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 .
Claim Status
The amended claim set filed 24 Aug 2025 is acknowledged. Claims 1-8 are currently pending. Of those, claim 1 is currently amended, and no claims are new. Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 May 2025. No claims are cancelled. Claims 1-5 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 24 Aug 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 5 June 2025 will be referred to as “NFOA.”
Priority
It is acknowledged that applicant submitted a English translation of KR 10-2021-0145421 on 24 Aug 2025. However, this is not a certified copy of the application from the Korean patent office as required by 37 CFR 1.55. The effective filing date for claims 1-5 remains 19 Oct 2022.
Also, applicant should be aware that the certified copy has not been filed during the time period set forth in 37 CFR 1.55. For original applications filed under 35 U.S.C. 111(a) (other than a design application) on or after November 29, 2000, the time period is during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. In addition, if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet. See 37 CFR 1.55(d)(1). For national stage applications under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and the Regulations under the PCT. See 37 CFR 1.55(d)(2). If applicant desires priority under 35 U.S.C. 119(a)-(d), or (f), 365(a) or (b), or 386(a) based upon a prior foreign application, applicant must file a petition for an unintentionally delayed priority claim under 37 CFR 1.55(e). The petition must be accompanied by (1) the priority claim under 35 U.S.C. 119(a)-(d), or (f), 365(a) or (b), or 386(a) in accordance with 37 CFR 1.55 identifying the prior foreign application to which priority is claimed, unless previously submitted; (2) a certified copy of the foreign application, unless previously submitted or an exception under 37 CFR 1.55 applies; (3) the applicable petition fee under 37 CFR 1.17(m)(1) or (2); and (4) a statement that the entire delay between the date the claim was due under 37 CFR 1.55 and the date the claim was filed was unintentional. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
If applicant believes this is incorrect and a certified copy of the foreign priority document was already submitted, please confirm in Patent Center that the document is part of the application’s file and contact the Office with the date that the document was filed. This could be done as an interview or in the next response.
Objection(s) and Rejection(s) Withdrawn
The drawings were received on 24 Aug 2025. These drawings are acceptable. The objection to the drawings is withdrawn.
Objections – Specification/ Sequence Listing
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – The "Sequence Listing" has not been entered into the application because the amendment does not direct entry of either the "Sequence Listing" (as required by 37 CFR 1.825(a)(2) or 1.825(b)(2)) or contain the required Incorporation by Reference paragraph into the application.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – The "Sequence Listing" has not been entered into the application because the required statement of no new matter is missing. See 37 CFR 1.825(a)(4) or 1.825(b)(5).
Required response – Applicant must provide:
A proper statement of no new matter.
Specific deficiency – The "Sequence Listing" has not been entered into the application because the required statement of support is missing. See 37 CFR 1.825(a)(3) or 1.825(b)(4).
Required response – Applicant must provide:
A proper statement of support.
Claim Objections
Claim 1 is objected to because of the following informalities: the species name Toxoplasma gondii should be italicized to match naming conventions in the field. Applicant corrected this error in two locations, but the incorrect term is still found in step (1) before the full name of the AMA1 protein. Appropriate correction is required.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)
Claims 1-5 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the reasons of record and the reasons herein.
Applicant argues (Remarks pg. 7) that a substitute sequence listing was submitted to replace the original sequence listing of record.
This argument has been considered but does not overcome the rejection because the substitute sequence listing was not entered. In particular, applicant has not pointed out support for the amended sequences in the specification as originally filed or stated that the amendment does not contain new matter.
Claim Rejections - 35 USC § 112(b)
Claims 4-5 remain rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends for the reasons of record and the reasons herein.
Applicant argues (Remarks pg. 7) that a substitute sequence listing was submitted to replace the original sequence listing of record.
This argument has been considered but does not overcome the rejection because the substitute sequence listing was not entered. In particular, applicant has not pointed out support for the amended sequences in the specification as originally filed or stated that the amendment does not contain new matter.
Claim Rejections - 35 USC § 102
Claims 1-3 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Park et al. (WO 2022158705 A1, published 28 Jul 2022, priority to 22 Jan 2021; hereafter Park; PTO-892 mailed 5 Jun 2025) for the reasons of record and the reasons herein.
Applicant argues (Remarks pg. 8-11) that:
The instant application shows superior antibody response in the context of RH strain infection, and can detect TH strain infection even at low doses, citing to Figures 3-4. The specification shows over 90% sensitivity and specificity, compared to ~70% for conventional TLA.
Park does not teach or enable a method for diagnosing RH strain (Type I), because Park references RH strain only as background information and only performs experiments and data using the ME49 strain (Type II strain); Park does not demonstrate that the same methods or antigens would work for an acute RH infection.
Previously researchers had uncertainty about serologically diagnosing acute toxoplasmosis caused by the RH strain. Mentioning a RH strain would not have rendered obvious how to successfully diagnose RH strain toxoplasmosis. RH strain infections are immunologically different from chronic infections and have no established serodiagnostic protocol, so a method proven to work on a Type II strain like ME49 cannot be assumed to work for a Type I strain without evidence.
