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 .
Claim Status
Claims 1-5 are pending. Claims 1-4 are withdrawn as directed to a non-elected invention. Claim 5 is presently considered.
Election/Restrictions
Applicant’s election without traverse of Group II (method of claim 5) and the species of “aCys_H_H_H” in the reply filed on 3/04/2026 is acknowledged.
The elected species is understood as follows: The originally elected species is understood to be the species of “aCys_H_H_H”, corresponding to a method of stabilizing vancomycin by preparing an aqueous solution comprising 5.0 mg/mL vancomycin HCl and 16.9 mg/mL N-acetylated D-cysteine, having a pH of 6.0, and being present in a container with a headspace comprising 21.0% oxygen, with filtration in PVDF syringe filter (0.45μm pore size) and storage at 25°C, as described in Table 6 and paragraphs [0066]-[0072] of the specification. The originally elected species is understood to read upon instant claim 5.
Following extensive search and examination, the originally elected species has been deemed free of the prior art in view of the combined processing steps and specific limitations pertaining to vancomycin, N-acetylated D-cysteine, pH of 6.0, and also container headspace. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species of method comprising steps of combining vancomycin with N-acetylated D-cysteine. Following extensive search and examination, the non-elected species was deemed obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/04/2026.
Claim 5 is presently considered.
Priority
The priority claim to EP20214654.4 (filed 12/16/2020) is acknowledged.
Information Disclosure Statement
The IDS filed 5/19/2023 is acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 5 is representative of the pending claim scope and presently recites:
5. (Original) Method for stabilizing glycopeptide antibiotics, selected from the group consisting of vancomycin, telavancin, oritavancin, teicoplanin, dalbavancin and mixtures thereof, especially vancomycin, which involves addition of N-acetylated D-cysteine (D-aCys) to a solution comprising such glycopeptide antibiotic(s), especially vancomycin, or addition of glycopeptide antibiotic(s), especially vancomycin, to a solution comprising N-acetylated D-cysteine (D-aCys ).
Applicable claim interpretations are discussed below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Additional claim interpretations are discussed below.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 should begin with an article (e.g., “A method for…”).
At claim 5, the plural usage of “antibiotics” at the preamble of “for stabilizing glycopeptide antibiotics” at line 1, and the alternative usage of “glycopeptide antibiotic(s)” at both lines 4 and 5 are inconsistent. The claim should be amended for consistency. For example, “for stabilizing glycopeptide antibiotic(s), selected from the group of antibiotic(s) consisting of…”.
Appropriate correction is required.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
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.
Claim 5 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the phrase “especially vancomycin” at lines three, four, and five each render the claim scope indefinite, because the phrase appears to be exemplary claim language. Per MPEP § 2173.05(d), “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim”. Here, it is unclear what nuanced meaning should be attributed to “especially vancomycin”, and therefore the phase raises confusion and uncertainty regarding the pending claim scope. See MPEP § 2173.05(d). Applicant may overcome this rejection by amending claim 5 to remove all instances of “especially vancomycin”.
Accordingly, claim 5 is rejected.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over US2017/0348385A1 (Dec. 7, 2017).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claim 5, US'385 explicitly teaches and discloses methods of making compositions comprising a glycopeptide antibiotic, such as vancomycin, in combination with an N-acetyl-D-amino acid, having a pH of about 3-6, wherein N-acetyl-D-Ala is exemplified (see, e.g., US'385 at claims 1-4, 10-13, 34-47, 65, 69, 78, 81, 97; see esp. id. at claims 78).
US’385 differs from instant claim 5 as follows: Instant claim 5 differs from the disclosure of US’385 because instant claim 5 requires the specific N-acetyl-D-amino acid of N-acetyl-D-Cys, rather than the N-acetyl-D-Ala as utilized by US’385. Accordingly, the relevant issue is whether or not the substitution of one N-acetyl-D-amino acid for another N-acetyl-D-amino acid in the prior art methodology of US’385 is obvious or non-obvious.
