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 .
Non-Final Rejection
The Status of Claims:
Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100-101, 103-108,110,112,114, 116-134, 136-144 are pending.
Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100,119-134, 136-139 are rejected.
Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100-101,119-134, 136-139 are objected.
Claims 103-108,110,112,114, 116-118, 140-144 are withdrawn from the consideration.
DETAILED ACTION
1. Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100-101,119-134, 136-139 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/JP2020/039897 10/23/2020 ,which has a foreign priority document, JAPAN JP2019-194753 10/25/2019.
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Drawings
3. None.
IDS
4. The IDS filed on 5/25/2022 is reviewed by the examiner.
Election/Restriction
Applicant’s election without traverse of Group I (claims33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100-101, 119-134, 136-139 on 9/09/2025 is acknowledged. Claims 103-108,110,112,114, 116-118, 140-143 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups II-III, there being no allowable generic or linking claim.
The elected compounds are allowable.
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and
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488
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.
Claim Objections
Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100-101,119-134, 136-139 are objected to because of the following informalities:
In claims, many different variables and the corresponding limitations are too vague and blurry and unrecognizable. The examiner recommends to file a clear version of the claimed set as a replacement for the previous one. Appropriate correction is required.
In claims 46-48, 56, 79. 81-82, 88-91 some parentheses are used for describing limitations such as “
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” and others. The use of these parentheses can be confusing. The examiner recommends to remove them from the claims.
Claims 101 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100, 103-108,110,112,114, 116-134, 136-139 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.
Claims 33 and claims dependent thereon are rejected because the term “substituted are indefinite. In the absence of the specific moieties intended to effectuate modification by the “substitution” or attachment to the chemical core claimed, the term “substituted” renders the claims in which it appears indefinite in all occurrences wherein applicants fails to articulate by chemical name, structural formula or sufficiently distinct functional language, the particular moieties applicants regards as those which will facilitate substitution, requisite to identifying the composition of matter claimed.
In claim 81-82,88-91, the limitation” d is the number of substitutable positions on a ring of R5“ is recited. This expression can be vague and indefinite because the number of substitutable positions for the variable “d” is undefined in the claims.
In claims 127-128 and 130, the phrases “selected from ceftazidime,… , or panipeneman”, “ “selected from aztreonam, … or carumonam” and “ selected from antibaterial agent, .. or an anti-allergic agent” are recited. These expressions are improper because the Markush expression would require a close ended “and “ instead of an open ended “or” at the end.
Regarding claims 137-138, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
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 119-120 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for specific drugs for treating a bacterial infection, does not reasonably provide enablement for a prophylactic drug for a bacterial infection. 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. Applicants are not enabled for the prophylactic drug for a bacterial infection or preventing any drugs for the bacterial infection. The only established prophylactics are vaccines not the compounds of the drugs such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the bacterial infection occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2)
3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical preventative anti-bacterial medicine and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become prevented from the bacterial infection before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in bacterial diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prophylactic drug for the bacterial infection generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent or drug to be able to prevent bacterial infection generally. That is, the skill is so low that no compound effective generally against preventing any bacterial infection by the any drug effectively has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally
considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by the terms” prophylactic drugs”.
The Examiner suggests deletion of terms” prophylactic drug” “from the claim 120.
Conclusion
Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100,119-134, 136-139 are rejected.
Claims 33-34, 37-48, 53-54, 56-60, 62-69, 71, 74, 76-77, 79-83, 88-91, 100-101,119-134, 136-139 are objected.
Claims 103-108,110,112,114, 116-118, 140-144 are withdrawn from the consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 10/28/2025
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