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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 13, 2026, has been entered.
Acknowledgments
In the reply, filed on July 13, 2026, Applicant requested the consideration of the amendment of June 11, 2026. The amendment is now considered.
Applicant amended claim 1.
Applicant cancelled claims 9-10.
In the final rejection of March 12, 2026, 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 objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claim 10. Applicant cancelled claim 10. Objection is withdrawn.
Examiner rejected claims 1-2 and 9-10 under 35 U.S.C. 112(b). Applicant amended claim 1. Rejection is withdrawn.
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
Claim Objections
Claim 1 is objected to because of the following informalities:
In regards to claim 1, line 29, “the locking part” should be changed to “each of the locking parts”.
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 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, line 35 recites “the locked state”. There is insufficient antecedent basis for this limitation in the claim. Claim 2 is 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 are rejected under 35 U.S.C. 103 as being unpatentable over Starchevich (US 6,341,757), and further in view of Rychlik (US 3,625,472) and 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, connected to the operating roller, and configured to move together with the operating roller (column 6, lines 66-67)
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)
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)
wherein each of the locking parts have a locking hook (62/64) disposed on an underside of the locking part and projecting downward to be locked onto a corresponding locking protrusion (66/68) formed on an outer surface of the body (Figure 3)
the locking parts locks the roller holder onto the body by engagement between the locking hooks and the locking protrusions (Figure 3)
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, wherein the connection stands are fitted between the roller connection hole and the operating roller, and rotary shafts of the operating roller are fitted into the fixing grooves, so that the operating roller and the roller holder move simultaneously along the roller connection hole, and wherein the locking parts are flexibly connected to the connection part such that the locking parts rotate with respect to the connection part, whereby downward rotation of the locking parts locks the roller holder onto the body by engagement between the locking hooks and the locking protrusions, and upward rotation of the locking parts releases the roller holder from the locked state. 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, wherein the connection stands are fitted between a roller connection hole (at top of body 22b) and an operating roller (26b), and rotary shafts (60b) of the operating roller are fitted into the fixing grooves, so that the operating roller and a roller holder (24b) move simultaneously along the roller connection hole (Figures 12-13). 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 flow rate regulator of Starchevich, 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).
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) such that the locking parts rotate with respect to the connection part, whereby downward rotation of the locking parts locks a roller holder (10) onto a body (7) (Figure 2b), and upward rotation of the locking parts 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 modified flow rate regulator of Starchevich and Rychlik, to be flexibly connected to the connection part such that the locking parts rotate 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 the combination of Starchevich, Rychlik, and Hirai, it is understood that there would be engagement between the locking hooks and the locking protrusions, as taught by Starchevich, when downward rotation of the locking parts locks the roller holder onto the body, as taught by Hirai.
In regards to claim 2, in the modified flow rate regulator of Starchevich, Rychlik, 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).
Response to Arguments
Applicant's arguments filed June 11, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Applicant respectfully submits that the cited combination does not teach or suggest this claimed arrangement as a whole (Remarks, page 7). Examiner disagrees. The combination of Starchevich, Rychlik, and Hirai renders obvious the claimed flow rate regulator of claim 1, as in the rejection above.
In regards to claim 1, Applicant argued: Starchevich does not disclose that its alleged locking parts rotate with respect to a connection part to selectively lock and release the roller holder in this manner. Starchevich's hooks are not part of a claimed assembly in which the same roller holder (301) is connected to the operating roller (200) through connection stands (332) and fixing grooves (332a) so as to move simultaneously with the operating roller (200) along the roller connection hole (120). Thus, even assuming that Starchevich discloses hooks and corresponding protrusions, Starchevich does not disclose the claimed cooperative relationship between the roller holder and the operating roller, nor the claimed lock/release operation in which rotation of the locking parts relative to the connection part selectively locks or releases the roller holder (Remarks, page 8). Examiner disagrees. In the combination of Starchevich, Rychlik, and Hirai, Hirai renders obvious that the locking parts (left and right portions of adhesive tape 10) rotate with respect to the connection part (middle portion of adhesive tape 10), whereby downward rotation of the locking parts locks a roller holder (10) onto a body (7) (Figure 2b), and upward rotation of the locking parts releases the roller holder from the locked state (Figure 4a). And Rychlik renders obvious 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, wherein the connection stands are fitted between a roller connection hole (at top of body 22b) and an operating roller (26b), and rotary shafts (60b) of the operating roller are fitted into the fixing grooves, so that the operating roller and a roller holder (24b) move simultaneously along the roller connection hole (Figures 12-13).
In regards to claim 1, Applicant argued: Applicant respectfully submits that this mapping is not proper. Hirai's left and right portions of adhesive tape 10 are not locking parts of a roller holder that has a connection part fitted to a roller connection hole and connected to an operating roller. Hirai's adhesive tape is a tamper-indicating tape. Its side portions may bend or be lifted relative to a middle portion, but that bending does not correspond to the claimed rotation of locking parts that lock the roller holder onto the body by engagement between locking hooks and locking protrusions and release the roller holder from the locked state by upward rotation (Remarks, page 8). Examiner disagrees. In the combination of Starchevich, Rychlik, and Hirai, Starchevich teaches the locking parts (58/60) locks the roller holder (56) onto the body (14/16/18) by engagement between the locking hooks (62/64) and the locking protrusions (66/68) (Figure 3). And 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), whereby downward rotation of the locking parts locks a roller holder (10) onto a body (7) (Figure 2b), and upward rotation of the locking parts releases the roller holder from the locked state (Figure 4a). In the combination of Starchevich, Rychlik, and Hirai, it is understood that there would be engagement between the locking hooks and the locking protrusions, as taught by Starchevich, when downward rotation of the locking parts locks the roller holder onto the body, as taught by Hirai.
