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
Newly submitted claim 15 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the originally presented product is distinct from the newly added process of use as the product as claimed can be used in a materially different process of using that product. In the instant case, the product can be used in a method for pumping in which the side-tube is entirely perpendicular or entirely parallel with respect to gravity.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 15 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
This office action is responsive to the amendment filed on July 16, 2026. As directed by the amendment: claims 1, 2, 8, and 11 have been amended and claims 14 and 15 have been added. Thus, claims 1-15 are presently pending in this application with claim 15 presently withdrawn.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed March 17, 2026.
Response to Arguments
Applicant's arguments filed July 16, 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 7 of the Remarks that “In using the particular precedent cited by the Office Action for the modification of DelCastillo's side tube diameter to be 3.1 mm there is an implied understanding that the modification cannot change a feature of the prior art device in a way that would change how the prior art device performs. DelCastillo's explicit teaching of how his device performs, however, is the opposite to how the claimed device performs”. The examiner respectfully disagrees and maintains that the function of DelCastillo to be “sufficiently small” as claimed would not modify operation of the device of DelCastillo. The examiner notes that an example diameter range of a side tube which is “sufficiently small” as claimed is “less than 3.1 mm” (pg. 11, line 1 of the specification). As noted previously and below, DelCastillo discloses that the dampening chamber can have an inner diameter of “about” 3.2 mm so that this range would encompass inner diameters slightly less than 3.2 mm and slightly greater than 3.2 mm. Since the upper range of the example diameter range provided in the specification is approximate the range provided in the prior art, it remains the examiner’s opinion that the prior art device of DelCastillo would not operate differently with the claimed inner diameter. Paragraph 37 of DelCastillo discloses that the dampening chamber needs to be above the fluid path so that gas within the fluid chamber does not enter the fluid being infused. The dampening chamber of DelCastillo can be placed in any orientation relative to gravity as long as the fluid path is below the dampening chamber. Further, the examiner notes that DelCastillo further discusses placing a diaphragm in the device to fully separate the liquid from the gas in order to allow the device to be oriented regardless of orientation relative to the fluid path (paragraph 40). Thus, it is the examiner’s opinion that the device of DelCastillo modified to have a side tube with an inner diameter which is “sufficiently small” as claimed would not impact operation of the device since the intention of the device of DelCastillo is not to orient the device in a specific manner but to avoid gas mixing with the fluid being infused. The modification set forth previously and below would not impact this operation.
With respect to Applicant’s arguments/amendments to claim 8, the examiner sets forth a new grounds of rejection in view of Applicant’s amendments.
Claim Objections
Claim 14 is objected to because of the following informalities: the claim should end in a period. Appropriate correction is required.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over DelCastillo (US 20090131859).
Regarding claim 1, DelCastillo discloses apparatus for use with a pump configured to operate in a pulsatile manner to pump a therapeutic substance to a subject (fig. 3), the apparatus comprising:
infusion tubing (fluid supply conduit 26, first fluid conduit 34, second fluid conduit 60 in fig. 1) configured to be coupled to the pump for transporting a pulsatile flow of the therapeutic substance to the subject (fig. 1 shows the tubing above coupled to pump 14; paragraph 20 discloses pulsatile flow of the pump), the infusion tubing having an upstream segment configured to be upstream of the pump (fluid supply conduit 26 in fig. 1) and a downstream segment configured to be downstream of the pump (first fluid conduit 34 and second fluid conduit 60 in fig. 1); and
a side-tube (dampening chamber 114 in fig. 3) which (i) has a proximal end that is in fluid communication with the downstream segment of the infusion tubing (fig. 3 shows the proximal end of chamber 114 coupled to connector 120 which is also connected to first fluid conduit 34), (ii) has a distal end that is sealed (paragraph 35 discloses the chamber has a “closed proximal end 118”, equated to the claimed distal end), and (iii) is filled with air (paragraph 36 discloses “gas in space 128”; paragraph 25 discloses the gas can be air), wherein:
(a) when fluid pressure in the downstream segment of the infusion tubing increases, some of the therapeutic substance in the downstream segment of the infusion tubing enters the side-tube via the proximal end of the side-tube, thereby compressing the air within the side-tube and reducing the pressure within the downstream segment of the infusion tubing (paragraph 36 discloses as pressure increases, fluid 18 partially fills dampening chamber 114 to compress the gas), and
(b) subsequently, when the fluid pressure in the downstream segment of the infusion tubing decreases, the compressed air pushes the therapeutic substance disposed within the side-tube back into the downstream segment of the infusion tubing (paragraph 25 discloses the pump comprises increases and decreases in pressure at regular intervals and that fluid 18 enters when the dampening chamber the pressure increases; since the dampening chamber serves to produce a less pulsatile flow as discussed in paragraph 25, the air would push the fluid 18 back into the downstream segment when the pressure decreases in order to produce this smoother flow).
