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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-2 and 5-13) in the reply filed on 08/10/2026 is acknowledged. For the species within Group I, Applicant elected the following:
the antibody or antigen binding fragment thereof that binds GM2AP comprising SEQ ID NOs: 16/17/18/19/20/21 for LCDR1/LCDR2/LCDR3/HCDR1/HCDR2/HCDR3 respectively SEQ ID NOs: 4-5 for LCVR and HCVR respectively; and
a labeling enzyme for the signal generating unit.
Claims 1-2 and 5-13 are directed to art-free subject matter and would be a potentially allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 14-24, directed to the process of making or using the potentially allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups I-II as set forth in the Office action mailed on 06/11/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Status
Claims 3-4 are cancelled. Claims 1-2 and 5-24 are pending. Claims 14-24 were previously withdrawn from consideration as a result of a restriction requirement and hereby rejoined. Claims 1-2 and 5-24 are currently under consideration for patentability under 37 CFR 1.104.
Priority
This application claims benefit of Provisional U.S. Application No. 63/386,320 filed on 12/07/2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claims 1-2 and 5-24 have an effective filing date of 12/07/2022 corresponding to Provisional U.S. Application No. 63/386,320.
Information Disclosure Statement
The information disclosure statement(s) filed on 09/05/2024 (2 filed on the same day) and 03/26/2026 has/have been considered. Signed copies are enclosed.
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 abstract of the disclosure is objected to because “complementary determining regions” should be replaced with “complementarity determining regions” (2 instances). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
SEQ ID NOs: 17, 23, and 29 refer to prohibited sequences, “000,” as they have less than 4 defined amino acids. Applicant should amend the specification to replace all mentions of SEQ ID NOs: 17, 23, and 29 with the actual sequences.
All instances of “complementary determining regions” should be replaced with “complementarity determining regions”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities regarding amino acid sequences: SEQ ID NO: 17 refers to a prohibited sequence, “000,” as it has less than 4 defined amino acids. Applicant should amend the claim to replace all mentions of SEQ ID NO: 17 with the actual sequence. Claims 2 and 5-24 are included in this objection as they depend on and/or incorporate claim 1.
For the purposes of claim interpretation, the sequence for SEQ ID NO: 17 will be treated as RMS as denoted in Table 4 of the instant specification.
Appropriate correction is required.
Claims 1, 7, 10-13, 17-18, and 23-24 are objected to because of the following informalities regarding typographical errors:
Claim 1: “light chain complementary determining regions” should be replaced with “light chain complementarity determining regions”.
Claim 1: “heavy chain complementary determining regions” should be replaced with “heavy chain complementarity determining regions”.
Claim 7: “further comprises a substrate” should be replaced with “wherein the kit further comprises a substrate”.
Claims 7 and 17: “a Fc” should be replaced with “an Fc”.
Claim 10: the extra space after “enzyme” should be deleted.
Claims 10, 11, and 18: “horse radish” should be replaced with “horseradish”.
Claims 12 and 13: “the kit further comprises” should be replaced with “wherein the kit further comprises”.
Claims 23-24: "the subject is determined to be a high risk population of lung cancer" should be replaced with "the subject is determined to be at a high risk for lung cancer".
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 1-2 and 5-24 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 recites the limitation "the antigen-binding fragment" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 2 and 5-24 are included in this rejection as they depend on and/or incorporate claim 1.
For the purposes of claim interpretation, "the antigen-binding fragment" will be treated as “an antigen-binding fragment”.
Regarding claim 1, the phrase "SEQ ID NO: 17" renders the claim indefinite because it refers to a prohibited sequence, “000,” as it has less than 4 defined amino acids. Claims 2 and 5-24 are included in this rejection as they depend on and/or incorporate claim 1.
For the purposes of claim interpretation, the sequence for SEQ ID NO: 17 will be treated as RMS as denoted in Table 4 of the instant specification.
Regarding claim 1, the phrase "an amino acid sequence SEQ ID NOs: 16/17/18/19/20/21" renders the claim indefinite because it is unclear if Applicant made an error when amending the claim or intended to claim fragments of the SEQ ID NOs comprising the antibody or antigen-binding fragment thereof. Claims 2 and 5-24 are included in this rejection as they depend on and/or incorporate claim 1.
For the purposes of claim interpretation, the phrase "an amino acid sequence SEQ ID NOs: 16/17/18/19/20/21" will not include fragments of the SEQ ID NOs comprising the antibody or antigen-binding fragment thereof and will be treated as “the amino acid sequences of SEQ ID NO: 16/RMS/SEQ ID NO: 18/SEQ ID NO: 19/SEQ ID NO: 20/SEQ ID NO: 21 respectively”.
