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
This application filed 06/20/2024 is a Continuation of PCT/SE2022/051208 , filed 12/20/2022 and claims foreign priority to 2151572-1, filed 12/21/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/06/2025 and 09/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-11 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 1, the phrase "such as" (lines 6, 9, 11) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation ’90 %’, and the claim also recites ’such as -99 %’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 3, the claim recites ‘or of each of the peptides according to (b)’ (line 4). Does the claim mean that in (b), SEQ ID NO: 1 and SEQ ID NO: 2 are each from about 10 nM to about 100 µM or does it mean that each of the peptides, range in concentration from about 1 nM to about 1000 µM. Since the interpretation is unclear, ambiguity arises.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the instant case, it is unclear whether the claim recites the broad limitation 1 nM to about 1000 µM or the narrow limitation 10 nM to about 100 µM.
Regarding claim 4, the phrase "such as" (line 4) renders the claim indefinite because it is unclear whether the limitations following the phrase, are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation ’1:1 to about 20:1’, and the claim also recites ‘about 1:1 to about 10:1’ and ’about 1:1’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 6, the phrase "such as" (line 5) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, it is unclear if the claim recites the broad limitation of enveloped virus or if the claim recites the narrow limitation of virus selected from the group consisting of the following virus families.
Regarding claim 8, the phrase "such as" (line 3) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the claim recites the broad limitation of close to the site of infection or the narrow limitation, i.e. topically.
Regarding claim 10 the phrase "such as" (line 3) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the claim recites the broad limitation -multiple doses, or the narrow limitation, i.e. two, three, four or five per day.
Claims dependent on the rejected independent claim, are rejected under 35 U.S.C. 112(b) or 35
U.S.C. 112 (pre-AIA ), second paragraph because they incorporate by dependency, the indefiniteness of the independent claim.
Claim Rejections - 35 USC § 112
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 1-11 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 ‘treating’, does not reasonably provide enablement for ‘preventing’. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Claim 1 is drawn to a ‘method for preventing and /or treating a viral infection and/or a disorder associated with a viral infection’.
Embodiments of the specification disclose ‘treating’ as ‘administering’ (see page 30, last 3 lines); and ‘disorder associated with a viral infection’ is disclosed by a broad range of disorders ranging from virus-induced cell death to coughing [0090].
While the instant specification is enabling for treating a viral infection in light of the specification, the specification is not enabling for preventing a viral infection or a disorder associated with a viral infection.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether
there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement
requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5.The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the
disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands
factors are applied to claims 1-11 as follows:
The breadth of the claims and the nature of the invention
Claims 1-11 are directed to a method of preventing viral infection and/or a disorder associated with the viral infection. The specification does not provide evidence for prevention. Under the broadest reasonable interpretation, words of the claim must be given their plain meaning unless such meaning is inconsistent with the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) (discussed below); Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1372, 69 USPQ2d 1857 (Fed. Cir. 2004). The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The term “prevention” includes
reducing the risk of developing an infection or disorder, and it refers to all actions that suppress or delay
the onset of a viral infection or virus-associated disorder. Since the claim recites preventing the genus of viral infections and their associated disorders, accordingly, claims 1-11 are unduly broad with respect to a method for preventing.
The State of the Prior Art
It is noted that there is no prior art that teaches SEQ ID NO: 1, SEQ ID NO: 2 in the prevention of
Viral infection.
The Level of Skill in the Art
Practitioners in this art (clinicians, immunologists) would presumably be highly skilled in the art for generating compositions with the treatment properties as claimed.
The Level of Predictability in the Art
It is noted that the therapeutic art is unpredictable, requiring each embodiment to be
individually assessed for physiological activity. The amount of guidance or direction needed to enable
the invention is inversely related to the amount of knowledge in the state of the art as well as the
predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). This is because it
is not obvious from the disclosure, of a specific method for prevention of the genus of viral infections.
In the instant case, the specification provides data on administering the peptide compositions upon infection by LGTV, flavivirus, KUNV, SARS-CoV-2, Influenza A and HIV-1 and cellular endpoints disclosed(see Examples 1-14). The specification does not demonstrate prevention of infection. Without any experimentation demonstrating the claimed function of the peptide composition, the level of unpredictability remains high. Therefore, it is unpredictable that the composition will function as claimed.
