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 a 3D blood vessel model (Group II – Claims 10-13 and 20) in the reply filed on August 29, 2025 is acknowledged. The traversal is on the grounds that “As all of the groups share a common search field, there is no undue burden on considering all of the groups” (Response to Restriction, Page 1). This is not found persuasive because the, “analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). See MPEP Chapter 1800, in particular MPEP § 1850, § 1875, and § 1893.03(d), for a detailed discussion of unity of invention under the Patent Cooperation Treaty (PCT)” (MPEP 823). According to PCT Rule 13, the international application (emphasis added), “shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”)” (PCT Rule 13.1). There is no search burden requirement.
The requirement is still deemed proper and is therefore made FINAL.
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.
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.
Claim 12 is 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.
Claim 12 contains the trademark/trade name, “TuskXC2700T by the company Materialize”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the material comprised within the polymeric skeleton and, accordingly, the identification/description is indefinite.
For the purposes of examination, the Examiner assumes the Applicant intended to claim the polymeric skeleton comprises a material that is compatible with stereolithography as this is the only descriptive element of the material provided in the disclosure that provides sufficient, non-relative structure to the claims (Instant Application, Specification, page 3, lines 5-23 and Instant Application, Specification, page 7, lines 18-21).
Claim 12 recites the limitation "the material commercialized under the denomination TuskXC2700T by the company Materialize" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 person shall be entitled to a patent unless –
(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.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 10-13 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kang [US 20190328935 A1].
Regarding claim 10 (Currently amended), Kang discloses:
A tridimensional blood vessel model (Kang, [0008], “In some preferred embodiments, the artificial tissue progenitor is an artificial lumen progenitor that can form an artificial lumen (e.g., an artificial blood vessel).”) comprising
a cavity (Kang, [0199], “As used herein, the term “lumen” refers to an organ that is tubular in shape and has a hollow cavity, such as, a circulatory lumen, digestive lumen, respiratory lumen, urinary lumen, or genital lumen…”),
wherein the tridimensional blood vessel model comprises
a polymeric skeleton (Kang, [0558], “In some preferred embodiments, the third component (tackifier) is selected from the group consisting of gelatin, block polymer F-127, agarose, polyethylene glycol, guar gum, polyvinyl alcohol, chitosan, collagen, hyaluronic acid, chitin, cellulose and a derivative thereof (such as hydroxypropyl cellulose), polyamino acid, poly N-isopropylacrylamide-polyethylene glycol block copolymer, polyethylene glycol copolymer (e.g., polyvinyl alcohol-polyethylene glycol copolymer), alginate (e.g., sodium alginate), a modified alginate (e.g., an oxidized alginate, such as oxidized sodium alginate), Matrigel, chitosan/sodium glycerophosphate series, and poly N-isopropylacrylamide (PNIPAAm) hydrogel.”) and
endothelial cells (Kang, [0144], “As shown in the figures, the artificial blood vessel and the normal blood vessel have a similar arrangement of cells, a similar layer of endothelial cells (as indicated by the thin arrow) and a similar layer of smooth muscle cells (as indicated by the thick arrow).”).
Regarding claim 11 (Currently amended), Kang discloses:
The tridimensional blood vessel model of claim 10, wherein the polymeric skeleton comprises a polymer (See citations above)
which is compatible with stereolithography (Kang, [0210], “In the present invention, bio-printing is preferably performed by a method that matches an automated or semi-automated, computer-assisted, three-dimensional prototype device (such as a bio-printer).”).
Regarding claim 12 (Currently amended), Kang discloses:
The tridimensional blood vessel model of claim 10, wherein the polymeric skeleton comprises the material commercialized under the denomination TuskXC2700T by the company Materialize (See citation above to see Kang discloses bio-printing).
Regarding claim 13 (Currently amended), Kang discloses:
The tridimensional blood vessel model of claim 10 further comprising connectors configured to enable and/or control fluid circulation into and out of the model (Kang, [0203], “In some embodiments, the lumen implant of the present invention comprises a plurality of tubular artificial tissue progenitors (or artificial lumens), and the tubular artificial tissue progenitors (or artificial lumens) is in fluid communication.”).
Regarding claim 20 (New), Kang discloses:
The tridimensional blood vessel model of claim 10, wherein the endothelial cells are at least one of human umbilical vein endothelial cells and smooth muscle cells (Kang, [0144], “As shown in the figures, the artificial blood vessel and the normal blood vessel have a similar arrangement of cells, a similar layer of endothelial cells (as indicated by the thin arrow) and a similar layer of smooth muscle cells (as indicated by the thick arrow).”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY JOSEPH POLLOCK whose telephone number is (703)756-5952. The examiner can normally be reached Monday-Friday 10:00am-8:00pm ET.
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715