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
This Non-Final Office Action is in response to the October 19, 2023 Preliminary Amendment and corresponding documents in the above-identified application
Claims 1-3, 6-10, 12-20, 22-25 and 27-33 are pending, claims 7, 9, 12,13, 15, 22-25 and 27 are currently amended, claims 1-3, 6, 8, 10, 14, 16-18 and 28-33 are original and claims 4, 5, 11. 21, 26 are cancelled in the above-identified application.
Priority
U.S. Pat. Appln. No.18/556,178, Filed: October 19, 2023 is a 371 Nat.’ l Stage Entry of WO 2022/224212A1 (i.e., PCT/IB2022/053772, Intern.’ l Filing Date: April 22, 2022), which claims foreign priority to GB 2105846.6, Filed: April 23, 2021.
Information Disclosure Statement
Two (2) Information Disclosure Statements (IDS) submitted on December 30, 2024 and October 19, 2023 is in compliance with the provisions of 37 CFR 1.97.
Accordingly, Information Disclosure Statements have been considered by the Examiner.
Claim Rejections - 35 USC § 112
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 22-25 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd 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(s)), regards as the invention.
In particular, claim 22 is rejected for lacking clarity and for being vague, ambiguous and indefinite for recitation of term “conditions” or “visceral conditions” as associated with the following phrases:
“gastrointestinal disorders or conditions”;
“symptoms of pain associated with gastrointestinal diseases or other visceral conditions”; and
“pulmonary diseases or conditions” diseases; and
for not distinguishing between:
broad and non-specific terms (i.e., could mean any GI-related or pulmonary related state, from a transient symptom to a severe disease, without defining the scope)
diseases vs conditions
GI/Pulmonary Condition
A broader term for any state of health affecting the GI or pulmonary system, regardless of whether it is disease or disorder.
Visceral Condition
A condition affecting the internal organs (viscera) of the GI or pulmonary systems, often involving visceral pain, motility, or function.
Lacking structural or functional specificity (i.e., unlike a named disorder, it does not describe a particular pathological process, making it impossible to determine the exact scope of the claimed invention).
Failing to define the boundaries (i.e., could cover multiple distinct diseases, each with different diagnostic, treatment, and functional impacts, without narrowing to a particular embodiment).
Such that the claims defined indeterminate phrases and definitions that fail to provide a clear, precise, and enabling definition, such that the metes and bounds of the claims cannot be determined with reasonable certainty by a person of ordinary skill in art.
Accordingly, claim 22 should be rewritten to incorporate the specific definitions of claims 23 to 25, while drawing distinctions between diseases vs conditions as supported by the actual specification or simply amending the claim to remove all terms that recited “conditions” .
Claim 23 recite examples of a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) , which may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 23 recites:
the broad recitation
and
the narrower statement of the range/limitation
A
mast cell related disorders
mast cell activation syndrome, clonal mast cell disorder, monoclonal mast cell activation syndrome, idiopathic urticaria, idiopathic anaphylaxis),
B
infectious diarrhea
Clostridium difficile, Salmonella, Shigella toxin
Appropriate correction is required accordingly.
2, 3 & 4. Nature Of The Invention, State of the Art and Predictability In The Art.
ALLOWABLE SUBJECT MATTER
The following is a statement of reasons for the indication of allowable subject matter:
Claims 1-3, 6-10, 12-20, 22-25 and 27 contain allowable subject matter; i.e., as NO prior art was found in the above-identified application.
over the prior art.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to GRACE C HSU whose telephone number is (571) 270-1689. The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicants is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kortney L. Klinkel can be reached on 571-270-5239.
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/G.C.H./
Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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