DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Election was made without traverse in the reply filed on April 30, 2025. Claims 1-4 and 7-26 are pending. Claims 5 and 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant’s election of influenza virus (as the elected virus species); influenza infection (as the elected viral infection); fucoidan derived or isolated from brown algae from the Fucus group (as the elected algan polysaccharide); and benzalkonium chloride (as the elected excipient) are acknowledged.
Pending claims 1-4 and 7-26 have been examined on the merits.
Specification & Claim Objections
The disclosure is objected to because of the following informalities:
The specification contains the terms “SP-Versaflex”, “Merquat 295 Polymer” and “Incroquat Behenyl TMC-85-PA” (See, e.g., Example 1, Table(s) 1 and 2), among others, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM or ® following the terms.
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 throughout.
Claim 8 contains typographical and grammatical error(s) (e.g. a comma is missing between species “severe acute respiratory syndrome (SARS)” and “coronavirus (SARS-CoV)”). Appropriate correction is required.
Please note the above are considered necessary grammatical corrections; however, it is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection (See MPEP 601.01(g)). Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim(s) 1-4 and 7-26 is/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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are broadly drawn to a method for inhibiting, halting, or slowing replication of a virus and/or viral infection (e.g. influenza), comprising administering to a nasal cavity of a subject in need thereof a composition comprising colostrum (and in some embodiments said composition further comprising benzalkonium chloride (BKC) and/or fucoidan). However, Applicant’s specification only demonstrates that the claimed method and/or composition(s) against bacteriophage MS2 and φX14 strains that specifically infects and replicates only within bacterial cells (See Example 2: AntiViral Activity, pages 26-29). Furthermore, the specification fails to demonstrate the claimed mode of administration where the method comprises “administering to a nasal cavity of a subject in need thereof” as claimed in the instant application.
The art teaches that development of anti-viral treatments is unpredictable and time consuming. The art teaches that there are very few drugs available that are actually to function as broad-spectrum antiviral drugs (see Geraghty, et al. (Viruses (2021), vol 13, p. 667). In addition, the art teaches the composition and physiochemical properties of colostrum are highly dynamic and variable (see McGrath, et al. “Composition and properties of bovine colostrum: a review.” Dairy Sci. & Technol. 96, 133–158 (2016)). Thus, the one of ordinary skill in the art would not expect that a composition comprising colostrum effective for MS2 and φX14 bacteriophage strains would necessarily function the same way for other types of viral infections (e.g. influenza). In addition, the broad recitation of “virus” encompasses a vast range of viruses ranging from Adenovirus to Coronavirus (SARS-CoV), both of which currently have no approved medications for treatment. (see “Adenovirus” https://my.clevelandclinic.org/health/diseases/23022-adenovirus and “SARS” https://my.clevelandclinic.org/health/diseases/10856-severe-acute-respiratory-syndrome-sars). Thus, one of ordinary skill in the art would be forced to experiment unduly in order to determine if the claimed method/and or composition is actually capable of treatment of all types of viruses as broadly claimed. Therefore Applicant’ claims are not considered to be enabled to the full scope claimed.
In addition, Applicant’s claims are drawn to a method of inhibiting, halting, or slowing replication of a virus and/or viral infection broadly (i.e. enveloped and non-enveloped viruses) with a wide range of structures, virulence, replication strategies, host ranges and mechanisms of action. In order to be enabled for inhibiting, halting, or slowing replication of a virus and/or viral infection, Applicant must demonstrate that the invention is able to prevent a significant number of instances of that condition. Applicant’s specification does not set forth any evidence that the claimed method and/or composition is able to broadly prevent any virus and/or viral infection. Thus, since Applicant’s specification does not show for inhibiting, halting, or slowing replication of a virus and/or viral infection of any virus in general, or influenza in particular, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if Applicant’s invention actually functions as claimed. Therefore, the claims are not considered enabled for the prevention of virus and/or viral infection (e.g. influenza).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 7-26 is/are rejected under 35 U.S.C. 103 as obvious over Cornelli, U. (WO 2007/057748) in view of Day, L. et al. (US 2014/0186456 A1).
The instant claim(s) is/are of record, drawn to the following: a method for inhibiting, halting, or slowing replication of a virus, comprising administering to a nasal cavity of a subject in need thereof a composition comprising colostrum.
Cornelli, U. generally teaches use of bovine colostrum (broadly comprising no more than 800 mg per gram of said composition) as an active principle for preparing pharmaceutical compositions for treating/preventing influenza, as required in claim(s) 1-4, 7-9, 22-25. For example, Cornelli, U. teaches colostrum as containing immune factors and various growth factors and containing factors to help the body repel viruses, bacteria and fungi (Specification, page 3; claim 11), in particular effective in prevention of influenza infection (Specification, page 4). Moreover, Cornelli, U. teaches colostrum in combination with additional elements (e.g. coenzyme Q10, an antioxidant; Specification page 7) to be effective at preventing influenza infections, as required in claim 13.
Cornelli, U. is silent regarding the composition further comprising algae or an extract from algae (e.g. fucoidan), as required in claim(s) 14-19. Cornelli, U. is silent to the composition being administered to the nasal cavity of a subject. Cornelli, U. is silent regarding the composition further comprising at least one excipient capable of creating an ionic charge (e.g. benzalkonium chloride), as required in claim(s) 10-12. Cornelli, U. is further silent regarding the composition being at least 90% (as required in claim 20) or 99% (as required in claim 21) effective at killing virus particles.
Day, et al., teaches a tripartite bioactive composition comprising colostrum and fucoidan (broadly a percentage by weight of 10-20% fucoidan and 25-60% by weight colostrum) administered in effective quantities to provide anti-inflammatory effects and strengthen and enhance immune and cellular function of the body to enable increased ability to identify and kill pathogens, as required in claim(s) 14-19 (see Abstract, Specification [0011]). Day, et al. further teaches the composition can be provided in a liquid form in an (intraoral) spray and also discloses that the composition can be administered by other delivery methods (e.g. liquids) to other parts of the body (e.g. nasal cavity) (see Specification [0017]). Thus, a nasal spray (or other nasal application) would have been obvious to a person of ordinary skill in the art, particularly where it was well known in the art that influenza virus gains entry into the body and initiates infection through the nasal cavity (see Killingley, et al., “Routes of influenza transmission. Influenza Other Respir Viruses.” 2013 Sep;7 Suppl 2(Suppl 2):42-51). Moreover, it would have been known in the art to include benzalkonium chloride, a well-known pharmaceutical excipient used in nasal formulations as a cationic surfactant biocide, antiseptic and antimicrobial preservative which can also act as a solubilizing agent, as required in claim(s) 10-12. (See, Pereira B, et al., Benzalkonium Chlorides: Uses, Regulatory Status, and Microbial Resistance. Appl Environ Microbiol. 2019 Jun 17;85(13):e00377-19., at page 1).
Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Cornelli, U. and Day, et al. to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
Cornelli, U. and Day, et al. are relied upon for the reasons discussed above. If not expressly taught by the references, based upon the overall beneficial teaching provided by these references with respect to the ingredients of the composition(s) and method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (e.g. determining one or more suitable ranges for the percentage by weight of the ingredients of the composition (e.g. colostrum (as required in claim 9) or algan polysaccharide (as required in claim 19) in which to perform such a method) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants' composition with the composition of the prior art (including
compositions within the processes thereof), the burden is on applicant to show a novel or
unobvious difference between the claimed product and the product of the prior art (e.g. regarding effectiveness of the claimed composition(s) according to claim(s) 20 and 21, as discussed of record above). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and "as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
Currently no claim(s) are allowed.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655
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