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 Objections
Claim 53 is objected to because of the following informalities:
In line 2, “one or more fluid reservoirs” should be changed to “two or more fluid reservoirs” to be consistent with the language of amended claim 1.
Appropriate correction is required.
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 1, 2, 5-15, 17-20, 22-27, and 51-53 are 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 1 recites a cap element having “geometry suitable for sealing the uterine cervix… such that the catheter can be removed while avoiding accidental removal of hydrogel from the cervix.” MPEP 2173.05(b)(II) states that “[a] claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined… Miyazaki, 89 USPQ2d at 1212. In Brummer, the Board held that a limitation in a claim to a bicycle that recited "said front and rear wheels so spaced as to give a wheelbase that is between 58 percent and 75 percent of the height of the rider that the bicycle was designed for" was indefinite because the relationship of parts was not based on any known standard for sizing a bicycle to a rider, but on a rider of unspecified build. Brummer, 12 USPQ2d at 1655. In the instant case, the sizing or “geometry” of the cap element is not based on any known standard but on a cervix size which may vary greatly depending on the patient and condition of the physiology. Therefore, such a limitation will not be given patentable weight and/or the size/geometry of the cap element of the prior art will be interpreted as having geometry which is capable of performing the claimed function for at least one patient having the optimal physiology.
Similarly, claim 17 recites a cervical plug having “suitable geometry for placement within the cervix without expulsion following removal of the catheter.” This limitation of claim 17 is considered indefinite for similar reasons as set forth above regarding the cap of claim 1 and will therefore not be given patentable weight and/or the size/geometry of the cervical plug of the prior art will be interpreted as having geometry which is capable of performing the claimed function for at least one patient having the optimal physiology.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
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.
Claim 17, 26, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2007/0106174 to Sanders et al. (“Sanders”).
Regarding claim 17, Sanders teaches a transcervical access system for intrauterine movement of fluids with easy manipulation (Figs. 4 & 5), the transcervical access system comprising a graspable structure ([0043], syringe) comprising one fluid reservoir and one actuator to direct flow from or into the reservoir (reservoir and actuator/plunger of conventional syringe), a catheter (40) comprising a tubular element (40) with a lumen (lumen of 40), an outer diameter (outer diameter of 40), and one distal port (22’), wherein the catheter engages the graspable structure with a configuration to provide fluid flow through the tubular element of the catheter ([0043]), a cervical plug (12’) having an inner lumen (inner lumen of 12’) with an inner diameter (inner diameter of inner lumen of 12’) larger than the outer diameter of the tubular element of the catheter such that the cervical plug can slide over the catheter and is removable from the catheter ([0043]), wherein the cervical plug has suitable geometry for placement within the cervix without expulsion following removal of the catheter (see 112 rejection above for interpretation, the plug of Sanders is capable of securing placement if the catheter is removed in a patient given the correct physiology).
Regarding claim 26, Sanders teaches the transcervical access system of claim 17 as shown above, Sanders further teaching that the cervical plug position can be selected to a particular location along the catheter ([0042]-[0043]).
Regarding claim 52, Sanders teaches the transcervical access system of claim 17 as shown above, Sanders further teaching the catheter comprises a single lumen (40 has a single lumen).
Claim 17, 19, 26, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2005/0255039 to Desai.
Regarding claim 17, Desai teaches a transcervical access system for intrauterine movement of fluids with easy manipulation (Fig. 22), the transcervical access system comprising a graspable structure (syringe 314) comprising one fluid reservoir (reservoir of syringe 314) and one actuator (plunger of syringe 314) to direct flow from or into the reservoir, a catheter (300) comprising a tubular element (tube of 300) with a lumen (lumen of 300), an outer diameter (outer diameter of 300), and one distal port (322), wherein the catheter engages the graspable structure with a configuration to provide fluid flow through the tubular element of the catheter (Fig. 22), a cervical plug (284) having an inner lumen (inner lumen of 284) with an inner diameter (inner diameter of inner lumen of 284) larger than the outer diameter of the tubular element of the catheter such that the cervical plug can slide over the catheter and is removable from the catheter ([0107], catheter 300 can be slid through plug 284), wherein the cervical plug has suitable geometry for placement within the cervix without expulsion following removal of the catheter (see 112 rejection above for interpretation, the plug of De is capable of securing placement if the catheter is removed in a patient given the correct physiology).
