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 .
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:
“An actuation mechanism operably coupled to the extendable assembly and configure to move the wires between a retracted…” in claims 1-6, 14, 16 and 17.
Based on a review of the specification, the actuation mechanism is interpreted as the setup described in paragraphs [0030]-[0031] and depicted in figure 1; a catheter; or equivalents thereof for providing the claimed function. It is noted that claims 8-13 and 15 do not invoke 112(f) interpretations as they recite sufficient structure to define the mechanism.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kurz (US 4,204,548).
Regarding claims 1 and 15; Kurz discloses a sizing device (figure 1) configured to measure a dimension of an airway in a patient (wherein the examiner notes that Kurz is capable of measuring a dimension of an airway as it discloses measuring hollow organs and hollow parts of the body; column 1, lines 54-60), the sizing device comprising:
an elongated member (element 11) insertable into the airway of the patient and defining a lumen extending therethrough from a proximal end to a distal end (wherein the device is for insertion into a hollow organ or body part of the body and element 1 extends through element 11; figure 1);
an extendable assembly (combined elements 1 and 2) insertable into the lumen, the extendable assembly including wires (elements 2) having a shape-set memory bias (wherein the examiner notes that springs inherently have a shape memory bias), the shape-set memory bias configured to cause the wires to extend radially outward from a central axis of the elongated member (column 3, lines 50-57; figures 1 and 2); and
an actuation mechanism (combined elements 6, 12, 13 and 24) operably coupled to the extendable assembly and configured to move the wires (elements 2) between a retracted position (figure 1), wherein the wires are disposed within the lumen, and a plurality of deployed positions (figure 2), wherein the wires (elements 2) extend distally beyond the distal end of the elongated member, wherein in the deployed positions (figure 2), the shape-set memory bias causes the wires to extend radially outward to define a plurality of testing dimensions (wherein movement of element 11 via moving elements 12 and 13 relative to each other either expands or retracts the wire elements 2 towards the walls of the lumen; column 3, line 66 – column 4, line 63; figures 1, 2, 7).
Further regarding claim 15; Kurz discloses the actuation mechanism is a catheter (wherein the examiner notes that elements 6, 12, 13 and 24 meet the BRI of a catheter as they are tubular elements insertable into the body having a lumen for passing elements; see figures 1-2)
Regarding claims 16-19; Kurz discloses Kurz discloses a sizing device (figure 1) configured to measure a dimension of a lumen in a patient (wherein the Kurz discloses measuring hollow organs and hollow parts of the body; column 1, lines 54-60), the sizing device comprising:
an elongated member (element 11) insertable the patient and defining a lumen extending therethrough from a proximal end to a distal end (wherein the device is for insertion into a hollow organ or body part of the body and element 1 extends through element 11; figure 1);
an extendable assembly (combined elements 1 and 2) insertable into the lumen, the extendable assembly including elements (elements 2) having a shape-set memory bias (wherein the examiner notes that springs inherently have a shape memory bias), the shape-set memory bias configured to allow the elements to extend radially outward from a central axis of the elongated member (column 3, lines 50-57; figures 1 and 2); and
an actuation mechanism (combined elements 6, 7, 8, 12, 13 and 24) operably coupled to the extendable assembly and configured to move the elements (elements 2) between a retracted position (figure 1), wherein the elements are disposed within the lumen, and a plurality of deployed positions (figure 2), wherein the elements (elements 2) extend distally beyond the distal end of the elongated member, wherein in the deployed positions (figure 2), the shape-set memory bias causes the elements to extend radially outward to define a plurality of testing dimensions (wherein movement of element 11 via moving elements 12 and 13 relative to each other either expands or retracts the wire elements 2 towards the walls of the lumen; column 3, line 66 – column 4, line 63; figures 1, 2, 7).
Further regarding claim 17-19; Kurz discloses the extendable assembly comprises: a base (element 1) including a first end portion (distal end of element 1 where it is connected to elements 2), a second end portion (proximal end of element 1 near housing element 24) and a body (body of probe element 1), the body extending between the first end portion and the second end portion, wherein a proximal portion of each of the elements (elements 2) is attached to the body of the base (spring elements 2 are attached to distal end of probe element 1; column 3, lines 50-57); wherein the actuation mechanism (element 6, 12, 13 and 24) is removably coupled to the second end of the portion of the base (wherein the examiner notes that probe element is capable of being removed from elements 6, 12, 13 and 24 by pulling it through distal end of jacket element 11).
