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 .
Applicant’s amendment and reply filed January 23, 2026 have been received and entered into the case. Claims 3 – 4, 11 and 13 are canceled; claims 1 – 2 and 5 – 6 are pending and have been considered on the merits. All arguments have been fully considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 2 and 5 – 6 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a method for modifying a protein with a peptidylprolyl isomerase (PPIase) and an enzyme selected from protease, protein glutaminase and laccase. Claim 5 indicates the protein to be modified are unlimited in that they may be any protein from plant, animal, microorganism or insect.
These claims are considered genus claims that encompass a wide array of enzymes and enzyme combinations, and also ANY protein that might be acted on. PPIase are a known superfamily of proteins consisting of immunophilins and parvulins. In turn, the immunophilin family is further subdivided into the FK506-binding proteins (FKBPs) and cyclophilins. In humans, there are 18 FKBPs, 24 cyclophilins, and 3 parvulins (Dunyak, p. 2). The FK506-binding proteins (FKBPs) (a PPIase subfamily of 18 proteins) are widely expressed but especially abundant in skeletal and cardiac muscle, the central nervous system, peripheral nerves, and blood cells (Dunyak, p.3). Cyclophilins are also widely distributed across tissues types (Dunyak, p.4). Further, there are hundreds, if not thousands, of proteases that exist in nature. In the human genome alone, there are at least 700 known proteolytic enzymes (Sanman et al., introduction). The claims are unlimited in terms of what protein the combination of enzymes might act on. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of enzyme combinations to act on any, unlimited number of proteins.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all enzyme combinations that might modify any protein. The possible variations of enzyme combinations acting on any protein are limitless with potentially millions of combinations. The instant disclosure identifies only 4 enzyme combinations and only 4 proteins on which the enzyme combinations are applied. Specifically, a particular PPIase with each of 1) protease; 2) glutaminase; 3) pepsin; 4) laccase; acting to modify azo casein, soybean protein, wheat gluten, 33 mer peptide, and casein. More specifically,
FKBP12, Aspergillus oryzae - derived protease, and casein;
Cyclophilin A, protein glutaminase, and soybean protein;
a single sequence derived from Streptomyces griseus (SgPPI), protein glutaminase and each of wheat gluten, soybean protein, pea proteins, milk casein and egg albumin;
SgPPI, laccase, and milk casein.
The specification further suggests that they have newly discovered that PPIase acts on proteins rather than as a chaperone to the enzymes. The art recognizes that PPIase function to as chaperones in protein folding and regulation rendering them essential to protein function and folding (Dunyak, p.2). Applicant has failed to describe a method wherein both the PPIase and protease/protein glutaminase/laccase enzymatically modify the same protein as claimed.
Example 1 discloses PPIase FKBP12, protease, casein versus azocasein and protease and that the combination of FKBP12 and protease results in more decomposition of azocasein. Applicant asserts this shows the FKBP12 promotes protease decomposition of the protein. However, the example fails to demonstrate that FKBP12 modifies casein or azocasein as claimed. Specifically, the example fails to show FKBP12 alone with a protein results in composition of the protein.
Example 2 discloses protein glutaminase, cyclophilin A and soybean protein versus protein glutaminase alone increases protein deamidation. However, the example fails to demonstrate that cyclophilin A acts on protein as claimed. Specifically, the example fails to show cyclophilin A alone results in deamidation of the soybean protein.
Example 3 discloses a single sequence derived from Streptomyces griseus (SgPPI) promotes deamidation of wheat gluten, soybean protein, pea proteins, milk casein and egg albumin when combined with protein glutaminase versus the protein glutaminase alone. However, the example fails to demonstrate that the SgPPI acts on proteins as claimed. Specifically, the example fails to show SgPPI alone results in deamidation of the proteins.
Example 4 discloses laccase, SgPPI and milk casein results in higher crosslinking of casein compared to laccase alone. However, the example fails to demonstrate that the SgPPI acts on proteins as claimed. Specifically, the example fails to show SgPPI alone results in crosslinking the proteins.
Example 5 discloses chickpea protein and SgPPI results in uniform dispersal. However, no nexus is made between the dispersal of chickpea milk and SgPPI, or how the example demonstrates the specific SgPPI modifies chickpea protein or the claimed invention.
Moreover, each of the examples fail to describe the invention as claimed. Rather, the examples appear to show specific combinations of specific PPIases, specific enzymes, and specific protein substrates may result in higher modification of the protein than the enzyme alone. Moreover, the PPIase are confirmed to act as chaperons of the enzymes (proteins).
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of enzyme/protein combinations to reflect this variance in the genus since the specification does not provide any examples of such a genus of enzyme combinations that modify any particular genus of protein. Accordingly, the specification fails to provide adequate written description for the genus of enzymes and proteins to be acted upon, and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these enzyme and proteins, the specification does not describe the claimed method for producing a modified protein in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these variations at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
Response to Arguments
Applicant argues that the claims have been amended to limit the protein modification enzyme to those disclosed in examples 1 – 4. However, the claims are not limited to any particular PPIase, protease or protein. In this regard, the claims remain rejected for the reasons stated above.
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to the cancelation of the rejected claims.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 as being anticipated by Schönbrunner et al. (1992) as evidenced by RNase (Wikipedia) and Aspergillus Oryzae (Wikipedia) are withdrawn due to the amendment excluding oxidoreductase from the claims.
No claims are allowed.
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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