DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 1, 2026 has been entered.
Response to Arguments
Applicant's arguments filed May 1, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments as per the double patenting rejection of claim 1, the Examiner respectfully disagrees. The claims as amended raise issues under 35 U.S.C. 112(b) wherein it’s unclear from the claim language if the intermediate portion is being compared to a generic “V-shaped” passage, or if the inlet end is intended to be limited to comprising a V-shaped passage. There is no language in the claims which defines the inlet end as having a V-shaped cross-section and therefore the scope of the claims cannot be reasonably ascertained by one of ordinary skill in the art. For this reason, the claims are not considered to have been amended with language sufficient to overcome the previous rejection. To state that “a cross-sectional area of the flow passage at an intermediate portion between the inlet end and the outlet end is larger compared to an increasing flow passage that increases at a constant rate of change along the flow passage from the inlet end to the outlet end” does not require the prior art to teach a non-linear expansion or the like. For example, as depicted below, the intermediate section of a constantly increasing cross-section will be larger than a selection taken closer to the input end. The language fails to substantially limit the intermediate cross-section to be anything other than larger than the inlet end cross-section.
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It can be clearly seen that, even at position “B” in the above figure, the cross-section is larger than that taken at portion ”A”. This is the case in a constantly increasing cross-section. This is known from the patent claim 1 which discloses an increasingly widening second section, widening at a different rate (but still increasing) than the first section. The claim language is not considered to overcome the double patenting rejection as the scope of the current claims are considered to be anticipated from the patent as maintained below.
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 1-20 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 claims 1, 16, 18, and 20, the claims set forth “wherein a cross-sectional area of the flow passage at an intermediate portion between the inlet end and the outlet end is larger compared to a V-shaped flow passage that increases at a constant rate of change along the flow passage….” It is unclear from this language if the cross-sectional area of the passage at an intermediate portion is being compared to a generic V-shaped flow passage that increases at a constant rate of change, or if the claim is intending to limit a first portion of the flow passage to comprise a V-shaped cross-section which increases at a constant rate of change. The language is such that one of ordinary skill in the art would not reasonably understand the scope of the claim limitation as currently set forth and for this reason the claims are considered indefinite. Claims 2-15, 17, and 19 are rejected due to their dependence from claims 1, 16, and 18. For the purposes of examination, the claims will be considered to limit the intermediate portion to have a larger cross-sectional area of the flow passage compared to a first portion of the flow passage increasing at a constant rate.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11,331,428 in view of Breitweiser et al. (US 2014/0135731 as cited in the IDS filed April 1, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses, as per claim 1, a method of assembling a cassette (set forth in claim 13; it is noted that the patent discloses the device and the instant method claims are an assembling of the structure of the device and intended use; therefore the disclosure of the structure of the cassette and the method of assembling it is known from the structure of the patent device), the method comprising: providing the cassette (claim 13) for use with a pumping apparatus having a pumping system for engaging a pump set (see preamble of claim 13), the cassette having a cassette body (Col. 14, lines 5-7); mounting a fitting assembly (e.g., Col. 14, lines 8-16) into the cassette body, the fitting assembly comprising an inlet, an outlet (first port and second port), a first attachment portion of the inlet, a first attachment portion of the outlet, and a second attachment portion of the outlet with first attachment portion of the outlet in fluid communication with the second attachment portion of the outlet (Col. 13, lines 43-46; the claim is setting forth first and second connectors with inlets and outlets fluidly coupled through the valve; this is known from lines 56-64 of claim 13 which sets forth the valve between first and second ports which will necessarily have inlet and outlet portions in fluid communication through the valve so that it may control the flow therethrough), and a valve mechanism disposed between the first attachment portion of the inlet and the second attachment portion of the inlet (Col. 13, line 56; the first and second ports of the inlet section are analogous to the first and second attachment portions), the valve mechanism including a stem (Col. 13, line 57) rotatably mounted to selectively communicate the inlet with the outlet (Col. 13, lines 57-59), the stem including a flange (Col. 14, lines 11-16) to secure the fitting assembly to the enteral feeding pumping apparatus when the stem is rotated to communicate the inlet with the outlet (Col. 14, lines 11-16), the stem including a flow passage extending through the stem from an inlet end of the flow passage to an outlet end of the flow passage whereby the inlet end of the flow passage communicates with the inlet and the outlet end of the flow passage communicates with the outlet (Col. 13, lines 59-66), wherein a cross-sectional area of the flow passage at an intermediate portion between the inlet end and the outlet end is larger compared to a flow passage that increases at a constant rate of change along the flow passage from the inlet end to the outlet end (Col. 13, line 66-Col. 14, line 3; see also annotated figure above; the patent discloses that the cross-section increases at a rate different from a first portion adjacent the inlet and therefore it must be larger than the first portion as claimed), second attachment portion of the inlet selectively communicates with the inlet end of the flow passage and the outlet end of the flow passage selectively communicates with the first attachment portion of the inlet (via the valve); and connecting tubing for carrying a fluid, the tubing comprising a first tubing connected to a fluid source containing the fluid to be pumped (inlet section of tubing; Col. 13, lines 64-65) and the tubing comprising a second tubing configured to engage the pumping apparatus (Col. 13, lines 65-66 disclose a pump engagement section of tubing which is considered as the ). The patent does not explicitly disclose the cassette as being for use with an enteral feeding system or the function and location of the tubing assembly components.
