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 .
Election/Restrictions
Applicant’s election without traverse of Group III, claims 63-66,68-70, 78, 86-87, 90-92, 94, and 96-98 and foam in a water solvent in the reply filed on December 4, 2025 is acknowledged. Claims 1-3, 7-9, 19, 21-22, 25-27, 30-33, 35, 37-40, 42, 45, 100-101, and 105 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to because: Figures 1B and 2D are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 63-66,68-70, 78, 86-87, 90-92, 94, and 96-98 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.
Claim 63 recites “a foam capacity and foam stability comparable to”. It is unclear as to if comparable means the same as, or simply that a comparison can be made. Claim 91 is rejected for substantially the same reasons for the recitation of “comparable”.
Claim 63 recites “similar contents by identify and quantity”. It is unclear as to what would and would not encompass a similar identity and quantity. For example, it is unclear as to if the claim requires the same composition with the exception of the protein components, or as to if some other variation in composition may be present, and if so, how much.
Claim 69 is unclear as no unit of measure has been included for the recited range.
Claims 70, 78, 86, and 97 recite the limitation "the protein component" in claim 63. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to if the claim intends to depend on claim 63 and recite “a protein component”, or if the claim should depend on claim 65 which provides antecedent basis for the term. It is further unclear as to if the term is limited to only proteins, or if the protein component may contain other elements with the protein, such as fats.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 70 recites the broad recitation at least 8%, and the claim also recites at least 10%, at least 20%, etc. which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 78 and 86 are rejected to for substantially the same reasons.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Note: The prior art does not teach or suggest a powdered composition for forming a foam as claimed, wherein the composition comprises an rOVD having an amino acid sequence no 1-44 in combination with an rOVA having an amino acid sequence of 45-118 as recited in claim 98.
Claims 63, 64, 66, 68, 69, 91, 94, and 96 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Anchel (WO 2016/077457).
Regarding claim 63, Anchel teaches an egg white protein composition that is powdered, i.e. dried or spray dried (paragraphs 6, 76, 107, 145, and 158). Anchel teaches the egg white protein composition comprises two or more proteins, wherein the proteins are selected from the group including recombinantly produced ovalbumin (rOVA) and recombinantly produced ovomucoid (rOVD) (paragraphs 6, 7, 14-15, 88, and 94), thus encompassing the combination of rOVA and rOVD in a powdered composition. Additionally refer to paragraph 179 wherein Anchel teaches that varying amounts of protein components can be mixed together in proportions matching those found in animal derived egg whites and spray dried as a packaged egg white protein, and paragraph 80 wherein Anchel teaches that egg white contains approximately 10% proteins, 88% water, and 1-2% carbohydrates wherein egg white proteins may include both about 54% ovalbumin and about 11% ovomucoid.
Regarding the powder composition as capable of being solubilized and aerated to produce a foam composition that has a foam capacity and stability comparable to or higher than the foam capacity and stability of a control composition that comprises similar components by identity and quantity as a control composition except the protein of the control composition is one of chicken egg white or egg white substate, ovomucoid alone, or ovalbumin alone as recited in claim 63, wherein the foam composition has a protein concentration of less than 20% as recited in claim 64, the claimed limitation is unclear for the reasons discussed above. Regardless, it is noted that a foam composition is not claimed, rather a powder composition capable of producing a foam and the claimed limitation is intended use and only requires the ability of the product to perform. As the teachings of Anchel encompass a composition which overlaps that as claimed, including one with the same protein components, the product of Anchel would be expected to be able to perform in the same manner as claimed, especially when compared to a control composition which is the same except for the protein component is one of chicken egg white or egg white substate, ovomucoid alone, or ovalbumin alone. This position is further supported as Anchel teaches that the powdered product resembles animal derived egg whites in consistency, taste, functional properties and/or appearance (paragraph 79 and claim 26); Anchel teaches whipping ability is improved when stored at low moisture levels (paragraph 146), i.e. such as dried; and as Anchel teaches that the egg white protein composition can form a foam which has a foam height, seep and strength, i.e. stability, comparable or greater to an egg white foam (paragraphs 18, 75, 101-103, 190-193, and Figure 18).
