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 .
Election/Restrictions
Claims 62-64 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/12/2026.
As Applicant notes, the elected claims do not recite a filter arrangement, and thus appear generic to the elected species (with the exception of claims 49-51 which appear drawn to species c.iii).
Applicant argues the restriction is improper as the identified subspecies do not constitute a serious burden. Applicant further argues normal search skills and duties would be able to construct a search for the recited negative pressure wound therapy system including “any canister shape, one or more filters in the device, and one or more baffles of virtually any shape, size, and/or arrangement”, such as within CPCP A61M1/98, and that there is no serious search burden between subspecies c.ii-ix. However, while there would not be burden in searching generically for a canister of any shape, any filter arrangement, or any baffle arrangement, or for a singular, specific arrangement of canister shape, filter, or baffles, the subspecies c.ii-ix represent mutually exclusive arrangements of baffles (e.g. the fin baffles of c.vii appear to be a distant arrangement to the dual baffle arrangement of c.iii, and such arrangements are not disclosed as being obvious variants or combinable with one another). There appears to be no evidence of such arrangements being obvious variants of one another, thus each mutually exclusive arrangement would require separate searching for their respective features. As such, Applicant’s traversal is unpersuasive and the restriction is maintained.
Status of the Claims
Claims 47-64 remain pending in the present application with claims 62-64 being withdrawn. Claims 47-61 are examined on the merits.
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 47 and 58-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schenk, III et al. (US 2010/0036333 A1), hereinafter Schenk.
Regarding claim 47, Schenk discloses a negative pressure wound therapy system (Figs. 2, 7, and 10, apparatus 10 and system 130; Abstract) comprising:
a negative pressure source (vacuum pump 132) configured to aspirate fluid from a wound covered by a wound dressing (wound 250 and dressing 200);
a canister comprising an interior volume configured to store fluid aspirated by the negative pressure source (canister apparatus 10 receiving fluids 30; ¶ 24); and
a sensor (sensors 40a and 40b) configured to detect a particular volume of fluid collected in the interior volume of the canister (¶s 24 and 29-36),
wherein a portion of each of the two electrodes extends a predetermined distance from a top surface of the canister into the internal volume of the canister (Figs. 1 and 2 show the sensors 40a and 40b suspended from a top surface of the container),
wherein the predetermined distance from the top surface of the canister corresponds to the particular volume of fluid collected in the interior volume of the canister (it is inherent that a particular volume of fluid in the canister will rise to a particular height in the canister when it contacts the conductive sensors 40), and
wherein a change in an electrical property associated with the two electrodes indicates that the particular volume of fluid has been stored in the interior volume of the canister (¶s 24 and 29-36 describe how the fluid contacts a sensors and create a current path between the sensing elements to indicate a predetermined fluid level).
Regarding claim 58, Schenk further discloses a circuit (electrical circuit 60) configured to detect the change in the electrical property associated with the two electrodes, when the change in the electrical property comprises a change in voltage (¶ 31 indicates conductance which is the inverse of resistance, and also voltage).
Regarding claim 59, Schenk further discloses the change in the electrical property associated with the two electrodes are used to activate an indicator for indicating a condition (¶s 28-37 describe container full alarms controlled by the sensors).
Regarding claim 60, Schenk further discloses the particular volume of fluid that has been collected in the canister comprises a volume associated with a replace-canister condition (¶s 28-37 describe container full alarms controlled by the sensors, and how the container should be emptied or replaced).
Regarding claim 61, Schenk further discloses the particular volume of fluid that has been collected in the canister comprises a volume associated with a full-canister condition (¶s 28-37 describe container full alarms controlled by the sensors).
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.
Claims 48-51 are rejected under 35 U.S.C. 103 as being unpatentable over Schenk, as applied to claim 47 above, and further in view of Stamer et al. (US 5,583,544 A).
Regarding claim 48, Schenk does not explicitly teach comprising a baffle unit disposed inside the canister.
However, in addressing the same problem as Applicant, the problem being fluid level sensing inside containers exposed to suction, Stamer teaches a fluid level sensor (Fig. 2; Abstract) which uses sensors supported by a top of a container (rods 66, 68, 70, and 72) and a baffle unit disposed inside the container (shield 56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schenk to comprise the shield of Stamer. Doing so would thus comprise a baffle disposed inside the container, and would be advantageous in protecting the sensors from foam, froth, or mist (as recognized in Col. 2, lines 9-19 of Stamer), such as those created by the aspiration of wound fluids and which could potentially cause a false fluid level reading.
