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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-15) in the reply filed on 08/10/2026 is acknowledged. The traversal is on the ground(s) that Applicant “submits that Group I and II are indistinct” since both independent claim 1 (of Group I) and independent claim 16 (of Group II) recite language of the distal end of the hybrid urethral stent being above the sphincter without penetrating the sphincter in use. This is not found persuasive because Group I (a hybrid urethral stent) and Group II (a method of inserting a hybrid urethral stent) are indistinct. As disclosed in the MPEP, stated in the Requirement for Restriction dated 06/10/2026, and mentioned by Applicant in the response dated 08/10/2026: “The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product”. It is to be noted that the invention of Group I is a product/device, wherein the claimed structure of the final produce/device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final product/device. Thus, in the instant case, the claimed structure of the final produce/device of Group I, i.e. the hybrid urethral stent, can be used in a materially different process such as one wherein the hybrid urethral stent/the distal end of the hybrid urethral stent can be placed within or below the sphincter and/or penetrate the sphincter during use; since there is no structural limitations set forth in independent claim 1 which would prevent the structure of the hybrid urethral stent from achieving such a process.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/10/2026.
Status of Claims
This office action is responsive to the amendment filed on 08/10/2026 wherein claim 1 has been amended.
Applicant has amended previously presented claim 1, however fails to provide details on where in the specification the support for these amendments can be found. It is the applicant's responsibility to specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06(i).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the hybrid urethral stent system comprising, in the second, coiled orientation, the straight portion transitioning prior to the proximal end into a U-shaped neck element (claim 1), the hybrid urethral stent system configured with a non-seating stent body and a plurality of eyelets to facilitate fluid flow both through and around the hybrid urethral stent (claim 2), the hybrid urethral stent system wherein the swan neck and straight stem configured to stent the male prostatic or female urethra is adapted to permit dual pathway intra-tubular and peri-tubular urine flow (claim 3), the hybrid urethral stent system comprising a first eyelet in the second surface of the second section of the coiled element, a second eyelet located along the stabilizing elbow, and at least an eyelet contained within the single coil and an optional eyelet in the upper portion of the straight stem (claim 4), the hybrid urethral stent system wherein the swan neck and straight stem configured to stent the male prostatic or female urethra is adapted to permit dual pathway intra-tubular and peri-tubular urine flow, and wherein the peri-tubular urine flow is configured to displace pathogenic microbes from the urinary tract (claim 5), the hybrid urethral stent system wherein the swan neck and straight stem configured to stent the male prostatic or female urethra is adapted to permit dual pathway intra-tubular and peri-tubular urine flow, and wherein the dual pathway urine flow is configured to produce a higher urine flow rate to flush microbial film and contaminants from the urinary tract (claim 6), the hybrid urethral stent system wherein the swan neck and straight stem configured to stent the male prostatic or female urethra is adapted to permit dual pathway intra-tubular and peri-tubular urine flow, and wherein the dual pathway urine flow, along with retaining detrusor muscle function, and external and internal sphincter function is configured to reduce post void residual urine in the bladder claim 7), the hybrid urethral stent system wherein the swan neck and straight stem configured to stent the male prostatic or female urethra is adapted to permit dual pathway intra-tubular and peri-tubular urine flow, and wherein the system is configured internally to protect the urinary tract mucosal barrier and eliminate the need for an external- collection component (claim 8), the hybrid urethral stent system wherein the second coiled orientation enabling drainage at the bladder base facilitates a complete bladder evacuation (claim 9), the hybrid urethral stent system wherein placement of the straight stem proximal to the external sphincter is configured to preserve volitional voiding, which further comprises engaging a detrusor muscle contraction functionality and an internal and external sphincter functionality (claims 10 and 11), and the hybrid urethral stent system comprising the swan neck flexing feature which allows the distal stem to traverse the external sphincter to promote bladder emptying in neurogenic and female patients in a state of urine retention (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, which sets forth the parameters of: “upon application of an internal force applied through the internal fluid passage to the proximal end, the stent body transforms into a first, straight orientation for insertion into a patient's urethra and bladder and, upon removal of the internal force, the stent body transforms into a thermoset second, coiled orientation” (emphasis added) on lines 4-8, “the straight portion transitions prior to the proximal end into a U-shaped neck element” (emphasis added) on line 11, “a coiled element that encircles the straight portion of the stent body below the U-shaped neck element by more than 360 degrees” (emphasis added) on lines 14-16, and “the coiled element further comprises first, second and third sections, the first section of the coiled element extends from the right-angle bend around and away from the substantially straight portion of the stent body, wherein the second section of the coiled element extends around the substantially straight portion of the stent body from the first section of the coiled element to the third section of the coiled element, wherein the third section of the coiled element extends from the second section of the coiled element around and towards the substantially straight portion of the stent body” on lines 18-24; however, these parameters were never mentioned or suggested in the originally filed disclosure. It is to be noted that all the above mentioned parameters were newly added to claim 1 in the amendment dated 08/10/2026, and therefore are not part of the originally filed disclosure.
