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 on 02/23/26 has been entered in the case. Claims 1-5, 13-14 are pending for examination; claims 6-7 are withdrawn (please see Examiner Notes- Election/Restrictions below) and claims 8-12 are cancelled.
Examiner Notes - Election/Restrictions
As mentioned in the previous Non-Final Office Action 10/23/25, Examiner states as below:
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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.
Claims 1-5, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Yashiro et al. (US 7,318,818).
Regarding claim 1, Hamilton discloses a needle hub unit 18 provided with:
a recess 24 provided in a base end side 21 of a needle hub 18 and into which a tip portion 14 of an injection cylinder 11 is inserted;
a needle insertion through hole 26 provided on a tip side 23 of the needle hub 18 and communicating with the recess 24;
an injection needle 27 inserted into the recess 24 and the needle insertion through hole 26;
and elastic body 30, which is internally provided in the recess 24 from a side of an opening 19 of the recess 24 and a tip surface 24 of the elastic body 30 abuts on a bottom surface 25 of the recess 24, and which fills a gap between the tip of the injection cylinder 11 and the recess 24;
wherein,
a tip (taper portion of the needle 27, on the right side in the Fig. 1) and a base end (edge end of the needle 27, on the left side in the Fig. 4) is formed in a shape of a needle;
a guide recess (an open ends on each side of the elastic body and a lumen 35) for guiding the injection needle is provided, respectively, on a tip end surface 34 and a base end surface 31 along a direction toward the injection needle of the elastic body 30;
a solder 27’ is filled inside the needle insertion through hole; Note: it is well-known in the art that an adhesive can be replaced for the solder and performing same function of securing the needle. Also see the modification by Yashiro below.
a tip of the injection needle protrudes outside from the needle insertion through hole 26, Fig. 3;
the base end of the injection needle is exposed within the recess, see Fig. 6.
Note: although the Fig. 3 shows that the base end of the needle extends beyond the recess 24; however, a person skilled in the art would recognize that the length of the needle 27 can be formed in shorter length, as for intended use purpose and therefore, the base end of the needle is to be located within the recess 24. See Yashiro also.
In addition, the Fig. 6 also shows that the base end of the needle 27 is located within the recess 24.by internally providing the elastic body in the recess, the base end of the injection needle is punctured into the elastic body via the guide recess on the tip end surface and penetrates through the elastic body 30 via the guide recess on the base end surface.
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Hamilton does not disclose that: a) the guide recess on the tip end surface and the guide recess on the base end surface are each a bottomed recess that does not communicate with each other; b) an adhesive is filled inside the needle insertion through hole; wherein the injection needle is fixed by the adhesive.
Yashiro discloses a needle hub unit 11 comprising: a recess (wherein a plug 8 inserts therein) provided in a base end side of the needle hub; an elastic body 8, which is internally provided in the recess from a side of an opening of the recess, see Fig. 1; and a tip side of the elastic body abuts on a bottom surface of the recess; a guide recess 23 & 25 for guiding an injection needle 33 is provided, respectively, on a tip end surface 23 and a base end surface 25 along a direction toward the injection needle 33 of the elastic body, see Figs 1 & 7; wherein the guide recess on the tip end surface and the guide recess on the base end surface are each a bottomed recess that does not communicate with each other (when the injection needle 33 is not inserted through the elastic body, see Fig. 4);
an adhesive 45 (or 84) is filled inside the needle insertion through hole, see Fig. 3 or Fig. 6; and the injection needle 33 is fixed by the adhesive 45/84; a base end (adjacent to #41 in Fi. 9) of the injection needle 33 is exposed within the recess.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the elastic body of the device of Hamilton with providing two recesses on each side of the elastic body; wherein the two recesses being spaced by a distance (e.g., the two recesses are not being communicated with each other), the base end needle is exposed within the recess, as taught by Yashiro, in order to prevent leaking and prevent liquid communicate with each other before or after use.
Because both of Hamilton and Yashiro teach a securing in between the injection needle and the needle hub, it would have been obvious to one skilled in the art to substitute an equivalent element. i.e. elastic body adhesive for solder, to achieve the predictable result of firmly attaching in between the injection needle and the needle hub.
Regarding claim 2, Hamilton in view of Yashiro discloses all claimed subject matter as required. Hamilton further discloses that the guide recesses are provided, respectively, at a diameter substantially in a size as, or slightly larger than, an outer diameter of the injection needle. Alternatively, Yashiro discloses that the guide recesses are provided, respectively, at a diameter substantially in a size as, or slightly larger than, an outer diameter of the injection needle, see Fig. 3.
Regarding claim 3, Hamilton in view of Yashiro discloses all claimed subject matter as required. Because the elastic body has elasticity characteristic; therefore, the guide recesses are filled up when the elastic body is compressed by the injection cylinder, see Fig. 3 in Hamilton or Figs. 1-2 in Yashiro.
Regarding claim 4, Hamilton in view of Yashiro discloses all claimed subject matter as required. Hamilton further discloses that wherein the elastic body 32 is formed in vertical symmetric shape.
Regarding claim 5, Hamilton in view of Yashiro discloses all claimed subject matter as required. Hamilton further discloses that wherein the needle hub 18 is configured by a single member.
