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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/22/26 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-8, 11, 13-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,646,781 to Mcintyre et al. (hereinafter, "Mcintyre") in view of US 2015/0250931 to 3M Innovative Properties Company (hereinafter, "3M"), and further in view of US 3,401,719 to Rosser (hereinafter “Rosser”).
Regarding Claim 1, Mcintyre discloses a low pressure valve assembly (The valve will operate under a low pressure and in small channels, Col. 1, Lns. 41-42) comprising:
an elastomeric material including
a first backing material (17)
a second backing material (19)
wherein the elastomeric material is between the first backing material and the second backing material (flexible diaphragm 18 is located between body elements 17 and 19, Fig. 3 thru 6), and
wherein the deformable portion is configured to deform at a range of pressures including a pressure of less than or equal to 1 mmH20 (pressure on said valve, as an input valve or an output valve, may be on the order of from -4 to +20 psi [1 mmH20 is equal to 0.0014223343307953 psi], Col. 2, Lns. 63-65).
Mcintyre fails to explicitly disclose at least one cut that forms the deformable portion. 3M teaches that it was known in the art before the effective filing date to form a valve having at least one cut that forms a deformable portion (valve 630 includes slits 635 [cuts] that form a deformable portion that enables valve flap 636 to move, Fig. 23A, 23B and 23C). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve of McIntyre to include the at least one cut as taught by 3M. The motivation for doing so would have been to provide a cut that forms the deformable opening in the elastomeric portion of the valve in order to reliably perrform the required valving function.
McIntyre also fails to disclose the first and second backing materials having flat top and bottom surfaces across their entire lengths. However Rosser teaches that it was known in the art before the effective filing date to form similar first and second backing materials (23, 24) with flat top and bottom surfaces across their entire lengths (e.g., see FIG 2). To simplify the manufacture of McIntyre’s device, it would have been obvious to use first and second backing materials having flat top and bottom surfaces across their entire lengths, as claimed by Applicant and taught by Rosser.
Regarding Claim 2, modified Mcintyre renders obvious the low pressure valve assembly of claim 1, but Mcintyre fails to explicitly disclose wherein the elastomeric material includes at least two cuts. 3M teaches at least two cuts (valve 630 includes two slits 635 [cuts] that form a deformable portion that enables valve flap 636 to move, Fig. 23A, 23B and 23C). it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the valve of McIntyre to include the at least two cuts as taught by 3M. The motivation for doing so would have been to provide cuts that form the deformable opening in the elastomeric portion of the valve in order to reliably perform the required valving function.
Regarding Claim 3, modified McIntyre renders obvious the low pressure valve assembly of claim 1, wherein the outlet is circular (outlet conduits 11 and 24 are circular, Fig. 3 and 4).
Regarding Claim 4, modified McIntyre renders obvious the low pressure valve assembly of claim 1, wherein the outlet is configured to not obstruct the deformable portion (body element 17 [first backing] includes outlet conduit 11 and body element 19 [second backing] includes outlet conduit 24 that do not obstruct flexible diaphragm 18 that is deformed at protruding surfaces 21 and 20, at least when the valve is open, Fig. 3 thru 6).
Regarding Claim 5, modified Mcintyre renders obvious the low pressure valve assembly of claim 1, comprising an inlet (intake conduits 10 and 25 are circular, Fig. 3 and 4) but Mcintyre fails to explicitly disclose the inlet is rectangular. It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide an inlet that is rectangular, since a change in shape of an element involves only routine skill in the art. Alternatively consider that rectangular inlets were well-known in the art at the time of filing (taken as admitted prior art because Applicant did not traverse the prior assertion of well-known status). The motivation for doing so would be to provide an inlet that matches a connection device of a pump and/or reservoir.
Regarding Claim 6, modified McIntyre renders obvious the low pressure valve assembly of claim 1, wherein the inlet is configured to obstruct the deformable portion (body element 17 [first backing] includes intake conduit 10 integral with protruding surface 20 [inlet) and body element 19 [second backing} includes intake conduit 25 integral with protruding surface 21 [intet] that obstruct deformable portion of flexible diaphragm 18, e.g., when the valve is closed, Fig. 3 thru 6).
Regarding Claim 7, modified Mcintyre renders obvious the low pressure valve assembly of claim 6, wherein the inlet is configured to prevent backflow (Fig. 6 illustrates how the valve seals against backward flow, the pressure in the reverse direction of the valve causes the diaphragm 18 to seal shut against the entrance to conduit 25, Col. 4, Lns. 6-9).
Regarding Claim 8, modified Mcintyre renders obvious the low pressure valve assembly of claim 1, but Mcintyre fails to explicitly disclose wherein the at least two cuts are parallel. 3M teaches at least two cuts that are parallel (valve 630 includes two parallel slits 635 {cuts], Fig. 23A, 23B and 23C). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve of Mcintyre to include parallel cuts as taught by 3M. The motivation for doing so would have been to provide a configuration that is known to ensure effective operation of the elastomeric portion of the valve.
Regarding Claim 11, Mcintyre discloses a low pressure valve assembly comprising:
an elastomeric material including
a first backing material (17)
a second backing material (19)
wherein the elastomeric material is between the first backing material and the second backing material (flexible diaphragm 18 is located between body elements 17 and 19, Fig. 3 thru 6), and
wherein the first deformable portion and the second deformable portion are each configured to deform at a range of pressures including a pressure of less than or equal to 1 mmH2O (pressure on said valve, as an input valve or an output valve, may be on the order of from -4 to +20 psi [1 mmHZ2O is equal to 0.0014223343307953 psi], Col. 2, Lns. 63-65).
