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 .
Claims 1-20 filed 08/20/2024 are pending in the application.
Priority
This application is a continuation of PCT/IB2023/052011 filed 03/03/2023, which claims the benefit of 63/316,731 filed 03/04/2022.The parent application 63/316,731 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-20 of this application.
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 16-20 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.
Claim 16 is drawn to a tautomer of the compound of claim 1. However, the compound recited in claim 1 does not have a double bond in the formula which can facilitate enolization to form a tautomer.
Claims 17-20 recite the limitation "bacterial infection" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 is drawn to a tautomer of the compound of claim 1. However, the compound recited in claim 1 does not have a double bond in the formula which can facilitate enolization to form a tautomer.
Claims 17-20 recite the limitation "bacterial infection" in claim 1. However, claim 1 is not drawn to a bacterial infection.
Claims 16-20 do not further limit parent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews et al (WO 2019/046126 A1).
Andrews et al, drawn to aminoglycosides, teaches the following compounds (pages 205, 426, 521 and 527):
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The difference is in the substitutions for R5 and Rb of the formula in claim 1 and the presence of OH between the two amino groups in the second sugar moiety from the left (part of the structural limitations of the compound recited in claims 1, 10-12, 15, and limitations of claims 2, 5, 6, 8, 9, 13). The embodiment of Andrews also includes a pharmaceutical composition comprising the compounds or a pharmaceutically acceptable salt, solvate tautomer, or stereoisomer and a pharmaceutically acceptable carrier (page 627, claim 126; as in claim 16).
However, Andrews has shown that its compounds are active against bacteria (page 475 through page 481; page 527, claim 127 through 529, claim 140; bacterial infection as in claims 17-20). Andrews also discloses several synthetic procedures for making the above compounds.
Therefore, it would be obvious to one of ordinary skill in the art to synthesize the compounds as instantly claimed, make their pharmaceutical composition and test them for activity against several bacteria as claimed based on the teachings of Andrews.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, aminoglycosides having the structural features as in the compounds of the instant claims are known in the art to be useful for treating several bacterial infections. Thus, it is obvious to arrive at the claimed invention.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
Obviousness based on similarity of structure and function entails motivation to make the claimed compound in expectation that compounds similar in structure will have similar properties. Where prior art compounds essentially bracket the claimed compounds and are well known antibacterial agents, one of ordinary skill in the art would be motivated to make the claimed compounds in searching for new antibacterial agents. In re Payne, 606 F. 2d 303, 203, USPQ, 245, 254-55 (C.C.P.A. 1979). The artisan would also be motivated to synthesize all the compounds having the various substitutions as in claims 1-16 to look for compounds with enhanced antibacterial activity against bacterial infections taught by Andrews.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 9-13 of U.S. Patent No. 11,414,450 (‘450) in view of Andrews et al (WO 2019/046126 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to an aminoglycoside. Dependent claims 2-15 recite further structural limitations. Claim 16 is drawn to a pharmaceutical composition and claims 17-20 recite bacterial infections.
Claims 9-13 of ‘450 are also drawn to an aminoglycoside having the same structural features. Claim 9 also includes compounds wherein ring A has the same pyranose ring and overlapping substitutions. The claims of ‘450 also include tautomers.
Claims 9-13 of ‘450 differ from the instant claims in that the instant claims in that the instant claims, even though claim tautomers, does not show the presence of a double bond with an enaolizable H close by.
The teachings of Andrews is set forth above which includes tautomers and pharmaceutical compositions.
It would have been obvious to one of ordinary skill in the art before the filing date of the instant invention that the instant compounds and its pharmaceutical composition can be arrived at from the compounds of ‘450 in view of Andrews.
In the instant case ‘450 teaches compounds that have overlapping structural features applicant claims. One of ordinary skill in the art would readily recognize that the instant compounds and their pharmaceutical compositions can be made in view of Andrews with a reasonable expectation of success. The use of known members of classes compounds taught in the prior art is not seen to render the instantly claimed compounds unobvious over the art. Once structurally close compounds are individually taught in the prior art, the burden is on the applicant to present reason or authority for believing that the instant compounds cannot be conceived and made in view of the combined teachings of the prior art.
Conclusion
Pending claims 1-20 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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