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/Restriction:
Applicant's election without traverse of Group I (claims 1-19), filed on 1/12/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/12/2026.
Amended claims 1, 3, 12, 17, (1/12/2026), and original claims 2, 4-11, 13-16, and 18-19, are under consideration by the Examiner.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 1/12/2026, and 10/3/2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim Rejections - 35 USC § 112(a), scope of enablement
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
4a. Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), because the specification, while being enabling for a method of treating acute pancreatitis in a human individual, comprising intravenously administering to the human individual an effective amount of an IL-22 dimer, wherein the effective amount of the IL-22 dimer is 2 µg/kg to 200 µg/kg, wherein the IL-22 dimer comprises two monomeric subunits, wherein each monomeric subunit comprises an IL-22 domain and a dimerization domain, and wherein each dimerization domain comprises CH2 and CH3 domains of a human IgG, does not reasonably provide enablement for a method of treating all “metabolic diseases”, comprising intravenously administering an IL-22 dimer to a human individual an effective amount of an IL-22 dimer, wherein the effective amount of the IL-22 dimer is 2 µg/kg to 200 µg/kg, wherein the IL-22 dimer comprises two monomeric subunits, wherein each monomeric subunit comprises an IL-22 domain and a dimerization domain, and wherein each dimerization domain comprises CH2 and CH3 domains of a human IgG. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The instant claims encompass a method of treating any and all “metabolic diseases” comprising administering an IL-22 dimer. However, the instant specification teaches that IL-22 dimer significantly improved the pathology score in an animal model for pancreatitis, (See Example 6, pages 26-27).
Claim 1 encompasses administering the recited IL-22 dimer to any individual to treat any metabolic disease. Claim 18 recites disparate diseases to be treated by administering the recited IL-22 dimer. Thus, the instant claims encompass treating disparate diseases that have different etiologies and clinical manifestations. Thus, one skilled in the art would not expect that the administration of the same agent would result in the treatment of the metabolic diseases diabetes, hyperlipidemia, hyperglycemia, and obesity, as well as would not expect that administration of the IL-22 dimer would achieve one or more effects selected from the group consisting of: losing weight, reducing adipocyte size, reducing deposition of triglycerides, and improving glucose tolerance, following the guidance in the instant specification. For example, Merck online Medical Dictionary defines these diseases as follows:
“Metabolic syndrome is being characterized by a large waist circumference (due to excess abdominal fat), hypertension, abnormal fasting plasma glucose or insulin resistance, high triglyceride level, and low HDL level. Causes, complications, diagnosis, and treatment are similar to those of obesity.”
Thus, one would not reasonably expect that every and all disparate metabolic diseases would be treatable by the administration of an IL-22 dimer, following the guidance in the instant specification.
The criteria set forth in Ex parte Forman (230 USPQ 546 (Bd. Pat. App. & Int. 1986), and reiterated in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)), which include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims, is the basis for determining undue experimentation. In the instant case, it is unpredictable that the recited IL-22 dimers would be effective in the treatment of the disparate diseases encompassed in the claims because the specification only establishes a link between said IL-22 dimer and treating pancreatitis. A large quantity of experimentation would be necessary to determine whether the IL-22 dimer of the instant invention would treat disparate metabolic diseases encompassed by claims. Due to the lack of direction/guidance presented in the specification regarding the same, lack of working examples, the teachings of the prior art, and the complex nature of the invention, undue experimentation would be required of the skilled artisan to use the claimed invention for treating all metabolic diseases.
The practice of the claimed method without the need for substantial undue experimentation and additional inventive contribution requires the disclosure of an effective route, duration and quantity of administration of the IL-22 dimer to an individual suffering from a “metabolic disease” and this information is not provided by the instant specification. The text on page 20 of the instant specification clearly fails to supply the guidance that would be needed by a routine practitioner and essentially constitutes nothing more than an invitation to engage in additional experimentation. The instant specification has also failed to disclose how these parameters are to be determined, how a similar method was practiced in the art with a different agent or to provide even a single working example, prophetic or actual, of the claimed method. In the absence of this guidance a practitioner would have to resort to a substantial amount of undue experimentation involving the variation in the amount and duration of administration of the IL-22 dimer of the instant invention. The instant situation is directly analogous to that which was addressed in In re Colianni, 195 U.S.P.Q. 150,(CCPA 1977), which held that a "[d]isclosure that calls for application of "sufficient" ultrasonic energy to practice claimed method of fusing bones but does not disclose what "sufficient" dosage of ultrasonic energy might be or how those skilled in the art might select appropriate intensity, frequence, and duration, and contains no specific examples or embodiment by way of illustration of how claimed method is to be practiced does not meet requirements of 35 U.S.C. 112 first paragraph".
