DETAILED ACTION
Examiner acknowledges receipt of the reply filed 9/03/2026, in response to the non-final office action mailed 6/03/2026.
Claims 1, 16, 17, 19, 20, and 29 are pending and being examined on the merits in this office action.
Claims 2-15, 18, 21 and 22 are cancelled.
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 .
Specification- withdrawn
The objection to the abstract is withdrawn in view of the amendment filed 9/03/2026.
Claim Objections- withdrawn
The objection of claims 1, 2, 8, 12, 20, and 29 is withdrawn in view of the amendment filed 9/03/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 11, 15, and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 9/03/2026, canceling the claims.
The rejection of claims 1-22 and 29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amendment filed 9/03/2026.
Claim Rejections - 35 USC § 103- withdrawn
The rejection of claims 1-22 and 29 under 35 U.S.C. 103 as being obvious over Lükten et al. (U.S. 2024/0156893, PGPUB of copending Appl. No. 18/546794), and further in view of Ruuskanen et al (Lancet 377:1264-1275 (2011)), is withdrawn in view of the statement of common ownership, disqualifying Lükten as prior art. See reply filed 9/3/2026 at p. 9.
Response to Arguments
Applicant’s amendment filed 9/03/2026 with respect to the above objections and rejections have been fully considered and are persuasive. The objections and rejections have been withdrawn.
Applicant's arguments filed 9/03/2026 have been fully considered but they are not persuasive. An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained Rejections
Claim Rejections - 35 USC § 103
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, 16, 17, 19, 20, and 29 remain/are rejected under 35 U.S.C. 103 as being unpatentable Stensen et al (U.S. 20110172145- previously cited), and further in view of Cillóniz et al (Ann Res Hosp 2:1 (2018) - previously cited). The rejection is maintained from the office action mailed 6/03/2026, but has been amended to reflect claims filed 8/25/2026.
Stensen et al teach a compound of formula (I) AA-AA-AA-X—Y—Z wherein, in any order, 2 of said AA (amino acid) moieties are cationic amino acids and 1 of said AA is an amino acid with a lipophilic R group, the R group having 14-27 non-hydrogen atoms; X is a N atom, which may be substituted by a branched or unbranched C1-C10 alkyl or aryl group which group may incorporate up to 2 heteroatoms selected from N, O and S; Y represents a group selected from —Ra—Rb—, —Ra—Rb—Rb— and —Rb—Rb—Ra— wherein Ra is C, O, S or N, and Rb is C; each of Ra and Rb may be substituted by C1-C4 alkyl groups or unsubstituted; and Z is a group comprising 1 to 3 cyclic groups each of 5 or 6 non-hydrogen atoms, 2 or more of the cyclic groups may be fused and one or more of the cyclic groups may be substituted; the Z moiety incorporates a maximum of 15 non-hydrogen atoms; and wherein the bond between Y and Z is a covalent bond between Ra or Rb of Y and a non-hydrogen atom of one of the cyclic groups of (abstract, claim 1). The compounds have utility as antimicrobial or antitumoral agents (e.g., abstract, paras. [0028]-[0030], [0039], [0051]-[0055], claim 15). Stensen et al reduced to practice compound 1 (LTX-7) and compound 2 (LTX-109):
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(e.g., para [0027], Exs 1-6 claim 13). The peptides can be used in methods of treating bacterial, viral or fungal infections (para [0051], claim 15). Table 1 discloses peptides compound 1 (LTX-7) and compound 2 (LTX-109) that had antibacterial and antifungal activity against Gram-positive bacteria (Listeria, Enterococcus), Gram-negative bacteria (E. coli, Staphylococcus) and fungi (Candida, Aspergillus) (Ex 1). The treatment can be therapeutic (e.g., paras [0028]-[0030], [0039], [0051]). Stensen et al do not require any assessment of infectious agent prior to treatment.
Although Stensen et al. teach treatment of a bacterial infection comprising the claimed peptide compounds, the reference does not explicitly teach that the infection is pneumonia.