Regarding claim 2, the phrase "an amino acid sequence" renders the claim indefinite because it is unclear if Applicant made an error when amending the claim or intended to claim fragments of the SEQ ID NOs comprising the antibody or antigen-binding fragment thereof.
For the purposes of claim interpretation, the phrase "an amino acid sequence" will not include fragments of the SEQ ID NOs comprising the antibody or antigen-binding fragment thereof and will be treated as “the amino acid sequence”.
Claim 9 recites the limitation "the signal generating unit" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 10-11 are included in this rejection as they depend on and/or incorporate claim 9.
For the purposes of claim interpretation, claim 9 will be treated as dependent on claim 7.
Claim 11 recites the limitation "the substrate" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of claim interpretation, claim 11 will be treated as dependent on claim 7.
Claim 14 recites the limitation "said biological samples" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Claims 15-24 are included in this rejection as they depend on and/or incorporate claim 14.
For the purposes of claim interpretation, "said biological samples" will be treated as “said biological sample” in claim 14 and as well as in its dependent claims 20-21.
Regarding claim 14, the phrase "(a) determining a GM2AP content in a biological sample through the recombinant antibody or the antigen-binding fragment thereof according to claim 1 or the kit according to claim 6" renders the claim indefinite because it is unclear how the recombinant antibody or antigen-binding fragment thereof, or the kit comprising said recombinant antibody or antigen-binding fragment thereof, is used for determining GM2AP content. For example, GM2AP content can be determined by (i) direct detection of GM2AP by the recombinant antibody or antigen-binding fragment thereof or (ii) indirect detection in an immunoassay using the recombinant antibody or antigen-binding fragment thereof.
Claims 15 and 17-24 are included in this rejection as they depend on and/or incorporate claim 14. Claim 16 recites additional limitations for step (a) of claim 14, including applying the recombinant antibody or antigen-binding fragment thereof to a biological sample, incubating with a secondary antibody conjugated to a detectable label, and detecting the detectable label to determine GM2AP content. Therefore, claim 16 does not have an indefiniteness issue and will not be included in this rejection.
For the purposes of claim interpretation, the phrase "(a) determining a GM2AP content in a biological sample through the recombinant antibody or the antigen-binding fragment thereof according to claim 1 or the kit according to claim 6" will be treated as determining GM2AP content via (i) direct detection of GM2AP by the recombinant antibody or antigen-binding fragment thereof or (ii) indirect detection in an immunoassay using the recombinant antibody or antigen-binding fragment thereof.
Art-Free Subject Matter
It is noted that the antibody or antigen binding fragment thereof that binds GM2AP of instant claim 1 comprising the amino acid sequences of SEQ ID NO: 16/RMS/SEQ ID NO: 18/SEQ ID NO: 19/SEQ ID NO: 20/SEQ ID NO: 21 for LCDR1/LCDR2/LCDR3/HCDR1/HCDR2/HCDR3 respectively, SEQ ID NO: 4 for LCVR, and SEQ ID NO: 5 for HCVR was thoroughly searched corresponding to the limitations of the claim and is free of prior art. Instant claims 2 and 5-24 depend on instant claim 1, incorporating all limitations.
The closest prior art to instant claims 1-2 and 5-24 is US11780917B2 (filed 2021-08-16, hereinafter referred to as US ‘917). US ‘917 teaches a “[a] recombinant antibody or the antigen-binding fragment thereof which specifically binds GM2-activator protein (GM2AP)” (claim 1). However, US ‘917 does not teach said antibody or antigen binding fragment comprising the amino acid sequences as recited in instant claim 1.
Therefore, instant claims 1-2 and 5-24 are not anticipated by US ‘917 because the prior art fails to disclose each and every element of the claimed invention. In addition, instant claims 1-2 and 5-24 are not rendered obvious by US ‘917. While US ‘917 teaches a recombinant antibody or antigen binding fragment thereof that binds GM2AP, the prior art does not provide a teaching, suggestion, or motivation to modify the sequences of said antibody or antigen binding fragment to arrive at the claimed invention.
Conclusion
Claims 1-2 and 5-24 are pending. Claims 14-24 were previously withdrawn from consideration as a result of a restriction requirement and hereby rejoined. Claims 1-2 and 5-24 are objected to. Claims 1-2 and 5-24 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Priest whose telephone number is (571)272-8469. The examiner can normally be reached Mon-Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.P./Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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