Regarding claim 4, which depends from claim 1 which sets forth the parameter of “a first eyelet in the second surface of the second section of the coiled element and a second eyelet located along the stabilizing elbow”, and claim 4 further sets forth the parameter of “at least an eyelet contained within the single coil and an optional eyelet in the upper portion of the straight stem”; however, this parameter was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests, or illustrates the stent system comprising a first eyelet in the second surface of the second section of the coiled element, a second eyelet located along the stabilizing elbow, and further also having at least one eyelet contained within the single coil and an optional eyelet in the upper portion of the straight stem.
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 1-15 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.
Regarding claim 1, lines 1-3 set forth “A hybrid urethral stent system, the stent comprising: a stent having a stent body”; however this is found to be confusing since it is not clear how many stent there actually are, and/or also includes a lack of antecedent basis for the term “the stent”. In order to avoid confusion and clarify the claim language, it is suggested the words “the stent” on line 2 be deleted. Furthermore, the 9th – 8th to last lines of the claim set forth the parameter of “the stabilizing elbow is configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back in proximity with a sphincter” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally/chemically, is meant by a “snap back in proximity with a sphincter”. Specifically, it is not clear what exactly, i.e. a specific structure and/or a specific chemical/material, would be needed in order to meet the limitation of a “snap back” and/or which portion of the urethral stent would need said specific structure and/or material, just the stabilizing elbow, or the entire urethral stent structure, or some other portion of the urethral stent. Moreover, it is also unclear what, if any, structural limitation the limitation of the snap back being “in proximity with a sphincter” has on the final structure of the claimed device/the hybrid urethral stent system; is this mere recitation of intended use/function, i.e. the urethral stent being placed in proximity with a sphincter, or would the final structure of the urethral stent need to have some additional structure to meet having a snap back “in proximity with a sphincter”. Additionally, claim 1 recites the limitation of “a straight stem”, on the 7th to last line, and “the straight stem”, on the 6th to last line; however, there is confusion as to what the structure of this limitation is and/or how it relates to the final structure of the urethral stent system. Specifically, is “a straight stem”/“the straight stem” supposed to be the same structure as the “substantially straight portion”, as first set forth on lines 10-11, or is it some other completely different structure; and if so then it is further unclear how this completely different structure would be part of/relate to the final structure of the urethral stent system. As can be gleaned from the originally filed disclosure, it seems this limitation is the same structure as the straight portion, as first set forth on lines 10-11; therefore, it is suggested the limitation of “a straight stem”, on the 7th to last line, and “the straight stem”, on the 6th, to last line, both be amended to state “the straight portion”. Finally, the 5th to last line recites the limitations of “the external sphincter” and “the sphincter”; however, there is insufficient antecedent basis for these limitations in the claim. Specifically, the limitation of an “external sphincter” has never been set forth in the claim, therefore the limitation of “the external sphincter”, on the 5th to last line, should be amended to state “an external sphincter”; and it is further unclear if the limitation of “the sphincter”, on the 5th to last line is meant to be an external sphincter, or if it is supposed to be the same sphincter as first set forth on the 8th to last line. As can be gleaned from the originally filed disclosure, it seems “the sphincter” on the 5th to last line is the same as the external sphincter, therefore it is suggested the limitation of the sphincter”, on the 5th to last line, be amended to state “the external sphincter”.
