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 .
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.
Election/Restrictions
Applicant’s election of species with traverse in the reply filed on 06/16/2026 is acknowledged. The traversal is on the ground(s) that search of all the species would not impose an undue burden because applicant claims, structurally distinct or require different treatment modalities is insufficient to demonstrate that searching additional species would be unduly burdensome. This is not found persuasive because structure of all JAK inhibitors are not the same. Similarly causes of all celiac diseases are not the same. Each of the species would require different search strategies therefore would be undue burden on the examiner. See pages 4-6 of the Election of Species Requirement mailed 18 March 2026.
The requirement is still deemed proper and is therefore made FINAL.
Applicants elected compliant species of
JAK inhibitor: tofacitinib
Celiac disease: Type II Refractory celiac disease
Examiner found prior art on applicant elected species.
Elected species read on claims 1, 3-4, 7, 11, 15, 20, 22-23, 27,32,34,38,42-43 and 46.
Current Status of 18/566,270
This Office Action is in response to the amended claims of 06/16/2026.
Claims 1, 3-4, 7, 11, 15, 20, 22-23, 27,32,34,38,42-43 and 46 are previously presented; and claims 8-9, 26 and 35 are original.
Claims 1, 3-4, 7, 11, 15, 20, 22-23, 27,32,34,38,42-43 and 46 are examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 12/01/2023, 03/01/2024, 03/25/2025 and 06/16/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 06/07/2021.
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 32, 34-35, 38, 42-43, and 46 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 does not reasonably provide enablement for prevention. 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.
Factors to be considered in making the determination as to whether one skilled in art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
Claims 32, 34-35, 38, 42-43, and 46 are directed to limitations drawn to preventing the risk of lymphoma in a subject having or suspected of having celiac disease.
State of the prior art:
Lymphoma is a group of malignant neoplasms of lymphocytes with more than 90 subtypes. It is traditionally classified broadly as non-Hodgkin or Hodgkin lymphoma. The etiology of lymphoma remains largely unexplained.
Level of one of ordinary skill/ Level of predictability art
An ordinary person skilled in the art is an artisan who is a medicinal chemist and or oncologist that has experience treating cancer have to navigate ways for preventing lymphoma without knowing the etiology of lymphoma. There are no known method of preventions as state above, therefore an artisan skilled in the art would not be able to determine the course of preventing such diseases.
A person skilled in art would not be able to envision preventing lymphoma with the experiments disclosed in the specification (Wands factor (d)) because the specification does not provide guidance for preventing lymphoma in claims 32, 34-35, 38, 42-43, and 46 with (wand faction (e)). Moreover, preventions lymphoma are unpredictable because no one method can prevent lymphoma (wand factor (e)).
Amount of direction provided by the inventor:
Although the specification teaches methods of treating lymphoma, there is no working example that shows prevention of lymphoma. Moreover, prevention of diseases/condition are unpredictable because no one method can prevent a disease/condition from occurring when the etiology and cause of the disease (e.g. lymphoma) remains largely unexplained.
It would require undue experimentation and be unduly burdensome to practice the claimed method of preventing lymphoma because the etiology and cause of lymphoma is unknown.
Therefore, method claims 32, 34-35, 38, 42-43, and 46 are rejected for lacking scope of enablement for prevention of lymphoma.
Claims 1, 3-4, 7-9, 11, 15, 20, 22-23, 26-27, 32, 34-35, 38, 42-43, and 46 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. While Applicants have shown possession of the species tofacitinib, there is no evidence in the specification for applicants possession of vast number of JAK inhibitors and prodrug thereof. This is a written description rejection.
MPEP 2163(I) states “The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.”
Instant claims 1, 4 and 32 are drawn very broadly to plurality of species within the broad genus of “JAK inhibitor and prodrug thereof” for treating and reducing symptoms of celiac diseases without providing evidence for the use of plurality of compounds of JAK inhibitor or prodrug thereof. For example, on page 18 applicant provided evidence of JAK inhibitor tofacitinib but there is no evidence in the specification applicants possession of vast number of JAK inhibitors or possible prodrugs thereof. A person skilled in the arts would not be able to infer from the specification if the applicant is in possession of all the species of JAK inhibitors or possible prodrugs thereof as asserted in the claims. Therefore, claims 1, 4 and 32 are rejected for of lacking written description.
Claims 3, 7-9, 11, 15, 20, 22-23, 26-27, 34-35, 38, 42-43, and 46 are also rejected for depending on rejected claims 1 and 32.
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, 3-4, 7-9, 11, 15, 20, 22-23, 26-27, 32, 34-35, 38, 42-43, and 46 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.
The term “prodrug” is not defined by independent claims 1, 4 and 32. Although specification provide definition of the term “prodrug” specification does not provide any examples of prodrug. One of ordinary skill in the art could not reasonably determine the full scope of the term “prodrug” (see Zawilska et.al. Pharmacological Reports, 2013, 65, Page 1-14). As drafted “prodrug” in claim 1, 4 and 32 renders the metes and bounds of claims 1, 4 and 32 indefinite.
Claims 3, 7-9, 11, 15, 20, 22-23, 26-27, 34-35, 38, 42-43, and 46 are also rejected because they refer to claims 1, and 32 but do not remedy the bases for the rejection.
Claims 23 and 43 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.