Regarding claim 49, Stamer further teaches the baffle unit at least partially surrounds the electrodes (Col. 3, lines 5-8 describe how the shield is cylindrical and thus would surround the two electrodes).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schenk to comprise the shield of Stamer. Doing so would thus comprise a baffle at least partially surrounding the two electrodes, and would be advantageous in protecting the sensors from foam, froth, or mist (as recognized in Col. 2, lines 9-19 of Stamer), such as those created by the aspiration of wound fluids and which could potentially cause a false fluid level reading.
Regarding claim 50, Stamer further teaches the baffle unit comprises a first baffle member, the first baffle member supported by the canister and extending from the top surface of the canister into the interior volume of the canister (shield 56 can be seen extending from the top of the canister to the bottom in Fig. 2).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schenk to comprise the shield of Stamer. Doing so would be advantageous in protecting the sensors from foam, froth, or mist (as recognized in Col. 2, lines 9-19 of Stamer), such as those created by the aspiration of wound fluids and which could potentially cause a false fluid level reading.
The combination of Schenk and Stamer do not explicitly teach the baffle unit comprises a second baffle member, the second baffle member supported by the canister and extending from the top surface of the canister into the interior volume of the canister.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the first baffle member of Stamer since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, particularly as Stamer discloses a number of different shield shapes may be used (Col. 3, lines 5-8). Furthermore, the court 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). See MPEP 2144.04(VI)(B) which relates to Duplication of Parts. Further, Applicant has not demonstrated any criticality on the particular arrangement of two baffles (¶ 117 of Applicant’s specification).
Regarding claim 51, the combination of Schenk and Stamer do not explicitly disclose a length of the first baffle member is greater than a length of the second baffle member. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Schenk and Stamer to have the length of the first baffle member be greater than the length of the second baffle member since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Schenk and Stamer would not operate differently with the claimed relative baffle length. Further, Applicant places no criticality on the range claimed (¶ 117 of Applicant’s specification makes no indication of the relative baffle leads in this only appears to be shown in the figures).
Claims 52-57 are rejected under 35 U.S.C. 103 as being unpatentable over Schenk, as applied to claim 47 above, and further in view of Roe et al. (US 6,501,002 B1).
Regarding claim 52, Schenk does not explicitly teach wherein at least one of the two electrodes comprise a coating, the coating configured to dissolve when the coating is in contact with the fluid collected in the interior volume of the canister for a predetermined time.
In addressing the same problem as Applicant, the problem being coatings for biosensors, Roe teaches a waste sensors comprising a dissolvable coating (Col. 7, lines 33-46 describe how the sensors comprise a membrane used to restrict access to specific molecules or substances, said coating may be soluble).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensors of Schenk to comprise the dissolvable coating of Roe. Doing so would be advantageous in allowing the sensors to be selected for particular substances, as taught by Roe.
Further, the limitations of the coating being configured “to dissolve when the coating is in contact with the fluid collected in the interior volume of the canister for a predetermined time” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the sensors and coating of Schenk and Rowe has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to dissolve the manner as claimed).
Regarding claim 53, the limitations of the coating being configured “to inhibit encrustation formed by the drying of fluid collected in the interior volume of the canister” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the sensors and coating of Schenk and Rowe has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to inhibit encrustation of drying fluid).
Regarding claim 54, Roe further teaches the coating comprises a water-soluble coating (Col. 7, lines 33-46 describe how the coating may be water-soluble).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensors of Schenk to comprise the water-soluble coating of Roe. Doing so would be advantageous in allowing the sensors to be selected for particular substances, as taught by Roe.
Regarding claim 55, the limitations of the predetermined time depending on at least one of a characteristic of the water-soluble coating, a characteristic of the fluid collected in the interior volume of the canister, and a rate of flow of the fluid into the canister are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the sensors and coating of Schenk and Rowe has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the coating would inherently have solubility characteristics, and the characteristics of the fluid collected in the canister, and the rate of flow of fluid into the canister would depend on the use of the device).
Regarding claim 56, the limitations of the characteristics of the water-soluble coating is at least one of a thickness of the water-soluble coating, a density of the water-soluble coating, and a composition of the water-soluble coating are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the sensors and coating of Schenk and Rowe has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the coating would inherently have the claimed characteristics, and the exact functions of those characteristics would depend on how the system as a whole is used).
Regarding claim 57, the limitations of the characteristics of the fluid collected in the interior volume of the canister is at least one of a pH of the fluid, a viscosity of the fluid, and an ionic composition of the fluid are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the sensors and coating of Schenk and Rowe has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. fluid properties of pH, viscosity and ionic composition would depend on with what fluid the device is used; further, such parameters would be inherent to any fluid and would also inherently affect dissolving behavior of a dissolvable coating).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781