Regarding claim 19, Desai teaches the transcervical access system of claim 17 as shown above, Desai further teaching an egress limiter comprising a tubular member (298) and a cap element (288) fixedly attached to the tubular member at or near an end (Fig. 22), the tubular member having an inner lumen (inner lumen of 298) with an inner diameter (inner diameter of 298) larger than the outer diameter of the tubular element of the catheter such that the egress limiter can slide over the catheter and is removable from the catheter ([0107] catheter 300 slides through outer tube 298), wherein the cervical plug can be mounted distal to the distal end of the egress limiter (Fig. 22 as well as being capable of such a position given the provision of adjustability [0107]), wherein the tubular member has a length less than the length of the tubular element of the catheter (Fig. 22), wherein the length of the tubular member allows for adjustment of a distal catheter length ([0107]), and wherein the distal catheter length comprises a length from the distal end of the catheter to the distal end of the cervical plug (Fig. 22).
Regarding claim 26, Desai teaches the transcervical access system of claim 17 as shown above, Desai further teaching that the cervical plug position can be selected to a particular location along the catheter ([0107]).
Regarding claim 52, Desai teaches the transcervical access system of claim 17 as shown above, Desai further teaching the catheter comprises a single lumen (300 has a single lumen).
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.
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 1, 2, 6, 13, 14, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2007/0106174 to Sanders et al. (“Sanders”) in view of U.S. Patent No. 8,647,670 to Shu.
Regarding claim 1, Sanders teaches a transcervical access system for movement of fluids with easy manipulation (Figs. 4 & 5), the transcervical access system comprising a graspable structure ([0043], syringe) comprising one fluid reservoir and one actuator to direct flow from or into the reservoir (reservoir and actuator/plunger of a conventional syringe), a catheter (40) comprising a tubular element (40) with a lumen (lumen of 40), an outer diameter (outer diameter of 40), an average wall thickness (outer wall thickness of 40), and one or more distal ports (22), wherein the catheter engages the graspable structure with a configuration to provide fluid flow through the tubular element of the catheter upon actuation of the actuator ([0043]), and an egress limiter comprising a tubular member (19’) and a cap element (12’) fixedly attached to the tubular member, wherein the tubular member extends proximal to the cap element ([0027], Figs. 4 or 5, 19 extends proximal to 12), the egress member having an inner lumen with an inner diameter larger than the outer diameter of the tubular element of the catheter such that the egress limiter can slide over the catheter and is removable from the catheter ([0043]), the cap element having a singular flow path (flow path of 12), the singular flow path being co-axial with the inner lumen of the egress limiter (applicator 12 has only one co-axial flow path), wherein the tubular member has a length less than the length of the tubular element of the catheter ([0013]), wherein the position of the tubular member allows for adjustment of a distal catheter length ([0046]), and wherein the distal catheter length comprises a length from the distal end of the catheter to the distal end of the cap element (as better seen in the embodiment of Fig. 1) wherein the tubular member has a proximal end that is open (18’) and the cap element has a geometry suitable for sealing the uterine cervix without fully entering the cervical canal ([0036]), such that the catheter can be removed while avoiding accidental removal of hydrogel from the cervix (see 112 rejection above for interpretation, the cap of Sanders is capable of avoiding accidental removal of hydrogel upon removal of the catheter is removed in a patient given the correct physiology), but does not teach the claimed two or more reservoirs configuration of the graspable structure.
Shu teaches a graspable structure having two or more reservoirs (Fig. 1). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the graspable structure of Sanders (single syringe) with the graspable structure of Shu (dual syringe) in order to yield the predictable result of providing a fluid source to a catheter device system.
Regarding claim 2, Sanders and Shu teach the transcervical access system of claim 1 as show above, Sanders further teaching the tubular element of the catheter of Sanders having a flexible distal end (in light of the polymeric material disclosed in claim 19, such a catheter would be considered “flexible” given the broadest reasonable interpretation), but does not disclose the ranges of the catheter length and the outer diameter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the catheter taught by Sanders to have a length from 16 cm to 26 cm, and an outer diameter from 1 mm to 3 mm at the distal end thereof, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Sanders would not operate differently with the claimed length and outer diameter, as these lengths and outer diameters would be suitable for providing proper insertion into the body cavity and the provision of treatment fluids therein.
