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 .
Claim Interpretation
Claim 3 recites “the seal area is an area no less than any planar cross-section intersecting the canister parallel to the joint plane” which is interpreted to mean the area of the seal area is greater than other planar cross-sections (i.e., the seal area represents the largest area in a plane parallel to said area).
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.
Claim(s) 1-5, 8, 9, 11, 16, 17, 19-24, 2730, and 32-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170106127 A1 (Chang et al.).
Regarding Claim 1, Chang teaches a semi-disposable (at least the liner being single-use [0083]) medical-fluid waste management apparatus (1000) (Figs. 1-6), the apparatus comprising:
a rigid canister ((1100) and (1200)) (Fig. 1) having a first canister portion (1200) (Fig. 6) with a canister opening (1213) and a second canister portion (1100), one of the first and second canister portions having an interstitial vacuum port (1170) therein [0090], the first and second canister portions including a first seal portion (1229) and a second seal portion (1140), respectively, which when sealingly engaged form a canister joint (this being formed by the mating surfaces between the two components, as seen in Figs. 2-4 and described in [0095]) in a canister-closed position (seen closed in Fig. 3), the canister joint defining a seal area (essentially the upper perimeter of the second canister portion, as seen in Fig. 4) and the canister opening defining an opening area smaller than the seal area (the opening seen in Fig. 6 necessarily being smaller than the seal area); and
a disposable assembly (at least 1310 and 1400 and their respective subcomponents, as seen in Fig. 3) comprising:
a lid (1410) configured to sealingly mate with the first canister portion at the canister opening [0105] and having lid-ports ((1440), (1450), and (1460)) for vacuum and fluid connections thereto [0102-0103]; and
a suction liner (1310) sealingly attached to the lid [0107] and configured to be inserted into the canister and receive medical-fluid waste when the canister is in the canister-closed position and the lid is mated with the canister (as seen in Fig. 3).
Regarding Claim 2, Chang further teaches the canister joint (the connection between (1229) and (1140) as described in Claim 1) defines a joint plane (said plane extending over said joint and being essentially parallel with (1200) as seen in Fig. 3).
Regarding Claim 3, Chang further teaches the seal area (the upper perimeter of the second canister portion, as seen in Fig. 4 and previously described in Claim 1) is an area no less than any planar cross-section intersecting the canister parallel to the joint plane (the interaction between the canister portions forming the largest area, as seen in Fig. 3).
Regarding Claim 4, Chang further teaches the lid (1410) is configured to pass into the first canister portion (1200) through the canister opening (1213) when not sealingly mated with the canister (the upper portion of the lid, to include at least lid ports (1450) and (1460), passing through the opening before sealing occurs).
Regarding Claim 5, Chang further teaches the disposable assembly (1310 and 1400) is configured to be removed from the canister when the first (1200) and second (1100) canister portions are disengaged in a canister-open position ([0103] describing removal, the canister-open position being considered the position wherein the first and second canister portions are not sealed, such as the position seen in Fig. 2).
Regarding Claims 8 and 9, Chang further teaches the suction liner (1310) is a suction bag formed by bonding together two sheets of flexible material ([0261] describing the formation of the liner using different panel shapes to form an expandable cavity);
wherein each of the two sheets is circular [0261] before the suction bag is formed.
Regarding Claim 11, Chang further teaches the first canister portion (1200) is a top canister portion (being placed atop the second canister portion, as seen in Fig. 1), and the second canister portion (1100) is a bottom canister portion (Fig. 1).
Regarding Claim 16, Chang further teaches the canister ((1100) and (1200)) includes a hinge (elements (1151) and (1251), as described in [0096]) between the first (1200) and second (1100) canister portions.
Regarding Claim 17, Chang further teaches the lid-ports ((1440), (1450), and (1460)) include a fluid disposal port (1460), a vacuum port (1440), and a patient port (1450) [0102-0103].
Regarding Claim 19, Chang further teaches a porous vent plug (1560) in the vacuum port (1440) (Fig. 3), configured to permit gas flow therethrough only when the plug is dry [0117].
