-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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on November 25, 2025 has been entered.
Priority
This application is a continuation of 17/262,790 filed on 01/25/2021, which is a 371 of PCT/US19/43675 filed on 07/26/2019 and claims benefit in provisional application 62/711,241 filed on 07/27/2018.
Claim Status
Claims 1-6, 8-10, and 12-35 are pending and examined. Claims 26-35 were newly added. Claims 1, 8, 10, 12, 14, 16, 23, and 24 were amended. Claims 7 and 11 were canceled.
Withdrawn Claim Rejections — 35 USC § 112
Rejections of claims 10, 12, 16, 23, and 24 are withdrawn because rejections were obviated with claim amendments.
Withdrawn Claim Rejections —35 USC § 103
Rejections of claims 1-5, 12, 13, and 15-25 as being unpatentable over Tabatadze (US 2016/0289182 Al Published October 6, 2016); rejections of claims 6-11 over Tabatadze and Purmal (US 2002/0150950 Al, Published October 17, 2002); rejection of claim 14 as being unpatentable over Tabatadze and Wang et al. (US 2013/0131423 Al Published May 23, 2013) are withdrawn because the claims were amended to require (iii) forming a first treated sample by removing or reducing the compound having Structure I in the sample from step (ii) by treatment with a solid phase agent and (iv) forming a second treated sample by treating the first treated sample from step (iii) with one or more neutralizing agents which eliminate or further reduce the toxicity of the compound having Structure I. The sequence of steps (iii) and (iv) would not have been obvious over the cited references.
Applicant’s arguments against these rejections are moot because rejections are withdrawn.
The declaration by Sachais was fully considered but it is not sufficient to show that instantly claimed method has unexpected advantage as argued by the declarant because the declaration does not meet the requirements set forth in MPEP 716.02 (a)-(f). The declarant provided a conclusion that the declarant would not have expected the advantageous characteristic of the method of claim based on the teachings of the cited references, however the conclusion was not supported by evidence. The method described in Attachment A does not teach the claimed steps (iii) and (iv), which are assertedly critical to the claimed invention. The TS resin was added to a blood sample treated with ZD10. The method does not teach a step that corresponds to claimed step (iv).
Withdrawn Double Patenting Rejections
Rejections of claims 1-7, 12, 13, 15, and 17-25 over claims 2-10 of copending Application No. 18/171,062 (reference application); rejections of claims 8-11 over claims 2-10 of copending Application No. 18/171,062 (reference application) and Purmal; rejection of claim 16 over claims 2-10 of copending Application No. 18/171,062 (reference application) and Tabatadze; and rejection of claim 14 over claims 2-10 of copending Application No. 18/171,062 (reference application) and Wang are withdrawn because applicant filed a terminal disclaimer that was approved on December 4, 2025.
Rejections of claims 1-16, 18, and 21-25 over claims 1-20 of copending Application No. 18/935,993 (reference application); and rejections of claims 17, 19, and 20 over claims 1-20 of copending Application No. 18/935,993 (reference application) and Tabatadze because applicant filed a terminal disclaimer that was approved on November 25, 2025.
Terminal Disclaimer
The terminal disclaimer filed on December 4, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application No. 18/171,062 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer filed on November 25, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patented granted on Application No. 18/935,993 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claims 21 and 22 are objected for lack of consistency and it is recommended to replace “the treated sample” with “the second treated sample”.
Claims 34 and 35 are objected because the first word in the claims does not start with a capital letter.
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.
Claims 1-6, 8-10, and 12-35 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended to require a new step between steps (ii) and (iii), and now recites steps (i), (ii), (iii) (new step), and (iv) (previous step iii). This amendment introduces new matter because the application as filed does not provide support of the sequence of steps (iii) and (iv), as claimed. In the remarks dated November 25, 2025, the applicant did not indicate where support is provided for newly added limitations. After reviewing the application, support was not found for amendments made to claim 1.
The relevant teachings appear in the following sections of the specification. Paragraph 0013 teaches that “The elimination or reduction of the residual alkylating compound may be performed by treatment with a solid–phase agent, which reacts with, or otherwise sequesters the alkylating compound, or alternatively by treatment with a solution of a neutralizing compound, which eliminates or reduces the toxicity or other undesirable properties of the alkylating compound, preferably by eliminating its alkylating properties followed, in some instances, by removal of the products of neutralization of the alkylating compound and/or the excess of the neutralizing compounds by means of a solid phase agent that sequester them.”. A similar teaching is present in paragraph 0014. Paragraph 0138 teaches “In some embodiments of the invention, reduction of the residual compound of Structure I to the desired level by a single treatment with a solid phase agent may not be achieved. In such cases, two or more subsequent treatments with the solid phase agent may be required, as it is illustrated in Figure 9.”.
From these teachings, it is apparent that the solid phase agent is an alternative to a treatment with a solution of a neutralizing compound, which eliminates or reduces the toxicity or other undesirable properties of the alkylating compound. In the embodiment where a solution of a neutralizing compound, which eliminates or reduces the toxicity or other undesirable properties of the alkylating compound was used, it was contemplated to remove the products of neutralization of the alkylating compound and/or the excess of the neutralizing compounds, in some instances, by means of a solid phase agent that sequester them. Thus, the specification provides support for treating the sample with a solution of a neutralizing compound, which eliminates or reduces the toxicity or other undesirable properties of the alkylating compound, followed by treatment with a solid phase agent to remove the products of neutralization of the alkylating compound and/or the excess of the neutralizing compounds.
The specification also provides support for two or more treatments with the solid phase agent. However, the specification does not provide support for claimed steps (iii) and (iv).
Claim 28 requires conducting the step iii at a pH of 6-8, which introduces new matter because the application as filed does not teach the pH of the sample during treatment with the solid phase agent.
Claim 29 requires the one or more neutralizing agents in step (iv) to be up to about 1 mM, which introduces new matter because it is not supported in the application as originally filed. Paragraphs 0086 and 0268 teach that the concentrations of the neutralizing compound in the treated sample can be up to 1 M, preferably up to 0.1 M, and even more preferably up to 10 mM.
Claim 31 recites -OS(O)(O)S and -S(O)(O)S, which introduce new matter because these limitations are not supported in the application as filed. Paragraph 0018 provides support for -OS(O)(O-)S- and -S(O)(O-)S-.
Claims 2-6, 8-10, 12-27, 30, and 32-35 are rejected for new matter because the claims depend from claim 1 and contain new matter limitations of claim 1.
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 10, 20, and 31 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.
Regarding claim 10, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 20 recites “according to any one of claim 1 to 16”. The claim is indefinite because the claim depends from canceled claims 7 and 11. The range “claim 1 to 16” includes canceled claims 7 and 11.
Claim 31 is indefinite because the scope of the alternatives from which the reactive groups are selected is not clear. The claim recites “selected from the group consisting of” followed by a list of chemical moieties separated by three occurrences of “or” and one “and”, which is improper Markush language and makes it unclear which compounds are alternatives. Ground of rejection may be obviated by separating the alternatives with a comma and an “and” between the last two alternatives. It is noted that mercapto and thiol have the same meaning and it is not necessary to recite both.
Conclusion
No claims are allowed.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617