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 9 and 15 are objected to because of the following informalities: it appears the claim should be amended to recite “…is formed from an antistatic material” to correct for grammar. 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 1-16 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 1, the claim recites that the “curved drop former…configured to…form, based on a curvature of its surface, one or more droplets having a substantially uniform consistency”. The scope of the term “consistency” cannot be determined in light of the specification. It is unclear if the term is intending to encompass a size or shape of the droplet or a material property (e.g. viscosity, composition, density). The specification does not appear to provide guidance on how the term should be interpreted. For examination purposes, the limitation is interpreted to mean that droplets have a substantially uniform characteristic.
Regarding claim 7, the claim is directed towards a body of the drip chamber forms a predetermined contact angle so that the droplets are uniform and consistent. It is unclear in light of the specification if the body of the drip chamber is the same as the drop former or another portion of the drip chamber. Paragraph 34 of the published application discloses that the hydrophobic coating is applied to the sides of the drop former which allows the drops to be uniform/consistent; however, the claim does not relate the “body” to the already claimed drop former so that it is unclear if the “body” of claim 7 is the same as the drop former. For examination purposes, the body of claim 7 is interpreted to mean the drop former.
Regarding claim 11, the claim recites that the hand pump comprises “another” filter. This is the first recitation of a filter in claims 1, 8, and 11 so that it is unclear if this implies that the hand pump has two filters due to the term “another”, if claim 8 should be amended to be dependent on claim 2, or if the term “another” should be removed from the claim. For examination purposes, the last interpretation was used.
Claims 2-6, 8-10, and 12-16 are also rejected by virtue of being dependent on claim 1.
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, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi (US 20190275233) in view of Vest (US 6899702).
Regarding claim 1, Yamaguchi discloses an IV set (fig. 1), comprising:
a second portion of tubing (paragraph 36 discloses “a tube” attached to opening 11b in fig. 1); and
a drip chamber (drip cylinder 10 in fig. 1) including:
a spikeless inlet (see below),
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an outlet fluidically coupled to the second portion of tubing (opening 11b in fig. 1; paragraph 36), and
a curved drop former positioned within the drip chamber between the inlet and the outlet (nozzle 22 in fig. 10B; paragraph 59 discloses the extended wall portion 23 of the nozzle 22 in fig. 4 can comprise a hydrodynamic shape which can be a “curved outer surface”), and configured to receive a fluid via the spikeless inlet and form, based on a curvature of its surface, one or more droplets having a substantially uniform consistency and flowing at a substantially constant rate through the drip chamber (paragraph 59 discloses that the hydrodynamic shape of the extended wall portion 23 ensures that the flow of the liquid is “uniform” and that the size of the liquid droplets are “stabilized”; the examiner notes that the stabilized size of the droplets and the uniform flow is equated to the claimed uniform consistency and the constant rate, respectively, as best understood by the examiner).
While Yamaguchi appears to suggest that the spikeless inlet is intended to connect to a first portion of tubing (see annotated figure above), Yamaguchi does not explicitly teach or disclose a first portion of tubing fluidically coupled to the spikeless inlet.
Vest teaches a similar IV set (fig. 1) comprising a first portion of tubing (fluid passageway 24 in fig. 1) which is fluidically coupled to a spikeless inlet (cap 34 in fig. 1) of a drip chamber (drip chamber 30 in fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the IV set of Yamaguchi to further comprise a first portion of tubing fluidically coupled to the spikeless inlet of Yamaguchi, as taught by Vest, as this modification appears to be within the intended use of the IV set of Yamaguchi and would allow the drip chamber to receive fluid from a reservoir.
Regarding claim 6, modified Yamaguchi teaches all of the claimed limitations set forth in claim 1, as discussed above.
In a different embodiment (fig. 11B), Yamaguchi teaches that the curved drop former (nozzle 122 in fig. 11B) can be made from a hydrophobic material (paragraph 70 discloses a resin having “water repellency”) which is different from the material forming the needle (portion 124 in fig. 11B; paragraph 73 discloses a “hydrophilic material”). Yamaguchi further teaches that instead of forming the needle from a hydrophilic material, the needle can include a hydrophilic coating instead (paragraph 74).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the curved drop former of the first embodiment of Yamaguchi to be formed from a hydrophobic material, in order to make the liquid drops less likely to spread along the outer surface of the drop former (paragraph 73). Additionally, it would have been obvious to have coated the drop former with a hydrophobic material instead of forming the drop former from a hydrophobic material as Yamaguchi teaches that this is a suitable substitution for rendering a surface having water-repellent properties.
Regarding claim 7, modified Yamaguchi teaches all of the claimed limitations set forth in claim 1, as discussed above. Yamaguchi further discloses a body of the drop chamber (as discussed above with respect to the 112(b) rejection, this is interpreted to mean the “drop former”; nozzle 22 in fig. 10B) comprises a predetermined contact angle such that the one or more droplets are uniform and consistent (fig. 10B shows a tapered surface 22c forming a predetermined contact surface). However, in this embodiment, Yamaguchi does not teach or disclose the body includes a hydrophobic coating.
