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 .
Response to Amendment
The amendment filed 04/22/26 has been entered. Claim 13 has been amended. Claims 16-20 are in the original/ previously presented form. Claims 1-12 and 14-15 are cancelled. Claims 21-31 are newly presented. Thus, claims 13 and 16-31 remain pending in the application. There were no objections or 112 rejections previously set forth in the Non-Final Office Action mailed 02/06/26. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 line 6 reads “each or the plurality of rows” and should likely read “each [[or]] of the plurality of rows” because “or” appears to be a typo that should instead read “of” for grammatical reasons
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.
(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, 20-21, 23, 25-27, and 31 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
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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 the embodiment of FIG. 14B, see [0114-0115]: needle 103 may have various forms of the roughened portions 126, such as the recesses as shown in FIG. 14B. See also [0116]: FIG. 15 has 3 roughened portions 126 along outer peripheral surface of needle), the textured outer surface (roughened portions 126) comprising a plurality of rows (see ‘Plurality of Rows’ below. Embodiment where FIG. 15 comprises roughened portions 126 as in FIG. 14B and supported in [0014-0015]. Each of the 3 roughened portions 126 in FIG. 15 comprise the 4rows or circumferential rows as shown in FIG. 14B and described in [0115], forming a total of 12rows),
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each or the plurality of rows (the 12 rows as in the figure ‘Plurality of rows’ above) comprising a plurality of craters (see ‘Modified FIG. 14B’ below and [0115]. ‘Modified FIG. 14B’ below only depicts 4 rows of the total 12 rows, but is provided to aid in visualization purposes)
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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 ‘Plurality of Rows’ figure above) are arranged axially along a length (see figure ‘Plurality of rows’ above and [0115], [0116], & [0118]) of the cylindrical needle body (see [0091]) at the proximal end (as shown in ‘Modified FIG. 15’ above); 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 (roughened portions 126) to a surrounding needle support (107, see FIG. 9 and [0093]); and
wherein the plurality of rows (see ‘Plurality of rows’ figure above) comprises at least a first row grouping (first set of 4 rows on the first roughened portion 126) and a second row grouping (second set of 4 rows on the second roughened portion 126), each of the first row grouping (first set of 4 rows on the first roughened portion 126) and the second row grouping (second set of 4 rows on the second roughened portion 126) including a number of rows (4 rows as shown in ‘Fig. 14B’) each spaced apart axially from an adjacent row in the respective first grouping or second grouping by a first distance (see ‘First and Second Gap Distances’ Figure below),
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and wherein the first row grouping (first set of 4 rows on the first roughened portion 126) is spaced apart axially from the second row grouping (second set of 4 rows on the second roughened portion 126) by a gap (see ‘First and Second Gap Distances’ Figure above) where an outer surface of the cylindrical needle body is free of craters (see FIG. 15 and [0116-0118]), where the gap comprises a second distance (the axial length along which the gap extends) that is greater than the first distance (see [0118]: portions 126 have equal width and are arranged at equal intervales. Therefore the adjacent row first distance MUST be smaller than the gap second distance because the adjacent row first distance spans occurs three times—between each adjacent row set—within the same width of the gap second distance).
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).
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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 ‘Plurality of Rows’ Figure above) extends circumferentially about an entirety of the outer surface (see FIG.11) to cover a full cylinder (see ‘Modified FIG. 11’ below)
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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).
Regarding claim 21, Ooyauchi discloses a syringe (101, see FIG. 8 and [0088]. See also [0040-0047]: FIG. 8 includes disclosed embodiments of FIG. 14B and 15) comprising:
a syringe barrel (102) comprising a proximal end (proximal end of barrel terminates at flange, see ‘Modified FIG. 8’ below)
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and a distal end (see ‘Modified FIG. 8’ above), the distal end including a shoulder (see ‘Modified FIG. 8’ above) and a hub portion (105) extending out distally from the shoulder (see [0090]), with a channel (105a, see FIG.9 and [0090]) formed in the hub (105);
a plunger assembly (104a) movable within the syringe barrel (102) along a longitudinal axis to facilitate administering of an injectable fluid (see [0089]); and
an injection needle (103) is secured to the hub portion (105) within the channel (105a, see FIG. 9 and [0092]);
wherein the injection needle (103, see FIG. 15. Again see [0040-0047] needle of FIG.8 includes configurations described for FIG. 14B and 15) comprises:
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
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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 the embodiment of FIG. 14B, see [0114-0115]: needle 103 may have various forms of the roughened portions 126, such as the recesses as shown in FIG. 14B. See also [0116]: FIG. 15 has 3 roughened portions 126 along outer peripheral surface of needle), the textured outer surface (roughened portions 126) comprising a plurality of rows (see ‘Plurality of Rows’ below. Embodiment where FIG. 15 comprises roughened portions 126 as in FIG. 14B and supported in [0014-0015]. Each of the 3 roughened portions 126 in FIG. 15 comprise the 4rows or circumferential rows as shown in FIG. 14B and described in [0115], forming a total of 12rows),
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each of the plurality of rows (the 12 rows as in the figure ‘Plurality of rows’ above) comprising a plurality of craters (see ‘Modified FIG. 14B’ below and [0115]. ‘Modified FIG. 14B’ below only depicts 4 rows of the total 12 rows, but is provided to aid in visualization purposes)
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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 ‘Plurality of Rows’ figure above) are arranged axially along a length (see figure ‘Plurality of rows’ above and [0115], [0116], & [0118]) of the cylindrical needle body (see [0091]) at the proximal end (as shown in ‘Modified FIG. 15’ above); 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 (roughened portions 126) to a surrounding needle support (107, see FIG. 9 and [0093]).