Further regarding claims 18-19; Kurz discloses the actuation mechanism comprises: a handle portion (elements 6, 12, 13 and 24) attached to the proximal end of the elongated member (wherein element 12 is attached to proximal end of jacket element 11), the handle portion including: a proximal handle (elements 6 and 13); a slider handle (elements 12 and 24) including a working lumen extending therethrough (wherein there is a lumen defined by element 12 which element 6 is inserted into), the working lumen connected to the lumen of the elongated member (wherein the widened lumen of element 24 narrows down and is connected to lumen of jacket element 11; column 4, lines 23-25; figures 1 and 2) and a rod (tubular element of 6 which extends distally from element 13) having a first end section and a second end section, the first end section of the rod coupled to the proximal handle (wherein element 6 is coupled to element 13 via being integral), the second end section (distal section of element 6) of the rod coupled to the second end portion of the base (wherein proximal second end portion of element 1 is coupled to distal end of rod element 6 to allow for relative movement of the jacket element 11 in relation to probe element 1; column 3, line 66 – column 4, line 63; figures 1, 2, 7).
Further regarding claim 19; Kurz discloses moving the proximal handle (element 13) toward the slider handle (element 12) translates the rod (portion of element 6 distal to proximal handle 13) to extend the elements (element 2) past the distal end of the elongated member (element 11; see figure 2), and wherein moving the proximal handle (element 13) away from the slider handle (element 12) translates the rod (portion of element 6 distal to proximal handle element 13) to retract the elements (element 2) within the elongated member (element 11) (column 3, line 66 – column 4, line 63; figures 1, 2, 7).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurz as applied to claim 1 above, and further in view of Mirizzi et al (US 2003/0125759 A1).
Regarding claims 2-8; Kurz is described in the rejection of claim 1 above; however, Kurz does not explicitly disclose a core insertable into the lumen and configured to guide the wires through the lumen.
Mirizzi, in the field of elongate devices insertable into the body and for extending expandable members through the distal end thereof, teaches a device (element 10) having a core (distal tip element 18) insertable into the lumen (element 12) and configured to guide an expansible element (elements 20) through the lumen (wherein billet tip, element 18, is inserted into the distal end of lumen, element 12, via element 43 and depicted in figures 3a, 3b, 4a, 4c); paragraph [0036]) in order to guide the expansible elements radially outward and forward toward the walls of a lumen from the distal end the core and lumen (paragraph [0036]; figures 3a, 3b, 4a, 4c).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kurz to include a core insertable into the lumen as taught by Mirizzi in order to help direct the radially expandable wires (elements 2 of Kurz) radially and forward toward the vessel walls.
Further regarding claim 3; Mirizzi further discloses the core (element 18) comprises tracks (elements 42’, 44’, 42’’, 44’’), each track configured to guide an element through the lumen and prevent contact with other elements (paragraph [0036]; figures 3a, 3b, 4a, 4c). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Kurz/Mirizzi combination having a core element 18 of Mirizzi in the distal end of Kurz elongate member element 11 would also provide tracks to guide wire elements 2 of Kurz through the lumen and prevent contact with other wire elements as taught by Mirizzi.
Further regarding claims 4-8; the Kurz/Mirizzi combination is described in the rejection of claim 2 above. Kurz further discloses the extendable assembly comprises: a base (element 1) including a first end portion (distal end of element 1 where it is connected to elements 2), a second end portion (proximal end of element 1 near housing element 24) and a body (body of probe element 1), the body extending between the first end portion and the second end portion, wherein a proximal portion of each of the wires (elements 2) is attached to the body of the base (spring elements 2 are attached to distal end of probe element 1; column 3, lines 50-57).
Further regarding claim 5; the Kurz/Mirizzi combination is described in the rejection of claim 2 above. It would have been obvious to one of ordinary skill in the art at the time of filing that the core (billet tip element 18 of Mirizzi) is removably attached to the first end portion of the base (wherein the examiner notes that the end portion of the base [where wire elements 2 are connected to element 1] would be coupled to/attached to the tip, element 18, of the Kurz/Mirizzi combination when wire element 2 are fully extended out of the distal end and base distal end portion abuts the proximal end of tip, element 18).