In a different embodiment (fig. 11B), Yamaguchi teaches that the body (nozzle 122 in fig. 11B) can be made from a hydrophobic material (paragraph 70 discloses a resin having “water repellency”) which is different from the material forming the needle (portion 124 in fig. 11B; paragraph 73 discloses a “hydrophilic material”). Yamaguchi further teaches that instead of forming the needle from a hydrophilic material, the needle can include a hydrophilic coating instead (paragraph 74).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the body of the first embodiment of Yamaguchi to be formed from a hydrophobic material, in order to make the liquid drops less likely to spread along the outer surface of the drop former (paragraph 73). Additionally, it would have been obvious to have coated the body with a hydrophobic material instead of forming the drop former from a hydrophobic material as Yamaguchi teaches that this is a suitable substitution for rendering a surface having water-repellent properties.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Vest, as applied to claim 1 above, and further in view of Becker (US 4396016).
Regarding claim 2, modified Yamaguchi teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the drip chamber further comprises a filter of a predetermined surface area fluidically coupled to the outlet such that the filter captures particulates from the fluid before it exits the drip chamber.
Becker is directed towards an IV set (fig. 1) comprising a drip chamber (flow regulator 106 which includes the domes 130 and drip chamber 36 is equated to the “drip chamber”) which comprises a filter of a predetermined surface area (filter membrane 122 in fig. 1) fluidically coupled to the outlet (fig. 1 shows membrane 22 fluidically coupled to the outlet connected to tube 36) such that the filter captures particulates from the fluid before it exits the drip chamber (3:67-4:10 discloses filtering particles and bacteria from the fluid).
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 modified Yamaguchi to further comprise the filter housing (dome 130 in fig. 1), which comprises the filter, of Becker, in order to filter the fluid delivered to the patient (3:67-4:10) to improve patient safety.
Regarding claim 3, modified Yamaguchi teaches all of the claimed limitations set forth in claims 1 and 2, as discussed above, but does not explicitly teach or disclose the predetermined surface area of the filter is between 500 cm2 and 1000 cm2.
Becker teaches that the flow rate through the filter is proportional to the surface area of the filter (2:40-44). As such, the surface area of the filter is disclosed to be a result effective variable in that changing the surface area of the filter will, in turn, change the flow rate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the filter of modified Yamaguchi to have a surface area within the claimed range. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the filter of modified Yamaguchi by making the surface area of the filter to be between 500 cm2 and 1000 cm2 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, modified Yamaguchi teaches all of the claimed limitations set forth in claims 1 and 2, as discussed above, but does not explicitly teach or disclose the filter includes pore sizes between 20-80 microns.
Becker teaches that the flow rate through the filter is proportional to the pore size of the filter (2:40-44). As such, the pore size of the filter is disclosed to be a result effective variable in that changing the pore size of the filter will, in turn, change the flow rate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the filter of modified Yamaguchi to have pore sizes within the claimed range. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the filter of modified Yamaguchi to have pore sizes between 20-80 microns as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, modified Yamaguchi teaches all of the claimed limitations set forth in claims 1 and 2, as discussed above, but does not explicitly teach or disclose the filter includes pore sizes between 180-200 microns.
Becker teaches that the flow rate through the filter is proportional to the pore size of the filter (2:40-44). As such, the pore size of the filter is disclosed to be a result effective variable in that changing the pore size of the filter will, in turn, change the flow rate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the filter of modified Yamaguchi to have pore sizes within the claimed range. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the filter of modified Yamaguchi to have pore sizes between 180-200 microns as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 8, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Vest, as applied to claim 1 above, and further in view of Mason (US 20050033262).
Regarding claim 8, modified Yamaguchi teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a third portion of tubing; and a hand pump including an inlet fluidically coupled to the second portion of tubing and an outlet fluidically coupled to the third portion of tubing, the hand pump including a first portion, a second portion adjacent to the first portion, and a third portion adjacent to the second portion, wherein the first, second, and third portions have respective heights and respective radii, the second portion having a height and a radius greater than the respective heights and radii of the first and third portions.
Mason teaches an IV set (fig. 2) comprising a drip chamber (drip chamber 36 in fig. 2) comprising a second portion of tubing which is fluidically connected to an outlet of the drip chamber (connective tube 16 in fig. 2) and a third portion of tubing (catheter 18 in fig. 2). Mason further teaches a hand pump (bolus injector 14 in fig. 2) including an inlet fluidically coupled to the second portion of tubing (inlet port 52 in fig. 2) and an outlet fluidically coupled to the third portion of tubing (outlet port 54 in fig. 2), the hand pump including a first portion, a second portion adjacent to the first portion, and a third portion adjacent to the second portion, wherein the first, second, and third portions have respective heights and respective radii (see below), the second portion having a height and a radius greater than the respective heights and radii of the first and third portions (see below; portions can be delimited so that the second portion has the claimed properties).
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Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the IV set of modified Yamaguchi to comprise the claimed third portion of the tubing and the claimed hand pump, as taught by Mason, for the purpose of enabling delivery of a single large bolus immediately to assist in pain management (paragraph 6).
