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 .
DETAILED ACTION
Election/Restriction
Applicant’s election, without traverse, of Group II, claims 13-15, drawn to an in vitro method for preparation of a muscle and/or adipose tissue, in the reply filed on 08/12/2026 is acknowledged.
Claims 1-12 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Status
Claims 1-17 are pending.
Claims 1-12 and 16-17 are withdrawn.
Claims 13-15 are considered on the merits.
Priority
This application is a 371 of PCT/IB2023/050422 (filed on 01/18/2023), which claims benefit from foreign application IT102022000000788 (filed on 01/19/2022). The priority claim of the instant application has been granted and the earliest benefit date is 01/19/2022 from the application IT102022000000788.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The corresponding signed and initialed PTO form 1449 has been mailed with this action.
Objection to Drawings
Sequence Compliance
Figure 6 and Figure 7 (nucleotide sequences for temperature-responsive promoters) of the Specification do not conform to sequence rules, requiring the use of “SEQ ID NO:” (37 CFR 1.821-1.825).
Where the description/figures or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description or claims, even if the sequence is also embedded in the text of the description/figures or claims of the patent application. 37 CFR 1.821 (d).
The applicant is reminded that the specification must be amended in order to comply with regulations cited above. All references to sequences in claims and specification should be referred to as “SEQ ID NO:1”, for example. To avoid all doubts of the examiner and to ensure correct interpretation of the claims and specification, the identification of sequences with proper sequence identifiers is required.
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. 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.
Claim Objections
Claims 13-14 are objected to because of the following informalities:
Claim 13 b) recites the phrase “differentiation of said cells in muscle and/or adipose cells”. It is recommended to chang to “differentiation of said cells into muscle and/or adipose cells”.
Claim 14 recites the phrase “which at least one second reactor” in line 2. It is recommended to change to “which the at least one second reactor” since it has been recited prior to this limitation.
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.
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 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 13 depends directly or indirectly on withdrawn claim 10 and claim 1. Accordingly, claim 13 is indefinite because it refers to the limitations of the withdrawn claims, thus lacks antecedent basis. It is recommended to make claim 13 independent by listing all the limitations of the withdrawn claims. Claims 14-15 are rejected as being dependent from claim 13 but not resolving the ambiguity.
Additionally, claims 13-15 all recite the term “preferably”, which renders the claims indefinite because it is a subjective term. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. See MPEP § 2173.05(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In the instant case, the limitation in claim 14 “means for the regulation of temperature in said second reactor” is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is limited by the description in the specification (page 18, lines 17-20), which recites “Suitable means for regulating the temperature can include any system or device allowing to fix the temperature of the plant reactor, container or component considered at a pre-established value and/or to vary the temperature in such plant reactor, container or component in a controlled manner during the cell differentiation process”.
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.
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.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein et al., (WO 2018/227016 A1) in view of Tsang et al., (WO 1999/023216 A2, cited in IDS 07/18/2024).
With respect to claim 13, it is noted that claim 13 depends directly or indirectly on withdrawn claims 10 and 1. Thus, claim 13 a) is examined as: culturing engineered cells having myogenic and/or adipogenic capacity, comprising an expression vector comprising (i) a temperature-responsive promoter operably linked to (ii) at least one nucleic acid sequence encoding for a regulatory factor of myogenesis and/or at least one nucleic acid sequence encoding for a regulatory factor of adipogenesis, at a temperature suitable for the proliferation of said cells.
Elfenbein teaches an ex vivo method for producing cell cultured food product including meat (see e.g., title and abstract), thus teaches the preamble of claim 13, an in vitro method for the preparation of a muscle tissue such as cultured meat.