Applicant’s arguments have been carefully considered but are not found persuasive. For the allegedly unexpected results in applicant’s argument (a), evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). See also MPEP 2131.04. In the interest of compact prosecution, it is noted that the alleged unexpectedness of this result is only found in the attorney’s arguments and is not asserted in the specification. Therefore, the alleged unexpectedness appears to only be opinion that is not supported by proof. Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984), and also MPEP 2145.
In response to arguments (b) and (c), applicant’s arguments relate to the intended uses of “measuring… to compare the level with that of a control sample” and the amendment of the intended use in the preamble “A method of diagnosing toxoplasmosis… wherein the toxoplasmosis is caused by an infection with tachyzoites of RH strain of Toxoplasma gondii.”
Applicant is reminded that the currently claimed method contains two steps: (1) inducing an antigen-antibody reaction by bringing a sample isolated from a patient into contact with a composition for diagnosing toxoplasmosis, wherein the composition comprises, as an active ingredient, Toxoplasma gondii virus-like particles (VLPs) comprising influenza virus matrix protein 1 (M1) and Toxoplasma gondii apical membrane antigen 1 (AMA1); and (2) measuring a level of the antigen-antibody reaction. The prior rejection pointed out how both of these steps were anticipated in Park (see NFOA par. 13).
The claim does not have a step of comparing the antigen-antibody reaction level to a control, or using that comparison to diagnose the subject; these features are intended uses of the method. However, a recitation of the intended use of the claimed invention must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art (see MPEP 2111.02). If the prior art method is capable of performing the intended use, then it meets the claim.
The specification does not disclose any methodological differences that would occur in the assay when performed with the intent to diagnose toxoplasmosis compared to when performing the identical assay with another intent, such as diagnosing non-RH strain T. gondii or measuring the level of antibody response to a vaccine. The arguments also do not argue that the two steps of inducing an antigen-antibody reaction and measuring the level of reaction are methodologically different as a result of this change in the strain. Applicant’s arguments that the method cannot be proven to “work” for a Type I strain without evidence are not persuasive because the method ends with measuring the level of reaction and does not include a comparison or diagnosis step. So, measuring any level of reaction, including measuring that there is no antigen-antibody reaction in the sample, would fulfill the claimed step. The argument that Park does not perform the method using a sample infected with an RH strain is not persuasive because the claim states one can use any “sample isolated from a patient”; there is no requirement in the claims that the subject be already known to have the RH strain prior to testing.
Therefore, the rejection is maintained for the because the method’s steps (1) and (2) are anticipated by Park, as described in the NFOA par. 13.
Claims 1-3 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (May 2020; hereafter Kim; PTO-892 mailed 5 Jun 2025) for the reasons of record and the reasons herein.
Applicant argues (Remarks pg. 8-9) that:
As for the rejection of Park, the instant application shows superior antibody response in the context of RH strain infection, and can detect TH strain infection even at low doses, citing to Figures 3-4. The specification shows over 90% sensitivity and specificity, compared to ~70% for conventional TLA.
Kim teaches the RH strain in context but does not provide practical teaching or data for diagnosing RH strain infections. Kim acknowledges the strain’s existence and generally acknowledges the challenges of acute toxoplasmosis, and teaches that serological diagnosis of RH-strain induced toxoplasmosis was previously unknown. Kim is primarily concerned with T. gondii infections of the ME49 strain, and does not present any data showing successful detection of RH strain T. gondii infection.
Previously researchers had uncertainty about serologically diagnosing acute toxoplasmosis caused by the RH strain. Mentioning a RH strain would not have rendered obvious how to successfully diagnose RH strain toxoplasmosis. RH strain infections are immunologically different from chronic infections and have no established serodiagnostic protocol, so a method proven to work on a Type II strain like ME49 cannot be assumed to work for a Type I strain without evidence.
Applicant’s arguments have been carefully considered but are not found persuasive. As discussed above for Park, evidence of secondary considerations (argument (a)) does not overcome a 102 rejection.
For argument (b), applicant did not point out specific locations in Kim supporting the claims. The examiner cannot identify the teaching in Kim that “serological diagnosis of RH-strain induced toxoplasmosis was previously unknown” (Remarks pg. 9) or any discussion of “general challenge of [diagnosing] acute toxoplasmosis” (Remarks pg. 9).
Nevertheless, for arguments (b) and (c), as discussed above for Park, these arguments relate to the intended uses of the method, but do not result in a methodological difference in either of the claimed steps. Therefore, the intended use does not differentiate the steps from those disclosed in the art. Therefore, the rejection is maintained for the because the method’s steps (1) and (2) are anticipated by Kim, as described in the NFOA par. 15-16.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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, Gary Nickol can be reached at (571)272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645