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 reply to the Restriction Requirement, dated August 3, 2026, has been received. By way of this submission, Applicant has elected Group I: claims 1-2, 10, 14-17, 21-22, 27-28, 36, and 55, and the species of OVM-014 (SEQ ID NO: 10), biotin-PEG, and connection to the C-terminus.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-2, 10, 14-17, 21-22, 27-28, 36, 55, 101-102, 110, 116, 140-141, and 149 are pending in the application. Claims 22, 101-102, 110, 116, 140-141 and 149 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 22) or invention (claims 101-102, 110, 116, 140-141 and 149), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 3, 2026.
Claims 1-2, 10, 14-17, 21, 27-28, 36, and 55 are therefore under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at pages 37 and 38. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1 and 27 are objected to because of the following informalities: the claims introduces a group of peptides called “yolk serum albumin”, but the group of peptides later in the claim is referred to as only “serum albumin”. Appropriate correction is required.
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.
Claim 55 is 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 55 recites the limitation of "the detectably labeled anti-human antibody". There is insufficient antecedent basis for this claim limitation, as parent claim 27 recites "allergy associated immunoglobulin (AAI)-specific labeling reagent". These two limitations are not the same.
Claims 1-2, 10, 14-17, 21, 27-28, 36, and 55 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 and 27 both recite the limitation of "up to about 65 egg peptides". The term "about" is not defined by the specification, and there is no context to provide any indication as to what range of specific activity is covered by the term "about." As this term creates vagueness as to the exact metes and bounds of the claims, the claims are indefinite. MPEP 2173.05(b)(III)(A).
For the purposes of claim construction, the claims are read to require anywhere from 1 to 65 peptides, unless the exact number of peptides is clearly indicated.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1, 2, and 10 are directed to a set of peptides comprising naturally occurring products. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are drawn to a "composition comprising up to about 65 egg peptides from 1 to 7 egg proteins". Because the peptides are composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The recited set of peptides is a nature-based product that must be compared to its closest naturally occurring counterpart to determine if it has markedly different characteristics than the counterpart. Because the peptides do not occur together in nature, there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is compared to its naturally occurring components, i.e., peptide. The peptides are naturally occurring, so neither would be eligible as claimed on their own. While the mixture of these two or more naturally occurring components is novel and does not occur in nature, there is no indication that "mixing" or assembling these components together into a set changes the structure, function, or other properties of the peptides. Instead, the peptides retain their naturally occurring structure and function. (See Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948)) Thus, for at least one embodiment within the broadest reasonable interpretation, the claimed set as a whole does not display markedly different characteristics compared to the naturally occurring counterparts. Accordingly, each peptide component is a "product of nature" exception, and the claim is directed to at least one exception (Step 2A prong one: YES).
Because there are no different characteristics. there are no markedly different characteristics. Because the claimed set does not have markedly different characteristics, it is a "product of nature" exception natural phenomenon exception, and the claims do not recite additional elements that integrate the judicial exception into a practical application. (Step 2A: Prong 2 NO).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. Because the component elements (the peptides "product of nature" exceptions) do not occur together in nature and are not markedly changed by their combination into a set, each is considered as an additional element to the other. This consideration provides an opportunity to explore whether this combination of "products of nature" amounts to significantly more than the products themselves. As discussed above, assembling the peptides into a set does not markedly change the characteristics of either component, because each component continues to have the same properties in the set as it had alone. Thus, the claim as a whole does not amount to significantly more than each "product of nature" by itself (Step 2B: NO).
Therefore, claims 1, 2, and 10 do not qualify as patent eligible subject matter.
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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 10, 14, 27-28, 36, and 55 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Getts (US20170219578A1, cited previously).
Getts teaches a composition, comprising a plurality of peptides, wherein the peptides may include DCLLCAYSIEFGTNI (SEQ ID NO: 416), which is identical to Applicant's SEQ ID NO: 10 (claim 26, also see para. 0080).
Getts further teaches peptides of NATDKEGKDVLVCNK (SEQ ID NO: 406), DLRPICGTDGVTYTN (SEQ ID NO: 411), VCGTDGVTYDNECLL (SEQ ID NO: 434), LKISQAVHAAHAEIN (SEQ ID NO: 385), YTNDCLLCAYSIEFG (SEQ ID NO: 415), and SSLRDILNQITKPND (SEQ ID NO: 305, which are identical to Applicant's SEQ ID NOs: 3, 7, 19, 51, 9, and 39, respectively (para. 0080), which is pertinent to claim 10.
Getts further teaches that the above peptides may be conjugated to a solid support (para. 0035), which is pertinent to claim 14.
Getts further teaches kits comprising the above, including an anti-human IgE antibody that is conjugated to a reporter moiety (i.e., a detectable reagent) (para. 0072-0073), which is pertinent to claims 27-28, 36, and 55.
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 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 15-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Getts as applied to claim 14 above, and further in view of Sampson (US20150168389A1).
The teachings of Getts have been described supra. However, Getts does not teach a biotin-PEG linker-spacer.
Sampson teaches arraying peptide epitopes of an allergen on a solid support for the purpose of an IgE microarray immunoassay (para. 0010 and 0076).
Sampson further teaches that the peptides may be bound to the support with a linker moiety, such as ethylene glycol oligomers (i.e., polyethylene glycol (PEG)) (para. 0078).
Sampson further teaches that the peptides may be modified with biotin to allow for site-specific immobilization and accessibility for antibody binding (para. 0085).
Sampson further teaches that the peptides may be modified at the N- or C-terminus (para. 0073).
Sampson also teaches that the allergen may be an egg allergen (para. 0011, also see Table 1).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Getts and Sampson to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Getts and Sampson are concerned with immunoassays for allergens. According to both Getts and Sampson, it was known to attach peptide epitopes of an allergen to a solid support for the purpose of performing an immunoassay. Sampson teaches methods by which peptides may be attached to the support, such as with biotin or ethylene glycol oligomers. One of ordinary skill could apply the biotin and ethylene glycol oligomers of Sampson to the peptides and solid support of Getts by known methods, with each component performing its known, usual function, and the combination would yield nothing more than predictable results.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1642
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