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 02/09/2024, 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 objections
(i) Claims 2-3 and 5-18 are objected to because of the following informalities: preamble of these claims cites “A compound”. It should be changed to “The compound”, since these are referring a compound of independent claim. Appropriate correction is required.
(ii) Claim 17 is objected to because of the following informalities: in the line two, recited “(Original)” should be removed. Appropriate correction is required.
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.
(i) Claims 8 and 13 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 pre-AIA the applicant regards as the invention.
The claims recite the word “preferably”, which renders the claims indefinite for the following reasons:
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(d). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "preferable" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim recites the broad recitation, and the claim also recites the narrower statement of the range/limitation.
(ii) Claim 17 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 pre-AIA the applicant regards as the invention.
Claim may not refer to the Specification. Verily, claims that refer to the specification are improper. See Ex parte Fressola, 27 USPQ.2d 1608 (BPAI 1993). Claim 17 improperly refers to Tables 1 and 3 in the specification. Incorporation by reference to a specific table is permitted only in exceptional circumstances where there is not practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table in the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience. Reference to the polymyxin analogues defined in Tables 1 and 3 can be readily incorporated into the claim and therefore reference to the specification in claim is improper.
Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 5-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gallardo-Godoy (J.Med.Chem., 2016, 59, 1068-1077) in view of Yim (Chem.Soc., 2020, 11, 5759-5765).
For claim 1:
Gallardo-Godoy teaches the following compound:
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[see Fig.1 and its broader scope in Table 1].
In the above compound, the scope of exocyclic chain and heptapeptide ring overlaps with the scope of applicants’ compound of formula (I) except for “A”.
Difference is that Gallardo-Godoy is silent on applicants claimed group “A”.
However, the following art teaches S-linked lipopeptides and their advantages:
Yim teaches S-linked lipopeptides, wherein the scope of chemical groups, such as lipid, alkyl or aryl groups etc., coupled to thiol moiety overlaps with the scope of applicants claimed group “A” [see Fig.1]. Yim further teaches advantages of S-linked chemical groups on the peptides towards their antibacterial properties, and such modifications enhances antibacterial activity or increase in the MIC values [see Table 2].
Therefore, a skilled person in the art would be motivated to replace fatty acid in the teachings of Gallardo-Godoy with S-linked chemical groups of Yim and arrive at applicants compound of formula (I) with a responsible expectation of success.
For claims 2-3 and 5-6:
As explained above, Gallardo-Godoy silent on applicants claimed group “A”. However, Yim teaches applicants claimed group “A” [see Fig.2] and some of these groups are identical to applicants chemical group “A”.
For claim 7:
Yim teaches applicants claimed group “A” [see Fig.2], wherein H in -NH2 [see C-series in Fig.2] reads applicants R1 group.
For claim 8:
Yim teaches applicants claimed group “A” [see Fig.2], wherein C2-C9 alkyl group, phenyl group, C4alkyl-Phe reads applicants R2 [see C-series in Fig.2] reads applicants R1 group.
For claim 9:
Gallardo-Godoy teaches Dab at the same position [see Fig.1].
For claim 10:
Gallardo-Godoy teaches Dab at the same position [see Fig.1].
For claim 11:
Gallardo-Godoy teaches D-Phe at the same position [see Fig.1].
For claim 12:
Gallardo-Godoy teaches Leu at the same position [see Fig.1].
For claims 13-16:
See above For claims 1-3, 5-12 and also Fig1 and Table 1 in the teachings of Gallardo-Godoy.
For claims 17-18:
See For claim 1 above, since same reasoning is applicable to address claim 17.
For claim 19:
Gallardo-Godoy teaches that their compounds stock solutions were prepared in water and it is interpreted as pharmaceutical composition.
For claim 21:
Gallardo-Godoy teaches MIC values for their compounds against various bacteria [see Table 2] and this is interpreted as a method of killing bacteria contacting the bacteria with bactericidal amount of compound of claim 1. Differences are explained and provided reasoning in For claim 1 above.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components, such as polymyxin and S-linker chemical groups, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present invention.
Also, the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant 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, 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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