DETAILED ACTION
A complete action on the merits of claims 1-22 follows below.
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 .
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 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.
Claim Objections
Claims 8 and 17-18 are objected to because of the following informalities:
“the uterine cavity” in each of claims 8 and 17 should be amended to recite --a uterine cavity of a patient--.
“at least one pump, and aspiration catheter” in claim 18 should be amended to recite --the at least one pump, and the aspiration catheter--.
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 7-8 and 16-17 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 pre-AIA the applicant regards as the invention.
Each of claims 7, 8, 16 and 17 recite the limitation “the sheath” in various places of the claims. There is insufficient antecedent basis for this limitation in the claim. It is noted that “an outer sheath” and “an inner sheath” as well as “a catheter” have been introduced in the independent claims 1 and 9 on which these claim depend on. It is at most unclear which is “the sheath” referring to if any or if a sheath in addition to those claimed is being introduced and referred to. Clarification and appropriate correction is required.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 4-7, 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US Pub. No. 2019/0388133), hereinafter Sharma in view of Sharma (US Pub. No. 2016/0354140), hereinafter Sharma’140.
Regarding Claim 1, Sharma teaches an ablation catheter for ablating endometrial tissue of a patient (abstract, [0269] and Fig. 11B), comprising:
an outer sheath (1146b in Fig. 11B or alternatively 1407 in Fig. 14B) having a first diameter and a length extending between a proximal end and a distal end (Fig. 11B), the outer sheath configured with at least one opening (“The air pump propels air via said first and second inputs 1165, 1166 through the first and second lumens to inflate the balloons 1147, 1148 so that the catheters 1145a, 1145b are held in position for an ablation treatment” [0376]); an inner shaft (1146a in Fig. 11B or alternatively 1405 in Fig. 14B) having at least one lumen (“fluid pump pumps a liquid, such as water/saline, via said third input 1167 through the second third lumen 1157 to the heating element 1150” [0376]), wherein the lumen is configured to receive a volume of fluid ([0376]);
at least one positioning element (positioning element 1147, 1148 in Fig. 11B, also see [0096]) positioned proximate a proximal or distal end of the inner shaft ([0373]), wherein the at least one positioning element is configured to expand from a first compressed delivery configuration to a second expanded deployed configuration ([0376]); at least one first port (“ports 1149” [0376] and Fig. 11B/ ports 1440 in Fig. 14B, 16B) positioned on the inner shaft;
at least one heating component 1150 positioned within the lumen 1167 ([0374]), wherein the at least one heating component 1150 comprises at least one electrode (“the heating element 1150 comprises a plurality of electrodes” [0374]) positioned circumferentially around a central core ([0037], Fig. 11B), and wherein the at least one heating component 1150 is configured to convert the volume of fluid received by the lumen to a vapor that exits from the at least one first port 1149/1440 and the at least one second port (“delivering vapor through the at least one port positioned at the distal end of the second catheter” [0022] and [0372]-[0376] and [0387]); and
a handle coupled to a proximal end of the inner shaft (handles shown in Figs. 2A-2D and 15A-15H);
although Fig. 11B shows a tip that does not appear to be sharp or tapered, throughout the specification, Sharma refers to the tip as a needle; thereby, it is unclear if the embodiment of Fig. 11 includes a sharp tip or an atraumatic tip positioned on a distal end of the inner shaft, wherein the atraumatic tip comprises at least one second port in fluid communication with the inner shaft.
