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 .
The Final Office action mailed on June 2, 2026 is vacated. The prosecution is hereby reopened to make new rejections present in this Non-final Office action.
Applicant’s amendment filed on March 19, 2026 has been considered. Claims 1, 3, and 8-19 are pending and under examination in this Office action. Claims 1, 3, and 8-13, have been amended. Claims 1, 3 and 8-19 are pending and under examination in this Office action.
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.
Rejection of Claims 1 and 3 under 35 U.S.C. 102(a)(1) as being anticipated by Bragger et al. (US Application Publication US 2014/0065161) is withdrawn in view of Applicant’s amendment.
Rejection of 16 under 35 U.S.C. 102(a)(1) as being anticipated by Bragger et al. (US Application Publication US 2014/0065161) is maintained.
Bragger et al., discloses 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.
Response to Applicant’s argument.
Applicant argues that Bagger discloses the lysozyme as part of the milk-protein components and not as an antiviral agent.
It is the Examiner’s position that the lysozyme in Bagger reads on the broadly recited antiviral agent. Thus, the rejection is maintained.
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 1, 3, 8-15 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).
Applicant amended claims 1 and 3 to recite the limitations of claim 7.
Applicant argues that Bragger is directed to treating bacterial, intramammary bovine mastitis and not human antiviral therapy and that the rejection relies on impermissible hindsight.
In response Examiner notes that 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 and therefore the rejection is maintained.
New Rejections and Objections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16 and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim are directed to:
16. (Original) A combination of: (i) 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; and (ii) at least one antiviral agent.
18. (Original) 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, wherein where the combination includes lactoferrin the lactoferrin content of the combination is less than 40% w/w.
19. The combination according to claim 18 wherein where the combination includes lactoferrin the lactoferrin content of the combination of the at least two proteins is less than 10% w/w.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are drawn to naturally occurring milk proteins, such as lactoferrin and lysozyme. Gonzalez-Chavez et al. (International Journal of Antimicrobial Agents, 2009, p. 1-8) disclose lactoferrin milk protein together with lysozyme (see Figure 2). Alvarez-Mayorga (Molecules 2024, Vol. 29, p. 1-12) disclose lactoferrin having pH of 6.8 and above (see Figure 1). Applicant’s specification discloses that lactoferrin is naturally occurring and extracted from milk.
Milk proteins are naturally occurring and isolating (extracting) specific proteins from milk would not result in any markedly different characteristics. The isoelectric point of a protein is an innate characteristic of the protein.
While methods of using the compositions are eligible, the compositions themselves fall within a judicial exception without integration into a practical application or inventive concept.
Thus, the present claims are rejected as drawn to judicial exception.
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.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 17 recites various anti-viral agents with accompanying terminology in parentheses. This includes various trademarks such as Abacavir or Ampligen, etc., which render the claim indefinite. See MPEP 2173.05(u).
The combination according to claim 16 wherein the antiviral agent is selected from: Abacavir (HIV); Acyclovir (Aciclovir) (Herpes Simplex); Adefovir (Hepatitis B); Amantadine (Influenza); Ampligen (Avian Influenza); Amprenavir (Agenerase) (HIV); Umifenovir (Arbidol) (Influenza); Atazanavir (HIV); Atripla (HIV); Baloxavir marboxil (Xofluza) (Influenza A, Influenza B); Biktarvy (HIV); Boceprevir (Hepatitis C); Bulevirtide (Hepatitis D and Hepatitis B); Cidofovir (AIDS); Cobicistat (Tybost) (HIV); Combivir (HIV); Daclatasvir (Daklinza) (Hepatitis C); Darunavir (HIV); Delavirdine (Hepatitis C); Descovy (Hepatitis B); Didanosine (HIV); Docosanol (Herpes Simplex); Dolutegravir (HIV); Doravirine (Pifeltro) (HIV); Edoxudine (Herpes Simplex); Efavirenz (HIV); Elvitegravir (HIV); Emtricitabine (HIV); Enfuvirtide (HIV); Entecavir (HIV); Etravirine (Intelence) (HIV); Famciclovir (Herpes Zoster); Fomivirsen (AIDS); Fosamprenavir (HIV); Foscarnet (Herpes); Ganciclovir (Cytovene) (Cytomegalovirus (CMV)); Ibacitabine (Herpes labialis); Ibalizumab (Trogarzo) (HIV); Idoxuridine (Herpes); Imiquimod (Genital wart); Imunovir (Herpes Simplex); Indinavir (HIV); Lamivudine (HIV); Letermovir (Prevymis) (Cytomegalovirus (CMV)); Lopinavir (HIV); Loviride (HIV); Maraviroc (HIV); Methisazone (Smallpox); Moroxydine (Influenza); Nelfinavir (HIV); Nevirapine (HIV); Nexavir (formerly Kutapressin) (Herpes Zoster); Nitazoxanide (Broad- spectrum antiviral); Norvir (HIV); Oseltamivir (Tamiflu) (Influenza); Penciclovir (Herpes);Peramivir (Influenza); Penciclovir (Herpes); Peramivir (Rapivab) (Influenza); Pleconaril (Picornavirus); Podophyllotoxin (Genital wart); Raltegravir (HIV); Remdesivir (COVID-19); Ribavirin (Hepatitis C); Rilpivirine (HIV); Rimantadine (Influenza A); Ritonavir (HIV); Saquinavir (HIV); Simeprevir (Olysio) (Hepatitis C); Sofosbuvir (Hepatitis C); Stavudine (HIV); Taribavirin (Viramidine) (Hepatitis Syndromes in which Ribavirin is active); Telaprevir (Hepatitis C); Telbivudine (Tyzeka) (Hepatitis B); Tenofovir alafenamide (Hepatitis B); Tenofovir disoproxil (Hepatitis B, HIV); Tipranavir (HIV); Trifluridine (Eye related Herpes); Trizivir (HIV); Tromantadine (Herpes Simplex); Truvada (HIV); Umifenovir (Influenza); Valaciclovir (Valtrex) (Herpes Simplex, Herpes Zoster); Valganciclovir (Valcyte) (HIV); Vicriviroc (HIV-1); Vidarabine (Herpes Simplex, Varicella Zoster); Zalcitabine (HIV); Zanamivir (Relenza) (Influenza A, Influenza B); and Zidovudine (HIV).
The names of the various viruses within parentheses also raise another parenthetical ambiguity issue because it is unclear if the anti-viral agents are interpreted to have a “generic” or a “specific” function, where the specific function is stated in the parentheses.
They need to be removed from the claim because the use of them, irrespective of formatting, renders the claim indefinite because trademarks (TMs) indicate the source of the product—not the product itself. TMs do not describe the product and, therefore, cannot describe the metes and bounds of a claimed product.
Applicant can have the names in the specification, but they must be properly formatted to indicate they are TMs. This preserves the proprietary nature of the TMs. If TMs are used as generic terms for products, they risk becoming invalid due to the legal concept of genericide.
The rejection can be overcome by removing all the parenthetical language from the claim. The TMs and viruses within the parentheses add nothing except ambiguity. For example, if they want acyclovir, then just claim acyclovir. Correction is required.
Specification
The disclosure is objected to because of the following informalities: Specification on pages 5 and 6 lists multiple trade names.
The use of the term Abacavir, Ampligen, and other which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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
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