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100,(CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure”. The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art”, “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement”.
Accordingly, the instant specification is only enabling for treating acute pancreatitis, comprising intravenously administering an effective amount of IL-22 dimer to an individual, wherein the amount of IL-22 dimer administered is 2 µg/kg to 200 µg/kg, wherein said dimer comprises two monomeric subunits, wherein each monomeric subunit comprises an IL-22 domain and a dimerization domain, and wherein each dimerization domain comprises CH2 and CH3 domains of a human IgG.
Claim Rejections - 35 USC § 112(b)
5. 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.
5a. Claims 1-19 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 pre-AIA the applicant regards as the invention.
Claim 1 is vague and indefinite for several reasons.
Claim 1, line 3, is vague and indefinite because it recites “about 2 µg/kg to about 200 µg/kg” which can encompass “0.1 µg/kg to 300 µg/kg” or even “5 µg/kg to 50 µg/kg”. Therefore, the metes and bounds of the limitation “about” are unclear. This rejection can be obviated by deleting the recitation of the term “about” from the claim.
Similarly claims 2-4 are rejected as vague and indefinite for the recitation of the term “about”.
Claim 9 is vague and indefinite because it recites “about 6 to about 30 amino acids” which can encompass “4 to 25 amino acids”. Therefore, the metes and bounds of the limitation “about” are unclear. This rejection can be obviated by deleting the recitation of the term “about” from the claim.
Claims 5-8, and 10-19 are rejected as vague and indefinite insofar as they depend on the above rejected claims for their limitations.
Claim Rejections - 35 USC § 102(a)(2):
6. 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 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)(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.
6a. Claims 1-5, 8-9, 11-12, 14-15, and 18-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Scheer et al. (US 2014/0314711 (10/23/2014), with an effective filing date of 3/15/2013, via U.S. Provisional Applications 61/800795 and 61/801144).
Scheer et al discloses IL-22 Fc fusion proteins: hIL-22 IgGl and hIL-22 IgG4, wherein the Fc is fused at the C-terminus of the IL-22 domain via a linker of about 10 amino acids (See Figure 3; page 12, [0128]); the amino acid sequence of the human IL-22 (SEQ ID NO:4 in the reference) is 100% identical to the instantly claimed SEQ ID NO:3. The Scheer et al reference also teaches the IL-22 Fc fusion protein which can be a dimeric IL-22 Fc fusion protein (page 4, [0027], and page 13, [0143]); the Fc region comprising the CH2 and CH3 domains of IgG2 or IgG4 (page 12, [0128]). Furthermore, Scheer teaches the use of IL-22 Fc fusion proteins for increasing HDL and decreasing LDL in metabolic syndrome, improving glucose tolerance, treating acute pancreatitis and insulin-related disorders, reducing hyperlipidemia, treatment of diabetic foot ulcer, and accelerating diabetic wound healing (page 10, [0113]-[116]). Finally, Scheer teaches that the pharmaceutical composition of the IL-22 Fc protein is administered intravenously, subcutaneously, intraperitoneally or topically (page 5, [0032]); and that depending on the type and severity of the disease, about 1 ug/kg to 20 mg/kg of the polypeptide can be an initial candidate dosage for administration to the subject, whether, for example, by one or more separate administrations, or by continuous infusion; and that the doses may be administered intermittently, e.g. every week, every two weeks, or every three weeks (See page 34, [0376]).
Therefore, the reference anticipates claims 1-5, 8-9, 11-12, 14-15, and 18-19.
Claim Rejections - 35 USC § 103
7. 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7a. Claims 1-9, 11-12, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Scheer et al. (US 2014/0314711 (10/23/2014) in view of US 2003/0104535 A1 (Capon et al).
The teachings of Scheer et al are set forth above in paragraph 6a.
The reference is silent with respect to the IL-22 domain fused to the C-terminus of the dimerization domain within each monomeric subunit and administering the IL-22 dimer for no more than once a month or no more than once every three months.
However, Capon et al teaches CD4 adhesons in which CD4 is fused to an immunoglobulin constant domain to increase its circulating half-life and that the immunoglobulin constant domain can be fused to either the N-terminus or C-terminus of CD4 and maintains functionality (See page 2, [0011]-[0013]; page 16, claim 7).
