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
Priority to US 63/118,254, filed 11/25/2020 and US 63/172,163, filed 63/172,163, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 10/25/2024, before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 and 34-50, filed 12/29/2023, are pending. Claims 1 and 34-50 are under examination.
Claim Interpretation
In claim 41, “or a disease” may refer to a cause of an infection or a target of treatment of the method. The specification makes note of a sexually transmitted disease caused by Neisseria gonorrhoeae (Specification, page 34, line 7). Consequently, the “disease” shall be interpreted to be the cause of an infection.
In order to advance compact prosecution, claim 43 is interpreted to refer to claim 42, not claim 424. “Claim 424” is likely a typographical error.
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 41-50 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.
Regarding claim 41, it is not clear whether the phrase “or a disease” refers to a cause of an infection or a target of treatment of the method. Clarification is required.
Regarding claim 42, claim 41 is rejected as described above. Claim 42 does not resolve the indefiniteness of claim 41 and therefore is rejected.
Regarding claim 43, the phrase "other Gram-negative pathogens" is functionally equivalent to “or the like” which renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by " other Gram-negative pathogens "), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). Also, claim 43 does not resolve the indefiniteness of claim 41 and therefore is rejected.
Regarding claims 44-47, claim 41 is rejected as described above. These claims do not resolve the indefiniteness of claim 41 and therefore are rejected.
Regarding claim 48, the specification defines “pests” as “the term "pest" includes, but not limited to insects, fungi, bacteria, nematodes, mites, ticks and the like.” (Specification, page 26, line 1). The phrase "or the like" renders the claim indefinite because the claim include elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 49, claim 48 is rejected as described above. Claim 49 does not resolve the indefiniteness created by the term “pest” and is consequently rejected.
Regarding claim 50, the phrase "other Gram-negative pathogens" is functionally equivalent to “or the like” which renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by " other Gram-negative pathogens "), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Also, claim 50 does not resolve the indefiniteness created by the term “pest” and is consequently rejected.
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 43 and 50 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 43 refers to claim 424, which is not present in the application.
Furthermore, claim 43 contains an open-ended clause, “and other Gram-negative bacteria”, which functionally gives this claim the same scope as claim 42: all Gram-negative bacteria.
Regarding claim 50, claim 50 contains an open-ended clause, “and other Gram-negative bacteria”, which functionally gives this claim the same scope as claim 49: all Gram-negative bacteria.
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 34-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites the following structural schemes:
PNG
media_image1.png
331
446
media_image1.png
Greyscale
PNG
media_image2.png
308
462
media_image2.png
Greyscale
These schemes have several variable positions, including X which may be S, and Z, which is any post-β-carbon side chain from any natural or non-natural amino acid. Y is chosen from seven members, but occurs twice in each scheme. Also R1, represents any number of natural and non-natural amino acids. This combines to form a very large sequence space, potentially infinite factoring in R1.
In this case, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. (MPEP § 2163 (II.A.3.a.ii.))
According to MPEP § 2163 (II.A.3.a.ii.), a "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
As described above, claim 1 recites extremely large (open-ended) genus of peptides.
MPEP § 2163 (II.A.3.a.ii.) states that “for inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’”
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Since each genus recited in the instant claims is large, it would be very challenging to describe sufficient species to cover the structures of the entire genus.
In the instant case, Applicant reduces two formulae to practice. At the time the invention was made, the level of skill for preparing peptides with desired functional properties was high. However, even if a synthesis and selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identify peptides that yield polypeptides with the recited properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); see also Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1876 (Fed. Cir. 2011) (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”) Absent the conserved structure (length) provided by the provided species, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what peptide with a particular set of properties would look like structurally.
Applicant discloses formulae I-XIII and reduces I and III to practice. None of these examples utilize sulfur double bonded to carbon and all are between five and fifteen amino acids in length. Therefore, the provided examples only represent a limited structural diversity.
Since only a limited number of species of fusion proteins are taught within the claimed genus above, the instant claim above fails the written description requirement. A representative number of species has not been taught to describe this genus. Regarding the peptides, a single point mutation can change the biophysical properties of a peptide: “In summary, we have shown that the structural changes in the fibrillar state of the Aβ42 peptide that are observed to occur upon introduction of single point mutations can be accompanied by changes in the dominance of the microscopic processes by which these aggregates are themselves formed.” (Bolognesi et al. ACS Chem Bio 9:2 (2013) page 381 col. 2 para. 3) and “In summary, while ovispirin-1 and novispirin G-10 both had solution structures that were helical and amphipathic in the presence of TFE, a relatively simple change in their primary structure (a single glycine–isoleucine exchange) had profound effects on their respective toxicities for human erythrocytes and epithelial cells.” (Sawai et al. Protein Eng. 15:3 (2002) page 232 col. 1 para. 3).
