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 .
Drawings
The drawings are objected to as failing to adequately use solid black lines. 37 CFR 1.84(a)(1) requires black ink to secure solid black lines and 37 CFR 1.84(l) states that every line must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “18” and “19” have both been used to designate a pinch valve, “54” and “56” have both been used to designate a guide cover, “76” and “83” have both been used to designate a cylindrical tubular body, and “78” and “79” have both been used to designate a flow path hole. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
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: the “opening and blocking unit in claims 9-11 and the “spherical body detecting unit” in claims 6 and 7.
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. The “opening and blocking unit” in claims 9-11 have been interpreted as at least the cylindrical space, first end portion, second end portion, and spherical body; and the “spherical body detecting unit” in claims 6 and 7 have been interpreted as a sensor.
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 9, 10, and 12-15 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.
Claims 9 and 10 recite instances when the “power supply to the contrast medium injection system is shut off.” It is unclear if the claim is stating that the entire system is actually being turned off or if it is perhaps only power to the valve mechanism or both. There doesn’t seem to be a reason for the entire system to just be turned off, if the claim is referring to a default state that the valve takes when there is a situation in which there is a power outage, then such a limitation should be clarified and details of the valve should be included.
Claim 12 recites a “bridge” but it is unclear how or why a bridge would only be attached to a single element, namely, the downstream-side fluid injection flow path. Bridges are understood as linking two elements, it is unclear if the bridge here is actually attached to another element or perhaps attached to two different points of a single element. In either case, if the intended structure is intended to “bridge” at least two points, clarification is required.
Claims 13-15 are rejected by virtue of being dependent on a rejected base claim.
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 1-3, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2004357985 to Obayashi (“Obayashi”) in view of U.S. Patent Publication No. 2021/0353396 to Russell et al. (“Russell”).
Regarding claim 1, Obayashi teaches a contrast medium injection system (Fig. 1) comprising at least one fluid injection flow path (108), and an opening and blocking unit (122) provided in the fluid injection flow path, but does not show the details of the opening and blocking unit.
Russell teaches an opening and blocking unit (Fig. 25a-b) comprising a generally cylindrical space (111) provided therein and a spherical body (14) that is disposed so as to be movable between a first end portion (4) and a second end portion (arms extending from 112a) opposite to the first end portion in the generally cylindrical space, and the spherical body blocks the fluid injection flow path when the spherical body is in close contact with the first end portion ([0119]), and the fluid injection flow path is opened when a state in which the spherical body is in close contact with the first end portion is released ([0006]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the opening and blocking unit of Obayashi with the opening and blocking unit of Russell to yield the predictable result of providing a selective switching valve. Obayashi already discloses the generic use of a switching valve, Russell merely teaches an example of a switching valve in an analogous system as would be understood by one of ordinary skill.
Regarding claim 2, Obayashi and Russell teach the contrast medium injection system according to claim 1 as shown above, Russell further teaching the spherical body maintains a state in which the fluid injection flow path is opened when the spherical body is in close contact with the second end portion ([0006]).
Regarding claim 3, Obayashi and Russell teach the contrast medium injection system according to claim 1 as shown above, Russell further teaching the second end portion is a tubular body (right-most section of 112a in Fig. 25b) that has a through hole (Fig. 25a) in an axial direction therein and a through channel (channels formed between arms of tubular body as previously defined) that extends from the through hole to an outer circumferential surface of the tubular body (Fig. 25b).
Regarding claim 9, Obayashi teaches a contrast medium injection system (Fig. 1) comprising a fluid injection flow path (108) a liquid pressure measuring unit (104) installed in the fluid injection flow path and an opening and blocking unit (122) that is installed in the fluid injection flow path and is configured to open and block the fluid injection flow path, but does not show the details of the opening and blocking unit (see claim interpretation above).
