DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2 and 4-6; Species vaccine comprising a protein; and SEQ ID NO: 3 in claim 2, in the reply filed on 12/2/25 is acknowledged.
Claims 1, 2 and 4-6 are under examination.
Claims 1, 2 and 6 read on the elected Species.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
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 1, 2 and 4-6 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 4-6 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a protein vaccine (claim 1) or a nucleic acid vaccine (claim 1, 4 and 5) and the proteins from SEQ ID Nos: 3-29 in claim 3 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Protein vaccines and nucleic acid vaccines comprise biologically, structurally and chemically distinct products. Polypeptides, which are composed of amino acids, and polynucleotides, which are composed of purine and pyrimidine units, are structurally distinct molecules. They do not have the same mode of action when administered. Additionally, there are patentably distinct products contained within claim 2, e.g., proteins comprising different amino acid sequences which are structurally distinct chemical compounds and are unrelated to one another. The proteins would elicit different immunogenic responses and bind to different antibodies.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. NOTE: given the same source, T.cruzi, and high homology, 96.4%, the polypeptide with the amino acid sequence set forth in SEQ ID NO: 4 may be a true species of elected SEQ ID NO: 3. However, the polypeptides from other species of Trypansoma (SEQ ID NOS: 5-29) and with 28-89% homology to elected SEQ ID NO: 3 are different inventions, not different species.
Claim Rejections - 35 USC § 112-Written Description
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 and 6 are 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.
The claims are drawn to, for example:
A vaccine composition, the composition comprising: a protein having an amino acid identity of at least 48% over the full length of SEQ ID NO: 1 and an adjuvant (claim 1); and additionally, a pharmaceutically acceptable carrier (claim 6).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed protein vaccines such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
Proteins with at least 48% amino acid identity over the full-length of SEQ ID NO: 1 include vastly different proteins from many different sources with different functions. See sequence alignment in supplemental content tab. Additionally, it is unclear what the rest of the structure would need to be to possess the function of a vaccine as instantly claimed.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of proteins vaccines such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Devos et al., (Proteins: Structure, Function and Genetics, 2000, Vol. 41: 98-107), teach that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, page 98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude that "Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, and page 105).
Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340,) also highlight the difficulties associated with "Prediction of protein function from protein sequence and structure": "To reason from sequence and structure to function is to step onto much shakier ground", closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer (page 309, paragraph 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein's role fundamentally (page 323, paragraph 1). C. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function);
Because the art is unpredictable, in accordance with the Written Description Guidelines, the recitation of "a sequence at least 48% identical to oneof SEQ ID No: 1” with any changes (and any combination of changes) is not adequate. The scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
There are no drawings or structural formulas disclosed of any of thesefragments or variants of the claimed polypeptides which display “vaccine” functionality. There is no teaching in the specification regarding which 52% of the structure can be varied and still produce a polypeptide which can function as a vaccine. Although the disclosure of SEQ ID NO: 1 combined with the knowledge in the art, may put one in possession of peptides that are at least 48% identical to SEQ ID NO: a, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those peptides would have the required functional activities. Based on the lack of knowledge and predictability in the art, those of ordinaryskill in the art would not conclude that the applicant was in possession of theclaimed genus of polypeptides.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
Claim Rejections - 35 USC § 112-Scope of Enablement
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 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A pharmaceutical composition comprising a protein having the amino acid sequence set forth in SEQ ID NO: 3 and an adjuvant; (and further comprising a pharmaceutically carrier- claim 6),
does not reasonably provide enablement for:
