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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. US 12,053,277 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims would anticipate the instant application claims.
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) 1-2 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0322981 A1 to Chae et al. (“Chae”) in view of US 2020/0330014 A1 to Ueda et al. (“Ueda”).
As to claim 1, Chae discloses an insertion needle structure, which is formed by bending a flat blank and is configured for receiving and allowing a biosensor to be partially implanted underneath a skin surface of an organism (see [0101] – “After forming the first slanted surface (5521) and the second slanted surface (5522) at the front end portion of the needle original plate (5500) through this cut process, both side end portions of the need original plate (5500) with respect to the width direction are bent along bending lines (BL) as illustrated in FIG. 11, and this can be performed through a press forming processing according to an embodiment of the present disclosure.), the insertion needle structure comprising:
a needle sharp (see Fig 11); and
a needle body integrally connected to the needle sharp and having a receiving space for receiving the biosensor (see Fig 3), the needle body comprising:
a base wall (see Fig 7(a)-(c) showing base);
two side walls located at two sides of the base wall, respectively, each of the two side walls being at least partially flat (see Fig 7(a)-(c) showing side walls; see also Fig 5 showing flat portions);
two slope sections located at the two sides of the base wall, respectively, each of the slope sections connected between each of the side walls and the needle sharp, each of the slope sections being curved (see Fig 5, element 5502 and [0085] – “The variation portion (5502) is formed at the back portion of the point tip portion (5501), and a variation extension surface (5512) forming the same plane as the slanted enlargement surface (5511) at the front end portion and extending in the Y axis and Z axis directions in a structure of continuously changing a direction of facing a side as being toward the back is formed at the variation portion (5502).”); and
two curved connecting sections located at the two sides of the base wall, each of the curved connecting sections being connected between each of the side walls and the base wall and between each of the slope sections and the base wall (see Fig 7(a)-(c) – rounded fillets joining the vertical side arms 5513 to the curved bottom at each cross section);
wherein the needle sharp extends from the base wall and the curved connecting sections (see Fig 5 – tip 5514 positioned at the convergence of the base and side structures).
Chae fails to disclose the two side walls being at least partially nonparallel. In a related disclosure, Ueda teaches two similar side walls being at least partially nonparallel (see Fig 6(a)-(c) showing sidewalls 105-106 converging to point “F”). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the sensor sharp of Chae with the converging nonparallel sidewalls of Ueda in order to achieve the predictable result taught by Ueda of controlling puncture resistance through the geometry of the flanking surfaces.
2. The insertion needle structure of claim 1, wherein each of the side walls has a first inner edge and a first outer edge, each of the first inner edges is near the receiving space, each of the first outer edges faces away from the receiving space, and each of the first inner edges is curved (see [0082] – “…the inside edge line (5516) can be formed in a curved surface structure without an edge by a grinding operation.”).
5. The insertion needle structure of claim 2, wherein each of the slope sections has a second inner edge connected to the first inner edge, and a second outer edge connected to the first outer edge, and each of the second inner edges is curved (see [0087] – “the inside edge line (5516) and the outside edge line (5517) of the variation extension surface (5512) are formed to be continuously formed with the inside edge line (5516) and the outside edge line (5517) of the slated enlargement surface (5511).”).
As to claim 6, Chae fails to disclose wherein each of the second outer edges is partially flat and inclined in a direction away from the receiving space. However, Ueda teaches a blade surface portion having a flat surface (see claim 3 of Ueda – “the concave surface constituting the first blade portion comprises a flat surface”).
As to claim 7, Chae further discloses wherein the needle sharp comprises two slants connected to the two curved connecting sections, respectively, the two slants intersect at a needle tip, and each of the slants comprises: a needle sharp top edge being curved and connected to each of the second inner edges; and a needle sharp bottom edge being curved or flat and connected to each of the second outer edges (see Fig 5 – slanted enlargement surfaces 5511 on either side of dot point tip 5514, bounded by inside edge line 5516 and outside edge line 5517).
As to claim 8, Chae fails to disclose wherein the needle sharp bottom edge is flat, and each of the second inner edges is partially flat. In a similar invention, Ueda teaches a needle sharp bottom edge is flat, and each of the second inner edges is partially flat (see claim 16 and claim 9 of Ueda). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Chae and Ueda in order to achieve the predictable result of reducing puncture resistance while simplifying manufacture.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 12,697,051 B2 to Jeong et al. (“Jeong”) in view of Chae and further in view of Ueda.
As to claim 19, Jeong discloses
a cover having a main space (see Fig 1, element 100);
an inserting module disposed within the main space of the cover and comprising an insertion needle structure of claim 1 (see Fig 4, element 551 and 520 – the reasons for obviousness provided in the treatment of claim 1 are apparent therein and will not be repeated); and
a removing module comprising:
a base detachably limited within the inserting module (see Fig 5, element 510); and
the biosensor detachably assembled with the base and at least a part thereof received in the receiving space of the insertion needle structure (see Fig 5, element 520);
wherein when the cover is pressed downward, the inserting module is driven to allow the insertion needle structure to move downward so as to carry the biosensor to implant underneath the skin surface of the organism for conducting a measurement of a physiological signal inside the organism (see col 9, lns 14-33).
It would have been obvious to one of ordinary skill in the art to combine the insertion assembly of Jeong with the needle configuration of claim 1 as shown above to provide the predictable result of controlling puncture resistance through the geometry of the flanking surfaces.
Allowable Subject Matter
Claims 3-4 and 9-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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