Regarding step a), Elfenbein teaches the method comprises culturing a population of self-renewing cells in culture media and inducing differentiation in the population of cells to form myocytes (e.g., [003], thus the self-renewing cells have myogenic capacity). Elfenbein teaches the cells having self-renewal capacity are cultured and expanded to a desired quantity using bioreactors (e.g., [068] in p. 19) and teaches a bioreactor system for producing cultured tissues comprising a population of self-renewing cells cultivated within bioreactor, the system comprising at least one sensor for monitoring the reactor chamber, the at least one sensor being configured to monitor at least temperature (e.g., [037]). In regard to the cells being engineered, Elfenbein teaches the population of self-renewing cells comprises at least one cell that has been modified to undergo inducible differentiation and has been modified to incorporate a genetic construct comprising an open reading frame (ORF) of a regulatory factor comprising at least one myogenic factor such as Myogenic Differentiation 1 (MyoD) and sometimes the genetic construct comprises an inducible promoter controlling expression of the open reading frame (ORF) of the regulatory factor (e.g., [013] in p. 5-6). Thus, Elfenbein teaches step a) culturing engineered cells having myogenic capacity (i.e., the self-renewing cells) comprising an expression vector (i.e., a genetic construct) comprising (i) an inducible promoter operably linked to (ii) at least one nucleic acid sequence encoding for a regulatory factor of myogenesis (e.g., the open reading frame of MyoD), in a bioreactor at a temperature suitable for the proliferation of said cells (e.g., being expanded to a desired quantity).
Regarding step b), Elfenbein teaches the inducing differentiation comprises exposing the at least one cell to an induction agent to induce expression of the ORF of the regulatory factor and comprises generating myotubes within the population of self-renewing cells (e.g., [013] in p. 6), thus teaches step b) exposing the cells to an induction agent to induce the expression of the regulatory myogenic factor to promote the differentiation of the stem cells into muscle cells.
Regarding step c), Elfenbein teaches in some instances, three-dimensional scaffolding is used to provide structural support and guide the growth of the cultured cells into the desired structure and/or texture analogous with the equivalent food product produced using conventional methods. Alternatively or in combination, micro-scaffolds can be used to enhance stem cell proliferation (e.g., instant step a), direct cell differentiation into the relevant lineage (e.g., instant step b), and modulate flavor, texture, and tensile elasticity of the final meat product (e.g., instant step c) (see e.g., [068], p. 20). Elfenbein exemplifies a method for producing salmon using embryonic stem cells in Example 7 comprising the steps of culturing embryonic stem cells to achieve cellular proliferation (i.e., instant step a), inducing differentiation of the stem cells into myocytes (i.e., instant step b), and culturing and expanding the myocytes to a desired quantity of cells (i.e., instant step c) (see Example 7, [0209]). Thus, Elfenbein teaches step c) culturing the differentiated cells to obtain the tissue.
Regarding the optional step d), Applicant is reminded that 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 (I).
However, although Elfenbein exemplifies a tetracycline inducible promoter controlling expression of MyoD (see e.g., [099] in p. 35, also see Fig 14), Elfenbein is silent on a temperature-responsive promoter in claim 13 a), nor teach increasing the cultivation temperature to promote differentiation in claim 13 b).
Tsang teaches a method for effecting the inducible expression of polynucleotides in cells by using heat shock promoters (e.g., p. 3, para 1). Tsang teaches the inducible promoter is a heat shock promoter and the conditions which activate the heat shock promoter are hyperthermic conditions (e.g., p. 3, last para.). Thus, Tsang teaches a temperature-responsive promoter (e.g., a heat shock promoter) for effecting the inducible expression of polynucleotides in cells, related to claim 13 a). Tsang exemplifies a method comprising the steps including cells are transfected with an expression vector comprising an HSP70B promoter operably linked to a reporter EGFP gene, and heat shock is administered by completely submersing culture flasks in a temperature controlled waterbath, and four hours after exposure to 42°C heat shock for one hour, the mean relative fluorescence is 7-9 times greater (Example 1 “The Heat Shock Promoter Can Induce Expression of a Reporter Gene”, p. 53-54, also see Fig 2), thus teaches a step of increasing the cultivation temperature (e.g., 42°C heat shock) to induce the expression of polynucleotides in cells in claim 13 b).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for preparing a muscle tissue by inducible differentiation using a tetracycline inducible promoter disclosed by Elfenbein, by substituting a temperature-responsive promoter for the tetracycline inducible promoter as suggested by Tsang with a reasonable expectation of success. Since Elfenbein teaches removing the induction agent (e.g., tetracycline or doxycycline) after the self-renewing cells being treated with the induction agent and before being processed for human consumption (e.g., [013] in p. 6), one of ordinary skill in the art would have had a reason to substitute with a temperature-responsive promoter in order to achieve inducible expression of a myogenic factor to prepare a muscle tissue for human consumption by a simpler (i.e., omitting the addition and removal of tetracycline or doxycycline) and safer approach (i.e., avoiding residual antibiotics in the muscle tissue). Furthermore, since Tsang reduces to practice a step of increasing the cultivation temperature (e.g., to 42°C) to induce the expression of polynucleotides in cells, one of ordinary skill in the art would have had a reason to combine a step of increasing the cultivation temperature so as to induce the expression of the myogenic factor to promote differentiation of the stem cells into muscle cells.