In the same field of invention, Sharma’140 teaches “a device to perform ablation of endometrial tissue, comprising a catheter having a shaft through which an ablative agent can travel, a first positioning element attached to said catheter shaft at a first position, wherein said first positioning element is configured to center said catheter in a center of a cervix, and an optional second positioning element attached to said catheter shaft at a second position, wherein the shaft comprises a plurality of ports through which said ablative agent can be released out of said shaft and wherein said ports are located between said first position and second position” in [0061]. Sharma’140 also teaches “The device includes a blind, atraumatic and clear distal end 1526 for insertion into a patient's rectum” in [0576] and “in some embodiments, the catheter 320 includes venting tubes 338, 339 to allow the expanded air or extra vapor 337 to vent out passively. The venting tubes 338, 339 allow for the escape of hot air or excess vapor 337 from an area between the two balloons 325, 326 to a space distal to balloon 326 or proximal to balloon 325” in [0498]. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the distal tip of the inner sheath atraumatic depending on the area of treatment in order to prevent unintentional puncture of the tissue. In addition, it would have been obvious to one having ordinary skill in the art to have the atraumatic tip comprises at least one second port in fluid communication with the inner shaft in order to allow for the escape of hot air or excess vapor out the distal tip.
Regarding Claim 2, Sharma teaches wherein the at least one electrode comprises at least one array of electrodes (Figs. 1B-1G and 11B, “a plurality of electrodes” [0374]).
Regarding Claim 4, Sharma teaches wherein a wall of the inner shaft comprises at least one insulation layer ([0372] and “insulated distal surface” marked on Fig. 11).
Regarding Claim 5, Sharma teaches wherein the core is tapered at a proximal end of the core (Fig. 5B shows the core having different sections at least one section is tapered at a proximal end of the core to give it variable stiffness allows for both bending at the middle portion and pushability along the catheter body [0313]; thereby either the core in the embodiment of Fig. 11B is also made of different sections/ tapered proximal end or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add the variable flexibility in order to allow the whole catheter to flex and bend better).
Regarding Claim 6, Sharma teaches wherein the at least one positioning element comprises a wire mesh structure (“Optionally, said at least one positioning element is any one of an inflatable balloon, a wire mesh disc, a cone shaped attachment, a ring shaped attachment, or a freeform attachment” [0096]).
Regarding Claim 7, Sharma teaches wherein the handle comprises at least one sliding button to control movement of the sheath to control deployment of the at least one positioning element (in view of the 112 rejection above and as best understood, [0101] teaches “said ablation device further comprises a coaxial member configured to restrain said at least one positioning element and said step of deploying said at least one distal positioning element further comprises removing said coaxial member from said ablation device” although a button or controller is not shown in the figures associated with movement of the coaxial member [0392] teaches “The first handle component 1505 includes a first thumbscrew 1532 to extend the catheter system 1400 beyond the endoscope” as shown in Fig. 15A and button 1665 in Fig. 16E; therefore, either a similar button or controller is used to slide/remove the coaxial member or alternatively the deployment of the catheter through the endoscope is here interpreted to be movement of the sheath to control deployment of the at least one positioning element).
Regarding Claim 9, Sharma teaches an ablation system for ablating endometrial tissue of a patient (abstract, [0269] and Fig. 11B), comprising: a catheter (Figs. 11B and 15A) comprising:
an outer sheath (1146b in Fig. 11B or alternatively 1407 in Fig. 14B) having a first diameter and a length extending between a proximal end and a distal end (Fig. 11B), the outer sheath configured with at least one opening (“The air pump propels air via said first and second inputs 1165, 1166 through the first and second lumens to inflate the balloons 1147, 1148 so that the catheters 1145a, 1145b are held in position for an ablation treatment” [0376]); an inner shaft (1146a in Fig. 11B or alternatively 1405 in Fig. 14B) having at least one lumen (“fluid pump pumps a liquid, such as water/saline, via said third input 1167 through the second third lumen 1157 to the heating element 1150” [0376]/ “1417, 1415 in Fig. 14B), wherein the lumen is configured to receive a volume of fluid ([0376] and Fig. 14B);
at least one positioning element (positioning elements 1147, 1148 in Fig. 11B, also see [0096]) positioned proximate a proximal or distal end of the inner shaft ([0373] and Fig. 11B), wherein the at least one positioning element is configured to expand from a first compressed delivery configuration to a second expanded deployed configuration ([0376]);
at least one first port positioned on the inner shaft (“ports 1149” [0376] Fig. 11B/ ports 1440 in Fig. 14B, 16B);
at least one heating component 1150 positioned within the lumen 1167, wherein the at least one heating component comprises at least one electrode (“the heating element 1150 comprises a plurality of electrodes” [0374]) positioned circumferentially around a central core (Fig. 11B), and wherein the at least one heating component 1150 is configured to convert the volume of fluid received by the lumen to a vapor that exits from the at least one first port 1149/1440 and the at least one second port (“delivering vapor through the at least one port positioned at the distal end of the second catheter” [0022] and [0372]-[0376], [0387]); and
a handle coupled to a proximal end of the inner catheter shaft (handles shown in Figs. 2A-2D and 15A-15H);
a fluid reservoir 14 (Fig. 1A, also see Fig. 18) configured to contain the volume of fluid and in fluid communication with the at least one lumen ([0274], [0282] and [0376]); a pump (15 in Fig. 1A/ 179 in Fig. 1I) configured to pump fluid from the fluid reservoir into the at least one lumen ([0012], [0274], [0286] and [0376]); and
a controller having at least one processor, wherein the controller is configured to deliver an electrical current to the at least one electrode and to cause the volume of fluid to pass into the lumen from the fluid reservoir when activated ([0012], [0022], [0060], [0092], [0264], [0274], [0294] and [0376]);
although Fig. 11B shows a tip that does not appear to be sharp or tapered throughout the specification, Sharma refers to the tip as a needle; thereby, it is unclear if the embodiment of Fig. 11 includes a sharp tip or an atraumatic tip positioned on a distal end of the inner shaft, wherein the atraumatic tip comprises at least one second port in fluid communication with the inner shaft.
In the same field of invention, Sharma’140 teaches “a device to perform ablation of endometrial tissue, comprising a catheter having a shaft through which an ablative agent can travel, a first positioning element attached to said catheter shaft at a first position, wherein said first positioning element is configured to center said catheter in a center of a cervix, and an optional second positioning element attached to said catheter shaft at a second position, wherein the shaft comprises a plurality of ports through which said ablative agent can be released out of said shaft and wherein said ports are located between said first position and second position” in [0061]. Sharma’140 also teaches “The device includes a blind, atraumatic and clear distal end 1526 for insertion into a patient's rectum” in [0576] and “in some embodiments, the catheter 320 includes venting tubes 338, 339 to allow the expanded air or extra vapor 337 to vent out passively. The venting tubes 338, 339 allow for the escape of hot air or excess vapor 337 from an area between the two balloons 325, 326 to a space distal to balloon 326 or proximal to balloon 325” in [0498]. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the distal tip of the inner sheath atraumatic depending on the area of treatment in order to prevent unintentional puncture of the tissue. In addition, it would have been obvious to one having ordinary skill in the art to have the atraumatic tip comprises at least one second port in fluid communication with the inner shaft in order to allow for the escape of hot air or excess vapor out the distal tip.
Regarding Claim 10, Sharma teaches further comprising a power source positioned in the controller ([0012], [0022] and [0376]).
Regarding Claim 11, Sharma teaches wherein the pump comprises a syringe pump (“for generating steam, fluid is delivered from a reservoir, such as a syringe, to the heating chamber 130 by a pump or any other pressurization means” [0282] and Fig. 16F).
Regarding Claim 12, Sharma teaches wherein the at least one electrode comprises at least one array of electrodes (Figs. 1B-1G and 11B, “a plurality of electrodes” [0374]).
Regarding Claim 13, Sharma teaches wherein the core is tapered at a proximal end of the core (Fig. 5B shows the core having different sections at least one section is tapered at a proximal end of the core to give it variable stiffness allows for both bending at the middle portion and pushability along the catheter body [0313]; thereby either the core in the embodiment of Fig. 11B is also made of different sections/ tapered proximal end or alternatively it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add the variable flexibility in order to allow the whole catheter to flex and bend better).