The term “samples are the same type of sample” in claims 23 and 43 are not defined by the claim. The specification does not provide a standard for ascertaining the requisite degree in which one of ordinary skill in the art would not be reasonably apprised of the scope of the invention recited in the phrase “samples are the same type of sample”. There is no ascertainable standard by which to measure “same type of sample” in the claims or Specification. As drafted “samples are the same type of sample” in claims 23 and 43 renders the metes and bounds of claims 23 and 43 indefinite.
Claim Rejections - 35 USC § 102
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.
Claim(s)1, 7-9, 15, 32 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CERF-BENSUSSAN (WO 2018-041989).
CERF-BENSUSSAN et.al. discloses a method of treating refractory celiac disease type 2 (applicant elected species, thus anticipates instant claim 15) or reducing the symptoms thereof in a patient and a method of preventing enteropathy-associated T-cell lymphoma (page 7, line 25-30) in a patient diagnosed with refractory celiac disease type 2, the methods comprising administering to the patient a therapeutically effective amount of a JAK inhibitor (see page 6, lines 27-29; page 11, lines 25-30; and claim 7) anticipating claims 1 and 32. Furthermore JAK inhibitor include tofacitinib. (page 11, line 1-25), thus anticipating claims 7 and 34. (Please note CERF-BENSUSSAN lists other JAK inhibitors of claim 34, used in treating or reducing symptoms of t-cell lymphoma caused by celiac disease type 2). Cerf-Bensussan state typical dosage of active ingredient is 0.01mg-500 mg which is within the range of 1 to 50 mg of claims 8-9 (page 12 lines 7-10), thus anticipating claims 8-9.
Claim(s) 1, 7 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hudson et.al. (US 2019/0389895)
Hudson et.al. discloses a method of treating a gastrointestinal inflammatory disease or alleviating the symptoms such as diarrhea, bloody stools, and abdominal pain, (instant claim 20) thereof in a mammal, wherein the gastrointestinal inflammatory disease is celiac sprue( is another name for celiac disease) or ulcerative colitis, the method comprising administering to the mammal prodrugs of tofacitinib (instant claim 7), applicant elected species of JAK inhibitor (see abstract; paragraphs [0058], [0062]; and claims 28, 29, 32) thus anticipating claim 1.
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.
Claim(s) 1,3-4, 7-9, 11, 20, 22-23 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Hudson et.al. (US 2019/0389895).
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of prior art.
Hudson et.al. teachers claims 1, 7 and 20 see 102 rejections above.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although Hudson teaches method of treatment for reducing symptoms or sign of CD by administering JAK inhibitor, a prodrug of tofacitinib, Hudson does not teach the dosage tofacitinib or frequency of the dosage. Furthermore, Hudson does not teached method of reducing symptoms of ulcerative jejunitis with Jak inhibitor.
Although Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area Anisel et.al. does not teach dosage or frequency of dosage of tofacitinib.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient training in treating symptoms of gastrointestinal inflammation.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in art would be motivated to use prodrug of tofacitinib to treat or reduce symptoms of gastrointestinal inflammatory disease (Hudson et.al. see abstract; paragraphs [0058], [0062]; and claims 28, 29, 32) such as ulcerative jejunitis because Hudson et.al teaches the use of prodrug of tofacitinib for treating ulcerative colitis. Therefore it would be expected prodrug of tofacitinib would also be able to treat and reduce the symptoms of any ulcerative in gastrointestinal inflammation including ulcerative jejunitis, of instant claims 3-4. Therefore, it would be prima facie obvious for develop a method treating and reducing symptoms of ulcerative jejunitis using the teaching of Hudson et. al.
Regarding claims 22-23 and 26-27, claim 22 is directed to obtaining samples before and after administering of JAK inhibitor and assessing the samples for the efficacy of JAK inhibitor. Claims 23 and 26-27 are directed to type of samples collected to assess the efficacy of JAK. Examiners considered this to be routine experimentation for determining efficacy of JAK inhibitor in patients with CD.
Claims 8-9 and 11 are directed to dosage and frequency of the dosage of tofacitinib or JAK inhibitor. Examiners interpret these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim(s) 1, 7-9, 11, 15, 20, 22-23, 26-27, 32, 34-35, 38, 42-43, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
CERF-BENSUSSAN (WO 2018-041989).
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of prior art.
Cerf-Bensussan et.al. teaches claims 1, 7-9, 15, 32 and 34 see 102 rejections above. Cerf -Bensussan teaches
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although Cerf-Bensussan et.al. teaches method of treatment for reducing symptoms or sign of CD by administering JAK inhibitor, a prodrug of tofacitinib, Hudson does not teach the dosage tofacitinib or frequency of the dosage.
Although Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area Anisel et.al. does not teach dosage or frequency of dosage of tofacitinib.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient training in treating symptoms of gastrointestinal inflammation.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Regarding claims 22-23, 26-27, 42-43 and 46; claims 22 and 42 is directed to obtaining samples before and after administering of JAK inhibitor and assessing the samples for the efficacy of JAK inhibitor. Claims 23, 26-27, 43 and 46 are directed to type of samples collected to assess the efficacy of JAK. Examiners considered this to be routine experimentation for determining efficacy of JAK inhibitor in patients with CD.
Claims 8-9 and 11 are directed to dosage and frequency of the dosage of tofacitinib or JAK inhibitor. Examiners interpret these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Conclusion
No Claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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