DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-5, 11-12, 18, 24-25, 27-29, 31, 37-38, 45-47, and 50 are pending and represent all claims currently under consideration.
Priority
This application is a 371 of PCT/US2022/047764, which claims priority to PRO 63/346,660 and PRO 63/271,662.
Claims 1, 4, 24-25, 27-29, 31, 37-38, and 45-47 are considered to have an effective filing date of 10/25/2021.
Claims 2-3, 5, 11-12, 18, and 50 are considered to have an effective filing date of 05/27/2022.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/271,662, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Regarding claim 2, there is no support for the population of cells being engrafted and vascularized in the subject.
Regarding claim 3, there is no support for the population of cells comprising induced pluripotent cell (iPSC)-derived cells, embryonic stem cell-derived cells, or engineered cells.
Regarding claim 5, there is no support for engineered cells engineered to express or secrete a protein.
Regarding claim 11, there is no support for the engineered tissue construct to be layered on the dome of the liver, and/or covered with omentum.
Regarding claim 12, there is no support for the muscle site being on a surface of a muscle, within a muscle sheath, or beneath a muscle.
Regarding claim 18, there is no support for the construct being implanted subcutaneously with an omental flap, subcutaneously with an adjuvant, or subcutaneously with an arteriovenous fistula.
Regarding claim 50, there is no support for implantation using an open surgical procedure or a minimally invasive surgery.
Information Disclosure Statement
The information disclosure statement filed 11/26/2024 has been considered. Citation numbers T*, U*, V*, W*, and X* were not considered, because each does not include a filing date as required. See MPEP § 1.98.
Claim Objections
Claim 1 is objected to because of the following informalities: “the liver”, “the pancreas”, “the spleen”, and “the kidney” should read “a liver”, “a pancreas”, “a spleen”, and “a kidney”, respectively. Appropriate correction is required.
Specification
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The use of the terms Sigma and RECOTHROM, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to because the terms FIBRYGA in Figure 26 and Rotea in Figure 39 are trade names and should include a proper symbol as indicated above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 11, 24-25, 27, 31, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, and 13-15 of copending Application No. 18/646,092 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the reference teaches a method comprising implanting an engineered tissue construct comprising a population of hepatocytes and a population of stromal cells (i.e., mammalian cells) in a human subject (reference, claim 1), wherein the construct includes a biocompatible hydrogel scaffold (reference, claim 13), and wherein the implantation site is selected from a group comprising an extraperitoneal site, an extrapleural site, a site on the surface of the liver, and muscles (reference, claim 15).
Regarding claim 3, the reference teaches the hepatocytes are primary human hepatocytes (i.e., primary cells; reference, claim 6).
Regarding claim 11, the reference teaches the engineered tissue construct is implanted into the subject at a site on the surface of the liver (reference, claim 15).
Regarding claim 24, as above the reference teaches a population of hepatocytes and a population of stromal cells (reference, claim 1).
Regarding claim 25, as above the reference teaches the hepatocytes are primary human hepatocytes (i.e., primary cells; reference, claim 6). The reference further teaches the stromal cells are fibroblasts (reference, claim 7).
Regarding claim 27, the reference teaches the fibroblasts are selected from the group consisting of normal human dermal fibroblasts and neonatal foreskin fibroblasts (reference, claim 8).
Regarding claim 31, the reference teaches the biocompatible scaffold comprises fibrin (reference, claim 14).
Regarding claim 47, the reference teaches the method for treating acute liver failure (reference, claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 nonobviousness.
Claims 1-5, 11-12, 18, 24-25, 27-29, 31, 37-38, 45-47, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO 2021150837 A1; IDS reference, 11/26/2024).
Regarding claim 1, Chen teaches a method of treating liver failure in a subject comprising implanting an engineered tissue construct into the subject (Chen, claim 80), wherein the engineered tissue construct comprises one or more mammalian cell populations (Chen, claim 1) and a biocompatible scaffold (Chen, page 169, embodiment 100). Chen teaches the subject can be a human (Chen, page 126, 3rd paragraph), and teaches implantation at the intraperitoneal space (i.e., a peritoneal site; Chen, page 139, 6th paragraph).
Chen is considered to be analogous to the claimed invention, because both Chen and the instant invention are in the field of methods for treating liver disease with engineered tissue constructs. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Chen under the meaning of 35 U.S.C. 103.
