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 .
Response to Arguments / Amendment
The response, filed 01/28/2026, has been entered. Claim 19 is cancelled. Claims 1-18 and 20-30 are pending. Applicant’s arguments regarding claims 1-18 and 20-30 have been fully considered but are unpersuasive and/or moot due to a new grounds of rejection, necessitated by amendment. All arguments are on page 6 of the response. Applicant traversed the double patenting rejection but provided no reasons for the traversal. As such the examiner finds the aforementioned argument unpersuasive. Further, the double patenting rejection is altered due to amendment. Applicant traversed the 112b rejection of claims 19 and 30 but provided no reasons for the traversal. As such the examiner finds the aforementioned arguments unpersuasive. It is noted that the previous 112b rejection of claim 19 is withdrawn due to amendment. Further, this necessitated the new grounds of rejection. Specifically, the previous claims (1 and 19) recited a method of measuring liquid volume in a “sealed” container, yet previous claim 19 explicitly recited “measuring a time for gas to bleed from or into the container”, which contradicts / is impossible if the container is sealed. The amendment removing “sealed” and incorporation of previous claim 19 into claim 1 results in amended claim 1 (including the limitations of previous claim 19) no longer being unclear. Since the scope of the claim has changed and the claim is no longer unclear, prior art may be properly applied, resulting in the new grounds of rejection. As for claim 30, it was previously rejected under 112b as lacking antecedent basis and being unclear as to what is meant by “means for venting air from the ‘wet side’ of the container”. The amendment from “the wet side” to “a wet side” alleviates the antecedent basis issue; however, the lack of clarity remains. In interpreting the claims, limitations from the specification may not be imported into the claims. It is unclear how a “wet side” is formed, what is meant by that “side”, if there is some requirement for a “dry” side, etc. In the specification the container is divided into a “dry” compartment/side and a “wet” compartment/side by an air-permeable membrane. However, instant claim 30 as a whole is unclear, as set forth above, without the impermissible import of limitations from the specification that are not present in the claim. The examiner recommends clarification of claim 30 by further amendment such that it is clear what is meant by a “wet side”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,287,231. Although the claims at issue are not identical, they are not patentably distinct from each other since the instant claim 1 is merely broader than claim 17 of U.S. Patent No. 12,287,231.
Claims 2-11, 13-18, and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,287,231 in view of one or more of: Bartlett et al. (US 20210154382 A1, prior art of record), Henn (DE 19750620 A1 - all citations are to the attached English translation), Ly et al. (US 20150057601 A1, prior art of record), Gray et al. (US 20140260551 A1, prior art of record), and Schmid et al. (US 20160193615 A1, prior art of record). Any limitations not recited in claim 1 of U.S. Patent No. 12,287,231 is taught and rendered obvious by the aforementioned prior art, as cited below. It is also noted that all the limitations of instant claims 2-11, 13-18, and 20-30 are contained in claims 1-30 of U.S. Patent No. 12,287,231.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 12,287,231 in view of Henn (DE 19750620 A1 - all citations are to the attached English translation). Claim 28 of U.S. Patent No. 12,287,231 fails to teach the limitations of claim 30 as a method but, rather, as a device with a processor configured to carry out method steps. The use of the device, which the examiner holds as prima facie obvious, of claim 28 of U.S. Patent No. 12,287,231 results in the method steps of instant claim 30 except for the limitation of “wherein the first and second parameters are each one of pressure and amount of the gas, wherein changing a first parameter of the gas by a known amount comprises increasing or decreasing the pressure in the container, and wherein measuring a change in a second parameter of the gas comprises measuring a time for gas to bleed from or into the container”. This is taught by [0007], [0016]-[0018], [0021], and [0031] of Henn. It would have been obvious to incorporate the teachings of Henn as it is an art-recognized equivalent way to measure fluid level by [changing a first parameter of the gas by a known amount; measuring a change in a second parameter of the gas; and calculating the volume of gas in the container using the measured change and a predetermined operation equation; and determining the volume of liquid in the container based on the calculation].
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.
Claim 30 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 30: It is unclear what is meant by “means for venting air from a ‘wet side’ of the container”.
