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 .
Response to Amendment
This office action is responsive to the amendment filed on 27 July 2026. As directed by the amendment: claim 3 has been amended, claims 1-2 and 5-7 have been or remain canceled. Thus claims 3-4 and 8-14 are presently pending in this application. Applicant’s amendments to the Claims have overcome each 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed 27 March 2026.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 27 July 2026, have been fully considered but they are not persuasive.
Applicant argues on page 7 that the injection of Wyatt is not the same as the injection required by claim 2 which requires that liquid is injected by moving a plunger though a needle to eject the liquid from the tip of the needle. In contrast, the tissue in Wyatt is released as the needle is moved upwardly towards the plunger. The examiner respectfully disagrees. The plunger and the needle of Wyatt move relative to each other to release the tissue, as such, even if the plunger is held static relative to the brain, the plunger is essentially moved through the needle.
Applicant’s arguments, with respect to the newly amended limitations have been fully considered and are persuasive. Therefore, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wyatt et al. (US 5,004,457 A), Matsutani et al. (US 6,214,030 B1), and Enk (US 9,162,033 B2) as outlined further below.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 3, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt et al. (US 5,004,457 A) in view of Matsutani et al. (US 6,214,030 B1), and Enk (US 9,162,033 B2).
Regarding claim 3, Wyatt et al. discloses a microsyringe unit (Fig 2A-2E) comprising: a microsyringe including a cylindrical needle (400 Fig 2C) and a plunger (500 Fig 2D) that is passed through the needle (as shown in Figs 4A-4D); and a cylindrical needle guide (200 Fig 2A) that the needle is passed through (needle 400 passes into needle guide 200 as shown in Figs 5A-5E, Col 6 lines 24-27 “the second cannula assembly 20 is inserted into the outer guide cannula 210 of the first cannula assembly 10 (see FIG. 5A)”), wherein a base portion of the needle (the bottom end of cap 420 as shown in Fig 2C) abuts on a guide base portion that supports the needle guide (the top end of cap 220 as shown in Fig 2A, Col 6 lines 41-43 “the end cap 220 of the cannula 200 abuts the end cap 420 of cannula 400”), thereby causing a tip of the needle (430 Fig 2C) to protrude from a tip of the needle guide (230 Fig 2A) in a first specified state (Col 6 lines 29-33 “In this "piggy-back" position, the lower end 230 of the cannula 200 is disposed slightly above the lower end 430 of cannula 400 (as shown in FIG. 5C)”) in which movement of the needle passed through the needle guide in a direction towards the tip of the needle guide is stopped (As described in col 6 lines 35-52 the movement of cannula 400 relative to cannula 200 is stopped), the tip of the needle (430 Fig 2C) has a convex curved surface (the tapered end is a conical surface, cones have a convex curved surface as the outer surface curves to form a circular profile) whose outer diameter gradually decreases toward a tip end of the needle (the outer diameter of 430 Fig 2C gradually decreases to form a tip), the microsyringe unit being for injecting liquid into brain tissue of a patient (the microsyringe is fully capable of being used with a liquid, tissue generally has an amount of liquid in it), the liquid being injected by moving the plunger through the needle to eject the liquid from the tip of the needle of the microsyringe unit and inject the liquid into the brain tissue (See the relative movement of 510 from Fig 5C to 5E, the transplant is into brain tissue).
However, Wyatt et al. fails to teach wherein a surface roughness of the convex curved surface of the tip of the needle is greater than a surface roughness of an outer side surface of the needle and hydrophilic functional groups are imparted to the tip of the needle.
Matsutani et al. teaches a surface roughness of the convex curved surface of the tip of the needle (6 Fig 2) is greater than a surface roughness of an outer side surface of the needle (Col 5 lines 21-22 “the strip rough surface 6 is provided only on the tapered portion 3”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the tip of the needle of Wyatt et al. to include the surface roughness with the limitations as taught by Matsutani et al. allowing the tissue to be impaled by the needle with less force (Col 5 lines 31-36).
Enk teaches hydrophilic functional groups (“a hydrophilic coating along curved tapered end portion 16 such as PHOTO-LINK coating material commercially available from SurModics, Inc., Eden Prairie, Minn. The material is a liquid mixture of PV05 Photo-Polyvinylpyrrolidone copolymer, PA05 Photo-Polyacrylamide copolymer, 2-propanol and distilled water.” Col 5 lines 23-28) are imparted to the tip of a tapered shaft inserted into tissue (Col 5 lines 23-24 “a hydrophilic coating along curved tapered end portion 16”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for hydrophilic functional groups to be imparted to the tip of the needle as taught by Enk to “To further reduce the friction, and hence reduce the force necessary” to urge the device into the target tissue (Col 3 lines 16-17).