Breitweiser et al. (henceforth Breitweiser) teaches an enteral feeding pump apparatus (Figure 2; ¶ [0031]) comprising a first tubing section (inlet tubing 77) connected to a feeding source containing a feeding solution (¶ [0034]), and a second tubing (portion of tubing 77 engaged with pump via cassette 5 as disclosed in ¶ [0045]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of patent claim 13 by connecting the pumping apparatus to an enteral feeding solution so as to deliver nutrients to a patient during a procedure as taught by Breitweiser. Furthermore, it would have been obvious to engage the pumping section via first and second tubing portions as a means fluidly conveying the feeding solution to a patient during a procedure as taught by Breitweiser.
Regarding claim 2, the subject matter is known from claim 13 as modified by Breitweiser wherein the tubing is stated as being connected from a fluid source to the valve inlet as claimed (¶ [0034] of Breitweiser).
Regarding claim 3, the subject matter is known from claim 13 in view of Breitweiser which discloses connecting a first end of the second tubing to a first attachment portion of the inlet; and connecting a second end of the second tubing to a first attachment portion of the outlet (it can be seen in Figure 2 of Breitweiser that the pump engagement tubing section comprises a first end connected to a distal portion of a first tubing inlet fitting and a second end connected to a distal portion of an outlet tubing outlet fitting; e.g., the pump engagement section resides within the cassette and connects to inlet and outlet fittings to provide a flow path around the pump roller).
Regarding claim 4, the patent in view of Breitweiser teaches the claimed invention substantially as set forth above for claim 3, but fails to disclose the tube channel of the body. Breitweiser et al. (henceforth Breitweiser) teaches (Figure 5) a feeding pump set comprising a second tubing (portion of tubing 45 connected to outlet of 81) inserted into a tube channel formed by guide walls (e.g., walls 101 and 103 of the tubing receiving portion) and an arcuate wall (stator member 113).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent/Breitweiser device to comprise the guide wall and arcuate wall of the tubing receiving portion of Breitweiser so as to provide a means for securing the tubing to the pump housing and allowing the peristaltic pump to control fluid delivery through the tubing as taught by Breitweiser (e.g., ¶¶ [0040] and [0042]).
Regarding claim 5, Breitweiser further teaches the use of tabs (see Figure 5, the tubing passes through tab receiving portions 88 for maintaining the tubing in a desired orientation within the tubing receiving portion; alternatively, the lips 100 may also be considered tabs for maintaining the tubing within the cassette) for engaging and holding the tubing within the tubing receiving portion of the pump. It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cassette body of the patent to comprise the guide tabs of Breitweiser so as to substantially maintain the tubing in a desired orientation within the tubing receiving portion of the cassette so as to ensure alignment of the tubing with the pump assembly during a procedure as taught by Breitweiser (¶¶ [0039] and [0040]).
