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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/26 has been entered.
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: “navigation mechanism” in claim 1 and “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 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Deal (US 2011/0224489 A1) in view of Soble et al. (US 6,997,867 B2) (“Soble”) and Knapp (US 2004/0267213 A1).
Regarding claim 1, Deal discloses (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); and a navigation mechanism (22) configured to be disposed in one of the passageways (paragraph 0030).
Deal 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 by suction provided from a suction source. Deal fails to explicitly disclose a port coupled to the removal device adapted to receive saline for infusion through one of the passageways. Deal also fails to explicitly disclose that the second passageway is characterized by a diameter of between about 1 mm (3 Fr.) and about 2.6 mm (8 Fr.). However, Deal discloses that the lumens may have any size, cross-sectional area, shape, and/or configuration, and may extend through proximal end (16a) and distal end (16b) of elongated member (16). Further, Deal discloses that an aspiration lumen and/or an irrigation lumen may extend longitudinally through elongated member (16). Alternatively, working channel (24) may be used for irrigation and/or aspiration.
In the same field of endeavor, Soble teaches (Figure 2) a removal device for use in a passageway of a urinary tract of an in vivo patient comprising a vacuum tube (10) sized to receive and transport kidney stone fragments having a diameter of at least 2 mm through a passageway by suction provided from a suction source (Column 5, lines 31-35). Soble further teaches a port (20) coupled to the removal device adapted to receive saline for infusion through the passageway (Column 4, lines 14-18).
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 Deal 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 a suction source, as taught by Soble. Deal discloses that the lumens of the vacuum tube may have any size, cross-sectional area, shape, and/or configuration (paragraph 0033). This modification would provide a passageway with a cross section that maximizes suction and allows removal of stones and fragments up to 5 mm in diameter (Soble, Column 5, lines 31-35). It also 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 disclosed by Deal to include a port coupled to the removal device adapted to receive saline for infusion through one of the passageways, as taught by Soble. This modification would allow the removal device to be coupled to a source of positive pressure to allow the treatment site to be irrigated (Column 2, lines 41-44).
In the same field of endeavor, Knapp teaches (Figure 23) a removal device with a vacuum tube comprising a first passageway (96) and a second passageway (100) that is characterized by a diameter of between about 1 mm (3 Fr.) and about 2.6 mm (8 Fr.). Knapp teaches that the second passageway is sized to receive a small navigation mechanism (paragraph 0078).
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 second passageway taught by Deal in view of Soble to have a diameter of between about 1 mm (3 Fr.) and about 2.6 mm (8 Fr.), as taught by Knapp, in order to be sized to accommodate the navigation mechanism. Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed in the prior art’ a prima facie case of obviousness exists” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range, indicating 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 US PG Publication.
NOTE: the limitation "navigation 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 guidewire. However, the Applicant discloses that the navigation mechanism may comprise other devices or mechanisms that assist in positioning portions of the removal device. (see paragraph 0100 of US PG Publication). Deal discloses a functionally equivalent steering wire that is manipulated to steer the removal device within the anatomical passageway.
Regarding claim 2, Deal as modified by Soble and Knapp above teaches the invention substantially as claimed. However, the combined teaching fails to teach a valve in fluid communication with a suction source.
Soble further teaches a switch or valve in fluid communication with a suction source 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 Deal in view of Soble and Knapp above to further include a valve in fluid communication with a 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).
Regarding claim 3, Deal as modified by Soble and Knapp above teach the invention substantially as claimed. However, the combined teaching above fails to teach that the removal device is configured to be used in conjunction with fluoroscopy.
Knapp further teaches that advancement and positioning can be verified with fluoroscopy (paragraph 0095).
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 Deal in view of Soble and Knapp above to be configured to be used in conjunction with fluoroscopy, as further taught by Knapp. This modification would allow an operator to verify advancement and positioning of the removal device during the procedure (Knapp, paragraph 0095).
Regarding claim 4, Deal as modified by Soble and Knapp above teaches the invention substantially as claimed. However, the combined teaching fails to teach a control mechanism configured to control suction from the suction source.
Soble further 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 Deal in view of Soble and Knapp above to further 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.
Regarding claim 5, Deal as modified by Soble and Knapp teaches that the first and second passageways extend longitudinally through the vacuum tube (Deal, paragraphs 0030 and 0033).
Regarding claim 6, Deal as modified by Soble and Knapp teaches that the vacuum tube is configured to remove debris through one of the passageways by application of suction (Soble, Column 5, lines 32-35).
Regarding claim 7, Deal as modified by Soble and Knapp above teaches the invention substantially as claimed. However, the combined teaching above fails to teach a catch coupled to the vacuum tube that is configured to collect debris that has been removed through the vacuum tube.
Knapp further teaches (Figure 26) that the vacuum tube can be coupled to a suction source (Toomey syringe) with a catch (syringe barrel) that is configured to collect debris that has been removed through the vacuum tube (paragraph 0100).
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 Deal as modified by Soble and Knapp above to have a suction source with a catch that is configured to collect debris that has been removed through the vacuum tube, as further taught by Knapp. This modification would provide vacuum source that is useful for removing the debris and would allow the debris to be disposed of after the procedure (Knapp, paragraph 0100).
Regarding claim 8, the removal device taught by Deal as modified by Soble and Knapp is capable of being positioned adjacent to one or more kidney stones or kidney stone fragments (Deal, Figures 5-8).
Regarding claim 9, Deal as modified by Soble and Knapp teaches that the vacuum tube comprises a tip capable of being positioned in a lowest part of a kidney (Deal, paragraphs 0028 and 0048).
Regarding claim 11, Deal as modified by Soble and Knapp teaches (Deal, Figure 4) that positioning and/or navigation of the vacuum tube is controllable using a control mechanism (46) that is a lever (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. The Deal, Soble et al., and Knapp references are newly cited.
Applicant's arguments filed 2/17/26 regarding the interpretation of “navigation mechanism” and “control mechanism” under 35 U.S.C. § 112(f) have been fully considered but they are not persuasive. The Applicant has not provided a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
As explained in MPEP § 2181, subsection I, these claim limitations meet the following three-prong test to be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
The use of “mechanism” is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed functions (navigation and control). “Mechanism” does not provide specific structure for performing the navigating or controlling functions.
The generic placeholder (mechanism) is modified by functional language (navigation and control).
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
For these reasons, the Examiner’s interpretation of the claim limitations “navigation mechanism” and “control mechanism” under 35 U.S.C. § 112(f) is proper. If Applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant may amend the claim limitations to avoid 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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