Regarding claim 12, modified Wyatt et al. teaches the microsyringe unit according to claim 3. Wyatt et al. further discloses further comprising a stylet (300 Fig 2B) that is passed through the needle guide (As shown in Fig 3A stylet 300 passes through needle guide 200) and is columnar at least in a tip of the stylet (Fig 2B, the body of the stylet from the cap 320 to the tip 330 is long and rigid, col 4 lines 18-20) wherein a base portion of the stylet (320 Fig 2B) abuts on the guide base portion (220 Fig 2A) that supports the needle guide, thereby causing the tip of the stylet to protrude from the tip of the needle guide in a second specified state in which movement of the stylet passed through the needle guide in a direction towards the tip of the needle guide is stopped (while this configuration is not shown in the drawings, the cap 320 of the stylet would abut the cap 220 of the needle guide to prevent movement towards the tip of the needle guide as claimed, the guide needle has a length of 94mm, the cap 220 of the guide needle is 10mm long so when combined the length of 104mm is 1mm shorter than the length of the stylet which is 105mm so the stylet would protrude at least 1mm, Col 4 lines 5-27).
Regarding claim 14, modified Wyatt et al. teaches the microsyringe unit according to claim 12. Wyatt et al. further teaches wherein a protruding length of the stylet from the tip of the needle guide in the second specified state is equal to or greater than a protruding length of the needle from the tip of the needle guide in the first specified state (the needle 400 has a length of 104mm, col 4 lines 41-43, and the stylet 300 has a length of 105mm, col 4 line 25, the stylet would protrude a greater length than the needle).
Claim(s) 4, 8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt et al. (US 5,004,457 A) in view of Matsutani et al. (US 6,214,030 B1), Enk (US 9,162,033 B2) and Grabinky (US 2007/0106219 A1).
Regarding claim 4, modified Wyatt et al. teaches the microsyringe unit according to claim 3. Wyatt et al. further discloses wherein: the tip of the needle guide (230 Fig 2A) has a convex curved surface (the tapered end is a conical surface; cones have a convex curved surface as the outer surface curves to form a circular profile) whose outer diameter gradually decreases toward a tip end of the needle guide (the outer diameter of 230 Fig 2A gradually decreases to form a tip).
However, Wyatt et al. fails to teach a radius of curvature of the convex curved surface of the tip of the needle is greater than a radius of curvature of the convex curved surface of the tip of the needle guide.
Grabinsky teaches a radius of curvature of the convex curved surface of the tip of a piercing element (14 Fig 3) (radius of curvature of surface 30 of tip 24 Fig 3) is greater than a radius of curvature of the convex curved surface of the tip of the needle guide (12 Fig 3) (the radius of curvature of surface 54 at edge 44 Fig 5). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the dimensions of the tips of the needle guide and the needle of modified Wyatt et al. to have the outer diameter and radius limitations as taught by Grabinsky to make the edge of the needle guide blunt to prevent further cutting, and to make the tapering of the tip of the needle longer and sharper.
Regarding claim 8, modified Wyatt et al. teaches the microsyringe unit according to claim 3. Wyatt et al. further discloses wherein: the tip of the plunger (530 Fig 2D) has a convex curved surface (the end is a cylindrical surface; cylinders have a convex curved surface as the outer surface curves to form a circular profile) and the tip is blunt compared to the tip of the needle (Col 4 lines 52-53).
However, modified Wyatt et al. fails to teach wherein: the tip of the plunger has a convex curved surface whose outer diameter gradually decreases toward a tip end of the plunger; and a radius of curvature of the convex curved surface of the tip of the plunger is smaller than a radius of curvature of the convex curved surface of the tip of the needle.
Grabinsky teaches a convex curved surface of a non-piercing tip has an outer diameter that gradually decreases toward the tip end (See the edge 44 tapering to form a rounded surface) and a radius of curvature of the non-piercing tip (the radius of curvature of surface 54 at edge 44 Fig 5) is smaller than a radius of curvature of a piercing tip (the radius of curvature of surface 30 of tip 24 Fig 3 is much larger than the curvature of 44 as shown in Fig 5). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the dimensions of the tips of the plunger and the needle of modified Wyatt et al. to have the outer diameter and radius limitations as taught by Grabinsky to make the edge of the plunger blunt to prevent further cutting, and to make the tapering of the tip of the needle longer and sharper.
