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 .
Claims 23-32 and 34-47 are pending in this application, Claims 44-46 are acknowledged as withdrawn, Claims 23-32, 34-43 and 47 were examined on their merits.
The objection to Claim 47 has been withdrawn due to the Applicant’s amendments to the claims filed 06/26/2026.
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.
Claims 23, 24, 25, 26, 28, 34, 36, 38, 41, 42 and 43 are rejected under
35 U.S.C. § 103 as being unpatentable over Elfenbein et al. (WO 2018/227016 A1),
cited in the IDS, in view of Padly et al. (US 4,511,589), of record.
Elfenbein et al. teaches producing cultured tissue in a sterile/pathogen-free
environment (thus indicating that the bioreactor is sterilized) and harvesting cultured
tissue (Fig. 21) and packaging the cultured tissue/food product (e.g. into a package or
"chamber", thus the packaging is "suitable" for packaging the cultured tissue/food
product) (Pg. 114, Claims 37 and 39), and wherein the cultured food product is meat for
consumption (Abstract and Pg. 111, Claim 1), reading on Claims 23 and 38;
wherein the method includes an additional processing step of producing a
plurality of slices (Pg. 114, Claim 39), reading on Claim 24;
wherein the process temperature in the bioreactor is 37 °C (Figs. 22A-B and Pg.
50, Paragraph [0132]), and reading on Claim 34;
and wherein the bioreactor comprises a 3D micro-scaffold, which may be a
hydrogel (Pg. 111, Claims 13 and 7), reading on Claims 41 and 42.
While Elfenbein et al. does not specifically teach that the cultured meat product is
sliced under sterile conditions, transferred to sterile packaging (e.g. a chamber) and
sealed, all under aseptic conditions, this would have been obvious to those of ordinary
skill in the art as a means of preserving sterility of the cultured food product before it
reaches the consumer. Those of ordinary skill in the art would have been motivated to
make this modification in order to maintain sterility and prevent contamination and/or
spoilage of the packaged cultured food product.
See the MPEP at 2141, I., which states:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at 417, 82 USPQ2d at 139
There would have been a reasonable expectation of success in making this
modification because the reference already teaches culturing under sterile conditions.
With regard to Claim 43, the Specification as published at Paragraph [0022]
provides a definition for the term "fresh" as;
"Preferably the cultured tissue is fresh cultured tissue, wherein fresh relates to the cultured tissue not being post-processed by means of heat suitable for a sterilization environment".
As Elfenbein et al. does not teach the cultured meat product is post-processed with heat, the reference meets the claim limitation.
Elfenbein et al. does not teach a method wherein the process pressure in the sterilized bioreactor is in a range of 2 to 11 bar absolute, as now required by Claim 23;
wherein all the method steps are performed in a single sterile enclosure, as required by Claim 25;
wherein at least some of the steps are performed in separate sterile enclosures and wherein transferring cultured tissue between the separate sterile enclosures is performed under aseptic conditions, as required by Claim 26;
wherein the method steps are performed in the sterilized bioreactor, as required by Claim 28;
wherein the cultured meat product is transferred to the sterile packaging at a temperature of 37 °C, as required by Claim 35;
or wherein cultured tissue is transferred to the sterile package at a pressure in a range of 2-4 bar absolute, as now required by Claim 36.
Padly et al. teaches a method wherein a harvested food product (egg yolk) is sterilized at a temperature and pressure generally not more than 3 bar absolute (Column 1, Lines 48-59), wherein the sterilization time is related to the temperature and pressure under which the process is performed (Column 1, Lines 35-44).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic production, harvest and packaging of a cultured meat product of Elfenbein et al. to perform the method steps at the pressure range of Padly et al. because the pressure in combination with the temperature the method is performed at will affect the time required to sterilize and maintain sterility of the food product. Those of ordinary skill in the art would have been motivate to make this modification in order to maintain sterile conditions in the aseptic production, harvest and packaging of a cultured meat product.
There would have been a reasonable expectation of success in making this modification because both references are drawn to the aseptic processing of food products.
