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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/145,814, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application does not disclose an adjustment mechanism as recited in claims 26 and 27 which are not entitled to the benefit of the application.
Claim Objections
Claim 21 is objected to because of the following informalities: claim 21 recites “such that the flow resistor configured” this should be “such that the flow resistor is configured.”. 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 17-20 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. Claim 11 recites a recess defined within the central column, the recess being sized and shaped for receiving a flow resistor to couple the flow resistor downstream of the central column. However, in Applicant’s discussion of Figs. 5 it discloses that instead of a flow resistor being downstream of the pump the pump receives the flow resistor ([0045]). It is therefore not clear how the resistor can be both downstream of the pump and received within the recess as the recess is within the pump and that is disclosed as an alternative to having the resistor downstream. For purposes of examination, it is considered that the resistor is received within the pump and receives flow from the pump.
Claims 9 and 25 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 1 and 21 recite the flow resistor is coupled downstream of the pump, claims 9 and 25 recite the flow resistor is within the central column of the pump. It is not clear how the flow resistor could be both downstream of and within the pump. As such it appears claims 9 and 25 are failing to include the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-5, 10, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2020/0325999 A1) in view of Rajendran et al. (US 2019/0217045 A1).
With regard to claims 1-5 and 10, Aklog et al. teach a system for delivering a constant flow rate of fluid along a pathway, the system comprising: a pump ([0106], [0117]); a flow resistor (Fig. 12A member 100) being downstream and in fluid communication with the central column of the pump, the flow resistor including a resistive member (Fig. 12A member 130) and a moveable element (Fig. 12A member 120) situated within the flow resistor, the moveable element configured to move within the flow resistor and to define a constricted cross-sectional flow path, between an inner surface of the flow resistor and the moveable element, the resistive member having a linear elastic property configured to define a predetermined relationship between an input pressure at an inlet of the flow resistor and an output pressure at an outlet of the flow resistor such that the flow resistor passively regulates the fluid flow to a substantially constant flow rate (abstract, [0086], [0087], [0106]); and the pathway being in fluid communication with an output of the flow resistor for directing the fluid flow to a site of interest at the substantially constant flow rate (cl.14, Fig. 12A output 108 connects to a pathway, exemplary 1804 in Fig. 18). Aklog et al. teach an elastomeric balloon pump may be used ([0117]) but do not disclose the explicit structure. However, Rajendran et al. teach an elastomeric pump which comprises a central column, surrounding inner and outer elastomer layers within a protective outer sheath, and which is connected to a filter which is beneficial for maintaining a uniform and constant flow rate (Figs. 13 and 14, column 1328 with input channel 1354/1356 and output channel 1360, inner member 1324, outer member 1326, sheath 1312, filter 1368, [0212], [0218], [0219]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pump in Aklog et al. as in Rajendran et al. as Aklog et al. teach using an elastomeric pump and Rajendran et al. teach such a pump is beneficial for providing uniform and constant flow.
With regard to claims 21-24, Aklog et al. teach a method for delivering fluid to a site of interest, the method comprising: selecting a flow resistor (Fig. 12A member 100) having resistive member (Fig. 12A member 130) and a moveable element (Fig. 12A member 120) situated within the flow resistor, the moveable element configured to define a constricted cross-sectional flow path, the resistive member having a linear elastic property configured to define a predetermined relationship between an input pressure at an inlet of the flow resistor and an output pressure at an outlet of the flow resistor such that the flow resistor configured to modify a flow rate through the flow resistor to a substantially constant flow rate (abstract, [0086], [0087], [0106]); fluidly coupling the flow resistor downstream to a pump ([0106], [0117]); directing at least a portion of the volume of fluid through an output along the constricted cross-sectional flow path of the flow resistor to the site of interest at the substantially constant flow rate (cl.14, Fig. 12A output 108 connects to a pathway, exemplary 1804 in Fig. 18). However, Rajendran et al. teach an elastomeric pump which comprises a central column, surrounding inner and outer elastomer layers within a protective outer sheath, and which is connected to a filter which is beneficial for maintaining a uniform and constant flow rate (Figs. 13 and 14, column 1328, inner member 1324, outer member 1326, sheath 1312, [0212], [0218], [0219]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pump in Aklog et al. as in Rajendran et al. as Aklog et al. teach using an elastomeric pump and Rajendran et al. teach such a pump is beneficial for providing uniform and constant flow.
Claim(s) 9 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2020/0325999 A1) and Rajendran et al. (US 2019/0217045 A1) as applied to claims 1 and 21 above, and further in view of Hessel (US 5,263,935).
