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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a liquid blocking unit” in claims 9 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-18 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.
The term “significant” in claims 1, 10, and 18 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the change in flow speed is indefinite.
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.
Claim(s) 1, 2, 4, 9-11, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2013/0310743 A1) in view of Ruhland (US 2021/0379267 A1).
With regard to claims 1 and 4, Yagi et al. teach an infusion apparatus, comprising: a liquid driver (Fig. 2 at least 23 and 30) configured to be connected to at least one infusion supply unit (Fig. 2 member 2); wherein the liquid driver is connected to one end of a tube (Fig. 2 tube 4), and another end of the tube is connected to a needle (Fig. 2 needle 5); a detection unit configured to test a state of a section of the tube adjacent to the needle to correspondingly generate a detected signal (Fig. 7 unit 7, [0129]); a controller electrically connected to the liquid driver and the detection unit (Fig. 2 controller 22); wherein the controller is configured to control the liquid driver to be operated, so that an input liquid from the at least one infusion supply unit is injected and a blood return detecting procedure is performed by the controller (Figs. 5-7); and wherein the blood return detecting procedure comprises: controlling the liquid driver to stop operating to reduce a hydraulic pressure in the tube ([0105]); and controlling the detection unit to detect the state of the section of the tube adjacent to the needle to generate the detected signal, so as to determine whether or not the blood of the living body returns to the section of the tube adjacent to the needle (Figs. 5-7, S5, S25, S45); wherein, in response to the blood of the living body not returning to the section of the tube adjacent to the needle, an extravasation is determined to have occurred and a notification data is correspondingly generated (exemplary [0147], Figs. 5-7 s11, s32, s52); wherein, in response to determining that the blood returns to the section of the tube adjacent to the needle, the extravasation is determined to not have occurred and the liquid driver is re-operated (exemplary [0146], Figs. 5-7 s7, s27, s47). Yagi et al. teach confirming if extravasation occurs but do not teach that the blood return detecting procedure is in response to a significant change in a flow speed. However, Ruhland teaches an extravasation detection procedure is done in conjunction with flow rate detection (Fig. 6). Ruhland teaches that using flow rate allows for more accurate detection ([0008]-[0012], [0063]). Further, if the needle is dislodged the flow rate would necessarily change indicating a possible extravasation which may need to be confirmed. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use flow rate as an initial marker to trigger extravasation detection in Yagi et al. as Ruhland teaches this to allow for more accurate detection and would allow for detection more quickly.
With regard to claim 2, see Fig. 2 emitter 8 receiver 9.
With regard to claim 9 see Figs. 4 21T.
With regard to claim 10, Yagi et al. teach a method for detecting extravasation applied in an infusion apparatus, wherein the infusion apparatus is connected to a tube (Fig. 2 tube 4), and one end of the tube is connected to a needle (Fig. 2 needle 5), the method comprising: stop injecting an input liquid from at least one infusion supply unit to reduce a hydraulic pressure in the tube ([0105]); and detecting a state of a section of the tube adjacent to the needle to correspondingly generate a detecting signal and determining whether or not the blood of the living body returns to the section of the tube adjacent to the needle according to the detecting signal (Figs. 5-7, S5, S25, S45); in response to determining that the blood does not return to the section of the tube adjacent to the needle, the extravasation is determined to have occurred and a notification data is correspondingly generated (exemplary [0147], Figs. 5-7 s11, s32, s52); and in response to determining that the blood returns to the section of the tube adjacent to the needle, the extravasation is determined to not have occurred and the liquid driver is re-operated (exemplary [0146], Figs. 5-7 s7, s27, s47). Yagi et al. teach confirming if extravasation occurs but do not teach that the blood return detecting procedure is in response to a significant change in a flow speed. However, Ruhland teaches an extravasation detection procedure is done in conjunction with flow rate detection (Fig. 6). Ruhland teaches that using flow rate allows for more accurate detection ([0008]-[0012], [0063]). Further, if the needle is dislodged the flow rate would necessarily change indicating a possible extravasation which may need to be confirmed. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use flow rate as an initial marker to trigger extravasation detection in Yagi et al. as Ruhland teaches this to allow for more accurate detection and would allow for detection more quickly.
With regard to claim 11, see Fig. 2 emitter 8 receiver 9.
With regard to claim 17, see Figs. 4 21T.
Claim(s) 3 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2013/0310743 A1) and Ruhland (US 2021/0379267 A1) as applied to claims 1 and 10 above, and further in view of Crane et al. (US 2004/0215081 A1).
With regard to claims 3 and 12, Yagi et al. teach ad device and method substantially as claimed. Yagi et al. do not disclose an image capture device. However, Crane et al. teach using imaging to detect extravasation to allow for real-time detection ([0011], [0014]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use image capture in Yagi et al. as Crane et al. teach this is beneficial for real-time detection of extravasation.
Claim(s) 5, 6, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2013/0310743 A1) and Ruhland (US 2021/0379267 A1) as applied to claims 1 and 10 above, and further in view of Kucklick (US 2008/0172013 A1).
With regard to claims 5, 6, 13, and 14, Yagi et al. teach ad device and method substantially as claimed. Yagi et al. do not disclose withdrawing fluid or an auxiliary liquid. However, Kucklick teaches using suction and dilution to remove dangerous infusates when extravasation is detected ([0032]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use withdrawal and a diluting liquid in Yagi et al. as Kucklick teaches this is beneficial to remove dangerous infusates when extravasation is detected.
Claim(s) 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2013/0310743 A1) and Ruhland (US 2021/0379267 A1) as applied to claims 1 and 10 above, and further in view of Kalafut et al. (US 2007/0276327 A1).
With regard to claims 7 and 15, Yagi et al. teach ad device and method substantially as claimed. Yagi et al. do not disclose a test. However, Kalafut et al. teach delivering a test injection of a benign liquid to do a preliminary check for patency/extravasation ([0059]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a test in Yagi et al. as in Kalafut et al. as this is beneficial to check for proper placement before beginning the procedure.
Claim(s) 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2013/0310743 A1) and Ruhland (US 2021/0379267 A1) as applied to claims 1 and 10 above, and further in view of Yagi (US 2018/0001022 A1).
With regard to claims 8 and 16, Yagi et al. teach ad device and method substantially as claimed. Yagi et al. do not disclose a block detector. However, Yagi ‘022 teaches detecting a blockage via a pressure sensor and stopping delivery if detected ([0053], [0054]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use blockage detection in Yagi et al. as Yagi ‘022 teach this is beneficial for detecting an occlusion.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. (US 2013/0310743 A1) and Ruhland (US 2021/0379267 A1) as applied to claim 10 above, and further in view of Reichenbach et al. (US 2011/0313238 A1).
With regard to claim 18, Yagi et al. and Ruhland teach a device substantially as claimed. Ruhland teaches a variety of flow rate detectors may be used ([0045]) but does not specifically teach using the current of the motor. However, Reichenbach et al. teach motor current is sensed which is then used to compute flow rate ([0063]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use motor current to determine flow rate in Yagi et al. and Ruhland as Reichenbach et al. teach this is an art effective means for determination and would yield the same predictable result.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brabrand (US 2004/0176690 A1) teaches that when a cannula becomes dislodged a change in flow rate occurs (abstract, [0045]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783