It would have been further obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic production, harvest and packaging of a cultured meat product of Elfenbein et al. and Padly et al. to perform the method steps in a single sterile enclosure (such as the sterile bioreactor) at the same temperature as the culturing or alternatively, to perform the method steps in separate sterile enclosures wherein material is transferred between the sterile enclosures under aseptic conditions at the same temperature and pressure as culturing/harvesting because there are only two ways to perform the cultured meat production method aseptically; either in the same/single sterile enclosure or in separate sterile enclosures wherein material transfer therebetween is performed aseptically. See the MPEP at 2143, I., E. Those of ordinary skill in the art would have found obvious keeping the packaging temperature and pressure the same as the culturing/harvesting temperature as this would eliminate the need to adjust the temperature and pressure between process steps. Those of ordinary skill in the art would have been motivated to make this modification in order to produce, harvest and package a food product (cultured meat) at a constant temperature which is suitable for consumption and is uncontaminated with microbes.
There would have been a reasonable expectation of success in making this modification because the Elfenbein reference implicitly teaches that production is performed under sterile conditions at 37 °C, while Padly teaches sterilely harvesting a food product at a pressure generally not more than 3 bar absolute and the application of sterile conditions and the same temperature/pressure to any other processing step would have been obvious, as well as the performance of the method in either; the same/single sterile enclosure or in separate sterile enclosures.
Claims 23, 24, 25, 26, 28, 29, 30, 31, 34, 36, 38, 41, 42 and 43 are rejected under 35 U.S.C. § 103 as being unpatentable over Elfenbein et al. (WO 2018/227016 A1), cited in the IDS, in view of Padly et al. (US 4,511,589), of record, as applied to Claims 23, 24, 25, 26, 28, 34, 36, 38, 41, 42 and 43 above, and further in view of Tanimoto (US 2014/0290162 A1), of record.
The teachings of Elfenbein et al. and Padly et al. were discussed above.
Neither reference taught a method wherein the process comprises a Grade A isolator capable of self-sterilizing, as required by Claims 29-31.
Tanimoto teaches the maintenance of a culture of cells or tissues without a specially organized facility such as a cell processing center (Pg. 1, Paragraph [0009)); comprising an isolator capable of maintaining a Grade A cleanliness environment (Pg. 1, Paragraph [0017 and Pg. 2, Paragraph [0018]);
and wherein the isolator is self-sterilizing (Pg. 2, Paragraphs [0023]-[0024]).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic production, harvest and packaging of a cultured meat product of Elfenbein et al. and Padly et al. to perform the method steps in a sterile enclosure such as the isolator of Tanimoto because this would allow the production, harvesting and packaging method of the cultured meat product to be performed aseptically without a specially organized facility. Those of ordinary skill in the art would have been motivated to make this modification in order to simplify the process and eliminate the need for a cell processing center. There would have been a reasonable expectation of success in making this modification because Elfenbein et al. is not limited to any particular method of aseptically performing the method and Tanimoto provides a specific means for processing cultured cells sterilely.
Claims 23, 24, 25, 26, 28, 27, 34, 36, 38, 39, 40, 41, 42 and 43 are rejected under 35 U.S.C. § 103 as being unpatentable over Elfenbein et al. (WO 2018/227016 A1), cited in the IDS, in view of Padly et al. (US 4,511,589), of record, as applied to Claims 23, 24, 25, 26, 28, 34, 36, 38, 41, 42 and 43 above, and further in view of Mogna (WO 2008/038075 A2), of record.
The teachings of Elfenbein et al. and Padly et al. were discussed above.
Neither reference taught a method comprising transferring cultured tissue to a sterilized connecting piece; transferring cultured tissue from said sterilized connecting piece to said sterile package; wherein the steps are executed under aseptic conditions and wherein said sterilized connecting piece connects said sterile package with said sterilized bioreactor of cultured tissue, as required by Claim 27;
wherein the sterile package is suitable for storage between -20 to 50°C, as required by Claim 39;
or wherein said sterile package, said sterilized connecting piece and said sterilized bioreactor of cultured tissue are easily sterilized by conventional sterilization methods, as required by Claim 40.
Mogna et al. teaches a method of preparing a cell culture wherein measures to prevent as much as possible contamination risks are taken for the bioreactor: air getting into the fermentation compartment (e.g. bioreactor) is filtered by way of sterile filters; the compartment itself is sterilized with high-temperature vapor between one production cycle and the following one (Pg. 23, Lines 3-10) and;
the first packaging of the enriched liquid starter culture as described above aims also at reducing almost completely the risks of contamination for the product, and occurs in specific environments under a laminar flow of sterile air.