Cillóniz et al teach that Streptococcus pneumoniae is the most frequent causative pathogen of community acquired pneumonia (CAP) (e.g., p. 1). Other bacterial causative agents of pneumonia include Legionella, Mycoplasma, Moraxella spp, Haemophilus influenzae, and Staphylococcus aureus (e.g., table 1, p. 3 and 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to administer a peptide LTX-109 or LTX-7 to a patient with bacterial pneumonia, e.g., caused by e.g. Streptococcus pneumoniae, in order to treat the pneumonia. The skilled artisan would have recognized from Stensen et al. that the peptides can be used to treat bacterial infections, as well as viral and fungal infections. Cillóniz et al explicitly taught Streptococcus pneumoniae is the most common cause of bacterial pneumonia. The skilled artisan would have had a reasonable expectation of success in treating bacterial pneumonia caused by Streptococcus pneumoniae because this was the specific patient population (e.g., a subject with a bacterial infection) that Stensen et al. sought to treat with the instantly claimed peptides of LTX-7 or LTX-109. Stensen et al further taught that the claimed peptides had antibacterial activity against Streptococcus pneumoniae (e.g., Table 1). See also antibacterial activity against the bacterium Haemophilus influenzae and Staphylococcal aureus- other known causative agents of pneumonia. The skilled artisan would further have had a reasonable expectation of success in treating an infection because Stensen et al explicitly taught that the peptides exhibit broad antimicrobial activity and could be used in treating bacterial, viral or fungal infections (e.g., paras [0028], [0039], [0050]-[0051], [0055], claim 15). Stensen et al further did not require that assessment of an infection prior to treatment/administering the peptide.
Accordingly, instant claims 1, 17, and 29 are rendered obvious.
Regarding claim 16, Stensen et al teach that the peptides can be used to treat a viral infection (e.g., paras [0050]-[0051]). Regarding claim 17, Stensen et al teach that the peptides have antibacterial activity against Streptococcus pneumoniae, the causative agent of pneumonia (e.g., Ex 1, Table 1).
Regarding claim 19, the subject is a human (e.g., para [0051]). Regarding claim 20, the compound is in a pharmaceutical formulation comprising a suitable diluent, carrier or excipient (e.g., paras [0049]-[0056], claim 17). Regarding claims 21 and 22, the treatment can be therapeutic or prophylactic (e.g., paras [0028]-[0030], [0039], [0051]).
Accordingly, claims 1, 16, 17, 19, 20, and 29 are rendered obvious in view the teachings of the cited references.
Response to Arguments
Applicant traversed the rejection at pp 9-12 of the reply filed 9/03/2026. Applicant asserts Stensen does not provide any data that demonstrates antiviral activity and does not teach that the peptides can be used to treat sinusitis, pneumonia, or otitis (p. 10). Applicant asserts Cillóniz discloses difficulty with microbial identification of pathogenic microbiome and that the reference does not disclose any treatment of community acquired pneumonia (CAP). Id. Applicant asserts Cillóniz does not disclose the claimed peptides, nor provide “any teaching in relation to sinusitis or otitis”. Id.
Applicant asserts that pneumonia, sinusitis, and otitis can be caused by bacteria, viruses and even fungi, yielding substantially the same symptoms (p. 10). Applicant states at p. 10: If no tests are performed, a treatment may be initiated that is not effective against the causative agent and may result in unnecessary use of antibiotics and worsening of the infection. Applicant asserts the claimed peptides are effective in therapeutic treatment of pneumonia, sinusitis, and otitis, irrespective if caused by bacteria, viruses or fungal infection (p. 11). Applicant refers to the Examples for the assertion that the claimed peptides having activity against different viruses, bacteria and fungi (reply at p. 11).
Applicant asserts that the cited references do not provide the skilled person with sufficient information to motivate arriving at the presently claimed invention with a reasonable expectation of success. Applicant asserts the cited references do not provide a reason to combine the respective teachings nor a reasonable expectation of success in treating the claimed conditions (p. 110.
Applicant further states at pp 11-12 that “[n]either Stensen nor Cillóniz prompts the skilled person to treat a subject absent having previously determined the causative agent of pneumonia, let alone sinusitis or otitis, and still less by administration of the presently claimed compounds. The skilled person would have no reasonable expectation of success in treating pneumonia, sinusitis or otitis caused by an unknown pathogen with the compounds now recited in claim 1”. Applicant asserts hindsight analysis (reply at p. 12).
