DETAILED ACTION
Claims 1-24 are currently pending in the instant application.
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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7 and 9-16 drawn to a compound or composition comprising said compound of formula I
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, classified in C07D477/20.
II. Claim 8, drawn to a method of making a compound of Formula I
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, classified in C07D477/20.
III. Claims 17-24, drawn to a method of treating a bacterial infection comprising contacting with a compound of Formula I
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, classified in A61K31/407.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case Invention II is drawn to a process of synthesizing a compound. As there are other compounds found in Invention I, they are synthesized by a route beyond what is taught by Invention II.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the invention is taught to be used for treating bacterial infections in the prior art (see Sunagawa et al (see Journal of Antibiotics, 1997, Vol. 50, No. 7, p. 621-627).
Inventions II and III are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions have different designs and effects as one is drawn to a method of use of a product while the other is drawn to a process of making the product. As a result, different steps are required for each of the inventions, and they do not overlap in scope.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species- compounds where each variable is defined, such as those found in claim 7. The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species – for example, R2 is recited to be H or CH2NHSO2NH2, which would be considered different variables. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-6, 9-14, 16-22 and 24 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
--the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification;
--the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Edwin Flores on 04/07/2026 a provisional election was made without traverse to prosecute the invention of Group I, drawn to claims 1-7 and 9-16 and election of species
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. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8 and 17-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicants' elected species of
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does not appear allowable, therefore the search and examination of the claims has not been extended beyond the elected species (see the following 35 USC 103(a) rejection).
Claims 2, 4-6, 10 and 12-14 do not read on the elected embodiment and are therefore considered withdrawn claims. Since the elected embodiment is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration. It has been determined the entire scope claimed is not patentable.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 05/09/2024 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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 1, 9 and 16 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 1 and 9 recite a compound of Formula I with variable M -
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. However, no definition for the variable M is found in the claims. As claim 16 does not fix the issue, it has been rejected as well.
Claim 16 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. Claim 16 recites “structurally modified carbapenem”. However, it is unclear this term is a relative term which renders the claim indefinite since is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree or amount of structural modification to the carbapenem is unclear, and thus compound having various functional groups and chemical reactivity are encompassed by the instant claims. The “structurally modified carbapenem” is not defined by a structural formula so as to know the metes and bounds of the claim. Such language fails to clearly define the subject matter being claimed.
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.
Claims 1, 3, 7, 9, 11 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sunagawa et al (see Journal of Antibiotics, 1997, Vol. 50, No. 7, p. 621-627).
Sunagawa et al teach compounds of formula
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with various substituents as R1 and R2 including
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(see Fig. 1, p. 621). Compound 8 of Sunagawa et al has an (S) configuration in the 8-position but Sunagawa et al teaches R1 = CH(OH)-Ethyl rather than CH(OH)-Me as found in the elected species. The compounds of Sunagawa et al are taught to have antimicrobial activity against β-lactamase producing strain, in particular with activity against P. aeruginosa (see p. 624). Further the compounds are used in biological assays and thus prepared as compositions (see p. 623).
MPEP 2144.09, Section II states compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). It has long been established that this type of difference --- varying the size of a chain --- constitutes a form of homology, and is a fact of very close structural similarity, rendering the homolog obvious. Adjacent homologues are considered to be obvious absent unexpected results. See In re Henze, 85 USPQ 261, 263.
In the absence of unexpected results, one skilled in the art would expect that the instant claims which are directed to a compound that is a homologue to the compound of Sunagawa et al is prima facie obvious. One skilled in the art would be motivated to synthesize structurally similar compounds with the expectation that they would have similar properties and utilities. The explicit teaching of Sunagawa et al together with the enabled examples would have motivated one skilled in the art to synthesize compounds with such generic teaching with the expectation that they would have similar utility as antimicrobials.
Regarding claim 16, MPEP 2144.06, Section I states that it is obvious to combine equivalents known for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). Thus, it would be obvious to combine the compound of Sunagawa et al with other carbapenem antibiotics in a composition as demonstrated by Heng et al (see US Pat. No. 11,883,460, filed. 02/12/2021).
Claims 1, 3, 7, 9, 11 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sunagawa et al (see Journal of Antibiotics, 1997, Vol. 50, No. 7, p. 621-627) in view of Sunagawa et al (see US Pat. No. 4,933,333, issued 06/12/1990, hereafter referred to as US ‘333).
The teachings of Sunagawa et al are described above. Compound 1 of Sunagawa et al is the enantiomer of the elected species (i.e. it has 8R vs 8S). US ‘333 teaches the compound in racemic form - see Example 4
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(col. 64). Thus, it would be obvious to one of ordinary skill in the art to obtain the corresponding enantiomer from the racemate. In order to patent an optical isomer, it is necessary to show that they possess "qualities [which] are utterly unobtainable" in the racemic mixture. Sterling Drue v. Watson, 108 USPQ 37. Note also, Pfizer v. Int. Rectifier Corp., 190 USPQ 273, 280; v. Cienerex, 174 USPQ 65. See also, In re Volweiler, 146 USPQ 137 (requiring that the claimed component of an old mixture "be so different in properties and uses as to be in effect a new compound"). A mere improvement in properties does not necessarily suffice. Weijland, 69 USPQ 86; Ex parte Hald, Paper 15 in U.S. Patent No. 2,647,145; Ex parte Cavallito, 89 USPQ 449. The reference does not have to suggest resolution of the racemate. One skilled in the art is presumed to be able to do so. The expectation with regard to enantiomers is that activities as they pertain to living systems are expected to be different. In re Adamson, 275 F.2d 952, 125 U.S. P.Q. 233 (C.C.P.A. 1960). The expectation with regard to enantiomers is that activities as they pertain to living systems are expected to be different.
Regarding claim 16, MPEP 2144.06, Section I states that it is obvious to combine equivalents known for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). Thus, it would be obvious to combine the compound of Sunagawa et al with other carbapenem antibiotics in a composition as demonstrated by Heng et al (see US Pat. No. 11,883,460, filed. 02/12/2021).
Conclusion
None of the claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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