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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 10-12, and 14 are objected to because of the following informalities:
Regarding claim 1, it is recommended to amend the claims to recite “a direction from the branch” in line 11, “a direction towards the branch” in line 13, “a pressure difference” in line 14, “a side of the check valve” in line 15, and “a side of the check valve” in line 16 to provide antecedent basis for the claim terminology.
Regarding claim 10, it is recommended to amend the claims to recite “a direction from the branch” in line 6 to provide antecedent basis for the claim terminology.
Regarding claim 11, it is recommended to amend the claims to recite “a direction from the branch” in line 9, “a direction towards the branch” in line 12, “a pressure difference” in line 12, “a side of the check valve” in line 13, and “a side of the check valve” in line 14 to provide antecedent basis for the claim terminology.
Regarding claim 12, it is recommended to amend the claims to recite “a direction from the branch” in line 12, “a direction towards the branch” in line 14, “a pressure difference” in line 14, “a side of the check valve” in line 15, and “a side of the check valve” in line 17 to provide antecedent basis for the claim terminology.
Regarding claim 14, it is recommended to amend the claim to recite “the conveyed liquid” in line 4 since claim 13 recites the pump is “for conveying liquid” which inherently implies a conveyed liquid.
Appropriate correction is required.
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 12 and 22 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.
Regarding claim 12, the claims recites that the “at least one further supply line branches off from…positions of the supply lines between the branch and the liquid retaining filter membranes” in lines 3-4 and “wherein the threshold value pR(n) is determined to be greater than the threshold value pR(n - 1) wherein pR(n) is less than the breakdown pressure pMem, pMem(2) , ...,pMem(n - 1) of the liquid- retaining filter membranes of the first through (n - 1)-th supply lines” in the last section of the claim. This claim covers a condition in which the third supply line comprises a liquid-retaining filter membrane; however, the third supply line is not defined to comprise a liquid-retaining filter membrane in this claim nor in any of the parent claims. As such, it is unclear if the claim is now requiring the third supply line to comprise a liquid-retaining filter membrane.
Regarding claim 22, the claim recites “the threshold value palarm is selected such that no value Δp(n) (n = 2, 3, ..., nmax) exceeds a breakdown pressure pmem(n) (n = 1,3, ..., nmax) when the pump upstream pressure falls below the threshold value palarm.” This claim is dependent on claims 1, 13, 14, and 21 in which the only Δp and pmem recited are provided in relation to the pmem of the filter membrane provided in the first supply line and the Δp of the check valve provided in the second supply line; however, this Δp does not have an associated “n”. As such, it is not clear if Δp(n) is the same as the Δp defined in claim 1. Additionally, since the parent claims do not introduce any further supply lines beyond the first and second lines introduced in claim 1, it is unclear if the claim is now introducing “n” number of supply lines or if the claim should be interpreted to be dependent on claim 12 instead which properly sets forth an “nth” supply line. The examiner notes that due to the above ambiguities, although no art is applied against the claim, the claim is also not indicated as containing allowable subject matter pending Applicant’s response.
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) 1-9 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Virag (US 4034754) in view of Motta (US 5032117) and in further view of Wong (US 20150018765).
Regarding claim 1, Virag discloses an infusion set or transfusion set for administering a liquid from a container using a pump (set 10 in fig. 1 is functionally capable of being used with some sort of pump),
wherein the infusion set or transfusion set comprises a branch (connection site 32 in fig. 1), wherein a fluid connection is provided via the branch between one end of each of a first supply line (flexible tubing 38 in fig. 1; see below), a second supply line (tubing 50 in fig. 1; see below), and a discharge line (tubing 50 in fig. 1; see below),
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wherein the first supply line is configured to be connected to the container at its end remote from the branch (fig. 1 shows tubing 38 above fluidically connected to solution source 46),
wherein at least the second supply line comprises a check valve (one-way valve 30 in fig. 1),
wherein the check valve is closed to passage of a fluid in the direction from the branch (3:53-55).
However, Virag does not explicitly teach or disclose the check valve is configured to be closed for passage of fluid in the direction towards the branch if the pressure difference Δp = pA - pZ between a pressure pA present in the second supply line on the side of the check valve facing away from the branch and a pressure pz present in the second supply line on the side of the check valve facing towards the branch is less than a threshold value pR, wherein the check valve is configured to be open for fluid passage in the direction towards the branch if the pressure difference Δp = pA - pz between the pressure pA present in the second supply line on the side of the check valve facing away from the branch and the pressure pz present in the second supply line on the side of the check valve facing towards the branch is greater than the threshold value pR. Additionally, Virag does not teach or disclose wherein at least the first supply line comprises a liquid-retaining filter membrane having a breakdown pressure pMem, wherein pR is less than the breakdown pressure pMem of the liquid-retaining filter membrane.
