DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. According to the Amendment, filed 30 January 2026, the status of the claims is as follows:
Claim 1 is currently amended;
Claims 4 and 9 are previously presented; and
Claims 2, 3, 5-8 and 10-18 are as originally filed.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 5-6, filed 30 January 2026, with respect to the rejection of claims 1-18 under 35 U.S.C. 103 as being unpatentable over Cheney, II et al, U.S. Patent No. 5,568,806 A (“Cheney”), in view of Haindl, U.S. Patent No. 4,889,529 A (“Haindl”), and further in view of Bittner et al., U.S. Patent No. 5,515,871 A (“Bittner”), have been fully considered in view of the Amendment, filed 30 January 2026, but are moot in view of the new ground(s) of rejection, which was necessitated by amendment, as discussed below.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 16-18 are 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.
Claim 16 recites the limitation “a longitudinal slit connected in communication with the inner dimension”, claim 17 recites the limitation “wherein the longitudinal slit is in communication with the elongate opening”, and claim 18 recites the limitation “wherein the elongate opening and longitudinal slit extend entirely through a distal edge of the wall structure to form a cross sectional C-shape”. Claim 1, for which claims 16-18 are dependent on, recites “a slot extending to a distal tip of the needle…” The original disclosure, filed 24 January 2022, supports a “slot 34 that extends to the distal end of the needle 10” in para. [0107]-[0111] and figs. 18-19. However, the original disclosure is silent on having both a slot and a slit as claimed by claims 16-17. It appears from the original disclosure that the description of “a slit” in para. [0018] is in reference to the description of the “slot” in para. [0107]-[0111]. Thus, for purpose of further examination, Examiner will interpret the limitations of claims 16-18 describing a “slit” to further limit the “slot” defined in base claim 1. Examiner suggests amending claims 16-18 to provide proper antecedent basis for the “slot” instead of stating “a slit”.
Claim Rejections - 35 USC § 103
6. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. 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.
8. Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al., U.S. Patent Application Publication No. 2015/0051457 A1 (“Matsumoto”), in view of Haindl, U.S. Patent No. 4,889,529 A (“Haindl”), and further in view of Bittner et al., U.S. Patent No. 5,515,871 A (“Bittner”).
As to Claim 1, Matsumoto teaches the following:
A needle (“insertion needle”) 30 for delivering a sensor (“sensor”) 12 through an outer skin layer and into a sensor depth (see “The present invention relates to a sensor inserting device for inserting a detector of a sensor, for measuring biological information of a person, into a body of the person and an operating method of the device.” in para. [0002]), the sensor 12 pre-connected to sensor electronics (“transmitter 14 (signal processor)”) 14 prior to delivery of the sensor 12 through the outer skin layer (see “As illustrated in FIG. 1, the sensor inserting device 10 is a device that is disposed at a suitable location (e.g., an unobtrusive portion of a person's body where the body motion is small such as an abdomen, specifically, a location near a navel, etc.) on a skin S of a patient (person to be measured), and may insert a sensor 12 (see FIG. 4) into the body of the patient, by a predetermined operation by a user, to allow the sensor 12 and the transmitter 14 (signal processor) to be placed on the skin S.” in para. [0063]; and see fig. 3), the needle 10 comprising:
a wall structure (walls, not labeled, of “insertion needle” that is “formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction”) having a central axis (Z1 direction, see fig. 4), an interior surface (the surface, not labeled, of “insertion needle side groove 46” in fig. 4), a tip ( “distal end portion”, not labeled) (see “The distal end portion of the insertion needle 30 is partially cut to have an acute angle (i.e., the needle is sharp or sharpened) so as to easily pierce the skin S.” in para. [0075]), at least one cross dimension (“U-shaped (or C-shaped) cross section opening in the Y1 direction”, not labeled, see para. [0075]) and defining at least one inner dimension sized to contain the sensor 12 for delivery (see “The insertion needle side groove 46 extends along the axial direction and can contain the detector 36 of the sensor 12. That is, the sensor 12 is held at the distal end portion of the push handle 18 with the sensor base part 40 covered by the sensor cover 32 and the detector 36 covered by the insertion needle 30.” in para. [0075]);
at least one cutting edge (not labeled) on the wall structure configured to pierce the outer skin layer (see “The distal end portion of the insertion needle 30 is partially cut to have an acute angle (i.e., the needle is sharp or sharpened) so as to easily pierce the skin S. The insertion needle 30 is formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction. The inside of the U-shape forms an insertion needle side groove 46.” in para. [0075], and fig. 4);
…
wherein the wall structure 30 is configured for removal from the outer skin layer to leave the sensor 12 at the sensor depth (see “After that, the user retreats the push handle 18 to remove the insertion needle 30 from the sensor 12 (step S6: retreat motion step).” in para. [0130]); and
