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 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.
Claims 5 and 9-10 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 5 recites the limitation "the inflatable tube”. There is insufficient antecedent basis for this limitation in the claim. Examiner acknowledges an inflatable tube is introduced in claim 4, but claim 5 is not dependent on claim 4.
The term “about” in claims 9 and 10 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa (US 6039701 A) in view of Mazza (WO 2017042000 A1).
Regarding claim 1, Sliwa teaches a method for determining cervical stiffness in a patient having a cervix (Col 2, lines 41-43 “methods for measuring and detecting changes in the size of a patient's cervix and cervical os”), comprising:
inserting a probe to a position wherein a distal end of the probe engages the cervix (cervimeter 22; Fig. 2, Fig. 2D);
activating the probe to deform the cervix (Col 16, lines 40-48 “a wire loop 14 is shown resident in a channel or groove 36, which in this case runs around an outside diameter of the cervix. … structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38'. It is to be noted again that structure 39 may have any desirable shape and may be composed of multiple materials;” Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Col 9, lines 53-61 “FIGS. 2 and 2E show wire 17 being fed into loop 14. One may measure the amount, or more correctly the linear length, of such wire as it is fed into the expanding loop 14. Since circumference is Pi times the diameter (C=.pi.D), the loop diameter change can be determined from the circumference change (which equals the incremental wire feed amount) divided by Pi. One might use, for example, a linear displacement sensor (not shown here) through which the wire 17 passes to achieve this purpose.”).
However, Sliwa fails to identify a force needed to deform the cervix a predetermined amount or identify the cervical stiffness based on that force.
Mazza teaches a device and method for measuring the deformability of the uterine cervix for the prediction of preterm birth. Mazza discloses a predetermined first amount; identifying the amount of force needed for the probe to deform the cervix the first amount; and identifying an initial cervical stiffness value based on how much force was needed to deform the cervix the first amount (Pg 19, lines 24-29 “The pressure required to deform the soft tissue 5 over the specified distance is then used to determine the elasticity of the soft tissue 5, since the pressure required to deform the soft tissue 5 over the specified distance is proportional to the stiffness of the soft tissue 5. Herein, the deformability of the soft tissue 5 is measured as the pressure difference between the pressure sensors of the suction channel 13 and of the measuring channel 13'”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sliwa to include identifying the amount of force needed for the probe to deform the cervix a set amount and identifying a cervical stiffness value based on that force as disclosed in Mazza to measure the elastic deformability of the cervix in a simple and reliable manner for the assessment of preterm birth risk (Mazza pg 3, lines 14-15 and pg 12, lines 5-7).
Regarding claim 2, the combination of Sliwa/Mazza discloses the method of claim 1, wherein the cervix is deformed by compressing the cervix the first amount (Sliwa: Col 16, lines 40-48 “structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38'”; Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Mazza: Pg 19, lines 24-29 “deform the soft tissue 5 over the specified distance”).
Regarding claim 3, the combination of Sliwa/Mazza discloses the method of claim 1, wherein the cervix is deformed the first amount by placing a ring-shaped cuff around the cervix (Sliwa: cervimeter 22; Fig. 2, Fig. 2D) and reducing an inner diameter of the cuff to compress the cervix the first amount (Sliwa: Col 16, lines 40-48 “structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38'”; Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Mazza: Pg 19, lines 24 “deform the soft tissue 5 over the specified distance”).
Regarding claim 4, the combination of Sliwa/Mazza discloses the method of claim 3, wherein the cuff comprises an inflatable tube and the inner diameter of the tube is reduced by inflating the tube with a gas (Sliwa: Col 17, lines 2-5 “Expandable support structure 39… The expansive mechanism, as mentioned earlier, may optionally be provided for by an inflatable balloon or bag structure utilizing a gas (or a liquid) or by an expansive spring structure.”).
Regarding claim 5, the combination of Sliwa/Mazza discloses the method of claim 3, wherein the inflatable tube is inflated with a liquid (Sliwa: Col 17, lines 2-5 “Expandable support structure 39… The expansive mechanism, as mentioned earlier, may optionally be provided for by an inflatable balloon or bag structure utilizing a gas (or a liquid) or by an expansive spring structure.”).
