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 .
Claims 1-22 are canceled.
Claims 23-43 are added.
Claim Interpretation
5. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an orientation feature configured to interface with at least one rib of a patient user when the pump body is implanted between adjacent ribs of the patient user and configured to orient the pump body at a desired angle relative the at least one rib” in claim 11. The recitation of “feature” is a generic placeholder coupled with the function of “orientation…configured to interface with at least one rib of a patient user when the pump body is implanted between adjacent ribs of the patient user and configured to orient the pump body at a desired angle relative the at least one rib.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
7. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: stability and orientation feature 200 of Figs. 14A-14B as described on instant pg. 14, lines 15-18, pg. 46, line 13 until pg. 47, line 5; the particular shape of the pump providing arbitrary angle of the pump relative to the chest wall of Figs. 15-19 and 22 including an L-shape of Fig. 15 or a lozenge shape as in Figs. 16-18 and 22 or a flanged-mushroom shape of Fig. 19 as described on instant pg. 15, line 18 until pg. 16, line 6 and lines 17-21 and pg. 47, line 6 until pg. 50, line 5 for Figs. 15-19 and pg. 54, lines 11-15 for Fig. 22.
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.
Claim 23-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 12-14, 16, and 25-34 of U.S. Patent No. 11,571,555. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of the claim 4 and 16 of the patent would result in a claim including each and every limitation of claim 23 of the instant application. Furthermore, dependent claims 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 12, 13, 14 of the patent include each and every limitation of claims 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36 of the instant application.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 37-43 are rejected under 35 U.S.C. 103 as being unpatentable over Browd (US Pub. No. 2013/0197422 A1) or Browd (US Pub. No. 2013/0197422 A1) in view of Mayse (US Pub. No. 9,393,387 B1).
Claim 37. Browd discloses an electro-mechanical pump-based fluid management system comprising:
an electro-mechanical pump (204) ([0057]) in fluid communication with an inlet (230) and an outlet (240) (Fig. 2B); and
a first tube (108a) configured to extend from the inlet and allow fluid movement from a first area of a patient's body to the inlet (Fig. 1A; i.e., brain); and
a second tube (108b) configured to extend from the outlet and allow fluid movement from the outlet to a second area of a patient's body (Fig. 1A; i.e., peritoneal cavity) ([0025]-[0026]);
wherein the electro-mechanical pump comprises:
a pump body (i.e., housing of valve device 204 similar to housing 128 for valve device 104) having an interior chamber (i.e., interior chamber of catheter 102 in housing 128 throughwhich fluid flows through) in fluid communication with the inlet and the outlet (Fig. 2B);
an inlet valve (230a) in general proximity to the inlet configured to allow fluid movement from the inlet to the interior chamber and at least substantially preclude movement from the interior chamber to the inlet ([0057]; i.e., as actuated by controller 110, see [0070]-[0072], Figs. 5A-5D for additional details of how actuator 230a can be controlled by controller 110);
an outlet valve (230b) in general proximity to the outlet configured to allow fluid movement from the interior chamber to the outlet and at least substantially preclude movement from the outlet to the interior chamber ([0057]; i.e., as actuated by controller 110, see [0070]-[0072], Figs. 5A-5D for additional details of how actuator 230b can be controlled by controller 110);
an actuator (230c) operably connected with the interior chamber and which is capable of moving fluid from the inlet to the outlet ([0057]);
a controller (110) operably connected to the actuator and capable of controlling the actuator ([0057]); and
a battery (122) operably connected to the controller to provide energy to the controller and the actuator ([0037]).
Browd does not explicitly disclose that the inlet and outlet valves (230a, 230b) being one-way valves. However, Browd discloses that valve device 104 can include one-way valve as a purely mechanical form of preventing undesired retrograde flow ([0050]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Browd with the inlet and outlet valves of valve device 204 as one-way valves disclosed for valve device 104 of Browd so as to prevent unwanted retrograde flow ([0050]) and since valve device 204 including features generally similar to the valve device 104 ([0057]).
