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 .
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-43
Withdrawn claims: None
Canceled claims: None
Amended claims: 5-11, 13-17, 20-24, 28-34, 36-38, and 41-43
New claims: None
Claims currently under consideration: 1-43
Currently rejected claims: 1-43
Allowed claims: None
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 13, 28, and 36 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 13 and 36 recite “an E. coli species,” which is vague and indefinite in that “E. coli” already recites the species.
Claim 28 recites the limitation “the protein bar composition” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan et al. (U.S. 2021/0007384 A1) in view of Chimel et al. (U.S. 2005/0069625 A1).
Regarding claim 1, Mahadevan et al. discloses a protein bar composition ([0147], [0363], Example 24) comprising recombinantly-produced ovomucoid (rOVD), a fat component (cocoa, which Chimel et al. indicates would contain at least some fat, [0020]), a fruit component (dates), and a nut component (almonds and walnuts) ([0363]).
Mahadevan et al. does not disclose the protein bar composition as comprising at least 2% water w/w.
However, Chimel et al. discloses granola bars comprising 9% water ([0092], table).
It would have been obvious to one having ordinary skill in the art to produce a protein bar composition according to Mahadevan et al. having a water content of at least 2% w/w. Mahadevan et al. discloses generally that various bar formulations may be produced ([0147]), which provides motivation for consulting an additional reference, such as Chimel et al., in determining suitable alternative bar formulations. Since Chimel et al. discloses a granola bar comprising 9% water and discloses the bars may comprise protein, such as egg protein ([0020]), indicating the similarity with the bars of Mahadevan et al., a skilled practitioner would find the production of protein bars according to Mahadevan et al. comprising at least 2% water w/w to be obvious.
As for claim 2, Mahadevan et al. discloses the rOVD as having a glycosylation pattern different from that of a native chicken ovomucoid ([0089]).
As for claim 3, Mahadevan et al. discloses the rOVD protein as comprising at least one glycosylated asparagine residue and as being substantially devoid of N-linked mannosylations ([0004]).
As for claim 4, Mahadevan et al. discloses each glycosylated asparagine residue as comprising a single N-acetylglucosamine ([0005]).
As for claim 5, Mahadevan et al. discloses the rOVD as comprising at least three glycosylated asparagine residues ([0005]).
As for claim 6, Mahadevan et al. discloses the rOVD as providing protein fortification to the protein bar composition and improved texture and hardness ([0086]-[0087]).
As for claim 7, Mahadevan et al. discloses the protein bar composition as comprising at least 1% rOVD w/w ([0104]).
As for claim 8, Mahadevan et al. discloses the protein bar composition as comprising at least 5% rOVD w/w ([0104]).
As for claim 9, Mahadevan et al. discloses the protein bar composition as comprising at most 25% rOVD w/w ([0104]).
As for claim 10, Mahadevan et al. discloses the protein bar composition as having sensory properties comparable to or better than those of a control composition that comprises a plant-derived protein source instead of rOVD ([0126]).
As for claim 11, Mahadevan et al. discloses the rOVD as being produced by a microbial host cell ([0025]).
As for claim 12, Mahadevan et al. discloses the microbial host cell as being a yeast, a fungus, or a bacterium ([0025]).
As for claim 13, Mahadevan et al. discloses the microbial host cell as being a Pichia species ([0025]).
As for claim 14, Mahadevan et al. discloses the protein bar composition does not comprise any egg-white protein other than rOVD ([0100], where “rOVD protein may be used on its own”).
As for claim 15, Mahadevan et al. discloses the protein bar comprises one or more excipients ([0203]).
As for claim 16, Mahadevan et al. discloses the protein bar composition may comprise a solvent ([0190], [0203], e.g., a polyol).
As for claim 17, Mahadevan et al. discloses the rOVD comprises an amino acid sequence of SEQ ID No. 1 ([0219], [0221], Table 1, SEQ ID No. 1).
Claims 18-38 and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan et al. (U.S. 2021/0007384 A1).
Regarding claim 18, Mahadevan et al. discloses a solid consumable comprising at least 1% of a recombinant ovomucoid protein (rOVD) w/w and at least one more consumable ingredient ([0363]).
Mahadevan et al. does not explicitly disclose the rOVD as providing binding activity to the solid consumable composition.
However, MPEP 2112 I states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." The rOVD of Mahadevan et al. is thus presumed to function in the manner presently claimed, thus rendering the claimed function obvious. Further, no other component in the mixture is described as functioning as a binding agent ([0363]), thus suggesting that the rOVD functioned as a binding agent.
As for claim 19, Mahadevan et al. discloses the solid consumable composition as comprising at least 5% rOVD w/w ([0104]).
As for claim 20, Mahadevan et al. discloses the solid consumable composition as comprising at least 10% rOVD w/w ([0104]).
As for claim 21, Mahadevan et al. discloses the solid consumable composition as comprising at least 15% rOVD w/w ([0104]).