With regard to claims 9 and 25, as combined Rajendran et al. has a central column with a recess which outputs flow to the destination (Fig. 13 space between 1360 and output at 1362) but does not disclose the flow resistor within the recess. However, Hessel teaches placing a flow control resistor within the central channel of an elastomeric pump which is beneficial for controlling the rate of flow (exemplary Fig. 8 member 72, Fig. 10 member 88, Col. 2 lines 9-11). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the flow resistor of Aklog et al. within the channel of Rajendran et al. as Hessel teaches such placement is effective for regulating the flow to the patient from the pump and would yield the same predictable result.
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2020/0325999 A1) and Rajendran et al. (US 2019/0217045 A1) as applied to claims 1 and 21 above, and further in view of Chappel et al. (US 2012/0048403 A1).
With regard to claims 26 and 27, Aklog et al. teach and adjustment mechanism may be used ([0083], [0093]) but does explicitly show it to adjust the elastic property of the resistive member. However, Chappel et al. teach a flow resistor with a resistive (Fig. 7 member 7) and movable member (Fig. 7 member 5) in which the resistive member may be adjusted (Fig. 7 member 4) to control flow ([0162]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an adjustment mechanism in Aklog et al. as Chappel et al. teach this is beneficial for achieving desired flow control.
Claim(s) 11, 13, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 2020/0325999 A1) in view of Rajendran et al. (US 2019/0217045 A1) and Hessel (US 5,263,935).
With regard to claims 11, 13, and 17-20, Aklog et al. teach an elastomeric pump ([0106], [0117]) comprising: an elastomer layer defining a cavity for receiving a volume of fluid ([0117] an elastomer balloon pump would necessarily include an elastomer later defining a cavity); a flow resistor to couple the flow resistor downstream of the central column, the flow resistor having a linear elastic property configured to define a predetermined relationship between an input pressure at an inlet of the flow resistor and an output pressure at an outlet of the flow resistor (Fig. 12A member 100, resistive member 130 with a linear elastic property, abstract, [0086], [0087], [0106]).
Aklog et al. teach an elastomeric balloon pump may be used ([0117]) but do not disclose the explicit structure. However, Rajendran et al. teach an elastomeric pump comprising: an elastomer layer defining a cavity for receiving a volume of fluid (Figs. 13 and 14, inner member 1324); and an outer elastomer layer (Figs. 13 and 14, inner member 1326),disposed between the elastomer layer and a protective outer sheath (Figs. 13 and 14, sheath 1312); and a central column disposed at least partially within the cavity and in fluid communication with the cavity (Figs. 13 and 14, column 1328), a recess defined within the central column, and the recess having an output channel for directing fluid out of the elastomeric pump to a destination site (Fig. 13 space between 1360 and output at 1362). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pump in Aklog et al. as in Rajendran et al. as Aklog et al. teach using an elastomeric pump and Rajendran et al. teach such a pump is beneficial for providing uniform and constant flow.
As combined Rajendran et al. has a central column with a recess which outputs flow to the destination (Fig. 13 space between 1360 and output at 1362) but does not disclose the flow resistor within the recess. However, Hessel teaches placing a flow control resistor within the central channel of an elastomeric pump which is beneficial for controlling the rate of flow (exemplary Fig. 8 member 72, Fig. 10 member 88, Col. 2 lines 9-11). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the flow resistor of Aklog et al. within the channel of Rajendran et al. as Hessel teaches such placement is effective for regulating the flow to the patient from the pump and would yield the same predictable result. As combined the inlet of the resistor of Aklog et al. would be in communication with and output 1360 of Rajendran et al.
Response to Arguments
Applicant's arguments filed 23 April 2026 have been fully considered but they are not persuasive. Applicant argues that combining Aklog with Rajendran does not yield a predictable result and that the office action gives no explanation regarding the modification. The Examiner maintains that as rejected Aklog specifically teaches an elastomeric balloon pump may be used, using the elastomeric balloon pump as provided by Rajendran would not change the operation. Additionally, Rajendran provides information regarding the benefits of such a pump. Further, Applicant remarks Rajendran does not teach a downstream flow resistor, Rajendran is not relied upon to teach this feature. Regarding the rejection over 35 U.S.C. 112, Applicant argues that recitation to a recess partially extending into the central column is not the same as the flow resistor being within the central column of the pump. As shown in Applicant’s Figs. 5, when the recess is provided extending partially into the central column and as recited in the claims the resistor is received within the recess, this places the resistor in a location that is not downstream of the pump. It is not clear how the recess couples the resistor downstream of the pump.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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