Motta teaches a similar infusion set (fig. 1) comprising a check valve (check valve 18 in fig. 1) which is configured to be closed for passage of fluid in the direction towards the branch if the pressure difference Δp = pA - pz between a pressure pA present in the second supply line on the side of the check valve facing away from the branch and a pressure pz present in the second supply line on the side of the check valve facing towards the branch is less than a threshold value pR (4:12-14 discloses that the valve is closed when the pressure below the valve exceeds the pressure above the valve so that Δp is a negative value which is less than a threshold value pR of 0), and is configured to be open for fluid passage in the direction towards the branch if the pressure difference Δp = pA - pz between the pressure pA present in the second supply line on the side of the check valve facing away from the branch and the pressure pz present in the second supply line on the side of the check valve facing towards the branch is greater than the threshold value pR (4:12-14 discloses the valve is closed when the pressure below the valve exceeds the pressure above the valve so that the valve would be opened when the pressure above the valve exceeds the pressure below the valve so that Δp is a positive value which is greater than a threshold value pR of 0).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the check valve of Virag to be configured to be closed for passage of fluid when Δp is less than zero and to be opened for passage of fluid when Δp is greater than zero, as taught by Motta, in order for to prevent backflow of fluid to ensure proper dosing.
Wong teaches an infusion set (infusion set 10 in fig. 1) comprising a supply line (tubing 40 in fig. 1) which comprises a spike (spike 30 in fig. 1) and a drip chamber (drip chamber 20 in fig. 1). Wong teaches that the supply line comprises a liquid-retaining filter membrane (hydrophilic membrane 21 in fig. 1), which has a breakdown pressure Pmem (paragraph 20 discloses a “bubble pressure point” of 0.3 bar; the examiner notes that the “bubble pressure point” is defined in Applicant’s specification on pg. 5, lines 1-2 as equivalent to the claimed Pmem). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the drip chamber of both supply lines of modified Virag (i.e. drip chambers 26 and 42 in fig. 1) to comprise the liquid-retaining filter membrane of Wong having the claimed Pmem. Wong teaches that this modification prevents air bubbles and particles from entering the body of the patient during infusion therapy (paragraph 30).
Once modified with the teachings of Motta and Wong, modified Virag teaches wherein pR is less than the breakdown pressure pMem of the liquid-retaining filter membrane since pR is equal to 0 and pMem is equal to 0.3 bar, as discussed above.
Regarding claim 2, in the modified device of Virag, Virag discloses the branch is configured as a Y-port (fig. 1 shows connection site 32 as a Y-port).
Regarding claim 3, in the modified device of Virag, Virag discloses the infusion set for sequentially administering first the liquid as a first liquid from the container as a first container and then a further liquid as a second liquid from a further container as a second container using the pump (the infusion set 10 in fig. 1 is capable of performing the claimed function), wherein the first supply line is configured to be connected to the first container at its end remote from the branch (fig. 1 shows tubing 38 fluidically connected to solution 46), and wherein the second supply line is configured to be connected at its end remote from the branch to the second container (fig. 1 shows tubing 50 fluidically connected to solution 24).
Regarding claim 4, in the modified device of Virag, Motta discloses the threshold value pR is predetermined to be greater than or equal to a predetermined minimum threshold value pRmin and/or wherein the threshold value pR is predetermined to be less than or equal to a predetermined maximum threshold value pRmax (4:12-14 discloses that valve only opens when ΔP is greater than zero so that the pRmin and pRmax is equal to zero so that pRmin and pRmax are equal to pR).
Regarding claim 5, in the modified device of Virag, Motta discloses the maximum threshold value pRmax is determined to be at most 190 mbar (as discussed above, pRmax is 0 so that it is less than 190 mbar) and the maximum threshold value pRmax is determined to be less than pMem by at least 10 mbar (as discussed above pRmax is 0 which is 300 mbar less that the pMem set forth above in claim 1).
Regarding claim 6, in the modified device of Virag, Virag discloses the first supply line comprises a drip chamber (drip chamber 42 in fig. 1) which comprises an inlet through which the liquid from the container may enter in the form of drops (drop-forming member 48 in fig. 1), and which comprises an outlet through which the liquid may flow into the remaining first supply line (see below).
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Regarding claim 7, in the modified device of Virag, Virag discloses the second supply line comprises a drip chamber (drip chamber 26 in fig. 1) which comprises an inlet through which the second liquid may enter from the second container in the form of drops (drop forming member 28 in fig. 1), and which comprises an outlet through which the second liquid may flow into the remaining second supply line (see below).
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Regarding claim 8, in the modified device of Virag, Wong discloses the liquid-retaining filter membrane of the first supply line is an air-stop membrane (paragraph 29 discloses membrane 21 in fig. 1 preventing air bubbles from passing through).
Regarding claim 9, in the modified device of Virag, Wong discloses the liquid-retaining filter membrane of the first supply line is a hydrophilic and/or a porous membrane (paragraph 20 discloses that membrane 21 is hydrophilic and has a mean pore size, so that it is porous).
Regarding claim 15, in the modified device of Virag, Wong discloses the liquid-retaining filter membrane is arranged between the inlet and the outlet of the drip chamber (fig. 1 shows membrane 21 positioned between the drop forming member of the inlet and outlet 22).
Regarding claim 16, in the modified device of Virag, Wong discloses the liquid-retaining filter membrane is arranged in an outlet region of the drip chamber (fig. 1 shows membrane 21 in the immediate vicinity of outlet 22).
