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.
Drawings
The drawings are objected to because in the specification 106 is listed as the inner member and 108 as the outer member, however, the opposite appears shown in the Figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 2-5 and 18 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 2 recites the pump includes at least one inner elastomer. Claim 3 recites the pumps includes an outer elastomer. Claim 1 at the outset recites the pump has an inflatable member. It is not clear if the inner and outer elastomers are part of the inflatable member or a separate structure. For purposes of the rejection the elastomers are considered as part of the inflatable member. Claim 18 recites the flow resistor includes an inlet in fluid communication with the output channel to receive fluid from the cavity. However, the output channel in claim 11 is recited as directing fluid out to the destination site. It is not clear how these could be the same output channel. For purposes of the rejection the output channel of claim 18 is considered as separate from claim 11.
Claim 25 is 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. Claim 21 recites the flow resistor is coupled downstream of the pump, claim 25 recites 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 claim 25 is 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 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 an elastic property and configured to affect the movement of the moveable element, the flow resistor configured to modify a flow rate of a fluid flow through the flow resistor to passively regulate 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, a surrounding inflatable member with an inner and outer elastomer layer 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 an elastic property and configured to affect the movement of the moveable element, 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, a surrounding inflatable member with an inner and outer elastomer layer 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).
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 Rajendran et al. (US 2019/0217045 A1) in view of Hessel (US 5,263,935).
With regard to claims 11, 13, and 17-20, 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). Rajendran et al. do not disclose the column is sized to receive a flow resistor. 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 seal 77, Fig. 10 member 88 seal 102, 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 a flow resistor within the channel of Rajendran et al. as Hessel teaches such placement is effective for regulating the flow to the patient from the pump. As combined the inlet of a capillary member like 88 of Hessel would be in communication with and output 1360 of Rajendran et al.
Conclusion
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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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783