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The rejections pursuant to 112(b) are withdrawn in light of cancelation of claim 3.
Response to Arguments
Applicant's arguments filed 1/8/2026 have been fully considered.
Regarding the rejections under 102 and 103, Applicant’s argument have been considered. The amendments to the claims overcome the 102 rejections over Mitsumoto and the 103 rejections over Mitsumoto in view of Kito and therefore the rejection is withdrawn. However, upon further consideration in light of the amendments to the claims, a new rejection is made over Mitsumoto as previously applied to claim 10 and a new rejection is made over Mitsumoto in view of Kito as previously applied to claim 16.
Applicant’s arguments to Mitsumoto are pertinent to the new rejection and therefore will be addressed below.
With regards to applicants’ argument under “Rejections under 35 U.S.C. § 102” on pages 10-13 of Remarks for claim 10, have been fully considered. Applicant argues that Mitsumoto discloses the insertion portions 38 (minimum diameter portions 38b) are arranged in the circumferential direction with rounded edges, rather than "the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction, and wherein each of the plurality of rotation restricting portions comprises a pair of rotation restricting protrusions and a slide groove arranged between the pair of rotation restricting protrusion” as recited in claim 10. This argument is not convincing as Mitsumoto does disclose that the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction as shown in figure 5 of Mitsumoto. Even though the rotation restricting protrusions (38 – Fig.5) are rounded edges, the plurality of them together form a circumferential shape and since each edge (rotation restricting protrusions) is rounded, they are formed in a circumferential shape.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-11, 15, and 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 10 discloses the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction. In Para [0038] of the specification, it discloses that the rotation restricting portions 31 are formed at some parts of the claw portion 30 in the circumferential direction but it is silent to the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction. Therefore, it is not clear how to make or use the invention because one having ordinary skill in the art would not know how to use or interpret the inner edges of the rotation restricting portions being formed in a circumferential shape. Claims 4-9, 11, 15, 21-23 are rejected upon being dependent on claim 10. The specification also fails to disclose a plurality of rotation restricting portions as there is support for two rotating restriction portions (31) as shown in Figure 4 but “plurality” can include more than two and thus there is not support for more than two rotation restricting portions.
Claims 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 16 discloses the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction. In Para [0038] of the specification, it discloses that the rotation restricting portions 31 are formed at some parts of the claw portion 30 in the circumferential direction but it is silent to the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction. Therefore, it is not clear how to make or use the invention because one having ordinary skill in the art would not know how to use or interpret the inner edges of the rotation restricting portions being formed in a circumferential shape. Claim 17 is rejected upon being dependent on claim 16. The specification also fails to disclose a plurality of rotation restricting portions as there is support for two rotating restriction portions (31) as shown in Figure 4 but “plurality” can include more than two and thus there is not support for more than two rotation restricting portions.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-11, 15-17 and 21-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the statement “the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction” renders the claim indefinite because it is unclear whether ”inner edges formed in a circumferential shape” in line 21, is referring to each of the rotation restricting portion’s inner edge being in a circumferential shape or the plurality of rotation restricting portions inner edge, as a whole, are formed in a circumferential shape. For purposes of examination, the examiner interprets the limitation of “the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction”, as the plurality of rotation restricting portion’s inner edge, as a whole, is formed in a circumferential shape. Claims 4-9, 11, 15, 21-23 are rejected upon being dependent on claim 10.
Regarding claim 16, the statement “the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction” renders the claim indefinite because it is unclear whether ”inner edges formed in a circumferential shape” in line 21, is referring to each of the rotation restricting portion’s inner edge being in a circumferential shape or the plurality of rotation restricting portions inner edge, as a whole, are formed in a circumferential shape. For purposes of examination, the examiner interprets the limitation of “the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction”, the plurality of rotation restricting portion’s inner edge, as a whole, are formed in a circumferential shape. Claim 17 is rejected upon being dependent on claim 16.
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, 21-23 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 and a claw portion (35 – Fig.4) protruding to an inner peripheral side from a 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 being caught in the annular rib extending in the circumferential direction of the nozzle portion (Para [0037-0038]), 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);
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), the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction (See annotated Fig.5 below), 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 (“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).
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 and 16-17 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, and a claw portion (35 – Fig.4) protruding to an inner peripheral side from a 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 being caught in the annular rib extending in the circumferential direction of the nozzle portion (Para [0037-0038]), 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), the plurality of rotation restricting portions having an inner edge formed in a circumferential shape when viewed from the axial direction (See annotated Fig.5 above), 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 (“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]).
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.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783