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 .
Election/Restrictions
Claims 1-21 are pending.
Applicant’s election without traverse of Group I, corresponding to claims 1-15 and 21 without traverse in the reply filed on 02/18/2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/18/2026.
Claims 1-15 and 21 have been examined on their merits.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraph [0352], reference to NCBI website.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they (specifically Fig. 3) fail to show genetic details as described in the specification. Specifically, the various sites on the plasmid are illegible in Fig. 3. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Claim Objections
Claim 1 is objected to for the following informalities: claim 1 has multiple periods to separate substeps. Additionally, the word “Cultivating” is improperly capitalized. A claim should be a single sentence starting with a capital letter and ending with a period (see MPEP 608.01(m). Using a parenthesis and using a lowercase-C (e.g., “a) cultivating in suspension . . .”) would be ameliorative.
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.
Claims 1-2, 4-7, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Maria Biressi et al. (WO2023139493, on IDS 12/12/2025).
In regards to claims 1 and 15, Maria Biressi teaches non-human animal cell cultivation methods (specifically for culturing meat) (Claim 13; p14, lines 28-13).
In regards to step a), Maria Biressi teaches that the method comprises cultivating poultry and cattle (avian and bovine) cells with a nucleic acid sequence encoding a nucleic acid encoding a regulatory factor for myogenesis or adipogenesis operably linked to a heat shock promoter at a proliferation temperature. Since the cells proliferate, the proliferation is necessarily at a first time period. Maria Biressi also discloses that the method is carried out in a bioreactor comprising a culture medium (p17, lines 21-25; Fig. 5). Maria Biressi teaches that the bioreactor is being continuously stirred (p5, lines 29-21, referring to Fig. 5), and a person of ordinary skill in the art would have recognized that this implies that the culturing is being done in suspension. Indeed, Maria Biressi discusses culturing specific cell types in suspension (p15, lines 3-8).
In regards to step b), Maria Biressi teaches increasing the cultivation temperature to promote differentiation (thus, at a heat shock temperature to induce expression of the factor) (claim 13; Figs. 1 and 5).
In regards to steps c) and d), Maria Biressi teaches that the method includes preparing an edible product from the cultured cells (tissue) (claim 13; Figs. 1 and 5)., which a person of ordinary skill in the art would have recognized requires separating the cells from the media and harvesting cells.
In regards to claim 2, Maria Biressi teaches that the cells are cultured at a proliferation temperature of 37°C (p5, line 29, Fig. 5), which overlaps with the claimed range.
In regards to claim 4, Maria Biressi teaches that the cells are exposed to a heat shock temperature of the range of 20°C and 45°C (claim 15), and specific embodiments of 37°C to 42°C (Fig. 5), which overlaps with the claimed range. A temperature of at least 42°C is at least 3°C higher than the proliferation temperature. In regards to the timings, Maria Biressi teaches embodiments where cells are exposed to heat shock temperatures for 2 hours, which overlaps with the timing of “about 3 hours.”
In regards to claims 5 and 6, Applicant should note that whether cells a substantial portion of cells express the nucleic acid at 43°C or whether 10% of the cells express the nucleic acid at or below 37°C is a natural consequence of expressing a nucleic acid linked to a heat shock promoter at these temperatures. In the instant case, because Maria Biressi teaches expressing a nucleic acid linked to a heat shock promoter at the claimed temperatures, the resultant proteins would have these same properties. Furthermore, Maria Biressi also teaches that the cells increasingly express the protein over the range of 37°C to 43°C (Fig. 11, p6, line 14), and therefore, appear in fact these properties.
In regards to claim 7, similarly to as above, whether cells have a basal doubling time of 24 and wherein the cells return to a basal doubling time within 6 days of exposure to the heat shock temperature, is a property to exposing cells to a heat shock promoter. Additionally, it is noted that the claims do not require a timing of 6 days exposure. In the instant case, because Maria Biressi teaches the same cells expressing the same nucleic acid linked to a heat shock promoter at the claimed temperature, the cells as taught by Maria Biressi would have this same property absent evidence to the contrary.
In regards to claim 11, Maria Biressi teaches that the factor associated with the fat phenotype is PPARγ (PPARG) (p12, line 2).
In regards to claim 12, Maria Biressi teaches that the step b) is carried out in a differentiation system for a second time period, comprising culturing the cells in a second bioreactor (which appears to comprise a pipe) through which the cells flow (claim 14; Fig. 5).
In regards to claim 13, Maria Biressi is silent as to the specific timings. However, a person of ordinary skill in the art could have arrived at a timing of between 1 and 14 days by routine optimization the disclosure does not point to a criticality in this timing (see MPEP 2144.05(II)(A), differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). In the instant case, because in experiments prior to transfection, Maria Biressi teaches that cells can be cultured for a minimum of 3 days (Culture of porcine pericytes, p20), a person of ordinary skill in the art could have arrived at a timing of 1 to 14 days by routine optimization with predictable results and a reasonable expectation of success.