With respect to claim 14, it is noted that the limitation “means for the regulation of temperature in said second reactor” is interpreted under 112 (f), that is limited by the specification (page 18, lines 17-20), which recites “Suitable means for regulating the temperature can include any system or device allowing to fix the temperature of the plant reactor, container or component considered at a pre-established value and/or to vary the temperature in such plant reactor, container or component in a controlled manner during the cell differentiation process” (underlined by examiner).
As stated supra, Elfenbein teaches a method for producing salmon using embryonic stem cells in Example 7 comprising the steps of culturing embryonic stem cells to achieve cellular proliferation (i.e., instant step a), inducing differentiation of the stem cells into myocytes (i.e., instant step b), and culturing and expanding the myocytes to a desired quantity of cells to generate the texture and consistency of conventional sushi-grade salmon (i.e., instant step c) (see Example 7, [0209]). Elfenbein teaches three-dimensional scaffolding can be used to provide structural support and guide the growth of the cultured cells into the desired structure and/or texture analogous with the equivalent food product produced using conventional methods. Alternatively or in combination, micro-scaffolds can be used to modulate flavor, texture, and tensile elasticity of the final meat product (see e.g., [068], p. 20). Thus, Elfenbein suggests that step c) can be carried out with three-dimensional scaffolding and/or micro-scaffolds to modulate the texture of the muscle tissue. Elfenbein also characterizes and optimize low-cost, animal component-free, culture media for food production in Example 17 (p. 104). Elfenbein teaches a bioreactor system for producing cultured tissues comprising at least one sensor for monitoring the reactor chamber, being configured to monitor at least temperature (e.g., [037]). Thus, Elfenbein suggests that step c) can be carried out in three-dimensional scaffolding and/or micro-scaffolds in a reactor chamber (i.e., a second reactor) comprising a culture medium, which the at least one second reactor is operably linked to a device allowing to fix the temperature of the reactor at a pre-established value, e.g., the reactor chamber is operably linked to a sensor for monitoring and controlling the temperature in the reactor chamber.
Accordingly, one of ordinary skill in the art would have chosen to carry out the step c) in a second reactor that is operably linked to means for regulating the temperature with a reasonable expectation of success. One of ordinary skill in the art would have had a reason to do so in order to culture the differentiated muscle cells in a reactor with appropriate scaffolds to provide structural support and guide the growth of the cultured cells into the desired structure and/or texture.
With respect to claim 15 directed to the step b) being carried out at a temperature between 20 and 45 °C, as stated supra, Tsang exemplifies inducing gene expression in cells transfected with an expression vector comprising an HSP70B promoter by exposing the cells to 42°C heat shock (Example 1, p. 53-54 and Fig 2).
Accordingly, one of ordinary skill in the art would have chosen to carry out the step b) at a temperature between 20 and 45 °C (e.g., 42°C) with a reasonable expectation of success. Since Tsang reduces to practice the induction step being carried out at 42°C that achieves 7-9 times gene expression (see Example 1), one of ordinary skill in the art would have had a reason to do so in order to achieve inducible high expression of the myogenic regulatory factor to promote differentiation of the stem cells into muscle cells.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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