Russell teaches an opening and blocking unit (Fig. 25a-b) comprising a generally cylindrical space (111) provided therein and a spherical body (14) that is disposed so as to be movable between a first end portion (4) and a second end portion (arms extending from 112a) opposite to the first end portion in the generally cylindrical space, and the spherical body blocks the fluid injection flow path when the spherical body is in close contact with the first end portion ([0119]), and the fluid injection flow path is opened when a state in which the spherical body is in close contact with the first end portion is released ([0006]), wherein the opening and blocking unit opens the fluid injection flow path when power supply to the contrast medium injection system is shut off ([0006], with no power, the magnet would not hold the ball valve therefore allowing fluid to flow). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the opening and blocking unit of Obayashi with the opening and blocking unit of Russell to yield the predictable result of providing a selective switching valve. Obayashi already discloses the generic use of a switching valve, Russell merely teaches an example of a switching valve in an analogous system as would be understood by one of ordinary skill.
Regarding claim 11, Obayashi teaches an injection line kit (Fig. 1) comprising at least one fluid injection flow path (108), an opening and blocking unit (122) that is provided in the fluid injection flow path and is configured to open and block the fluid injection flow path, and a connector (see annotated Fig. 1 below) provided upstream of the opening and blocking unit, wherein a downstream-side fluid injection flow path including the opening and blocking unit of the fluid injection flow path is configured to be attachable and detachable via the connector with respect to an upstream-side fluid injection flow path of the fluid injection flow path ([0050], 108 is detachable), but does not show the details of the opening and blocking unit (see claim interpretation above).
Russell teaches an opening and blocking unit (Fig. 25a-b) comprising a generally cylindrical space (111) provided therein and a spherical body (14) that is disposed so as to be movable between a first end portion (4) and a second end portion (arms extending from 112a) opposite to the first end portion in the generally cylindrical space, and the spherical body blocks the fluid injection flow path when the spherical body is in close contact with the first end portion ([0119]), and the fluid injection flow path is opened when a state in which the spherical body is in close contact with the first end portion is released ([0006]), wherein the opening and blocking unit opens the fluid injection flow path when power supply to the contrast medium injection system is shut off ([0006], with no power, the magnet would not hold the ball valve therefore allowing fluid to flow). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the opening and blocking unit of Obayashi with the opening and blocking unit of Russell to yield the predictable result of providing a selective switching valve. Obayashi already discloses the generic use of a switching valve, Russell merely teaches an example of a switching valve in an analogous system as would be understood by one of ordinary skill.
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Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Obayashi and Russell as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2019/0358387 to ELBADRY et al. (“Elbadry”).
Regarding claim 4, Obayashi and Russell teach the contrast medium injection system according to claim 1 as shown above, Russell further teaching the opening and blocking unit including a container (11) and the generally cylindrical space (111) is formed in the container (Fig. 25a), but Russell does not explicitly mention the container having a transparent portion.
Elbadry teaches a container (Figs. 76A-B) that has a transparent portion ([0154]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a portion of the container of Russell transparent to yield the predictable result of allowing a user to view the status of the ball of valve or to allow for an optical sensor arrangement to be used. Additionally, it would have been an obvious design choice to modify the container of Russell to have a transparent portion since Applicant has not disclosed that having a transparent container solves any stated problem or provides any unexpected result, and it appears that the container of Russell would perform equally well with a transparent portion.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Obayashi and Russell as applied to claim 1 above, and further in view of U.S. Patent No. 5,205,819 to Ross et al. (“Ross”).
Regarding claim 5, Obayashi and Russell teach the contrast medium injection system according to claim 1 as shown above, Russell further teaching a magnet (5) and a magnet moving unit that moves the magnet between a position opposed to the first end portion in the generally cylindrical space and a position opposed to the second end portion in the generally cylindrical space, wherein the spherical body is a magnetic body, and the spherical body moves between the first end portion and the second end portion in the generally cylindrical space in accordance with movement of the magnet between the position opposed to the first end portion in the generally cylindrical space and the position opposed to the second end portion in the generally cylindrical space which is caused by the magnet moving unit ([0006]), but does not explicitly show the claimed position of the magnet.
Ross teaches a magnet (30/36) disposed outside of the generally cylindrical space (Fig. 1). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the magnet configuration of Russell with the magnet configuration of Ross to yield the predictable result of controlling a ball of a ball valve. Both Ross and Russell use a magnet to control a position of a ball valve, Ross merely shows an art-recognized alternative magnet configuration to accomplish the identical function.
Claim 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Obayashi and Russell as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2002/0151854 to Duchon et al. (“Duchon”).
