be designed to make the stylet pusher collar 100 visible with the blunt end 38 in a desired position or range of positions with respect to the sharpened tip 34 of the cannula 30.” It is noted that Fig. 11 includes a similar indicator toward the end of the housing and Hopman states at para. [0056] that “[i]t will be understood by the reader that a device similar to a combination of the devices 90 and 124 might include all of the colored collar 100, the viewing window 92, the viewing window 132, and the colored band or collar 130, so that the user might discern both that the inner tube or stylet 36 is free to move, as indicated by alignment of the colored band 130 with the viewing window 132, and that the inner tube or stylet 36 may have been forced into the bore of the outer cannula, if the collar 100 is seen to be aligned with the viewing window 92.”
At the time of filing, it would have been obvious to one of ordinary skill in the art to incorporate the sharp bevel indicator that is configured to provide a visual indication when the engagement lever is in a sharp bevel exposure position as taught by Hopman into the invention of Armstrong in view of Tran. Armstrong, Tran and Hopman are analogous in the art of Veress style introducer needles; therefore, a combination is proper. Additionally, Hopman provides motivation for incorporating the sharp bevel indicator into the invention of Armstrong in view of Tran in providing an improved safety feature for preventing further puncture of tissue once the needle is positioned in the perineal cavity. See Hopman para. [0004] discussing unintended needle punctures and Hopman para. [0056] discussing the advantages of using the sharp bevel indicator in order to discern when the stylet is free to move and when it has been forced into the bore of the outer cannula, i.e. exposing the sharp tip.
Armstrong in view of Tran and Hopman meet the claim limitations as described above for claim 1; however, they fail to teach where the guidewire lumen is connected to an exterior of the shaft and an exterior of the handle and wherein the second lumen is parallel to the first lumen, these limitations are obvious in view of Safa.
Regarding claim 1 and 22, Safa discloses a tubular conduit with a primary lumen and a parallel secondary lumen. See Figs. 10A and 10D. As shown in 10A the second lumen is connected to the exterior of the shaft and exterior of the handle.
At the time of filing, one skilled in the art would have been motivated to provide the second lumen being a parallel lumen connected to an exterior of the shaft and handle as taught by Safa into the invention of Armstrong in view of Tran and Hopman. The motivation to provide the second lumen as a parallel lumen connected to an exterior of the shaft would have been in order to free the primary lumen to receive an additional instrument while also advancing the guidewire. By advancing two instruments at the same time, the total time of the procedure could be shortened thereby increasing the safety to the patient. See US Pub. No. 2007/0123840 for further evidence of advancing multiple instruments during a single procedure (Figs. 2B+).
Regarding claims 21 and 23-24, Armstrong discloses a guidewire lumen configured to receive a guidewire (48 and see para. [0036] stating, “The interior diameter of the fluid passage 38 and the central opening 46 are suitably sized to allow passage of a guide wire 48 therethrough in which the guide wire is of the type used for peritoneal dialysis catheter insertion.”) Furthermore, as stated in para. [0031], “[t]he hollow needle 12 is typically a rigid, metal needle which is elongate in a longitudinal direction from a first end 16 which is sharpened to form a pointed tip to a second end 18 opposite the first end. An elongate hollow passage spans the full length of the needle between the first end and second end thereof.” As shown in Fig. 2, the hollow needle 12 accepts the blunt tip (14). As shown in Fig. 1, inner tube (14) has a lumen for the guidewire. See also Fig. 8.
Regarding claim 25, as shown in Fig. 4, the second end of the guidewire lumen is located at the second end of the handle (20).
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Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Tran and/or Hopman and Safa and in further view of US Pub. No. 2016/0089180 to Entabi (“Entabi”).
Armstrong in view of Tran and/or Hopman and Safa meet the claim limitations as described above for claim 1; however, they fail to teach the shaft having a diameter that is equal to or within 3 millimeters of a diameter of the peritoneal dialysis catheter.
Regarding claim 4, Entabi discloses, “When the flexible sheath 1100 and the safety needle 1000 are secured together, the flexible sheath 1100 may fit snugly over the sharp outer cannula 1002, such that the coupled safety needle 1000 and flexible sheath 1100 can penetrate the cavity wall without the flexible sheath catching on any tissues, peeling away from the safety needle, or allowing any tissues to lodge between the sharp outer cannula 1000 and the flexible sheath 1100. For example, the difference between the outer diameter of the sharp outer cannula and the inner diameter of the flexible sheath may be less than about 500 μm (e.g., in a range of about 25 μm to about 400 μm, in a range of about 50 μm to about 300 μm, or any value or range of values therein).”