The amount of Direction Provided by the Inventor and The Presence or Absence of
Working Examples
The instant specification does not provide adequate guidance with regard to the method of
prevention. Applicant’s limited disclosure is noted but is not sufficient to justify claiming the composition broadly. Absent a reasonable a priori expectation of success for using the peptide composition, one skilled in the art would have to extensively test the peptides, determine an effective dose for prevention, ascertain symptoms etc. Since each prospective embodiment, and indeed future
embodiments as the art progresses, would have to be empirically tested, and those which initially failed
tested further, an undue amount of experimentation would be required to practice the invention as it is
claimed in its current scope, because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he
Level of Predictability in the Art” section supra, the specification teaches working examples with cells
and gene expression data.
There is no prior art that teaches SEQ ID NO: 1 or SEQ ID NO: 2 in the prevention of viral infection. Also, as noted in the “Breadth of the Claims and Nature of Invention” section, the
specification does not provide evidence that the peptide composition when administered, prevents onset of viral infection or virus-associated disorders.
As such, the examples used in the specification are not indicative broadly of a method of prevention, with the desired result of an absence of symptoms. It is further noted that Applicant provides no data, examples, figures, etc. demonstrating a preventative method.
In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that,
based on the evidence regarding each of the above factors, the specification, at the time the application
was filed, would not have taught one skilled in the art how to make and/or use the full scope of the
claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d
1510,1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claims 1-11, in view of the Applicant’s
entire disclosure, it is concluded that the practice of the invention as claimed in claims 1-11 would not
be enabled by the written disclosure for preventing viral infection. Therefore claims 1-11 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to practice a method of treatment as 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.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being obvious over Torbjörn Bengtsson et al., hereinafter Bengtsson (US12064464B2, PCT Filed Feb 20, 2019) in view of Yasunari Kageyama et al., hereinafter Kageyama (Yasunari Kageyama et al., Experimental and Therapeutic Medicine, 2021 Nov 2;23(1):20).
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Bengtsson teaches bacteriocin PLNCS αβ, wherein the peptide of the bacteriocin PLNCS αβ is a peptide A (i.e. SEQ ID NO: 2 in instant) and peptide B (i.e. SEQ ID NO: 1 in instant) (Col 2, line 26-35). Bengtsson teaches administering a pharmaceutical composition comprising SEQ ID NO: 2 (i.e. SEQ ID NO: 1 (i.e. (a)) (Col 2, line 33); and SEQ ID NO: 2 and SEQ ID NO: 1 (i.e. SEQ ID NO: 2 (i.e. (b)) (Col 2, line 33-35) in Figs 1-8, 12-27 and marked inhibition of growth and survival of different strains of bacterial infection.
Bengtsson does not teach viral infection or disorder.
Kageyama teaches that L. plantarum demonstrates superior immunomodulatory ability and mimicks the blood cytokine environment produced by early immune responses to viral infection. Daily consumption of L. plantarum as an anti-COVID-19 probiotic may be a possible option for preventing COVID-19 during the pandemic (see Abstract; Table 1, Table II; Figure 2).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bengtsson, directed to anti-bacterial infection, and use the composition to treat viral infection, as specifically suggested in Kageyama. One motivated to do so, would have a reasonable expectation of success, as both references explore the anti-microbial characteristics of L. plantarum. Thus, one would have recognized that applying the teaching of Bengtsson to the teaching of Kageyama would have yielded predictable results and improved the composition, as Kageyama discloses that L. plantarum, stimulates innate cytokine changes similar to those induced by oral QFPD, may also potentially provide a protective benefit against COVID-19; (page 10, 1st paragraph, last line). In support, Kageyama teaches that L. plantarum demonstrates proinflammatory effect with superior ability to stimulate the production of IL-8 and IL-12 markedly inhibits viral proliferation in the lung and alleviates clinical symptoms in mice when orally administered before or after influenza virus challenge (see page 9, last paragraph). See MPEP §2143.
Regarding claim 2, the obviousness rationale has been set forth above. Additionally, Bengtsson teaches D-amino acid residues in the peptides (see Col 2, line 49; Fig 4A-4D; Fig 5-7, Fig 15, Fig 24, Fig 25, Table 2(line 2)).
Regarding claim 3, Bengtsson teaches pharmaceutical composition comprises between 10 nM to 50 µM of the first peptide and/or second peptide (i.e. 1 nM to 1000 µM) (Col 18, 2nd paragraph).
Regarding claim 4, Bengtsson teaches molar ratio of 1: 1 is most efficient at inhibiting
and killing S. epidermidis (FIG. 2). However, a ratio of between 1: 1 to 1 :7 also showed a good effect. First and second peptides are present in a in a molar ratio of from between 5: 1 to 1 :20, most preferably 1:1 to 1:7, most preferably 1:1 (Col 17, last 2 paragraphs).
