DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, 3-13, 17-18, and 23-28 are currently pending. Claims 18 and 23-28 are withdrawn from consideration. Claim 2 and 16 remains cancelled. Claims 14-15 and 19-22 have been newly cancelled. Claims 1, 13, 18, and 23 have been amended. Claims 1, 3-13, and 17 remain under consideration herein.
Response to Arguments
Applicant’s arguments filed March 20th, 2026 have been fully considered but they are not persuasive..
Regarding applicant’s argument pertaining to Cartledge failing to disclose the amended limitations of claim 1, examiner agrees that the amended claim limitations have overcome the previously presented rejection of claim 1,, however, in light of the teachings of Francis et al. (U.S. Publication 2020/0246505) the newly presented limitations of the screw rod formed by winding of a slender plate of the biodegradable material around itself would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
Claim(s) 1, 3-4, 12, 13, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (U.S. Publication 2022/0071756) in view of Hixon (U.S. Publication 2008/0004578) as evidenced by Hillas et al. (U.S. Publication 2006/0147501) and further in view of Francis et al. (U.S. Publication 2020/0246505).
Regarding claim 1, Cartledge discloses a biodegradable double-J stent (Fig. 5), comprising:
a main tube (portion between curled elements 24 and 26) made of a biodegradable material (¶0086 bioabsorbable medical device optionally prepared from biodegradable polyester) with biocompatibility (designed to be used in-vivo and thus biocompatible) and having a first end portion (where end of main tube meets curled element 24) and a second end portion (where end of main tube meets curled element 26) opposing the first end portion (opposing ends of main tube);
a first retaining tube 26 made of the biodegradable material (¶0086 made of biodegradable polyester) curled (¶0052 curled), and connected to the first end portion of the main tube; and
a second retaining tube 24 made of the biodegradable material (¶0086 made of biodegradable polyester), curled (¶0052 curled), and connected to the second end portion of the main tube,
wherein the biodegradable material comprises collagen (¶0135 materials may be added to the polymer composition…such materials include…collagen) wherein the main tube comprises a helical structure (Fig. 5 shows helical structure, ¶0159 helically wound comprising helical body curling and winding along an axis) formed by a rod (tubular structure forming helical winds as seen in Fig. 5, ¶0173 braided monofilament scaffold) winding along a longitudinal axis (Fig. 5 axis through center of helical winds of body 20).
While Cartledge does not expressly disclose the collagen being “derived from an organism”, collagen would necessarily be derived from an organism as it is a protein naturally synthesized by biological organisms and is currently not known in the art to be synthetically synthesized.
Furthermore, the claimed phrase of “derived from an organism” is being treated as a product by process limitation as a material that results from an organism. As set forth in MPEP 2113, “Even 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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of being derived from an organism imparts structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “derived from an organism” is being given very little patentable weight.
Cartledge does not expressly disclose the biodegradable material consisting essentially of collagen.
However, Hixon, in the same field of endeavor of biodegradable urinary stents ¶0005, teaches utilizing a biodegradable collagen as the main body material (¶0028 the elongate body may be formed from any material or materials known in the art…For example…collagen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the biodegradable base material of Cartledge that performs the function of providing a biodegradable material for the biodegradable collagen of Hixon since these elements perform the same function of allowing a device to degrade in situ. Simply substituting one biodegrading material means for another would yield the predictable result of allowing a(n) stent to degrade once placed in the patient. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the biodegradable material of Cartledge out of collagen, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The suitability of collagen as a base biodegradable material for stents is evidenced by the disclosure of Hillas, in the same field of endeavor of collagen containing biomaterials for use in biomedical applications (Title and ¶0003), which describes the ability to select the type of collagen used based on its collagenase resistance (¶0046), which would affect its biodegradation rate, as well as its surface area ¶0068, pore size ¶0070, and tensile strength ¶0073.
This teaching of Hillas along with the teaching of Hixon stating that making the body of urethral stents out of collagen was known before the effective filing date of the claims invention, shows that one of ordinary skill in the art would have found collagen to be a suitable material for the biodegradable material of Cartledge, as the rate at which the collagen material degrades can be selected based on the collagen type utilized which would allow for the difference in degradation profiles presented in Cartledge.
Cartledge in view of Hixon and Hillas do not expressly disclose or suggest the helical structure being formed by a screw rod winding along a longitudinal axis, the biodegradable material being formed as a slender plate, and the screw rod being formed by winding the slender plate around itself. While Cartledge does disclose the helical structure being formed of from braided filaments (¶0173 braided monofilament scaffold) there is no clear disclosure by Cartledge or Hixon as to what the structure of the collagen material itself is present.
However, Francis, in the same field of endeavor of collagen based structures for implantation (Abstract biopolymer fiber containing collagen, implantable), discloses a method of forming (Fig. 14) collagen filaments 1402, having a slender plate structure (Fig. 22 element 2206, ¶0306 uniform and thin ribbon-like structures) and extruding then twisting microfibers to form a screw rod structured filament 1405.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the collagen material of Cartledge in view of Hixon to have modified the rod as disclosed by Cartledge in view of Hixon to have been a screw rod formed of slender plate collagen that is wound around itself, as taught by Francis, for the purpose of providing the collagen fibers in a form factor that is easier to work with than a single fiber (¶0136 of Francis) and increasing the tensile properties of the collagen (¶0309 increased tensile properties of all the extruded ribbon-like collagen microfibers) which would provide the benefit of allowing the device to withstand greater tension during use.
Regarding claims 3 and 4, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 1. Cartledge further discloses the first retaining tube featuring a first degradation rate that is faster than a second degradation rate featured by the second retaining tube (¶0013 proximal end of the stent, which is the end that is inserted into the kidney of the host, has a coating, or additional coating, not present on the distal end of the implant. The proximal end degrades more slowly in vivo than does the distal end of the stent) and therefore the first and second degradation rates being different from each other).
Regarding claim 12, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 1. Cartledge further discloses the main tube, the first retaining tube, and the second retaining tube being integrally formed (Fig. 5 shows single piece construction).
Regarding claim 13, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 12. Cartledge further discloses the main tube, the first retaining tube, and the second retaining tube each having a helical structure (Fig. 5 shows helical structure, ¶0159 helically wound comprising helical body curling and winding along an axis, and the helical structure comprises a plurality of helical circles spaced apart from each other by a pitch of 0 mm to 2.5 mm (¶00228 wrapped around cord at 33 to 35 coils per inch equivalent to 0.7257 coils - 0.769 coils per mm equivalent to 1 coil per 1.30 mm – 1.377 mm, with a 0.047” diameter which is equivalent to 1.1938 millimeters this would leave 0.703 mm – 0.780 mm spacing between each coil or 703 – 780 um which is between the required 0 mm to 2.5mm range).
Regarding claim 15, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 13. Cartledge further discloses the helical body being a screw rod (¶0159 braided and helically wound).
Regarding claim 17, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 1. Cartledge further discloses the main tube having an outer diameter of 1.050 – 4.200 mm (¶0133 sleeve ranges from 1 to 4mm inner diameter with 50-200 micrometer thickness).
Cartledge does not expressly disclose the main tube having an outer diameter of 0.33 mm to 3.33 mm however, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer diameter of Cartledge from between 1.050 mm and 4.200 mm to 0.33 mm to 3.33 mm as applicant appears to have placed no criticality on the claimed range (¶0063 dimensions of the wall thickness and outer diameter of the main tube are subject to changes as needed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Cartledge would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the outer diameter is adjustable within the range of 0.33 mm to 3.33mm and the dimensions of the wall thickness and outer diameter of the main tube are subject to changes as needed.
Claim(s) 3, 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (U.S. Publication 2022/0071756) in view of Hixon (U.S. Publication 2008/0004578) as evidenced by Hillas et al. (U.S. Publication 2006/0147501) and further in view of Francis et al. (U.S. Publication 2020/0246505), as applied in the rejection of claim 1 above, and further in view of Zhong (U.S. Patent No. 6,368,356).
Regarding claims 3 and 5, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 1. Cartledge further discloses different portions of the device having different degradation rates (¶0016 protective coating may be applied to selected regions to mitigate the rate of coil degradation) and thus discloses first and second degradation rates, but does not expressly disclose or suggest the main tube and/or the first retaining tube featuring a first degradation rate, and the second retaining tube featuring a second degradation rate.
However, Zhong in the same field of endeavor of biodegradable double-J stents (Fig. 2), teaches
a biodegradable double-J stent (Fig. 2), comprising:
a main tube 12 made of a biodegradable material (20, Col. 4 lines 22-30 cross linkable polymers; Col. 12 lines 58-68 biodegrade; Col. 21 lines 4-9 segment 20 represents a material having a slower rate of dissolution, dissolution shows degradability) with biocompatibility (Col. 2 lines 49-51 biological compatibility) and having a first end portion (where end of 12 meets element 16) and a second end portion (where end of 12 meets element 17) opposing the first end portion (opposing ends of longitudinal axis of 12);
a first retaining tube 16 made of the biodegradable material (18, Col. 4 lines 22-30 cross linkable polymers; Col. 12 lines 58-68 biodegrade; Col. 21 lines 4-9 segment 20 represents a material having a faster rate of dissolution, dissolution shows degradability) curled (pigtail), and connected to the first end portion of the main tube; and
a second retaining tube 17 made of the biodegradable material (18, Col. 4 lines 22-30 cross linkable polymers; Col. 12 lines 58-68 biodegrade; Col. 21 lines 4-9 segment 20 represents a material having a faster rate of dissolution, dissolution shows degradability), curled (pigtail), and connected to the second end portion of the main tube.
the main tube featuring a first degradation rate (Col. 21 lines 4-9 segment 20 represents a material having a slower rate of dissolution, dissolution shows degradability) that is slower (Claim 5) than a second degradation rate of the second retaining tube (Col. 21 lines 4-9 segment 20 represents a material having a faster rate of dissolution, dissolution shows degradability), with the first and second degradation rates being different from each other (faster and slower) for the purpose of allowing migration of the device from the ureter and into the bladder (Col. 11 lines 64-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the position of the different degradation profiles disclosed by Cartledge such that the retaining features had a degradation rate different from the main body degradation rate for the purpose of allowing migration of the device from the ureter and into the bladder as taught by Zhong (Col. 11 lines 64-68).
Regarding claims 6, 8, and 10, Cartledge in view of Hixon and further in view of Francis suggest the biodegradable double-J stent of claim 1. Cartledge further suggest a coating that has variation of hydrophilicity (¶0144), but does not expressly disclose:
a lubrication layer made of a biocompatible, hydrophilic material or having a surface hydrophilically modified, wherein the lubrication layer is coated on:
The main tube, the first retaining tube, and the second retaining tube, or
The main tube and the first retaining tube;
a contrast agent layer made of a biocompatible radiopaque material, wherein the contrast agent layer is coated on:
The main tube, the first retaining tube, and the second retaining tube, or
The main tube and the first retaining tube;
Or a contrast agent and lubrication combo layer made of a mixture of a biocompatible radiopaque material and a biocompatible, hydrophilic material, wherein the contrast agent and lubrication combo layer is coated on:
The main tube, the first retaining tube, and the second retaining tube, or
The main tube and the first retaining tube;
However, Zhong in the same field of endeavor of biodegradable double-J stents (Fig. 2), teaches a contrast agent and lubrication combo layer (Col. 12 lines 6-24 sheet provided as coating for an underlying medical device, Col. 4 lines 58-67 radiopaque fillers blended into cross linkable polymer, Col. 4 lines 31-57 hyaluronic acid as lubricant) made of a mixture of a biocompatible radiopaque material (Col. 4 lines 58-67 radiopaque fillers blended into cross linkable polymer) and a biocompatible, hydrophilic material, (Col. 4 lines 31-57 hyaluronic acid as cross linkable polymer) wherein the contrast agent and lubrication combo layer is coated on the main tube, the first retaining tube, and the second retaining tube (coats underlying medical device) [This layer therefore discloses both a lubrication layer and a contrast layer as required in limitations of Claims 6 and 8] for the purpose of decreasing tendency to induce thrombosis, encrustation, and inflammation (Col. 1 lines 65-67) as well as enhancing the radiopacity (Col. 4 lines 58-63) which would allow the implant to be better visualized by imaging technology when implanted into the patient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device suggested by Cartledge in view of Hixon and further in view of Francis, to have included the combination coating as taught by Zhong for the purpose of decreasing tendency to induce thrombosis, encrustation, and inflammation (Col. 1 lines 65-67) as well as enhancing the radiopacity (Col. 4 lines 58-63) which would allow the implant to be better visualized by imaging technology when implanted into the patient.
Examiner notes that while Zhong doesn’t expressly state the limitation of “lubrication”, the limitation of “lubrication” is considered functional language (based on Paragraph 0081-0083 of Applicant’s specification indicating this term is used to denote the reduction in friction of the device through the use of a hydrophilic material). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Cartledge discloses all the structure as claimed, and is made of a material comprising hyaluronic acid, a hydrophilic material. As such, it is capable of performing the functions as claimed (i.e., the hyaluronic acid functions as a hydrophilic material that reduces friction of the device).
Regarding claims 7, 9, and 11, Cartledge in view of Hixon and further in view of Francis and Zhong suggest the biodegradable double-J stent of claims 6, 8, and 10. Zhong does not expressly suggest the coating layer being 1 μm to 0.66 mm in thickness.
However, Cartledge, in the same field of endeavor of coatings of biodegradable urinary stents, teaches a coating with a thickness of 50 to 200 μm ¶0133 and that thickness of the coating influences the rate of biodegradation ¶0094.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating taught by Zhong to have been a thickness of 50 to 200 μm as taught by Cartledge for the purpose of influencing the rate of biodegradation of the device (¶0094 of Cartledge).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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