At the time of filing, it would have been obvious to make the needle sheath of Armstrong within 3 millimeters of the diameter of the catheter in order to prevent the catheter from catching on any tissue as taught by Entabi (see above).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Tran and/or Hopman and Safa and in further view of US Pub. No. 2012/0232389 A1 to Guzman (“Guzman”).
Armstrong in view of Tran and/or Hopman and Safa meet the claim limitations as described above for claim 1; however, they fail to teach wherein the first end of the shaft includes an echogenic texture for ultrasound visualization.
However, Guzman teaches a veress needle made from echogenic material for ultrasound visualization. See Guzman paras. [0073-0074].
At the time of filing, it would have been obvious to incorporate the from echogenic material for ultrasound visualization as taught by Guzman into the needle of Armstrong in view of Tran. The motivation is provided by Guzman in stating that the material permits the location of the needle to be determined by ultrasound. This incorporation would have provided yet another safety feature to the device of Armstrong in view of Tran thereby increasing the prevention of unwanted tissue penetration while using the device.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Tran and/or Hopman and Safa and in further view of US Pub. No. 2017/0042573 A1 to Savvouras et al. (“Savvouras”).
Armstrong in view of Tran and/or Hopman and Safa meet the claim limitations as described above for claim 1; however, they fail to teach wherein at least a portion of the blunt tip includes a transparent material, the blunt tip includes an endoscope camera; and the endoscope camera is communicatively coupled to at least one of a tablet computer, a smartphone, or workstation, or a display monitor.
Regarding claims 9-10, Savvouras discloses, at least a portion of the blunt tip includes a transparent material (transparent dome 64), and wherein the blunt tip includes an endoscope camera (see para. [0101] stating, “It should be optically clear so that both the illumination light can get through it as well as images of the area distal to the tip can be taken by the digital image sensor. Such cover 64 can offer a protection from contaminants getting onto the distal flat polished optical surface of the lens and illumination fibers, as well as introduce a blunter surface for the distal end of the visualization stylet, FIG. 9;” and the endoscope camera is communicatively coupled to at least one of a tablet computer, a smartphone, or workstation, or a display monitor (see para. [0062] stating, “This hardware/firmware translates the electrical signals from the digital sensor to an image to be displayed in a computer or onto a monitor, or a hand-held tablet or smart phone, or to a storage device (all such display and storage devices are indicated by arrow 30 in FIG. 2).”
At the time of filing, it would have been obvious to incorporate the at least a portion of the blunt tip includes a transparent material, the blunt tip includes an endoscope camera; and the endoscope camera is communicatively coupled to at least one of a tablet computer, a smartphone, or workstation, or a display monitor as taught by Savvouras into the invention of Armstrong in view of Tran since all three references are drawn to peritoneal access needles; therefore, a combination is proper. Additionally, Savvouras provides the motivation for the incorporation as “the surgeon is provided with direct visualization during entry such that tissue separation can be visualized and organ and tissue damage can be avoided (i.e., the surgeon can see the tissue prior to dissecting the same), while at the same time, the instrument penetrating the tissue has a small overall OD (less than 3.1 mm and preferably less than 2.1 mm, like a small size standard Veress needle) that requires a small incision of less than 2 mm for its entry, and can support abdomen insufflation while at the same time provide images and live video of the area distal to the puncture instrument.” See Savvouras para. [0025].
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Tran and/or Hopman and Safa.
Armstrong in view of Tran and/or Hopman and Safa meet the claim limitations as described above for claim 1; however, they fail to teach wherein the engagement lever is located at the top of the handle and wherein the engagement lever is actuated by twisting the handle.
However, these claims amount to mere rearrangement of parts. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
In this case, moving the engagement mechanism to the top of the handle and actuating the engagement mechanism by twisting the handle would still result in the locking or unlocking of the blunt tip. The overall operation of the device would not be modified by rearranging the engagement mechanism to the top of the device and making it twist activated.
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.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993