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 without traverse of Group II (claims 13-15, 17-19, 21-24), drawn to a method of using a medication, in the reply filed on 05/18/2026 is acknowledged.
Claims 1-3, 5-7, 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/18/2026.
Claims Status
Claims 4, 8, 16, 20, 25-70 is/are cancelled. Claims 1-3, 5-7, 9-15, 17-19, 21-24 is/are currently pending with claims 1-3, 5-7, 9-12 withdrawn. Claims 13-15, 17-19, 21-24 is/are under examination.
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 13-15, 17-19, 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of insulin resistance, hyperglycemia, prediabetes, and type 2 diabetes in subjects having these diseases, does not reasonably provide enablement for treatment of insulin resistance, hyperglycemia, prediabetes, or type 2 diabetes in any subject which does not have any one of these diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims:
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. As such, the broadest reasonable interpretation of the claimed method is that it encompasses treatment of insulin resistance, hyperglycemia, prediabetes, or type 2 diabetes in any subject, including subjects which do not have any of these diseases. A skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification.
The existence of working examples:
What is enabled by the working examples is narrow in comparison to the breadth of the claims: The specification discloses testing of the claimed method in vivo in db/db mice (paragraph [0112]), providing enablement for the claimed methods in subjects represented by db/db mice, having diseases predictably modeled by db/db mice.
The amount of direction provided by the inventor and the level of predictability in the art:
The specification teaches that the methods were tested in db/db mice (paragraph [0112]). The art at the time of filing teaches that db/db mice are representative of type 2 diabetes and diabetic dyslipidemia (Srinivasan and Ramarao, 2007, page 457). The specification as filed does not provide guidance that overcomes this unpredictability within the art, as the specification does not teach that the claimed method can treat a disease in a subject which does not have said disease, and instead teaches, supported by the prior art, that the claimed method can treat insulin resistance, hyperglycemia, prediabetes, and type 2 diabetes in subjects having these diseases.
The quantity of experimentation needed to make or use the invention:
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution. Given that the nature of the invention is treatment of insulin resistance, hyperglycemia, prediabetes, or type 2 diabetes in subjects in need thereof, a person having ordinary skill in the art would have to perform multiple further experiments in animal models to show that a disease can be treated in a subject which does not have said disease, in order to demonstrate the invention could be used with a reasonable expectation of success in its full scope. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating any CNS disorder or neurodegenerative disease. Therefore, Claims 13-15, 17-19, 21-24 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13-15, 18-19, 21-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US20180237490A1).
Regarding claim 13, Kim teaches a method of treating type 2 diabetes, the method comprising administering to a subject in need thereof a pharmaceutical composition comprising an immunoglobulin (immunoglobin) Fc region (claim 1).
Regarding claims 14-15, Kim teaches that the immunoglobulin Fc region is an IgG1, IgG2, IgG3, or IgG4 Fc region (paragraphs [0131], [0134]).
Regarding claims 18-19, Kim teaches that the immunoglobin Fc peptide may be a chimera of IgG, IgA, IgD, IgE, and/or IgM: “the immunoglobulin Fc region may be derived from IgG, IgA, IgD, IgE, IgM, or a combination or hybrid thereof” (paragraph [0131], emphasis added), wherein “the term ‘combination’ means that polypeptides encoding single-chain immunoglobulin Fc regions of the same origin are linked to a single-chain polypeptide of a different origin to form a dimer or multimer” (paragraph [0132] and “the term ‘hybrid’ means that sequences corresponding to two or more immunoglobulin Fc fragments of different origins are present in a single-chain immunoglobulin Fc region” (paragraph [0133]).
Regarding claim 21, Kim teaches that the taught method improves insulin sensitivity (Abstract).
Regarding claim 22, Kim teaches that the taught method improves glucose tolerance (Abstract).
Regarding claim 23, Kim teaches that the taught method improves β cell function (paragraph [0020]).