Regarding claim 6, Obayashi and Russell teach the contrast medium injection system according to claim 1 as shown above but do not show the detecting unit.
Duchon teaches an opening and blocking unit ([0188], ball in the check valve) comprising a spherical body detecting unit that is configured to detect the spherical body (sensor 571). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a spherical body detecting unit into the device of Obayashi and Russell as taught by Duchon to yield the predictable result of generating a signal indicative of the position of the ball so that the state of the valve may be ascertained by a user to ensure proper functioning and treatment.
Regarding claim 7, Obayashi, Russell, and Duchon teach the contrast medium injection system according to claim 6 as shown above, Duchon further teaching the spherical body detecting unit detects that the spherical body is at a position where the spherical body is in close contact with the first end portion ([0188]).
Regarding claim 8, Obayashi, Russell, and Duchon teach the contrast medium injection system according to claim 6 as shown above, Duchon further teaching the spherical body detecting unit is an infrared sensor ([0188]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Obayashi and Russell as applied to claim 9 above, and further in view of U.S. Patent Publication No. 2010/0113923 to Hieb et al. (“Hieb”).
Regarding claim 10, Obayashi and Russell teach the contrast medium injection system according to claim 9 as shown above, Obayashi further teaching the fluid injection flow path includes a plurality of fluid injection flow paths (Fig. 1), a second fluid injection flow path (107) that is not the fluid injection flow path in which the liquid pressure measuring unit is installed has a second opening and blocking unit (116) configured to open and block the second fluid injection flow path, but do not mention the claimed details of the second opening and blocking unit.
Hieb teaches an opening and blocking unit blocking a fluid injection flow path when power supply to the system is shut off [0056]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second opening and blocking unit of Obayashi to block a fluid injection flow path when a power supply is shut off as taught by Hieb in order to improve the safety of the device ([0056]) to prevent the accidental flow of liquid during a power outage.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Obayashi and Russell as applied to claim 11 above, and further in view of U.S. Patent Publication No. 2010/0130922 to Borlaug et al. (“Borlaug”).
Regarding claim 12, Obayashi and Russell teach the injection line kit according to claim 11 as shown above, Obayashi further teaching the opening and blocking unit (122) in the downstream-side fluid injection flow path and the details of the opening and blocking unit as shown above, but do not teach the bridge.
Borlaug teaches a bridge (401, Fig. 5B) and a downstream-side fluid injection flow path (508/512) held by the bridge. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a bridge with the device of Obayashi and Russell as taught by Borlaug to yield the predictable result of providing a simple means of organizing lines in an injection line kit to simply connections and allow for simple disconnection for disposable components after use as is known in the art.
Regarding claim 13, Obayashi, Russell, and Borlaug teach the injection line kit according to claim 12 as shown above, Russell further teaching the spherical body maintains a state in which the downstream-side fluid injection flow path is opened when the spherical body is in close contact with the second end portion ([0006]).
Regarding claim 14, Obayashi, Russell, and Borlaug teach the injection line kit according to claim 12 as shown above, Russell further teaching the second end portion is a tubular body (right-most section of 112a in Fig. 25b) that has a through hole (Fig. 25a) in an axial direction therein and a through channel (channels formed between arms of tubular body as previously defined) that extends from the through hole to an outer circumferential surface of the tubular body (Fig. 25b).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Obayashi, Russell, and Borlaug as applied to claim 12 above, and further in view of Elbadry.
Regarding claim 15, Obayashi, Russell, and Borlaug teach the injection line kit according to claim 12 as shown above, Russell further teaching the opening and blocking unit including a container (11) and the generally cylindrical space (111) is formed in the container (Fig. 25a), but Russell does not explicitly mention the container having a transparent portion.
Elbadry teaches a container (Figs. 76A-B) that has a transparent portion ([0154]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a portion of the container of Russell transparent to yield the predictable result of allowing a user to view the status of the ball of valve or to allow for an optical sensor arrangement to be used. Additionally, it would have been an obvious design choice to modify the container of Russell to have a transparent portion since Applicant has not disclosed that having a transparent container solves any stated problem or provides any unexpected result, and it appears that the container of Russell would perform equally well with a transparent portion.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783