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 1-18, filed 20 June 2024 are pending in the application.
Priority
This application is a 371 of PCT/EP2022/080514 filed 11/02/2022. This application claims foreign priority to GERMANY 10 2021 133 895.6 filed 12/20/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
The parent application 10 2021 133 895.6 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-18 of this application.
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.
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Brondlund (US 8,642,563) in view of Collins et al (US 2016/0199328 A1).
Brondlund teaches a composition comprising ribose, alanine, glycine and glutamine. The mixture contains the components in water (col. 1, lines 53-54; col. 2, lines 33-67; col. 5, lines 7-10; components recited in claim 1 and aqueous solution as in claim 1). According to Brondlund the above mixture is suitable as medicine for resistance-breaking of antibiotic resistances of pathogens including multiple antibiotic resistances (col. 5, lines 23-25). Advantageously, the mixture is used in addition to a treatment with antibiotic (col. 3, lines 52-54). The ribose used is D-ribose. The alanine used is racemic (D/L) alanine and glutamine is L-glutamine (col. 1, lines 53-54; limitations of claim 2). Glutamine can be present in the range of 20g/l to 80g/l (col. 4, line 26; part of the limitation of claim 3 for glutamine concentration). Brondlund suggests ratios of the amino acids and that of ribose to amino acids (col. 2, line 51 through col. 5, line 3 and col. 6, lines1-23). Based on this teaching the artisan can adjust the concentrations, ratios and amounts of the components as in claims 3-6 and 8-10
Brondlund does not expressly teach a method of treating bacterial infection in a patient selected from bacterial urinary tract infection, bacterial respiratory tract infection, bacterial soft tissue infection and bacterial bone infection via administration of tis aqueous solution as in claim 1 and does not teach part of the limitations of claim 3 and the limitations of claims 4-18. However, the teaching of Brondlund at col. 5, lines 23-25 suggests that it can be used for treating a bacterial infection.
Collins’ invention is drawn to a method of treating bacterial infections in subjects undergoing treatment with an aminoglycoside antibiotic using a proton motive force stimulating compound which can be ribose (paras 0018, 0051; ribose as in claim 1). The method of Collins includes treatment of urinary tract infection (para 0026; infection recited in claims 1 and 12). Collins also suggests treatment of respiratory tract infections and soft tissue infections (para 0071, 0130; as in claim1). Ciprofloxacin can be used as an antibiotic (para 0227; fluoroquinolone antibiotic as in claim 11 and ciprofloxacin as in claim 17). Other active agents that can be used are cefazolin and trimethoprim (para 083; as in claims 11 and 17). The bacterial infection treated can be Escherichia coli and Klebsiella (paras 0020 and 75; as in claims 13 and 18).
Collins teaches administration of the aminoglycoside antibiotic and proton motive force stimulant, which can be ribose, twice or thrice or more, from day 1, 2 days or more etc., to 10 hours, 9 hours or 1 hour or immediately (paras 0114-0115). In view of this and the teaching of Brondlund the artisan can administer the instant active agents as in claims 7 and 15-16. The teaching of Collins and Brondlund also renders obvious the administration as in claim 14. The artisan would also have a reasonable expectation of success in treating bacterial bone infection as in claim 1.
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, the use of the instant active agents is known in the art for treating the claimed bacterial infections in a patient being treated with antibiotic.
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. Method improvement is the motivation. In addition, Brondlund teaches that the composition according to its invention represents a combination of active agents which strengthens various body functions in addition to treating bacterial infections (col. 1, lines 40-45). This is an added advantage of the method and the composition used which will motivate the artisan.
Conclusion
Pending claims 1-18 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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