Regarding claim 6, Sanders and Shu teach the transcervical access system of claim 1 as shown above, Sanders further teaching that the tubular member (19’) may be grasped during a single-handed manipulation of the system (the tubular member 19’ is capable of being grasped by a user during a single-handed manipulation of the system of Sanders).
Regarding claim 13, Sanders and Shu teach the transcervical access system of claim 1 as shown above, Sanders further teaching the cap element comprising a conical shape (Figs. 4 & 5) but does not specifically disclose range of the cap element length and width.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the cap element as taught by Sanders to have a length from 5 mm to 3 cm, and a width from 5 mm to 1.5 cm, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Sanders would not operate differently with the claimed length and width, as these lengths and outer diameters would be suitable for providing proper fitment onto the cervix for proper treatment thereafter.
Regarding claim 14, Sanders and Shu teach the transcervical access system of claim 1 as shown above, Shu further teaching a first syringe (2A) comprises a first reservoir (reservoir of 2A) and a first connector (connector at distal end of 2A) and a second syringe (2B) comprising a second fluid reservoir (reservoir of 2B) and a second connector (connector at distal end of 2B), the system further comprising a Y-branch conduit (4) having a first branch connected with the first syringe and a second branch connected with the second syringe (see annotated Fig. 1 below) and a mixing chamber connected with the first branch and the second branch, the mixing chamber comprising a mixing structure (see annotated Fig. 1 below) to provide a mixed flow from a distal outlet (see annotated Fig. 1 below), and wherein the one or more actuator comprises a plate (1) that operably connects to the plungers of the syringes to provide for simultaneous advancement of the plungers (inherent function of the plunger clip 1 as would be understood by a skilled artisan). Once the catheter of Sanders is modified with the graspable structure of Shu, the catheter would be connected to the distal outlet of the mixing chamber such that mixed fluid flows through the tubular element of the catheter.
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Regarding claim 51, Sanders teaches the transcervical access system of claim 1 as shown above, Sanders further teaching the catheter comprising a single lumen (40 has a single lumen).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Shu as applied to claim 1 above, and further in view of U.S. Patent No. 6,622,367 to Bolduc et al. (“Bolduc”), U.S. Patent Publication No. 2015/0174368 to Garrison et al. (“Garrison”), and U.S. Patent No. 4,430,076 to Harris.
Regarding claim 5, Sanders and Shu teach the transcervical access system of claim 1 as shown above, but does not teach the stiffening segment of the catheter and the frictional engagement.
Regarding the stiffening segment, Bolduc teaches a tubular element (catheter 30) comprising a stiffening segment (the proximal section as described in column 9, lines 30-33), the stiffening segment having a length that is from 30% to 70% of the length of the catheter (column 9, lines 32-37, Bolduc discloses various ranges for a stiffening segment, for example, assuming the distal portion extends 10 cm from the distal end and the proximal portion/stiffening portion extends up to 40 cm from the distal end making the proximal section 30 cm, the proximal section or stiffening segment would be 50% of the length of the catheter, i.e., within the claimed ranged of the stiffening segment of claim 5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Sanders to have a stiffening segment as taught by Bolduc since stiffening of a proximal portion of a catheter provides beneficial rigidity to prevent bucking and kinking while allowing the sufficient flexibility of the distal portion to navigate tortuous physiologies (column 9, lines 37-43).
Bolduc does not explicitly disclose the stiffening segment having a wall thickness greater than the average wall thickness of the tubular element, although such a limitation is merely the result of using a thicker wall thickness to provide greater stiffness as would be known by one of ordinary skill in the art.
Garrison has been cited to explicitly teach that sections of varying stiffness in a catheter can be achieved by using varying the thickness. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have increased the thickness of the stiffening segment as a way to increase stiffness as taught by Garrison, since varying thickness is a known way of providing stiffness (paragraph [0025]). Once modified, the stiffening segment would have a greater wall thickness than the average wall thickness of the tubular element, since the remaining portion of the tubular element has less stiffness and thereby has less thickness. Once combined, the system is suitable for single-handed manipulation (the combined apparatus is “suitable” for single handed manipulation in that a user is capable of some form of manipulation of the device using a single hand).