As for claim 22, Mahadevan et al. discloses the solid consumable composition as comprising at least 20% rOVD w/w ([0104]).
As for claim 23, Mahadevan et al. discloses the solid consumable composition as comprising at most 25% rOVD w/w ([0104]).
As for claim 24 Mahadevan et al. discloses the rOVD as having a glycosylation pattern different from that of a native chicken ovomucoid ([0089]).
As for claim 25, Mahadevan et al. discloses the rOVD protein as comprising at least one glycosylated asparagine residue and as being substantially devoid of N-linked mannosylations ([0004]).
As for claim 26, Mahadevan et al. discloses each glycosylated asparagine residue as comprising a single N-acetylglucosamine ([0005]).
As for claim 27, Mahadevan et al. discloses the rOVD as comprising at least three glycosylated asparagine residues ([0005]).
As for claim 28, Mahadevan et al. discloses the rOVD as providing protein fortification to the solid consumable composition and improved texture and hardness ([0086]-[0087]).
As for claim 29, Mahadevan et al. discloses the solid consumable of claim 18 but does not explicitly disclose the rOVD as providing a comparable or higher shelf life to the solid consumable composition than a different protein at the same concentration or no substitute protein.
However, MPEP 2112 I states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." MPEP 2112.01 I states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In light of the rOVD being the same in the present application as that of Mahadevan et al., the rOVD of Mahadevan et al. is presumed to function in the manner presently claimed by providing a comparable or higher shelf life to a solid consumable composition, thus rendering the claimed function obvious.
As for claim 30, Mahadevan et al. discloses the solid consumable of claim 18 but does not explicitly disclose the rOVD as providing a comparable or lower water activity to the solid consumable composition than a different protein at the same concentration or no substitute protein.
However, MPEP 2112 I states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." MPEP 2112.01 I states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In light of the rOVD being the same in the present application as that of Mahadevan et al., the rOVD of Mahadevan et al. is presumed to function in the manner presently claimed by providing a comparable or lower water activity to a solid consumable composition, thus rendering the claimed function obvious.
As for claim 31, Mahadevan et al. discloses the solid consumable as having a higher cohesiveness than a control product comprising a different protein ([0372], where the nOVD product was “less sticky”, and the rOVD product “was cohesive”).
As for claim 32, Mahadevan et al. discloses the solid consumable of claim 18 but does not explicitly disclose the rOVD as providing a comparable or higher moistness to the solid consumable composition than a different protein at the same concentration or no substitute protein.
However, MPEP 2112 I states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." MPEP 2112.01 I states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In light of the rOVD being the same in the present application as that of Mahadevan et al., the rOVD of Mahadevan et al. is presumed to function in the manner presently claimed by providing a comparable or higher moistness to a solid consumable composition, thus rendering the claimed function obvious.
As for claim 33, Mahadevan et al. discloses the solid consumable as having improved flavor compared to a control product comprising a different protein ([0372], where the nOVD product was “had a strong OVD-like, metallic and acidic taste”, and the rOVD product “had no acidity…and had a pleasant aftertaste”).
As for claim 34, Mahadevan et al. discloses the rOVD as being produced by a microbial host cell ([0025]).
As for claim 35, Mahadevan et al. discloses the microbial host cell as being a yeast, a fungus, or a bacterium ([0025]).
As for claim 36, Mahadevan et al. discloses the microbial host cell as being a Pichia species ([0025]).
As for claim 37, Mahadevan et al. discloses the solid consumable composition does not comprise any egg-white protein other than rOVD ([0100], where “rOVD protein may be used on its own”).
As for claim 38, Mahadevan et al. discloses the solid consumable composition comprises one or more egg-white proteins other than rOVD ([0097]).
As for claim 41, Mahadevan et al. discloses the solid consumable composition is a protein bar ([0147], [0363], Example 24).
As for claim 42, Mahadevan et al. discloses the solid consumable composition is a protein bar ([0147], [0363], Example 24).
As for claim 43, Mahadevan et al. discloses the solid consumable comprises fruits (dates) and nuts (almonds and walnuts) ([0363]).
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Mahadevan et al. (U.S. 2021/0007384 A1) in view of Anchel (U.S. 2018/0355020 A1).
As for claim 39, Mahadevan et al. discloses the solid consumable composition of claim 38 but does not explicitly disclose the consumable as comprising ovalbumin.
However, Anchel discloses ovalbumin ([0006]) that may be added to a protein bar ([0075]).
It would have been obvious to one having ordinary skill in the art to add ovalbumin to the solid consumable composition of claim 38. Mahadevan et al. discloses the consumable product may comprise an egg-white protein other than rOVD ([0097]), which would prompt a skilled practitioner to consult Anchel for clarification. Since Anchel discloses ovalbumin as a suitable egg white protein ([0006]) for addition to a protein bar ([0075]), the addition of ovalbumin as the egg white protein in Mahadevan et al. would be obvious to a skilled practitioner.
As for claim 40, Anchel disclose the ovalbumin as being recombinant ovalbumin ([0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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