Regarding claim 2, which sets forth the parameter of “configured with a non-seating stent body and a plurality of eyelets to facilitate fluid flow…”, however this parameter is found to be confusing for a few reasons. Firstly, it is not clear what exactly, structurally, is meant by the term “a non-seating stent body”, is this term meant to be a structurally limiting term, and if so then it is unclear what exactly the structural limitations are in order to meet the term “a non-seating stent body”; or is this term meant as a functional/intended use term, and if so then it is unclear what additional structural limitation(s) to the final structure of the device/the hybrid urethral stent system would be needed to meet the functional/intended use. Secondly, it is unclear if “a plurality of eyelets” is in addition to the first and second eyelets, as first set forth on lines 26-27 of claim 1 from which claim 2 depends, or if the first and second eyelets (of claim 1) count as the “plurality of eyelets” (of claim 2). Moreover, if the limitation of “a non-seating stent body” is meant as a functional/intended use term, and “plurality of eyelets” are the same eyelets as the first and second eyelets, then it is further unclear what, if any, additional structural limitations this claim imparts on the final structure of the inventive device, i.e. the hybrid urethral stent system; since the parameter set forth in the claim would merely be reciting intended use/functional language, and not including any additional structure, for the inventive device/the hybrid urethral stent system, which would be needed in order to meet the function/intended use. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 3, which recites the limitations “the swan neck”, on line 1, and “the straight stem”, on line 2; there is insufficient antecedent basis for these limitations in the claim. Furthermore, it is unclear what exactly, structurally, is meant a “swan neck” and/or how it relates to the final structure of the urethral stent system; and what structure is meant by “the straight stem”, is it the same structure as “the straight portion”, as first set forth on lines 10-11 of claim 1 from which claim 3 depends, or is it some other completely different structure, and if so then it is further unclear how it relates to the final structure of the urethral stent system. Moreover, it is unclear what, if any, additional structural limitations this claim imparts on the final structure of the inventive device, i.e. the hybrid urethral stent system. The parameter set forth in the claim merely seems to be reciting intended use/functional language, however does not include any additional structure, for the inventive device/the hybrid urethral stent system, which would be needed in order to meet the function/intended use. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 4, which recites the limitation “the single coil”, on line 2; there is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what exactly, structurally, is meant “the single coil”, is it the same structure as “the coiled element”, as first set forth on line 14 of claim 1 from which claim 4 depends, or is it some other completely different structure, and if so then it is further unclear how it relates to the final structure of the urethral stent system. Moreover, claim 4 depends from claim 1 which, on lines 24-26, sets forth the parameter(s) of “a first eyelet in the second surface of the second section of the coiled element and a second eyelet located along the stabilizing elbow”, and claim 4 further sets forth the parameter(s) of “further comprising at least an eyelet contained within the single coil and an optional eyelet in the upper portion of the straight stem”; however this parameter(s) is/are found to be confusing since it is not clear exactly how many eyelets there actually are. Specifically, is the “at least an eyelet”, as set forth in claim 4, supposed to be the same structure as the first eyelet (as set forth in claim 1), or the second eyelet (as set forth in claim 1), or is it another different and distinct eyelet in addition to the first and second eyelets, and/or is the “optional eyelet”, as set forth in claim 4, supposed to be the same structure as the first eyelet (as set forth in claim 1), or the second eyelet (as set forth in claim 1), or is it another different and distinct eyelet in addition to the first and second eyelets. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 5-9, it is unclear what, if any, additional structural limitations these claims impart on the final structure of the inventive device, i.e. the hybrid urethral stent system. The parameters set forth in each of the above mentioned claims merely seem to be reciting intended use/functional language, however none of the claims include any additional structure, for the inventive device/the hybrid urethral stent system, which would be needed in order to meet the function/intended use. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 10, which recites the limitation “the straight stem”, on lines 1-2; there is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what structure is meant by “the straight stem”, is it the same structure as “the straight portion”, as first set forth on lines 10-11 of claim 1 from which claim 10 depends, or is it some other completely different structure, and if so then it is further unclear how it relates to the final structure of the urethral stent system. Moreover, it is unclear what, if any, additional structural limitations this claim imparts on the final structure of the inventive device, i.e. the hybrid urethral stent system. The parameter set forth in the claim merely seems to be reciting intended use/functional language, however does not include any additional structure, for the inventive device/the hybrid urethral stent system, which would be needed in order to meet the function/intended use. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 11, it is unclear what, if any, additional structural limitations this claim imparts on the final structure of the inventive device, i.e. the hybrid urethral stent system. The parameter set forth in the claim merely seems to be reciting intended use/functional language, however does not include any additional structure, for the inventive device/the hybrid urethral stent system, which would be needed in order to meet the function/intended use. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 12, which recites the limitations “the swan neck flexing feature”, on lines 1-2, and “the distal stem”, on line 2; there is insufficient antecedent basis for these limitations in the claim. Furthermore, it is unclear what exactly, structurally, is meant a “swan neck flexing feature” and/or how it relates to the final structure of the urethral stent system; and what structure is meant by “the distal stem”, is it the same structure as “the distal end”, as first set forth on line 2 of claim 1 from which claim 12 depends, or “the straight portion”, as first set forth on lines 10-11 of claim 1 from which claim 12 depends, or is it some other completely different structure, and if so then it is further unclear how it relates to the final structure of the urethral stent system. Moreover, it is further unclear how the distal stem would “traverse the external sphincter to promote bladder emptying”, when the 6th – 5th to last lines of claim 1, from which claim 12 depends, sets forth the parameter of “the straight stem configured to stent a male prostatic or female urethra and to be placed above the external sphincter without penetrating the sphincter during use” (emphasis added). Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 13, which recites the limitation “the system”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, and keep claim terminology consistent, it is suggested the above mentioned limitation be amended by adding the words “hybrid urethral stent” between the words “the” and “system”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 7, 11 and 12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 7, 11 and 12 all set forth parameters which positively recite portions of a human body as part of the invention, thereby going against section 33(a) of the America Invents Act, as mentioned above.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as currently elected claims 1-15, only the claimed structure of the final inventive device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final inventive device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) 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.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US PG Pub. 2018/0043135), hereinafter Chen, in view of Galloway (US Patent No. 4,738,667).
Regarding claims 1 and 4, Chen discloses a hybrid urethral stent system (102), illustrated in Figures 1A and 1B, comprising a stent having a stent body including a proximal end (120), a distal end, and an internal fluid passage/lumen (142) open (144) at the distal end, wherein the proximal end (120) terminates into a tapered/rounded tip and the distal end of the stent body comprising an extraction thread (126), wherein the stent body is flexible such that, upon application of an internal force, via for example a stylet, applied through the internal fluid passage/lumen to the proximal end (120), the stent body transforms into a first, straight orientation, illustrated in Figure 5, for insertion into a patient's urethra and bladder and, upon removal of the internal force/stylet, the stent body transforms into a thermoset second, coiled orientation, such that no sheath is required for placement of the stent ([0011], Lines 8-9; [0055]; [0057]; [0059]; [0078]; [0079] & [0091], Last 4 Lines); wherein in the second, coiled orientation, the stent body comprises a substantially straight portion (122) extending from the distal end towards the proximal end (120), the straight portion (122) transitions prior to the proximal end into a U-shaped neck element (U) and a right-angle bend (RB), wherein the U-shaped neck element and the right-angle element are configured to form a stabilizing elbow; the stabilizing elbow is configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back in proximity with a sphincter, the stabilizing elbow terminating into a straight stem/the straight portion (122) culminating in the distal end of the stent body, the straight stem/portion (122) configured to stent a male prostatic/female urethra and to be placed above the external sphincter (110) without penetrating the sphincter during use, illustrated in Figures 1A, 1B, 2B and modified figure 1B, below ([0011], Lines 1-3; [0013], Lines 1-3; [0016], Last 3 Lines; [0055], Lines 1-10; [0057], Lines 1-13; [0064] & [0084]); but does not teach the specific shape of the second, coiled orientation as set forth in the claim.
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However, Galloway teaches a hybrid urethral stent system, illustrated in Figures 1-4, comprising a stent body (10) including proximal and distal ends, wherein the stent body is flexible such that it transforms into a first straight orientation, for insertion into a patient's urethra and bladder, to a thermoset second, coiled orientation, wherein in the second, coiled orientation the stent body (10) comprises a substantially straight portion which transitions prior to the proximal end into a U-shaped neck element and a right-angle bend that further transitions into a coiled element that encircles the straight portion of the stent body below the U-shaped neck element by more than 360 degrees, wherein the coiled element is perpendicular to the straight portion and defines a first surface facing in a direction towards the distal end of the stent body and a second surface facing in a direction opposite the direction of the first surface, wherein the coiled element further comprises first, second and third sections, the first section of the coiled element extends from the right-angle bend around and away from the substantially straight portion of the stent body, wherein the second section of the coiled element extends around the substantially straight portion of the stent body from the first section of the coiled element to the third section of the coiled element, wherein the third section of the coiled element extends from the second section of the coiled element around and towards the substantially straight portion of the stent body, wherein the U-shaped neck element and the right-angle element are configured to form a stabilizing elbow, wherein the stent body comprises a first eyelet (20) in the second surface of the second section of the coiled element and a second eyelet (20) located along the stabilizing elbow, illustrated in Figures 1-3B (Column 2, Lines 55-66; Column 3, Lines 13-25, 36-41 & Column 4, Lines 9-22).
