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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12, drawn to a method of modifying a surface texturing of an injection needle, classified in B23K26/355.
II. Claims 13-20, drawn to an injection needle, classified in A61M5/329.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the injection needle can be made by another and materially different process, such as forming the craters/depressions of the needle shaft by a process using a punch machine.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification. The inventions have acquired a separate status in the art due to their recognized divergent subject matter. The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Nicholas Lewis on 01/27/26 a provisional election was made without traverse to prosecute the invention of Invention II, claims 13-20 drawn to an injection needle. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-12 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/03/25 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ooyauchi et al.(U.S. PGPUB No. 2016/0184532), hereinafter Ooyauchi.
Regarding claim 13, Ooyauchi discloses an injection needle (see FIG. 15) comprising:
a cylindrical needle body (see [0091]: cylindrical) comprising a distal end (see [0091]: distal end is cut) and a proximal end (see [0091]: proximal end is before tapered region as shown in FIG. 15 as “103c”. see ‘Modified FIG. 15’ below for clarity) and defining a lumen (see [0092]); and
PNG
media_image1.png
854
440
media_image1.png
Greyscale
a beveled injection tip (see [0091]: distal end provided with acute angle cut for piercing) formed at the distal end (see ‘Modified FIG. 15’ above);
wherein the proximal end (see [0091] and ‘Modified FIG. 15’ above) of the cylindrical needle body (see [0091]) comprises a textured outer surface (126 as in FIG. 14B, see [0114-0115]), the textured outer surface (126) comprising a plurality of rows (see ‘Modified FIG. 14b’ below),
PNG
media_image2.png
529
464
media_image2.png
Greyscale
each or the plurality of rows (see ‘Modified FIG. 14B’ above) comprising a plurality of craters (see ‘Modified FIG. 14B’ above and [0115]) depressed radially inward into the outer surface (see [0115]: recesses recessed relative to the outer peripheral surface of needle), and wherein the plurality of rows (see ‘Modified FIG. 14B’ above) are arranged axially along a length (see ‘Modified FIG. 14B’ above) of the cylindrical needle body (see [0091]) at the proximal end (at portion 126 as shown in ‘Modified FIG. 15’); and
wherein the plurality of craters (see ‘Modified FIG. 14B’ above and [0115]) is configured to enhance bonding (see [0091] & [0100]: roughened portion 106 facilitates joining/ enhances bonding to needle support 107. See [0046]: fig 14b having portion 126 is modification of fig. 9 having portion 106 and [0114-0115]: roughened portion 106 can have various forms such as 126 as shown in FIG. 14B. Therefore, the roughened portion 126 achieves same effect as disclosed for roughened portion 106 and is “configured to” enhance boding) of the textured outer surface (126) to a surrounding needle support (107, see FIG. 9 and [0093]).
Regarding claim 14, Ooyauchi discloses the injection needle of claim 13, and Ooyauchi further discloses wherein each of the plurality of rows (see ‘Modified 14Bi’ below)
PNG
media_image3.png
529
376
media_image3.png
Greyscale
is immediately adjacent (aligning with Applicant disclosure in [0049]: rows only separated by axial gap between) another of the plurality of rows (see ‘Modified 14Bi’ above).
Regarding claim 15, Ooyauchi discloses the injection needle of claim 13, and Ooyauchi further discloses wherein the plurality of rows comprises at least a first row grouping and a second row grouping (see ‘Modified FIG. 14Bii’ below),
PNG
media_image4.png
483
633
media_image4.png
Greyscale
each of the first row grouping and the second row grouping including a number of rows (see multiple rows in each of the first and second row groupings in ‘Modified FIG. 14B’ above), and wherein the first row grouping is spaced apart axially from the second row grouping by a gap where an outer surface of the cylindrical needle body is free of craters (see ‘Modified FIG. 14Bii’ above).
Regarding claim 16, Ooyauchi discloses the injection needle of claim 13, and Ooyauchi further discloses wherein each of the plurality of craters (as seen in ‘Modified FIG. 14’ above) has a rounded bottom and a sharp edge (rounded bottom and sharp edge disclosed by Applicant in the current Application’s FIG.9-10 and [0048]. The associated structures as shown in ‘Modified FIG. 14Biii’ below align with as much as is disclosed by Applicant in FIGs.9-10 and [0048]) about the circumference thereof (see ‘Modified FIG. 14Biii’ below).