Applicant has described the product with parameters which cannot be measured by the office for prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability purposes. 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 re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facie case of anticipation has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
Regarding claim 66, Anchel teaches the egg white protein composition includes additives, wherein the one or more additives include coloring, pH adjusters, sweeteners, and thickeners or bulking agents (paragraphs 15 and 146-157).
Regarding claims 68 and 69, the product of Anchel overlaps the composition as claimed as Anchel teaches the product is dried to at least 0.001% or more water, including 1% or more, (paragraph 158) and that the protein composition comprises at least 50% dry weight protein (paragraphs 98).
Regarding claim 91, Anchel teaches that the powdered product resembles animal derived egg whites in consistency, taste, functional properties and/or appearance (paragraph 79).
Regarding claims 94 and 96, Anchel teaches that the host cell is selected from the group comprising: bacteria including E coli and Pichia species, filamentous fungi, and any combinations thereof (paragraphs 21, 25, 124, and 126-127).
Claims 65, 70, 78, 86, and 97 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Anchel (WO 2016/077457).
As discussed above, Anchel teaches a powdered egg white protein composition comprising two or more proteins including recombinantly produced ovalbumin (rOVA) and recombinantly produced ovomucoid (rOVD).
Regarding the powder as having a protein component that consists essentially of rOVD and rOVA as recited in claim 65 and the protein as not comprising any egg white proteins other than rOVD and rOVA as recited in claim 97, for the purpose of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to comprising.” (MPEP 2111.03) Regardless, as Anchel teaches that the protein comprises two or more of the egg white proteins selected from the group including rOVD and rOVA (paragraphs 6, 7, 14-15, 88, and 94), wherein no other proteins are required (all), the teachings of Anchel encompasses, or alternatively, make obvious the powder as having a protein component that consists essentially of rOVD and rOVA, i.e. only two egg white proteins.
Regarding at least 5% of the protein component as rOVD as recited in claim 70, or at least 5% as rOVA as recited in claim 78, or the ratio of rOVD to rOVA as 1:20 to 20:1 as recited in claim 86, as Anchel teaches that varying amounts of protein components can be mixed together in proportions matching those found in animal derived egg whites and spray dried as a packaged egg white protein (paragraph 179), and that egg white contains approximately 10% proteins, 88% water, and 1-2% carbohydrates wherein egg white proteins may include both about 54% ovalbumin and about 11% ovomucoid (paragraph 80), wherein the protein is dried to a moisture content of 0.01% or more (paragraph 158), the teachings of Anchel would encompass or alternatively make obvious the powder protein component as comprising about 54% rOVA and about 11% rOVD and a ratio of rOVD (11) to rOVA (54) of about 1:4.9 which encompass the claimed ranges. Additionally, the claimed ranges are considered further obvious in view of the prior art. As Anchel teaches the egg white protein composition comprises two or more proteins, wherein the proteins are selected from the group including recombinantly produced ovalbumin (rOVA) and recombinantly produced ovomucoid (rOVD) (paragraphs 6, 7, 14-15, 88, and 94), the teachings of Anchel would at least suggest rOVD and rOVA in an amount of less than 100% and in ratios of 1:100 to 100:1 which make obvious the claimed ranges.
Claims 87, 90, and 92 are rejected under 35 U.S.C. 103 as obvious over Anchel (WO 2016/077457).
As discussed above, Anchel teaches a powdered egg white protein composition comprising two or more proteins including recombinantly produced ovalbumin (rOVA) and recombinantly produced ovomucoid (rOVD).
Regarding claim 87 and the rOVD as with a glycosylation pattern different from that obtained from a chicken egg, it is first noted that the limitations following said clause are optional as they are preceded by “and/or”. Regardless, as disused above, Anchel teaches a powdered egg white protein composition comprising two or more proteins including rOVD and rOVA. Although Anchel is not specific to said proteins as glycosylated, as Anchel generally teaches the proteins have glycosylation pattern different from that of a chicken egg (paragraphs 11, 89, and 93), the teachings of Anchel at least make obvious the rOVD as with a glycosylation pattern different from that obtained from a chicken egg.
