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 .
Status of Application/Claims/Election
Applicant’s election without traverse of Group I (Claims 1-14 and 16-20) on 8/17/2026 is acknowledged.
Claims 1-20 are pending. Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-14 and 16-20 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application EP21306143.5 and 371 of PCT/EP2022/073485 filed on 8/25/2021 and 8/23/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 8/25/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/22/2024 and 4/3/2026 were received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Claim Rejections - 35 USC § 112b
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.
Claims 3, 11 and 12 are 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 pre-AIA the applicant regards as the invention.
Claim 3 describes the growth of a cell population as single cells or clusters “such as” spheroids. Claim 11 describes “preferably” harvesting the cellular products not comprising a cell filtration step. Similarly, claim 12 describes “preferably” separating the cells from the hydrogel matrix by mechanical separation and/pr dissolution of the hydrogel not comprising a tyrosination step. A description of preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim, see MPEP 2173.05(d). As a result, one of ordinary skill in the art would not understand if the cell population morphology, cell filtration or separation steps are required to be performed or are merely exemplary in nature.
Claim 3 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 pre-AIA the applicant regards as the invention.
Claim 3 describes a cell population which is derived from AGE.CR1TM and EB.66TM among other commercially available cell lines. Trademarks cannot be used to identify any particular material or product in patent claims, see MPEP 2173.05(u). The value of a trademark is lost to the extent that it becomes descriptive of a product rather than used as an identification of a source or origin of a product. Thus, the use of a trademark in a claim to identify or describe a material or product (i.e. cell population) would not only render a claim indefinite, but would also constitute an improper use of the trademark.
Claim Interpretation
Claims 3, 7, 9, 10, 13, 17 describe optional method steps and limits. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, see MPEP 2111.04.
The breadth of claims read on a method for performing a bioproduction process for producing ANY cellular product by a cell population, which is considered extraordinarily broad. The current claim language seemingly encompasses the production of any cellular product released by the cells or the cultured cells themselves. This expansive range of products reads on anything from insulin production to collagen, antibodies, cultured synthetic meat and any number of cells.
Claim Rejections - 35 USC § 102
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 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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kang et al. US 2020/0283736, published 9/10/2020 (hereinafter Kang).
Claim 1: Kang discloses a method for performing a bioproduction process to produce a cell population dispersed in a hydrogel matrix comprising an alginate three-dimensional structure (Kang, fig 2 and para 8-20).
Claim 2: Kang describes extruding a bioink composition comprising alginate which forms a three-dimensional structure into which a second bioink composition comprising cells is extruded into (Kang, claim 1).
Claim 3: Kang describes the use of a cell population including spheroids (Kang, para 110 and claim 12).
Claims 4-7: Kang describes extruding an alginate and fibrin based bioink to form a three-dimensional structure which has internal cavities and a porous structure in an additive manufacturing process (Kang, para 12, 105 and Fig 9A).
Claim 8: Kang describes culturing the cell spheroids in a liquid culture media under standard culturing conditions (Kang, para 60, 67, 85).
Claims 9-10: Kang describes culturing the cell spheroids in a liquid culture media under standard culturing conditions for a predetermined amount of time and thus achieving a particular cell density. (Kang, para 60, 67, 85).
Claim 11: Kang provides embodiments wherein the cellular product is released by the cells in the cell culture medium. Specifically, Kang describes culturing mouse primary hepatocyte spheroids at varying distances from vascular endothelial cells and measuring albumin and urea secretion from those hepatocyte spheroids over a period of 7 days to characterize spheroid function (Kang, para 108-109).
Claims 12-13: Kang describes harvesting cultured cell spheroids by removing the matrix generated by the first bioink (Kang, para 85). Kang describes methods wherein an alginate lysase may be added to enzymatically remove the matrix and harvest the cultured cell spheroids (Kang, para 60, 85).
Claim 14: Kang describes the formation of a cellularised structure embedded in the hydrogel matrix forming a three-dimensional structure in a liquid medium (Kang, para 47-56, 60, 109 and Fig 2).
Claims 16-17: Kang describes using a controlled printing process to extrude the first bioink and generate one or more internal cavities and pores (Kang, para 69, 72, 93). As shown in Fig 2, the PCL printing module deposits the bioink composition as a filament (Kang, Fig 2).
Claims 18-19: Kang describes the use of a CaCl2 solution to cross-link the alginate contained in the first bioink which is compatible with the growth of the cultured spheroid cells contained in the matrix (Kang, para 59).
Claim 20: Kang describes using a chemically defined culture medium and does not describe the inclusion of detergents which are often cytotoxic (Kang, para 60, 67 and claim 1).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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