Regarding claim 6, the patent fails to explicitly disclose receiving the rotor in a recess formed by the arcuate wall of the cassette body when the cassette is engaged with the enteral feeding pumping apparatus. Breitweiser further teaches a rotor recess (97) within the cassette body (51) and adjacent the arcuate wall (113) for receiving the rotor of the pump during assembly (¶ [0040]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cassette of the patent to comprise the rotor recess of Breitweiser so as to allow the cassette to be placed over the pumping mechanism during assembly, wherein the rotor is in a position to engage the pump rotor as taught by Breitweiser.
Regarding claim 7, the patent fails to explicitly disclose the third tubing connected to a second attachment portion of the outlet, wherein the second attachment portion of the outlet is in fluid communication with the first attachment portion of the outlet. Breitweiser further teaches (Figures 1 and 10) a third tubing (outlet tubing 83) connected to a second attachment portion of an outlet (at 81; ¶ [0036]) and wherein the second attachment portion of the outlet is in fluid communication with the first attachment portion (79) of the outlet. It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent cassette to provide the step of installing a third outlet tubing such as that taught by Breitweiser so as to allow a user to provide a fluid flow means from the cassette to the patient during a procedure as taught by Breitweiser.
Regarding claim 8, the patent fails to explicitly disclose engaging the second tubing with rollers of the pump apparatus when the cassette is engaged with the pumping apparatus. Breitweiser teaches engaging the second tubing (45) with rollers (43) of a pumping assembly after installation of the cassette onto the pump (¶ [0034]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cassette of the patent to engage the second tubing with the rollers of the pump during assembly so as to provide a means for engaging the tubing with the pumping mechanism during installation of the cassette as taught by Breitweiser (see ¶¶ [0047] and [0050]).
Regarding claim 11, the patent fails to explicitly disclose the one or more pins or raised projections at a bottom of the cassette housing. Breitweiser teaches the step of inserting one or more pins or raised projections (119) at a lower end of the cassette housing (Figure 4) into corresponding slots (121) of a housing (3) for securing the cassette to the pump housing (¶ [0045]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pump and cassette of the patent to comprise the pins and slot securement features of Breitweiser to allow for a means of locating the cassette properly on the housing during installation as taught by Breitweiser (¶ [0045]).
Regarding claims 12 and 13, Breitweiser further teaches rotating the cassette body until a tab (125) on the cassette body engages with a corresponding ledge (127) of the housing when the cassette is engaged with the housing, and wherein the tab is located at about a top of the cassette housing (Figures 1 and 4). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cassette of the patent to comprise the tab of Breitweiser to provide a means for releasably securing the cassette to the housing during installation as taught by Breitweiser (¶ [0045] further teaches depressing tab 125 to release the attachment from the housing as claimed in claim 134.
Regarding claim 14, the patent fails to explicitly teach the steps of mounting the fitting in the cassette. Breitweiser teaches (Figure 5) first and second cutouts (85) in the cassette for receiving the inlet (69; it’s fully capable of receiving one of two inlet portions as claimed) and outlet (71) of the fitting assembly; inserting a base (67) of the fitting assembly to engage with a bottom of a locator wall (87; ¶ [0039]) and tops of vertical projections (87B) of a U-shaped wall (89, Figure 7; ¶ [0039]) of the cassette body; and inserting tabs (84) of the base into corresponding openings (86) of the cassette body (¶ [0035]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cassette of the patent to comprise the fitting assembly receiving structure taught by Breitweiser so as to provide a means of releasably securing the fitting to the cassette during installation as taught by Breitweiser.
Regarding claim 15, the subject matter is known from claim 13 which sets forth the cassette as attachable to the pumping apparatus (Col. 14, lines 5-6).