It would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the IL-22 dimer administered in the method of Scheer et al, with fusion of the functional IL-22 domain to the C-terminus of the dimerization domain comprising CH2 and CH3 domains in the Fc domain of IgG, to extend the stability and circulating half-life of the short-lived IL-22 dimer, because Capon et al provides the motivation and expectation of success with fusions of short-lived proteins to the C-terminus of Fc.
Furthermore, it would have been obvious to one of ordinary skill in the art, in this case, a physician or other clinician familiar with metabolic disease, to have the motivation and ability to monitor the schedule of administration of the IL-22 dimer using the teachings of Scheer et al as a starting point. It would have been common sense for the clinician to optimize the schedule of administration of the IL-22 dimer to obtain the best and efficacious course of treatment. Dosage of administration, times of dosage and route of administration are “result effected variables” that have an effect on the outcome of a method. Furthermore, such determination via routine experimentation would have been well-within the skill set of one of ordinary skill in the art, and thus it would have been obvious to determine the appropriate schedule of administration of the IL-22 dimer in the treatment method. MPEP 2144.05 states:
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 454, 105 USPQ 223, 235, (CCPA 1955).
Therefore, the teachings of Scheer et al render obvious claims 1-9, 11-12, 14-16, and 18-19, in the absence of evidence to the contrary.
Claim rejections-Double Patenting
Non-statutory double patenting rejection (obviousness-type)
8. The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
8a. Claims 1-19 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-19 of US Patent No. 11,654,104 (‘104) (same inventive entity as the instant application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘104 recites a method of treating a disease in a human individual, comprising intravenously administering to the human individual an effective amount of an IL-22 dimer, wherein the amount of the IL-22 dimer is about 2 µg/kg to about 200 µg/kg, wherein the IL-22 dimer comprises two monomeric subunits, wherein each monomeric subunit comprises an IL-22 domain and a dimerization domain, wherein the dimerization domain comprises the CH2 and CH3 domains of human IgG, and wherein the disease is liver disease, Parkinson's disease, or stroke.
Instant independent claim 1 recites a method of treating a metabolic disease in a human individual, comprising intravenously administering to the human individual an effective amount of an IL-22 dimer, wherein the effective amount of the IL-22 dimer is about 2 µg/kg to about 200 µg/kg, wherein the IL-22 dimer comprises two monomeric subunits, wherein each monomeric subunit comprises an IL-22 domain and a dimerization domain, and wherein each dimerization domain comprises CH2 and CH3 domains of a human IgG.
Claims 1-19, in the instant application are generic to claims 1-21 in the ‘104 patent because a method as recited in instant claims 1-19 encompasses the method of claims 1-21 of the ‘104 patent, and in both applications the same IL-22 dimer is administered to treat a metabolic condition. However, the patented claims are directed to one specific embodiment encompassed by the instant claims. The instant method claims include the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, included a method as recited in the patented claims.
The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
8b. Claims 1-19 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of US Patent No. 10,543,169 (‘169) (same inventive entity as the instant application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘169 recites a method of treating pancreatitis in a human individual, comprising intravenously administering to the human individual an effective amount of an IL-22 dimer, wherein the IL-22 dimer comprises two monomeric subunits, wherein each monomeric subunit comprises IL-22 fused to a dimerization domain, and wherein the amount of the IL-22 dimer is about 2 µg/kg to about 200 µg/kg.
Instant independent claim 1 recites a method of treating a metabolic disease in a human individual, comprising intravenously administering to the human individual an effective amount of an IL-22 dimer, wherein the effective amount of the IL-22 dimer is about 2 µg/kg to about 200 µg/kg, wherein the IL-22 dimer comprises two monomeric subunits, wherein each monomeric subunit comprises an IL-22 domain and a dimerization domain, and wherein each dimerization domain comprises CH2 and CH3 domains of a human IgG.
Claims 1-19, in the instant application are generic to claims 1-16 in the ‘169 patent because a method as recited in instant claims 1-19 encompasses the method of claims 1-16 of the ‘169 patent, and in both applications the same IL-22 dimer is administered to treat a metabolic condition. However, the patented claims are directed to one specific embodiment encompassed by the instant claims. The instant method claims include the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, included a method as recited in the patented claims.
The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
Conclusion
Claims 1-19 are rejected.
No claim is allowed.
Advisory Information
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674