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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 June 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 29 April 2025. As directed by the amendment: claim 3 has been amended and claims 1-2 and 5-7 have been or remain canceled. Thus claims 3-4 and 8-14 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 29 April 2025 have been fully considered but they are not persuasive. Applicant argues that the art of record is not concerned with the injection of a liquid into a minute space, as is required by the microsyringe of claim 3. The examiner respectfully disagrees.
In response to applicant's argument that the claimed microsyringe is for injecting a liquid into a minute space, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The microsyringe of Wyatt is concerned with injection of tissue, which would contain a liquid, into an animal’s brain, this is a minute space. The injection of a liquid alone would also be into a minute space. The area defined by “minute space” is not clearly defined as minute is a relative term, see the rejection under 112(b) below. The space inside a brain that would receive liquid during use of the system of Wyatt is a relatively minute space. Further, if the needle of Wyatt is modified to include a roughened surface only at the tip of the needle, it would have the same capabilities as the claimed roughened surface.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3-4 and 8-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “minute” in claim 3 is a relative term which renders the claim indefinite. The term “minute” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how small the space must be to meet the claim limitation.
Claims 4 and 8-14 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claim 3.
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.
Claims 3, 12, 14 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).
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), and the microsyringe unit being for injecting liquid into a minute space 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 minute space (See the relative movement of 510 from Fig 5C to 5E, a brain transplant site is a minute space).
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.
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).
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).
Claims 4, 8, 13 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 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 9 is 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 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 10 is 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 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 11 is 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 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
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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