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 of this title, 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, 4, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett et al. (US 20210154382 A1, prior art of record) in view of Henn (DE 19750620 A1 - all citations are to the attached English translation).Regarding claim 1:Bartlett teaches a method of measuring liquid volume in a container of a breast pump of known volume comprising liquid and gas, the method comprising:
in a measurement phase, measuring the volume of gas in the container by: changing a first parameter of the gas by a known amount; measuring a change in a second parameter of the gas; and calculating the volume of gas in the container using the measured change and a predetermined operation equation; and determining the volume of liquid in the container based on the calculation([0061]-[0062], where the first parameter is pressure and the second parameter is volume with the equation being the ideal gas law)Bartlett fails to teach:
wherein the first and second parameters are each one of pressure and amount of the gas, wherein changing a first parameter of the gas by a known amount comprises increasing or decreasing the pressure in the container, and wherein measuring a change in a second parameter of the gas comprises measuring a time for gas to bleed from or into the containerHenn teaches:
wherein the first and second parameters are each one of pressure and amount of the gas, wherein changing a first parameter of the gas by a known amount comprises increasing or decreasing the pressure in the container, and wherein measuring a change in a second parameter of the gas comprises measuring a time for gas to bleed from or into the container ([0007], [0016]-[0018], [0021], [0031])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pressure change and gas bleed time, as taught by Henn, in the method of Bartlett as it is an art-recognized equivalent way to measure fluid level by [changing a first parameter of the gas by a known amount; measuring a change in a second parameter of the gas; and calculating the volume of gas in the container using the measured change and a predetermined operation equation; and determining the volume of liquid in the container based on the calculation].
Regarding claim 2:Bartlett and Henn teach all the limitations of claim 1, as mentioned above.Bartlett also teaches:
wherein the first and second parameter are each one of: the pressure, the amount of gas, the temperature and the volume of gas, and wherein the first parameter is different to the second parameter ([0061]-[0062] - the first parameter is pressure and the second parameter is volume of gas, which the examiner interprets as meeting “amount of gas”)
Regarding claim 4:Bartlett and Henn teach all the limitations of claim 1, as mentioned above.Bartlett also teaches:
wherein determining the volume of liquid in the container based on the calculation comprises: calculating the difference between the volume of the container and the volume of gas in the container (inherent in the teachings of [0061]-[0062] in that Bartlett determines volume of liquid / milk based on the change in volume of the gas and, thus, the volume of the container must be known)
Regarding claim 9:Bartlett and Henn teach all the limitations of claim 1, as mentioned above.Bartlett also teaches:
wherein changing the first parameter comprises pumping gas to or from the container using a pump (e.g., [0061]-[0062], FIG. 3)
Regarding claim 10:Bartlett and Henn teach all the limitations of claim 9, as mentioned above.Bartlett also teaches:
wherein changing a first parameter by a known amount comprises running a pump to a threshold value; and wherein measuring a change in a second parameter comprises measuring the pressure of the container, the amount of gas pumped using an external flow rate sensor, the number of pump cycles, or the time taken to reach the threshold value(e.g., [0061]-[0062], FIG. 3)
Regarding claim 11:Bartlett and Henn teach all the limitations of claim 7, as mentioned above.Bartlett also teaches:
wherein the threshold amount is a threshold pressure in the container, a threshold volume of gas pumped, a threshold time of operation of the pump, or a threshold number of pump cycles(e.g., [0061]-[0062], FIG. 3)
Claims 3, 5-8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett et al. (US 20210154382 A1, prior art of record) in view of Ly et al. (US 20150057601 A1, prior art of record).Regarding claim 3:Bartlett and Henn teach all the limitations of claim 1, as mentioned above.Bartlett also teaches:
using ideal gas law to calculate the volume of gas in the container ([0061]-[0062])Bartlett fails to explicitly teach:
wherein calculating the volume of gas in the container comprises: using the measurement and the predetermined operation equation to determine the volume of gas pumped from the containerLy teaches:
wherein calculating the volume in the container comprises: using the measurement and the predetermined operation equation to determine the volume pumped from the container (e.g., abstract, [0132]-[0134])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the volume correction (predetermined operation equation) of Ly in the device of Bartlett to increase accuracy. As set forth in Ly, a pump is configured to move a set quantity of volume per cycle; however, the theoretical amount may differ by the actual amount due to various reasons (e.g., Ly - [0049]-[0050]). Thus, empirically measuring true value(s) and using a correction equation/function yields increased accuracy.
Regarding claim 5:Bartlett and Henn teach all the limitations of claim 1, as mentioned above.Bartlett fails to teach:
wherein the predetermined operation equation is determined during a calibration phaseLy teaches:
wherein the predetermined operation equation is determined during a calibration phase (e.g., abstract, [0132]-[0134])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the volume correction / calibration phase (predetermined operation equation) of Ly in the device of Bartlett to increase accuracy. As set forth in Ly, a pump is configured to move a set quantity of volume per cycle; however, the theoretical amount may differ by the actual amount due to various reasons (e.g., Ly - [0049]-[0050]). Thus, empirically measuring true value(s) and using a correction equation/function yields increased accuracy.
