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 .
Priority
This application claims priority to foreign application SE2150022-8, filed on 13 January 2021, and PCT application PCT/EP22/50663, filed on 13 January 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date is 13 January 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 April 2024 is being considered by the examiner.
Status of Application, Amendments, and/or Claims
Claims 1-31 are the original claims filed on 12 July 2023. In the preliminary amendment of 12 July 2023, claims 2-4, 11-15, 17, 19, 21-31 are amended. Claims 1-31 are pending and the subject of this office action.
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 3 is rejected due to the incorporation of a reference, Table 3. As stated in MPEP 2173.05(s), the incorporation of a reference to a specific figure or table is only permissible in exceptional circumstances such as when “there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim.” Incorporation by reference is a necessity doctrine, not for applicant’s convenience (Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)). Claims should be complete in themselves. Amending the claim, in such a fashion as to duplicate the reference into the claim, may obviate the rejection.
Claims 21-24 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. The applicant recites a use without any active, positive steps delimiting how this use is actually practiced, see MPEP 2173.05(q).
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 1-16, 19, and 20 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a product of nature without significantly more. The claims are directed towards an isolated allergenic protein which is not markedly different from its natural counterpart, because there is no indication that isolation has caused the protein to have any characteristics that differ from the naturally occurring protein expressed in Cupressus sempervirens (common cypress). In fact, claim 1 recites the limitation that the isolated protein be functionally equivalent to the protein encoded by SEQ ID NO: 53 (a naturally occurring isoform of the Cup s 7 allergenic protein). Furthermore, the applicant defines limitations establishing possible amino acid substitutions, claims 3-13. These substitutions are derived from other naturally occurring gibberellin-regulated proteins, but the applicant has provided no evidence that these substitutions would have any characteristics that would differentiate the substitution-containing protein from the natural form, and would only expand the scope of the claimed invention to include allergenic proteins from additional species. This judicial exception is not integrated into a practical application because the isolated allergenic protein has not been shown to perform any function that the naturally occurring allergen is not capable of performing. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
Claims 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the method of using an isolated natural allergen, the claimed invention, is directed to a natural product without significantly more. The claims recite a method of using an isolated natural product for an in vitro diagnostic kit or assessment of Type 1 allergies. The isolation of the allergen does not provide markedly different utility than an allergen extract would in the context of the diagnostic kit. This judicial exception is not integrated into a practical application because merely placing a natural product into a diagnostic kit as it does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the integration of the allergen into a diagnostic kit, or an equivalent assay, for the detection of allergen-specific IgE (i.e. allergy biomarkers) is considered a routine activity in the field, and as such does not meet the requirements necessary to be considered a significant extra-solution activity, as established in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017). For further guidance regarding well-understood, routine, and conventional activity see MPEP 2106.05(d).
Claim Rejections - 35 USC § 102
(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 1-13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, https://allergen.org/viewallergen.php?aid=997, submitted in November of 2019. This entry provides a protein sequence comprising an amino acid sequence sharing 100% sequence identity with SEQ ID NO:53 of the instant application, as shown in the amino acid sequence alignment below. This amino acid sequence is noted to be the result of multiple groups combing mass spectrometry amino acid sequencing data, which when compiled led to the determination of the sequence of the Cup s 7 allergen, containing isoleucine amino acid at position 23, in November of 2019. It is well-known in the art that N-terminal amino acid sequencing requires a protein sample of considerable purity, and this fact demonstrates that the groups responsible for the entry successfully isolated the Cup s 7 isoform prior to the effective priority date of the instant application.
