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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 27 February 2026, have been entered in full. Claim 11 is withdrawn from consideration as being drawn to a non-elected invention. Claims 2, 3, 5-7 and 10 are canceled. Claims 1, 4, 8 and 9 are amended. Claims 1, 4, 8 and 9 are under examination.
Foreign Priority
Acknowledgment is made of the submission of the English translation of foreign priority document CHINA 201911207253.1. The translation has been placed of record in the file (27 February 2026).
Withdrawn Objections And/Or Rejections
The objection to the drawings as failing to comply with 37 CFR 1.84(p)(5), as set forth at pages 3-4 of the previous Office Action (28 November 2025), is withdrawn in view of the amendment (27 February 2026).
The objection to the specification because of the Nucleotide and/or Amino Acid Sequence Disclosure, as set forth at pages 4-6 of the previous Office Action (28 November 2025), is withdrawn in view of the amendment (27 February 2026).
The rejection to claims 1-4, 8 and 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre- AIA ), second paragraph, as set forth at page 6 of the previous Office Action (28 November 2025), is withdrawn in view of the amendment (27 February 2026).
The rejection to claims 1-4, 8 and 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre- AIA ), first paragraph, written description, as set forth at pages 6-14 of the previous Office Action (28 November 2025), is withdrawn in view of the amendment (27 February 2026).
The rejection to claims 1, 2, 4, 8 and 9 under 35 U.S.C. 102(a2) as being anticipated by Howell (US 2021/0148910; published May 20, 2021, priority date August 16, 2017), as set forth at pages 14-15 of the previous Office Action (28 November 2025), is withdrawn in view of the amendment and the submitted English Translation of foreign priority document CHINA 201911207253.1 (27 February 2026).
The rejection to claims 1, 2, 4, 8 and 9 under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Comeau et al. (US 2009/0238823; published 24 September 2009), as set forth at page 16 of the previous Office Action (28 November 2025), is withdrawn in view of the amendment and the submitted English Translation of foreign priority document CHINA 201911207253.1 (27 February 2026).
MATTER OF RECORD
Claims 1, 4 and 8 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 11, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 28 August 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Objections
Claims 9 and 11 are objected to because of the following informalities:
Claims 9 and 11 are missing the phrase “according to claim 1” after the phrase “a composition comprising the antibody or antigen-binding portion thereof”.
Amending claims 9 and 11 to recite, “A kit comprising the antibody or antigen-binding portion thereof according to claim 1 and/or a composition comprising the antibody or antigen-binding portion thereof according to claim 1”, would obviate this objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
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.
Claim 11 is 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.
Claim 11 is indefinite because of the recitation “preferably”.
The phrase "preferably" recited in lines 8, 10, and 11 renders claim 11 indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Enablement
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.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 11 is drawn to a method of treating a TSLP-related disorder, comprising the step of administering to the mammal a therapeutically effective amount of the antibody or antigen-binding portion thereof according to claim 1 and/or a composition comprising the antibody or antigen-binding portion thereof, wherein the TSLP-related disorder is selected from a TSLP-related inflammatory disorder and an autoimmune disease; preferably, the TSLP-related inflammatory disorder is selected from allergic inflammation, asthma, chronic obstructive pulmonary disease, atopic dermatitis, or eosinophilic esophagitis; preferably, the allergic inflammation is selected from allergic rhinitis, allergic sinusitis or allergic conjunctivitis; preferably, the autoimmune disease is selected from rheumatoid arthritis or multiple sclerosis.
The instant claim is not enabled for the following reasons:
1. The claim recites preferably, the TSLP-related inflammatory disorder is selected from allergic inflammation, asthma, chronic obstructive pulmonary disease, atopic dermatitis, or eosinophilic esophagitis. Because the claim recites “preferably”, the claim encompasses other TSLP-related inflammatory disorder besides those recited and would not be enabled for such breadth.
The claim recites preferably, the allergic inflammation is selected from allergic rhinitis, allergic sinusitis or allergic conjunctivitis; preferably, the autoimmune disease is selected from rheumatoid arthritis or multiple sclerosis. Because the claim recites “preferably”, the claim encompasses other types of allergic inflammation besides those recited and would not be enabled for such breadth.
The claim recites preferably the autoimmune disease is selected from rheumatoid arthritis or multiple sclerosis. Because the claim recites “preferably”, the claim encompasses other types of autoimmune diseases besides those recited and would not be enabled for such breadth.
2. Regarding the disorders that are recited; the specification fails to teach the use of any animal model that would be predictive of those disorders. The specification fails to teach administering the antibody or antigen-binding portion thereof according to claim 1 to a particular animal model.