DelCastillo does not explicitly teach or disclose an inner diameter of the side-tube is sufficiently small such that in the absence of positive pressure within the downstream segment of the infusion tubing, surface tension of the therapeutic substance at the proximal end of the side-tube prevents the therapeutic substance from flowing into the side-tube regardless of the orientation of the side-tube with respect to gravity.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify DelCastillo to have a side tube with an inner diameter less than 3.1 mm 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, DelCastillo discloses that the inner diameter of the side-tube can be “about” 3.2 mm (paragraph 35). Since “about” 3.2 mm would encompass inner diameters which are slightly less than 3.2 mm, it is the examiner’s opinion that DelCastillo would not operate differently with the claimed inner diameter since the upper range of the claimed diameter is approximate the lower range provided by DelCastillo so that it appears within the scope of DelCastillo. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the inner diameter is “in some applications” (pg. 7, lines 6-7) the claimed range and that the inner diameter is “e.g. less than 3.1 mm” (pg. 11, line 1), indicating that the claimed range is merely an example range.
With regards to the limitation “an inner diameter of the side-tube is sufficiently small such that in the absence of positive pressure within the downstream segment of the infusion tubing, surface tension of the therapeutic substance at the proximal end of the side-tube prevents the therapeutic substance from flowing into the side-tube regardless of the orientation of the side-tube with respect to gravity”, the examiner notes that an example provided by Applicant which is “sufficiently small” is “less than 3.1 mm”, as discussed on pg. 11 of the Specification. As such, modified DelCastillo is considered to teach this limitation, as discussed above.
Regarding claim 2, DelCastillo teaches the inner diameter is configured such that the surface tension of the therapeutic substance inhibits air within the side-tube mixing with the therapeutic substance under positive pressure when therapeutic substance is disposed within the side-tube (paragraph 37).
Regarding claim 3, DelCastillo teaches the inner diameter of the side-tube is less than 3.1 mm (as discussed above with respect to the rejection of claim 1, DelCastillo was modified to have the inner diameter of the side tube be less than 3.1 mm).
Regarding claim 4, DelCastillo discloses a length of the side tube is 5-50 cm (paragraph 35 discloses a length of 5.1 cm).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over DelCastillo, as applied to claim 1 above, and further in view of Ovadia (US 20230390485).
Regarding claim 5, DelCastillo teaches all of the claimed limitations set forth in claim 1, but does not teach or disclose a length of the side tube is 50 – 200 cm.
Ovadia teaches a side-tube (fig. 12) which comprises a length between 50-200 cm (Table 5A shows an ID of the dampener as 90 cm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the side-tube of DelCastillo to be configured into a loop with a length of 90 cm, as taught by Ovadia, as this would enable the system to be attached to two pumps and two sources of fluid (fig. 11) to infuse multiple therapeutic agents to the patient.
Regarding claim 7, DelCastillo teaches all of the claimed limitations set forth in claim 1, but does not teach or disclose the inner diameter of the side-tube is greater than or equal to an inner diameter of the infusion tubing.