Regarding friction engagement, Harris teaches a tubular member (10) having frictional engagement (column 3, lines 35-41) with a segment of a catheter (1) such that the length of the distal catheter length can be set by position of the egress limiter with some resistance to change of the length (the distal catheter length is inherently changed by movement relative to the egress limiter, and the friction taught by Harris imparts resistance). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented frictional engagement between the catheter and the egress limiter of Sanders, in order to prevent axial slippage, intentional or inadvertent, of the catheter as the catheter is inserted into the uterus of the patient (column 3, lines 39-41). Once combined, the tubular member of the egress limiter would have frictional engagement with the stiffening segment of the catheter, as the catheter is inserted into the egress limiter.
Claim 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Shu as applied to claim 1 above, and further in view of U.S. Patent No. 5,421,346 to Sanyal.
Regarding claim 7, Sanders and Shu teach the transcervical access system of claim 1 as shown above, but do not teach the recessed surface and/or is silent regarding details as to how the egress limiter is attached to the tubular element.
Sanyal teaches an egress limiter comprising a recessed surface and wherein the egress limiter is attached to the tubular element along the recessed surface (Fig. 1, where end portion 41 of the tube 12 is attached to the stopper body 31). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the recessed surface-type of connection between an egress limiter and tubular element in Sanders as taught by Sanyal in order to yield the predictable result of forming an attachment between an egress limiter and associated tubular element.
Regarding claim 8, Sanders and Shu teach the transcervical access system of claim 1 as shown above, Sanders further teaching a cervical plug (12’) comprising a lumen (lumen of 12’) with an inner diameter larger than the outer diameter of the tubular element of the catheter such that the cervical plug can slide over the catheter ([0043), but does not teach the particulars of how the cervical plug is attached to the tubular element.
Sanyal teaches a cervical plug being removable from the tubular element (via the body threads 34) and mounted distal to the distal end of the egress limiter (cervical plug 30 is mounted to the distal end of the tubular member 9). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the threaded-type of connection between an egress limiter and tubular element in Sanders as taught by Sanyal in order to yield the predictable result of forming an attachment between an egress limiter and associated tubular element.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders, Shu, and Sanyal, as applied to claim 8 above, and further in view of U.S. Patent Publication No. 2001/0046518 to Sawhney.
Regarding claim 9, Sanders, Shu, and Sanyal teach the transcervical access system of claim 8, but do not teach the cervical plug comprising a preformed hydrogel.
Sawhney teaches a cervical plug comprising a preformed hydrogel (paragraph [0117]) and wherein the cervical plug is hydrolytically degradable (paragraph [0079]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a hydrogel material for the cervical plug of Sanders and Sanyal as taught by Sawhney, in order to satisfactorily hold a plug in a cervical canal and prevent leakage during treatment (paragraph [0117]).
Sawhney is silent as to dimensions of the hydrated cervical plug, and does not specifically disclose the range of the length and average outer diameter. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the cervical plug taught by Sawhney to have a length from about 1.0 cm to about 4.0 cm and an average outer diameter from about 4.5 mm to about 9 mm, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the plug of Sawhney would not operate differently with the claimed length and diameter, as these ranges would be suitable for proper fitment to a cervix may vary in depth and width depending on the physiology and condition of the patient.
Sawhney does not explicitly mention the range of swelling wt%.
Sawhney discloses that the swelling capabilities ([0009]) of hydrogels are desirable to aid in the temporary occlusion of body lumens ([0010]) such as the cervical canal ([0117]). The range of swelling wt% is a result effective variable in that changing the wt% of swelling is necessary to optimize the fit of the cervical plug within the cervix which may vary greatly in size and shape according to the patient. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Sanders, Shu, Sanyal, and Sawhney to swell within the claimed wt% range, as it involves only adjusting the properties of the disclosed hydrogel which would require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cervical cap of Sanyal and Sawhney by implementing a swelling range from 25 wt% to +300 wt% as measured after 24 hours in a neutral buffered saline solution as a matter of routine optimization since it has been held that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Sawhney does explicitly mention the time period of degradation.