Regarding Claim 20, Chang further teaches a one-way valve (the fluid port check valve described in [0113]) in the patient port (1450) configured to permit flow only into the suction liner (1310) [0113].
Regarding Claims 21 and 22, Chang further teaches the disposable assembly (1310 and 1400) further includes port caps (1550) configured to temporarily cover the lid-ports (covering (1450) and (1460) as described in [0126] and seen in Fig. 3);
wherein the port caps are integrally formed as a port-cap assembly (the port caps being attached to lid as described in [0126] and shown exemplarily in Fig. 73).
Regarding Claim 23, the device of Claim 22 is considered to teach the port-cap assembly includes the lid (1410), and the port caps (1550) are tethered to the lid (as described in Claim 22), as the components are attached together as claimed and can be considered to form an “assembly”.
Regarding Claim 24, Chang teaches a semi-disposable (at least the liner being single-use [0083]) medical-fluid waste management apparatus (3000) (Figs. 49-55), the apparatus comprising:
a rigid canister ((3100) and (3200)) (Fig. 49) having a convex outer wall (3120) formed as a body-of-revolution (formed about the central axis of the cylinder) and defining a maximum cross-sectional area (the area where (3100) and (3200) meet) and a canister volume (3130), the canister including (a) an interstitial vacuum port (3170) and (b) a canister opening (3213) defining an opening area smaller than the maximum cross-sectional area (seen in Fig. 55); and
a disposable assembly (at least 3310 and 3400 and their respective subcomponents [0202]) comprising:
a lid (3410) configured to sealingly mate with the canister at the canister opening and including lid-ports (3450) [0219] for vacuum and fluid connections thereto; and
a suction bag (3310) sealingly attached to the lid and configured to be inserted into the canister and receive medical-fluid waste when the lid is mated with the canister [0230].
Regarding Claims 27 and 28, Chang further teaches the suction liner (3310) is a suction bag formed by bonding together two sheets of flexible material ([0261] describing the formation of the liner using different panel shapes to form an expandable cavity);
wherein each of the two sheets is circular [0261] before the suction bag is formed.
Regarding Claim 29, Chang further teaches the canister ((3100) and (3200)) has a lid-mating surface (3214) and an outwardly-projecting portion between the lid-mating surface and the canister (the rim around (3214), as seen in Fig. 55).
Regarding Claim 30, Chang further teaches the lid-ports (3450) include a fluid disposal port, a vacuum port, and a patient port (the ports described in [0233] and considered equivalent to the ports further detailed in [0102-0103]).
Regarding Claim 32, Chang further teaches a porous vent plug (3560) in the vacuum port (as seen in Fig. 51, [0202]), configured to permit gas flow therethrough only when the plug is dry [0117].
Regarding Claim 33, Chang further teaches a one-way valve (the fluid port check valve described in [0113]) in the patient port (3450) configured to permit flow only into the canister (3100) [0113].
Regarding Claims 34 and 35, Chang further teaches the lid (3410) includes port caps (3551) for temporary covering of each port [0238];
wherein the port caps are formed as a port-cap assembly (being connected, as seen in Fig. 71 and described in [0238]).
Regarding Claim 36, the device of Claim 35 is considered to teach the port-cap assembly includes the lid (3410), and the port caps (3551) are tethered to the lid (as described in Claim 35), as the components are attached together as claimed and can be considered to form an “assembly”.
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(s) 6, 25, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of US 20220031926 A1 (Leadingham et al.).
Regarding Claim 6, Chang further teaches a plurality of canister shapes (including rectangular, circular, or elliptical [0252]), but fails to teach the canister is substantially spherical.
Leadingham teaches a medical-fluid waste management apparatus (Fig. 1) wherein the canister (2) is substantially spherical [0064].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the canister shape of Chang with the spherical shape taught by Leadingham to utilize a more efficient shape [Leadingham 0064] which is strong and minimizes material usage [Leadingham 0017].
Regarding Claims 25 and 26, Chang further teaches a plurality of canister shapes (including rectangular, circular, or elliptical [0252]), but fails to teach the canister is spheroidal or spherical.
