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 .
Status of the claims
The Preliminary Amendment filed 02/04/22 is acknowledged and has been entered. Claims 3-5 have been amended. Claims 11-13 have been canceled. Currently, claims 1-10 are pending and under examination.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract is not limited to a single paragraph. Also, the instant abstract utilizes implied phrases see “The present invention relates to:”.
The use of the term Tween 20 (e.g. page 17, paragraph 0046), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites a sandwich method with use of the monoclonal antibodies according to a) and b). However, the body of the claim fails to provide for any steps of contacting the antibodies with a sample and forming complexes of the antibodies bound to the HD5 and detecting the HD5 in the sample. Method claims should clearly set forth the various method steps in a positive, sequential manner using active tense verbs such as mixing, reacting and detecting. Method claims should also clearly state each component used in the method and the relationship of the various components, and should not be a mere cataloging of parts. The claims should also conclude with a step relating the method result to the purpose of the method, preferably to the purpose as also set forth in the preamble of the claim. In order to avoid any possible ambiguity of what the intended purpose of the method is, it is recommended to have the preamble of the claim recite the intended purpose of the method. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Written Description
Claim 2 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The methodology for determining adequacy of Written Description to convey that applicant was in possession of the claimed invention includes determining whether the application describes an actual reduction to practice, determining whether the invention is complete as evidenced by drawings or determining whether the invention has been set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention (Guidelines for Examination of Patent Applications under 35 USC § 112, p 1 “Written Description” Requirement; (Federal Register/Vol 66. No. 4, Friday, January 5, 2001; II Methodology for Determining Adequacy of Written Description (3.)).
Claim 2 is broadly drawn, such that they apply to a genus of amino acid sequences having 90% or more sequence identity to the amino acid sequence of SEQ IED NO: 13. However, the working examples provided in the instant application only demonstrate specific species of SEQ ID NO: 13 which possess the unique capability of specifically binding to a-defensin HD5 with intramolecular disulfide bonds. Despite the large variety of partial sequences, fragments thereof and homologue sequences that could be constructed, the specification only cites possession of the specific SEQ ID NO: 13 which possess the unique capability of specifically binding to a-defensin HD5 with intramolecular disulfide bonds.
It was known in the prior art that small changes in antigen structure profoundly affect antibody-antigen interactions. Harlow & Lane (Harlow, E. and Lane, D., Antibodies: A Laboratory Manual (1988) Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, pages 23-26) discus how even small changes in antigen structure can profoundly affect the strength of an antibody-antigen interaction. See entire selection, in particular page 26, first full paragraph. In particular, the loss of a single hydrogen bond can reduce the strength of interaction by 1000-fold (ibid).
Many other researchers have reported similar findings to those of Harlow & Lane. For example, Lederman et al. ("A single amino acid substitution in a common African allele of the CD4 molecule ablates binding of the monoclonal antibody, OKT4" Mol Immunol. 1991 Nov;28(11):1171-81) found that a single amino acid substitution on the antigen CD4 ablated binding of a monoclonal antibody (see title and abstract). Similarly, Colman et al. (Research in Immunology, 1994; 145(1): 33-36) teach that amino acid changes in an antigen can effectively abolish antibody antigen binding entirely (see entire document, particularly pages 33-34).
As noted above, the variability among the protein sequences encompassed by the claims is also enormous; and would encompass changes much more substantial than the loss of a single hydrogen bond or the mutation of a single amino acid; yet even such minor changes as these were known to dramatically affect function.
Given the unpredictability associated with making even minor changes to antigen structure while preserving function, with limited exception it is not possible to predict which, out of the enormous number of peptides encompassed by the claims, would be capable of binding to autoantibodies of rheumatoid arthritis.
MPEP § 2163, states “[A] biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
The Revised Interim Guideline for Examination of Patent Applications under 35 USC § 112, p1 “Written Description” Requirement (Federal Register/ Vol 66. No 4, Friday January 5, 2001) states “The claimed invention as a whole may not be adequately described if the claims require an essential or critical element which is not adequately described in the specification and which is not conventional in the art” (column 3, page 71434), “when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus”, “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” (column 2, page 71436, emphasis added).
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize the [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Considering the potentially large numbers of sequences encompassed by partial sequences, fragments thereof and homologues of sequences of 90% homology or more, the disclosure is not sufficient to show that a skilled artisan would recognize that the applicant was in possession of the claimed invention (genus) commensurate to its scope at the time the application was filed. It appears that the specification is limited to SEQ ID NO: 13 which possess the unique capability of specifically binding to a-defensin HD5 with intramolecular disulfide bonds.
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 1-5 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 1 provides for the use of the monoclonal antibodies according to a) and b), but, since the claim does not set forth any steps involved in a sandwich method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim 2 is vague and indefinite because the monoclonal antibody of claim 1 a) already requires the heavy chain variable region to comprise SEQ ID NO’s: 1-3 and claim 2 now requires SEQ ID NO: 13 thus causing confusing as to if the SEQ ID NO: 13 is to replace one or all or SEQ ID NO’s 1-3 or if the heavy chain variable region of claim 1a further comprises SEQ ID NO: 13. Also, if applicant intends the replacement of one of the SEQ ID NO:’s it is unclear which is to be replaced. It is recommended to delete claim 2..
Claim 2 is vague and indefinite because the monoclonal antibody of claim 1 a) already requires the light chain variable region to comprise SEQ ID NO’s: 4-6 and claim 2 now requires SEQ ID NO: 14 thus causing confusing as to if the SEQ ID NO: 14 is to replace one or all or SEQ ID NO’s 4-6 or if the light chain variable region of claim 1a further comprises SEQ ID NO: 14. Also, if applicant intends the replacement of one of the SEQ ID NO:’s it is unclear which is to be replaced. It is recommended to delete claim 2.
Claim 2 is vague and indefinite because the monoclonal antibody of claim 1 b) already requires the heavy chain variable region to comprise SEQ ID NO’s: 7-9 and claim 2 now requires SEQ ID NO: 15 thus causing confusing as to if the SEQ ID NO: 15 is to replace one or all or SEQ ID NO’s 8-9 or if the heavy chain variable region of claim 1b further comprises SEQ ID NO: 15. Also, if applicant intends the replacement of one of the SEQ ID NO:’s it is unclear which is to be replaced. It is recommended to delete claim 2.
Claim 2 is vague and indefinite because the monoclonal antibody of claim 1 b) already requires the light chain variable region to comprise SEQ ID NO’s: 10-12 and claim 2 now requires SEQ ID NO: 16 thus causing confusing as to if the SEQ ID NO: 16 is to replace one or all or SEQ ID NO’s 10-12 or if the light chain variable region of claim 1b further comprises SEQ ID NO: 16. Also, if applicant intends the replacement of one of the SEQ ID NO:’s it is unclear which is to be replaced. It is recommended to delete claim 2.
Allowable Subject Matter
Claims 1-5 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, 35 U.S.C. 101 and the Double Patenting rejections set forth in this Office action. The prior art of record does not teach nor fairly suggest monoclonal antibodies having the specific heavy and light chain CDRs SEQ ID NOs as currently recited.
Claim 6-10 are allowable because the prior art of record does not teach nor fairly suggest monoclonal antibodies having the specific heavy and light chain CDRs SEQ ID NOs as currently recited.
Conclusion
Claims 1-5 are rejected. Claims 6-10 are considered allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schwaderer et al. (WO 2016/161413) discloses methods and kits for the detection of HD5 (e.g. abstract, pgs 14 and 29).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GARY COUNTS/ Primary Examiner, Art Unit 1678