Regarding claim 6, the combination of Sliwa/Mazza discloses the method of claim 3, wherein the force needed to compress the cervix the first amount is measured by measuring the pressure needed to inflate the cuff enough to reduce the inner diameter enough to compress the cervix the first amount (Sliwa: Fig. 2D; Col 16, lines 40-48 “structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38';” Col 17, lines 2-5 “Expandable support structure 39… The expansive mechanism, as mentioned earlier, may optionally be provided for by an inflatable balloon or bag structure utilizing a gas (or a liquid) or by an expansive spring structure.” Mazza: Pg 19, lines 24-29 “The pressure required to deform the soft tissue 5 over the specified distance is then used to determine the elasticity of the soft tissue 5).
Regarding claim 7, the combination of Sliwa/Mazza discloses the method of claim 3, wherein the cuff comprises a string, and the inner diameter is reduced to compress the cervix the first amount by shortening a length of the string around the cervix (Sliwa: Fig. 2D; Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Mazza: Pg 19, lines 24 “deform the soft tissue 5 over the specified distance”).
Regarding claim 8, the combination of Sliwa/Mazza discloses the method of claim 7, wherein the force needed to compress the cervix the first amount is measured by measuring a tension on the string after it compresses the cervix the first amount (Sliwa: Fig. 2D; Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Col 3, lines 57-64 “The gauge is coupled to the wires for measuring movement of said wires as an indication of changes in cervical size. Alternatively, the measuring means can comprise an expansible coil which is insertible into a cervical os and which uncoils as the os dilates. The gauge, such as a force measuring element, can be coupled to the coil for measuring size changes in the cervical os.”; Mazza: Pg 19, lines 24 “The pressure required to deform the soft tissue 5 over the specified distance”).
Regarding claim 9, the combination of Sliwa/Mazza discloses the method of claim 1, wherein the first amount is a cervical compression in a diameter of the cervix of at least about 2 mm (Sliwa: Fig. 2D; Col 16, lines 40-48 “structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38'. It is to be noted again that structure 39 may have any desirable shape and may be composed of multiple materials;” Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Mazza: Pg 19, lines 20-22 “a specified distance between contact of the soft tissue with the surrounding housing bottom can be 4 millimetres, especially between 2 and 6 millimeters, preferably between 3 and 5 millimeters… The pressure required to deform the soft tissue 5 over the specified distance”).
Regarding claim 10, the combination of Sliwa/Mazza discloses the method of claim 1, wherein the first amount is a cervical compression in a diameter of the cervix of about 1-5 mm (Sliwa: Fig. 2D; Col 16, lines 40-48 “structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38'. It is to be noted again that structure 39 may have any desirable shape and may be composed of multiple materials;” Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Mazza: Pg 19, lines 20-22 “a specified distance between contact of the soft tissue with the surrounding housing bottom can be 4 millimetres, especially between 2 and 6 millimeters, preferably between 3 and 5 millimeters… The pressure required to deform the soft tissue 5 over the specified distance”).
Regarding claim 11, the combination of Sliwa/Mazza discloses the method of claim 1, wherein the probe includes a piston at the distal end of the probe, the cervix is deformed the first amount by pressing the piston into the cervix, and the force needed to deform the cervix the first amount is measured by measuring the force on the piston when it deforms the cervix the first amount (Mazza: Fig. 4; Pg 19, lines 9-29 “The soft tissue 5 that is sucked into the cavity 19 is deformed such, that it touches the pin 110, 110' at the central part of contact surface 127 and increasingly pushes the pin 110, 110' further into the cavity 19 of the housing 1 6. 16.sup.' and towards the probe channel 13. Once the soft tissue 5 is deformed to such an extent that it has pushed the pin 110, 110' to the distal end 11 of the probe 1, the pin 110, 110' is in the final position and closes the suction channel 13 and thereby interrupts a further aspiration of air out of the cavity 19. In the final position, the pin 110, 1 10' is fully received within the cavity 19. Moreover, the distance along which the soft tissue 5 has to deform into the cavity 19 so as to push the pin 110, 110' from the initial position all the way up to the suction channel 13 corresponds to a specified distance. … The pressure required to deform the soft tissue 5 over the specified distance is then used to determine the elasticity of the soft tissue 5, since the pressure required to deform the soft tissue 5 over the specified distance is proportional to the stiffness of the soft tissue 5. Herein, the deformability of the soft tissue 5 is measured as the pressure difference between the pressure sensors of the suction channel 13 and of the measuring channel 13' .”).