Regarding claim 12, in the modified set of Yamaguchi, Mason discloses the third portion of tubing is a predetermined length and radius (fig. 2).
Regarding claim 13, modified Yamaguchi teaches all of the claimed limitations set forth in claims 1 and 8, as discussed above. Mason further discloses that the hand pump is configured, when compressed, to accelerate a flow of the fluid so that a predetermined volume of fluid is delivered “instantaneously” (paragraph 48), implying that the hand pump of Mason is capable of delivering the claimed flow rate. However, modified Yamaguchi does not explicitly teach or disclose the claimed flow rate.
There is no evidence of record that modifying the hand pump of modified Yamaguchi to be capable of delivering a flow rate of at least 13 L/min would result in a difference in function of the modified Yamaguchi device. Further, PHOSITA being face with modifying the flow rate of modified Yamaguchi would have a reasonable expectation of success in making such a modification and it appears the device would function as intended given the claim flow rate, namely providing a quicker, more concentrated fluid delivery. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, merely indicating “in some implements”, the hand pump delivers the claimed flow rate; as such, there appears to be criticality placed on the range as claimed such that it produces unexpected results.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the hand pump to be configured to accelerate a flow of fluid when compressed to at least 13 L/min as an obvious matter of design choice within the skill of the art.
Regarding claim 14, in the modified set of Yamaguchi, Mason discloses the hand pump comprises a resilient material such that a body of the hand pump rebounds to an uncompressed state after it is compressed (paragraph 26).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Vest in view of Mason, as applied to claims 1 and 8 above, and further in view of Yamamoto (US 20170175263).
Regarding claim 9, modified Yamaguchi teaches all of the claimed limitations set forth in claims 1 and 8, as discussed above, but does not teach or disclose the hand pump is formed an antistatic material.
Yamamoto is directed towards a polymeric container for liquids (fig. 1) which is formed from an antistatic material (paragraph 42). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the hand pump to comprise anti-static coatings, as taught by Yamamoto, for the purpose of reducing the adherence of particulates on the surface of the hand pump to improve cleanliness (paragraph 16).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Vest in view of Mason, as applied to claims 1 and 8 above, and further in view of Proust (US 7021195).
Regarding claim 10, modified Yamaguchi teaches all of the claimed limitations set forth in claims 1 and 8, as discussed above. Mason further discloses the first and third portions have the same respective heights (portions can be delimited which are of the same height). While it appears that the portions share a common radii at some point along the height of the portions, modified Yamaguchi does not explicitly teach or disclose this limitation.
Proust teaches a substantially similar hand pump (fig. 1) comprising first and third portions (coupling zones 2 in fig. 1) having the same respective radii (2:47-52). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the hand pump of modified Yamaguchi to have the same respective radii along the first and third portions, as taught by Proust, which would enable the hand pump to be connected to the respective tubes regardless of the orientation of the hand pump to simplify assembly.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Vest, as applied to claim 1 above, and further in view of Yamamoto.
Regarding claim 15, modified Yamaguchi teaches all of the claimed limitations set forth in claim 1, as discussed above. Yamaguchi teaches that the drip chamber is formed from a resin (paragraph 36). However, modified Yamaguchi does not teach or disclose the drip chamber is formed from an antistatic material.
Yamamoto is directed towards liquid vessels which can be made from resin (paragraph 12) and which are further formed from an antistatic material (paragraph 16 discloses inner and outer surfaces which are coated in an antistatic material). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the surfaces of the drip chamber of modified Yamaguchi to be further formed from an antistatic material, as taught by Yamamoto, in order to improve cleanliness (paragraph 16).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi in view of Vest, as applied to claim 1 above, and further in view of Mittleman (US 4413990).
Regarding claim 16, modified Yamaguchi teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the drip chamber comprises a resilient material such that the drip chamber rebounds to an uncompressed state after it is compressed.
Mittleman is directed towards a drip chamber (chamber 66 in fig. 5) which comprises a resilient material such that the drip chamber rebounds to an uncompressed state after it is compressed (2:7-14 discloses the chamber rebounding to its original, uncompressed state upon “release”, indicating that the chamber comprises a resilient material). 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 modified Yamaguchi so that the chamber comprises a resilient material such that the drip chamber rebounds to an uncompressed state after it is compressed, as taught by Mittleman, for the purpose of enabling air from the drip chamber to be expelled from the chamber (5:54-57).
Allowable Subject Matter
Claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 Mason, as discussed above, which does not teach or disclose the hand pump includes a filter. Mason teaches that the IV set includes a filter (filter 72 in fig. 2); however, this filter is upstream from the drip chamber (wall 74 in fig. 2). Mason further discloses that a bolus dosage is delivered to the patient upon compression of the hand pump “instantaneously” (paragraph 48). As such, it is the examiner’s opinion that PHOSITA would not be motivated to modify the hand pump of Mason with a filter since this filter will likely impede the speed of the bolus delivery.
Conclusion
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/COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783