Sawhney discloses that biodegradable properties ([0048]) of hydrogels can be used to eliminate the need for a second surgical procedure to remove functionally equivalent non-absorbable devices ([0047]) or for controlling drug release ([0049]). The range of degradation time is a result effective variable in that changing the time of degradation is necessary to adjust the length of time that the cervical cap is to be left in vivo and/or to adjust the length of the time of drug treatment depending on the particular protocol prescribed by the medical practitioner. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the cervical cap of Sanyal and Sawhney to degrade within the claimed time range, as it involves only adjusting the properties of the disclosed hydrogel which would require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cervical cap of Sanders, Shu, Sanyal, and Sawhney by implementing a period of time of degradation that is selected to be from 1 day to 5 weeks as a matter of routine optimization since it has been held that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, Sanders, Shu, and Sanyal teach the transcervical access system of claim 8 as shown above, but do not teach the cervical plug being biodegradable.
Sawhney teaches the use of biodegradable plugs (paragraph [0079]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the cervical plug of Sanders, Shu, and Sanyal out of biodegradable material because the use of such materials is old and well-known in the art in order to restore access to the cervix at the end of treatment without the cervical plug having to be physically removed (paragraph [0079]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Shu as applied to claim 1 above, and further in view of U.S. Patent No. 6,165,165 to Cecchi et al. (“Cecchi”).
Regarding claim 11, Sanders and Shu teach the transcervical access system of claim 1 as shown above, Sanders further teaching the tubular element and the tubular member together have a stiffness that allows for creating a fluid seal between the cap element and the cervix ([0042]), but do not explicitly teach the material of the catheter and the hardness value.
Cecchi teaches a distal tip of a catheter comprising a polymer having a shore hardness value from about 20A to about 80A (column 2, lines 45-50; Cecchi recites 80 shore A and polyurethane) in a catheter for use in the uterus (abstract). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented a softer distal tip as indicated by the shore hardness value, in the catheter of Sanders, because the use of catheters having softer distal and more rigid proximal ends is old and well-known in the art to facilitate insertion into the uterus (column 2, lines 36-40).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view Shu as applied to claim 1 above, and further in view oof U.S. Patent No. 4,775,362 to Kronner.
Regarding claim 12, Sanders and Shu teach the transcervical access system of claim 1 as shown above, but do not teach the specifically claimed materials of the catheter, tubular member, and the cap element, although Sanders mentions the general use of polymeric material (claim 10).
Kronner teaches a catheter (12) made of polyvinyl chloride (column 2, lines 46-48), a tubular member (42) made of polyethylene (column 3, lines 54-58), and a cap element (10) made of polyethylene (column 3, lines 54-58) in a highly analogous intrauterine device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used to materials as disclosed in Kronner for the catheter, tubular member, and cap element of Sanders, because the use of such materials is old and well-known in the medical arts and are mere examples of the general polymeric materials disclosed originally in Sanders. Once combined, each of the catheter, tubular member, and cap element would “independently” comprise one of the materials given the broadest reasonable interpretation.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders and Shu as applied to claim 14 above, and further in view of U.S. Patent Publication 2004/0267308 to Bagaoisan et al. (“Bagaoisan”).
Regarding claim 15, Sanders and Shu teach the transcervical access system of claim 14 as shown above, but do not explicitly mention a static mixer, although the compositions each of the two syringes of Shu are being mixed together (abstract).
Bagaoisan teaches a mixing structure comprising a static mixer (110, Fig. 1). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have incorporated the static mixer of Bagaoisan into the mixer structure of Shu, because the components of each of the two syringes are inherently designed to be mixed together, and Bagaoisan merely shows an example of a mixing structure, as static mixers are old and well-known in the art to provide mixing of multiple components without the use of active or moving mixing structures. The resulting combined apparatus would yield the predictable results of mixing multiple components.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Shu, as applied to claim 17 above, and further in view of U.S. Patent No. 6,622,367 to Bolduc et al. (“Bolduc”), U.S. Patent Publication No. 2015/0174368 to Garrison et al. (“Garrison”), and U.S. Patent Publication 2016/0199630 to Cline et al. (“Cline”).
