DETAILED ACTION
This action is in reply to papers filed 6/25/2024. Claims 1-15 and pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20250084378A1, Published 3/13/2025.
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.
Claims 4, 6-10 and 13-15 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the phenotype" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites, inter alia, “…wherein the stem cells are differentiated into cells of one or more germ layers selected from ectoderm, endoderm and mesoderm.” Claim 6 depends on claim 2. Claim 2 depends on claim 1. Neither of these claims recite a step of ‘differentiating’. A ‘co-culturing’ step, as recited in claim 1, is not considered to be equivalent to a step of ‘differentiating’. Note that the term ‘differentiated’ in claim 6 is written in past tense. The implication is therefore, that the step of differentiating has already occurred. None of claims 6, 2 or 1 recite an active step of differentiating the stem cells. As such, the metes and bounds of claim 7 are unclear in view of the limitations recited in claim 2 and claim 1. Claims 8-10 are included in rejection as they depend on claim 6.
Claim 7 recites, inter alia, “…wherein the stem cells are differentiated into adipocytes, chondrocytes, endothelial cells and muscle precursor cells.” Claim 7 depends on claim 2. Claim 2 depends on claim 1. Neither of these claims recite a step of ‘differentiating’. A ‘co-culturing’ step, as recited in claim 1, is not considered to be equivalent to a step of ‘differentiating’. Note that the term ‘differentiated’ in claim 7 is written in past tense. The implication is therefore, that the step of differentiating has already occurred. None of claims 7, 2 or 1 recite an active step of differentiating the stem cells. As such, the metes and bounds of claim 7 are unclear in view of the limitations recited in claim 2 and claim 1. Claims 13-15 are included in rejection as they depend on claim 7.
Claims 9 and 14 recite the limitation "the different cell types" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Clarification is requested.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Prior Art Rejection 1
Claim(s) 1-4 and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hariri et al. (PgPub US20160304832A1, Published 10/20/2016) in view of Ben-Arye et al. (PgPub US20200140810A1, Filed 7/15/2018; Ref. AJ in IDS filed 9/3/2024) and Forgacs et al. (PgPub US20130029008A1, Published 1/31/2013) .
Claim interpretation: In the interest of compact prosecution, Examiner is interpreting claim 1 to include a step of differentiating the stem cells into the cell types of claim 6 and claim 7.
Hariri et al. teach a method of culturing mesenchymal stem cells (Pg. 1, para. 11) derived from the placenta of a mammalian source, comprising contacting said cells with a plurality of microcarriers, wherein said microcarriers comprise extracellular matrix (ECM) derived from the placenta of a non-human mammalian source (as in claim 1 (in-part) and claim 2) (Pg. 1, para. 9; Pg. 1, para. 4). Hariri teaches the MSCs are CD10+ (claim 3), CD34−CD105+, CD100+ (Pg. 1, para. 12). Hariri teaches the MSCs are cultured for a number of population doublings, e.g., anywhere from about 3 to about 35 population doublings (as in claim 4) (Pg. 15, para. 152).
However, Hariri fails to teach the MSCs are from a non-human mammalian placenta.
Ben-Arye et al. teach a method for producing an edible meat composition (as further in claim 1 and claim 12) (Abstract), comprising differentiating stem cells isolated from a sheep’s (as in claim 11) placenta (Pg. 5, para. 78-79; Abstract) into a plurality of cells comprising myoblasts (mesoderm (as in claim 6 and claim 8) (Pg. 4, para. 59) and at least one ECM-secreting cell type comprising adipocytes and endothelial cells (as in claim 8 and claim 13) (Pg. 4, para. 60). Ben- Arye teaches the cells are seeded in a sequential manner (as in claim 9 and claim 14) (Pg. 5, para. 80).
And although Ben-Arye teaches the plurality of cells comprises ECM-secreting cells, Ben-Arye fails to teach chondrocytes (as in claim 7).
Before the effective filing date of the claimed invention, Forgacs et al. teach engineered meats comprising non-human cells. Forgacs teaches the engineered meat products include connective tissue (cells differentiating into chondrocytes (as further in claim 7), epithelial cells (including endothelial cells that form linings in cavities and vessels or channels) among others (Pg. 7, para. 52; Abstract). Forgacs teaches cellular compositions are chosen for purposes of appearance, taste, and texture (as in claim 10 and claim 15) (Pg. 4, para. 100).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Hariri et al., wherein Hariri teaches seeding MSCs derived from a mammalian placenta on an ECM derived from a non-human placenta , with the teachings of Ben-Arye et al., wherein Ben-Arye teaches an edible meat consumption comprising myoblasts and least one ECM-secreting cells including endothelial cells and adipocytes, with the teachings
Forgacs et al., wherein Forgacs teaches an engineered meat comprising chondrocytes, with a reasonable expectation of arriving at the claimed invention.
That is, for the purposes of deriving an edible meat composition, it would have been prima facie obvious to differentiate MSCs on an ECM derived from a non-human placenta, as taught in Hariri, wherein such cells differentiate into myoblasts and ECM-secreting cells adipocytes, endothelial cells and chondrocytes, as taught in Ben-Arye and Forgacs.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
Prior Art Rejection 2
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hariri et al. (PgPub US20160304832A1, Published 10/20/2016) in view of Ben-Arye et al. (PgPub US20200140810A1, Filed 7/15/2018; Ref. AJ in IDS filed 9/3/2024) and Forgacs et al. (PgPub US20130029008A1, Published 1/31/2013) as applied to claims 1-4 and 6-15 and further in view of Edinger et al. (PgPub US20160129048A1, Published 5/12/2016).
The teachings of Hariri et al., Ben-Arye et al. and Forgacs et al. are relied upon as detailed above. However, none of these references teach wherein the stem cells are expanded and frozen as a master cell bank prior to co-culturing (as in claim 5).
Edinger et al. teach methods of culturing, proliferating and expanding placental stem cells (Abstract). Specifically, Edinger teaches method of making a placental stem cell bank, comprising: expanding primary culture placental stem cells from a human post-partum placenta for a first plurality of population doublings; cryopreserving said placental stem cells to form a Master Cell Bank prior to use (as in claim 5) (Pg. 20, para. 195).
When taken with the teachings of Hariri et al., Ben-Arye et al. and Forgacs et al., wherein the combination teaches an edible composition comprising a plurality of cells derived from stems cells of a non-human placenta, one of ordinary skill in the art would have found it prima facie obvious to expand and then freeze the placenta derived stem cells, as taught in Edinger. The skilled artisan would have found it prima facie obvious to do in order to bank a sufficient number of cells for deriving the meat product.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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