Ovadia teaches a similar system (fig. 1) comprising a side-tube (fig. 9) which comprises an inner diameter greater than or equal to an inner diameter of the infusion tubing (Table 4A shows that in experiment 17, which is equated to the embodiment shown in fig. 9, the side-tube has an ID of ~9.5 mm and the tubing has a ID of 1.6 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the infusion tubing of modified DelCastillo to have an inner diameter less than an inner diameter of the side-tube, as taught by Ovadia. Since the system of Ovadia is directed towards the same function and principle of DelCastillo (paragraph 7 of Ovadia), such modification would not impact operation of the device, as evidenced by Ovadia, and would provide for a less bulky tubing system.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over DelCastillo, as applied to claim 1 above, and further in view of Osborne (US 5681294).
Regarding claim 6, DelCastillo teaches all of the claimed limitations set forth in claim 1, but does not teach or disclose the inner diameter of the side-tube is less than an inner diameter of the infusion tubing.
Osborne teaches a peristaltic pump comprising an infusing tubing having an upstream segment (second length 49 in fig. 1) which comprises an inner diameter of 3.3 mm (15:40-44). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner diameter of the upstream segment to be 3.3 mm, as taught by Osborne, since Osborne teaches this diameter is a suitable diameter to be used in a peristaltic pump.
Once modified with the teachings of Osborne, modified DelCastillo teaches that the inner diameter of the side-tube is less than an inner diameter of the infusion tubing since the inner diameter of the side-tube of modified DelCastillo is less than 3.1 mm, as discussed above.
Claim(s) 8, 9, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over DelCastillo in view of Cragg (US 20140246024).
Regarding claim 8, DelCastillo discloses apparatus for use with a pump configured to operate in a pulsatile manner to pump a therapeutic substance to a subject (fig. 3), the apparatus comprising:
infusion tubing (fluid supply conduit 26, first fluid conduit 34, second fluid conduit 60 in fig. 1) configured to be coupled to the pump for transporting a pulsatile flow of the therapeutic substance to the subject (fig. 1 shows the tubing above coupled to pump 14; paragraph 20 discloses pulsatile flow of the pump), the infusion tubing having an upstream segment configured to be upstream of the pump (fluid supply conduit 26 in fig. 1) and a downstream segment configured to be downstream of the pump (first fluid conduit 34 and second fluid conduit 60 in fig. 1); and
a side-tube (dampening chamber 114 in fig. 3) which (i) has a proximal end that is in fluid communication with the downstream segment of the infusion tubing (fig. 3 shows the proximal end of chamber 114 coupled to connector 120 which is also connected to first fluid conduit 34), (ii) has a distal end that is sealed (paragraph 35 discloses the chamber has a “closed proximal end 118”, equated to the claimed distal end), and (iii) is filled with air (paragraph 36 discloses “gas in space 128”; paragraph 25 discloses the gas can be air), wherein:
(a) when fluid pressure in the downstream segment of the infusion tubing increases, some of the therapeutic substance in the downstream segment of the infusion tubing enters the side-tube via the proximal end of the side-tube, thereby compressing the air within the side-tube and reducing the pressure within the downstream segment of the infusion tubing (paragraph 36 discloses as pressure increases, fluid 18 partially fills dampening chamber 114 to compress the gas), and
(b) subsequently, when the fluid pressure in the downstream segment of the infusion tubing decreases, the compressed air pushes the therapeutic substance disposed within the side-tube back into the downstream segment of the infusion tubing (paragraph 25 discloses the pump comprises increases and decreases in pressure at regular intervals and that fluid 18 enters when the dampening chamber the pressure increases; since the dampening chamber serves to produce a less pulsatile flow as discussed in paragraph 25, the air would push the fluid 18 back into the downstream segment when the pressure decreases in order to produce this smoother flow).
DelCastillo does not explicitly teach or disclose an inner diameter of the side-tube is less than 2.5 mm.
Cragg teaches a side-tube (feedback tubing 1510 in fig. 71) which is configured to dampen fluid pressure changes (paragraph 467). Cragg further teaches that the side-tube inner diameter is less than 2.5 mm (paragraph 467 discloses between about 0.05 and 0.01 inches equal to 1.27 mm to 0.254 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner diameter of the side-tube of DelCastillo to be less than 2.5 mm, as taught by Cragg, since Cragg teaches that this diameter is useful in regulating fluid pressure changes and it appears that the side-tube of DelCastillo would operate equally well with the claimed inner diameter (paragraph 35 discloses that the diameter provided of the dampening chamber is merely an example and is not critical to the functionality of the device of DelCastillo).
