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 .
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 1-10, 12, 13 and 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.
Claims 1 recites “has a moisture content consistent with a corresponding fresh raw meat product”. Here, the term “fresh” is not clear inasmuch as to how it further modifies “raw”. Raw is considered to be “uncooked” and appears to be consistent with the use of the term in the instant specification as noted in instant paragraph [0024] which refers to “raw (uncooked)”. There is no clear indication of what the scope of “fresh” may be in the context of “raw meat”. The term “fresh” may be applied to cooked or uncooked as it may be seen to be associated with a time rather than a stated (cooked/uncooked). The instant specification refers to “fresh raw meat” only once in [0096] and does not expand on the term fresh such that the scope of the term is clearly understood. In other words, it is not clear what state of the meat product would constitute fresh as compared to not fresh. Claims 12, 13 and 15 also recite “corresponding fresh raw meat product” and is rejected for the same reasons. Claims 2-10 depend from claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 states that partially drying comprised drying the cell-based meat product until configured for packaging as a raw meat product. Claim 1, from which claim 8 depends, states “preparing the comestible cell-based meat product for packaging as a refrigerated raw meat product by partially drying”. Since claim 1 already indicates that the raw meat product is prepared for packaging by partially drying, it is not clear how claim 8 further limits the partially drying step of claim 1. If the partial drying of claim 1 is such that the meat product is prepared for packaging, it is not clear how partial drying until configured for packaging recited in claim 8 is further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 3-5, 8, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/158831 (Kayser) in view of US 2024/0215626 (Johansson).
Regarding claims 1, 8, and 22, Kayser discloses a method of inserting a comestible cell-based meat product comprising a cultured cell mass (biomass) harvested from a bioreactor [0028-0029]. The meat product is partially dried but not frozen to a point where the meat product has a moisture content that mimics conventional uncooked meat which is 65-85% [0260, 0276]. The range of 65-85% overlaps the claimed range and is prima facie obvious. Kayser discloses packaging the meat products [0069]. Kayser discloses dehydration below 100F so as not to cook the meat product and uses forced air dehydration but does not disclose vacuum under refrigeration conditions [0260]. Johansson discloses a biomass cultivated in a bioreactor and harvested to form a meat-like product [0004, 0067]. Johansson discloses that the moisture level of the biomass can be decreased by “chilled vacuum dehydration” which is beneficial and cost-efficient [0018]. It would have been obvious to one of ordinary skill in the art to use chilled vacuum dehydration as a known method to reduce the moisture content of the meat product of Kayser in a cost-efficient manner and with a reasonable expectation of successfully removing moisture from the product.
Regarding claims 3-5, and 25, Kayser discloses weighing the mass before drying and weighing the mass after drying and the difference in weight is reported as moisture loss. The recitation of a predetermined time is not seen to provide a patentable distinction to Kayser as the dehydration must occur for an amount of time and that time may be variable depending upon the type of cells, temperature, size of the mass etc., and can be estimated by one of ordinary skill in the art based upon repetition and routine experimentation (i.e. learned).
Claim(s) 2-7, 10-16, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/158831 (Kayser) in view of US 2024/0215626 (Johansson) as applied to claim 1 above, and further in view of US 2020/0370830 (Purdon) (cited on IDS filed 01/25/2024) and US 4942053 (Franklin).
Kayser as modified by Johansson does not disclose using an amount of moisture evacuated or humidity reading as part of determining the moisture content of the mass. Kayser does disclose weighing the meat product before and after drying to report moisture loss but does not expressly disclose a predetermined mass based on an initial mass.
