DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 7/30/26 has been entered in full. Replacement sheets for Figure 1 are submitted. The specification is amended. Claims 1-5, 8-12, 16-22, 24, 27, 38, 40 and 42-44 are amended. New claim 47 is added.
Claims 1-31, 34-44 and 46-47 are pending.
New claim 47 depends from claim 1 and is part of inventive Group I.
Applicants’ election of Group I, currently claims 1-31, 34 and 47, was previously acknowledged and treated as an election without traverse. Claims 35-44 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants’ election of “HLA” and “6 histidines” as the species of (1) target antigen and (2) polymer/other antigen/oligopeptide polyhistidine was also previously acknowledged. Claims 4, 13-15, 24, 28-30 and 47 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-3, 5-12, 16-23, 25-27, 31 and 34 are under consideration, as they read upon the elected species.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (7/30/26).
The objection to the drawings at pages 2-3 is withdrawn in view of the replacement sheets filed on 7/30/26.
The objections to the specification at pages 3-4 are withdrawn in view of the amendments to the specification.
The objections to claims 16 and 20-22 at page 4 are withdrawn in view of the amendments to the claims except as maintained below.
The rejection of claims 2-3, 5, 8-12, 17-19, 23-27, 31 and 34 at pages 4-5 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
Maintained Objections and/or Rejections
Claim Objections
The following objections to claims 20-22 and 31 were set forth at page 4 of the 5/6/26 Office action and are maintained as follows:
Claim 20 was objected to because line 3, “a target antigen protein” should be “the target antigen”. Compare with claim 11, line 2, which recites, “the target antigen”. In the reply, Applicants changed claim 20 to recite “a target antigen” but did not change the article, which should be “the”.
Claim 31 was objected to because each word of “Human leukocyte antigen” should be capitalized, i.e., “Human Leukocyte Antigen”, as on page 4, ¶ 13 of the specification. In the reply, Applicants made this amendment to claim 16 but not 31.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 20-22 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 pre-AIA the applicant regards as the invention. This rejection was set forth at pages 4-5 of the 5/6/26 Office action.
Claim 20 refers to “at least two contiguous histidine peptides” in line 4, but the number of required histidines is unclear due to the use of the term “peptides”, which refers to two or more amino acids that are linked by a bond. For example, it is unclear whether “at least two contiguous histidine peptides” refers to two contiguous histidine amino acids or two contiguous histidine peptides of indeterminate length. It appears that the former is intended, and if so, the claim could be rendered definite by amending to the claims to recite, “contiguous histidine amino acids”. In the reply, Applicants made this change to the other that were rejected, but not to claim 20, and thus this rejection is maintained.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above and encompass the same indefinite subject matter.
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.
(1) Claims 1-3, 5-12, 17-23 and 25-27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Pinter et al, U.S. Patent Application Publication 20030105282, published 6/6/03, filed 1/2/02, and claiming priority to 9/8/98 (cited previously). The earliest date to which the instant application claims priority is 2/3/21. This rejection as set forth at pages 6-9 of the 5/6/26 Office action.
(2) Claims 1-3, 5, 7-9, 17-19, 23 and 26-27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mamalaki et al, U.S. Patent Application Publication 20110097749, published 4/28/11, filed 8/2/208 and claiming priority to 8/24/07 (cited previously). The earliest date to which the instant application claims priority is 2/3/21. This rejection was set forth at pages 9-10 of the 5/6/26 Office action.
In response to the rejection, Applicants have amended the independent claims (claims 1 and 17) in two significant ways. First, the preamble of each has been amended to indicate that the method is for “reducing false positive results”. This new limitation has been fully considered in the context of each claim and is interpreted as an intended use for the method because it does not result in a manipulative difference between the method as defined by the steps and a prior art method teaching the same steps. See MPEP 2111.02. As such, this intended use does not distinguish the claimed method from a prior art method comprising the same step(s). Thus, the new limitation is not sufficient to distinguish the claims from the teachings of Pinter or from the teachings of Mamalaki.
Second, Applicants have limited the target antigen to one selected from a group including HLA; one related to auto-immune disease; or one selected from a group of pathogens including HIV. However, the teachings of each reference are directed to a target antigen that is encompassed by the recited group of target antigens. The teachings of Pinter are directed to a target antigen that is a fusion protein that comprises the V1/V2 domain of gp120, which is from HIV-1; see page 6 of the 5/6/26 Office action. Thus, the new limitation that narrows the target antigen is still met by the teachings of Pinter. The teachings of Mamalaki are directed to hepcidin and the relevant art appreciates that hepcidin is associated with at least one auto-immune disease. For example, Kunireddy et al (2018. Ind J Clin Biochem. 33(4):406-413) teaches that hepcidin is associated with Systemic Lupus Erythematous (SLE); see the title, which is “Hepcidin and Ferritin: Important Mediators in Inflammation Associated Anemia in Systemic Lupus Erythematosus Patients”.