Regarding claim 23, Ooyauchi discloses the syringe of claim 21, and Ooyauchi further discloses wherein the syringe barrel (102, see FIG. 8) is formed of a moldable polymeric material (see [0089]: resin material such as polycarbonate, a known material for injection molding), and wherein the needle (103) is attached to the hub portion (105) within the channel (105a, see FIG. 9) via an over-molding (see [0093-0096]: 107 pressed into port hole while being heated and fused and therefore port 105 is over-molded onto needle 103 by way of 107) of the hub (105) onto the textured outer surface (3 roughened portions 126 of FIG. 15 or shown as 106 in FIG. 9) of the cylindrical needle body (103).
Further, the recitation that the needle is attached to the hub portion within the channel “via an over-molding” is a product-by-process limitation. Therefore, regardless of the method of manufacturing that joins the needle to the hub portion, the joined needle and needle hub structure disclosed in Ooyauchi anticipates the claim (see MPEP § 2113.I: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.").
Regarding claim 25, Ooyauchi discloses the syringe of claim 21, and Ooyauchi further discloses wherein each of the plurality of rows (see ‘Plurality of Rows’ figure above) is immediately adjacent another of the plurality of rows (see ‘Modified FIG. 14Bi’ below).
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Regarding claim 26, Ooyauchi discloses the syringe of claim 21, and Ooyauchi further discloses wherein the plurality of rows (see ‘Plurality of rows’ figure above) comprises at least a first row grouping (first set of 4 rows on the first roughened portion 126) and a second row grouping (second set of 4 rows on the second roughened portion 126), each of the first row grouping (first set of 4 rows on the first roughened portion 126) and the second row grouping (second set of 4 rows on the second roughened portion 126) including a number of rows (4 rows as shown in ‘Fig. 14B’), and wherein the first row grouping (first set of 4 rows on the first roughened portion 126) is spaced apart axially from the second row grouping (second set of 4 rows on the second roughened portion 126) by a gap (see ‘First and Second Gap Distances’ Figure above in rejection of claim 13) where an outer surface of the cylindrical needle body is free of craters (see FIG. 15 and [0116-0118]).
Regarding claim 27, Ooyauchi discloses the syringe of claim 21, 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’ above with rejection of claim 16 align with as much as is disclosed by Applicant in FIGs.9-10 and [0048]) about the circumference thereof (see ‘Modified FIG. 14Biii’ above).
Regarding claim 31, Ooyauchi discloses the syringe of claim 21, and Ooyauchi further discloses wherein each of the plurality of rows (as seen in ‘Plurality of Rows’ Figure above) extends circumferentially about an entirety of the outer surface (see FIG.11) to cover a full cylinder (see ‘Modified FIG. 11’ below)
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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.
Claims 17 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Ooyauchi as applied to claims 13 and 21, respectively, above, and further in view of Brandt et al. (U.S. PGPUB No. 2019/0247590), hereinafter Brandt.
Regarding claims 17 and 28, Ooyauchi discloses the injection needle of claim 13 and the syringe of claim 21, respectively, 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 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ooyauchi (U.S. PGPUB No. 2016/0184532).
Regarding claims 18 and 29, Ooyauchi discloses the injection needle of claim 13 and the syringe of claim 21, respectively, but Ooyauchi (FIG.15 with roughened portions 126 of 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 crater 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 claims 19 and 30, Ooyauchi discloses the injection needle of claim 13 and the syringe of claim 21, respectively, and Ooyauchi further discloses wherein each of the plurality of rows (see ‘plurality of rows’ figure above) 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—see similar rejection for claim 20 above) 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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ooyauchi as applied to claim 21 above, and further in view of Lundquist (U.S. PGPUB No. 2012/0010573).
Regarding claim 22, Ooyauchi discloses the syringe of claim 21, and Ooyauchi discloses that using an adhesive to bond the outer surface of a needle body to a hub is known in the art (see [0007]).
Ooyauchi is silent to “comprising an adhesive applied onto the proximal end of the cylindrical needle body, with the adhesive filling the plurality of craters of the textured outer surface and forming a bond between the textured outer surface and the hub portion to secure the needle to the hub portion.”