Regarding moisture evacuation and humidity, Purdon discloses humidity sensors may be present within the drying chamber and activating a fan creates convection to drive off moisture within the drying chamber, the humidity within the drying chamber may increase. The convection equipment, which may be configured to regulate the temperature and humidity of the drying chamber 106 to dry the organic materials 102 within the product container 104, may include a fan 118 and a heating device 120, and may be located within the drying chamber 106 [0062]. Information sent by the temperature and humidity sensors 124 is used by the system 100 for drying organic materials to regulate activation/deactivation cycles of the fan 118 and heating device 120 as performed during the drying mode [0072]. Because activating the fan creates convection to drive off moisture within the drying chamber, the humidity within the drying chamber may increase to a certain level (e.g., a threshold humidity level). Thus, as seen in check 606, the drying mode may proceed by checking whether a significant relative humidity rate of change has been achieved. If a significant rate of change is not taking place anymore, i.e., the humidity in the drying chamber is not increasing significantly, then the drying mode may proceed by deactivating the fan, as seen in step 608 [0097]. Still further, Purdon discloses that in an embodiment, before the vacuum pump 116 (or other suitable vacuum generating device) turns off, the control valve 114, along with one or more gas valves 112, may open to allow air or other gases into the drying chamber 106 while the relative humidity of the chamber drops as the extracted moisture from the organic materials 102 are evacuated from the drying chamber 106. Reaching a target mass or target moisture may signal the processor 130 when the process is complete [109]. It would have been obvious to use humidity sensors and moisture removal (evacuation) as disclosed by Purdon in the dehydration step of Kayser as modified by Johansson in a similar manner to regulate drying and as parameters in determining whether the desired moisture content has been obtained. Also, Purdon discloses the memory may generally store programs, executable code, and data such as timing intervals and temperature, humidity, pressure, and mass ranges [0076].
Regarding a predetermined mass threshold, as noted above Kayser does take an initial and final mass. Purdon discloses use of this information and establishing a target mass. Specifically, Purdon discloses releasing humidity from the material (biomass) which decreases the mass of the organic material and that when the mass reaches a target level, the system will deactivate drying mode [0075]. Here, mass change is reflective of the moisture removal (i.e. humidity released from the organic material) [0075]. Purdon also states that the mass may be constantly measured which is considered to be multiple measurements. Thus, Purdon demonstrates that it is known in the art to take an initial mass before drying and detect whether the mass has reached a target level (threshold), thus obviating using such measurements in the process of Kayser as modified by Johansson to determine whether the desired level of dryness has been reached.
Further regarding claims 2-7, 10-16, and 23-25, Kayser discloses a final moisture content of 65-85% to mimic raw meat which is seen to meet the post-drying moisture to solid content ratio. For example, a 100g sample would have 85g moisture and 25 g solids would have 3.4 g moisture for every gram of solid, thus a ratio of moisture to solid content of 3.4. Moreover, one of ordinary skill would have found it obvious to determine the level of moisture necessary to mimic the meat product as Kayser discloses that the desired moisture of the meat product is such that it is similar to moisture content of the convention meat. An example of an initial mass is not disclosed by Kayser. However, the cellular materials are grown in a bioreactor in a manner similar to applicants and are harvested by scraping [0028] or other methods and would be expected to be variable depending upon the type of cell used, as well as the environment of the bioreactor. Absent some showing of criticality, the pre-dried weight is not seen to provide a patentable distinction to the method overall. The amount of moisture removed would have been obvious to one of ordinary skill and the starting point at which a weight is taken may also be variable as various preparations may be taken prior to dehydration depending on the manner in which the material is harvested (Kayser [0028]). As Kayser discloses the same desired moisture level as that claimed (raw meat), the starting moisture level would dictate the amount of moisture necessary to remove to reach the target. Moreover, measuring the initial mass and knowing the amount of moisture present in the initial mass and the target moisture (65-85%), one can calculate the final mass based upon conservation of mass.
Still further, Franklin discloses that the system evaporates moisture on a predictable basis and the desired final weight can be predicted (col. 5, lines 63-66). Franklin also weighs the meat before and after drying (Examples 1-6), thus also indicating that an initial weight may be taken and a later weight taken to determine the moisture loss. It would have been obvious to estimate/determine the amount of time needed based upon the parameters (mass of meat, temperature and pressure as indicated by Franklin since the process of using a vacuum with cooling evaporates moisture on a predictable basis and based upon conservation of mass, the final weights can be estimated based upon a projected moisture loss.
Regarding claim 13, Kayser discloses weighing the mass before drying and weighing the mass after drying and the difference in weight is reported as moisture loss. The recitation of a predetermined time is not seen to provide a patentable distinction to Kayser as the dehydration must occur for an amount of time and that time may be variable depending upon the type of cells, temperature, size of the mass etc., and can be estimated by one of ordinary skill in the art based upon repetition and routine experimentation (i.e. learned).
Claim(s) 4, 13, and 25 are further rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/158831 (Kayser) in view of US 2024/0215626 (Johansson) as applied to claim 1 above, and further in view of US 2020/0370830 (Purdon) (cited on IDS filed 01/25/2024) as applied to claim above and further in view of JP 2009/250819 (Matsumoto).
Kayser discloses taking initial mass and final mass and calculating the moisture loss. Balancing the equation for dehydration where the initial mass is a sum of the water removed and solids is considered within the purview of one of ordinary skill.
Purdon likewise discloses taking mass readings constantly until the mass reaches a target level which is indicative of humidity loss. Kayser discloses the desired moisture corresponds to a raw meat product and is 65-85% [0260]. Determining a pre-dried moisture content is seen to be obvious to one of ordinary skill if it is not seen to be readily conveyed by Purdon based upon its establishment of a target mass. Kayser and Purdon both disclose taking initial weights and repeated experimentation would naturally lead the ordinary artisan to seek information regarding reproducibility and predict or estimate results. Kayser and Purdon do not disclose establishing a predetermined time per se although, as noted above, this is not seen to provide a patentable distinction. Moreover, Matsumoto discloses prediction of time for dehydration. Matsumoto discloses estimation of moisture content by using a sample weighing section 5 for weighing the sample 8 and continuously or intermittently outputting the mass value (m), and a weighing data processing section 9 for calculating the moisture content or moisture percentage contained in the sample based on a series of finite number of mass values (m) in a predetermined period output continuously or intermittently. The weighing data processing section 9, using the series of finite number of mass values (m) in the predetermined period, predicts, by a predetermined prediction operation, the time transition of decrease of the mass values (m) until the sample 8 dries completely and the time transition of time variation (Δm) of the mass values (m), and estimates and calculates the moisture content or moisture percentage contained in the sample before measurement (problem to be solved). Matsumoto discloses the use of mass measurements as well as time periods to calculate moisture content from the weight of the sample before drying and estimate the time change until the sample is dry. One of ordinary skill would have been motivated to use similar methodology to that of Matsumoto and apply it to the biomass of Kayser as modified above to predict the amount of time needed to dry to the desired moisture level and estimate a mass of the final product. Matsumoto discloses determining the moisture of the pre-dried material and as noted above Kayser establishes a target. Estimation of time is known and may be accomplished by repeated measurements to establish expectations for similarly run experiments. This concept is well known to one of ordinary skill as exemplified by Matsumoto. Performing repeated experiments to establish predictability of future experiments is well within the purview of one of ordinary skill. Balancing the equation for dehydration where the initial mass is a sum of the water removed and solids is considered within the purview of one of ordinary skill.
Claim(s) 9 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/158831 (Kayser) in view of US 2024/0215626 (Johansson) in view of US 2020/0370830 (Purdon) (cited on IDS filed 01/25/2024) and US 4942053 (Franklin) and further in view of in view of US 2022/0079194 (Li). Kayser, Johansson, Purdon, and Franklin do not expressly disclose addition of agents to bind the proteins.
Regarding claims 9 and 26, Li discloses the addition of peptide cross-linking agents which are considered protein binders [0151] and are added to a dry ingredient mixture thus indicating the obviousness of adding the binder when the material may be dry.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16 and 22-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s amendments and arguments have overcome the 101 rejection. Applicant’s amendments have overcome the 102 rejections over Sato and Frankin.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
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