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 filed January 14, 2025, fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statement (IDS) submitted on December 18, 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 9 are examined here-in.
Claim Objections
Claims 1 – 9 are objected to because of the following informalities:
In claim 2, the “A” of “polyglycolic acid” is capitalized.
In claim 2, polycyanoacrylate and polycaprolactone are misspelled as “polycynoacrylate” and “plycarprolaction”.
Several claims (including 2 – 6 and 8) use the abbreviation “ABD” although this abbreviation is not explicitly identified in claim 1. (The abbreviation is defined in paragraph 0024 of the instant specification.) Claims 1, 7, and 9 do not abbreviate artificial bile duct. The abbreviation should be set out in claim 1 for clarity, or otherwise not used in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 3 is rejected under 35 U.S.C. 112(b as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 recites the limitation "wherein the biocompatible polymer". There is insufficient antecedent basis for this limitation in the claim because it is unclear if the biocompatible polymer is the biodegradable polymer of an inner fibrous layer set out in claim 1, or the biodegradable polymer of an outer porous foam layer set out in claim 1, or both.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Buisson (Buisson, E.M. et al. “Transplantation of patient-specific bile duct bioengineered with chemically reprogrammed and microtopographically differentiated cells” Bioengineering and Translational Medicine, 2022, 7 (1), e10252 pages 1 – 14) in view of Callaghan (US 2013/0144322 A1).
Buisson teaches implantable artificial bile ducts with a fibrous inner layer and outer porous foam layer (abstract).
Buisson teaches the fibrous layer is polycaprolactone (abstract).
Buisson teaches the outer porous layer is polyurethane (page 11 column 2).
Buisson does not teach the artificial bile duct includes ursodeoxycholic acid.
Callaghan teaches the missing element of Buisson.
Callaghan teaches devices and methods to treat gallstone disease, including a device for insertion in the gallbladder interior (abstract).
Callaghan teaches including ursodeoxycholic acid with the device may aid in the chemical dissolution of existing gallstones and prevent the formation of future gallstones (paragraph 0139).
Claims 1 – 9 are prima facie obvious over the combination of Buisson and Callaghan as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to modify Buisson’s artificial bile duct to include ursodeoxycholic acid because Callaghan teaches ursodeoxycholic acid may aid in the chemical dissolution of existing gallstones and prevent the formation of future gallstones (paragraph 0139). The combination of Buisson and Callaghan’s teachings would be expected to yield predictable results, i.e. an artificial bile duct with ursodeoxycholic acid to help break down gallstones, which is prima facie obvious according to MPEP 2143(i)(a).
The combination of Buisson’s teaching for an implantable artificial bile duct with a fibrous inner layer and outer porous foam layer (abstract) and Callaghan’s teaching to include ursodeoxycholic acid with a gallbladder treatment device to aid in the dissolution of gallstones (paragraph 0139) reads on instant claim 1. The recitation “for improvement or treatment of biliary tract diseases” is an intended use limitation. Buisson and Callaghan both teach treatment of biliary tract diseases (Buisson teaches treatment of cholangiopathy, Callaghan teaches treatment of biliary cholic) and the combination of their teachings appears to be capable of meeting the intended use “for improvement or treatment of biliary tract diseases” because the artificial bile duct and ursodeoxycholic acid are both targeted to bile ducts.
Buisson’s teaching that the fibrous layer is polycaprolactone (abstract) reads on instant claim 2.
Buisson’s teaching that the outer porous layer is polyurethane (page 11 column 2) reads on instant claim 3.
Buisson teaches that the fibrous layer and porous layer are fused (Figure 2 panel B), reading on instant claim 4.
Instant claim 5 recites “The ABD of claim 1, wherein the inner fibrous layer is electrospun using needles with a diameter of 15 G or more”. The limitation that the fibrous layer of the artificial bile duct is produced via electrospinning is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps according to MPEP 2113.
Even though product-by-process claims are written as defined by the process, the 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 of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Buisson’s teaching for an artificial bile duct which includes a fibrous inner layer made of polycaprolactone (abstract) reads on the claimed artificial bile duct having a fibrous layer and a porous layer. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process of producing the fibrous layer by electrospinning is not patentable under 35 U.S.C. 103, in view of Buisson.
Buisson teaches hepatic progenitor cells reprogrammed with A83-01 and CHIR99021 are present in the artificial bile duct scaffold in the fibrous layer (abstract, page 2 column 1, page 3, page 6 column 1), reading on instant claim 6. Notably, the limitation of instant claim 6 “reprogrammed by a medium composition that comprises a hepatocyte growth factor, A83-01, and CHIR99021” appears to be a product-by-process limitation, which, as described above, even though product-by-process claims are written as defined by the process, the 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 of the prior art, the claim is unpatentable even though the prior product was made by a different process. Since Buisson teaches the inclusion of hepatic progenitor cells in the fibrous layer, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding the process of reprogramming by a medium composition that comprises a hepatocyte growth factor, A83-01, and CHIR99021 is not patentable under 35 U.S.C. 103, in view of Buisson.
As discussed above, Buisson teaches the artificial bile duct for the treatment of cholangiopathy (abstract), reading on instant claim 7.
Buisson teaches the artificial bile duct was manufactured by 3D printing water-soluble polyvinyl acetate, electrospinning polycaprolactone to produce the fibrous layer, dip-coating in polyurethane to produce the outer porous layer, immersing in a solvent to remove salt particles, then seeding differentiated cells in the fibrous layer of the artificial bile duct (page 11 column 2 to page 12 column 2), reading on instant claim 8. Although Buisson does not teach missing ursodeoxycholic acid with the biodegradable polymer for the fibrous inner layer, a person of ordinary skill in the art would be motivated to include ursodeoxycholic acid in the fibrous inner layer because Callaghan teaches the ursodeoxycholic acid aids in the breakdown of gallstones, therefore a person of ordinary skill in the art would recognize that ursodeoxycholic acid should be included in the portion that will be in contact with bile, i.e. the inner fibrous layer.
Buisson teaches in vivo transplantation of the artificial bile duct (Figure 7, page 12 column 2), reading on instant claim 9.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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