Regarding the rOVD as comprising at least three glycosylated asparagine residues as recited in claim 90, Anchel teaches a powdered egg white protein composition comprising two or more proteins including rOVD and rOVA. Although Anchel is not specific to said proteins as glycosylated as Anchel generally teaches that the isolated recombinant egg white protein may have glycosylation and one or more amino acid insertions, deletions, or substitutions (paragraphs 1, 11, 12, 61, 79, 89-90, 93, 96-97, 121, and 169), one or more glycosylated amino acids, such as three or more glycosylated asparagine residues in the disclosed proteins, including the rOVD would have been an obvious suggestion of the prior art.
Regarding the rOVA as with a glycosylation pattern different from that obtained from a chicken egg as recited in claim 92, as disused above, Anchel teaches a powdered egg white protein composition comprising two or more proteins including rOVD and rOVA. Although Anchel is not specific to said proteins as glycosylated, as Anchel generally teaches the proteins have glycosylation pattern different from that of a chicken egg and that, (paragraphs 11, 89, and 93), the teachings of Anchel at least make obvious the rOVA as with a glycosylation pattern different from that obtained from a chicken egg.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 63-66, 68-70, 78, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 18 of U.S. Patent No. 11,279,748 (‘748). Although the claims at issue are not identical, they are not patentably distinct from each other because both recite an egg white composition comprising rOVA and rOVD (claim 2 ‘748). ‘748 further claims that the composition of claim 2 is spray dried (claim 18), and thus would be a powder.
Regarding the powder composition as capable of being solubilized and aerated to produce a foam composition that has a foam capacity and stability comparable to or higher than the foam capacity and stability of a control composition that comprises similar components by identity and quantity as a control composition except the protein of the control composition is one of chicken egg white or egg white substate, ovomucoid alone, or ovalbumin alone as recited in claim 63, wherein the foam composition has a protein concentration of less than 20% as recited in claim 64, the claimed limitation is unclear for the reasons discussed above. Regardless, it is noted that a foam composition is not claimed, rather a powder composition capable of producing a foam and the claimed limitation is intended use and only requires the ability of the product to perform. As the claims of ‘748 encompass a composition which overlaps that as claimed, including one with the same protein components, the product claimed by ‘748 would be expected to be able to perform in the same manner as claimed, especially when compared to a control composition which is the same except for the protein component is one of chicken egg white or egg white substate, ovomucoid alone, or ovalbumin alone. This position is further supported as ‘748 claims the composition resembles animal derived egg white in consistency, taste, and appearance and that the proportion of rOVA and rOVD is similar to the operation in an animal derived egg white (claim 2).
Applicant has described the product with parameters which cannot be measured by the office for prior art comparison, because the office is not equipped to manufacture the reference application products and compare them for patentability purposes. 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 re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 65, for the purpose of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to comprising.” (MPEP 2111.03). Thus, by claiming a composition with rOVA and rOVD, the claims of ‘748 encompass a product as claimed.
Regarding claim 66, ‘748 teaches the powder contains additional additives including proteins, ovotransferrin (claim 2).
Regarding claims 68 and 69, and the protein content as at least 1% or at most 99% respectively, wherein the rOVD is at least 5% of the protein component as recited in claim 70, and the rOVA is at least 5% of the protein component as recited in claim 78, as ‘748 claims the composition resembles animal derived egg white in consistency, taste, and appearance and that the proportion of rOVA and rOVD is similar to the operation in an animal derived egg white (claim 2), and egg white contains approximately 10% proteins, 88% water, and 1-2% carbohydrates wherein egg white proteins may include both about 54% ovalbumin and about 11% ovomucoid, the claimed limitations are encompassed, or alternatively obvious over the dried product claimed by ‘748. For example with the product dried, up to 88% of the water, or less, would be removed, and the remaining dried product would consists of 10 gram protein and 1-2 grams carbohydrate, wherein the protein comprised about 54% OVA and 11% OVD.
Regarding claim 91, ‘748 claims the composition resembles animal derived egg white in consistency, taste, and appearance (claim 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792