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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 17th, 2025 has been entered.
Claim Status
Claims 1 and 3-28 are currently pending. Claims 14 and 18-28 are withdrawn from consideration. Claim 2 remains cancelled. Claim 16 has been newly cancelled. Claim 1 has been amended. Claims 1, 3-13 and 15, and 17 remain under consideration herein.
Response to Arguments
The affidavit under 37 CFR 1.132 filed December 17th, 2025 is insufficient to overcome the rejection of claim 1 because:
The objective evidence of the nonobviousness is not commensurate in scope with the claims. The affidavit makes reference to a particular collagen utilized that has a particular tensile strength measured by its test results while the current scope of the claim only requires the biodegradable material to be made of collagen, without a particular type mentioned, and does not require a particular tensile strength, furthermore the tensile strength of collagen can vary depending upon the type and source from which the collagen is derived (see evidence of Hillas et al. (U.S. Publication 2006/0147501) below). Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716.
Furthermore in the present original disclosure of the application there does not appear to be sufficient disclosure such that one skilled in the art would have been able to make and use the invention in the way purported by the affidavit submitted on December 17th, 2025, as the original disclosure only describes that the biodegradable material be selected from either extracellular matrix-derived material or pure collagen ¶0008,¶0025, ¶0054; through degradation turns into soft, thin-film-shaped or thin-yarn-shaped collagen material, or that the hydrophilic material can be from a natural protein including collagen ¶0086. There is no disclosure present that would lead one of ordinary skill in the art to be able to make and use the invention such that it was made of a very particular type of collagen that has a particular tensile strength as purported by the affidavit and as such the affidavit. The experimental results submitted in the affidavit are all drawn toward a particular form of collagen having particular physically measured properties which as evidenced by Hillas, are not present in all forms of Collagen and are thus not described sufficiently by the original disclosure to allow one of ordinary skill in the art to make and use the invention in the way purported by the affidavit submitted on December 17th, 2025.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Regarding applicant’s argument pertaining to Cartledge failing to disclose the amended limitations of claim 1, examiner has withdrawn the 102 rejection previously submitted, however, in light of the teachings of Hixon (U.S. Publication 2008/0004578) as evidenced by Hillas et al. (U.S. Publication 2006/0147501) as detailed in the below 103 rejection of claim 1. The amended claim is considered to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding applicant’s argument that the dimension of 1.24 to 1.39 mm is directed to an outer diameter of a main tube formed by the polymer based scaffold and the sleeve, instead of a wall thickness of a main tube of a collagen-based stent and therefore fails to disclose any wall thickness falling within the claimed range, examiner disagrees with this statement in that Cartledge discloses the sleeve having a thickness of 50-200 micrometers which is within the 10 micrometer to 3.3 mm range stated in the claim limitations and as the sleeve makes up the wall of the device, this measurement is covered by Cartledge, furthermore Cartledge also discloses the monofilament for making the support structure 10 being 250 micrometers to 300 micrometers ¶0227 which if included alone or with the 50-200 micrometer sleeve thickness still presents a thickness within the 10 micrometer to 3.3 mm range stated in the claim limitation. As such this argument is not found to be persuasive.
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, 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).
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 24 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 26 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 a wall of the main tube being 10 μm to 3.3 mm in thickness (¶0228 coiled scaffold has 0.047” diameter equivalent to 1.19 mm with the sleeve having a thickness of 50-200 micrometers ¶0133 coming to a total of 1.24-1.39mm).
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.
Regarding claim 12, Cartledge in view of Hixon and Hillas 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 Hillas 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 Hillas 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 Hillas 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) 1, 3, 5-6, 8, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong (U.S. Patent No. 6,368,356) in view of Hixon (U.S. Publication 2008/0004578) as evidenced by Hillas et al. (U.S. Publication 2006/0147501).
Regarding claim 1, Zhong discloses 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 having a wall with a thickness (Col. 12 lines 1-6).
Zhong does not expressly disclose the biodegradable material consisting essentially of collagen derived from an organism
However, Hixon, in the same field of endeavor of biodegradable urinary stents ¶0005, teaches utilizing a biodegradable collagen as the main body material and the barrier material (¶0028 the elongate body may be formed from any material or materials known in the art…For example…collagen; ¶0034 Barrier formed of any suitable polymer material…for example, with a collagen based gelatin).
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 Zhong 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 Zhong 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; and also describes the crosslinking ability of collagen ¶0026.
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 Zhong, and is inherently capable of ionic and covalent crosslinks as required by Zhong (Col. 3 lines 32-45).
Regarding the wall of the main tube being 10 micrometers to 3.3 mm in thickness, Zhong does not expressly disclose the wall having this thickness, however, Zhong and Hixon both discloses modifying/selecting the thickness of the walls in order to change the rate at which the walls dissolve or degrade (Zhong Col. 12 lines 1-6; Hixon ¶0048 barrier can have various thicknesses which will alter the rate of absorption or degradation of the barrier) and adjusting this degradation rate depending on particular patient physiology and the desired length of time for the device to remain in the patient’s body (¶0048 of Hixon).
It would have been obvious to one of ordinary skill in the art before the effective filing date for the thickness of the wall to be 10 micrometers to 3.3 mm in thickness since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation and is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Zhong and Hixon disclose the necessity to optimize the degradation rate of the device through the thickness of its walls the purpose of ensuring that the device remains implanted in the patient for the necessary duration of time and to account for patient parameter differences such as pH of urine.
Regarding claim 3, Zhong in view of Hixon and Hillas suggest the biodegradable double-J stent of claim 1. Zhong further discloses 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), and the second retaining tube featuring a second degradation rate (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).
Regarding claim 5, Zhong in view of Hixon and Hillas suggest the biodegradable double-J stent of claim 3. Zhong further discloses the first degradation rate being slower than the second degradation rate (Col. 21 lines 4-9 segment 20 represents a material having a slower rate of dissolution, dissolution shows degradability).
Regarding claims 6, 8, and 10, Zhong in view of Hixon and Hillas suggest the biodegradable double-J stent of claim 1. Zhong further discloses (Claim 10) 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.
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 claim 12, Zhong in view of Hixon and Hillas suggest the biodegradable double-J stent of claim 1. Zhong further discloses (Col. 14 lines 16-25) the main tube, the first retaining tube, and the second retaining tube being integrally formed (Col. 14 lines 16-25, shaped by extrusion, molding, compression, Col 15 lines 41-48 pigtails formed using sufficient covalent crosslinking, pigtails formed from same piece as main tube).
Claim(s) 4, 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong (U.S. Patent No. 6,368,356) 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 Cartledge et al. (U.S. Publication 2022/0071756) .
Regarding claim 4, Zhong in view of Hixon and Hillas suggest the biodegradable double-J stent of claim 1. Zhong discloses the pigtail ends being composed of segments made of a material 18 having a faster rate of dissolution and a material having a slower rate of dissolution 18, but does not expressly disclose or teach the degradation rate of the main tube or first retaining tube being faster than the degradation rate of the second retaining tube.
However, Cartledge, in the same field of endeavor of coatings of biodegradable urinary stents, teaches a proximal end of a tube inserted into the kidney being modified such that it degrades more slowly in vivo than a distal end of the tube for the purpose of achieving a preferential degradation at one end of the implant compared to the other end ¶0013.
It would have been obvious to one of ordinary skill in the art to have modified the device of Zhong to have the degradation of the main tube or first retaining tube to be faster than the degradation rate of the second retaining tube, as taught by Cartledge, for the purpose of achieving a preferential degradation at one end of the implant compared to the opposite end (¶0013 of Cartledge).
Regarding claims 7, 9, and 11, Zhong in view of Cartledge suggest the biodegradable double-J stent of claims 6, 8, and 10. Zhong does not expressly disclose 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 disclosed 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
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