However, Lundquist teaches a syringe (see FIG. 1D) comprising a syringe barrel (16) with a hub portion (16a), and an injection needle (12) secured to the hub portion (16a) within a channel (see FIG. 1F and [0039]). Lundquist further teaches the injection needle (12) comprising a textured surface (see surface in FIG. 2C and described in [0041]) with a plurality of craters (18, see [0041]) and the syringe comprising a material applied onto (see [0041]) the proximal end (12b) of the cylindrical needle body (12), with the material filling the plurality of craters of the textured outer surface (see [0041]: “…the polymeric material forming the distal end 17 or hub 200 flows into and fills in the notches 18 during the molding process, as described below, to provide enhanced friction and gripping force between the proximal end 12b and the distal end 17 or hub 200.”) and forming a bond between the textured outer surface and the hub portion to secure the needle to the hub portion (see [0041]).
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 modify the securement process of securing the needle to the hub disclosed in Ooyauchi to include flowing a material onto the proximal end of the needle to fill the plurality of craters of the textured outer surface as taught by Lundquist for the purpose of providing enhanced friction and gripping forces between the needle and hub (see [0041]), thus achieving “comprising” a material “applied onto the proximal end of the cylindrical needle body, with the” material “filling the plurality of craters of the textured outer surface and forming a bond between the textured outer surface and the hub portion to secure the needle to the hub portion.”
Ooyauchi in view of Lundquist (FIGs.1A-2C) remains silent to the securing material specifically comprising an “adhesive”.
However, Lundquist also teaches that the needle and hub securement may be achieved by other materials, such as adhesives (see [0066]: co-molded process of FIG.1A-2C may be replaced by adhesive bonding), and that such a process is known in the art (see [0004]).
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 select the material for bonding the hub and needle taught by Ooyauchi in view of Lundquist (Figs.1A-2C) to be an adhesive as taught by Lundquist for the purpose of using a known bonding method in the art that achieves securement of a needle hub to a needle (see [0004]), thus achieving the securing material specifically comprising an “adhesive”.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Ooyauchi as applied to claim 21 above, and further in view of Lindner et al. (U.S. PGPUB No. 2021/0300821), hereinafter Lindner.
Regarding claim 24, Ooyauchi discloses the syringe of claim 21, and Ooyauchi further discloses wherein the needle (103) is attached to the hub portion (105) within the channel (105a, see FIG. 9) via an over-molding (see [0093-0096]: 107 pressed into port hole while being heated and fused and therefore port 105 is over-molded onto needle 103 by way of 107) of the hub (105) onto the textured outer surface (3 roughened portions 126 of FIG. 15 or shown as 106 in FIG. 9) of the cylindrical needle body (103).
Further, the recitation that the needle is attached to the hub portion within the channel “via glass-forming” is a product-by-process limitation. Therefore, regardless of the method of manufacturing that joins the needle to the hub portion, the joined needle and needle hub structure disclosed in Ooyauchi anticipates the claim (see MPEP § 2113.I: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.").
Ooyauchi is silent to “wherein the syringe barrel is formed of glass,” and wherein the needle is attached to the hub portion within the channel via “glass-forming” of the hub onto the textured outer surface of the cylindrical needle body.
However, Lindner teaches a syringe (600, see Figure 6 and [0004-0005]) with a hub portion (610) secured to a cylindrical needle body (620) and a syringe barrel (only a portion of barrel is shown in FIG.6, see [0069]), wherein the syringe barrel is formed of glass (see [0069]: glass syringe with glass barrel), and wherein the needle (620) is attached to the hub portion (610) within a channel (see channel of 610 where proximal end of needle 620 is disposed in FIG. 6) via glass-forming (see [0006-0007] and [0072]: the glass syringe is heated during the process and therefore attached via ‘glass-forming’) of the hub onto the outer surface of the cylindrical needle body (see [0004-0005], [0069-0072]).
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 modify the securement between the syringe hub portion and the needle disclosed in Ooyauchi to be specifically a glass-forming securement between the needle and a glass syringe as taught by Lindner for the purpose of meeting regulatory requirements (see [0004-0005] & [0045]) while sufficiently bonding a needle to a glass syringe barrel, which is a known material forming syringes that is widely used in pharmaceutical and drug applications (see [0045]), thus achieving “wherein the syringe barrel is formed of glass,” and wherein the needle is attached to the hub portion within the channel via “glass-forming” of the hub onto the textured outer surface of the cylindrical needle body.
Response to Arguments
Applicant's arguments filed 04/22/26 have been fully considered but they are not persuasive.
A new interpretation of Ooyauchi has been applied in this rejection, effectively applying a new ground of rejection under 35 U.S.C. § 102 in view of the amended claim language. Therefore, the arguments are substantially moot and therefore non-persuasive.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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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.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights