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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
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.
In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 4, 5, and 8 have been canceled, Claims 9-12, 19, 22, and 23 are withdrawn, and Claims 1-3, 6, 7, 13-18, 20, and 21 are currently pending and being examined.
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, 3, 6, 7, 15, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Triebes (USPN 7,124,489) in view of Seare (USPN 5,911,757).
In reference to independent claim 1, Triebes discloses an enteral nutrition gastronomy access system (col 1, lines 23-27 discloses “In the case of enteral feeding, a stoma is formed leading into the stomach or intestine. The catheter is positioned to extend through the stoma so as to form a channel into the stomach or intestines through which enteral feeding solutions may be instilled.”) comprising:
a stoma liner grommet (made up generally of the head 112, catheter 110 and the balloon 118, fig 3) configured to penetrate and connect to tissues forming a human's abdominal wall and gastrointestinal wall (disclosed in the cite above),
wherein the stoma liner grommet includes an inflatable interior bladder (118, fig 3) that is adjustable (central channel 122, col 6, lines 11-15 discloses “It will be appreciated that the size of the catheter 110 as well as the length (inflated and uninflated) of the balloon 118 may be varied in accordance with the size and shape of the body cavity”); and a plug (the valve sub-assembly 124) removably inserted (although not mentioned all structures can be removed, the valve sub assembly is clearly a subcomponent from fig 3) into the central channel (122, fig 3); wherein the plug includes a plug channel (120, fig 3);
wherein the stoma liner grommet and the plug maintain a cross-cutaneous delivery channel for enteral fluid delivery (col 5, lines 34-38 discloses “the catheter 110 is shown with a proximal opening 120 to a feeding lumen 122 (FIG. 3) within the shaft 114 for bolus feeding or providing other nutrient fluids, formula, and the like to a patient (not depicted)”), however
Triebes does not teach an inflatable interior bladder that is adjustable to vary a cross-sectional diameter size of the central chamber.
Seare, a similar access system, teaches an inflatable interior bladder (60, fig 3) that is adjustable to vary a cross-sectional diameter size of the central chamber (fig 3 clearly shows the bladder central chamber with a varying central chamber).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the bladder of Seare in the access system of Triebes to “provide methods and apparatus permitting stable transcutaneous access to be established and maintained” col 2, lines 12-13; Seare. To be clear by adding the balloon of Seare into the internal passage of Triebes both access thru the central chamber and tension on the surrounding tissue can be more accurately controlled.
In reference to dependent claim 3, Triebes in view of Seare discloses the system of claim 1, Triebes further discloses where the plug is inserted into the central channel through application of a linear push force (although not explicitly mentioned fig 3 clearly shows the valve assembly being lined up with its cavity in a linear way indicating it would necessitate some amount of linear force).
In reference to dependent claim 6, Triebes discloses the system of claim 1, Triebes further discloses where the stoma liner grommet includes an external pinch point (where the bottom of 112 makes contact with the body) and an internal pinch point (where the top of the balloon 118 makes contact with the inside of the body) and connects to said tissues by application of oppositional pinching forces at the external pinch point and the internal pinch point (col 1, lines 20-34 discloses “Inflating the balloon causes the balloon to contact the anatomical structure (i.e., a duct or stomach wall) and thereby prevents the catheter from moving out of the proper position. In the case of enteral feeding, a stoma is formed leading into the stomach or intestine. The catheter is positioned to extend through the stoma so as to form a channel into the stomach or intestines through which enteral feeding solutions may be instilled. Depending on the type of catheter, the balloon may be positioned in a variety of locations along the catheter shaft. For example, with a G-tube the balloon will generally be at or near the distal end of the catheter, although the balloon or other retention mechanism may be slightly closer to the head of the catheter provided that the retention effect may still be achieved.” The retention effect is the balloon putting pressure on the inside and the circumference of the head 112 preventing the catheter from advancing further into the patient.).
In reference to dependent claim 7, Triebes discloses the system of claim 6, Triebes further discloses where the application of oppositional pinching forces is by inflation and/or deflation of the inflatable interior bladder (col 1, lines 20-34 discloses “Inflating the balloon causes the balloon to contact the anatomical structure (i.e., a duct or stomach wall) and thereby prevents the catheter from moving out of the proper position. In the case of enteral feeding, a stoma is formed leading into the stomach or intestine. The catheter is positioned to extend through the stoma so as to form a channel into the stomach or intestines through which enteral feeding solutions may be instilled. Depending on the type of catheter, the balloon may be positioned in a variety of locations along the catheter shaft. For example, with a G-tube the balloon will generally be at or near the distal end of the catheter, although the balloon or other retention mechanism may be slightly closer to the head of the catheter provided that the retention effect may still be achieved.” The retention effect is the balloon putting pressure on the inside and the circumference of the head 112 preventing the catheter from advancing further into the patient.).
In reference to dependent claim 15, Triebes discloses the system of claim 1, Triebes further discloses wherein the stoma liner grommet is symmetrical around the central channel (the stoma of fig 3 is generally symmetrical around the main channel).
In reference to dependent claim 16, Triebes discloses the system of claim 1, Triebes further discloses wherein the plug further includes a cap (132, fig 3) removably positioned in an exterior opening of the plug channel (col 6, lines 5-8 discloses “The plug 132 can be inserted in the opening 120 thereby reducing or precluding contamination when the opening 120 is not in use.”).
In reference to dependent claim 20, Triebes discloses the system of claim 1, Triebes further comprising saline positioned within the inflatable interior bladder (col 5, lines 64-67 discloses “Application of positive fluid pressure, such as with air or saline, within and/or upon the inflation lumen 128 by way of the inflation port 126 may cause the balloon 118 to inflate”).
Claim 2 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Triebes (USPN 7,124,489) in view of Seare (USPN 5,911,757) in reference to claim 1 above, and further in view of Haber (USPN 4,850,953).
In reference to dependent claim 2, Triebes in view of Seare discloses the system of claim 1, however
Triebes and Seare does not teach where the stoma liner grommet is roughly torus-shaped.
Haber, a similar stoma, teaches the grommet (1) is roughly torus-shaped (col 4, lines 62-66 discloses “the inflated membrane 8' has a torroidal (rather than spherical) cross-section which advantageously maximizes the surface area thereof and provides an improved sealing geometry for contact with the abdominal mucosa 52”).
It has been held that the configuration of the shape of an apparatus is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the toroidal shape of Haber in the stoma of Triebes in view of Seare to “maximize the surface area thereof and provides an improved sealing geometry for contact with the abdominal mucosa” col 4, lines 64-66; Haber.
In reference to dependent claim 21, Triebes in view of Seare discloses the system of claim 1, Triebes further discloses wherein the plug is inserted into the central channel through application of a linear push force (although not explicitly mentioned fig 3 clearly shows the valve assembly being lined up with its cavity in a linear way indicating it would necessitate some amount of linear force); wherein the stoma liner grommet includes an external pinch point (where the bottom of 112 makes contact with the body) and an internal pinch point (where the top of the balloon 118 makes contact with the inside of the body) and connects to said tissues by application of oppositional pinching forces at the external pinch point and the internal pinch point (described in detail in the cite below); and wherein the application of oppositional pinching forces is by inflation and/or deflation of the inflatable interior bladder (col 1, lines 20-34 discloses “Inflating the balloon causes the balloon to contact the anatomical structure (i.e., a duct or stomach wall) and thereby prevents the catheter from moving out of the proper position. In the case of enteral feeding, a stoma is formed leading into the stomach or intestine. The catheter is positioned to extend through the stoma so as to form a channel into the stomach or intestines through which enteral feeding solutions may be instilled. Depending on the type of catheter, the balloon may be positioned in a variety of locations along the catheter shaft. For example, with a G-tube the balloon will generally be at or near the distal end of the catheter, although the balloon or other retention mechanism may be slightly closer to the head of the catheter provided that the retention effect may still be achieved.” The retention effect is the balloon putting pressure on the inside and the circumference of the head 112 preventing the catheter from advancing further into the patient.).
Triebes and Seare do not teach where the stoma liner grommet is roughly torus-shaped.
Haber, a similar stoma, teaches the grommet (1) is roughly torus-shaped (col 4, lines 62-66 discloses “the inflated membrane 8' has a torroidal (rather than spherical) cross-section which advantageously maximizes the surface area thereof and provides an improved sealing geometry for contact with the abdominal mucosa 52”).
It has been held that the configuration of the shape of an apparatus is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the toroidal shape of Haber in the stoma of Triebes in view of Seare to “maximize the surface area thereof and provides an improved sealing geometry for contact with the abdominal mucosa” col 4, lines 64-66; Haber.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Triebes (USPN 7,124,489) in view of Seare (USPN 5,911,757) in reference to claim 1 above and further in view of Carlsson (USPN 11,202,719).
In reference to dependent claim 13, Triebes in view of Seare discloses the system of claim 1, however
Triebes and Seare are silent to a sensor at the stoma liner grommet.
Carlsson, a similar stoma for medical use, teaches a sensor at the stoma (claim 1 discloses “at least one optical sensor configured to detect a color or change in color at a visible portion of the at least one fluidic channel [the stoma] and output sensor information representative of the detected color or change in color”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the optical sensor of Carlsson in the stoma of Triebes in view of Seare “to prevent or limit leakage” col 1, line 25; Carlson. To be clear the modification is done by placing the sensor on an interior surface of the stoma liner grommet, as is made obvious by the art of Carlson.
In reference to dependent claim 14, Triebes in view of Seare and Carlsson discloses the system of claim 13, Carlson further discloses the sensor is an optical sensor positioned at an interior surface of the stoma liner grommet (claim 1 discloses a stoma and “at least one optical sensor configured to detect a color or change in color at a visible portion of the at least one fluidic channel and output sensor information representative of the detected color or change in color”).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Triebes (USPN 7,124,489) in view of Seare (USPN 5,911,757) in reference to claim 16 above, and further in view of Deckard (USPN 11,701,303).
In reference to dependent claim 17, Triebes in view of Seare discloses the system of claim 16, however
Triebes and Seare are silent to wherein the cap is removed from the plug channel though application of a combination of a linear pull force and at least one torsional force.
Deckard, a device used with feeding tubes like Haber, teaches a quick disconnection is affected though application of a combination of a linear pull force and at least one torsional force (col 4, lines 42-49 discloses “FIGS. 6 and 7, locking tabs 25 on body 21 and locking notch 35 on collet 31 may cooperate to provide a lock or locking mechanism or assembly with the ability to selectively secure collets against axial movement, or axial movement tending to withdraw collets 31 from bore 23 of body 21. In FIG. 6, collet 31 is rotated in bore 23 so that locking notches or recesses 35 are aligned or register with locking tabs 25 on body 21.” In order to remove the tubing the collet 31 is rotated then linear force is applied to the tubing out.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connector structure of Deckard in the device of Triebes in view of Seare “to provide the “breakaway” or “quick disconnect” feature: if excessive force or strain is exerted on tubing inserted in the connector 11, it will withdraw or “pull out” before damaging the feeding tube 9 or injuring patient” col 5, lines 9-12; Deckard.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Triebes (USPN 7,124,489) in view of Seare (USPN 5,911,757) in reference to claim 1 above, and further in view of Buchanan (USPAP 2019/0344064).
In reference to dependent claim 18 Triebes in view of Seare discloses the system of claim 1, however
Triebes and Seare are silent to the stoma liner grommet includes color changing material used to indicate the presence of inflammation, infection, or leakage.
Buchanan, a similar medical connector, teaches a connector including a color changing material used to indicate the presence of inflammation, infection, or leakage (para 0050 discloses “One type of material that could be used is a hydrochromic material, which changes color when it comes into contact with moisture or a liquid” by sensing liquid it can sense leakage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connector material of Buchanan in the device of Triebes in view of Seare “to avoid the possibility of infection” para 0050; Buchanan.
Response to Arguments
Applicant's arguments filed on 12/29/2025 have been considered but, unless otherwise addressed below, are moot in view of the new ground(s) of rejection.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783