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 .
Election/Restrictions
Claims 6 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01 December 2025.
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 7 and 17 and dependents thereof 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.
Claim limitation “an injection actuator” and “a suction actuator” in claim 7 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification fails to provide corresponding structure for an injection actuator and suction actuator. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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: an injection actuator, a suction actuator, and a detector in claim 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 actuators do not have written description and are indefinite as rejected above. The corresponding structure for a detector may include a sensor ([[0070]).
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7-8, 12-13, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoshino (US 2002/0198436).
Regarding claim 1, Hoshino discloses a catheter, comprising:
a tubular body (21, figure 1) configured to be inserted into a living body (device of Hoshino capable of being inserted into the body),
wherein the tubular body has a lumen (22) within the tubular body, the lumen held in fluid communication with an injection port (24, [0030]) defined in a distal end of the tubular body (figure 1) and a suction port (23, figure 1, [0030]) near a proximal end of the tubular body (figure 1), and
wherein the suction port is closed when the injection port is open, and the injection port is closed when the suction port is open ([0033], [0038-0039]).
Regarding claim 2 and 12, Hoshino discloses wherein the tubular body has a one-way valve (41) disposed in the tubular body that allows a fluid to flow in a direction from out of the lumen ([0033], [0038-0039]), and wherein the suction port has an opening capable of being selectively opened and closed ([0038-0039]).
Regarding claim 3 and 13, Hoshino discloses wherein the tubular body includes a first tube (21) having the injection port and the suction port and a second tube (16) rotatable or longitudinally slidable with respect to the first tube ([0036]), wherein the second tube is disposed in the first tube (figure 1), or the first tube is disposed in the second tube, and wherein the second tube has a fluid communication port (50) that is brought selectively into and out of fluid communication with the suction port when the second tube is rotated or longitudinally slid with respect to the first tube ([0036]).
Regarding claim 7, Hoshino discloses a catheter system comprising:
a catheter (21 and 15), the catheter comprising:
a tubular body (21, figure 1) configured to be inserted into a living body (device of Hoshino capable of being inserted into the body),
wherein the tubular body has a lumen (22) within the tubular body, the lumen held in fluid communication with an injection port (24, [0030]) defined in a distal end of the tubular body (figure 1) and a suction port (23, figure 1, [0030]) near a proximal end of the tubular body (figure 1), and
wherein the suction port is closed when the injection port is open, and the injection port is closed when the suction port is open ([0033], [0038-0039]).
an injection actuator (13) for supplying a fluid to the injection port through the lumen in the tubular body ([0029], [0038-0039]);
a suction actuator (13) for drawing in a fluid from the suction port through the lumen in the tubular body ([0029], [0038-0039]);
a detector (18) for detecting an intracranial pressure of the living body (detectors are generally able to perform the intended use of detecting pressure in the body); and
a controller (12 and 11, [0029]) for controlling the injection actuator and the suction actuator,
wherein the controller alternately controls the injection actuator and the suction actuator in order to keep the intracranial pressure detected by the detector within a first range ([0029, [0038-0039]).
Regarding claim 8, Hoshino discloses a detector (18), wherein the detector is capable of measuring a pressure of a cerebrospinal fluid of the living body (detectors are capable of performing the intended use of measuring pressure of a CSF in the body).
Regarding claim 17, Hoshino discloses a catheter system comprising:
a catheter (21 and 15), the catheter comprising:
a tubular body (21, figure 1) configured to be inserted into a living body (device of Hoshino capable of being inserted into the body),
wherein the tubular body has a lumen (22) within the tubular body, the lumen held in fluid communication with an injection port (24, [0030]) defined in a distal end of the tubular body (figure 1) and a suction port (23, figure 1, [0030]) near a proximal end of the tubular body (figure 1), and
wherein the suction port is closed when the injection port is open, and the injection port is closed when the suction port is open ([0033], [0038-0039]).
an injection actuator (13) for supplying a fluid to the injection port through the lumen in the tubular body ([0029], [0038-0039]);
a suction actuator (13) for drawing in a fluid from the suction port through the lumen in the tubular body ([0029], [0038-0039]);
a detector (18) for detecting an intracranial pressure of the living body (detectors are generally able to perform the intended use of detecting pressure in the body).
Regarding claim 18, Hoshino discloses further comprising: a controller (12 and 11, [0029]) that alternately controls the injection actuator and the suction actuator in order to keep the intracranial pressure detected by the detector within a first range ([0029, [0038-0039], device capable of the intended use of keeping intracranial pressure within range).
Regarding claim 19, Hoshino discloses wherein the detector measures a pressure ([0029]) of a cerebrospinal fluid of the living body (capable of performing the intended use of measuring CSF).
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 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hoshino (US 2002/0198436) in view of Frassica (US 5989230).
Regarding claims 4 and 14, Hoshino do not disclose wherein the one-way valve is disposed in a distal end portion of the second tube.
Frassica discloses a catheter for implant in the body and teaches wherein a one-way valve (370 and 371, col 20, lines 40-55), is disposed in a distal end portion of the second tube (362).
Frassica provides a valve to control the movement of material through the catheter (col 20, lines 40-55). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hoshino with the valve of Frassica in order to control the movement of material through the catheter.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hoshino (US 2002/0198436).
Regarding claim 5 and 15, Hoshino does not teach wherein the suction port comprises a plurality of ports.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) MPEP 2144. In this case, the duplication of the port of suction port into multiple ports has no patentable significance since duplication of the ports would lead to more fluid communication that is expected and not new. This duplication would expectedly increase the amount of fluid communicated. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hoshino to include multiple ports on the suction port in order to communicate more fluid.
Claims 9-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoshino (US 2002/0198436) in view of Tremblay (US 5704352).
Regarding claims 9-11, Hoshino does not teach wherein the detector measures oxygen concentration of a cerebrospinal fluid of the living body (claim 9), the controller has a temperature controller for controlling a temperature of the fluid supplied to the injection port (claim 10), a sensor for measuring oxygen concentration of the fluid supplied to the injection port and oxygen concentration of the fluid drawn in from the suction port, wherein the controller calculates an oxygen consumption rate on a basis of values measured by the sensor (claim 11).
Tremblay discloses a biosensor for monitoring physiological conditions of a patient and teaches a detector measures oxygen concentration (col 7, lines 35-45) of a cerebrospinal fluid of the living body (device capable of measuring oxygen in fluid in the body), the controller has a temperature controller for controlling a temperature of the fluid (col 3, lines 60-65), a sensor for measuring oxygen concentration of the fluid (col 7, lines 35-45), wherein the controller calculates an oxygen consumption rate on a basis of values measured by the sensor ((col 7, lines 35-45)). When combined with the device of Hoshino, the resulting device would be able to measure oxygen and temperature in the suction port or injection port.
Tremblay provides a biosensor in order to reduce infections and patient discomfort while measuring data on the body (col 3, lines 40-51). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hoshino by substituting the sensor with the biosensor of Tremblay in order to reduce infections and reduce patient discomfort while obtaining useful data on the body.
Regarding claim 20, Hoshino does not teach wherein the detector measures oxygen concentration of a cerebrospinal fluid of the living body.
Tremblay discloses a biosensor for monitoring physiological conditions of a patient and teaches a detector measures oxygen concentration (col 7, lines 35-45) of a cerebrospinal fluid of the living body (device capable of measuring oxygen in fluid in the body).
Tremblay provides a biosensor in order to reduce infections and patient discomfort while measuring data on the body (col 3, lines 40-51). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hoshino by substituting the sensor with the biosensor of Tremblay in order to reduce infections and reduce patient discomfort while obtaining useful data on the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781