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 Claims
There are two (2) claims submitted on 22 APRIL 2024. The claim set considered is the set consisting of three (3) pages where each the claims have a status identifier.
Current pending claims are Claims 1-18 where Claims 1-12 are ‘Original’ or ‘Currently Amended’ and Claims 13-18 are ‘New’.
Current pending claims are Claims 1-18 and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 OCTOBER 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1, 2, 3, 6 and 15 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 term “suitable” in claim 1 and 3 are a relative term which renders the claim indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 1, it is unclear how one is supposed to determine a risk based on only steps (i) and (ii). After the ‘contacting’ step occurs in (ii) ; nothing is done to determine this risk.
Regarding claims 2, 6 and 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 3, it is unclear if steps (iv-a to vii-a) is an “and” or an “or” situation.
Dependent claims follow the same reasoning as being dependent upon a rejected claim under 112(b).
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.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) after claims 1 and 2 occur which are extra solution activities, the steps of doing the same and then comparing is considered to an abstract idea , which can be performed in the mind and/or with a pen and paper.
This judicial exception is not integrated into a practical application because after the comparing step in claim 3 is performed; nothing else is done. All of the steps that are performed do not add any additional steps which transform the claim into something that integrates the abstract idea into a practical application of the abstract idea. The additional steps within the claims are merely broadly-recited pre-solution, data gathering steps which do not impart any significance to the abstract idea, nor the claim when viewed as a whole.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in claim 1 and 2 and claim 3 (iv-a to vi-a) are all considered to be insignificant extra solution activities and steps of providing the polypeptide and determining are all considered to be data gathering steps. There is nothing in the claims which are considered to be significantly more and/or are considered to be well understood routine and convention.
The claims below have been rejected under NAZY.
Claims 11 and 18, which depends from claim 3 does not add any sort of limitation which would make the overall method as a whole a practical application or add any limitation which is significantly more.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NAZY, submitted on the Information Disclosure Statement on 11 OTOBER 2023, Non-Patent Literature Documents Cite No. 6.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference NAZY discloses a method for determining whether a subject is at an increased risk of developing prothrombotic thrombocytopenia in response to a vaccination against a viral infection or in the event of a viral infection, abstract, comprising the steps of:
(i) providing a first polypeptide comprising an amino acid sequence having at least 75% identity to SEQ ID NO:1 or SEQ ID NO:2, page 1343-1344, STUDY DESIGN AND METHODS;
(ii) contacting the first polypeptide according to (i) with a sample of [[a]]the subject under suitable
conditions for allowing the formation of a complex between the first polypeptide and
antibodies which are present in the sample and capable of forming a complex with the first
polypeptide to obtain, if appropriate, a complex composed of first polypeptide and antibody, page 1343-1344, STUDY DESIGN AND METHODS.
Additional Disclosures Included are: Claim 2: wherein the method as claimed in claim 1, further comprising : (iii) determining whether and/or in what amount a complex composed of first polypeptide and antibody is present; wherein the determination is preferably carried out using an immunoassay, more preferably using an enzyme-linked immunosorbent assay (ELISA), page 1343-1344, STUDY DESIGN AND METHODS, RESULTS AND DISCUSSION.; Claim 3: wherein the method as claimed in claim 2, further comprising (iv-a) providing a second polypeptide comprising an amino acid sequence differing in at least one amino acid from the amino acid sequence of the first polypeptide; (v-a) contacting the second polypeptide according to (iv) with a sample of a subject under suitable conditions for allowing the formation of a complex between second polypeptide and antibodies possibly present in the sample and capable of forming a complex with the first polypeptide; (vi-a) determining whether and/or in what amount a complex composed of second polypeptide and antibody is present; (vii-a) optionally comparing the values from (iii) and (vi-a), wherein it is established that the sample contains antibodies specific for the first polypeptide if less complex is present in (vi-a) than in (iii), page 1343-1344, STUDY DESIGN AND METHODS, RESULTS AND DISCUSSION.; Claim 4: wherein the method as claimed in claim 1, further comprising : (iv-b) providing thrombocytes; (v-b) contacting the thrombocytes according to (iv-b) with the complex obtained according to (ii) and composed of first polypeptide and antibody; (vi-b) determining thrombocyte function, page 1343-1344, STUDY DESIGN AND METHODS, RESULTS AND DISCUSSION. ; Claim 5: wherein the method as claimed in claim 1, wherein the sample of a subject is selected from the group consisting of mucosa sample, body fluid sample, body excreta sample and body tissue sample, preferably from the group consisting of a nasal mucosa sample, a throat mucosa sample, a urine sample, a blood sample, a serum sample and a plasma sample, more preferably a serum sample, page 1343-1344, STUDY DESIGN AND METHODS.; Claim 6: wherein the method as claimed in claim 1, wherein the sample was collected from the subject after a vaccination with a vaccine which induces the formation of antibodies against a viral infection, abstract, page 1342, Patients/Methods.; Claim 7: wherein the method as claimed in claim 1, wherein the subject has been diagnosed with a viral infection, abstract, page 1343-1344, STUDY DESIGN AND METHODS.; Claim 8: wherein the method as claimed in claim 1, wherein the viral infection is a coronavirus infection, abstract, page 1343, STUDY DESIGN AND METHODS.; Claim 9: wherein the method of claim 1, wherein the subject is mammal, abstract, page 1343, STUDY DESIGN AND METHODS.; Claim 10: wherein the method of claim 1, wherein the sequence of the amino acid sequence of the first polypeptide is at least 84%, abstract, page 1343, STUDY DESIGN AND METHODS. ; Claim 11 : wherein the method as claimed in claim 3, wherein the amino acid sequence of the second polypeptide differs in at least 2 amino acids from that of the first polypeptide, page 1343, STUDY DESIGN AND METHODS, different antibodies are tested for.; Claim 12: wherein the method as claimed in claim 1, wherein the method is an in vitro method, page 1343, STUDY DESIGN AND METHODS.; Claim 13: wherein the method of claim 5, wherein the sample of the subject is a nasal mucosa sample, a throat mucosa sample, a urine sample, a blood sample, a serum sample, or a plasma sample, page 1343, STUDY DESIGN AND METHODS.; Claim 14: wherein the method of claim 6, wherein the sample was collected from the subject within a period of 4 to 20 days after a vaccination, abstract, page 1342, Patients/Methods. ; Claim 15: wherein the method of claim 8, wherein the coronavirus is preferably selected from the group consisting of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), SARS-CoV-1 (severe acute respiratory syndrome coronavirus 1) and MERS-CoV (Middle East respiratory syndrome coronavirus), abstract, page 1343, STUDY DESIGN AND METHODS.; Claim 16: wherein the method of claim 9, wherein the subject is human, page 1343, STUDY DESIGN AND METHODS.; Claim 17: wherein the method of claim 10, wherein the sequence identity of the amino acid sequence of the first polypeptide is at least 92% in relation to SEQ ID NO:1, abstract, the sequence ID in SARS-CoV2 has at least 92 % in relation, see pages 3 of instant specification disclosure. ; Claim 18: wherein the method of claim 11, wherein the amino acid sequence of the second polypeptide differs by 2 to 13 amino acids from that of the first polypeptide, page 1343, STUDY DESIGN AND METHODS, abstract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 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, LYLE ALEXANDER can be reached at (571) 272-1254. 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.
CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
Prosecution Insights