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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 20th, 2026 has been entered.
Response to Amendment
The rejections pursuant to 112(a) are withdrawn in light of amendments.
The rejections pursuant to 112(b) are withdrawn in light of amendments.
Response to Arguments
Applicant’s arguments, see pages 13-19, filed on 04/20/2026, with respect to the rejection(s) of claim(s) 4, 7, 8, 10, 15 and 21-23 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of the previously applied reference due to the new amendments made to claims 10 and 16.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., formed circumferentially when viewed in the axial direction and integrally connected in the circumferential direction) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 4, 7, 8, 10, 15, and 21-24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mitsumoto (JP 2013111165 A).
Regarding claim 10, Mitsumoto discloses a syringe assembly comprising:
a syringe body (11 – Fig.1B) having a lumen configured to accommodate a medicinal solution (Fig.1B);
a nozzle portion at a tip end of the syringe body (20 - Fig.2);
a lock adapter (30 – Fig.1A) attached to an outer periphery of the nozzle portion (Fig.1A);
the nozzle portion including a slide portion on a base end side (See annotated Fig.2 above) and on which the lock adapter is slidable in an axial direction (1a – Fig.1A)(“the locking projection slides on the top” - Para [0041]), a luer tip on a tip end side of the slide portion (21 – Fig.2), and an annular rib (26 – Fig.2) extending and protruding in a circumferential direction along a boundary between the luer tip and the slide portion (Fig.2);
the lock adapter including a cylindrical body portion (31 – Fig.6A) surrounding the periphery of the nozzle portion, a base end portion (35 – Fig.4) having a base end surface perpendicular to the axial direction (Fig.4), and a claw portion (See annotated Fig.4 below) protruding to an inner peripheral side from the base end surface of the base end portion of the cylindrical body portion (Fig.4), the claw portion configured to determine a tip end position of the lock adapter by contacting the annular rib extending in the circumferential direction of the nozzle portion (Para [0037-0038]), which prevents movement of the lock adapter to the tip end side (“the lock nut 30 is prevented from falling off the opening” – Para [0037]), and wherein the claw portion of the lock adapter is in a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction (Fig.4 and Fig.5);
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wherein the slide portion of the nozzle portion includes a rotation restricting rib (22 – Fig.2) extending in the axial direction (Fig.2), and wherein the rotation restricting rib is inward of the claw portion of the lock adapter (“the locking projection of the lock nut is in pressure contact with the top of the rib” – Para [0041]);
a plurality of rotation restricting portions (See annotated Fig.5 below) protruding inward from an inner peripheral portion of the claw portion of the lock adapter (Fig.4), and wherein each of the plurality of rotation restricting portions comprises a pair of rotation restricting protrusions (38 – Fig.5) and a slide groove (37 – Fig.5) arranged between the pair of rotation restricting protrusions (Fig.5); and
wherein the annular rib includes notches (25 – Fig.2) that allow the pair of rotation restricting protrusions of the plurality of rotation restricting portions to pass at a portion of the annular rib adjacent to the rotation restricting rib in the circumferential direction upon the claw portion contacting the annular rib of the nozzle portion (“An insertion projection inserted into the groove” – Para [0037]).
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Regarding claim 4, Mitsumoto discloses the syringe assembly as recited above, wherein an inner peripheral surface of the claw portion has an inner diameter (D37 – Fig.5) slightly larger than the outer diameter of a slide portion (See annotated Fig.2 below) on a base end side of the nozzle portion (Fig. 7A)(As the claw portion is disposed over the slide portion, the claw portion would inherently possess a larger diameter), the lock adapter configured be slidable in the axial direction on the slide portion of the nozzle portion (“the lock nut moves between the tip end position and the retracted position, the locking projection slides on the top” – Para [0041]).
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Regarding claim 7, Mitsumoto discloses the syringe assembly as recited above, further comprising:
a tip end surface perpendicular to the axial direction on a tip end side of the cylindrical body portion (See annotated Fig.6A below).
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Regarding claim 8, Mitsumoto discloses the syringe assembly as recited above, further comprising:
a plurality of lock protrusions protrude toward the tip end side of cylindrical body portion (See annotated Fig.4 below).
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Regarding claim 15, Mitsumoto discloses the syringe assembly as recited above, wherein a tip end surface of the annular rib (26 – Fig.3) is gradually reduced in diameter and inclined toward the tip end side, and a base end surface of the annular rib is erected perpendicularly to the axial direction (See annotated Fig.3).