Regarding claim 13, this claim is being rejected using same analysis as noted the above with regard to claim 1. Hamilton in view of Yashiro discloses a needle hub 18 manufacturing method, for manufacturing the needle hub unit.
Hamilton in view of Yashiro discloses the method comprising:
Hamilton providing an injection needle 27 internally in a recess 24 and a needle insertion through hole 26; filling an adhesive (as modified by Yashiro, as mentioned in the rejection in claim 1 above) inside the needle insertion through hole; and inserting an elastic body 32 into the recess of the needle hub 18; whereby base/edge portion at proximal portion of the injection needle penetrates through the elastic body 32, see Fig. 3;
wherein the needle hub unit is the needle hub unit according to claim 1 (please see the rejection in claim 1 above)
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Yashiro et al. (US 7,318,818) and Groskopf et al. (US 10,463,810).
Regarding claim 14, this claim is being rejected using same analysis as noted the above with regard to claim 1. Hamilton in view of Yokota discloses an injection device 10 in Hamilton comprising: a needle hub unit according to claim 1; the injection cylinder 11/14 inserted into the recess 24 until the top of the injection cylinder abuts on the elastic body 32.
Hamilton does not disclose a piston inserted into the injection cylinder until the tip of the piston abuts on the elastic body.
Groskopf discloses a piston 30 is inserted into an injection cylinder 16 at nose or distal end portion of the injection cylinder 16 for sealing a distal end portion of the injection cylinder.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Hamilton in view of Yashiro with including piston being located at distal end portion of the injection cylinder, as taught by Groskopf, in order to seal a distal portion or inlet port of the injection cylinder and control the fluid into the needle.
Since the piston 30 of Groskopf is provided at a distal end portion of the injection cylinder 14. Therefore, the piston 30 (as modified by Groskopf) is inserted into the injection cylinder 16 until the tip/distal end of the piston 30 abuts on the elastic body.
Claim 14 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Yashiro et al. (US 7,318,818) and de Beer (US 9,913,949).
Regarding claim 14, this claim is being rejected using same analysis as noted the above with regard to claim 1. Hamilton in view of Yashiro discloses an injection device 10 in Hamilton comprising: a needle hub unit according to claim 1; the injection cylinder 11/14 inserted into the recess 24 until the top of the injection cylinder abuts on the elastic body 32.
Hamilton does not disclose a piston inserted into the injection cylinder until the tip of the piston abuts on the elastic body.
De Beer discloses a needle hub unit 200; an injection cylinder 110; a piston 400b is inserted into an injection cylinder 110 for sealing a distal end portion of the injection cylinder or locking engage the syringe tip, see Fig. 1
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Hamilton in view of Yashiro with including piston being located at distal end portion of the injection cylinder, as taught by De Beer, in order to seal a distal portion or inlet port of the injection cylinder and control the fluid into the needle or to lock an engagement of the syringe tip.
Since the piston 400b of De Beer is provided at a distal end portion of the injection cylinder 110. Therefore, the piston 400b (as modified by De Beer) is inserted into the injection cylinder until the tip/distal end of the piston abuts on the elastic body in Hamilton.
Response to Arguments
Applicant's arguments filed 07/01/26 have been fully considered but they are not persuasive.
1) Applicant argues that the hole 35 in the Hamilton’s stopper 35 that is a through-hole from the beginning, not bottomed recesses on each end surface that do not communicate with each other as recited in claim 1. Applicant further states that Hamilton does not disclose an adhesive filled inside the needle insertion through hole to fix the injection needle.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, while hole 35 of the stopper in Hamilton is a through-hole—which differs from the requirements of the claimed invention—Yashiro discloses the missing feature. Specifically, Yashiro discloses that the tip end surface and the guide recess on the base end surface are each a bottomed recess that do not communicate with each other for purpose of preventing leakage. Furthermore, Hamilton discloses a solder 27’ filled inside the needle insertion through-hole 35 to fix the injection needle 27, whereas the claimed invention requires an adhesive. A person skilled in the art would recognize that besides using solder, one could use alternative options, such as an adhesive, to secure the injection needle to the needle hub. Indeed, Yashiro explicitly discloses using an adhesive filled inside a needle insertion through-hole to bond the injection needle to the needle hub for securing purposes.
2) Applicant argues that the stopper 30 in Hamilton is pre-installed in the needle hub 18, then the needle 27 is inserted through the stopper’s hole 36. Similarly, in Yashiro, the plug 8 is installed first in the catheter hub, and then the insertion needle 33 is punctured through the plug from the proximal side.
In response, the claimed invention does not require the stopper to be pre-installed or permanently installed in the needle hub. Instead, the claimed invention simply requires that the stopper—namely, the elastic body—be provided in the recess of the needle hub. In addition, the elastic body 21 in Fig. 10a of the present application is also shown as pre-installed in the needle hub 3. The only difference between the stopper in Hamilton and the claimed invention is that Hamilton's guide recess on the tip end surface and guide recess on the base end surface are each a bottomed recess, and these recesses do not communicate with each other until the injection needle punctures the plug. However, this feature is disclosed in Yashiro.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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