Regarding claim 17, in the modified device of Virag, Wong discloses a further liquid-retaining filter membrane is arranged between an inlet and an outlet of the drip chamber of the second supply line (the examiner notes that in the modification set forth in claim 1, both supply lines of Virag were modified to include membranes in the respective drip chambers; fig. 1 of Wong shows membrane 21 positioned between the drop forming member of the inlet and outlet 22).
Regarding claim 18, in the modified device of Virag, Wong discloses the further liquid-retaining filter membrane is arranged in an outlet region of the drip chamber of the second supply line (fig. 1 shows membrane 21 in the immediate vicinity of outlet 22).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Virag in view of Motta and in view of Wong, as applied to claim 1, and further in view of Hishikawa (US 20060155249).
Regarding claim 10, modified Virag teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the first supply line comprises a check valve between the branch and the liquid-retaining membrane, wherein the check valve of the first supply line is closed to passage of a fluid in the direction from the branch.
Hishikawa teaches a similar system comprising a first supply line (tube 31 in fig. 5) comprising a check valve (check valve 36 in fig. 5) between a branch (connector 32 in fig. 5) and a roller clamp (roller klemme 33 in fig. 5), wherein the check valve of the first supply line is closed to passage of a fluid in the direction from the branch (paragraph 119).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the first supply line of modified Virag to have a check valve between the branch and the liquid-retaining membrane by placing the check valve between the branch (arm 36 in fig. 1) and the roller clamp (clamp 40 in fig. 1), as taught by Hishikawa. Hishikawa teaches modification prevents transfusion from flowing to the upstream side to ensure proper dosing (paragraph 121).
Claim(s) 13, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Virag in view of Motta and in view of Wong, as applied to claim 1, and further in view of Ueda (US 20140100526).
Regarding claim 13, modified Virag teaches all of the claimed limitations set forth in claim 1, as discussed above. Virag further discloses the infusion set comprises a roller clamp (roller clamp 22 in fig. 1). However, modified Virag does not teach or disclose a pump (301) for conveying liquid through the supply lines and the discharge line.
Ueda teaches an infusion set (fig. 27) comprising a roller clamp (roller clamp 7 in fig. 27). Ueda further teaches a pump (infusion pump 1 in fig. 1) which is configured to receive the roller clamp (fig. 5 shows the roller clamp 7 received within the pump 1) and which is configured for conveying liquid through supply lines and the discharge line (paragraph 15 discloses feeding infusion liquid in one direction which would include feeding through the supply lines and discharge lines).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of modified Virag to further comprise the pump of Ueda which would receive the roller clamp of Virag (roller clamp 22 in fig. 1). Ueda teaches that this infusion pump helps prevent free flow during infusion (paragraph 6).
Regarding claim 19, in the modified system of Virag, Ueda discloses the pump is a peristaltic pump (paragraph 96 discloses a “peristaltic finger infusion pump”).
Regarding claim 20, in the modified system of Virag, Ueda discloses the peristaltic pump is engaged with or configured to be engaged with a portion of an outer wall of the discharge line (fig. 1 shows pump 1 engaging to portions of tube T).
Claim(s) 14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Virag in view of Motta in view of Wong and in view of Ueda, as applied to claims 1 and 13, and further in view of Jacobson (US 20100114027).
Regarding claim 14, modified Virag teaches all of the claimed limitations set forth in claims 1and 13, as discussed above, but does not teach or disclose a pressure measuring device for detecting a measured value corresponding to a pump upstream pressure of a conveyed fluid.
Jacobson is directed towards an infusion set (fig. 1) comprising a pressure measuring device for detecting a measured value corresponding to a pump upstream pressure of a conveyed fluid (sensor assembly 100 in fig. 1; paragraph 53 discloses that the sensor assembly 100 monitors pressure of the fluid pumped by pump 12 at a location upstream from the patient; the examiner notes that the claim does not presently require that the pressure be measured upstream from the pump). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the system of modified Virag to include the pressure measuring device of Jacobson in order to identify and alert users to the presence of occlusions in the line (paragraph 57) which would improve patient safety.
Regarding claim 21, in the modified system of Virag, Jacobson discloses the system is configured to send an alarm signal and/or to stop conveying liquid by the pump when the pump upstream pressure falls below a threshold value palarm (paragraph 57).
Allowable Subject Matter
Claim 11 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:
Regarding claim 11, the closest prior art is Virag modified with Motta and Wong, as discussed above. Modified Virag does not teach or disclose a system having a third supply line comprising the claimed check valve. The examiner notes that systems which comprise first, second, and third supply lines are known in the art (for example, fig. 8 of Hishikawa). However, Motta teaches that pR of the check valve is 0 in that the valve would open when a pressure upstream of the valve is greater than a pressure downstream of the valve and, conversely, would close when the upstream pressure is lower than the downstream pressure. As such, it is the examiner’s opinion that modifying a third supply line with a check valve would entail providing a check valve with a pR of 0 so that pR(3) would be equal to pR and not greater than, as required by the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783