A vaccine composition, the composition comprising: a protein having an amino acid identity of at least 48% over the full length of SEQ ID NO: 1 and an adjuvant; or vaccines compositions comprising a protein comprising SEQ ID NO: 3 and an adjuvant.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The specification states that substitutions, additions, or deletions, may be made to the defined sequences; however, the specification provides no guidance as which amino acids may be changed without causing a detrimental effect to the protein and its function as a vaccine. It is unpredictable as to which amino acids could be removed and which could be added. While it is known that many amino acid substitutions are possible in any given protein, the position within the protein’s sequence where amino acid substitutions can be made with a reasonable expectation of success are limited. Other positions are critical to the protein’s structure/function relationship, e.g., such as various positions or regions directly involved in binding, catalysis in providing the correct three-dimensional spatial orientation of binding and catalytic sites. These regions can tolerate only very little or no substitutions. Selective point mutation to one key residue could eliminate the function of the polypeptide. It could eliminate its functional properties. If the range of decreased binding ability after single point mutation of a protein antigen varies, one could expect point mutations in the protein antigen to cause varying degrees of loss of protection/function, depending on the relative importance to the binding interaction of the altered residue. Alternatively, the combined effects of multiple changes, as instantly claimed, in an antigenic determinant could again result in loss of function. A protein having multiple point mutations, or accumulated point mutations at key residues could create a new antigen that is precipitously or progressively unrecognizable. As stated above, Applicants have not shown the particular substitution and the result it produces. Applicants have provided no guidance to enable one of ordinary skill in the art how to determine, without undue experimentation, the effects of different amino substitutions and the nature and extent of the changes that can be made. It is expensive and time consuming to make amino acid substitutions at more than one position, in a particular region of the protein, in view of the many fold possibilities for change in structure and the uncertainty as to what utility will be possessed. See Mikayama et al. (Nov.1993. Proc.Natl.Acad.Sci. USA, vol. 90 : 10056-10060) which teaches that the three-dimensional structure of molecules is important for their biological function and even a single amino acid difference may account for markedly different biological activities. Amino acids owe their ‘significance’ to their inclusion in a pattern which is directly involved in recognition by, and binding to, the receptor and the significance of the particular amino acids and sequences for different amino acids cannot be predicted a priori, but must be determined from case to case by painstaking experimental study. The instant claims allow for substitutions with amino acids of vastly different properties and they do not recite the specific changes in the claims.
The working example in the instant specification uses the full-length protein comprising the amino acid sequence set forth in SEQ ID NO: 1 which is very different in homology to SEQ ID NO: 3. Claim 1 encompasses any protein that has 48% amino acid identity with SEQ ID NO: 1. However, the data provided in the application is limited to the protein with SEQ ID NO: 1 and there is no data provided for any other proteins encompassed by claim 1. Likewise, no data or working examples are provided for vaccines comprising any of the orthologous proteins with amino acids of SEQ ID NOs: 3-29 as set forth in claim 2. The application does not provide any arguments as to why the effect reported for the protein with SEQ ID NO: 1 could plausibly be achieved by any other proteins encompassed by claims 1 and 2. The protein with the amino acid sequence set forth in SEQ ID NO: 1 was tested as a therapeutic target for trypanosomatids. Mice vaccinated with a vaccine composition comprising said protein showed a significant reduction in first peak parasitemia, coinciding with a prolonged survival after challenge with wild type T. b. brucei parasites. A cross-protective effect using this vaccine composition, was also demonstrated against two other trypanosomatid species: T. congolense (Tcl3) and T. evansi. The immunogenic and prophylactic efficacy of the recombinant protein with SEQ ID NO: 1 against Leishmania major infection was evaluated in BALB/c mice. The experiment showed that, irrespective of the vaccination, comparable amounts of parasites were present at the infection site. However, a statistically relevant inhibition of development of lesions was observed in the vaccinated mice. An effect is shown for the protein with SEQ ID NO: 1 but not for any mutation of said protein having at least 48% amino acid identity and no data is reported for any of the proteins with SEQ ID NO: 3-29.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
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.