In regards to claim 14, in regards to wherein prior to step d), the cells express 0.5 fold to 30 fold increase in expression of factors associated with fat or muscle, Maria Biressi teaches that cells subjected to heat shock temperatures exhibit at least 50% more (0.5 fold) increase in expression driven by a heat shock promote (Fig. 11). A person of ordinary skill in the art would have been motivated to increase expression of factors associated with fat or muscle in order to provide a greater number of differentiated cells prior to being formulated into a comestible food product. Furthermore, because Maria Biressi teaches that expression increases with temperature (Fig. 11) and teaches that temperature can be used to control cell type prior to being formulated into a comestible food product (Fig. 5), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the teachings of Maria Biressi render the invention unpatentable as claimed.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Maria Biressi et al. (WO2023139493, on IDS 12/12/2025) as applied to claim 1 above, and further in view of Firpo et al. (WO2018208628A1, on IDS 12/12/2025).
In regards to claim 3, Maria Biressi teaches that cells can be cultured in bioreactors with high volumes (10,000 L; p17, line 20), but is silent as to a target density.
However, as above, a person of ordinary skill in the art could have arrived at a volume of 0.1 mil/mL cells to about 70mil/mL cells by routine optimization, and the disclosure does not point to a criticality in this amount (see MPEP 2144.05(II)(A) as above).
In the instant case, because Firpo teaches that cells can be cultured to densities of a wide range about 105 cells/mL to 1010 cells/mL (paragraph [0010]) for use in formulating comestible food products (paragraph [0002]), which overlaps with the claimed ranges, a person of ordinary skill in the art could have arrived at these densities by routine optimization with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Maria Biressi and Firpo renders the invention unpatentable as claimed.
Claims 8 and 10 is rejected under 35 U.S.C. 103 as being unpatentable over Maria Biressi et al. (WO2023139493, on IDS 12/12/2025) as applied to claim 1 above, and further in view of Steurer et al. (PLOS ONE, 2018).
In regards to claim 8, Maria Biressi teaches that the heat shock protein can derive from the HSP70 gene (p12, lines 6-10) which is a family of heat shock proteins of which HSP1A1 (HSP72) is a species.
In regards to HSP1A1 specifically, a person of ordinary skill in the art would have been motivated to choose this promoter because Steurer teaches HSPA1A (HSP72) is strongly upregulated upon stress (Abstract, p1) and therefore, would be more effective for eliciting expressing of a heat shock protein.
Furthermore, because Maria Biressi teaches that types of HSP70 heat shock genes can be used and because Steurer teaches that cells can be engineered to express this gene (Material and Methods, p2-3), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 10, Maria Biressi does not explicitly teach that the heat shock promoter is modified to exhibit reduced activation by heavy metals.
However, Steurer teaches that heavy metals are toxic to living organisms and known as environmental contaminants (Abstract, p1). Steurer teaches that while both heat and heavy metals denature cellular proteins and thus activate the heat shock responses, heat acts transiently, while heavy metals continue the denaturing action on the cells over long periods (Discussion, p13). Steurer also teaches that heavy metals more strongly induced the HSPA1A promoter in particular (Abstract, p1).
Therefore, a person of ordinary skill in the art would have been motivated to modify a heat shock promoter to exhibit reduced activation by heavy metals in order to control the timing and reduce the denaturing action on the cells over long periods.
Furthermore, Streuter teaches that the HSPA1A promoter can be mutated (Plasmids, p2-3) and that cells expressing mutated HSPA1A promoter exhibits reduced expression upon stimulation with heavy metals (Fig. 3, p8-9).
Therefore, the combined teachings of Maria Biressi and Streuter renders the invention unpatentable as claimed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Maria Biressi et al. (WO2023139493, on IDS 12/12/2025) as applied to claim 1 above, and further in view of Kowalski et al. (US5733745A, on IDS 12/12/2025).
In regards to claim 9, while Maria Biressi is silent as to whether the heat shock promoter is homologous to the species, a person of ordinary skill in the art would have been motivated to use a homologous heat shock promoter because it would be the most compatible with that species. Furthermore, because Kowalski teaches that bovines express hsp70 (column 4, lines 24-31), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Maria Biressi and Kowalski renders the invention unpatentable as claimed.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Maria Biressi et al. (WO2023139493, on IDS 12/12/2025) as applied to claim 1 above, and further in view of Elfenbein et al. (US20200140821A1, on IDS 12/12/2025).
In regards to claim 21, Maria Biressi does not explicitly teach that the cells are cultivated in serum free media. However, culturing cells in serum-free conditions is long understood in the art.
A person of ordinary skill in the art would have been motivated to use serum-free conditions in order to reduce having to raise live-stock (and thus costs) in order to obtain serum and reduce contamination by viruses, mycoplasma, prions, toxins, and other undesirables present in serum as taught by Elfenbein (paragraph [0121]). Furthermore, because Elfenbein teaches that animal cells for use as in vitro meats can be grown in serum-free media (paragraph [0059]) it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Maria Biressi and Elfenbein renders the invention unpatentable as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH PAUL MIANO/Examiner, Art Unit 1631