Regarding claim 9, in the modified apparatus of DelCastillo, DelCastillo discloses a length of the side tube is 5-50 cm (paragraph 35 discloses a length of 5.1 cm).
Regarding claim 11, in the modified apparatus of DelCastillo, DelCastillo teaches the inner diameter is configured such that the surface tension of the therapeutic substance inhibits air within the side-tube mixing with the therapeutic substance under positive pressure when therapeutic substance is disposed within the side-tube (paragraph 37).
Regarding claim 14, modified DelCastillo teaches all of the claimed limitations set forth in claims 1 and 3, as discussed above, but does not teach or disclose the inner diameter of the side-tube is less than 2.5 mm.
Cragg teaches a side-tube (feedback tubing 1510 in fig. 71) which is configured to dampen fluid pressure changes (paragraph 467). Cragg further teaches that the side-tube inner diameter is less than 2.5 mm (paragraph 467 discloses between about 0.05 and 0.01 inches equal to 1.27 mm to 0.254 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner diameter of the side-tube of DelCastillo to be less than 2.5 mm, as taught by Cragg, since Cragg teaches that this diameter is useful in regulating fluid pressure changes and it appears that the side-tube of DelCastillo would operate equally well with the claimed inner diameter (paragraph 35 discloses that the diameter provided of the dampening chamber is merely an example and is not critical to the functionality of the device of DelCastillo).
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over DelCastillo, as applied to claim 8 above, and further in view of Ovadia (US 20230390485).
Regarding claim 10, DelCastillo teaches all of the claimed limitations set forth in claim 8, but does not teach or disclose a length of the side tube is 50 – 200 cm.
Ovadia teaches a side-tube (fig. 12) which comprises a length between 50-200 cm (Table 5A shows an ID of the dampener as 90 cm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the side-tube of DelCastillo to be configured into a loop with a length of 90 cm, as taught by Ovadia, as this would enable the system to be attached to two pumps and two sources of fluid (fig. 11) to infuse multiple therapeutic agents to the patient.
Regarding claim 13, DelCastillo teaches all of the claimed limitations set forth in claim 8, but does not teach or disclose the inner diameter of the side-tube is greater than or equal to an inner diameter of the infusion tubing.
Ovadia teaches a similar system (fig. 1) comprising a side-tube (fig. 9) which comprises an inner diameter greater than or equal to an inner diameter of the infusion tubing (Table 4A shows that in experiment 17, which is equated to the embodiment shown in fig. 9, the side-tube has an ID of ~9.5 mm and the tubing has a ID of 1.6 mm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the infusion tubing of modified DelCastillo to have an inner diameter less than an inner diameter of the side-tube, as taught by Ovadia. Since the system of Ovadia is directed towards the same function and principle of DelCastillo (paragraph 7 of Ovadia), such modification would not impact operation of the device, as evidenced by Ovadia, and would provide for a less bulky tubing system.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over DelCastillo in view of Cragg, as applied to claim 8 above, and further in view of Osborne (US 5681294).
Regarding claim 12, DelCastillo teaches all of the claimed limitations set forth in claim 8, but does not teach or disclose the inner diameter of the side-tube is less than an inner diameter of the infusion tubing.
Osborne teaches a peristaltic pump comprising an infusing tubing having an upstream segment (second length 49 in fig. 1) which comprises an inner diameter of 3.3 mm (15:40-44). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner diameter of the upstream segment to be 3.3 mm, as taught by Osborne, since Osborne teaches this diameter is a suitable diameter to be used in a peristaltic pump.
Once modified with the teachings of Osborne, modified DelCastillo teaches that the inner diameter of the side-tube is less than an inner diameter of the infusion tubing since the inner diameter of the side-tube of modified DelCastillo is less than 2.5 mm, as discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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