With respect to the rejection over Pinter, at pages 13-14 of the reply, Applicants argue that the rejection should be withdrawn in view of the amendments to the claims. While Applicants acknowledge that “Pinter’s fusion protein relates to HIV” (page 14), Applicants argue that the teachings of Pinter are “directed to HIV vaccine development and antibody characterization” (page 13) and more specifically to “characterizing purified antibody fractions generated from immunized rats for vaccine research purposes” (page 14). Applicants argue that the teachings of Pinter are not directed to “performing an immunoassay to screen for antibodies” or reducing “false positive results in an immunoassay” (page 13). With respect to the “detecting” step of the claimed method, Applicants argue that the step of Pinter is directed to “analyzing eluted antibodies for antigen specificity” and not to “detecting binding of antibodies in said sample to the target antigen” as “part of a screening immunoassay”” (page 13).
These arguments have been fully considered but are not found persuasive. Applicants’ argument that the claimed method is for “reducing false positive results” concerns an intended use for the claimed method, and not to what is encompassed by the steps of the method as performed by the skilled artisan. The remainder of the preamble of the instant claims is directed to “when screening a biological sample for antibodies that specifically bind a target”, which is met by the method of the Pinter. Furthermore, the specifically claimed method steps are met by the individual teachings of Pinter for the reasons set forth in the rejection of record. The detecting step of the claimed method recites, “detecting binding of antibodies in said biological sample to the target antigen”, which only requires that the antibodies in the sample bind to the target antigen and are detected, which is taught by Pinter.
With respect to the rejection over Mamalaki, at page 14 of the reply, Applicants argue that this rejection should be withdrawn in view of the amendments to the claims and in view of further reasons. Applicants argue that Mamalaki is not directed to “performing an immunoassay to screen a biological sample for antibodies” or “reduce false positive results in an immunoassay screening a biological sample” (page 14). Applicants argue that the stated purpose in Mamalaki for “removing anti-His antibodies was to purify a reagent antibody” for “subsequent use in an ELISA to measure hepcidin levels”, not “to reduce false positive results in an immunoassay screening a biological sample” (page 14). With respect to the “detecting” step of the claimed method, Applicants argue that the step of Mamalaki is directed to “confirming the purity of a manufactured reagent antibody” and not to “detecting binding of antibodies in said sample to the target antigen” as “part of a screening immunoassay”” (page 13). Applicants further argue that hepcidin is a “peptide hormone involved in iron metabolism” and not an “antigen associated with an infectious disease pathogen, auto-immune disease or an HLA” (page 14).
These arguments have been fully considered but are not found persuasive. As above, Applicants’ argument that the claimed method is for “reducing false positive results” concerns an intended use for the claimed method, and not to what is encompassed by the steps of the method as performed by the skilled artisan. The remainder of the preamble of the instant claims is directed to “when screening a biological sample for antibodies that specifically bind a target”, which is met by the method of the Mamalaki. Furthermore, the specifically claimed method steps are met by the individual teachings of Mamalaki for the reasons set forth in the rejection of record. The detecting step of the claimed method recites, “detecting binding of antibodies in said biological sample to the target antigen”, which only requires that the antibodies in the sample bind to the target antigen and are detected, which is taught by Mamalaki. With respect to the antigen taught by Mamalaki, hepcidin, this antigen is associated with an autoimmune disease as described above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 16 and 31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Mamalaki et al, U.S. Patent Application Publication 20110097749, published 4/28/11 (cited previously), as applied to claims 1 and 17 above, and further in view of Gromme et al, 2011. Proc Natl Acad Sci USA. 96: 10326-10331 (cited previously).
This rejection was set forth previously at pages 10-11 of the 5/6/26 Office action. The rejection set forth previously inadvertently indicated that the rejection was over claims 7 and 31 instead of claims 7 and 16. However, it is believed that the rejection as sufficiently clear about what was being rejected because the subject matter of claim 16 rather than claim 7 was indicated in the body of the rejection, and in support of this, Applicants state in the reply that “It is also believed that the claim intended to be rejected in the Office Action was claim 16 directed to HLA rather than claim 7” (page 15).
In the reply at page 15, Applicants argue that the rejection should be withdrawn because the secondary reference of Gromme “fails to make up for the deficiencies of Mamalaki” set forth above.
This argument has been fully considered but is not found persuasive. The rejection of the parent claims over the teachings of Mamalaki has been maintained for the reasons set forth above. As such, Mamalaki does not have any deficiencies for the secondary reference of Gromme to “make up for”.
New objections and/or rejections necessitated by Applicants’ amendment
Specification
The disclosure is objected to because of the following informalities:
Applicants have amended ¶ 5 of the specification to delete a hyperlink. However, following the amendment, an extraneous “()” remains at the end of the sentence in the paragraph. These characters should also be deleted.
Appropriate correction is required.
Claim Objections
Claims 1-3, 5-12, 16-23, 25-27, 31 and 34 are objected to for the following informalities:
In each of independent claims 1 and 17, “SARS associated” should be “SARS-associated”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
