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 .
Applicant’s preliminary amendment filed on May 5, 2023 has been considered. Claims 1, 3, and 7-19 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 25, 2025 has been considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bragger et al. (US Application Publication US 2014/0065161).
Bragger et al. disclose a method of reducing the viral activity of a virus on or in a cell or in a subject, comprising administering an effective amount of a combination of at least two proteins extracted from milk such as lactoferrin, each protein having an isoelectric point of or above substantially 6.8 (see claims 53-61 and paragraphs [0019], [0033], [0071], and [0073]).
Regarding present claim 16. Bragger et al., teaches a composition comprising combination of at least two proteins, each protein having an isoelectric point of or above substantially 6.8 and which are extracted from milk; and (ii) at least one antiviral agent (see paragraphs [0048], [0050-0052], [0057], [0058]). The antiviral agent such as a lysozyme in Bagger et al., meets the imitation of the antiviral agent in present claim 16.
Bagger et al. paragraph [0057] In a preferred embodiment, as well as the lactoferrin, lactoperoxidase and angiogenin the cationic fraction may include at least one of the following: N-acetyl glucosaminidase, serum amyloid A beta. Defensin or lysozyme.
Bagger et al. paragraph [0058] In a preferred embodiment the cationic fraction shall be taken as meaning an extract which contains a number of milk micro-components, specifically lactoferrin, lactoperoxidase, angiogenin, N-acetyl glucosaminidase, serum amyloid A beta. Defensin or lysozyme.
Thus, by this disclosure Bagger et al., anticipate the present claim.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 7-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bragger et al. (US Application Publication US 2014/0065161) as applied to claims 1, 3 and 16 and further in view of Kane et al. (US Patent 11,298,379).
Bragger et al. teach a method of reducing the viral activity of a virus on or in a cell or on or in a subject, comprising administering an effective amount of a combination of at least two proteins, each protein having an isoelectric point of or above substantially 6.8 and which are extracted from milk in a subject (see claims 53-61 and paragraphs [0019], [0033], [0071], and [0073]).
Regarding present claim 16. Bragger et al., teaches a composition comprising combination of at least two proteins, each protein having an isoelectric point of or above substantially 6.8 and which are extracted from milk; and (ii) at least one antiviral agent (see paragraphs [0048], [0050-0052], [0057], [0058]). The antiviral agent such as a lysozyme in Bagger et al., meets the imitation of the antiviral agent in present claim 16.
Bagger et al. paragraph [0057] In a preferred embodiment, as well as the lactoferrin, lactoperoxidase and angiogenin the cationic fraction may include at least one of the following: N-acetyl glucosaminidase, serum amyloid A beta. Defensin or lysozyme.
Bagger et al. paragraph [0058] In a preferred embodiment the cationic fraction shall be taken as meaning an extract which contains a number of milk micro-components, specifically lactoferrin, lactoperoxidase, angiogenin, N-acetyl glucosaminidase, serum amyloid A beta. Defensin or lysozyme.
Bagger et al., does not teach the virus selected from Coronaviridae, human influenza or Herpes Simplex, SARS or COVID-19. Bagger et al., does not teach the antiviral agents of present claim 17. Bagger et al., does not teach the lactoferrin content.
Regarding present claims 7-13. Kane et al. teach compositions comprising milk fat globules and methods of treatment of Herpes Virus, Coronavirus, SARS, COVID-19, Epstein Barr virus, Influenza virus, Orthomyxovirus, Herpesviruses, Poxviruses, Hepadnaviruses, Asfarviridae, RNA viruses, Flavivirus, Alphavirus, Togavirus, Coronavirus, Hepatitis D, Orthomyxovirus, Paramyxovirus, Rhabdovirus, Bunyavirus, Filovirus, and Retroviruses (see claims 1-20, column 10, lines 47-67, Examples in columns 16-17).
Regarding present claims 14-15 and 18-19. Kane et al. teach various ratios of milk fat globules in the antiviral composition (see column 10, lines 1-25,
It would have been within the skill of the ordinary artisan to optimize the lactoferrin content of the Bagger’s combination to arrive at less than 40% or less than 10% w/w, in view of Kane who teaches various ratios of milk fat globules in the antiviral composition.
Regarding present claim 17. Kane teaches an antiviral agent Valacyclovir (see Experiment 4).
It would have been prima facie obvious to provide the composition of Bagger et al. further comprising an antiviral agent because Kane teaches using antiviral agents to treat viral infection.
It would have been prima facie obvious to provide the composition of Bagger et al. comprising at least two proteins, extracted from milk, each protein having an isoelectric point of or above substantially 6.8 and (ii) at least one antiviral agent and to use it in methods of treating viral infections of Kane et al. because Kane teaches that compositions comprising milk fat globules are effective in treatment of Herpes Virus, Coronavirus, SARS, COVID-19, Epstein Barr virus, Influenza virus, Orthomyxovirus, Herpesviruses, Poxviruses, Hepadnaviruses, Asfarviridae, RNA viruses, Flavivirus, Alphavirus, Togavirus, Coronavirus, Hepatitis D, Orthomyxovirus, Paramyxovirus, Rhabdovirus, Bunyavirus, Filovirus, and Retroviruses (see claims 1-20, column 10, lines 47-67, Examples in columns 16-17).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648