Regarding Claim 14, Sharma teaches wherein the controller comprises a foot pedal or switch configured to allow a user to control a flow of fluid to the lumen (foot pedal 25 in Fig. 1A, [0014], [0024], [0274], [0345] and [0358]).
Regarding Claim 15, Sharma teaches wherein the at least one positioning element comprises a wire mesh structure (“Optionally, said at least one positioning element is any one of an inflatable balloon, a wire mesh disc, a cone shaped attachment, a ring shaped attachment, or a freeform attachment” [0096]).
Regarding Claim 16, Sharma teaches wherein the handle comprises at least one sliding button to control movement of the sheath to control deployment of the at least one positioning element (in view of the 112 rejection above and as best understood, [0101] teaches “said ablation device further comprises a coaxial member configured to restrain said at least one positioning element and said step of deploying said at least one distal positioning element further comprises removing said coaxial member from said ablation device” although a button or controller is not shown in the figures associated with movement of the coaxial member [0392] teaches “The first handle component 1505 includes a first thumbscrew 1532 to extend the catheter system 1400 beyond the endoscope” as shown in Fig. 15A and button 1665 in Fig. 16E; therefore, either a similar button or controller is used to slide/remove the coaxial member or alternatively the deployment of the catheter through the endoscope is here interpreted to be movement of the sheath to control deployment of the at least one positioning element).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Sharma’140 and further in view of Gilbert (US Pub. No. 2017/0079708).
Regarding Claim 3, Sharma teaches wherein the array of electrodes comprises at least two electrodes, wherein the at least two electrodes are configured to be positioned circumferentially around the central core such that the two (electrodes) [tapered proximal ends] are offset from one another (Fig. 1D shows the electrodes offset with respect to the core), but does not specifically teach the electrodes having tapered proximal ends.
In the same field of invention, Gilbert teaches providing a configuration of a collapsable electrode array having a wider distal end and a tapered proximal end while maintaining gaps therebetween to allow for a more flexibility as seen in Fig. 35. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to shape the electrodes of Sharma in a similar manner in order to give them more surface area while maintaining gaps therebetween for more flexibility and better heat generation.
Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Sharma’140 and further in view of Carranza (US Pub. No. 2005/0055083).
Regarding Claim 18, Sharma teaches a kit comprising multiple components of an ablation system (Sharma teaches multiple components that operate together and thus interpreted to be a “kit”), the kit comprising: an ablation catheter comprising:
an outer sheath 1146b having a first diameter and a length extending between a proximal end and a distal end (Fig. 11B), the outer sheath configured with at least one opening (“The air pump propels air via said first and second inputs 1165, 1166 through the first and second lumens to inflate the balloons 1147, 1148 so that the catheters 1145a, 1145b are held in position for an ablation treatment” [0376]);
an inner shaft 1146a having at least one lumen, wherein the lumen (“fluid pump pumps a liquid, such as water/saline, via said third input 1167 through the second third lumen 1157 to the heating element 1150” [0376]) is configured to receive a volume of fluid ([0376]);
at least one positioning element (positioning elements 1147, 1148 in Fig. 11B, also see [0096]) positioned proximate a proximal or distal end of the inner shaft ([0373] and Fig. 11B), wherein the at least one positioning element is configured to expand from a first compressed delivery configuration to a second expanded deployed configuration ([0376]);
at least one first port positioned on the inner shaft (“ports 1149” [0376] Fig. 11B/ ports 1440 in Fig. 14B, 16B);
an atraumatic tip positioned on a distal end of the inner shaft (Fig. 11B shows a tip that does not appear to be sharp or tapered and thus is reasonably interpreted to be an atraumatic tip), wherein the atraumatic tip comprises at least one second port in fluid communication with the inner shaft ([0372);
at least one heating component 1150 positioned within the lumen, wherein the at least one heating component comprises at least one electrode (“the heating element 1150 comprises a plurality of electrodes” [0374]) positioned circumferentially around a central core (Fig. 11B), and wherein the at least one heating component 1150 is configured to convert the volume of fluid received by the lumen to a vapor that exits from the at least one first port and the at least one second port (“delivering vapor through the at least one port positioned at the distal end of the second catheter” [0022] and [0372]-[0376]); and
