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 .
Acknowledgments
In the reply, filed on December 3, 2025, Applicant amended claims 1-2 and 9-10.
Applicant cancelled claims 8 and 11.
In the non-final rejection of September 8, 2025, Examiner noted that the information disclosure statement filed September 13, 2022, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address this concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed November 20, 2023, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address this concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed February 27, 2024, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address this concern in the reply. Concern is maintained.
Examiner noted that Figure 1 should be designated by a legend such as --Prior Art--. Applicant submitted a replacement sheet for Figure 1. Concern is withdrawn.
Examiner objected to the Abstract. Applicant amended the Abstract; however, the amended Abstract was not presented on a separate sheet, apart from any other text. Objection is maintained.
Examiner objected to claims 1-2 and 8-10. Applicant amended claims 1-2 and 9-10, and cancelled claim 8. Objection is withdrawn.
Currently, claims 1-2 and 9-10 are under examination.
Information Disclosure Statement
The information disclosure statement filed September 13, 2022, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation has been provided for understanding of Written Opinion
The information disclosure statement filed November 20, 2023, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation has been provided for understanding of JPO Office Action
The information disclosure statement filed February 27, 2024, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation has been provided for understanding of JPO Office Action
Specification
The abstract of the disclosure is objected to because:
In line 1, “capable” should be changed to “the flow rate regulator capable”
In line 4, “thereinto” should be changed to “into the body”
In line 5, “thereto” should be changed to “to the body”
In line 6, “the front surface” should be changed to “a front surface”
In line 6, “thereof” should be changed to “of the body”
In line 8, “thereagainst” should be changed to “against the operating roller”
In line 10, “thereagainst” should be changed to “against the roller holder”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 10 is objected to because of the following informalities:
In regards to claim 10, line 2, “sides” should be changed to “the sides”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-2 and 9-10 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.
In regards to claim 1, lines 19-20 recite: wherein the locking parts are flexibly connected to the connection part so as to allow “controlled rotation with respect to the connection part”. It is unclear which component undergoes “controlled rotation with respect to the connection part”. Claims 2 and 9-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 20-21 recite: whereby “downward rotation locks the roller holder onto the body”. It is unclear which component undergoes “downward rotation”. Claims 2 and 9-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 21-22 recite: and “upward rotation” releases the roller holder from the locked state. It is unclear which component undergoes “upward rotation”. Claims 2 and 9-10 are rejected by virtue of being dependent upon claim 1.
Claim Rejections - 35 USC § 103
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 1-2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Starchevich (US 6,341,757), and further in view of Hirai (JP 2002-336351).
In regards to claim 1, Starchevich teaches a flow rate regulator (Figures 1-5, flow regulator 10) for intravenous injection, the flow rate regulator comprising:
a body (14/16/18) having a space portion (20) penetratedly formed into the body in an up and down direction to fittingly connect an infusion tube to the body and a roller connection hole (46/48) formed on a front surface of the body
an operating roller (22) fitted to the roller connection hole of the body, moving up and down along the roller connection hole, and pressurizing the infusion tube against the operating hole to allow a flow rate of an intravenous fluid to be regulated (Figure 1)
a roller holder (56) connected to the body to which the operating roller is fitted and supporting the operating roller against the roller holder to prevent the operating roller from arbitrarily moving (Figure 3)
wherein the roller holder comprises:
a connection part (middle portion of frame 56 between arms 58 and 60) fitted to the roller connection hole and connected to the operating roller
locking parts (58/60) connected respectively to both sides of the connection part and locked onto outer surfaces of the body to prevent the roller holder from moving so that the operating roller becomes locked (Figure 3)
Starchevich is silent about wherein the locking parts are flexibly connected to the connection part so as to allow controlled rotation with respect to the connection part, whereby downward rotation locks the roller holder onto the body and upward rotation releases the roller holder from the locked state. Hirai teaches a flow rate regulator (Figures 1-5) wherein locking parts (left and right portions of adhesive tape 10) are flexibly connected to a connection part (middle portion of adhesive tape 10) so as to allow controlled rotation with respect to the connection part, whereby downward rotation locks a roller holder (10) onto a body (7) (Figure 2b) and upward rotation releases the roller holder from the locked state (Figure 4a). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the locking parts, of the flow rate regulator of Starchevich, to be flexibly connected to the connection part so as to allow controlled rotation with respect to the connection part, as taught by Hirai, as such will allow for judging whether an illegal action has been performed during intravenous drip by confirming whether the roller holder is torn from the start to the end of intravenous drip (Abstract).