Preferably, packaging is carried out in 3 to 5 liter polyethylene/aluminum bags, which are filled up with a peristaltic pump and autoclavable silicone pipes (e.g. sterilized connecting piece), then sterilized and connected directly to the bioreactor.
Bags are also welded under sterile conditions. For the storage of the liquid starter culture according to the present invention after packaging, the latter is preferably kept at a temperature of 0-10 °C; more preferably of 3-5 °C (encompassed within the claimed temperature range of between -20 to 50°C) (Pg. 23, Lines 14-25 and Pg. 24, Lines 1-3).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic production, harvest and packaging of a cultured meat product of Elfenbein et al. and Padly et al. with the method of Mogna et al. of aseptically preparing and packaging a cultured cell product as a means of preventing microbial contamination of the cultured meat product. Those of ordinary skill in the art would have been motivated to make this modification because it would achieve the desired product of a sterile, packaged cultured meat product. There would have been a reasonable expectation of success because both references are reasonably drawn to the same field of endeavor, that is, the sterile culture and packaging of cultured cell products.
Claims 23, 24, 25, 26, 28, 32, 34, 36, 37, 38, 41, 42 and 43 are rejected under 35 U.S.C. § 103 as being unpatentable over Elfenbein et al. (WO 2018/227016 A1), cited in the IDS, in view of Padly et al. (US 4,511,589), of record, as applied to Claims 23, 24, 25, 26, 28, 34, 36, 38, 41, 42 and 43 above, and further in view of Croce et al. (US 4,771,630), of record.
The teachings of Elfenbein et al. and Padly et al. were discussed above.
Neither reference taught a method which further comprises an integrity test of the sterile package, as required by Claim 32;
or wherein the sealing of the sterile package is hermetic, as required by Claim 37.
Croce et al. teaches a method of testing a package or container containing a sterilized product for hermetic seal integrity (Column 1, Lines 43-55 and Column 24, Claim 1).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the aseptic production, harvest and packaging of a cultured meat product of Elfenbein et al. and Padly et al. with the method of Croce et al. of testing the integrity of hermetically sealed sterile packaging as a means of preventing microbial contamination of the sealed, sterile cultured meat product. Those of ordinary skill in the art would have been motivated to make this modification because it would achieve the desired product of a sterile, packaged cultured meat product. There would have been a reasonable expectation of success because both references are reasonably drawn to the same field of endeavor, that is, the sterile packaging of cultured products.
Claims 23, 24, 25, 26, 28, 34, 36, 38, 41, 42, 43 and 47 are rejected under 35 U.S.C. § 103 as being unpatentable over Elfenbein et al. (WO 2018/227016 A1), cited in the IDS, in view of Padly et al. (US 4,511,589), of record, as applied to Claims 23, 24, 25, 26, 28, 34, 36, 38, 41, 42 and 43 above, and further in view of McFarlane et al. (US 4,830,865).
The teachings of Elfenbein et al. and Padly et al. were discussed above.
Neither reference taught a method further comprising a three-valve system with a steam connection and a condensate drain, as required by Claim 47.
McFarlane et al. teaches a three-way valve system as part of an apparatus for
aseptically processing a food product (Abstract and Fig. 1, #84) with a steam
connection (Fig. 1, #84 and Column 6, Lines 61-68) and a condensate drain (Fig. 1, #85
and Column 7, Lines 4-6).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the aseptic production, harvest and
packaging of a cultured meat product of Elfenbein et al. and Padly et al. with the use of
a three-valve system of McFarlane et al. because this would allow the sterile processing
of a food product with steam and removal of condensed steam from the process as
needed.
Those of ordinary skill in the art would have been motivated to make this
modification because it would achieve the desired product of a sterile, packaged
cultured meat product. There would have been a reasonable expectation of success
because all of the references are reasonably drawn to the same field of endeavor, that
is, the sterile production of a food product.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/26/2026, with respect to the above withdrawn objection have been fully considered and are persuasive.
Applicant's arguments remaining arguments have been fully considered but they are not persuasive.
The Applicant argues that Elfenbein is directed to the production of cultured meat but does not disclose any particular packaging, let alone sterile packaging. Applicant asserts that Padly is directed to processing and pasteurization of eggs which is different from the cultured meat of the claimed invention (Remarks, Pg. 6, Lines 9-14).