In view of the teachings of Galloway, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shape of the coiled portion, of the second coiled orientation of the hybrid urethral stent system of Chen, such that after the U-shaped neck element and right-angle bend it further transitions into a coiled element that encircles the straight portion of the stent body below the U-shaped neck element by more than 360 degrees, wherein the coiled element is perpendicular to the straight portion and defines a first surface facing in a direction towards the distal end of the stent body and a second surface facing in a direction opposite the direction of the first surface, wherein the coiled element further comprises first, second and third sections, the first section of the coiled element extends from the right-angle bend around and away from the substantially straight portion of the stent body, wherein the second section of the coiled element extends around the substantially straight portion of the stent body from the first section of the coiled element to the third section of the coiled element, wherein the third section of the coiled element extends from the second section of the coiled element around and towards the substantially straight portion of the stent body, wherein the U-shaped neck element and the right-angle element are configured to form a stabilizing elbow, wherein the stent body comprises a first eyelet in the second surface of the second section of the coiled element and a second eyelet located along the stabilizing elbow, as taught by Galloway; since both references teach art equivalent means for retaining a urethral stent within the bladder in order to aid in draining the bladder, and doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 2, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, Chen further teaches the stent system is configured with a non-seating stent body, illustrated in Figure 1A, and both Chen and Galloway teach a plurality of eyelets (804 in Chen & 20 in Galloway) to facilitate fluid flow both through and around the hybrid urethral stent, illustrated in Figure 8A of Chen (Chen: [0013], Lines 1-3 & [0084]) and Figures 1, 2A, 3A and 3B of Galloway (Galloway: Column 2, Lines 60-65 & Column 3, Lines 31-41).
Regarding claim 3, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, wherein Galloway further teaches the swan neck/coiled element portion and straight stem configured to stent the male prostatic/female urethra and is adapted to permit dual pathway intra-tubular and peri-tubular urine flow due to the eyelets (20), illustrated in Figures 1, 2A, 3A and 3B(Galloway: Column 2, Lines 60-65 & Column 3, Lines 31-41).
Regarding claims 5-8, Chen in view of Galloway disclose the hybrid urethral stent system of claim 3, and inasmuch as only the structure of the final device bears patentable weight, the hybrid urethral stent of Chen in view of Galloway disclose all the structural limitations of the final device as set forth in the claims, and would be capable of meeting the function/intended use of the peri-tubular urine flow configured to displace pathogenic microbes from the urinary tract, the dual pathway urine flow configured to produce a higher urine flow rate to flush microbial film and contaminants from the urinary tract, the dual pathway urine flow, along with retaining detrusor muscle function, and external and internal sphincter function is configured to reduce post void residual urine in the bladder, and the system is configured internally to protect the urinary tract mucosal barrier and eliminate the need for an external-collection component; and therefore, read on the claim.
Regarding claim 9, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, wherein Galloway teaches the second coiled orientation enabling drainage at the bladder base facilitates a complete bladder evacuation (Galloway: Column 3, Lines 36-41).
Regarding claims 10 and 11, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, and inasmuch as only the structure of the final device bears patentable weight, the hybrid urethral stent of Chen in view of Galloway disclose all the structural limitations of the final device as set forth in the claims, and would be capable of meeting the function/intended use of placement of the straight stem proximal to the external sphincter is configured to preserve volitional voiding and further comprising engaging a detrusor muscle contraction functionality and an internal and external sphincter functionality.
Regarding claim 12, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, wherein Chen further teaches the swan neck flexing feature allows the distal stem to traverse the external sphincter to promote bladder emptying in neurogenic and female patients in a state of urine retention, illustrated in Figure 2C (Chen: [0065] & [0066]).
Regarding claim 13, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, and though it is not specifically disclosed that the system is configured to accommodate a urethral length from approximately 1 centimeter to 30 centimeters, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate size/length, for the hybrid urethral stent system of Galloway in view of Chen, including being configured to accommodate a urethral length from approximately 1 centimeter to 30 centimeters, since this is a known range of length of a human urethra, and such a modification would merely involve a change in the size/length of the component/stent, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Regarding claim 14, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, wherein Chen further teaches the stent body is comprised of a biocompatible material, silicone, and/or an antimicrobial coating (Chen: [0011], Lines 4-7 & 12-14).
Regarding claim 15, Chen in view of Galloway disclose the hybrid urethral stent system of claim 1, wherein Chen further teaches the hybrid urethral stent is configured to deliver a pharmaceutical medication to enhance delivery of drugs into the bladder or body cavity (Chen: [0023], Last 3 Lines).
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 08/20/2026
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