Regarding claim 5, as noted above Kageyama teaches SARS-Cov-2 (i.e. Coronaviridae).
Regarding claim 6, the rejection is noted above.
Regarding claim 7, Kageyama teaches that a large body of evidence has suggested that L. plantarum strengthens several aspects of the host defense mechanism against the infection by respiratory viruses, particularly seasonal and highly pathogenic influenza viruses (see Discussion, first paragraph).
Regarding claim 8, Bengtsson teaches that the composition is administered locally on the site of infection, such as topically (Col 18, line 46-47).
Regarding claim 9, Bengtsson teaches that the composition is formulated as a solution, a cream, a gel, or an ointment or formulated in immobilized form as a coating on a device (Col 18, line 41-42).
Regarding claim 10, Bengtsson teaches that the composition is administered and repeated every other day for seven days a total (i.e. 1-20 days) of four doses of treatment of the infected wounds (Col 25, paragraph 4).
Regarding claim 11, Kageyama teaches that administration of L. plantarum in mice significantly
suppressed viral replication in the lungs and reduced airway inflammation, thereby increasing survival rates (see Discussion, lines 5-7).
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 12064464 in view of Yasunari Kageyama et al., hereinafter Kageyama (Yasunari Kageyama et al., Experimental and Therapeutic Medicine, 2021 Nov 2;23(1):20).
The teachings of Bengtsson (Reference patent US12064464) and Kageyama have been set forth above.
Regarding claim 1, reference patent ‘464 teaches bacteriocin PLNCS αβ, wherein the peptide of the bacteriocin PLNCS αβ is a peptide A (i.e. SEQ ID NO: 2 in instant) and peptide B (i.e. SEQ ID NO: 1 in instant) (Col 2, line 26-35).
Reference patent ‘464 does not teach viral infection or disorder.
Kageyama teaches that L. plantarum demonstrates superior immunomodulatory ability and mimicks the blood cytokine environment produced by early immune responses to viral infection. Daily consumption of L. plantarum as an anti-COVID-19 probiotic may be a possible option for preventing COVID-19 during the pandemic (see Abstract; Table 1, Table II; Figure 2).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of reference patent ‘464, directed to anti-bacterial infection, and use the composition to treat viral infection, as specifically suggested in Kageyama. One motivated to do so, would have a reasonable expectation of success, as both references explore the anti-microbial characteristics of L. plantarum. Thus, one would have recognized that applying the teaching of reference patent ‘464 to the teaching of Kageyama would have yielded predictable results and improved the composition, as Kageyama discloses that L. plantarum, stimulates innate cytokine changes similar to those induced by oral QFPD, may also potentially provide a protective benefit against COVID-19; (page 10, 1st paragraph, last line). In support, Kageyama teaches that L. plantarum demonstrates proinflammatory effect with superior ability to stimulate the production of IL-8 and IL-12 markedly inhibits viral proliferation in the lung and alleviates clinical symptoms in mice when orally administered before or after influenza virus challenge (see page 9, last paragraph). See MPEP §2143.
Regarding claim 2, the obviousness rationale has been set forth above. Additionally, reference patent ‘464 teaches D-amino acid residues (see claim 8).
Regarding claim 3, reference patent ‘464 teaches pharmaceutical composition comprises between 10 nM to 50 µM (see claim 10).
Regarding claim 4, reference patent ‘464 teaches molar ratio of 5: 1 to 1 :20 (see claim 9).
Regarding claim 5, as noted above Kageyama teaches SARS-Cov-2 (i.e. Coronaviridae).
Regarding claim 6, the rejection is noted above.
Regarding claim 7, Kageyama teaches that a large body of evidence has suggested that L. plantarum strengthens several aspects of the host defense mechanism against the infection by respiratory viruses, particularly seasonal and highly pathogenic influenza viruses (see Discussion, first paragraph).
Regarding claim 8, reference patent ‘464 teaches that the composition is administered topically (claim 25).
Regarding claim 9, reference patent ‘464 teaches that the composition is formulated as a gel (claim 13).
Regarding claim 10, reference patent ‘464 teaches that in the method of treatment, specification discloses that the composition is administered and repeated every other day for seven days a total (i.e. 1-20 days) of four doses of treatment of the infected wounds (Col 25, paragraph 4). See claim 25.
Regarding claim 11, Kageyama teaches that administration of L. plantarum in mice significantly
suppressed viral replication in the lungs and reduced airway inflammation, thereby increasing survival rates (see Discussion, lines 5-7).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure: Chong et al., J. Dairy Sci. 102:4783–4797 (2019); ClinicalTrials.gov ID: NCT04517422.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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