This is not found to be persuasive for the following reasons, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner notes that Elfenbein was drawn to producing sterile cultured tissue (meat).
Padly was cited only for its’ teaching of sterilizing a food product at a particular temperature and pressure and the correlation between sterilization time and the
temperature and pressure the process is performed. That the cultured meat of Elfenbein and the egg product of Padly are somewhat different is immaterial as both are sterile food products, and thus are in the same field of endeavor.
The Applicant argues that the claimed invention is solid living or fresh cultured tissue which is of a different consistency from the liquid eggs/yolk of Padly. Applicant notes that Padly discloses pasteurization which would cook cultured meat tissue thereby rendering it unsuitable for its claimed purpose (Remarks, Pg. 6, Lines 15-23).
This is not found to be persuasive for the following reasons, the limitations “living” or “fresh” are not recited in the instant broad claim. Thus, even if Padly was cited for a teaching of pasteurization (which it was not), the reference would still be applicable and there the claimed product would not be rendered unsuitable for its’ intended purpose of being a sterile cultured tissue.
However, Padly was not cited for a teaching that the product must be pasteurized but for a suitable pressure range to perform the process under and the teaching that sterilization time is correlated with temperature and pressure. Thus, as Elfenbein teaches a suitable temperature to perform the culturing the ordinary artisan would look to Padly for a suitable pressure to perform the culturing.
Applicant argues that Padly is an older reference and cannot be related to cultured meat which did not exist at the time of the publication. Applicant concludes therefore, there would not have been a reasonable expectation of success that the pressure range of Padly could be applied to the process of Elfenbein, especially as Elfenbein does not teach or suggest aseptic packaging (Remarks, Pg. 6, Lines 24-30 and Pg. 7, Lines 1-9).
This is not found to be persuasive for the following reasons, initially as discussed above, Elfenbein teaches producing cultured tissue in a sterile/pathogen-free
environment (thus indicating that the bioreactor is sterilized) and harvesting cultured
tissue (Fig. 21) and packaging the cultured tissue/food product (e.g. into a package or
"chamber", thus the packaging is "suitable" for packaging the cultured tissue/food
product) (Pg. 114, Claims 37 and 39). Secondly, "The mere age of the references is not persuasive of the unobviousness of the combination of their teachings, absent evidence that, notwithstanding knowledge of the references, the art tried and failed to solve the problem."
In re Wright, 569 F.2d 1124, 1127, 193 USPQ 332, 335 (CCPA 1977) (100 year old patent was properly relied upon in a rejection based on a combination of references.). See also Ex parte Meyer, 6 USPQ2d 1966 (Bd. Pat. App. & Inter. 1988) (length of time between the issuance of prior art patents relied upon (1920 and 1976) was not persuasive of nonobviousness). In this instance, both Elfenbein and Padly are directed to the sterility of food products and are thus relevant to one another and would provide a reasonable expectation of success in the application of the pressure of Padly in modifying the sterile packaging method of Elfenbein.
The Applicant argues that there would have been no motivation to combine the references, expectation of success and hindsight (Remarks, Pg. 7, Lines 10-13).
In response to Applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In this instance, both references are drawn to the same field of endeavor, which are sterile food products and motivation to combine the references would come from the ordinary artisan in seeking a proper pressure to perform the aseptic processing of Elfenbein, looking to the prior art of Padly which discloses such a pressure in preparation method of a sterile food product. The ordinary artisan would therefore have a reasonable expectation of making the proposed modification because both references are drawn to the aseptic processing of food products.
The Applicant argues that the remaining references do not remedy the alleged deficiencies of Elfenbein and Padly and the invention provides advantages not disclosed or suggested by the prior art (Remarks, Pg. 7, Lines 14-18).
This is not found to be persuasive for the following reasons, in response to Applicant’s argument that the invention provides certain unclaimed general advantages, the MPEP states at 2145, II. that:
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)
The Examiner notes that the remaining references were only cited to address dependent claim limitations and the broad claim remains rejected under Elfenbein in view of Padly for reasons of record set forth above. Thus, the prior art would be expected to have the same general advantages even if not specifically recognized by the prior art.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm 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, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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