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 .
Response to Amendment
Claims 1-9 and 11 are pending in the application. Claim 10 has been canceled. Claim 1 has been amended.
Claim Interpretation
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.
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: “control mechanism” in claim 4.
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.
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.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer, Jr. et al. (US 2007/0255256 A1) (“Fischer”).
Regarding claim 1, Fischer discloses (Figures 5-7) a removal device for use in a passageway of a urinary tract of an in vivo patient, comprising: a sheath (51) sized to be inserted into the passageway of the patient (paragraph 0038); a vacuum tube (30/40/50) comprising a first passageway (35/46/50b) and a second passageway (34/45/50a), wherein the vacuum tube is configured to be disposed at least partially within the sheath (paragraph 0038) and is designed to couple to suction provided from a suction source (383) to transport kidney stone fragments through the first passageway (paragraphs 0025, 0033, 0035, 0036), wherein the vacuum tube (30/40/50) is capable of being inserted into the sheath (51) after removal of an instrument (5/5a/5b/54) therefrom; a guidewire (paragraph 0038) configured to be disposed in one of the passageways (the passageway of the urinary tract of the patient); and a port (48) coupled to the removal device adapted to receive saline (paragraphs 0005 and 0023) for infusion through one of the passageways (paragraph 0036).
Fischer fails to explicitly disclose that the vacuum tube is sized to receive and transport kidney stone fragments having a diameter of at least 2 mm through the first passageway, and wherein the second passageway is characterized by a diameter of between about 1 mm (3 Fr.) and about 2.6 mm (8 Fr.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum tube disclosed by Fischer to be sized to receive and transport kidney stone fragments having a diameter of at least 2 mm through the first passageway by suction provided from the suction source and to modify the second passageway to be characterized by a diameter of between about 1 mm (3 Fr.) and about 2.6 mm (8 Fr.), 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, the device of Fischer would not operate differently with the claimed dimensions since the purpose of the vacuum tube disclosed by Fischer is to both deliver irrigation fluid from a source (381) and to remove material to a collection facility (382) via a vacuum (383), and the modifications are adjustments dimensions of the vacuum tube. Further, it appears that the Applicant places no criticality on the dimension claimed, indicating simply that:
“The diameter of the second passageway 144 of the vacuum tube 104 is smaller than the diameter of the lumen 140 and is characterized by a diameter of between about 0.5 Fr. to about 8 Fr., and more preferably between about 3 Fr. to about 6 Fr. In one configuration, the second passageway 144 of the vacuum tube 104 is about 3 Fr. In a different configuration, the second passageway 144 of the vacuum tube 104 is about 4 Fr. In still a different configuration, the first passageway 144 of the vacuum tube 104 is about 7 Fr.” See paragraph 0099 of Specification.
“The first passageway 1342 and the second passageway 1344 can be configured to be any suitable sizes. For example, in one non-limiting configuration, the first passageway 1342 can have an internal diameter of about 3.0 millimeters, and the second passageway 1344 can have a cross-sectional area of about 2.6265 square millimeters.” See paragraph 00160 of Specification.
“The removal device 100 is also designed to remove small, medium, and large kidney stones or other debris. For example, in one configuration, the removal device 100 is designed to remove kidney stones having an approximate diameter of between about 0.0001 mm to about 8 mm. In a different configuration, the removal device 100 is designed to remove kidney stones having an approximate diameter of between about 0.1 mm to about 6 mm. In a different configuration, the removal device 100 is designed to remove kidney stones having an approximate diameter of between about 1 mm to about 5 mm. In still a different configuration, the removal device 100 is designed to remove kidney stones having an approximate diameter of between about 2 mm to about 4 mm.” See paragraph 00207 of Specification.
Regarding claim 2, Fischer teaches (Figure 5) a valve (351) in fluid communication with a suction source (383; paragraph 0033).
Regarding claim 3, the removal device taught by Fischer is capable of being used in conjunction with fluoroscopy.