Regarding claim 2, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the engineered tissue constructs are vascularized (Chen, page 24, 3rd paragraph) and further teaches implantation can lead to engraftment (Chen, page 73, 2nd paragraph).
Regarding claim 3, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the cells can be primary cells, embryonic stem cells (Chen, page 55), engineered cells (Chen, page 29, 2nd paragraph), or cell aggregates (Chen, page 71, “(i)”).
Regarding claim 4, Chen teaches all the elements of the current invention as applied to claim 3. Chen teaches engineered tissue constructs consisting of human lung fibroblasts were cultured for 7 days in vitro (i.e., expanded in vitro; Chen, page 161, example 9).
Regarding claim 5, Chen teaches all the elements of the current invention as applied to claim 3. Chen teaches the engineered tissue construct comprises at least one cell population engineered to express a gene (Chen, page 133, 1st paragraph), and exemplifies the expression of caspase 9 (i.e., a protein; Chen, page 23, 2nd paragraph).
Regarding claim 11, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the engineered tissue construct is placed onto fat pads in the abdomen (Chen, page 126, 3rd paragraph), and further teaches the construct is used to treat liver tissue (Chen, page 129, 3rd paragraph). Therefore, it would be reasonable for one of ordinary skill in the art to implant the construct onto a fat pad of the liver (i.e., onto the surface of the liver).
Regarding claim 12, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the engineered tissue construct can be placed in the intramuscular space (i.e., beneath the muscle; Chen, page 126, 3rd paragraph).
Regarding claim 18, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the engineered tissue construct can be placed in the subcutaneous space (Chen, page 126, 3rd paragraph). Chen further teaches the constructs can have an engineered material to aid in spatially guiding the direction of host cell and tissue invasion (i.e., an adjuvant; Chen, page 128, 3rd paragraph). Therefore, it would be prima facie obvious to one of ordinary skill in the art to implant the construct subcutaneously with an adjuvant.
Regarding claim 24, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches one or more cell populations which can comprise a population of hepatocytes (Chen, claim 66) and a population of stromal cells (Chen, claim 67).
Regarding claim 25, Chen teaches all the elements of the current invention as applied to claim 24. Chen teaches some embodiments comprise human primary hepatocytes and fibroblasts (Chan, page 55, 2nd paragraph).
Regarding claim 27, Chen teaches all the elements of the current invention as applied to claim 25. Chen teaches some embodiments comprise normal human dermal fibroblasts (Chen, page 58, 2nd paragraph).
Regarding claim 28, Chen teaches all the elements of the current invention as applied to claim 24. Chen teaches an engineered tissue construct further comprising a population of endothelial cells (Chen, page 169, embodiment 98).
Regarding claim 29, Chen teaches all the elements of the current invention as applied to claim 28. As above, Chen teaches an engineered tissue construct further comprising a population of endothelial cells (Chen, page 169, embodiment 98). Chen further teaches the cells can be pre-organized into cords (Chen, page 73, 3rd paragraph).
Regarding claim 31, Chen teaches all the elements of the current invention as applied to claim 1. As above, Chen teaches the engineered tissue construct comprises a biocompatible scaffold (Chen, page 169, embodiment 100). Chen further teaches the naturally-derived scaffolding can be fibrin (Chen, page 74, 5th paragraph).
Regarding claim 37, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the scaffold is degradable (i.e., resorbable) upon exposure to environmental conditions (Chen, page 64, 2nd paragraph).
Regarding claim 38, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the biocompatible scaffold can be a hydrogel (Chen, page 141, 3rd paragraph), and teaches the hydrogel can be fiber-reinforced (i.e., fiber is a reinforcing agent; Chen, page 64, 4th paragraph).
Regarding claim 45, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches the engineered tissue construct can be used in conjugation with various types of engineered tissue constructs (i.e., a plurality; Chen, page 128, 2nd paragraph).
Regarding claim 46, Chen teaches all the elements of the current invention as applied to claim 45. As above, Chen teaches the engineered tissue construct can be used in conjugation with various types of engineered tissue constructs (i.e., a plurality; Chen, page 128, 2nd paragraph). Chen further teaches the construct can be used to repair various tissues (i.e., different sites; Chen, page 129, 3rd paragraph).
Regarding claim 50, Chen teaches all the elements of the current invention as applied to claim 1. Chen teaches constructs are implanted by suturing (Chen, page 126, 3rd paragraph), which according to the instant specification (page 59, embodiments 44-45) is an open surgical procedure or a minimally invasive surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613