Furthermore, many sequences allowed by the current scope of the claims, result in non-functional aggregates. Wang (Wang, et al. MAbs. Vol. 1. No. 3. Taylor & Francis, (2009)) discloses a variety of aggregation prone motifs that occur in commercial antibodies (Wang, page 262, Table 2). The scope of the claims currently may incorporate such motifs and result in non-functional aggregates.
Given this unpredictability of protein design, the skilled artisan would not have been in possession of the substantial repertoire of peptide species encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of every polynucleotide molecule recited by claim 1. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus. Therefore, claim 1 is rejected.
Regarding claims 34-50, claim 1 is rejected as described above. All of these claims are ultimately dependent upon claim 1 and none of these claim reduce the size of the claimed genus in question. Consequently, the specification fails to disclose a representative number of species to describe the claimed genus of claims 34-50. Therefore, claims 34-50 are rejected.
Claims 41-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for Formulae I-VII for treatment of infections caused by Pseudomonas aeruginosa, Escherichia coli, Salmonella enterica typhimurium, Salmonella enterica Enteri--tidis, Acinetobactor baumannii, Klebsiella pneumoniae, Proteus mirabillis, Yersinia pseudotuberculosis, and Photorhabdus australis, does not reasonably provide enablement for formulae VIII-XIII nor schemes I-IV in general, nor enablement for Formulae I-VII against all possible infections. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Regarding claim 41, there are two main issues to be addressed: formulae I-VII and then formulae VIII-XIII and schemes I-IV. Formulae I-VII share a common motif HSYRF. Consequently, these formulae share a common structure-function relationship and therefore are enabled a group to the extent shown by the specification. Formulae VIII-XIII and schemes I-IV lack this common motif.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
Claim 41 encompasses 13 formulae and 4 schemes. The schemes, as described above, are incredibly broad. The formulae are very limited structures.
(B) The nature of the invention;
The invention is a series of molecules with activity against some Gram-negative bacteria.
(C) The state of the prior art;
Gruenheid et al. (Gruenheid, et al. FEMS microbiology letters 330.2: 81-89 (2012))
summarizes the situation: “Gram-negative pathogens use multiple mechanisms to resist AMPs. The respective contribution of each resistance mechanism is unclear, and a large degree of heterogeneity between species in terms of the relative importance of each mechanism of resistance appears to exist. A better understanding of the mechanisms of bacterial resistance to AMPs is warranted, both to better understand the host/pathogen interaction and to facilitate efforts to exploit AMPs for therapeutic interventions.” (Gruenheid et al., page 86, col. 1, para. 3). Figure 1 of Gruenheid shows multiple resistance paths that Gram negative bacteria can possess against antimicrobial peptides (Gruenheid, page 84, Fig. 1).
(D) The level of one of ordinary skill;
A person of ordinary skill in the art in the field of fusion proteins is usually at least a Master’s level education.
(E) The level of predictability in the art;
As discussed by Gruenheid above, multiple mechanisms are used by Gram-negative bacteria to resist anti-microbial peptides and the contributions of those mechanisms is not clear. This makes predictability low.
(F) The amount of direction provided by the inventor and the existence of working examples;
Applicant shows efficacy of formula I and formula III against various targets. In some cases, however, formula III did not appear to have an effect.
(G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
A large amount of experimentation would be required to test formulae VIII-XIII against a range of Gram-negative targets, but an enormous amount of experimentation would be required to test compounds that fit schemes I-IV against a range of Gram-negative targets.
Applicant shows various degrees of efficacy for the compounds of formula I and formula III in Table 1 of the specification. However, this only reasonably provides enablement for infections caused by those agents, not any possible infection as claimed. Not only may infections be caused by Gram-positive bacteria and other agents these compounds have no efficacy against, some infections may be caused by Gram-negative bacteria with defenses as described by Gruenheid above.