Examiner has reviewed an considered Applicant’s amendment and arguments, but is not persuaded.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As noted by Applicant at p. 10 of the reply, “the peptides defined herein exhibit broad antimicrobial activity and thus are also suitable as antiviral and antifungal agents” Stensen at paragraph [0050]. Stensen further states at para [0051]: “Methods of treating .. bacterial, viral or fungal infections .. which comprises administration to a human or animal patient one or more of the peptides or peptidomimetics as defined herein constitute further aspects of the present invention.” Stensen et al reduced to practice compounds of LTX-109 and LTX-7 (para [0027], examples, claim13). Thus, the skilled artisan would have recognized that LTX-109 and LTX-7 could be used to treat a bacterial, viral or fungal infection.
Regarding Applicant arguments asserting Stensen lacks data of antiviral activity- such data/information is not required by MPEP guidelines.
Patents and applications are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure … a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; proof of efficacy is not required for a prior art reference to be enabling. Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006).
MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein [e.g., administering the claimed peptides LTX-7 or LTX-109 to treat an infectious agent (regardless if bacterial, fungal or viral) causing pneumonia], such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
MPEP guidelines require a “reasonable” expectation of success, there is no requirement of a guarantee of success. Conclusive proof of efficacy is NOT required to show a reasonable expectation of success. Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQe2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367-68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). See MPEP § 2143.02.
Cillóniz was cited for the purpose that Streptococcus pneumoniae (peptides of Stensen had antibacterial activity against the bacterium (e.g., Table 1)) is the most frequent causative pathogen of community acquired pneumonia (CAP) (e.g., p. 1). Cillóniz further taught other bacteria that were known to cause pneumonia.
The U.S. Federal Circuit has explicitly stated that in order to make a prima facie case of obviousness, the suggestion and motivation to combine the references need not be explicitly stated in the text of the references. In DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641 (Fed. Cir. 2006), the Court writes, “the suggestion test is not a rigid categorical rule. The motivation need not be found in the references sought to be combined, but may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself. In re Dembiczak, 175 F.3d 994, 999 [50 USPQ2d 1614] (Fed. Cir. 1999). As we explained in Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1472 [43 USPQ2d 1481] (Fed. Cir. 1997), ‘there is no requirement that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art.’” See Dystar at 1645. “Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” See Dystar at 1650.
Stensen did not require that the identity of a causative agent of pneumonia be assessed prior to amendment. As noted above, Stensen taught that the peptides could be used to treat bacterial, fungal or viral infections. Cillóniz taught bacterial species that were known to cause pneumonia. Table 1 of Cillóniz further discloses distribution of viral infections and polymicrobial etiologies. Thus, the skilled artisan would have recognized that the peptides of Stensen could be used to treat an infectious agent causing pneumonia in a subject.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Accordingly, the rejection of the instant claims is maintained for at least these reasons.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 16, 19, 20, and 29 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 17, 18 and 20-26, of copending Application No. 18697318 (hereinafter referred to as “the ‘318 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The rejection is maintained from the office action mailed 6/03/2026, but has been amended to reflect claims filed 8/25/2026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1, 16, and 29, claim 1 of the ‘318 application is drawn to method for the treatment of a non-envelope virus infection in a subject in need thereof, comprising administering to said subject an effective amount of a compound of formula I
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. Claim 15 of the ‘318 application recites compound of
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. Claim 26 recites that the treatment is a therapeutic treatment. Claim 18 recites that the virus infection is the respiratory tract infection. The ‘318 application discloses that the compositions can be used to treat pneumonia (e.g., pp. 11-12). “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application. The claims of the recite ‘318 application do not require any assessment of infectious agent prior to treatment.
Regarding claim 19, claim 22 of the ‘318 application recites subject is a human.
Regarding claim 20, claim 23 of the ‘318 application recites that the compound is in a pharmaceutical formulation comprising a diluent, carrier, and an excipient.
Response to Arguments
Applicant requested that the ODP rejection be held in abeyance (reply filed 9/03/2026 at p. 12).