a slot (“insertion needle side groove”) 46 extending to a distal tip of the needle 30 (see “The insertion needle side groove 46 extends along the axial direction and can contain the detector 36 of the sensor 12. That is, the sensor 12 is held at the distal end portion of the push handle 18 with the sensor base part 40 covered by the sensor cover 32 and the detector 36 covered by the insertion needle 30.” In para. [0075], and fig. 4), the slot 46 configured to deliver the sensor 12 pre-connected to the sensor electronics 14 (see “As illustrated in FIG. 1, the sensor inserting device 10 is a device that is disposed at a suitable location (e.g., an unobtrusive portion of a person's body where the body motion is small such as an abdomen, specifically, a location near a navel, etc.) on a skin S of a patient (person to be measured), and may insert a sensor 12 (see FIG. 4) into the body of the patient, by a predetermined operation by a user, to allow the sensor 12 and the transmitter 14 (signal processor) to be placed on the skin S.” in para. [0063]; and see fig. 3), wherein the slot 46 is configured to allow for the removal of the needle 30 from the sensor 12 without disturbing the electrical connection established prior to delivery of the sensor 12 through the outer skin layer (see “As illustrated in FIG. 1, the sensor inserting device 10 is a device that is disposed at a suitable location (e.g., an unobtrusive portion of a person's body where the body motion is small such as an abdomen, specifically, a location near a navel, etc.) on a skin S of a patient (person to be measured), and may insert a sensor 12 (see FIG. 4) into the body of the patient, by a predetermined operation by a user, to allow the sensor 12 and the transmitter 14 (signal processor) to be placed on the skin S.” in para. [0063]; see “After that, the user retreats the push handle 18 to remove the insertion needle 30 from the sensor 12 (step S6: retreat motion step).” in para. [0130]; and see fig. 3).
Matsumoto does not teach the following:
a bend of the wall structure forming at least one blunt contour on the wall structure, … the blunt contour configured to bluntly dissect tissue as the wall structure advances into the sensor depth,
wherein the blunt contour, viewed along the central axis of the wall structure, occupies more than 50% of the cross dimension of the wall structure, …
However, Haindl teaches the following:
A needle (“needle tube”) 11, comprising:
a bend (“bending of the back side”) 15 of a wall structure (“axial side wall”) 11 forming at least one blunt contour (“punctuating portion”) 13 on the wall structure 11a, … the blunt contour 13 configured to bluntly dissect tissue as the wall structure 11a advances into the sensor depth, wherein the blunt contour 13, viewed along the central axis of the wall structure 11a, occupies more than 50% of the cross dimension (“outer diameter”) d of the wall structure 11a (“The needle 10 according to FIGS. 1 and 2 consists of a hollow rigid cylindrical needle tube 11 made of metal. The rear end of the needle tube is connectable, (e.g. to an injection syringe or a hose or the like) for connection of a fluid transfer system. Along the largest part of the length of the needle tube 11, the needle tube extends straight. In the embodiment shown in FIGS. 1 and 2, the outer diameter d of the needle tube is 0.7 mm. The through-channel 12 may have a diameter of 0.4 mm.
For forming a punctuating portion 13, the front end of the needle tube 11 is curved at one side wall and bent obliquely in a lateral direction. The opposite side wall 11a remains in axial course. This provides an oval lumen opening 20, i.e. an opening which connects the longitudinal channel 12 (the lumen) of the needle tube 11 to the outside.”, see col. 4, l. 62, to col. 5, l. 9; “The punctuating and cutting portions of the needle tube 11 are arranged within the contour of the needle tube 11 in the zone of the wall thickness of the axial side wall 11a. This prevents particles from being punched out of the natural or artificial layer of material to be penetrated, and outstanding separating characteristics are obtained.”, see col. 5, ll. 43-49; and figs. 1-3).
Thus, it would have been obvious for one of ordinary skill in the art at the time the application was filed to modify use of Matsumoto’s “insertion needle 30” to use Haindl “punctuating portion 13” in order to “[prevent] particles from being punched out of the natural or artificial layer of material to be penetrated, and outstanding separating characteristics are obtained” (see Haindl, col. 5, ll.43-49).
Matsumoto in view of Haindl does not teach the following:
… the bend extending through the central axis and positioning the tip between the central axis of the wall structure and an axis of the interior surface of the wall structure, …
However, Bittner teaches the following:
a bend (“hollow needle 1… is curved”) 1 (see col. 4, ll. 20-21) extending through a central axis (not labeled, see central axis running along the center of “duct 10”) and positioning a tip (“point”) 1’ between the central axis of a wall structure (“duct”) 10 and an axis (“extension 13 of the shell line”) 13 of the interior surface (not labeled, see interior surface of “duct 10” in fig. 1A) of the wall structure 10 (see fig. 1A, reproduced below).
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Thus, it would have been obvious for one of ordinary skill in the art at the time the application was filed to modify Matsumoto in view of Haindl to have a curved “hollow needle 1”, as shown in fig. 1A of Bittner, in order to “provid[e] an improved hollow needle, which always contains an open lumen, even in multiple use, i.e. with which the duct is not blocked or contaminated by flakes of membranes and/or tissue residue punched out from the puncture duct”, as stated by Bittner (see col. 3, ll. 9-14).
