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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 06/02/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2025.
Claims 1-18 are being examined on the merits.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sidney Fougler and Yue Wu (From IDS, US20060115556A1) hereinafter Fougler.
Fougler teaches a nutritional supplement drink (see abstract) and teaches wherein “spirulina is a microalga that contains 60% all vegetable protein, essential vitamins and phytonutrients, β-carotene, the rare essential fatty acid gamma-linolenic acid (GLA), sulfolipids, glycolipids, and polysaccharides. Research has shown that taking spirulina extracts results in the tumor fighting ability of natural killer cells and gamma-interferon. In another study, spirulina was shown to be a potent inducer of gamma-interferon and a moderate inducer of interleukin-4 and interleukin-1beta. Thus, spirulina strengthens the immune system and promotes immunity to intracellular pathogens and parasites” (see 0105).
Fougler teaches “vitamin C is also a requirement for the proper functioning of the immune system. It is involved in white blood cell production, T-cells, and macrophages. In addition, vitamin C is required in the synthesis of neurotransmitters. Fougler continues to teach that it protects against infection and assists in clearing up infections, is thought to enhance the immune system. Additionally, vitamin C can prevent degenerative diseases such as cardiovascular diseases. (see 0049).
Fougler teaches that vitamin D maintains a stable nervous system and normal heart action and for promoting the immune system (see 0044).
Fougler teaches spirulina in the drink in amounts of 100 mg (see example VII, 0123) which is right outside of the amount being claimed.
Fougler teaches wherein the drink can include vitamin D at 400 IU and vitamin C at 800 IU (see III, example, 0123).
Fougler teaches wherein the drink can include vitamin C at 1000 mg (see example II, 0123).
Fougler does not specifically teach the specific amount of vitamin D being within the instantly claimed range, however the range is just outside the range being claimed.
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to optimize the amount of spirulina, vitamin D and vitamin C to be within the instantly claimed range because each can exert their own immune enhancing benefits as just explained and to also use as a method for prophylactic agent against a phase of Covid-19 coronavirus infection wherein the phase comprises at least one of a neurological condition and a vascular condition because as Fougler teaches, Vitamin D maintains a stable nervous system and normal heart action, Vitamin C can assist with clearing the infection and spirulina can strengthen the immune system through inducing of interleukin-4 and interleukin-1beta. Each component has its own immune, neurological and vascular activities which can be optimized through routine experimentation. Administering the composition as a prophylactic against both a respiratory phase of Covid-19 infection during which the virus is replicating and during a post-viral neurological and post-viral vascular phase of the Covid19, or during the respiratory phase for at least three days would have also been prima facie obvious given information about each ingredient’s beneficial activities. Persons having ordinary skill in the art would administer the composition at the beginning of infection and until there was symptom relief as this drink is for nutrition and would have ingredients known to boost the immune system. It is also prima facie obvious to optimize the instantly claimed ingredients to be right outside of already taught ranges as this is well within the purview of any artisan.
Additionally, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jeremy Beard et. al. (Vitamin D and the anti-viral state, J Clin Virol. 2011 March; 50(3): 194–200.)), Ruben Manuel Luciano Colunga Biancatelli et. al. (The antiviral properties of vitamin C, Expert Review of Anti-infective Therapy, 1744-8336, Dec 2019) and Toshimitsu Hayashi et. al. (JPH05112461A).
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655