While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
Claims 1, 16, 19, 20, and 29 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 19-23, and 30-35 of copending Application No. 18546794 (hereinafter referred to as “the ‘794 application”), in view of Ruuskanen et al (Lancet 377:1264-1275 (2011)- previously cited). A notice of allowance was mailed 9/9/2026. The ‘794 application has not yet issued. The rejection is maintained from the office action mailed 6/03/2026, but has been amended to reflect claims filed 8/25/2026.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the ‘794 application are drawn to a method for the treatment of an Coronavirus, Orthopneumovirus or Orthomyxovirus infection in a subject in need thereof, comprising administering to said subject an effective amount of a compound of a recited compound [Ltx-109, LTX-7, LTX-12, or Arg-Phe(4-(1-Napthyl))-Arg-NH-CH2-CH2-Ph]. Claim 16 recites that the virus infection is the respiratory tract infection (Coronavirus, an Orthopneumovirus [causative agent of pneumonia] or an Orthomyxovirus). Claims 19, 30, and 31 recite coronavirus, respiratory syncytial virus, and Influenza A respectively. Claim 22 of the ‘794 application respectively recites that the treatment is a therapeutic treatment. The claims of the recite ‘794 application do not require any assessment of infectious agent prior to treatment.
However, the claims of the ‘794 application do not expressly recite that the respiratory tract infection is pneumonia.
Ruuskanen et al teach that pneumonia is a common illness that continues to be the major killer of young children in developing countries and elderly people in developed countries. Many microorganisms are associated with pneumonia, and now attention is turning to the importance of viruses as pathogens. The emergence of severe acute respiratory syndrome (SARS), avian influenza A (H5N1) virus, and the 2009 pandemic influenza A (H1N1) virus has re-emphasized the important role of respiratory viruses as causes of severe pneumonia (p. 1264). The panel at p. 1265 provides a list of viruses community-acquired pneumonia in children and adults, including Influenza A, Coronaviruses, Respiratory syncytial viruses.
It would have been obvious to one of ordinary skill in the art to administer a peptide of formula I to a patient with viral pneumonia, e.g., caused by SARS or influenza A, in order to treat the pneumonia. The skilled artisan would have recognized from the ’794 application claims that the peptides of formula I can be used to treat respiratory tract infection caused by viruses. Ruuskanen et al explicitly taught viruses e.g. Influenza A, Coronaviruses, Respiratory syncytial viruses are causative agents of viral pneumonia. The skilled artisan would have had a reasonable expectation of success because this was the same patient population (e.g., a subject with a respiratory tract infection caused by a virus, e.g., influenza A or a coronavirus) the claims of the ‘794 application sought to treat.
Accordingly, instant claims 1, 16, and 29 are rendered obvious.
Regarding claim 19, claim 20 of the ‘794 application recites subject is a human.
Regarding claim 20, claim 21 of the ‘794 application recites that the compound is in a pharmaceutical formulation comprising a diluent, carrier, and an excipient.
Response to Arguments
Applicant requested that the ODP rejection be held in abeyance (reply filed 9/03/2026 at p. 12).
While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
Relevant Art Not Relied Upon
Nilsson et al (Antimicrob Agents Chemo 59:145-151 (2015)- cited in IDS filed 8/17/2023) teach that LTX-109 can be used to treat nasal methicillin-resistant and -sensitive Staphylococcus aureus infections (abstract, pp. 149-150). One week after treatment initiation, LTX-109 was not detectable in any subject (abstract). Because of the spread of S. aureus in hospitals, leading to an increase in the infection rates, prevention programs aiming at decolonizing individual nasal S. aureus carriers have to be implemented. A recent U.S. study including 43 U.S. hospitals, 74 adult intensive care units (ICUs), and 74,256 patients revealed that universal decolonization of patients in the ICU, irrespective of confirmed nasal carriage, was the most effective strategy. This significantly reduced the MRSA-positive clinical cultures by 37% and bloodstream infections from any pathogen by up to 44%. Thus, universal decolonization of S. aureus carriers as infection prophylaxis will increase the need for new antibiotics with low propensity for resistance development.
Vickery et al (Curr Allergy Asthma Rep. 19:21 (2019)) teach that Staphylococcus aureus (S. aureus) is correlated with the development of persistent severe inflammatory disease of the upper airway including chronic rhinosinusitis with nasal polyps(CRSwNP) (abstract). Chronic rhinosinusitis (CRS) continues to be a highly prevalent and morbid clinical syndrome characterized by persistent inflammation of the nasal cavity and paranasal sinuses that results in symptoms of nasal obstruction, rhinorrhea, facial pain, and anosmia (p. 1). CRSwNP is also associated with higher rates of upper airway colonization with Staphylococcus aureus (S. aureus) and biofilm formation which correlate with more severe disease phenotypes (p 2).
Conclusion
No claims are allowed.
Claims 1, 16, 17, 19, 20, and 29 are pending and are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654
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