DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-23 are objected to because of the following informalities:
Claim 1, line 6, “that monitor an amount of body fluid” should be corrected to –“configured to monitor an amount of body fluid”.
Appropriate correction is 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.
The terms “first controllable flow means” and “second controllable flow means” is interpreted according to specification [0066] which state that the flow means equivalent structure are valves.
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: “Measuring device that monitors” in claim 1, and “an output device” of claim 6.
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 measuring device is mentioned to be a fluid sensor port as equivalent structure in [0066]. The output device is mentioned to be a collection bags equivalent structure in [0067].
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 5 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 5 recites “is connected to a patient for draining body fluids by gravity” which encompasses a human organism”. In an effort to compact prosecution, the limitation is interpreted as – configured to be connected to a patient for draining body fluids by gravity--.
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 1-23 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 1 recites “such that it is possible for multiple states to be active concurrently” which renders the claim indefinite. It is unclear if the limitation positively recites that multiple states are active concurrently. In an effort to compact prosecution the limitation is interpreted as –such that the first controllable flow means is configured to have multiple states be active concurrently--.
Claim 10 recites “wherein a multi-state valve may be manually operated” which renders the claim indefinite. It is unknown if this is the valve is the same as either of the controllable means in the first claim and “may be” renders the claim indefinite as it is unclear whether the limitations following the limitation is positively recited. In an effort to compact prosecution, the limitation is interpreted as –wherein a multi-state valve is configured to be manually operated--.
Claim 16 recites “which may include minute quantities and in very small time increments” which renders the claim indefinite. It is unclear if the limitation positively recites that multiple the limitation following may include. In an effort to compact prosecution the limitation is interpreted as not including the limitations following may.
Claim 17 recites “can be performed” which renders the claim indefinite. It is unclear if the limitation positively recites that multiple the limitation following can be. In an effort to compact prosecution the limitation is interpreted as –is performed--.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-12, 16-20, and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Patel (US 2022/0355015).
Regarding claim 1, Patel discloses an automated body fluid drain control system, the system comprising:
a first controllable flow means (three way flow diverters 25, figure 1B, [0074]) having a variant number of states including open to drain, partially open to drain, closed to drain, open to sample, partially open to sample and closed to sample such that the first controllable flow means is configured to have multiple states be active concurrently ([0135], [0137], the valve can be manifold, stopcock, which in this case can have multiple states and having the device be for example open to drain and open to sample concurrently);
a measuring device (sensor 23A) configured to monitor an amount of body fluid being drained ([0074]); and
a second controllable flow means (the second diverter 25, figure 1B) having an open and closed state ([0074]).
Regarding claim 2, Patel discloses the system further comprises a collection chamber of variable size (17, figure 1B, pump changes the size of the reservoir).
Regarding claim 4, Patel discloses wherein the system calculates a volumetric fluid flow on a periodic basis and adjusts the first controllable flow means to reduce or increase the volumetric fluid flow to fit uniformly within a calculated drainage volume desired for a time period ([0065], [0140], [0157]).
Regarding claim 5, Patel discloses wherein the first controllable flow means is configured to be connected to a patient for draining body fluids by gravity (figure 1A-1B, the arrangement of the pumps appears to have them be upright which means it would necessarily be effected by gravity which acts on flow downward).
Regarding claim 6, Patel discloses wherein the second controllable flow means is connected to an output device (14B) for purposes of collecting the body fluids ([0068]).
Regarding claim 7, Patel discloses wherein the body fluid is cerebrospinal fluid ([0007]).
Regarding claim 8-9, Patel discloses the system including a monitor system (129) that indicates an alarm when the body fluids cannot or do not generate a volumetric fluid flow to a flow volume that is requested or desired ([0086], alerts the user when flow is ceased), wherein the monitor system indicates an alarm when the system is not functioning (0065], [0086]).
