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 .
Status of Claims and Rejections
Claims 1-20 are currently pending. Claim 20 is newly-added. Claims 1-20 are herein rejected under 35 U.S.C. 103, as addressed below. The previous rejections under 35 U.S.C. 112(b) are withdrawn in view of applicant’s amendments.
Examiner’s Notes
The following observations of claim structure and clarity are provided to applicant as a courtesy at this point in prosecution.
Regarding steps (a), (b) & (c) of Claim 1:
With respect to the phrase "inoculating recombinant source material into a growth medium":
The claims do not recite any identifying or descriptive information regarding a “recombinant source material” regarding in what form or host this “material” is provided; this could be nucleic acids itself, vector-containing microorganisms, etc.
As such, this also leaves the term “inoculating” in question as to what is being inoculated, and with what material.
In step (b), the phrase "in the presence of yeast or bacteria or other edible biological host" does not clearly indicate the role or purpose of these microorganisms within the growth medium. For example, there is no connection recited between the yeast/bacteria/host and the “recombinant source material” which was inoculated somewhere within the growth medium.
Similarly, there is a disconnect between the "recombinant source material" in step (a) and how culturing this “in the presence of” yeast/bacteria/host is to somehow "form structural muscle protein" in step (b).
Claim 1 step (a) recites "a growth medium", while step (b) refers to culturing "on minimal growth medium", where no connection is established as to whether these are intended to be the same, or different, growth medium.
Claim 17 recites "conventionally produced meat" and claim 18 recites "conventional meat", where no standard is provided in the application for ascertaining what is intended by “conventional” or “conventionally”.
Claim 18: No standards of measurement, range of inclusion of what animals or location parameters are intended, or other baseline information is provided with respect to how this could be assessed such that the claimed method itself "results in a significant reduction in slaughtered animals."
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 following rejections are maintained from the previous Office action of March 20, 2025:
Claims 1-5 and 7-18, and new claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over President and Fellows of Harvard College et al. (Harvard, WO 2016/007879) taken together with Pronutria, Inc. (Pronutria, WO 2015/048339).
The references and rejection are hereby incorporated as cited in the previous Office action.
With respect to new claim 20, which requires that the yeast or bacteria comprises nucleic acids that encode actins, it is noted that secondary reference Pronutria, at paragraph [0168], teaches the production of various proteins including muscle proteins such as actin and myosin. As stated in the previous Office action, Pronutria teaches the recombinant production of nutritive edible proteins produced by microorganisms such as bacteria and yeast. Given these teachings as motivation, it would have been obvious to have selected any one, or several, of the known edible “nutritive polypeptides” taught by Pronutria, for microbial expression and use within known food products, including the specifically recited muscle proteins such as actin.
Claim 6 remains rejected under 35 U.S.C. 103 as being unpatentable over President and Fellows of Harvard College et al. (Harvard) taken together with Pronutria, Inc. (Pronutria) and University of Huazhong (Huazhong, CN 102453716).
The references and rejection are hereby incorporated as cited in the previous Office action.
Claim 19 remains rejected under 35 U.S.C. 103 as being unpatentable over President and Fellows of Harvard College et al. (Harvard) taken together with Pronutria, Inc. (Pronutria) and Ningxia Yiwei Moslem Food Co. Ltd. (NYM Food, CN 103892273).
The references and rejection are hereby incorporated as cited in the previous Office action.
Response to Arguments
Applicant's arguments filed June 30, 2025 have been fully considered but they are not persuasive for the reasons set forth below.
At page 8 of the 6/30/2025 response, applicant emphasizes steps (d) and (e) of claim 1, which are directed to:
Claim 1, step (d): cross-linking the structural muscle protein into filaments to produce protein filaments by a biochemical and/or chemical process;
Claim 1, step (e): bundling the protein filaments together to provide strength and rigidity.
Applicant’s arguments have been considered but are not deemed persuasive for the reasons of record, as set forth in the rejections under 35 U.S.C. 103 on March 20, 2025.
Initially, at page 9 of the response, applicant alleged “it is apparent that the Examiner is using improper hindsight reconstruction using a reference that clearly teaches away from the claimed present invention. The Examiner is selecting the portions of Pronutria that the Examiner likes while neglecting the parts that clearly teach away from the invention.”
This is not deemed persuasive. With respect 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).
More specifically, applicant’s allegation that “the Examiner is selecting the portions of Pronutria that the Examiner likes while neglecting the parts that clearly teach away from the invention”, emphasizing that “A prior art reference must be considered in its entirety, i.e., as a whole,” is not well-founded with respect to the record. Contrary to this allegation, pages 7- 15 of the previous Office action refer to numerous passages and teachings across the entire Pronutria document, each relevant to the claimed invention and the combination with the primary reference of Harvard. Applicant has not addressed any of these teachings with respect to the obviousness of the combination of references. In stark contrast, Applicant's response points to a single paragraph [0004] in the Background section at the third page of the 358-page (plus Figures) patent disclosure of Pronutria, in an attempt to negate the fully-supported obviousness rejection set forth in the previous Office action.
As applicant noted in the 6/30/25 response, par. [0004] of Pronutria states that “it would be useful in certain situations” to enhance the solubility of proteins, which admittedly does discuss one possible use of recombinant proteins to make them more soluble. This, of course, does not indicate that it would or should apply to all - or even most - situations where proteins are utilized in consumable products, and only represents but one utility of the recombinantly-produced proteins, as stated by Pronutria. As noted by applicant at page 9 of the response, "a prior art reference must be considered in its entirety, i.e. as a whole".
At pages 8-9 of the response, applicant refers to par. [0004] of secondary reference Pronutria, which states that “Nutritive proteins with higher solubility can exhibit desirable characteristics such as increased stability, resistance to aggregation, and desirable taste profiles.” Applicant then “respectfully notes that this passage shows that a desirable characteristic of supplying protein in a food source for mammalian consumption is to have the nutritive protein be soluble,” whereas by contrast,
“the present invention has as a step of ‘bundling the protein filaments together to provide strength and rigidity’. This is the exact opposite of what Pronutria describes as a desirable quality. Applicant notes that by bundling the protein filaments together, for example, using actin, the bundling renders the bundled protein insoluble. This is precisely the opposite of what Pronutria says is desirable.”
Applicant summarizes this by stating “Thus, it should be readily apparent to those of ordinary skill in the art that one would not use the Pronutria reference in combination with Harvard because the two references have divergent and opposite interests.”
This is not deemed persuasive for the reasons of record, as well as those addressed below.
Secondary reference Pronutria was relied upon to demonstrate that recombinant muscle proteins were known in the art, produced by edible organisms such as those recited in the previous Office action. Once such recombinant muscle proteins have been produced, a number of known processing methods may be employed, including either the numerous methods discussed in Pronutria, as well as those taught by the primary reference of Harvard.
For example, as stated at pages 5-6 of the Non-Final action, Harvard teaches the crosslinking of the proteins, including by the use of transglutaminase, to produce hydrogels which are then processed to produce the bioprotein tubes, as also recited at steps (d) and (e) of instant claim 1. Similarly, secondary reference Pronutria teaches the use of transglutaminase to cross-link the recombinantly-produced proteins, as well as the formation of gels (see claim 2 at pg 352 of Pronutria, as well as par. [00219-00220] at pages 56-58.
Continuing on, Pronutria par. [00109] at pages 298-299 discusses generating a solution with increased viscosity by using transglutaminase "to create a network consisting of enzyme-induced permanent covalent cross-links between nutritive polypeptides." Still further, par. [219] of Pronutria states:
In some embodiments, the viscosity of nutritive polypeptide-containing materials is enhanced by crosslinking the nutritive polypeptides or crosslinking nutritive polypeptides to other proteins present in the material. An example of an effective crosslinker is transglutaminase, which crosslinks proteins between an ε-aminogroup of a lysine residue and a γ-carboxamide group of glutamine residue, forming a stable covalent bond. The resulting gel strength and emulsion strength of nutritive polypeptides identified and produced as described herein are examined by preparing a transglutaminase-coupled nutritive protein composition, followed by gel strength and emulsion strength assays.
… This enzyme treatment can also be followed by thermal processing to make a viscous solution containing a nutritive polypeptide.
See also several of the examples in Pronutria, including Example 30, etc.
Additionally, par. [00220] of Pronutria discuss the rheological properties of the polypeptides, as well as the viscosity and gel viscoelasticity after treatment with transglutaminase or thermal treatments. This ties directly to the teachings of primary reference Harvard.
Par. [00518] of Pronutria discloses that "in some embodiments, proteins are processed into a dry form (e.g. by lyophilization)" to promote extended storage. Par [00545-00550] disclose that the proteins produced "can be formulated into a variety of forms", including a solid foodstuff (par. [00549]).
Finally, Example 19 at par. [00938] of Pronutria specifically states that "Alternative to soluble, homogenous, liquid formulations, nutritive polypeptides can be prepared alternatively. This example describes alternative nutritive polypeptide formulations such as slurries, gels, tablets and food ingredients" (emphasis added). This example also utilizes transglutaminase (par. [00940]), and at par. [00944] incorporates the nutritive polypeptides into solid food ingredients as dry solid formulations for use in foods such as pasta dough. These teachings stand in direct contrast to applicant’s position that Pronutria is solely directed to making soluble protein for use in liquid beverage preparations.
Thus, in contrast to applicant’s reference to a single paragraph [0004] of Pronutria, along with allegations that the teachings of this reference are “the exact opposite” of the claimed invention, it can be seen that Pronutria is well-suited to be combined with the teachings of primary reference Harvard for the reasons of obviousness as set forth in the previous non-final action, and does in fact teach all that applicant alleges it fails to teach – and more.
Conclusion
Applicant's amendment – adding new claim 20 – 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 KEITH D HENDRICKS whose telephone number is (571)272-1401. The examiner can normally be reached Monday - Friday, 8:00am-5:30pm.
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/Keith D. Hendricks/Primary Patent Examiner, Art Unit 1733