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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 7: “penetrates and that holds” should be “penetrates, and [[that]] the holding portion holds”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iwase et al (US 2017/0197035).
Regarding claim 1, Iwase discloses:
A needle assembly (2; Fig. 2) comprising: an injection needle (12) that includes a needle tube (12) in which a blade surface (¶0040) is formed at a needle tip (12a) and that is inserted into an administration site (¶0067); and a needle hub (13) that holds the injection needle (12), wherein the needle hub (13) includes a holding portion (47) that has a penetration region (¶0092 – the needle 12 passes through the close contact portion and forms a liquid tight contact surface, and therefore penetrates the region) through which the injection needle (12) penetrates and that holds the injection needle (12) penetrating the penetration region (¶0061), and an insertion portion (43) that is disposed on a distal end side of the holding portion (47) and that guides a proximal end portion of the injection needle (12) to the penetration region such that a puncture direction of the injection needle and a center line of the penetration region overlap with each other (Fig. 3 – because the puncture direction of the needle is vertical and the center line is also vertical, they overlap and are parallel).
Regarding claim 2, Iwase discloses:
The needle assembly according to claim 1, wherein the insertion portion (43) includes an opening portion (46) having a tapered axial cross section (Fig. 3) in which an inner diameter gradually decreases from the distal end toward the proximal end (¶0089), and a guide portion (walls of holding portion 47) that is provided in a recessed shape (48) from the proximal end of the opening portion (46) toward the holding portion (47) and guides the puncture direction of the proximal end portion of the injection needle (12) along the center line of the penetration region (Fig. 3 – because the puncture direction of the needle is vertical and the center line is also vertical, they overlap and are parallel).
Regarding claim 7, Iwase discloses the needle assembly according to claim 1, where the functionally claimed administration site is fully capable of being a biological tissue thinner than an upper layer portion of a human skin in a human or a small non-human animal.
Regarding claim 8, Iwase discloses:
An administration device (Fig. 1) comprising: the needle assembly (2) according to claim 1 (see rejection of claim 1); and a syringe (3) that has a first tubular portion (6) disposed on the proximal end side of the needle hub (13) and a second tubular (4) portion disposed on the proximal end side of the first tubular portion (6) and having an outer diameter larger than an outer diameter of the first tubular portion (¶0029), and that is connected (Fig. 4) to the needle hub (13) of the needle assembly (2).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Iwase.
Regarding claim 4, Iwase discloses the needle assembly according to claim 1 and further discloses a needle outer diameter of 0.2 mm (¶0039) but is silent regarding “an outer diameter of the injection needle is in a range of 0.08 mm or more and 0.18 mm or less.” It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the diameter of the needle to be in a range of 0.08 mm or more and 0.18 mm or less as applicant appears to have placed no criticality on the claimed range (instant ¶0087, the diameter “may” be in the range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Allowable Subject Matter
Claims 3 and 5-6 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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
Prosecution Insights