Regarding claim 12, the combination of Sliwa/Mazza discloses the method of claim 1, wherein the patient has a length of gestational term and the amount of force needed to deform the cervix the first amount is below a predetermined threshold value associated with the patient’s gestational term, the patient is designated to be at a preterm birth risk (Mazza: Pg 12, lines 3-8 “As described above, the measuring results sensed by the pressure sensors can be an under pressure value that is related to a certain degree of deformation of the soft tissue. Additionally, it is possible to correlated said under pressure value to a clinically relevant parameter such as the risk of a preterm birth, i.e., said risk being negative or positive, or high, moderate or low, respectively.”).
Regarding claim 13, the combination of Sliwa/Mazza discloses the method of claim 3, wherein the patient has a length of gestational term and the amount of force needed to compress the cervix the first amount is below a predetermined threshold value associated with the patient’s gestational term, a preterm birth risk warning is displayed (Mazza: Pg 12, lines 3-8 “As described above, the measuring results sensed by the pressure sensors can be an under pressure value that is related to a certain degree of deformation of the soft tissue. Additionally, it is possible to correlated said under pressure value to a clinically relevant parameter such as the risk of a preterm birth, i.e., said risk being negative or positive, or high, moderate or low, respectively. It is possible that the measuring result and / or a clinically relevant parameter are displayed on the probe or on a display of the control unit.”).
Regarding claim 14, Sliwa teaches a device for measuring cervical stiffness (cervimeter 22), comprising
a probe constructed and configured to be inserted into a patient’s vagina, having a proximal end and a distal end; a head located on the distal end, the head having an inner surface sized, configured and adapted to engage a cervix of the patient (cervimeter 22; Fig. 2, sleeve material 21, loop 14; Fig. 2D, loop 14, structure 39); a compression cuff located at the inner surface, the cuff adapted, sized, positioned and configured to surround the patient’s cervix (Fig. 2D, loop 14, structure 39, bias forces 38'),
the compression cuff functionally coupled to a pressure sensor (Col 3, lines 57-64 “The gauge is coupled to the wires for measuring movement of said wires as an indication of changes in cervical size. Alternatively, the measuring means can comprise an expansible coil which is insertible into a cervical os and which uncoils as the os dilates. The gauge, such as a force measuring element, can be coupled to the coil for measuring size changes in the cervical os.”);
an activator adapted to trigger the compression of the cuff (Col 16, lines 40-48 “a wire loop 14 is shown resident in a channel or groove 36, which in this case runs around an outside diameter of the cervix. … structure 39 is capable of inwardly urging wire 14 against the cervical outer diameter as indicated by bias forces 38'. It is to be noted again that structure 39 may have any desirable shape and may be composed of multiple materials;” Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.”).
However, Sliwa fails to explicitly measure and identify the force required to displace the cervix a set amount. The combination of Sliwa/Mazza discloses and the compression cuff and pressure sensor adapted, configured and constructed to measure and identify the force required to compress the inner diameter of the cuff a first amount around the patient’s cervix (Sliwa: Fig. 2D, loop 14, structure 39, bias forces 38'; Col 3, lines 61-64 “The gauge, such as a force measuring element, can be coupled to the coil;” Mazza: Pg 6, lines 13-16 “The probe channel and the further probe channel can each be connected to a pressure sensor. The deformability of the soft tissue can be measured as a pressure difference between the pressure sensors of the probe channel and of the further probe channel.” Pg 19, lines 24-29 “The pressure required to deform the soft tissue 5 over the specified distance is then used to determine the elasticity of the soft tissue 5, since the pressure required to deform the soft tissue 5 over the specified distance is proportional to the stiffness of the soft tissue 5”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sliwa to include identifying the force required to displace the cervix a set amount as disclosed in Mazza to measure the elastic deformability of the cervix in a simple and reliable manner for the assessment of preterm birth risk (Mazza pg 3, lines 14-15 and pg 12, lines 5-7).