In regards to claim 2, in the modified flow rate regulator of Starchevich and Hirai, Starchevich teaches wherein the body comprises flow rate scales (72) indicated on the body to check the flow rate of the intravenous fluid discharged through the infusion tube according to the movement of the operating roller (Figure 1).
In regards to claim 10, in the modified flow rate regulator of Starchevich and Hirai, Starchevich teaches wherein the locking parts are located at both sides of the connection part, respectively, and have locking hooks (62/64) disposed on undersides of the locking parts and locked onto locking protrusions (66/68) formed on the outer surfaces of the body to allow the roller holder to be locked onto the body (Figure 3).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Starchevich and Hirai, as applied to claim 1 above, and further in view of Rychlik (US 3,625,472).
In regards to claim 9, in the modified flow rate regulator of Starchevich and Hirai, Starchevich teaches wherein the connection part comprises:
a moving plate (middle portion of frame 56 between arms 58 and 60) coming into close contact with a top surface of the body and having a fitting hole formed into the moving plate to fit an upward protruding portion of the operating roller (Figures 3-4)
However, Starchevich does not teach connection stands disposed on both sides of an underside of the moving plate and having fixing grooves formed on undersides of the connection stands, fitted to the roller connection hole and rotary shafts of the operating roller simultaneously, and allowing the roller holder to move together with the operating roller. Rychlik teaches a flow rate regulator (Figures 12-15) wherein a connection part comprises: connection stands (bearing bars 134) disposed on both sides of an underside of a moving plate (130/132) and having fixing grooves (136) formed on undersides of the connection stands, fitted to a roller connection hole (at top of body 22b) and rotary shafts (60b) of an operating roller (26b) simultaneously, and allowing a roller holder (24b) to move together with the operating roller. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection part, of the modified flow rate regulator of Starchevich and Hirai, to comprise connection stands having fixing grooves, as taught by Rychlik, as such will form a bearing to ride upon and cooperate with the free ends of the rotary shafts of the operating roller, such that the rotary shafts are placed under a strain or are slightly distorted downwardly at their extremities by the roller holder and hence are maintained in a constant pressure relationship with the plane of the reference surfaces of the body (column 5, lines 19-34) to insure maintenance of the operating roller in a chosen position along the axis of the body (column 3, lines 54-56) for controlling fluid flow through resilient tubing (Abstract).
Response to Arguments
Applicant's arguments filed December 3, 2025, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Applicant respectfully submits that the references relied upon in the rejection under 35 U.S.C. 102 or 35 U.S.C. 103, considered singly or in any proper combination, do not disclose such a combination of features. In particular, the locking parts are flexibly connected to the connection part so as to allow controlled rotation with respect to the connection part, whereby downward rotation locks the roller holder onto the body and upward rotation releases the roller holder from the locked state. Specifically, as shown, for example, in FIGS. 9, 10 and 14 of the present application, the locking parts (340) are connected respectively to both sides of the connection part (330) and flexibly connected to the connection part (330) so as to allow controlled rotation with respect to the connection part (330) (see FIG. 14), whereby downward rotation locks the roller holder (301) onto the body (100) (see FIG. 10) and upward rotation releases the roller holder (301) from the locked state (see FIG. 9). That is, this flexibility results from a coupling in which a thin connecting portion between two parts (i.e., between the locking part and the connection part) is physically configured to allow rotational movement. This feature is not disclosed in any of the cited references (Remarks, page 9). Examiner disagrees. First, in the combination of Starchevich and Hirai, Hirai renders obvious wherein locking parts (left and right portions of adhesive tape 10) are flexibly connected to a connection part (middle portion of adhesive tape 10) so as to allow controlled rotation with respect to the connection part, whereby downward rotation locks a roller holder (10) onto a body (7) (Figure 2b) and upward rotation releases the roller holder from the locked state (Figure 4a). Second, the claim does not require “a coupling in which a thin connecting portion between two parts (i.e., between the locking part and the connection part) is physically configured to allow rotational movement”, as argued by Applicant.
In regards to claim 1, Applicant argued: In Hirai, the central portion and side wings of the adhesive tape are made of the same flexible film material. The wings bend only due to the material flexibility of the tape itself, not through any structural or mechanical joint. The bending motion in Hirai is not controlled by any mechanical connection but merely results from the elastic deformation of the adhesive tape. Moreover, the purpose of such deformation in Hirai is to detect tampering during intravenous drip, not to perform any controlled locking or releasing function (Remarks, page 10). Examiner disagrees. First, the claim does not preclude the connection part and the locking parts from being made of the same flexible film material. Second, the claim does not require “any structural or mechanical joint” or “any mechanical connection”, as argued by Applicant. Third, Hirai renders obvious whereby downward rotation locks a roller holder (10) onto a body (7) (Figure 2b) and upward rotation releases the roller holder from the locked state (Figure 4a).