a handle coupled to a proximal end of the inner catheter shaft (handles shown in Figs. 2A-2D and 15A-15H);
at least one pump 15 configured to pump fluid from a fluid reservoir 14 into the at least one lumen (Fig. 1A, also see Fig. 18);
an aspiration catheter (“Negative pressure, in the form of suction or vacuum, is applied to the ablated zone after the steam is turned off to increase blood flow to cool the tissue” [0336], also see [0052], [0077]);
although Fig. 11B shows a tip that does not appear to be sharp or tapered throughout the specification, Sharma refers to the tip as a needle; thereby, it is unclear if the embodiment of Fig. 11 includes a sharp tip or an atraumatic tip positioned on a distal end of the inner shaft, wherein the atraumatic tip comprises at least one second port in fluid communication with the inner shaft.
In the same field of invention, Sharma’140 teaches “a device to perform ablation of endometrial tissue, comprising a catheter having a shaft through which an ablative agent can travel, a first positioning element attached to said catheter shaft at a first position, wherein said first positioning element is configured to center said catheter in a center of a cervix, and an optional second positioning element attached to said catheter shaft at a second position, wherein the shaft comprises a plurality of ports through which said ablative agent can be released out of said shaft and wherein said ports are located between said first position and second position” in [0061]. Sharma’140 also teaches “The device includes a blind, atraumatic and clear distal end 1526 for insertion into a patient's rectum” in [0576] and “in some embodiments, the catheter 320 includes venting tubes 338, 339 to allow the expanded air or extra vapor 337 to vent out passively. The venting tubes 338, 339 allow for the escape of hot air or excess vapor 337 from an area between the two balloons 325, 326 to a space distal to balloon 326 or proximal to balloon 325” in [0498]. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the distal tip of the inner sheath atraumatic depending on the area of treatment in order to prevent unintentional puncture of the tissue. In addition, it would have been obvious to one having ordinary skill in the art to have the atraumatic tip comprises at least one second port in fluid communication with the inner shaft in order to allow for the escape of hot air or excess vapor out the distal tip.
Furthermore, although Sharma teaches multiple components that operate together and thus interpreted to be a “kit”, does not specifically show the packaging and thus a substrate comprising a plurality of spaces configured to receive the ablation catheter, at least one pump, and aspiration catheter, wherein at least one first cover portion of the substrate is configured to cover and protect at least one component of the ablation catheter; a base configured to receive the substrate; and a lid configured to be positioned over the substrate and secured to the base.
Sharma’140 teaches “a vapor ablation kit 4980” in [0808], but does not show the packaging and thus does it is unclear if it comprises a substrate comprising a plurality of spaces configured to receive the ablation catheter, at least one pump, and aspiration catheter, wherein at least one first cover portion of the substrate is configured to cover and protect at least one component of the ablation catheter; a base configured to receive the substrate; and a lid configured to be positioned over the substrate and secured to the base.
In the same field of medical instruments, Carranza teaches a functional packaging including a substrate 4 comprising a plurality of spaces (“a tray having multiple recesses” [0006], “tray 4” [0035] and Figs. 1-3) configured to receive the ablation catheter, at least one pump, and aspiration catheter (“recesses are used to hold one or more tools” [0006] and Figs. 1-3), wherein at least one first cover portion of the substrate is configured to cover and protect at least one component of the ablation catheter (at least one section of “cover 10” [0039] and Fig. 1 is configured to cover and protect at least one component of the ablation catheter by sealing the at least one component of the ablation catheter inside shell 8); a base (“outer shell 8” [0035] and Fig. 1) configured to receive the substrate (Fig. 1); and a lid (“tray top 6” [0035] and Fig. 1) configured to be positioned over the substrate and secured to the base ([0035]-[0040] and Fig. 1).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a similar functional packaging in the invention of Sharma in order to allow all of the tools required for the procedure to be held within a functional package for safety and ease of handling.