Although US'385 does not exemplify the combination of N-acetyl-D-Cys and a glycopeptide antibiotic (e.g., vancomycin), such combinations are obvious variants of the disclosed and claimed inventions of US'385 in view of the disclosure as a whole because US'385 identifies that the disclosed invention pertains to any and all "glycopeptide antibiotic compositions comprising an N-acetyl-D-amino acid” (see, e.g., US'385 at ¶¶[0020]-[0022]), and "a method for stabilizing glycopeptide antibiotics which involves addition of N-acetyl-D-amino acids to a solution comprising a glycopeptide antibiotic or addition of a glycopeptide antibiotic to a solution comprising N-acetyl-D-amino acids" (see, e.g., US'385 at ¶¶[0036]). The meaning and structures of N-acetyl-D-amino acids contemplated by US'385 are unambiguously identified (see, e.g., US'385 at ¶[0071]), and explicitly include all α-amino acid side chains, including D-Cysteine (see id; see also US'385 at ¶¶[0066], [0068]). Accordingly, an artisan would readily appreciate that the disclosure provided a broader teaching, namely that the claimed methods for forming stabilized compositions could be predictably and desirably practiced with any N-acetyl-D-amino acid, including N-acetyl-D-Cys as instantly claimed (see, e.g., US'385 at ¶¶[0036], [0066], [0068], [0071]). Therefore, the specification broadly informs artisans that the formulations and methods could be practiced using any N-acetyl-D-amino acid, wherein N-acetyl-D-amino acids would be understood to include the 20 unique D-amino acids explicitly recited (see US'385 at ¶[0068]).
The predicted and expected results of substituting one N-acetyl-D-amino acid disclosed by US’385 for another disclosed by US’385 would merely be predicted and expected to be approximately the same as the results shown for N-acetyl-D-Ala (see US'385 at ¶[0220]-[0223]).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed invention is the simple substitution of one N-acetyl-D-amino acid (i.e., N-acetyl-D-Cys) taught by US’385 for another N-acetyl-D-amino acid (i.e., N-acetyl-D-Ala) taught by US’385 in the prior art methodology of US’385, wherein vancomycin (or other glycopeptide) is combined with a N-acetyl-D-amino acid to enhance stability (e.g., US’385 at claims 78-81), wherein such substitution would predictably and expectedly yield a method of stabilizing a glycopeptide antibiotic, exactly as taught and suggested in view of the prior art (see, e.g., MPEP § 2143(I)(B)), because all of the N-acetyl-D-amino acids explicitly disclosed by US’385 are reasonably inferred and predicted to be functional equivalents (see, e.g., MPEP § 2144.06(II)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to practice a known prior art method of stabilizing glycopeptides by combining a known glycopeptide with a known N-acetyl-D-amino acids, to achieve the exact outcome taught, disclosed, and suggested by the prior art.
Claim 5 is rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO2016/071495A1 (12 May 2016) pertains to solutions of glycopeptides, including vancomycin, comprising an amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine, wherein the solutions are rendered stable or stabilized for long-term periods (see, e.g., WO’495 at title, abs, 5 at lines 15-25), wherein the compositions may have a pH of about 3-6 or about 4.0 to 5.5 (see, e.g., WO’495 at 4 at lines 24-31).
WO 2014/194296 Al (4 December 2014; cited in IDS filed 5/19/2023) pertains to vancomycin compositions having a pH of about 3 to 8, and exhibiting stability for at least about 12 months (see, e.g., WO’296 at title, abs, claims 1-2, 4-6).
WO2016/127087 (11 August 2016) pertains to aqueous vancomycin compositions (see, e.g., WO’087 at title, abs, claims), wherein the compositions comprise amino acids or amino acid derivatives (see, e.g., id. at ¶[0008], claims).
WO2020/208093A1 (15 October 2020) pertains to cysteine derivatives for use in the treatment and prevention of bacterial infections (see, e.g., WO’093 at title, abs, claims).
US2018/0133286A1 (17 May 2018) pertains to solutions of glycopeptides, including vancomycin, comprising an amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine, wherein the solutions are rendered stable or stabilized for long-term periods (see, e.g., US’286 at title, abs, ¶[0037]), wherein the compositions may have a pH of about 3-6 or about 4.0 to 5.5 (see, e.g., US’286 at ¶¶[0029]-[0030]]).
EP2520282A2 discloses that reduced oxygen content in vancomycin formulations is desirable (see, e.g., EP’282 at claims, abs, ¶¶[0001]-[0004], [0009]-[0010]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
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