One cannot extrapolate the teaching of the specification to the claimed invention because there is no guidance on or exemplification of any correlation between the in vitro data and treating a disorder. In vitro assays cannot duplicate the complex conditions of in vivo therapy.
See wherein Yu et al. teach autoimmune diseases as being characterized by a loss of self-tolerance and consequent autoimmune attacks against target tissues in the body. Yu et al. teach autoimmune diseases such as multiple sclerosis and myasthenia gravis. Yu et al. teach that animal models of autoimmune diseases refer to two groups, spontaneous and induced models. In the former group, animals with or without genetic modifications develop disease spontaneously, while in the latter group disease is artificially induced. Yu et al. teach that due to the complexity of autoimmune disorders in etiology and pathology, many strategies have been applied to induce autoimmune diseases in animals. Yu et al. teach that to establish an animal model for a specific autoimmune disease, the selection of an appropriate strategy and a suitable species are of great importance. (Yu et al. A methodological review of induced animal models of autoimmune diseases. Autoimmunity Reviews 17:473–479, 2018).
Huang et al. teach that there is no model that can totally mimic the whole features in human chronic obstructive pulmonary disease (COPD). Huang et al. teach that it is important to establish a useful and effective model which can highly mimic the human COPD characteristics. Huang et al. teach an ideal animal model of COPD should be induced by cigarette smoke or other pathogens related to human disease, with persistent moderate-to-high levels of neutrophilic airway inflammation, typical T cell immune responses, clearly evidenced mucus hyperproduction, progressed destruction of the lung parenchyma eventually leading to epithelial apoptosis and airspace enlargement, and declined lung functions (Huang et al. Neutrophilic Inflammation in the Immune Responses of Chronic Obstructive Pulmonary Disease: Lessons from Animal Models. Journal of Immunology Research. Volume 2017, Article ID 7915975, 9 pages, April 2017).
It is also noted that even when using the appropriate animal model, problems may exist. See wherein Morel teaches that while animal models have proved the best way to probe the mechanism of disease in general, and autoimmune disease in particular, one has to be careful in directly applying data obtained from animal models to human diseases. Morel teaches that human autoimmune diseases show an extremely heterogeneous clinical presentation, which animal models present as simplified versions. Morel teaches that an animal model provides only a partial representation of the real biological complexities underlying the human disease (page 1062). Morel teaches that mouse models have its pitfalls and that many differences exist between mice and human but those differences are outweighed by the power of the experimental system offered by the mouse (page 1064). Morel teaches examples of common mouse models of autoimmune diseases including the experimental autoimmune encephalitis (EAE) animal model for multiple sclerosis (page 1062, Table 1)(Morel, Mouse models of human autoimmune diseases: Essential tools that require proper controls, Plos Biology Vol. 2/No. 8:1061-1064, August 2004).
The references discussed above evidences the fact that the animal model used should be appropriate for the question(s) being addressed.
It cannot be said that the specification provides the necessary guidance for treating all TSLP-related inflammatory disorders, all allergic inflammations, all autoimmune diseases, asthma, chronic obstructive pulmonary disease, atopic dermatitis, eosinophilic esophagitis. allergic rhinitis, allergic sinusitis, allergic conjunctivitis, rheumatoid arthritis or multiple sclerosis. The skilled artisan would accordingly have no resort save trial-and-error experimentation to determine which mammal population can be treated with the antibody or antigen-binding portion thereof according to claim 1. Such experimentation would be undue.
The specification provides insufficient guidance with regard to these issues and provides no working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict the efficacy of the claimed method with a reasonable expectation of success. It would have been unpredictable what affects the administered antibody or antigen-binding portion thereof according to claim 1 would have when administered to a mammal for treatment.
Due to the inherent unpredictability and the large quantity of experimentation necessary to demonstrate that all TSLP-related inflammatory disorders, all allergic inflammations and all autoimmune diseases can be treated by administering the antibody or antigen-binding portion thereof according to claim 1; the lack of direction/guidance presented in the specification regarding a teaching of administering the antibody or antigen-binding portion thereof according to claim 1 to an animal model that correlates to any of the recited disorders; the absence of working examples regarding same; the complex nature of the invention; the state of the art which established the use of proper animal models to study in vivo treatment; and the breadth of the claims which fail to recite limitations regarding disorders that can be effectively treated in a mammal; undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
Allowable Subject Matter
Claims 1, 4 and 8 are allowed.
Conclusion
Claim 11 is rejected.
Claim 9 is objected to.
Claims 1, 4 and 8 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 4/27/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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