Claim(s) 1, 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dias et al (J. Structural Biol. 211(2). May 2020, pages 1-12; provided by Applicants), Jackson et al (Accession No. A0A2V2X60; EMBL/Genbank. 10/19/11 From: Proc. Natl. Acad. Sci. U.S.A. 109:3416-3421. 2012), Hebert L., et al (Submitted Sep-2016; Accession No. A0A1G4I0X4; January 18, 2017 public- Uniprot database) and Berna et al "Expanding an expanded genome: long-read sequencing of Trypanosoma cruzi."; Microb. Genom. 0:0-0(2018). Accession No. A0A2V2X6Q0; 12-SEP-2018, integrated into UniProtKB/TrEMBL) in view of Linares et al (US 2013/108660; provided by Applicants),
Berna et al discloses a Trypanosoma protein with an amino acid sequence that is 100% identical to SEQ ID NO: 3, over all 116 amino acids identical; 96.4% identical to SEQ ID NO: 4; and 56.6% to Applicant’s SEQ ID NO: 1. See Accession No. A0A2V2X6Q0 in supplemental content tab, Uniprot, and attached reference on PTO-892.
Hebert et al disclose a Trypanosoma protein with 100% identity to Applicants’ SEQ ID NO: 1. See Submitted Sep-2016; Accession No. A0A1G4I0X4; January 18, 2017 public- Uniprot database in supplemental content tab and attached reference on PTO-892.
Jackson et al researches antigenic diversity is generated by distinct evolutionary mechanisms in African trypanosome species and teaches a protein with 64.3% to Applicant’s SEQ ID NO: 1. Accession No. F9WFX2.
Dias discloses a protein having the amino acid sequence set forth in SEQ ID NO: 1 (Trypanosoma brucei brucei hypothetical protein Tb927.6.4140, is the protein set forth in Applicant’s SEQ ID NO: 1). Dias et al discloses the crystal structure of the T. cruzi protein Q4D6Q6 and mentions its orthologous gene Tb927.6.4140 from Trypanosoma brucei brucei (54% sequence identity to Applicants’ SEQ ID NO: 1). See column 1, first full paragraph, on page 2.
However, Dias, Jackson, Hebert and Berna do not particularly teach the use of the proteins as a vaccine along with an adjuvant.
Linares discloses a Trypanosoma vaccine for protecting against infections by an African trypanosome selected from Trypanosoma congolense, Trypanosoma vivax, Trypanosoma evansi and/or Trypanosoma brucei, and preferably against infections by Trypanosoma congolense. Paragarph [0061]-[0062] show that adjuvants are commonly used in such compositions, as well as prominent Trypanosoma proteins.
Although the primary references do not specifically recite the use of the Trypanosoma proteins as a vaccine, a “vaccine” is an intended use only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. An adjuvant is an obvious inclusion to a parasitic protein composition for further research and to raise antibodies as shown in the teachings of Linares and it would have been prima facie obvious to combine an adjuvant and/or pharmaceutically acceptable carrier with a known Trypanosoma protein. It is noted that the instant specification does not teach any results with SEQ ID NOS: 3-29, yet also suggests they be combined with an adjuvant for research/vaccination purposes.
Status of Claims:
No claims are presently allowed.
Prior art, not presently relied upon:
There are numerous prior art disclosures of proteins with amino acid sequences at least 48% identical to SEQ ID NO: 1.
For example, and not limited to:
Matthews J., et al. "An alternative strategy for trypanosome survival in the mammalian bloodstream revealed through genome and transcriptome analysis of the ubiquitous bovine parasite Trypanosoma (Megatrypanum) theileri.";Submitted (MAR-2017) to the EMBL/GenBank/DDBJ databases; Accession No. A0A1X0P259. 59.3% identity to Applicant’s SEQ ID NO: 1.
Bradwell et al "Genomic comparison of Trypanosoma conorhini and Trypanosoma rangeli to Trypanosoma cruzi strains of high and low virulence."; ( BMC Genomics 19:770-770(2018). 58.1% identical to Applicant’s SEQ ID NO: 1. Accession no. A0A422Q5A3;
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel E. Kolker, can be reached on (571) 272-3181.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 2/18/25