Claims 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,331,428 in view of Breitweiser. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses the patent discloses a pump set for use with a pumping apparatus (Col. 12, lines 35-36 disclose a pumping apparatus), the pump set comprising: tubing for carrying a feeding solution (Col. 12, line 37), the tubing comprising a first tubing for connection to a feeding source containing the feeding solution (Col. 12, lines 37-41) and a second tubing configured for engagement by the enteral feeding pumping apparatus to pump the feeding solution through the second tubing when the pump set is engaged with the pumping apparatus (Col. 12, lines 38-41; the pump engagement section is received by the pumping apparatus); and a valve mechanism attached to the tubing between the first tubing and the second tubing (Col. 12, lines 42-43), the valve mechanism comprising an inlet connected to the first tubing, an outlet connected to the second tubing, and a valve disposed between the inlet and the outlet (Col. 12, lines 43-47), the valve including a rotatable stem to selectively communicate the inlet with the outlet (Col. 12, lines 48-49), the stem including a flow passage extending through the stem from an inlet end of the flow passage to an outlet end of the flow passage whereby the inlet end of the flow passage communicates with the inlet and the outlet end of the flow passage communicates with the outlet (Col. 12, lines 44-55), wherein a cross-sectional area of the flow passage at an intermediate portion between the inlet end and the outlet end is larger compared to an increasing flow passage that increases at a constant rate of change (Col. 12, lines 57-61; the patent discloses that the flow passage widens at a rate different from a first portion, but is still widening or increasing in cross-section at the intermediate portion as claimed), wherein the cross-sectional area of the flow passage changes at different rates through the flow passage from the inlet end to the outlet end (Col. 12, lines 58-61), the inlet selectively communicates with the inlet end of the flow passage and the outlet end of the flow passage selectively communicates with a first attachment portion of the inlet (through the valve as claimed; Col. 12, lines 49-54 state that the inlet end of the flow passage communicates with the first port which is analogous to the inlet); wherein the flow passage includes a first section and a second section, the first section extending from the inlet end toward the outlet end, the first section widening as the first section extends from the inlet end, the second section extending from the first section toward the outlet end, the second section widening at a rate different from the first section as the second section extends from the first section toward the outlet end (Col. 12, line 62-Col. 13, line 2). The patent fails to explicitly disclose the pump as an enteral feeding pump device.
Breitweiser et al. (henceforth Breitweiser) teaches an enteral feeding pump apparatus (Figure 2; ¶ [0031]) comprising a first tubing section (inlet tubing 77) connected to a feeding source containing a feeding solution (¶ [0034]), and a second tubing (portion of tubing 77 engaged with pump via cassette 5 as disclosed in ¶ [0045]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of patent claim 1 by connecting the pumping apparatus to an enteral feeding solution so as to deliver nutrients to a patient during a procedure as taught by Breitweiser.
Regarding claim 17, the subject matter is known from claim 1 of the patent wherein the stem is rotated to selectively communicate the first port with the second port (or selectively prevent communication and therefore blocking fluid flow from the first port to the second port through the flow passage).
Regarding claims 18 and 20, the patent discloses the structure of the pump set as set forth above for instant claims 1 and 16, including the increasing cross-sectional area of the intermediate portion when compared to a constant rate increasing section of the flow passage, but fails to explicitly teach the structure of the housing and cassette recess. Breitweiser teaches (Figures 1 and 3) a housing (3) comprising a pumping unit (23) for pumping a feeding solution (¶ [0031]); and a cassette recess (6) in the housing for receiving a cassette (¶ [0032]). It would have been obvious to one of ordinary skill in the art to provide the pump housing and cassette recess of Breitweiser along with the patent structure of the cassette and valve fitting so as to provide a means for selectively pumping fluid from a fluid source to a patient during a feeding procedure as taught by Breitweiser.
Regarding claim 19, the subject matter is known from claims 1 and 13 of the patent which teach the stem as providing for rotation to selectively couple an inlet to an outlet to control fluid flow through the valve.
Claims 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11,331,428 in view of Breitweiser, and further in view of Harr et al. (US 2010/0211022).
Regarding claims 9 and 10, the patent/Breitweiser discloses the claimed method substantially as set forth above for claim 1, but fails to explicitly disclose two second attachment portions of the inlet. Harr et al. (henceforth Harr) teaches (Figure 4A a valve for a medical fluid delivery set comprising first and second attachment portions (26, 28) which are selected via rotation of a valve assembly to provide selective fluid flow from each of the inlet portions through an outlet (30; ¶ [0032]; see also rotation of the valve rotor 34 for selective communication as per claim 10). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent device to comprise first and second inlet portions to the cassette so as to allow the selective delivery of a medical fluid and a rinsing fluid through the cassette as taught by Harr.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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