Further regarding claim 6; the Kurz/Mirizzi combination is described in the rejection of claim 2 above. Kurz further discloses the actuation mechanism (element 6, 12, 13 and 24) is removably coupled to the second end of the portion of the base (wherein the examiner notes that probe element 1 is capable of being removed from elements 6, 12, 13 and 24 by pulling element 1 through distal end of jacket element 11).
Further regarding claims 7 and 8; the Kurz/Mirizzi combination is described in the rejection of claim 2 above. Kurz further discloses the actuation mechanism comprises: a handle portion (elements 6, 12, 13 and 24) attached to the proximal end of the elongated member (wherein element 12 is attached to proximal end of jacket element 11), the handle portion including: a proximal handle (elements 6 and 13); a slider handle (elements 12 and 24) including a working lumen extending therethrough (wherein there is a lumen defined by element 12 which element 6 is inserted into), the working lumen connected to the lumen of the elongated member (wherein the widened lumen of element 24 narrows down and is connected to lumen of jacket element 11; column 4, lines 23-25; figures 1 and 2) and a rod (tubular element of 6 which extends distally from element 13) having a first end section and a second end section, the first end section of the rod coupled to the proximal handle (wherein element 6 is coupled to element 13 via being integral), the second end section (distal section of element 6) of the rod coupled to the second end portion of the base (wherein proximal second end portion of element 1 is coupled to distal end of rod element 6 to allow for relative movement of the jacket element 11 in relation to probe element 1; column 3, line 66 – column 4, line 63; figures 1, 2, 7).
Further regarding claims 8; the Kurz/Mirizzi combination is described in the rejection of claim 2 above. Kurz further discloses moving the proximal handle (element 13) toward the slider handle (element 12) translates the rod (portion of element 6 distal to proximal handle 13) to extend the wires (element 2) past the distal end of the elongated member (element 11; see figure 2), and wherein moving the proximal handle (element 13) away from the slider handle (element 12) translates the rod (portion of element 6 distal to proximal handle element 13) to retract the wires (element 2) within the elongated member (element 11) (column 3, line 66 – column 4, line 63; figures 1, 2, 7).
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kurz in view of Mirizzi as applied to claim 8 above, and further in view of Griego et al (US 2006/0064039 A1).
Regarding claims 9-13; The Kurz/Mirizzi combination is described in the rejection of claim 8 above. Kurz further discloses a plurality of visual indicia (elements 10), wherein each of the plurality of indicia corresponding to one of the pluralities of testing dimensions (column 3, line 66 – column 4, line 20).
However, the Kurz/Mirizzi combination does not disclose the plurality of indicia are on the rod, but instead on the outer handle with an indicator (element 8) to show the corresponding dimensions (column 3, line 66 – column 4, line 20; figures 1).
Griego teaches a similar device for measuring the dimension of a lumen wherein a rod (element 25b and 25c) includes a plurality of visual indicia (element 53b and 53c), each of the visual indicium of the plurality of visual indicia corresponding to one of the plurality of testing dimensions (paragraph [0062]).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Kurz/Mirizzi combination to substitute the Kurz’s visual indicia measurement mechanism with Griego’s visual indicia measurement system on the rod with a viewing window on the sliding element (element 12 of Kurz/Mirizzi) as simples substitution of one known element for another to yield a predictable result (in this case substituting how the measurement is visualized).
Further regarding claims 10-13; the Kurz/Mirizzi/Griego combination is described in the rejection of claim 9 above. Kurz further discloses an embodiment where the thread (element 5) has different configurations with respect to the expandable wires (element 2) whereby the change in distance between the feelers (element 3) on the wires (elements 2) is not linear and instead uses a non-linear indicia scale thus allowing for more accurate and precise measurements when the the internal measurement of the hollow organs nearly correspond to the distance between the spread of the unattached end of the spring element at the extended state (column 2, lines 21-44, column 40-53; figures 5-6).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Kurz/Mirizzi/Griego combination to utilize a thread configuration as depicted in figure 5 of Kurz in order to provide a non-linear visual indicia that varies along the rod as taught by Kurz in order to allow for more accurate and precise measurements when the internal measurement of the hollow organs nearly correspond to the distance between the spread of the unattached end of the spring element at the extended state.
