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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 12/18/2025, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112 [Scope of 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.
Claims 7-13 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 treating a vascular malformation in a subject, does not reasonably provide enablement for preventing a vascular malformation in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The relevant factors are addressed below based on the comparison of the disclosure, the claims, and the state of the prior art in the assessment of undue experimentation.
The nature of the invention is utilizing the recited proteasome inhibitors, viz., carfilzomib, delanzomib, ixazomib, bortezomib, oprozomib, and marizomib, to treat and prevent vascular malformation, wherein vascular malformation is a venous malformation, lymphatic malformation, or combined venous and lymphatic malformation.
The meaning of “preventing” is completely eradicate the claimed vascular malformation, both existing as well as from the future occurrence.
The claim breath encompasses preventing all possible vascular malformations with an therapeutically effective amount of the proteasome inhibitors, viz., carfilzomib, delanzomib, ixazomib, bortezomib, oprozomib, and marizomib, in all possible modes of administrations [7 and 9-13], in all possible subjects [see claims 7-8 and 12-13]
The prior art teach vascular malformations cannot be prevented. Vascular malformations generally occur at birth. See Cox et al. (“Vascular Malformations: A Review”, Seminars in Plastic Surgery, 2014, pp. 58-63). The current available treatments alleviate symptoms but are not curative as recurrence is common often requiring repeat interventions. See page 2 in the specification filed November 10, 2022, 1st paragraph. When the malformation is extensive, the effects of the treatments are limited. See page 2 in the specification filed November 10, 2022, 1st paragraph. There are no pharmacotherapy or class of pharmacotherapies that have shown complete response and targeted therapies are sorely need. See page 2, 2nd and 3rd paragraphs in the specification filed November 10, 2022.
Applicants have not provided guidance or demonstrated the administration of carfilzomib, delanzomib, ixazomib, bortezomib, oprozomib, and marizomib prevents vascular malformation. Given the limitations known in the art in treating vascular malformation and the lack of direction provided by Applicants, one of ordinary skill in the art would not conclude the administration of carfilzomib, delanzomib, ixazomib, bortezomib, oprozomib, and marizomib prevent vascular malformation. Even with the level of skill of the artisan being high, given the unpredictability of the art with respect to treating and preventing vascular malformations, the artisan would need to conduct essentially trial and error experimentation in order to practice the claimed invention.
Therefore, given the analysis of factors that have been determined as critical in determining whether a claimed invention is enabled, that is, breadth of claims, nature of the invention, the state of the prior art, the level of predictability in the art, existence of working examples, amount of direction provided by the inventors and the level of skill in the art, the full scope of the claim cannot be considered enabled. Based on the critical factors, it is concluded that the skilled artisan would have needed to conduct undue and excessive experimentation in order the practice the full scope of the claimed invention.
Suggested language to overcome above rejection: delete term “preventing” from claim language.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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