Regarding claim 13, modified Wyatt et al. teaches the microsyringe according to claim 12. Wyatt et al. further teaches wherein: the tip of the stylet (330 Fig 2B) has a convex curved surface (the tapered end is a conical surface; cones have a convex curved surface as the outer surface curves to form a circular profile) whose outer diameter gradually decreases toward a tip end of the stylet (the outer diameter of 330 Fig 2B gradually decreases to form a tip).
However, modified Wyatt et al. is silent to; and a radius of curvature of the convex curved surface of the tip of the stylet is greater than a radius of curvature of the convex curved surface of the tip of the needle guide.
Grabinsky teaches a radius of curvature of a convex curved surface of a tip of a stylet (the radius of curvature of surface 30 Fig 3) is greater than a radius of curvature of a convex curved surface of a tip of the needle guide (the radius of curvature of surface 54 at edge 44 Fig 5). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Wyatt et al. to include the limitations as taught by Grabinsky to “mitigate against further penetration of the assembly 10 upon insertion into the desired area.” [0039] and because Grabinsky teaches “the curvature of the surface may be variously configured, and it is contemplated that various shapes and geometries may be implemented in order to achieve varying results” [0031].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt et al. (US 5,004,457 A) in view of Matsutani et al. (US 6,214,030 B1), Enk (US 9,162,033 B2) and Geliebter et al. (US 2007/0179455 A1).
Regarding claim 9, modified Wyatt et al. teaches the microsyringe unit according to claim 3. However, Wyatt et al. is silent to wherein at least a part of the needle is composed of a transparent member.
Geliebter et al. teaches at least a part of a needle is composed of a transparent member ([0024] “needles having a transparent or translucent barrel or a barrel including a transparent or translucent portion”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the needle of modified Wyatt et al. to include the limitations as taught by Geliebter et al. to allow for visualization which allows for confirmation that fluid is flowing, present, or absent in the lumen [0045].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt et al. (US 5,004,457 A) in view of Matsutani et al. (US 6,214,030 B1), Enk (US 9,162,033 B2) and Harris (US 3,401,692 A).
Regarding claim 10, modified Wyatt et al. teaches the microsyringe unit according to claim 3. However, modified Wyatt et al. is silent to further comprising a cylindrical packing that is arranged so as to abut on a side wall of a through hole penetrating a base portion of the needle and having a narrow portion that narrows toward a tip end inside the through hole and so as to abut on the narrow portion at the tip and that the plunger is passed through.
Harris teaches a cylindrical packing (47 Fig 3) that is arranged so as to abut on a side wall of a through hole (the sidewall of the cavity inside 40 Fig 3) penetrating a base portion of the needle (the needle 20 Fig 3 has the through hole within it as well) and having a narrow portion (the hole inside the tubular collet 47 is narrow to tightly fit the plunger 30) that narrows toward a tip end inside the through hole (the collet 47 is under circumferential tension to affect a high pressure seal Col 4 line 74-col 5 line 8, the collet would narrow along the entire longitudinal length including towards a tip end due to the inward tension) and so as to abut on the narrow portion at the tip and that the plunger is passed through (the collet 47 abuts on the plunger 30, the tip of the plunger would pass through the collet to be assembled as shown in Fig 3). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the microsyringe unit of modified Wyatt et al. to include the cylindrical packing with the limitations as taught by Harris to “effect a high pressure seal” that is “yet insufficient to prevent or markedly impair slidable travel” therethrough (Col 5 lines 5-8).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyatt et al. (US 5,004,457 A) in view of Matsutani et al. (US 6,214,030 B1), Enk (US 9,162,033 B2), Morris et al. (US 2006/0004408 A1).
Regarding claim 11, modified Wyatt et al. teaches the microsyringe unit according to claim 3. However, modified Wyatt et al. fails to teach wherein the needle guide has at least one stepped portion where its outer diameter decreases discontinuously from a rear end side to a tip side.
Morris et al. teaches an introducer element (44 and 18 Fig 1B) that has at least one stepped portion (42 Fig 1B) where its outer diameter decreases discontinuously from a rear end side to a tip side (See the larger diameter at the top in Fig 1B compared to the smaller diameter below the stepped portion 42). It would have been obvious to one of ordinary skill in the art at the time of effective filing for to include the outer diameter limitations as taught by Morris et al. on the needle guide of modified Wyatt et al. to provide the user with a tactile stop to indicate when a predetermined position has been reached [0055]. This would prevent over insertion of the needle guide and prevent damage to delicate tissues.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zamora et al. (US 7,217,769 B2) teaches adding hydrophilic compounds to medical devices for biocompatibility and lubricity to decrease trauma during tissue contact.
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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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