Regarding claim 24, as Kim teaches a method comprising all of the required steps of the instant claimed method of claims 13 and 24, using a composition comprising all of the required structural limitations of claims 13 and 24, it is interpreted that the method taught by Kim would produce the same outcomes as the instant claimed method. As described above, the benefits recited by instant claims 21-23 are explicitly taught by Kim as benefits provided by the methods of Kim. While Kim does not teach that the method of Kim results in reduced adipose tissue inflammation, it is interpreted that subjects administered the compositions of Kim in the method of Kim would experience the benefit of reduced adipose tissue inflammation as an inherent property of the method taught by Kim.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 13-15, 17-19, 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US20180237490A1), in view of Anthony (2010) and Wellen (2005).
Regarding claim 13, Kim teaches a method of treating type 2 diabetes, the method comprising administering to a subject in need thereof a pharmaceutical composition comprising an immunoglobulin (immunoglobin) Fc region (claim 1).
Regarding claims 14-15, Kim teaches that the immunoglobulin Fc region is an IgG1, IgG2, IgG3, or IgG4 Fc region (paragraphs [0131], [0134]).
Regarding claim 17, Kim teaches that “the Fc region may, if necessary, be modified by phosphorylation, sulfation, acrylation, glycosylation, methylation, farnesylation, acetylation, amidation, and the like” (paragraph [0125]).
Regarding claims 18-19, Kim teaches that the immunoglobin Fc peptide may be a chimera of IgG, IgA, IgD, IgE, and/or IgM: “the immunoglobulin Fc region may be derived from IgG, IgA, IgD, IgE, IgM, or a combination or hybrid thereof” (paragraph [0131], emphasis added), wherein “the term ‘combination’ means that polypeptides encoding single-chain immunoglobulin Fc regions of the same origin are linked to a single-chain polypeptide of a different origin to form a dimer or multimer” (paragraph [0132] and “the term ‘hybrid’ means that sequences corresponding to two or more immunoglobulin Fc fragments of different origins are present in a single-chain immunoglobulin Fc region” (paragraph [0133]).
Regarding claim 21, Kim teaches that the taught method improves insulin sensitivity (Abstract).
Regarding claim 22, Kim teaches that the taught method improves glucose tolerance (Abstract).
Regarding claim 23, Kim teaches that the taught method improves β cell function (paragraph [0020]).
Regarding claim 24, as Kim teaches a method comprising all of the required steps of the instant claimed method of claims 13 and 24, using a composition comprising all of the required structural limitations of claims 13 and 24, it is interpreted that the method taught by Kim would produce the same outcomes as the instant claimed method. As described above, the benefits recited by instant claims 21-23 are explicitly taught by Kim as benefits provided by the methods of Kim. While Kim does not teach that the method of Kim results in reduced adipose tissue inflammation, it is interpreted that subjects administered the compositions of Kim in the method of Kim would experience the benefit of reduced adipose tissue inflammation as an inherent property of the method taught by Kim.
However, Kim does not teach that the immunoglobulin Fc region is sialylated.
Anthony teaches that sialylation of immunoglobulin Fc regions enhances anti-inflammatory response.
Regarding claims 17 and 24, Anthony teaches that sialylated IgG Fc regions exhibit significantly enhanced anti-inflammatory activity (page S11). Wellen teaches that type 2 diabetes is an inflammatory disease (page 1111; abstract).
As type 2 diabetes is an inflammatory disease, caused by chronic inflammation, as taught by Wellen, as sialylation of IgG Fc regions enhances anti-inflammatory activity, and as Kim teaches methods of treating type 2 diabetes comprising administering to a subject in need thereof IgG Fc regions, it would have been obvious to an artisan at the time of filing to sialylate the IgG Fc regions used in the methods of Kim in order to enhance the anti-inflammatory activity of the composition of Kim. Increased anti-inflammatory activity would be obviously beneficial in a method of treating type 2 diabetes because chronic inflammation was known at the time of filing to significantly contribute to or cause type 2 diabetes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636
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