Applicant does not show any efficacy for formulae VIII-XIII and schemes I-IV against Gram-negative targets. Formulae VIII-XIII do not share a structural motif with formulae I-VII and therefore a person of ordinary skill in the art would not be able to reliably use the results for formula I and formula III and would be required to perform undue experimentation to determine if the claimed compounds can be used to perform the claimed method.
Consequently, claim 41 is rejected because The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Regarding claim 42, claim 41 is rejected as described above.
Applicant does not show any efficacy for formulae VIII-XIII and schemes I-IV against Gram-negative targets. Formulae VIII-XIII do not share a structural motif with formulae I-VII and therefore a person of ordinary skill in the art would not be able to reliably use the results for formula I and formula III and would be required to perform undue experimentation to determine if the claimed compounds can be used to perform the claimed method.
Applicant shows various degrees of efficacy for the compounds of formula I and formula III in Table 1 of the specification. However, this only reasonably provides enablement for infections caused by those agents, not any possible Gram negative bacteria as claimed. The specification discloses that these compounds have no efficacy against Gram-negative intestinal symbionts (Specification, page 19, line2). Furthermore, Table 1 of the specification shows that formula III appears to lack efficacy against a number of Gram-negative targets.
Consequently, claim 42 is rejected.
Regarding claim 43, claim 42 is rejected as described above. Claim 43 has an open-ended clause “and other Gram-negative “. This gives claim 43 the same scope as claim 42 and is rejected for the same reasons. If this clause were removed, an issue still exists in that according to Table 1 of the specification, formula III does not appear to have the same range of efficacy as formula I. Also, not every recited target is present in Table I. As noted above by the teachings of Gruenheid, the resistance mechanisms of Gram-negative bacteria are complex and unpredictable. A person of ordinary skill in the art would be required to perform undue experimentation to determine if the claimed compounds are enabled against all of the recited Gram-negative targets, especially with respect to schemes I-IV. Claim 43 is rejected.
Regarding claim 44, claim 41 is rejected as described above. Claim 44 further recites: “wherein the bacteria are susceptible bacteria, multidrug-resistant bacteria, polymyxin-resistant bacteria, carbapenam-resistant bacteria, and/or multi-drug resistant Neisseria gonorrhoeae.” First, no claimed molecule is shown to be efficacious against Neisseria gonorrhoeae. Also, qualifying the target Gram-negative bacteria with a phrase like “multidrug-resistant bacteria” does not alter the analysis given in claim 41 above. Formulae VIII-XIII and schemes I-IV still lack general enablement and formulae I-VII are still only enabled against a finite set of Gram-negative targets. Consequently, claim 44 is rejected.
Regarding claim 45, claim 41 is rejected as described above. Claim 45 recites various infections caused by bacteria. The resulting infection does not influence a given molecule’s efficacy against a Gram-negative target. Consequently, the analysis from claim 41 holds for claim 45 and claim 45 is rejected.
Regarding claim 46, claim 41 is rejected as described above. Claim 45 recites various diseases. This does not reduce the scope of claimed Gram-negative bacteria recited by claim 41. Consequently, the analysis from claim 41 holds for claim 46 and claim 46 is rejected.
Regarding claim 47, claim 41 is rejected as described above. Claim 47 recites various administration steps. This does not reduce the scope of claimed Gram-negative bacteria recited by claim 41. Consequently, the analysis from claim 41 holds for claim 47 and claim 47 is rejected.
Claims 48-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for Formulae I-VII for treatment of infections caused by Pseudomonas aeruginosa, Escherichia coli, Salmonella enterica typhimurium, Salmonella enterica Enteri--tidis, Acinetobactor baumannii, Klebsiella pneumoniae, Proteus mirabillis, Yersinia pseudotuberculosis, and Photorhabdus australis, does not reasonably provide enablement for formulae VIII-XIII nor schemes I-IV in general, nor enablement for Formulae I-VII against all possible pests. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Regarding claim 48, there are two main issues to be addressed: formulae I-VII and then formulae VIII-XIII and schemes I-IV. Formulae I-VII share a common motif HSYRF. Consequently, these formulae share a common structure-function relationship and therefore are enabled a group to the extent shown by the specification. Formulae VIII-XIII and schemes I-IV lack this common motif.
Also, the specification defines “pests” as “the term "pest" includes, but not limited to insects, fungi, bacteria, nematodes, mites, ticks and the like.” (Specification, page 26, line 1).