Reference MASFIPRNPIYVFLALLLIVQAWKVSTHAIEDDMKFVETGVGEKTYGGVKAQIDCDKECN 60
SEQ ID NO:53 --------------------------------------------------AQIDCDKECN 10
**********
Reference RRCSKASAHDRCIKYCGICCEKCHCVPPGTAGNEDVCPCYANLKNSKGGHKCP 113
SEQ ID NO:53 RRCSKASAHDRCIKYCGICCEKCHCVPPGTAGNEDVCPCYANLKNSKGGHKCP 63
*****************************************************
Additionally, this entry provides a nucleic acid sequence comprising a segment that encodes the allergenic protein described above. The nucleic acid described in SEQ ID NO: 10 of the instant application contains a number of variable positions within the sequence, and the variable positions, as defined by the IUPAC nomenclature, would allow for a sequence sharing 100% sequence identity with the reference sequence, shown below:
SEQ ID NO:10 ------------------------------------------------------------ 0
Reference aatcgctcactaatgcctccatattagttgagttattacacagtttgtctatgagaaaaa 60
SEQ ID NO:10 ------------------------------------------------------------ 0
Reference acaatgccttctatcttgtattatatataagagagctgttttaaagataaagaggtacag 120
SEQ ID NO:10 ------------------------------------------------------------ 0
Reference ctgtttgttttcatttgtgaatttgaagcacaatttggatcccaatggcttcctttatcc 180
SEQ ID NO:10 ------------------------------------------------------------ 0
Reference ctcgtaatcccatctatgtattcctcgccctgctgcttattgtgcaggcttggaaagtat 240
SEQ ID NO:10 ------------------------------------------------------------ 0
Reference ccacacatgcaattgaggatgatatgaagtttgtagagactggtgtgggtgaaaagactt 300
SEQ ID NO:10 --------------gcncanathgaytgygayaargartgyaaymgnmgntgywsnaarg 46
Reference atggaggagtgaaagctcagattgactgtgataaggaatgcaatagaagatgttccaagg 360
** ** ** ** ** ** ** ** ** ** * * ** ** *
SEQ ID NO:10 cnwsnnyncaygaymgntgyhtnaartaytgyggnathtgytgyraraartgymaytgyg 106
Reference catcagcacatgataggtgtatcaagtactgtggaatatgttgtgagaaatgtcactgcg 420
* ** ** * ** * ** ** ** ** ** ** ** * ** ** * ** *
SEQ ID NO:10 tnccnccnggnacnkmnggnaaygargaydbntgyccntgytaygcnmayytnaaraayw 166
Reference ttcctcctggcacagctggtaacgaagatgtatgtccttgttatgctaatttgaagaatt 480
* ** ** ** ** ** ** ** ** ** ** ** ** ** * * ** **
SEQ ID NO:10 snaarggnggncayaartgyccn------------------------------------- 189
Reference ccaagggtggacacaagtgcccttagtacattatcatatccatataataatctctattgc 540
** ** ** ** ** ** **
SEQ ID NO:10 ------------------------------------------------------------ 189
Reference ttgttcaaataatagattatgtttctatataacaatgctataatccccattcttttaaaa 600
SEQ ID NO:10 ------------------------------------------------------------ 189
Reference gaatggatgatatgttactgaacttatcttgaatatcaataaaacattctttcaataatg 660
SEQ ID NO:10 ------------------------------------------------------------ 189
Reference tcagaaattttgaaattataattcttttatttatgtaaattcttttacaattattgaatg 720
SEQ ID NO:10 ------------- 189
Reference aaaaagttgttct 733
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.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, https://allergen.org/viewallergen.php?aid=997, submitted in November of 2019 in view of Kuddus MR, et al. (2016) Expression, purification and characterization of the recombinant cysteine-rich antimicrobial peptide snakin-1 in Pichia pastoris. Protein Expr Purif. 2016 Jun;122:15-22 (herein Kuddus).
The Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, teaches an amino acid and nucleotide sequence corresponding to the isoform of Cup s 7 referenced in the instant application, as discussed in the 102 section of the current office action.
The entry does not teach an expression vector, comprising the sequence encoding the Cup s 7 allergen, or a host cell comprising said vector. Kuddus teaches these deficiencies.
Kuddus teaches a method for purifying a recombinant gibberellin-regulated protein, snakin-1 from potato (Solanum tuberosum), expressed in Pichia pastoris (abstract). Kussud teaches a recombinant pPIC9 expression vector comprising the DNA sequence encoding snaking-1 (Materials and methods: Construction of recombinant plasmid). This vector is transformed into P.pastoris cells and used for expression of the snakin-1 protein (Results: Transformation of P.pastoris and expression of the recombinant snakin-1).
It would have been obvious to one skilled in the art to combine the teachings of Kuddus (expression and purification of a gibberellin-regulated protein in Pichia pastoris) and the Cup s 7 isoform amino acid and nucleic acid sequences disclosed in the the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry. One of ordinary skill in the art at the time of filing would have been motivated to combine the expression technique/expression vectors, taught by Kuddus, to express the nucleic acid taught by the Cup s 7 entry. Due to the high cysteine content of gibberellin-regulated proteins, special consideration must be used when choosing an expression system for proteins that adopt this fold. Kuddus et al demonstrate that this expression and purification system is highly effective for the snakin-1 protein, a protein that is homologous to Cup s 7 (the two proteins share ~80% sequence identity), and provides ample motivation for the use of the disclosed techniques for the recombinant expression of Cup s 7, due to the apparent high likelihood of success.