Moreover, it is noted that Mayse also discloses an implantable pump with a pump comprising a one-way valve positioned proximity to the inlet and the outlet so as to preclude antegrade flow of flow from into through the outlet into the pump chamber and out of the pump chamber through the inlet (Fig. 3A; col. 7, lines 15-39). Thus, since both Browd and Mayse are drawn to implantable pumps for controlling fluid flow, it also would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the inlet and outlet valves of Browd as being one-way valves as disclosed by Mayse so as to ensure one-way fluid flow (col. 7, lines 15-39).
Claim 38. Browd discloses the electro-mechanical pump-based fluid management system of claim 37, wherein Browd does not explicitly disclose that the battery is configured to comprise sufficient energy to enable the electro-mechanical pump to move at least 27 liters of fluid from the inlet to the outlet.
However, since Browd discloses a battery for providing power to the system ([0037]), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the battery with an amount of energy sufficient to enable the electro-mechanical pump to move at least 27 liters of fluid from the inlet to the outlet depending on the amount of energy required for the treatment requirement so as to allowing for optimum fluid flow through the device to mimic optimal body function and 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. See MPEP 2144.05 for additional details.
Claim 39. Browd discloses the electro-mechanical pump-based fluid management system of claim 37, wherein the controller is programmed to operate the actuator at each of a plurality of times over a first period of time and, for each of the plurality of times, continue to operate the actuator for a specified period of time less than the first period of time ([0041); since controller 110 carry out an algorithm to operate valve device 104 a predetermined amount each time a measurement outside of a desired limit is detected during a treatment time period).
Claim 40. Browd discloses the electro-mechanical pump-based fluid management system of claim 37, wherein Browd further discloses that controller 110 carry out an algorithm that moves the valve device 104 a predetermined amount each time a measurement outside of a desired limit (e.g., desired CSF range) is detected ([0033] and [0038]), but does not explicitly the controller is programmed to operate the actuator for an amount of time to pump a desired volume of fluid on a first day post implantation of the electro-mechanical pump-based fluid management system in the patient and then decrease the amount of time the pump operates the actuator for at least one subsequent day post implantation.
However, depending on the particular treatment requirement and the patient’s condition, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller is programmed to operate the actuator for an amount of time to pump a desired volume of fluid on a first day post implantation of the electro-mechanical pump-based fluid management system in the patient and then decrease the amount of time the pump operates the actuator for at least one subsequent day post implantation so as to allowing for optimum fluid flow through the device to mimic optimal body function.
Claim 41. Browd discloses the electro-mechanical pump-based fluid management system of claim 37, further comprising a sensor (236a,236b) that senses fluid flow through the electro-mechanical pump ([0051]) and wherein the controller is programmed to operate the actuator at each of a plurality of times over a period of time and, for each of the plurality of times, continue to operate the actuator until a sensed fluid flow drops below a designated value ([0033]; i.e., each time the measurement is outside of a desired limit includes below and above a designated value).
Claim 42. Browd discloses the electro-mechanical pump-based fluid management system of claim 37, further comprising a sensor (236a,236b) that senses pressure inside the electro-mechanical pump ([0051]) and wherein the controller is programmed to operate the actuator at each of a plurality of times over a period of time and, for each of the plurality of times, continue to operate the actuator until a sensed pressure drops below a designated value ([0033]; i.e., when pressure is lower than a desired pressure).
Claim 43. Browd discloses the electro-mechanical pump-based fluid management system of claim 37, wherein the electro-mechanical pump comprises a liquid impermeable membrane (i.e., liquid-tight seal) separating the interior chamber from a housing compartment comprising the actuator, the controller, and the battery ([0025]); wherein the actuator is operably connected with the liquid impermeable membrane and capable of deforming the liquid impermeable membrane (Fig. 2B; via operation of actuator 230c).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHELSEA E STINSON whose telephone number is (571)270-1744. The examiner can normally be reached M-F 8am-4:30pm, Alt. Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alford Kindred can be reached at (571) 272-4037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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