In regards to claim 1, Applicant argued: In contrast, in the presently claimed embodiment, the locking parts and the connection part are structural components of the same roller holder and are connected through a physical structural linkage that allows controlled up-and-down rotation. As described in paragraph [0094] of the specification, the locking parts are flexibly connected to the connection part so that they can gently rotate with respect thereto. This flexibility does not rely on material bending but is achieved through a designed joint portion that allows limited, controlled movement (Remarks, page 10). Examiner disagrees. The claim does not require the locking parts and the connection part are “connected through a physical structural linkage” that allows controlled up-and-down rotation and “a designed joint portion that allows limited, controlled movement”, as argued by Applicant.
In regards to claim 1, Applicant argued: Accordingly, unlike Hirai's film-type bending structure, the presently claimed embodiment provides a mechanically coupled structure that achieves a controlled locking and releasing function through a structural connection between components. Therefore, Hirai neither teaches nor suggests the claimed configuration in which the locking parts perform controlled rotation to selectively lock or release the roller holder (Remarks, page 10). Examiner disagrees. First, the claim does not require “a mechanically coupled structure” that achieves a controlled locking and releasing function through “a structural connection between components”, as argued by Applicant. Second, Hirai renders obvious wherein locking parts (left and right portions of adhesive tape 10) are flexibly connected to a connection part (middle portion of adhesive tape 10) so as to allow controlled rotation with respect to the connection part, whereby downward rotation locks a roller holder (10) onto a body (7) (Figure 2b) and upward rotation releases the roller holder from the locked state (Figure 4a).
In regards to claim 1, Applicant argued: Hirai discloses a tamper-detection structure, in which the left and right wings of an adhesive tape bend or tear due to the inherent material flexibility of the adhesive film. The "flexible connection" in Hirai is not a mechanical linkage that allows controlled rotation, but merely a property of the flexible tape material itself, which permanently deforms or tears to indicate whether tampering occurred during drip administration (Remarks, page 11). Examiner disagrees. First, the claim does not require “a mechanical linkage”, as argued by Applicant. Second, Hirai renders obvious wherein locking parts (left and right portions of adhesive tape 10) are flexibly connected to a connection part (middle portion of adhesive tape 10) so as to allow controlled rotation with respect to the connection part.
In regards to claim 1, Applicant argued: In contrast, Starchevich relates to a roller clamp-type flow rate regulator designed for precise and stable mechanical control of intravenous flow. Its components, including the roller holder, are rigidly structured and must maintain consistent engagement and alignment during operation. Incorporating Hirai's adhesive film structure into Starchevich's mechanical regulator would compromise the mechanical stability of the device, not improve it. A person of ordinary skill in the art would clearly recognize that such a modification is incompatible and technically unreasonable (Remarks, page 11). Examiner disagrees. In the combination of Starchevich and Hirai, modifying the locking parts, of the flow rate regulator of Starchevich, to be flexibly connected to the connection part so as to allow controlled rotation with respect to the connection part, as taught by Hirai, would provide the additional benefit of allowing for judging whether an illegal action has been performed during intravenous drip by confirming whether the roller holder is torn from the start to the end of intravenous drip (Abstract).
In regards to claim 1, Applicant argued: Moreover, in the presently claimed embodiment, the locking parts are structurally connected to the connection part so as to allow controlled rotation to enable the roller holder to be selectively locked or released. The functional effect of this connection is to maintain a stable locking state against external vibration or patient movement, which is entirely different from the tamper-indicating function of Hirai (Remarks, page 11). Examiner disagrees. The claim does not require “to maintain a stable locking state against external vibration or patient movement”, as argued by Applicant.
In regards to claim 1, Applicant argued: Accordingly, Hirai's teaching of a flexible adhesive film cannot reasonably be combined with the rigid mechanical structure of Starchevich. The Examiner's proposed combination is based on a different purpose and incompatible mechanisms, and would not have been made by a person of ordinary skill in the art (Remarks, page 11). Examiner disagrees. Both Starchevich and Hirai teach flow regulators, thus being in the same field of endeavor and reasonably combinable before the effective filing date of the claimed invention.
Conclusion
THIS ACTION IS MADE FINAL. 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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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783