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
Claim 41 encompasses 13 formulae and 4 schemes. The schemes, as described above, are incredibly broad. The formulae are very limited structures.
(B) The nature of the invention;
The invention is a series of molecules with activity against some Gram-negative bacteria.
(C) The state of the prior art;
Antimicrobial peptides are known to be effective against non-bacterial targets. Monstesinos et al. (Montesinos,et al. Chemistry & biodiversity 5.7: 1225-1237 (2008)) describes an array of sequences with efficacy against bacteria, fungi, or both (Monstesino et al., page 1227, Table 1). Also, Lewer et al. (Lewer, et al. Journal of natural products 69.10: 1506-1510 (2006)) describes the discovery of a cyclic peptide that has insecticidal activity (Lewer et al., page 1507, col. 2, para. 3).
(D) The level of one of ordinary skill;
A person of ordinary skill in the art in the field of fusion proteins is usually at least a Master’s level education.
(E) The level of predictability in the art;
As shown in Monstesnios, a wide variety of anti-microbial peptides are known, but these lack consistent motifs and functionality. Furthermore, the cyclic peptide of Lewer is different from the peptides disclosed in this application. A single point mutation can change the biophysical properties of a peptide: “In summary, we have shown that the structural changes in the fibrillar state of the Aβ42 peptide that are observed to occur upon introduction of single point mutations can be accompanied by changes in the dominance of the microscopic processes by which these aggregates are themselves formed.” (Bolognesi et al. ACS Chem Bio 9:2 (2013) page 381 col. 2 para. 3) and “In summary, while ovispirin-1 and novispirin G-10 both had solution structures that were helical and amphipathic in the presence of TFE, a relatively simple change in their primary structure (a single glycine–isoleucine exchange) had profound effects on their respective toxicities for human erythrocytes and epithelial cells.” (Sawai et al. Protein Eng. 15:3 (2002) page 232 col. 1 para. 3). Therefore, the unpredictability is high as to exactly what activity each structure will possess.
(F) The amount of direction provided by the inventor and the existence of working examples;
Applicant shows efficacy of formula I and formula III against various targets. In some cases, however, formula III did not appear to have an effect.
(G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
An enormous amount of experimentation would be required to test the claimed compounds against the range of organisms defined by the term “pest”.
While some antimicrobial peptides possess activity against fungi and insects, they have no apparent common structural features. Applicant only provides data for bacterial targets. Consequently, a person of ordinary skill in the art would need to perform an undue amount of experimentation to enable formulae I-XIII and schemes I-IV for “pests” as defined in the specification. Claim 48 is rejected.
Regarding claim 49, claim 48 is rejected as described above. This claim has similar scope to claim 42 with respect to the active molecules and therapeutic targets.
Applicant does not show any efficacy for formulae VIII-XIII and schemes I-IV against Gram-negative targets. Formulae VIII-XIII do not share a structural motif with formulae I-VII and therefore a person of ordinary skill in the art would not be able to reliably use the results for formula I and formula III and would be required to perform undue experimentation to determine if the claimed compounds can be used to perform the claimed method.
Applicant shows various degrees of efficacy for the compounds of formula I and formula III in Table 1 of the specification. However, this only reasonably provides enablement for infections caused by those agents, not any possible Gram-negative bacteria as claimed. The specification discloses that these compounds have no efficacy against Gram-negative intestinal symbionts (Specification, page 19, line2). Furthermore, Table 1 of the specification shows that formula III appears to lack efficacy against a number of Gram-negative targets.
Consequently, claim 49 is rejected.
Regarding claim 50, claim 49 is rejected as described above. This claim is similar in scope to claim 43 with respect to the active molecules and therapeutic targets. Claim 50 has an open-ended clause “and other Gram-negative “. This gives claim 49 the same scope as claim 49 and is rejected for the same reasons. If this clause were removed, an issue still exists in that according to Table 1 of the specification, formula III does not appear to have the same range of efficacy as formula I. Also, not every recited target is present in Table I. As noted above by the teachings of Gruenheid, the resistance mechanisms of Gram-negative bacteria are complex and unpredictable. A person of ordinary skill in the art would be required to perform undue experimentation to determine if the claimed compounds are enabled against all of the recited Gram-negative targets, especially with respect to schemes I-IV. Claim 50 is rejected.
Conclusion
No claim is allowed.
Claims 1 and 34-50 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654