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Regarding claim 21, Mitsumoto discloses the syringe assembly as recited above, wherein the slide groove (37 – Fig.5) includes an inner periphery that is in a same position as an inner periphery of the claw portion in the circumferential direction (Fig.5).
Regarding claim 22, Mitsumoto discloses the syringe assembly as recited above, wherein the plurality of rotation restricting portions (See Annotated Fig.5 above) comprises two rotation restricting portions (Fig.5).
Regarding claim 23, Mitsumoto discloses the syringe assembly as recited above, wherein the pair of rotation restricting protrusions (38 – Fig.5) is separated from each other by the same width as that of the rotation restricting rib of the nozzle portion (“The locking projection of the lock nut is fitted into the locking recess formed in the rib” – Para [0035], even though Mitsumoto does not explicitly disclose that the they are the same width, the slide groove fitting into the rotation restricting rib inherently implies dimensional compatibility between the locking recess and rib).
Regarding claim 24, Mitsumoto discloses the syringe assembly as recited above, wherein the pair of rotation restricting protrusions of each of the plurality of rotation restricting portions are configured to prevent rotation of the lock adapter in the circumferential direction upon the claw portion contacting the annular rib of the nozzle portion (“Two fitting projections between the locking projections adjacent to each other in the circumferential direction of the lock nut are fitted into the grooves of the mouth. Thereby, the lock nut 30 can not rotate around the opening” – Para [0036]).
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mitsumoto in view of Iwase et al. (US Pub No. 20170197035 A1).
Regarding claim 5, Mitsumoto discloses the syringe assembly as recited above, wherein the cylindrical body portion (31 – Fig.4) has a circular insertion hole inside the cylindrical body portion (36 – Fig.5) but fails to explicitly disclose wherein an outer peripheral side of the cylindrical body portion has a hexagonal shape.
Iwase teaches a lock adapter (5 – Fig.2), wherein the outer peripheral side of the lock adapter’s cylindrical body (10 – Fig.2) portion has a hexagonal shape (“The lock main body portion… an outer circumference of a hexagonal shape” – Para [0034]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the lock adapter disclosed by Mitsumoto to be configured to have the outer peripheral side of the lock adapter’s cylindrical body portion to have a hexagonal shape as taught by Iwase to allow a user to easily turn the lock main body portion (Iwase, Para [0034]).
Regarding claim 6, Mitsumoto discloses the syringe assembly as recited above, further comprising:
a female screw (32 – Fig.4) on an inner peripheral portion of the cylindrical body portion, the inner peripheral portion facing the insertion hole (“A female screw is formed on the inner peripheral surface” – Para [0028]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsumoto.
Regarding claim 9, Mitsumoto discloses the syringe assembly as recited above, wherein the plurality of lock protrusions (See annotated Fig.4 above) are configured to make contact with an anti-loosening protrusion of a cap to prevent a loosening of the cap (It would be obvious to one in the ordinary skill in the art that the lock protrusions would make contact with an anti-loosening protrusion due to their shape, arrangement, and length).
However, Mitsumoto does not expressly disclose wherein each of the plurality of lock protrusions include an outer peripheral side having a quarter spherical shape.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer peripheral side shape of the plurality of lock protrusions since it has been held that mere changes in shape are obvious, MPEP 2144.04 IV B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). In the instant case, the device of Mitsumoto would not operate differently with the claimed shape of the outer peripheral side of the plurality of lock protrusions considering Mitsumoto discloses a half circular outer peripheral side of the plurality of lock protrusions. Further, applicant places no criticality on the shape claimed, indicating simply “Each lock protrusion has the outer peripheral side formed in a quarter spherical shape.” (Para [0036]).
Claims 11, 16-17, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mitsumoto in view of Kito et al. (US Pub No. 20060106349 A1).
Regarding claim 11, Mitsumoto discloses the syringe assembly as recited above, wherein the slide portion of the nozzle portion includes a rotation restricting rib extending in the axial direction (22 – Fig.2).
However, Mitsumoto does not expressly disclose wherein a protruding height of the rotation restricting rib is less than a protruding height of the annular rib.
Kito teaches a syringe assembly wherein a protruding height of a rotation restricting rib (226 – Fig.2) is less than a protruding height of an annular rib (227 – Fig.2).
it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the rotation restricting rib and annular rib as disclosed by Mitsumoto to have the height of the rotation restricting rib be less than the protruding height of the annular rib as taught by Kito since the annular rib restrains and inhibits the lock adapter from moving further towards the tip end, preventing the lock adapter from coming off the nozzle portion (Kito, Para [0119]).