PNG
media_image5.png
426
468
media_image5.png
Greyscale
Regarding claim 20, Ooyauchi discloses the injection needle of claim 13, and Ooyauchi further discloses wherein each of the plurality of rows (as seen in ‘Modified FIG. 14B’ above and see [0115]: recesses recessed relative to the outer peripheral surface of needle) extends circumferentially about an entirety of the outer surface (see FIG.11) to cover a full cylinder (see ‘Modified FIG. 11’ below)
PNG
media_image6.png
352
550
media_image6.png
Greyscale
of the cylindrical outer body (see FIG. 11, [0091], and [0100-0105]: roughened portion 106 covers entire cylinder around circumference of the cylindrical outer body by punching the roughened portion into the needle before the needle is rolled. [0114-0115]: roughened portion 106 can have various forms such as 126 as shown in FIG. 14B and thus 126 can be formed by same method).
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ooyauchi as applied to claim 13 above, and further in view of Brandt et al. (U.S. PGPUB No. 2019/0247590), hereinafter Brandt.
Regarding claim 17, Ooyauchi discloses the injection needle of claim 13, but Ooyauchi is silent to “wherein the depth of each of the plurality of craters is between 1.5 and 9.0 micrometers.”
However, Brandt teaches an injection needle comprising a cylindrical needle body (10, see FIG.1) comprises a textured outer surface (10a, see [0040]), the textured outer surface (10) comprising a plurality of rows (see rows of 11 in FIG. 2), each of the plurality of rows (rows of 11) comprising a plurality of craters (11, see [0042]: grooves) depressed radially inward into the outer surface (see [0042]: laser etched and therefore depressed radially inward from outer surface), wherein the depth (d, see FIG. 2) of each of the plurality of craters (11) is between 1.5 and 9.0 micrometers (see [0024]: 7 micrometers for an 18G needle with a texture portion length of 2mm).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the depth of the depression of the plurality of craters disclosed in Ooyauchi to be 7micrometers as taught by Brandt for the purpose of achieving a desired bonding strength between the needle and hub (see [0014]) in consideration of needle characteristics (see [0024]), thus achieving “wherein the depth of each of the plurality of craters is between 1.5 and 9.0 micrometers.”
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ooyauchi (U.S. PGPUB No. 2016/0184532).
Regarding claim 18, Ooyauchi discloses the injection needle of claim 13, but Ooyauchi (FIG.14B) is silent to “wherein each of the plurality of craters is 30 micrometers in diameter.”
However, Ooyauchi teaches that the size of the roughened portion, including the diameter or width of the structures, will achieve a specific joint strength between the needle shaft and hub (see [0116-0121]). Therefore, a person of ordinary skill in the art would consider the joint strength to be a result effect variable that is optimized through routine experimentation of changing/modifying the size of the roughened portion, such as the diameter of the craters, to obtain a desired joint strength between the needle and hub.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify each of the individual craters forming the size of the roughened portion disclosed in Ooyauchi by choosing the diameter of each crater to be 30micrometers to obtain “wherein each of the plurality of craters is 30 micrometers in diameter” and achieve a desired joint strength between the needle and hub as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, Ooyauchi discloses the injection needle of claim 13, and Ooyauchi further discloses wherein each of the plurality of rows (see ‘Modified FIG. 14B’ above and see [0115]: recesses recessed relative to the outer peripheral surface of needle) extends circumferentially about the outer surface to cover a portion of a cylinder (see [0112] & [0121]: roughened portion 106 can be formed on a “partial” circumference, thus forming a “portion” of a cylinder as shown in FIGs. 13A-B. Thus, there is an identified design need for a needle having this roughened portion on only a portion of the circumference. See also [0114-0115]: roughened portion 106 can have various forms such as 126 as shown in FIG. 14B and thus 126 can be formed by same method) of the cylindrical outer body (see [0091]).
Ooyauchi is silent to wherein each of the plurality of rows extends circumferentially about the outer surface to cover explicitly “a half” cylinder of the cylindrical outer body.
However, based on the disclosure of Ooyauchi, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have selected the portion of the cylinder of the cylindrical outer body covered in the plurality of rows disclosed in Ooyauchi to be a half cylinder/ half the circumference.
A person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the discretely (must select a circumference coverage greater than 0degrees and less than 360 degrees to form a “portion” as described in Ooyauchi) identified (Ooyauchi discloses/identifies “partial” circumference in [0112] and [0121]), predictable (a higher degree of the circumference covered will produce a larger cylindrical portion—for example, a ¾ cylinder. A lower degree of the circumference covered will produce a smaller cylindrical portion—for example, a ¼ cylinder) solutions with a reasonable expectation of success for covering a half cylinder portion of the needle shaft with the plurality of rows, thus achieving wherein each of the plurality of rows extends circumferentially about the outer surface to cover explicitly “a half” cylinder of the cylindrical outer body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern 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, Michael Tsai can be reached at (571) 270-5246. 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.
/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783