Regarding claim 10, Patel discloses wherein a multi-state valve is configured to be manually operated ([0127], [0144]).
Regarding claim 11, Patel discloses a spectral analysis port (129, [0059], [0095]).
Regarding claim 12, Patel discloses wherein the system further comprises a machine-readable identifier ([0062]).
Regarding claim 16, Patel discloses a method of use of the system of claim 1, the method comprising analysis of the actively draining fluid in quantities ([0016]).
Regarding claim 17, Patel discloses in the method, data processing and storage on the system such that each spectrophotometric signature is performed, analyzed and stored on the device even when not in contact with a data platform ([0075], memory that collects, manage, control, and store information).
Regarding claim 18, Patel discloses data indexing against cassette identification, drainage session and/or information about a patient ([0075], [0140], memory that collects, manage, control, and store information).
Regarding claim 19, Patel discloses in the method, an ability to transfer a plurality of spectrophotometric signatures to the data platform when connected ([0118]-[0119]).
Regarding claim 20, Patel discloses in the method, signature matching against a plurality of normative signature-patterns stored on the system ([0118-0119], [0144] comparison and matching of the wavelengths via management system).
Regarding claim 23, Patel discloses diluting the CSF and manipulating and conditioning the CSF, ([0050]), where an infusion test is monitored and analyzed ([0063-0064]) for change in drainage fluid spectrographic signature to determine an amount of dilution, if any, and when and after what volume of drained cerebrospinal fluid has the cerebrospinal fluid returned to a pre-infusion level ([0064], concentration is adjusted post infusion).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Krueger (US 5772625).
Regarding claim 3, Patel does not disclose wherein the system further comprises a vent that connects the collection chamber to open air; and the system further comprises a filter.
Krueger discloses a drainage device in the same field of endeavor as the Applicant. Kruger teaches wherein the system further comprises a vent (65, figure 7) that connects the collection chamber (55) to open air (col 5, lines 1-6); and the system further comprises a filter (66).
Krueger provides a vent and filter to equalize pressure while preventing contamination (col 5, lines 1-6). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Patel with the vent and filter of Krueger in order to vent the reservoir while preventing bacterial contamination.
Claims 13-15 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Patel.
Regarding claim 13-14, Patel discloses a drain cartridge (1800, figure 1A, [0070]) and can have the intended use of being inserted single-handedly since structurally Patel has the required cartridge but does not disclose a plurality of cassettes.
However, it has bee held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144 VIB). In this case, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Patel to include multiple cartridges/cassettes in order to ensure the correct cartridge is used ([0078]). Also it appears that only a single cartridge is ever used at a time in the instant invention and Patel still holds that a correct cartridge must be chosen for the system, thus it appears Patel would be able to have multiple cartridges.
Regarding claim 15, Patel discloses wherein the system further comprises a spectral analysis port and a spectrophotometric sensor and a light source ([0054], [0144])and are capable of generating and sensing light with wavelengths of approximately 250nm — approximately 1800nm in or from the spectral analysis port ([0144], spectrophometric sensors generally able to measure wavelengths of visible light).
Patel fails to disclose wherein the system a plurality of spectrophotometric sensors and a plurality of light sources.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144 VIB). In this case, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Patel to include multiple sensors and light sources in order to perform more analysis on the fluid.
Regarding claim 21, Patel does not specifically discloses in the method, an ability to download normative signature-patterns to be stored on the system.
However, the management system is a computer ([0144]), which would have the necessary feature of being able to transfer data and have data be downloaded from it as various readings and data are stored and moved on the management system ([0144]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to have the knowledge that the computer system of Patel can have data be downloaded.
Regarding claim 22, Patel discloses alerting a user when signatures deviate from the normative signature-pattern ([0086]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shachar (US 2017/0325685) disloses a CSF monitoring device.
Redmond (US 4500311) discloses a CSF monitoring device.
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 3761
/KAI H WENG/Primary Examiner, Art Unit 3781