Further regarding claims 11-13; the Kurz/Mirizzi combination is described in the rejection of claim 10 above. The Kurz/Mirizzi/Griego combination discloses the spacing between adjacent visual indicia of the plurality of visual indicia corresponds to a stroke length required to radially extend the plurality of wires from one of the plurality of testing dimensions to another one of the plurality of testing dimensions (column 2, lines 21-44, column 40-53 of Kurz).
Further regarding claims 12-13; the Kurz/Mirizzi combination is described in the rejection of claim 11 above. Kurz further discloses the stroke length is a distance the proximal handle moves relative to the slider handle when moving between adjacent visual indicia (column 2, lines 21-44, column 40-53 of Kurz).
Further regarding claim 13; the Kurz/Mirizzi combination is described in the rejection of claim 12 above. Kurz further discloses a first spacing between adjacent visual indicia on the second end section of the rod is smaller (non-linear spacing of indicia when near the fully open configuration) than a second spacing between adjacent visual indicia on the first end section of the rod (non-linear spacing of indicia when in the nearly closed state) to increase the stroke length required as the plurality of testing dimensions increases (column 2, lines 21-44, column 40-53 of Kurz).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kurz as applied to claim 1 above, and further in view of Jain (US 5,919,147).
Regarding claim 14; the Kurz/Mirizzi combination is described in the rejection of claim 1 above.
Kurz does not explicitly disclose the sizing device further comprising a capacitance sensor in communication with distal ends of the wires, the capacitance sensor configured to transmit a signal when each of the wires is in contact with the airway of the patient.
Jain teaches a similar lumen sizing device having radially biased expanding member for contacting the lumen wall wherein the distal ends of the radially expanding wires include electronic sensors on the outer tips in order to provide an audible or visible signal to confirm contact of the arms with the lumen wall (column 2, lines 40-52; figures 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kurz’s device to include electronic sensors at the distal tip of wire elements 2 as taught by Jain in order to provide an audible or visible signal to confirm contact of the wires with the lumen wall to ensure proper measurement. Furthermore, the examiner takes official notice that it would have been obvious to one of ordinary skill in the art at the time of filing to use known and conventional electronic sensors for detecting contact, including well known capacitance sensors for sending the signal when the sensors (and distal tips of expanding wires) contact the lumen wall.
Examiner’s Note
The examiner encourages the applicant to set up and interview with the examiner after reviewing the office action as the examiner has identified some features which would appear the overcome the prior art of record and hopefully advance the application to allowance. These include reciting more detailed structural features, specifically with regards to the core (i.e. its location, its positional relationship to the expansible wire/elements, the structure of the mechanisms used for removeable attachability, further features of the sizing device such as the flex cable (element 180) as depicted in figure 7, and relationships between elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2005/0148903 A1 to Diamantopoulos; discloses a catheter having radial extending arms to generate a signal indicative of radial displacement of the arms to determine dimensions of the vascular tissue.
US 2017/0181666 A1 to Johnson; discloses a light based endoluminal sizing device.
US 2007/0156068 A1 to Dubey et al; discloses a anatomical hollow body sizing device having radially expanding wires.
US 2005/0010138 A1 to Mangiardi et al; discloses a limen measuring device and method.
US 2006/0064038 A1 to Omata et al; discloses a device for measuring elastic characteristics of organism tissue.
US 7,383,639 B2 to Malandain; discloses a measurement instrument for percutaneous surgery.
US 5,919,147 to Jain; discloses a method and apparatus for measuring the vascular diameter of a vessel.
US 9,770,194 B2 to Azagury et al; discloses a device and methods for measuring an airway lumen.
US 9,427,318 B2 to Hjelle et al; discloses a intra-operative heart size measuring tool.
US 4,362,167 to Nicolai et al; discloses a diagnostic measuring instrument for measuring the diameter of a hollow body.
US 6,427,351 to Matthews et al; discloses an arthroscopic measuring device.
US 5,010,892 to Colvin et al; discloses a body lumen measuring instrument.
US 4,685,474 to Kurz et al; discloses a device for the determination of the inner dimensions of hollow organs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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