As to Claim 2, Haindl teaches the following:
wherein the blunt contour 13 is more than 60% of the cross dimension of the wall structure 11a (see col. 4, l. 62, to col. 5, l. 9, and figs. 1-3).
As to Claim 3, Haindl teaches the following:
wherein the wall structure 11a further defines a beveled edge (“circumferentially beveled edge”) 16 (see col. 5, ll. 10-34).
As to Claim 4, Matsumoto in view of Haindl teaches the following:
wherein the cutting edge (not labeled, see Matsumoto, para. [0075], and fig. 4) is formed on less than 50% of the beveled edge 16 (see Haindl, col. 4, l. 62, to col. 5, l. 9, col. 5, ll. 10-34, and figs. 1-3).
As to Claim 5, Matsumoto in view of Haindl teaches the following:
wherein the cutting edge (not labeled, see “distal end portion of the insertion needle 30 is partially cut to have an acute angle (i.e., the needle is sharp or sharpened)” in Matsumoto, para. [0075], and fig. 4), when viewed along the central axis of the wall structure 15 (see Cheney, col. 4, ll. 63-67 and figs. 1 and 2), is spaced closer to the central axis (“longitudinal central axis”) 14 than an adjacent outer edge of the blunt contour 13 (see col. 4, l. 62, to col. 5, l. 9, and figs. 1-3).
As to Claim 6, Haindl teaches the following:
wherein the central axis 14 passes through the blunt contour 13 (see fig. 1).
As to Claims 7 and 8, Haindl teaches the following:
wherein the blunt contour 13 is at least 2/3 of an area centered on the central axis 14 and circumscribing an outer edge (“back side”) 15 of the blunt contour 13, wherein the area is a circular area and has a diameter matching a diameter of the wall structure 11a (see fig. 1).
As to Claim 9, Matsumoto in view of Haindl teaches the following:
wherein the cutting (not labeled, see “distal end portion of the insertion needle 30 is partially cut to have an acute angle (i.e., the needle is sharp or sharpened)” in Matsumoto, para. [0075], and fig. 4) is formed on less than 40% of the beveled edge 16 (see Haindl, col. 4, l. 62, to col. 5, l. 9, col. 5, ll. 10-34, and figs. 1-3).
As to Claim 10, Matsumoto in view of Haindl teaches the following:
wherein the blunt contour 13 is sufficiently large in proportion to the cutting edge (not labeled, see “distal end portion of the insertion needle 30 is partially cut to have an acute angle (i.e., the needle is sharp or sharpened)” in Matsumoto, para. [0075], and fig. 4) to reduce wound volume by at least 15% (see Haindl, col. 4, l. 62, to col. 5, l. 9, and figs. 1-3).
As to Claims 11 and 12, Haindl teaches the following:
wherein the beveled edge 16 is angled at least 7 degrees, wherein the beveled edge is angled at least 10 degrees (see “α” in fig. 1, and col. 5, ll. 61-65).
As to Claims 13 and 14, Haindl teaches the following:
wherein the wall structure 11a further includes a bend (“length of the bending of the back side 15”) positioned proximal to the cutting edge 18, wherein the bend is subjacent a bevel, wherein the bend is at least 13 degrees (see col. 5, ll. 55 and 61-65, and fig. 1).
As to Claim 16, Matsumoto teaches the following:
wherein the wall structure (walls, not labeled, of “insertion needle” that is “formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction”) defines a longitudinal slit (“insertion needle side groove”) 46 connected in communication with the inner dimension (inner space, not labeled, within the “insertion needle side groove 46”) (see “The insertion needle side groove 46 extends along the axial direction and can contain the detector 36 of the sensor 12. That is, the sensor 12 is held at the distal end portion of the push handle 18 with the sensor base part 40 covered by the sensor cover 32 and the detector 36 covered by the insertion needle 30.” in para. [0075]).
As to Claim 17, Matsumoto teaches the following:
wherein the wall structure (walls, not labeled, of “insertion needle” that is “formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction”) defines an elongate opening (“U-shaped (or C-shaped) cross section opening in the Y1 direction”, not labeled) and the inner dimension is a diameter of the opening and wherein the longitudinal slit 46 is in communication with the elongate opening (see “The insertion needle 30 is formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction. The inside of the U-shape forms an insertion needle side groove 46.” in para. [0075], and fig. 4).
As to Claim 18, Matsumoto teaches the following
wherein the elongate opening (“U-shaped (or C-shaped) cross section opening in the Y1 direction”, not labeled) and longitudinal slit 46 extend entirely through a distal edge of the wall structure (walls, not labeled, of “insertion needle” that is “formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction”) to form a cross sectional C-shape (see “The insertion needle 30 is formed to have a U-shaped (or C-shaped) cross section opening in the Y1 direction. The inside of the U-shape forms an insertion needle side groove 46.” in para. [0075]).
Conclusion
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached on Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached on 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 02/24/2026