Regarding claim 15, the combination of Sliwa/Mazza discloses the device for measuring cervical stiffness of claim 14, comprising a distance sensor adapted to measure the first amount the cervix is compressed by the cuff (Sliwa: Col 3, lines 57-64 “The gauge is coupled to the wires for measuring movement of said wires as an indication of changes in cervical size. Alternatively, the measuring means can comprise an expansible coil which is insertible into a cervical os and which uncoils as the os dilates. The gauge, such as a force measuring element, can be coupled to the coil for measuring size changes in the cervical os.” Col 9, lines 53-61 “FIGS. 2 and 2E show wire 17 being fed into loop 14. One may measure the amount, or more correctly the linear length, of such wire as it is fed into the expanding loop 14. Since circumference is Pi times the diameter (C=.pi.D), the loop diameter change can be determined from the circumference change (which equals the incremental wire feed amount) divided by Pi. One might use, for example, a linear displacement sensor (not shown here) through which the wire 17 passes to achieve this purpose”).
Regarding claim 16, the combination of Sliwa/Mazza discloses the device for measuring cervical stiffness of claim 14, comprising a force sensor adapted to measure the amount of force needed for the cuff to compress the cervix the first amount (Sliwa: Col 3, lines 57-64 “The gauge is coupled to the wires for measuring movement of said wires as an indication of changes in cervical size. Alternatively, the measuring means can comprise an expansible coil which is insertible into a cervical os and which uncoils as the os dilates. The gauge, such as a force measuring element, can be coupled to the coil for measuring size changes in the cervical os.” Mazza: Pg 19, lines 24-29 “The pressure required to deform the soft tissue 5 over the specified distance is then used to determine the elasticity of the soft tissue 5, since the pressure required to deform the soft tissue 5 over the specified distance is proportional to the stiffness of the soft tissue 5”).
Regarding claim 17, the combination of Sliwa/Mazza discloses the device for measuring cervical stiffness of claim 14, wherein the cuff is an inflatable tube adapted to be inflated with gas or liquid (Sliwa: Col 17, lines 2-5 “Expandable support structure 39… The expansive mechanism, as mentioned earlier, may optionally be provided for by an inflatable balloon or bag structure utilizing a gas (or a liquid) or by an expansive spring structure.”).
Regarding claim 18, the combination of Sliwa/Mazza discloses the device for measuring cervical stiffness of claim 14, wherein the cuff is a flexible loop, adapted to compress the cervix when a length of the loop is shortened (Sliwa: Fig. 2D; Col 9, lines 12-13 “polymeric tubular material or even circumferential springs which are wrapped or sleeved coaxially with the wire 14… sleeve material 21;” Col 9, lines 25-28 “Sleeve material 21 may also provide a mechanical biasing force (i.e., may itself be radially expandable or contractible) to cause the loop or hoop 14 to grow (or even shrink) or extract (or eject) incremental source wire 17.” Mazza: Pg 19, lines 24 “deform the soft tissue 5 over the specified distance”).
Regarding claim 20, the combination of Sliwa/Mazza discloses the device for measuring cervical stiffness of claim 16, wherein the loop is formed from flexible wire, polymer or natural fiber material (Sliwa: Col 9, lines 12-13 “polymeric tubular material or even circumferential springs which are wrapped or sleeved coaxially with the wire 14… sleeve material 21”).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa (US 6039701 A) in view of Mazza (WO 2017042000 A1), and in further view of O’Brien (US 20210161388 A1).
Regarding claim 19, the combination of Sliwa/Mazza discloses the device for measuring cervical stiffness of claim 14. However, the combination of Sliwa/Mazza fails to disclose a video scope.
O’Brien teaches methods and systems for using Raman spectroscopy to identify biochemical markers associated with cervical remodeling over the course of pregnancy of humans. O’Brien discloses and comprising a video scope on the distal end (Fig. 7A, camera 220).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sliwa/Mazza to include a video scope on the distal end as disclosed in O’Brien to visually guide the placement of the probe and acquire images of the cervix for the medical provider to review (O’Brien [0085]).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791