Claims 14, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, https://allergen.org/viewallergen.php?aid=997, submitted in November of 2019 in view of US2019/0079083 A1 (herein Harwanegg).
In regard to claim 25, The Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, teaches an amino acid and nucleotide sequence corresponding to the isoform of Cup s 7 referenced in the instant application, as discussed above.
The entry does not teach a method for in vitro diagnosis or assessment of Type 1 allergies comprising the following steps: contacting an immunoglobulin-containing biological sample from a subject with an isolated allergenic protein, fragment, or variant; determining the presence of antibodies that bind the isolated allergenic protein, fragment, or variant. Harwanegg teaches these deficiencies.
Harwanegg teaches a method for detecting allergen-specific immunoglobulins in a biological sample using an antigen array comprising antigen-coated beads fixed to a solid support (Abstract). One embodiment of the method taught by Harwanegg involves the coupling of an allergen to a bead, preferably polystyrene, the beads are then incubated with a sample from a subject, which may or may not contain immunoglobulin molecules (i.e. IgE), subsequently the beads are incubated with a detection reagent (i.e. an affinity binder for IgE that is directly labeled with a colored or fluorescent compound), and the resulting signal from the detection reagent is measured ([0051-0066]).
It would have been obvious to one skilled in the art to combine the teachings of Harwanegg (an allergen-specific IgE detection method) and the Cup s 7 isoform amino acid sequence disclosed in the the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry. One of ordinary skill in the art at the time of filing would have been motivated to combine the Cup s 7 isoform with a method for detecting Cup s 7-specific IgE molecules, as it would allow for identification of pollen food-associated syndrome associated with gibberellin-regulated proteins. Harwanegg et al demonstrate that the method is effective and provides ample motivation for the use of the disclosed method and represents a high likelihood of success.
In regard to claim 14, Harwanegg and the WHO/IUIS Allergen Nomenclature Sub-committee teach a method for detecting IgE antibodies specific to Cup s 7, as discussed above.
Harwanegg further teaches that the isolated allergenic proteins are coupled to beads, which results in a non-naturally occurring protein.
In regard to claim 26, Harwanegg and the WHO/IUIS Allergen Nomenclature Sub-committee teach a method for detecting IgE antibodies specific to Cup s 7, as discussed above.
Harwanegg further teaches a kit comprising an antigen array (comprised of isolated allergenic protein coupled to solid beads), a detection reagent, buffers, control samples, as well as instructions for using the kit (page 10 lines 12-18).
Claims 27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, https://allergen.org/viewallergen.php?aid=997, submitted in November of 2019 in Vervloet D, et al. (2007) Safety and efficacy of Juniperus ashei sublingual-swallow ultra-rush pollen immunotherapy in cypress rhinoconjunctivitis. A double-blind, placebo-controlled study. Int Arch Allergy Immunol. 2007;142(3):239-46 (herein Vervloet).
In regard to claim 27, 29, and 30, The Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, teaches an isolated polypeptide and nucleotide sequence corresponding to the isoform of Cup s 7 referenced in the instant application, as discussed above.
The entry does not teach a method for using a pharmaceutical composition comprising an isolated allergenic protein for the treatment or prevention of Type 1 allergy that is associated with pollen food-associated syndrome. Vervloet teaches these deficiencies.
Vervloet teaches a method for treating patients who experience seasonal cypress-associated rhinoconjunctivitis with a high-dose sublingual-swallow immunotherapy using a pharmaceutical composition comprised of Juniperus ashei pollen extract (Abstract and Materials and methods: Patients). The authors note that a selection criterion for entry into the trial was sensitivity to Cupressus sempervirens and Cupressus arizonica pollen (Material and Methods: Patients). A pharmaceutical composition comprising the allergen extract in a 50% glycerol aqueous solution (Material and Methods: Immunotherapy Protocol). Vervloet et al showed that patients largely tolerated the immune therapy, with only two of the 38 patients receiving the therapy discontinuing the therapy (Results: Safety). Additionally, patients receiving the treatment had more favorable medication scores during the cypress-pollen season when compared to the placebo group (Results: Symptom and Medication Scores). It should be notes that the authors selected Juniperus ashei extract, as opposed to that from Cupressus sempervirens or Cupressus arizonica, due to superior allergenicity (Introduction paragraph 3). The superiors allergenicity is due elevated Jun a 1 allergen, the major allergen, relative to the corresponding equivalents in Cupressus sempervirens or Cupressus arizonica (Discussion paragraph 6). This leads the authors to suggest the isolation recombinant or natural allergens as an effective means to treat Type 1 allergies. In essence, if one was motivated to increase the allergenicity of a pharmaceutical composition for the purpose of allergen specific immunotherapy, one could isolate or enrich for the desired allergen.
