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 .
Information Disclosure Statement
The information disclosure statement(s) (IDSs) submitted on 2/15/24 and 12/8/25 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-18 are pending in the application, with claims 1-12 under consideration and claims 13-18 withdrawn.
Election/Restriction Applicant's election without traverse of claims 1-12 in the 5/29/26 Restriction Response is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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 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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-12 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by KR 10-2022-0085413 (KR ‘413) (Cited to attached WIPO English Translation).
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As to claim 1, KR‘413 teaches an anti-reflux ureteral stent 100 (Fig.4-7; [0058]-[0068] ), comprising:
a hollow tube-shaped stent body 110 (main body 110; Fig.4-7; [0061]; [0042]-[0044]) [configured to be] inserted into ureter to guide urine from kidneys to bladder and provided with a flow path for flow of the urine thereinside (Fig.1-3; [0043]); and
an extratube backflow prevention mechanism 220 (expansion member 220; Fig.4-7;[0058]-[0065]) provided in an umbrella shape (Fig.7b), made of a flexible material (material having good elasticity; [0047]) on an outer side surface of the stent body 110 (Fig.7a-b) to be unfolded (Fig.7b) or folded (Fig.7a) along a flow direction of the urine and configured to prevent backflow of the urine while being unfolded by flow pressure of the urine when the urine backflows along an extratube gap formed between the stent body 110 and the ureter (Fig.7a and 7b; [0059]-[0062]),
wherein the extratube backflow prevention mechanism 220 is formed in a star-shaped cross-section (Fig.6-7) with a plurality of vertices 222 (Fig.7a,b; [0060]) centered on the stent body 110 (Fig.7a-b) and provided with a star-shaped cross section (Fig.6,7a,b) that expands toward the bladder along a longitudinal direction of the stent body 110 (as expanding as shown between Fig.7a and Fig.7b; [0058]-[0062] ;[0073]-[0074]).
As to claim 2, KR’413 teaches wherein the size of the star-shaped cross section of the extratube backflow prevention mechanism 220 is reduced while urine passages for passing the urine are formed between the vertices of the star-shaped cross section as spaces between the vertices of the star-shaped cross section are folded into a furrow shape when a flow direction of the urine is a forward direction (Fig.7a,b;[0059]-[0062];[0073]-[0074]), and increases while the urine passages formed between the vertices of the star-shaped cross section are removed as spaces between the vertices of the starshaped cross section expand and spread when a flow direction of the urine is a reverse direction (Fig.7a,b;[0059]-[0062];[0073]-[0074]).
As to claim 3, KR’413 teaches wherein the extratube backflow prevention mechanism 220 comprises:
a fixation member 221 (second coupling portion 221; Fig.7a,b; [0058]-[0059]) fixed to an outer side surface of the stent body 110 (Fig.7a,b; [0059],ll.1-2);
a plurality of support beam members 222a (folding portions 222a) configured to expand long from the fixation member 221 to the bladder to form the vertices of the star-shaped cross section (Fig.7a,b) of the stent body 110 (Fig.7a,b) and formed in an inclined structure far away from the stent body 110 as approaching the bladder (Fig.7b; [0060],ll.1-2); and a plurality of canopy members 222b respectively provided between the support beam members 222a to shield spaces between the support beam members 222a (canopy as forming inflow space 22b between folding portions/support beam members 222a Fig.7b for urine backflow; [0059],ll.4-6).
As to claim 5, KR’413 teaches wherein the extratube backflow prevention mechanism 120/220 is integrally formed with the stent body 110, and the fixation member 121/221 is connected to the outer side surface of the stent body 110 in an integrated structure (Fig.7a,b; [0049]).
As to claim 6, KR’413 teaches wherein the support beam members 222a are arranged to be spaced apart from each other at regular intervals along a perimeter of the fixation member 221 and formed to be thicker than the canopy member 222b to stably support the canopy members 222b (Fig.7a,b), and the canopy members 222b are folded in a furrow shape (Fig.7a) toward the stent body 110 according to flow pressure of the urine when a flow direction of the urine is a forward direction, and unfolded while expanding (Fig.7b) in an opposite direction of the stent body 110 according to flow pressure of the urine when the flow direction of the urine is a reverse direction ([0058]-[0062]).
As to claim 7, KR’413 teaches wherein the support beam members 222a and the canopy members 222b are formed in a funnel structure (Fig.7a,,b) expanding along a longitudinal direction of the stent body 110 toward the bladder side to form a urine inlet (Fig.7), into which the urine is introduced when the urine flows back, in an always open state (Fig.7a,b; [0058]-[0062]).
As to claim 8, KR’413 teaches wherein five support beam members 222a (Fig.7b,9) are provided to radially extend from the fixation member 221 (Fig.7b), and the canopy members 222b are respectively disposed between the support beam members 222a and provided in a shape convexly curved toward the stent body 110 such that they can be folded toward the outer side surface of the stent body 110 (Fig.7b; [0059]-[0062].
As to claim 9, KR’413 teaches wherein a bladder-side end of the stent body 110 is disposed inside one end of the ureter connected to the bladder 30, and a kidney-side 20 end of the stent body is disposed inside another end of the ureter connected to the kidneys (Fig.2), and at least one extratube backflow prevention mechanism 120/220 is disposed on the bladder-side end of the stent body 100/200 (Fig.2).
As to claim 10, KR’413 teaches wherein a single extratube backflow prevention mechanism 120/220 is disposed at a part connected to the bladder in the bladder-side end of the stent body 10/110 (Fig.2).
As to claim 11, wherein the extratube backflow prevention mechanism is manufactured in an integrated structure through a casting process using a mold and a die, and the mold and the die are manufactured through a 3D printing process [where the method of making a device is not considered for patentabillity]. See MPEP 2113(I).
As to claim 12, wherein a cavity is formed inside the mold and the die in a shape corresponding to the extratube backflow prevention mechanism, and a fine concavo-convex pattern corresponding to a stacking pattern of filaments is formed on a surface of the cavity in a process of manufacturing the mold and the die through a 3D printing process, and a roughness pattern corresponding to the fine concavo-convex pattern is formed on a surface of the extratube backflow prevention mechanism in a casting process using the mold and the die [where the method of making a device is not considered for patentabillity]. See MPEP 2113(I).
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 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 of this title, 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(a) 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 under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over KR’413.
As to claim 4, KR’413 teaches wherein the extratube backflow prevention mechanism 220 is detachably mounted on an outer side surface of the stent body 110 (Fig.7a,b), and the fixation member 221 is formed in a tubular shape surrounding the outer side surface of the stent body 110 (Fig.7a,b). KR’413 does not teach an installation groove for inserting and mounting the fixation member is provided in a recessed structure along a perimeter of the outer side surface of the stent body. However, it would have been obvious to one of skill before the effective filing date to provide the recited installation groove and recess, and one of skill would have been motivated to do so, where such a feature would be an obvious design choice to facilitate mounting of the fixation member to provide the detachable mounting of the backflow mechanism to the stent body as taught by KR’413. Additionally, to the degree that claim 4 reads on how the device is made, methods of making are not considered for patentability of device claims. See MPEP 2113(I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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