Leadingham teaches a medical-fluid waste management apparatus (Fig. 1) wherein the canister (2) is substantially spherical [0064].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the canister shape of Chang with the spherical shape taught by Leadingham to utilize a more efficient shape [Leadingham 0064] which is strong and minimizes material usage [Leadingham 0017].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Leadingham.
Regarding Claim 7, Chang further teaches the canister seal is circumferential, as seen in the embodiment of Fig. 49.
Claim(s) 10, 12-14, 18, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of US 20170304511 A1 (Harpham et al.).
Regarding Claim 10, Chang fails to teach the canister includes a mounting connection.
Harpham teaches a medical-fluid waste management apparatus (800) (Figs. 12-13) wherein the canister (812) includes a mounting connection (862) (Fig. 13).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the canister of Chang to incorporate the mounting connection of Harpham to all for attachment to a cart or holder, thereby providing a stable interface for the device [Harpham 0012].
Regarding Claims 12 and 13, Chang fails to teach the canister includes a mounting connection.
Harpham teaches a medical-fluid waste management apparatus (800) (Figs. 12-13) wherein the canister (811 and 812) includes a mounting connection (862) (Fig. 13); wherein the mounting connection is on the bottom canister portion (812).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the canister of Chang to incorporate the mounting connection of Harpham to all for attachment to a cart or holder, thereby providing a stable interface for the device [Harpham 0012].
Regarding Claim 14, Chang fails to teach the lid further includes pinch tabs configured to release the lid from the canister when the pinch tabs are depressed.
Harpham teaches a medical-fluid waste management apparatus (800) wherein the lid (811) further includes pinch tabs (856) configured to release the lid from the canister when the pinch tabs are depressed (pressed outwardly) [0093].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lid of Chang to incorporate the pinch tabs of Harpham to provide a positive locking connection [Harpham 0093].
Regarding Claim 18, Chang fails to teach the lid-ports further include a tandem port for daisy-chaining the apparatus to other apparatus.
Harpham teaches a medical-fluid waste management apparatus (100) (Fig. 1a) wherein the lid-ports ((104) and (110)) further include a tandem port (106) for daisy-chaining the apparatus to other apparatus [0004].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lid-ports of Chang to further include a tandem port as taught by Harpham to allow overflow to be directed to another container [Harpham 0004].
Regarding Claim 31, Chang fails to teach the lid-ports further include a tandem port for daisy-chaining the apparatus to other apparatus.
Harpham teaches a medical-fluid waste management apparatus (100) (Fig. 1a) wherein the lid-ports ((104) and (110)) further include a tandem port (106) for daisy-chaining the apparatus to other apparatus [0004].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lid-ports of Chang to further include a tandem port as taught by Harpham to allow overflow to be directed to another container [Harpham 0004].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of US 20110238022 A1 (Massi et al.).
Regarding Claim 15, Chang fails to teach the lid further includes one or more tear-away tabs configured to release the lid from the canister when the one or more tear-away tabs are torn off the lid.
Massi teaches a medical-fluid waste management apparatus (1000) (Fig. 7B) wherein the lid (1511) further includes one or more tear-away tabs (1512a) configured to release the lid from the canister when the one or more tear-away tabs are torn off the lid [0081].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Chang to incorporate the tear-away tab of Massi to ensure the device cannot be re-used [Massi 0081, 0091].
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of US 4397643 A (Rygiel).
Regarding Claim 37, Chang fails to teach the suction bag has a maximum empty-bag-volume which is larger than the canister volume when the suction bag is filled within the canister.
Rygiel teaches a medical-fluid waste management apparatus (10) (Fig. 1) wherein the suction bag (14) has a maximum empty-bag-volume which is larger than the canister (12) volume when the suction bag is filled within the canister, the suction bag having an accordion or bellows-style construction which would necessarily allow expansion beyond the volume pictured in Fig. 1, thereby being considered to have a volume greater than the canister containing it.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suction bag of Chang to incorporate the expandable suction bag of Rygiel to allow for expansion without undesired change or deformation of the suction bag walls (Rygiel Col. 4: ll. 59-68).
Conclusion
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/HANS KALIHER/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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