Regarding claim 5, Fischer teaches (Figures 5-7) the first (35/46/50b) and second passageways (34/45/50a) extend longitudinally through the vacuum tube.
Regarding claim 6, Fischer teaches (Figures 5-7) that the vacuum tube (30/40/50) is capable of removing debris through one of the passageways (35/46/50b) by application of suction (paragraphs 0025 and 0033-0036).
Regarding claim 7, Fischer teaches (Figure 5) a catch (382) coupled to the vacuum tube (30) that is configured to collect debris that has been removed through the vacuum tube (paragraph 0033).
Regarding claim 8, the removal device taught by Fischer (Figures 5-7) is capable of being positioned adjacent to one or more kidney stones or kidney stone fragments.
Regarding claim 9, Fischer discloses (Figures 5-7) the vacuum tube (30/40/50) comprises a tip (33, 43, 56) that is capable of being positioned in a lowest part of a kidney.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer, Jr. et al. (US 2007/0255256 A1) (“Fischer”) in view of Soble et al. (US 6,697,867 B2) (“Soble”).
Regarding claim 4, Fischer teaches the invention substantially as claimed. However, the Fischer fails to explicitly teach a control mechanism configured to control suction from the suction source.
Soble teaches a control mechanism in the form of a switch or valve configured to control suction from the suction source. Soble teaches that the control mechanism is configured to turn the suction source on/off and/or regulate pressure (Column 7, lines 64-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the removal device taught by Fischer to include a control mechanism configured to control suction from the suction source, as further taught by Soble. This modification would allow an operator to turn the suction source on/off and/or regulate pressure (Soble, Column 7, lines 64-67).
NOTE: the limitation "control mechanism" has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The corresponding structure disclosed in the specification is a knob, a lever, a button, a foot pedal, combinations thereof, and the like (see paragraph 0101 of the US PG Publication). The switch/valve taught by Soble is an equivalent structure to the disclosed control mechanisms.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer, Jr. et al. (US 2007/0255256 A1) (“Fischer”) in view of Deal (US 2011/0224489 A1).
Regarding claim 11, Fischer teaches the invention substantially as claimed. However, Fischer fails to teach positioning and/or navigation of the vacuum tube is controllable using a control mechanism selected from a knob, lever, button, foot pedal, or combination thereof.
In the same field of endeavor, Deal teaches (Figures 1-8) a removal device for use in a passageway of a urinary tract of an in vivo patient (paragraph 0028), comprising: a sheath (10) sized to be inserted into the passageway of the patient (paragraph 0028); a vacuum tube (16) comprising a first passageway and a second passageway (Figure 2; paragraphs 0030 and 0033), wherein the vacuum tube is configured to be disposed at least partially within the sheath (Figures 1 and 5), and is designed to couple to suction provided from a suction source to transport kidney stone fragments through the first passage (paragraph 0033). Deal further teaches (Figure 4) that positioning and/or navigation of the vacuum tube is controllable using a control mechanism (46) that is a lever (paragraph 0044).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum tube taught by Fischer such that positioning and/or navigation of the vacuum tube is controllable using a control mechanism that is a lever, as taught by Deal. This modification would allow the operator to control movement/positioning/navigation of the distal end of the vacuum tube with a single hand (Deal, paragraph 0044).
Response to Arguments
Applicant’s arguments with respect to claims 1-9 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
NOTE: the Applicant has amended claim 1 to overcome the interpretation under 35 U.S.C. § 112(f) from the previous Office Action. The limitation “control mechanism” in claim 4 was also interpreted under 35 U.S.C. § 112(f) in the previous Office Action. The Applicant has not provided arguments and has not amended claim 4. The Examiner has maintained the interpretation of “control mechanism” under 35 U.S.C. § 112(f) in the current Office Action. The claim limitation uses a generic placeholder (“mechanism”) that is coupled with functional language (“control”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
NOTE: in claim 11, the limitation “control mechanism” has NOT been interpreted under 35 U.S.C. § 112(f) because the claim recites sufficient structure (knob, lever, button, foot pedal) to perform the recited function.
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.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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