Mcintyre fails to explicitly disclose at least one first cut that forms the first deformable portion and at least one second cut that forms the second deformable portion. 3M teaches that it was known in the art before the effective filing date to form a valve having first and second cuts 635 that form a single deformable portion 636 (valve 630 includes first slit 635 [cut] and second slit 635 [cut] that form a deformable portion that enables valve flap 636 to move, Fig. 23A, 23B and 23C). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the valve of Mcintyre to include first and second cuts at each of Mcintyre’s deformable portions, as taught by 3M. The motivation for doing so would have been to provide cuts that form the deformable openings in the first and second deformable portions of Mcintyre’s valves in order to reliably perform the required valving function.
McIntyre also fails to disclose the first and second backing materials having flat top and bottom surfaces across their entire lengths. However Rosser teaches that it was known in the art before the effective filing date to form similar first and second backing materials (23, 24) with flat top and bottom surfaces across their entire lengths (e.g., see FIG 2). To simplify the manufacture of McIntyre’s device, it would have been obvious to use first and second backing materials having flat top and bottom surfaces across their entire lengths, as claimed by Applicant and taught by Rosser.
Regarding Claim 13, modified Mcintyre renders obvious the low pressure valve assembly of claim 11, wherein the first outlet is circular (outlet conduits 11 [second] and 24 [first] are circular, Fig. 3 and 4).
Regarding Claim 14, modified Mcintyre renders obvious the low pressure valve assembly of claim 11, wherein the second outlet is circular (outlet | conduits 11 [second] and 24 [first] are circular, Fig. 3 and 4).
Regarding Claim 15, modified McIntyre renders obvious the low pressure valve assembly of claim 11, wherein the first outlet and the second outlet are each configured to not obstruct the first deformable portion or the second deformable portion (body element 17 [first backing] includes outlet conduit 11 [second] and body element 19 [second backing] includes outlet conduit 24 [first] that do not obstruct flexible diaphragm 18 that is deformed at protruding surfaces 21 and 20, e.g., when the valve is open, see Fig. 3 thru 6).
Regarding Claim 16, modified McIntyre renders obvious the low pressure valve assembly of claim 11, comprising an inlet (intake conduits 10 [first] and 25 [second] are circular, Fig. 3 and 4) but Mcintyre fails to explicitly disclose the inlet is rectangular. It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide an inlet that is rectangular, since a change in shape of an element involves only routine skill in the art. Alternatively, note that rectangular inlets were also well-known in the art at the time of filing (taken as admitted prior art because Applicant did not traverse the prior assertion of well-known status). The motivation for doing so would be to provide an inlet that matches a connection device of a pump and/or reservoir.
Regarding Claim 17, modified McIntyre renders obvious the low pressure valve assembly of claim 11, comprising an inlet (intake conduits 10 [first] and 25 [second] are circular, Fig. 3 and 4) but Mcintyre fails to explicitly disclose the inlet is rectangular. It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide an inlet that is rectangular, since a change in shape of an element involves only routine skill in the art. Alternatively, note that rectangular inlets were also well-known in the art at the time of filing (taken as admitted prior art because Applicant did not traverse the prior assertion of well-known status). The motivation for doing so would be to provide an inlet that matches a connection device of a pump and/or reservoir.
Regarding Claim 18, modified McIntyre renders obvious the low pressure valve assembly of claim 11, wherein the first inlet and the second inlet are each configured to obstruct the first deformable portion and the second deformable portion (body element 17 [first backing] includes intake conduit 10 [first] integral with protruding surface 20 [inlet] and body element 19 [second backing] includes intake conduit 25 [second] integral with protruding surface 21 [inlet] that obstruct deformable portion of flexible diaphragm 18, e.g., when the valve is closed, see Fig. 3 thru 6).
Regarding Claim 19, modified Mcintyre renders obvious the low pressure valve assembly of claim 18, wherein the first inlet and the second inlet are each configured to prevent backflow (Fig. 6 illustrates how the valve seals against backward flow, the pressure in the reverse direction of the valve causes the diaphragm 18 to seal shut against the entrance to conduit 25 [second intake - first intake conduit 10 similar design], Col. 4, Lns. 6-9).
Regarding Claim 21, modified Mcintyre renders obvious a method of pumping fluid using a valve assembly of claim 1 (the invention relates to an improved valve particularly suited for application in small medical devices, particularly in infusion pumps, Col. 1, Lns. 9-13).
Claim(s) 9, 10, 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mcintyre in view of 3M and Rosser as set forth above, and further in view of US 2010/0179480 to Sugiki et al. (hereinafter, "Sugiki").
Modified McIntyre renders obvious the low pressure valve assembly of claim 1, but Mcintyre fails to explicitly disclose wherein the elastomeric material further includes at least one relief cut for each deformable portion as claimed. Sugiki teaches a valve body and medical tool (Abstract) having an elastomeric material that includes four relief cuts for a similar deformable portion (valve body 6 includes opening and closing section 60 [deformable portion] integral with concave portions 66 [relief cuts]). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify each deformable portion in the valve of McIntyre to include relief cuts as taught by Sugiki. The motivation for doing so would have been to provide a relief cut in order to make the elastomeric portion of the valve more flexible and easy to open, or to reduce localized stresses thereby prolonging the lifespan of Sugiki’s valve.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly claimed feature is taught by the Rosser reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM M MCCALISTER whose telephone number is (571)270-1869. The examiner can normally be reached M-F from 7am to 6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CRAIG SCHNEIDER, can be reached at telephone number 571-272-3607, or Kenneth Rinehart can be reached at 571-272-4881. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM M MCCALISTER/Primary Examiner, Art Unit 3753
5/28/26
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