Regarding claim 18, Sanders and Shu teach the transcervical access system of claim 17 as shown above, Sanders further teaching an outer diameter of the tubular element being smaller than the inner diameter of the singular inner lumen of the cervical plug ([0043]), but do not teach the stiffening segment of the catheter and the shape of the cervical plug.
Bolduc teaches a tubular element (catheter 30) comprising a stiffening segment (the proximal section as described in column 9, lines 30-33), the stiffening segment having a length that is from 30% to 70% of the length of the catheter (column 9, lines 32-37, Bolduc discloses various ranges for a stiffening segment, for example, assuming the distal portion extends 10 cm from the distal end and the proximal portion/stiffening portion extends up to 40 cm from the distal end making the proximal section 30 cm, the proximal section or stiffening segment would be 50% of the length of the catheter, i.e., within the claimed ranged of the stiffening segment of claim 18). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Sanders to have a stiffening segment as taught by Bolduc since stiffening of a proximal portion of a catheter provides beneficial rigidity to prevent bucking and kinking while allowing the sufficient flexibility of the distal portion to navigate tortuous physiologies (column 9, lines 37-43).
Bolduc does not explicitly disclose the stiffening segment having a wall thickness greater than the average wall thickness of the tubular element, although such a limitation is merely the result of using a thicker wall thickness to provide greater stiffness as would be known by one of ordinary skill in the art.
Garrison has been cited to explicitly teach that sections of varying stiffness in a catheter can be achieved by using varying the thickness. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have increased the thickness of the stiffening segment as a way to increase stiffness as taught by Garrison, since varying thickness is a known way of providing stiffness (paragraph [0025]). Once modified, the stiffening segment would have a greater wall thickness than the average wall thickness of the tubular element, since the remaining portion of the tubular element has less stiffness and thereby less thickness.
Cline teaches a cervical plug having an ovoid shape (Figs. 3, 4, 10, 11, and [0172]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cervical plug of Sanders to have an ovoid shape as taught by Cline because such a modification is simple art-recognized alternative design variant which yields the predictable result of providing occlusion of a cervix to suit a particular cervix shape or size. Once combined, the system is suitable for single-handed manipulation (the combined apparatus is “suitable” for single handed manipulation in that a user is capable of some form of manipulation of the device using a single hand).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders alone.
Regarding claim 20, Sanders teaches the transcervical access system of claim 17 as shown above, Sanders further teaching the tubular element of the catheter having a flexible distal end (in light of the polymeric material disclosed in claim 19, such a catheter would be considered “flexible” given the broadest reasonable interpretation), but does not specifically disclose range of the catheter length and the outer diameter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the catheter taught by Sanders to have a length from about 16 cm to about 26 cm, and an outer diameter from about 1 mm to about 3 mm at the distal end thereof, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Sanders would not operate differently with the claimed length and outer diameter, as these lengths and outer diameters would be suitable for providing proper insertion into the body cavity and the provision of treatment fluids therein.
Claims 22-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of U.S. Patent Publication No. 2017/0087344 to Ichim.
Regarding claim 22, Sanders teaches the transcervical access system of claim 17 as shown above, but is silent regarding the dimensions of the cervical plug or a cervical plug that swells.
Regarding the length and initial outer diameter of the cervical plug, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the cervical plug as taught by Sanders to have a length from about 2 cm to about 6 cm, and an average outer diameter from about 3 mm to about 10 cm, since it has been held that where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Sanders would not operate differently with the claimed length and outer diameter, as these lengths and outer diameters would be suitable for providing proper fitment onto the cervix for proper treatment thereafter.
Regarding the swelling cervical plug, Ichim teaches the use of a swelling cervical plug (paragraph [0116]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cervical plug of Sanders to swell as taught by Ichim, because the use of swelling plugs is old and well-known in the art to enable the cervical cap to gently anchor in the endocervical canal (paragraph [0116]).
Ichim does explicitly mention the range of swelling wt%. Ichim discloses that swelling of an intra-cervical plug upon contact with intra-vaginal and intra-cervical fluids or mucus allows for conformity to an irregular shape of the endocervical canal and enables gentle anchoring therein ([0116]). The range of swelling wt% is a result effective variable in that changing the wt% of swelling is necessary to optimize the fit of the cervical plug within the cervix which may vary greatly in size and shape according to the patient. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Sanders and Ichim to swell within the claimed wt% range, as it involves only adjusting the properties of the disclosed intra-cervical cap which would require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intra-cervical cap of Sanders and Ichim by implementing a swelling range from 25 wt% to +300 wt% as measured after 24 hours in a neutral buffered saline solution as a matter of routine optimization since it has been held that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 23, Sanders teaches the transcervical access system of claim 17 as shown above, but does not teach the cervical plug being biodegradable.