In regards to claim 1, Applicant argued: Hirai does not disclose locking hooks disposed on undersides of locking parts and projecting downward to be locked onto corresponding locking protrusions formed on outer surfaces of the body. Nor does Hirai disclose that upward rotation of such locking parts releases a roller holder from a locked state established by hook/protrusion engagement. Hirai's tape structure may indicate tampering when the tape is peeled, lifted, torn, or otherwise disturbed, but that is different from the claimed hook/protrusion-based lock/release mechanism of a roller holder (Remarks, pages 8-9). Examiner disagrees. First, in the combination of Starchevich, Rychlik, and Hirai, the primary reference of Starchevich already teaches wherein each of the locking parts (58/60) have a locking hook (62/64) disposed on an underside of the locking part and projecting downward to be locked onto a corresponding locking protrusion (66/68) formed on an outer surface of the body (14/16/18) (Figure 3), thus not having to be taught by the secondary reference of Hirai. Second, the claim does not require that upward rotation of such locking parts releases a roller holder from a locked state “established by hook/protrusion engagement”, as argued by Applicant. The claim instead recites: upward rotation of the locking parts releases the roller holder from the locked state. Hirai renders obvious wherein upward rotation of the locking parts (left and right portions of adhesive tape 10) releases the roller holder (10) from the locked state (Figure 4a).
In regards to claim 1, Applicant argued: Rychlik therefore does not disclose the claimed structural relationship in which the connection stands are fitted between the roller connection hole and the operating roller and cooperate with the fixing grooves and rotary shafts so that the operating roller and the roller holder move simultaneously along the roller connection hole. Further, Rychlik does not disclose or suggest integrating such alleged bearing bars/grooves with locking parts that rotate relative to a connection part to lock and release the roller holder by engagement between downwardly projecting locking hooks and locking protrusions on the outer surfaces of the body. Rychlik also does not teach or suggest the claimed integrated arrangement in which the connection stands are fitted between the roller connection hole and the operating roller, the rotary shafts are fitted into the fixing grooves so that the operating roller and the roller holder move simultaneously along the roller connection hole, and the locking parts of that same roller holder rotate to lock or release the roller holder by engagement between the locking hooks and the locking protrusions (Remarks, page 9-10). Examiner disagrees. First, in the combination of Starchevich, Rychlik, and Hirai, Rychlik renders obvious wherein the connection stands (bearing bars 134) are fitted between a roller connection hole (at top of body 22b) and an operating roller (26b), and rotary shafts (60b) of the operating roller are fitted into the fixing grooves (136), so that the operating roller and a roller holder (24b) move simultaneously along the roller connection hole (Figures 12-13). Second, the claim does not require “integrating” [the connection stands having fixing grooves] with locking parts that rotate relative to a connection part to lock and release the roller holder by engagement between downwardly projecting locking hooks and locking protrusions on the outer surfaces of the body, as argued by Applicant. In other words, the claim does not require the connection stands having fixing grooves and the locking parts to work together. Third, Starchevich teaches the locking parts (58/60) locks the roller holder (56) onto the body (14/16/18) by engagement between the locking hooks (62/64) and the locking protrusions (66/68) (Figure 3). And 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), whereby downward rotation of the locking parts locks a roller holder (10) onto a body (7) (Figure 2b), and upward rotation of the locking parts releases the roller holder from the locked state (Figure 4a). In the combination of Starchevich, Rychlik, and Hirai, it is understood that there would be engagement between the locking hooks and the locking protrusions, as taught by Starchevich, when downward rotation of the locking parts locks the roller holder onto the body, as taught by Hirai.
In regards to claim 1, Applicant argued: The Examiner's proposed combination therefore appears to rely on a hindsight reconstruction of Applicant's claimed assembly. Starchevich is relied upon for a general roller clamp and hook structure, Hirai is relied upon for bending side portions of an adhesive tape, and Rychlik is relied upon for bearing bars and grooves. However, the cited references do not teach or suggest combining these isolated features to form the amended claim as a whole: a roller holder that moves simultaneously with the operating roller along the roller connection hole through the fitted relationship among the connection stands, fixing grooves, and rotary shafts, and that is selectively locked and released by rotation of locking parts through engagement between locking hooks and locking protrusions (Remarks, page 10). Examiner disagrees. First, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Starchevich, Rychlik, and Hirai all teach flow rate regulators, thus being in the same field of endeavor and reasonably combinable before the effective filing date of the claimed invention. Second, in the combination of Starchevich, Rychlik, and Hirai, Rychlik renders obvious wherein the connection stands (bearing bars 134) are fitted between a roller connection hole (at top of body 22b) and an operating roller (26b), and rotary shafts (60b) of the operating roller are fitted into the fixing grooves (136), so that the operating roller and a roller holder (24b) move simultaneously along the roller connection hole (Figures 12-13). And Starchevich teaches the locking parts (58/60) locks the roller holder (56) onto the body (14/16/18) by engagement between the locking hooks (62/64) and the locking protrusions (66/68) (Figure 3). And 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), whereby downward rotation of the locking parts locks a roller holder (10) onto a body (7) (Figure 2b), and upward rotation of the locking parts releases the roller holder from the locked state (Figure 4a). In the combination of Starchevich, Rychlik, and Hirai, it is understood that there would be engagement between the locking hooks and the locking protrusions, as taught by Starchevich, when downward rotation of the locking parts locks the roller holder onto the body, as taught by Hirai.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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