Based on the teachings of Vervloet, it would have been obvious to combine the isolated allergenic protein, taught by the WHO/IUIS Allergen Nomenclature Sub-committee, with the treatment of Vervloet. One of ordinary skill in the art at the time of filing would have been motivated to combine the isolated Cup s 7 isoform with the Vervloet’s method for treating Type 1 allergies, as the method was shown to be safe and effective. Furthermore, the use of an isolated allergen, either recombinant or natural in nature, would allow for an increased allergenicity relative to a traditional extract, also taught by Vervloet. The referenced teachings demonstrate that the method is safe and effective, which provides ample motivation for the use of the disclosed method and provides a reasonable expectation of success.
Claims 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over the Allergen Nomenclature (WHO/IUIS Allergen Nomenclature Sub-committee) allergen database, Cup s 7 entry, https://allergen.org/viewallergen.php?aid=997, submitted in November of 2019 in Vervloet D, et al. (2007) Safety and efficacy of Juniperus ashei sublingual-swallow ultra-rush pollen immunotherapy in cypress rhinoconjunctivitis. A double-blind, placebo-controlled study. Int Arch Allergy Immunol. 2007;142(3):239-46 (herein Vervloet) and Tuppo L, et al. (2019) Isolation of cypress gibberellin-regulated protein: Analysis of its structural features and IgE binding competition with homologous allergens. Mol Immunol. 2019 Oct;114:189-195 (herein Tuppo).
In regard to claim 28 and 31, the WHO/IUIS Allergen Nomenclature Sub-committee and Vervloet teach a method for treating a Type 1 allergy using a pharmaceutical composition comprising isolated Cup s 7 allergen proteins, as discussed above.
The WHO/IUIS Allergen Nomenclature Sub-committee and Vervloet do not teach a method for treating a Type 1 allergy caused by pollen of the Cupressaceae species and is associated with pollen food-associated syndrome. Tuppo teaches these deficiencies.
Tuppo teaches that Cupressaceae pollen, more specifically a GRP isolated from the pollen and later referred to as Cup s 7, shares common IgE epitopes with allergenic GRPs found in several fruits, such as peach and pomegranate (Discussion, Results: Direct IgE binding, and Results: IgE inhibition experiments). These teachings help discern the link between pollen and fruit as they relate to PFAS. Essentially, the shared IgE reactivity/epitopes of the homologous allergenic GRP proteins found in certain fruit and pollen makes for natural immunologic cross-reactivity between GRPs from different sources (i.e. fruit, nuts, and pollen). The shared limitations established in instant claims 28 and 31 (Type 1 allergy caused by Cupressaceae pollen and associated with pollen food-associated syndrome) are inherent to the allergen described in claim 1 (SEQ ID NO:53) of the instant application and as such the method described in claim 26 of ‘330 would meet the limitations of the instant claims.
It would have been obvious to one skilled in to use the method for treating Type 1 allergies taught by the WHO/IUIS Allergen Nomenclature Sub-committee and Vervloet to treat Type 1 allergies caused by Cupressaceae pollen and associated with pollen food-associated syndrome isolated, because one skilled in the art would have recognized that a gibberellin-regulated protein (GRP) from Cupressaceae, such as that disclosed by the WHO/IUIS Allergen Nomenclature Sub-committee, would be inherently effective as a diagnostic tool for Type 1 allergies bought on by food-allergies or Cupressaceae pollen and/or pollen food-associated syndrome.
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 1-26, 29-31 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 15, 16, 20, 21, 26, 27, 30, 31, 32 of U.S. Patent No. 12539330 (herein ‘330). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘330 is drawn to an isolated allergen protein derived from the Cup s 7 allergen, comprising the amino acid sequence disclosed in SEQ ID NO: 4. In claims 1 and 2 of the referenced patent, the applicant limits the required sequence identity to at least 85 % (claim 1) or at least 90 % (claim 2). The amino acid sequence referenced in claims 1 and 2 of the instant application, SEQ ID NO: 53, shares 98.41 % sequence identity with SEQ ID NO:4 of the reference sequence and exceeds the minimum allowable sequence identity established in the reference claims 1 and 2 (85 % or 90 %, respectively), as shown below:
Instant SEQ ID NO:53 AQIDCDKECNRRCSKASAHDRCIKYCGICCEKCHCVPPGTAGNEDVCPCYANLKNSKGGH 60
Ref SEQ ID NO:4 AQIDCDKECNRRCSKASAHDRCLKYCGICCEKCHCVPPGTAGNEDVCPCYANLKNSKGGH 60
**********************:*************************************
Instant SEQ ID NO:53 KCP 63 (98.41 % Sequence Identity)
Ref SEQ ID NO:4 KCP 63
***
The subsequent claims limiting the amino acid substitutions of the allergenic protein in the instant application (claims 3-13) allow for amino acid substitutions in set positions, however all of them are bound to the same sequence identity limitations established in claim 1 and are encroaching on the claimed invention of ‘330 (see claims 1 and 2 of the referenced patent).