Regarding claim 16, Mitsumoto discloses a prefilled syringe comprising:
a syringe body (11 – Fig.1B) having a lumen accommodating a medicinal solution (Fig.1B);
a gasket (95 – Fig.1B) configured to be inserted from a base end side of the syringe body to seal the lumen (Para [0027]);
a nozzle portion at a tip end of the syringe body (Fig.2);
a lock adapter attached to an outer periphery of the nozzle portion (30 – Fig.1A);
the nozzle portion including a slide portion on a base end side (See annotated Fig.2 above) and on which the lock adapter is slidable in an axial direction (1a – Fig.1A)(“the locking projection slides on the top” - Para [0041]), a luer tip on a tip end side of the slide portion (21 – Fig.2), and an annular rib extending and protruding in a circumferential direction along a boundary between the luer tip and the slide portion (26 – Fig.2);
the lock adapter including a cylindrical body portion (31 – Fig.6A) surrounding a periphery of the nozzle portion, a base end portion (35 – Fig.4) having a base end surface perpendicular to the axial direction (Fig.4), and a claw portion (See annotated Fig.4 from claim 10 above) protruding to an inner peripheral side from the base end surface of the base end portion of the cylindrical body portion (Fig.4);
wherein the claw portion is configured to determine a tip end position of the lock adapter by contacting the annular rib extending in the circumferential direction of the nozzle portion (Para [0037-0038]), which prevents movement of the lock adapter to the tip side end (“the lock nut 30 is prevented from falling off the opening” – Para [0037]), and the claw portion of the lock adapter having a circumferential shape when viewed from the axial direction and is integrally connected in the circumferential direction (Fig.4 and Fig.5);
wherein the slide portion of the nozzle portion includes a rotation restricting rib (22 – Fig.2) extending in the axial direction (Fig.2), and wherein the rotation restricting rib is inward of the claw portion of the lock adapter (“the locking projection of the lock nut is in pressure contact with the top of the rib” – Para [0041]);
a plurality of rotation restricting portions (See annotated Fig.5 above) protruding inward from an inner peripheral portion of the claw portion of the lock adapter (Fig.4), and wherein each of the plurality of rotation restricting portions comprises a pair of rotation restricting protrusions (38 – Fig.5) and a slide groove (37 – Fig.5) arranged between the pair of rotation restricting protrusions (Fig.5); and
wherein the annular rib includes notches (25 – Fig.2) that allow the pair of rotation restricting protrusions of the plurality of rotation restricting portions to pass at a portion of the annular rib adjacent to the rotation restricting rib in the circumferential direction upon the claw portion contacting the annular rib of the nozzle portion (“An insertion projection inserted into the groove” – Para [0037]).
However, Mitsumoto does not expressly disclose wherein the prefilled syringe comprising a cap screwed into the lock adapter to seal the nozzle portion.
Kito teaches a prefilled syringe comprising a cap (7 – Fig.10) screwed into a lock adapter (23 – Fig.10) to seal a nozzle portion (22 – Fig.10)(Para [0170]).
it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the prefilled syringe as disclosed by Mitsumoto to comprise a cap that is screwable into the lock adapter as taught by Kito so the nozzle portion can be isolated (hermetically sealed) from the outside of the syringe , by the cap (Kito, Para [0194]).
Regarding claim 17, Mitsumoto discloses the prefilled syringe as recited above, wherein the slide portion of the nozzle portion includes a rotation restricting rib extending in the axial direction (22 – Fig.2).
However, Mitsumoto does not expressly disclose wherein a protruding height of the rotation restricting rib is less than a protruding height of the annular rib.
Kito teaches a syringe assembly wherein a protruding height of a rotation restricting rib (226 – Fig.2) is less than a protruding height of an annular rib (227 – Fig.2).
it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the rotation restricting rib and annular rib as disclosed by Mitsumoto to have the height of the rotation restricting rib be less than the protruding height of the annular rib as taught by Kito since the annular rib restrains and inhibits the lock adapter from moving further towards the tip end, preventing the lock adapter from coming off the nozzle portion (Kito, Para [0119]).
Regarding claim 25, Mitsumoto discloses the prefilled syringe as recited above, wherein the pair of rotation restricting protrusions of each of the plurality of rotation restricting portions are configured to prevent rotation of the lock adapter in the circumferential direction upon the claw portion contacting the annular rib of the nozzle portion (“Two fitting projections between the locking projections adjacent to each other in the circumferential direction of the lock nut are fitted into the grooves of the mouth. Thereby, the lock nut 30 can not rotate around the opening” – Para [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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