Regarding Claim 19, Sharma in view of Sharma’140 and Carranza teaches wherein the at least one first cover portion is partially cut out from a remainder of the substrate and is formed by folding the at least one first cover portion over the at least one component of the ablation catheter (“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); thereby regardless of whether the at least one first cover portion is partially cut out from a remainder of the substrate and is formed by folding the at least one first cover portion over the at least one component of the ablation catheter since the cover is shown covering the recesses where the tools will be positioned within and configured to be sealed to the shell to cover and protect the at least one component of the ablation catheter, examiner takes the position that the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Regarding Claim 20, Sharma in view of Sharma’140 and Carranza teaches further comprising at least one second cover portion and at least one third cover portion (“cover 10” [0040] is configured to be sealed to the outer shell 8 on all 4 sides, each section is here interpreted to be a first cover portion, a second cover portion and a third cover portion), wherein the at least one first, second, and third cover portions are configured to engage with each other to form an enclosure to cover the at least one component of the ablation catheter (by being sealed to shell 8, all 4 sides are configured to engage with each other to form an enclosure to cover the at least one component of the ablation catheter).
Regarding Claim 21, Sharma in view of Sharma’140 and Carranza teaches wherein the lid (“tray top 6” [0035] and Fig. 1) comprises a plurality of recessed cavities 40 that are recessed according to shapes of the ablation catheter, at least one pump, and aspiration catheter (“features 40 may be molded into the tray top 6 or otherwise formed into the tray top 6. The tray top 6 assists in restraining the tools held in the tray and protecting them from contamination” [0036] and Fig. 1).
Regarding Claim 22, Sharma in view of Sharma’140 and Carranza teaches wherein at least one space of the plurality of spaces of the substrate is configured to receive the ablation catheter comprising the at least one positioning element configured to expand from a first compressed delivery configuration to a second expanded deployed configuration, wherein the at least one positioning element is in the second expanded deployed configuration when the ablation catheter is positioned within the at least one space (Sharma teaches “at least one positioning element is any one of an inflatable balloon, a wire mesh disc, a cone shaped attachment, a ring shaped attachment, or a freeform attachment” whereas they are configured to expand from a first compressed delivery configuration to a second expanded deployed configuration during use and at least one of them is configured to maintain on the second deployment configuration when at rest for positioning within the at least one space of the packaging since Carranza teaches “package can be sealed, and sterilized along with its contents” [0006] and it would be beneficial to have the at least one positioning element is in the second expanded deployed configuration for sterilization), and wherein the at least one first cover portion is configured to cover and protect the at least one positioning element in the second expanded deployed configuration (sealing cover 10 to shell 8 during packaging in view of the teachings of Carranza).
Allowable Subject Matter
Claims 8 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claims 8 and 17, Sharma in view of Sharma’140 teaches the invention as applied above, but does not teach further comprising a stabilizer positioned coaxially around an outer circumference of the sheath on a proximal side of the first positioning element, wherein the stabilizer is configured to stabilize and maneuver the sheath during insertion inside the uterine cavity, the stabilizer comprising: a first proximal section; a second section attached to and perpendicular the first section; a third section attached to a distal end of, and at an angled orientation relative to, the second section, wherein the third section extends in a distal direction relative to the second section; and a fourth section extending in a distal direction relative to the second section, wherein the fourth section is attached to a side of a distal end of the third section, and wherein the fourth section is oriented parallel to the second section, and wherein the fourth section is configured to be hollow to accommodate passage of the sheath.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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