Claims 14, 19, 20, 25, 26, 29, 30, and 31 of the instant application share the identical limitations and/or claim language as their counterparts in ‘330, claims 15, 20, 21, 26, 27, 30, 31, and 32 respectively, and are effectively describing the same invention.
Claims 27 and 28 are not patentably distinct from claims 30, 31, and 32 of ‘330 as the referenced claims describe methods for using the allergenic protein for the treatment of a type 1 allergy, which may be caused by pollen from Cupressaceae and/or is associated with PFAS.
In regard to claims 15-18, the applicant is claiming an isolated nucleic acid molecule encoding a protein sharing at least 85% sequence identity with SEQ ID NO: 53. As described for claims 1-14, this described protein encroaches on claim 1 of ‘330. Additionally, the sequence referenced in instant claim 16, SEQ ID NO: 10, is nearly identical to the sequence referenced in claim 17 of ‘330, see below. The only variations act to define the possible nucleic acid limitations at the corresponding positions. However, there is significant overlap between the allowed nucleic acids, and as such the possible nucleic acid molecules defined by these are sequences could encode proteins of identical amino acid sequences, and as such are not patentably distinct.
Instant gcncanathgaytgygayaargartgyaaymgnmgntgywsnaargcnwsnnyncaygay 60
Reference gcncanathgaytgygayaargartgyaaymgnmgntgywsnaargcnwsnbyncaygay 60
*************************************************** ********
Instant mgntgyhtnaartaytgyggnathtgytgyraraartgymaytgygtnccnccnggnacn 120
Reference mgntgyytnaartaytgyggnathtgytgyraraartgymaytgygtnccnccnggnacn 120
****** *****************************************************
Instant kmnggnaaygargaydbntgyccntgytaygcnmayytnaaraaywsnaarggnggncay 180
Reference kmnggnaaygargaydbntgyccntgytaygcnmayytnaaraaywsnaarggnggncay 180
************************************************************
Instant aartgyccn 189
Reference aartgyccn 189
*********
In regard to claims 21-24, the instant application claims a method for using the isolated allergenic protein of instant claim 1, see above double patent rejection, in a diagnostic or assessment of a Type 1 allergy, wherein the allergy is a result of pollen from Cupressaceae, food-association, or pollen food-associated syndrome (PFAS). Claim 26 of ‘330 effectively describes a method for diagnosing or assessing Type 1 allergies using a Cupressaceae-derived GRP protein, which is relevant to instant claim 21. As taught by Tuppo L, et al. (2019) Isolation of cypress gibberellin-regulated protein: Analysis of its structural features and IgE binding competition with homologous allergens. Mol Immunol. 2019 Oct;114:189-195 (herein Tuppo), one skilled in the art would have recognized that a gibberellin-regulated protein (GRP) from Cupressaceae, such as that defined in claim 1 of ‘330 or claim 1 of the instant application, would be inherently effective as a diagnostic tool for Type 1 allergies bought on by food-allergies or Cupressaceae pollen, relevant to claims 22 and 23. Tuppo teaches that Cupressaceae pollen, more specifically a GRP isolated from the pollen and later referred to as Cup s 7, shares common IgE epitopes with allergenic GRPs found in several fruits, such as peach and pomegranate (Discussion, Results: Direct IgE binding, and Results: IgE inhibition experiments). These teachings help discern the link between pollen and fruit as they relate to PFAS. Essentially, the shared IgE reactivity/epitopes of the homologous allergenic GRP proteins found in certain fruit and pollen makes for natural immunologic cross-reactivity between GRPs from different sources (i.e. fruit, nuts, and pollen). The limitations established in instant claims 22-24 are inherent to GRP described in claim 1 of ‘330 and as such the method described in claim 26 of ‘330 would meet the limitations of the instant claims.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW CURRAN METCALF whose telephone number is (571)272-5520. The examiner can normally be reached 9:00AM-6:00PM.
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/MATTHEW CURRAN METCALF/ Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647