Ichim teaches the use of a biodegradable cervical plug (paragraph [0282]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cervical plug of Sanders to be degradable as taught by Ichim, to enable the cervical cap to anchor in place (paragraph [0116]) and in order to restore access to the cervix at the end of treatment without the cervical plug having to be physically removed (paragraph [0266]).
Regarding claim 24, Sanders teaches the transcervical access system of claim 17 as shown above, but does not teach the hydrogel material.
Ichim teaches a cervical plug comprising a preformed hydrogel (paragraphs [0123] & [0128]), wherein the cervical plug is hydrolytically degradable (paragraph [0123]) in a period of time that is selected to be from 1 day to 5 weeks (several weeks which overlaps with 1 day to 5 weeks, paragraph [0282], as well as variants that degrade between 1 to 4 weeks, paragraph [0376]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a hydrogel material for the cervical plug of Sanders as taught by Ichim, because the use of such materials is old and well-known in the art to allow the cervical cap to gently anchor in the endocervical canal (paragraph [0116]) and in order to restore access to the cervix at the end of treatment without the cervical plug having to be physically removed (paragraph [0266]).
Regarding claim 27, Sanders teaches the transcervical access system of claim 17 as shown above, but does not teach the cervical plug comprising a therapeutic agent.
Ichim teaches the use of various therapeutic agents (paragraph [0128]) for cervical plugs. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cervical plug of Sanders to incorporate therapeutic agents as taught by Ichim, because the use of therapeutic agents is old and well-known in the art to beneficially provide and/or supplement treatment in the cervical region through the provision of antibiotics or selective bacterio-therapy compositions (paragraph [0128]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Sawhney.
Regarding claim 25, Sanders teaches the transcervical access system of claim 17 as shown above, but does not teach the cervical plug comprising a crosslinked polyethylene glycol.
Sawney teaches the use of crosslinked polyethylene glycol hydrogels (paragraph [0048]) having various applications including hydrogel plugs (paragraph [0079]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a hydrogel material including crosslinked polyethylene glycol for the cervical plug of Sanders as taught by Sawhney, as such materials are known in the art in order to satisfactorily hold a plug in a cervical canal and prevent leakage during treatment (paragraph [0117]).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Shu as applied to claim 1 above, and further in view of Sawhney.
Regarding claim 53, Sanders and Shu teach the transcervical access system of claim 1 as shown above, Sanders and Shu already teaching a graspable structure with one or more fluid reservoirs as shown above, but does not teach the hydrogel precursor.
Sawney teaches a graspable structure further comprising a hydrogel precursor within the one or more fluid reservoirs ([0042], precursors in a double barrel syringe). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the graspable structure of Sanders which is used to convey a therapeutic agent (Sanders, paragraph [0043]) with the graspable structure of Sawney which also conveys a therapeutic agent, to obtain the predictable result of conveying a therapeutic agent through a catheter. Additionally or alternatively, It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used hydrogel precursors in Sanders as taught by Sawney, since the swelling of the hydrogels formed from the precursors further anchors the hydrogels for more stable treatment ([0045]) and enhanced therapeutic effect.
Response to Arguments
Applicant’s arguments with respect to drawing objections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn. However new 112 rejections have been made as shown above.
Applicant's arguments and amendments regarding the prior art rejections have been fully considered and are persuasive in-part.
Applicant’s amendments and arguments regarding claim 1 are persuasive, therefore the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made over Sanders and Shu as shown above.
Applicant’s amendments are arguments regarding claim 17 are not persuasive. Applicant argues that Sanders fails to teach a cervical plug that has a suitable geometry for placement without expulsion, however such a limitation is indefinite as shown above. The rejection is maintained as Sanders has been interpreted as capable of performing the claimed function given a particular patient physiology.
Alternatively regarding claim 17, claim 17 has been rejected over Desai in response to Applicant’s amendment.
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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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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