Regarding claim 6:Bartlett, Henn, and Ly teach all the limitations of claim 5, as mentioned above.As combined in the claim 5 rejection above Bartlett and Ly teach:
wherein the calibration phase comprises, for a gas in a container, the gas having a known volume and pressure: changing a first parameter by a threshold amount; measuring a change in a second parameter; and based on a relationship between the values, calculating a second operation equation linking the change in the first value to the change in the second value(the cited sections of each of Bartlett and Ly, as set forth in the claim rejections above, on which this claim depends, teach or, upon combination, render obvious the instant claim limitations)
Regarding claim 7:Bartlett, Henn, and Ly teach all the limitations of claim 5, as mentioned above.As combined in the claim 5 rejection above, Bartlett and Ly also teach or render obvious:
wherein the calibration phase comprises, for a plurality of containers of gas having a known volume and pressure: changing a first parameter by a threshold amount; measuring a change in a second parameter; and performing a regression analysis on the measurements to calculate an operation equation(Repeating the calibration phase for a plurality of containers is merely repeating the operation of Bartlett and Ly for use in different sized containers. Further, Ly teaches use on a plurality of containers/cassettes - e.g., [0149]-[0150]. The examiner takes Official notice that it is common to use regression analysis to arrive at a calibration function / factor such as that taught by Ly.)
Regarding claim 8:Bartlett, Henn, and Ly teach all the limitations of claim 5, as mentioned above.As combined in the claim 5 rejection above, Bartlett and Ly also teach or render obvious:
wherein the calibration phase comprises, for a gas in a container, the gas having a known volume and pressure: running the pump to a threshold value; measuring a change in the pressure or the number of pump cycles; based on a relationship between the values, calculating a second operation equation linking the change in the first value to the change in the second value(The cited sections of each of Bartlett and Ly, as set forth in the claim rejections above, on which this claim depends, teach or, upon combination, render obvious the instant claim limitations. One would find it obvious to experimentally calibrate various other value determinations as the ideal gas law is merely an estimation and is not exact in the practical applications of Bartlett and Ly.)
Regarding claim 13:Bartlett, Henn, and Ly teach all the limitations of claim 5, as mentioned above.As combined in the claim 5 rejection above, Bartlett and Ly also teach or render obvious:
wherein in the calibration phase the pump is run to a threshold value; and in the measurement phase, the pump is run to the same threshold value(the examiner takes Official notice that it is common to conduct the calibration phase in the same manner as the measurement phase for consistency.)
Regarding claims 14-18 and 20-29: These claims are taught or render obvious as follows. Claim 14 is addressed in claim 7. Claim 15 is addressed by the teachings cited in the rejection of claims 3 and 5. Claim 16 is merely the use of a well-known piston and the already addressed ideal gas law. See FIGS. 9A-9G of Ly. Alternatively, this claim is also considered rejected under 35 U.S.C. 103 over Bartlett in view of Henn and further in view of Gray et al. (US 20140260551 A1, prior art of record) with the motivation being art-recognized equivalent use of the ideal gas law for determination of one of PV = nRT. See FIG. 1 - piston 132 of Gray. Claim 17 is rejected for the same reasons as claim 16. Claim 18 is taught by combination with FIG. 5 of Gray with the motivation being art-recognized equivalent use of the ideal gas law for determination of one of PV = nRT. Claim 20 is taught by the aforecited sections of Bartlett. For claims 21-22, Bartlett explicitly teaches ([0038]) taking into account altitude regarding the pump and volume determination operations. Regarding claim 23, the volume of liquid and gas are known in Bartlett and the pump vents the air out of the container. Regarding claim 24, the volume of liquid, volume of gas/air, and container size are all known in Bartlett, as cited above. Regarding claim 25, as set forth above, Bartlett teaches the pump, container, pressure sensor, a processor, and the method of claim 1. Claim 26 is rejected under 35 U.S.C. 103 over Bartlett in view of Henn and further in view of Schmid et al. (US 20160193615 A1, prior art of record). Schmid teaches a gas flow meter (e.g., [0015]). Bartlett uses the ideal gas law PV = nRT. Bartlett determines changes in gas volumes to determine changes in liquid volume or the amount of liquid. A gas flow meter may be used to measure such changes in gas volume from an initial gas volume state (i.e., an equivalent way to obtain a measurement for ΔV given a known initial V. Regarding claim 27, Bartlett teaches (FIG. 3) a container (330) as claimed. Bartlett also teaches the limitations of claim 28 wherein the base level vacuum is the vacuum level for a specific amount of milk expression due to pressure differential. The limitations of claim 29 are taught by Bartlett in, for example, [0060]-[0062].
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter. The prior art, alone or in combination, fails to anticipate or render obvious “wherein the operation equation is derived from the change in pressure, the number of pump cycles and ideal gas law”, in conjunction with the remaining claim limitations. It is noted that, in claim 12, the “ideal gas law” is interpreted as a separate and distinct limitation compared to the “predetermined operation equation” of claim 1.
Conclusion
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 Herbert Keith Roberts whose telephone number is (571)270-0428. The examiner can normally be reached 10a - 6p MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Macchiarolo can be reached at (571) 272-2375. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HERBERT K ROBERTS/Primary Examiner, Art Unit 2855