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 .
Response to Amendment
The preliminary amendment filed on November 15, 2024 is acknowledged. The application will be examined accordingly.
Claim Objections
Claim 18 is objected to because of the following informalities:
The optional language of claim 18 is redundant. The recitation of “and/or” encompasses the optional language. The optional language should be deleted.
Appropriate correction is required.
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.
Claims 1-4, 6-9, 11, 12, 14-16, 18, 21, 23-26 and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process/mathematical calculation without significantly more. Independent claims 1 and 14 recite a step of determining a vector of change of a graph, which constitutes a mathematical concept as well as a mental process. They constitute a judicial exception under 35 U.S.C. 101. This judicial exception is not integrated into a practical application because nothing is done with it (i.e. the claimed method terminates with determining the vector of change). While claims 1 and 14 further recite a step of administering a therapeutic/prophylactic agent to a subject, this step constitutes insignificant extra-solution activity. Consequently, the judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, so as to obviate a rejection under 35 U.S.C. 101.
The dependent claims do not cure the deficiencies of claims 1 and 14. Consequently, they are also rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 3, 4, 6-8, 15, 21 and 28 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The scope of claims 3 and 15 is unclear because the scope of the limitations WQE and ODE is unclear. The limitations do not appear to be terminologies having well-known definitions, and the specification does not provide definitions for the limitations. Consequently, the scope of claims 3 and 15 cannot be ascertained. Specifically, the metes and bounds of the claimed calculations are unclear.
Claim 4 is indefinite because it recites a broad limitation together with a narrow limitation that falls within the broad limitation in the same claim. See MPEP § 2173.05(c). Specifically, claim 4 recites the broad limitation “immunotherapeutic agent”, followed by the narrow limitation “anti-CD3 antibody or antigen-binding fragments thereof”.
Relatedly, it is unclear whether the subject matter of claims 7-9 is conditionally directed to the optional subject matter. Given that the subject matter of claims 7-9 is tied explicitly to the administration of an anti-CD3 antibody, which is an optional step, the subject matter of claims 7-9 will be deemed optional subject matter.
Likewise, claims 21 and 28 are indefinite.
With respect to claim 21, the claim recites a generic “abnormal glucose tolerance on OGTT”, and it also recites a very specific “abnormal glucose tolerance on OGTT”.
With respect to claim 28, the claim recites an expanded list comprising teplizumab and a shorter list consisting of teplizumab.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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 1, 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Staib et al. (“Staib”) (US 2013/0297224 A1).
With respect to claim 1, Staib discloses a method of monitoring the health of a patient with diabetes (see abstract and [0007]), wherein the method comprises:
performing an oral glucose tolerance test (OGTT) on a subject is pre-diabetic or diabetic (see abstract and [0007]), and
plotting change over a period of time of mean glucose values (see Fig. 2) and mean C-peptide values (see Fig. 3) on a 2-dimensional grid. Staib further discloses that the test can be used to monitor the efficacy of various treatments (see [0080]). In light of the disclosure of Staib, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the method to determine the efficacy of various treatments for type I diabetes. Naturally, such a method would comprise administering a therapeutic or prophylactic agent to a subject that has type I diabetes prior to performing the method taught by Staib.
With respect to claim 2, the OGTT is a 2-hour test (see Figs. 1-2).
With respect to claim 12, Staib discloses the method is applicable for testing pre-diabetic patients to tracking the progression of diabetes in diabetic patients (see [0007]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the modified method to a subject who has stage 1, 2, 3 or 4 type I diabetes.
Claims 4, 6-9, 11, 14, 16, 18, 21, 23-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Staib as applied to claims 1, 2 and 12 above, and further in view of McKee et al. (“McKee”) (US 2012/0269826 A1).
With respect to claim 4, Staib does not disclose that the therapeutic or prophylactic agent comprises an immunotherapeutic agent. However, the use of antibodies, specifically anti-CD3 antibodies such as otelixizumab, to treat type I diabetes is well-known in the art (see [0232] and [0022] of McKee). In light of the disclosure of McKee, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the method of Staib to determine the efficacy of otelixizumab as a treatment for type I diabetes.
With respect to claims 6-9 and 11, as discussed above, the claims are deemed to be directed to optional subject matter. Consequently, prior art need not teach the subject matter of the claims to reject the claims.
With respect to claims 14 and 28, Staib discloses the method is applicable for testing healthy patients who are pre-diabetic (see [0007]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the modified method to a subject who is pre-diabetic and who is undergoing treatment to prevent or delay the onset of type 1 diabetes to determine the efficacy of the treatment. Naturally, such a method would comprise the step of administering an effective amount of a prophylactic agent, such as otelixizumab (see [0232] of McKee disclosing that anti-CD3 antibody can also be used to prevent diabetes) before conducting the method taught by Staib.
With respect to claims 16 and 18, the optional subject matter of claim 16 and the subject matter of claim 18 merely recite biomarkers, either individually or as a combination, commonly found in subjects who are “non-clinically diabetic”. Consequently, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have conducted the modified Staib method on a subject who comprises the claimed biomarkers.
With respect to claim 21, a non-clinically diabetic subject, by definition, would produce “abnormal” glucose tolerance on the OGTT.
With respect to claims 23 and 24, according to McKee, the anti-CD3 antibody is introduced intravenously (see [0018]), and the treatment can occur daily for 14 days (see [0006]), wherein many of the daily doses and the total doses taught by McKee appear to fall within the respective claimed ranges (see [0008]). In light of the disclosure of McKee pertaining to a suitable anti-CD3 antibody regimen for preventing the onset of diabetes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the regimen prior to conducting the method taught by Staib.
With respect to claim 25, as discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered to the subject a 14-day course of IV infusion of anti-CD3 antibody. Moreover, McKee discloses that the dosage may increase daily over the first five days (see [0010] disclosing approximately doubling dosage daily) before administering a maximum daily dose (see [0179]). In light of the disclosure of McKee directed towards dosage ramping, and based on the daily dosages disclosed by McKee (see [0006], [0008] and [0010]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered to the subject the claimed regimen.
With respect to claim 26, the subject matter of the claim is directed to a property of a prophylactically-effective dosage of the CD3 antibody. Given that McKee discloses the claimed anti-CD3 antibody, the prophylactic dosage taught by McKee is deemed to anticipate the subject matter of the claim (see also [0308] of McKee disclosing that single course of teplizumab preserves insulin production for at least 2 years).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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, Luan Van can be reached at 571-272-8521. 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.
/PAUL S HYUN/ Primary Examiner, Art Unit 1796
Prosecution Insights