DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed December 2, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1, 2, 10-13, 17, 18, 20, 21, 23, and 27-39 are pending.
Election/Restrictions
4. In the reply filed on April 30, 2025, applicant elected 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).
5. Claims 1, 2, 10-13, 17, 18, 20, 21, 23, and 27-39 are examined on the merits in regards to the elected species.
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.
6. Claims 1, 2, 10-13, 17, 18, 20 and 21 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.
Claim 1 recites the limitation "the airborne respiratory virus" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
7. Claims 1, 2, 10-13, 17, 18, 20, 21, 23, and 27-39 is/are rejected under 35 U.S.C. 103 as obvious over Cornelli (WO 2007/057748) in view of Day (US 2014/0186456 A1) for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues:
First, neither the Cornelli citation nor the Day citation discloses nasal administration of
the claimed composition for the treatment of an influenza virus, let alone a nasal spray, drops, mist, or swab, as recited in dependent claims 2, 27, and 34. Specifically, Cornelli only discloses colostrum tablets or capsules, preferably chewable tablets (see, e.g., Cornelli, pages 4 and 8). However, there is no teaching or suggestion in Cornelli of nasal administration of colostrum. Likewise, the Day citation discloses a bioactive composition that comprises fucoidan, trans-resveratrol, and colostrum, and is in the form of a capsule, sublingual drops, or an intraoral spray (see, e.g., Day, claims 1 and 12-14), but there is no teaching or suggestion of administering the composition Day to the nasal cavity of a subject as recited in the present claims.
However, as discussed in the previous Office action, Day 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 (see paragraph [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. The artisan would expect that the protective and treatment effects of the colostrum and fucoidan composition, as taught by Day and Cornelli, would be improved if administered directly the site known for infection initiation and the flu symptoms themselves. Thus, the modification of the references to include the administration to the nasal cavity is considered to be an obvious modification of what was known in the art prior to the effective filing date.
In addition, applicant argues:
Second, neither citation discloses nor suggests a composition comprising colostrum in the claimed amount (0.01% to 10% by weight), as both citations require much greater amounts of colostrum in their compositions. Specifically, in the colostrum compositions of Cornelli, colostrum is by far the largest ingredient in the compositions (see, e.g., Cornelli, pages 5-7, Tables 1-2 [formulations 1 and 2]) and thus would be outside the presently claimed range. Similarly, in the compositions of Day, the ratio of fucoidan, trans-resveratrol, and colostrum is in the range of from 1:1.5:1.5 to 1:10:10 in weight percent, and in terms of percentage by weight of the composition, Day discloses that colostrum can be 25-60% by weight of the composition (see e.g., Day, paragraph [0031], and claims 5 and11). Therefore, the amount colostrum in the compositions of Day is also well outside the presently claimed range. Further, there is no suggestion or motivation in either Cornelli or Day for modifying their respective compositions to reduce the amount of colostrum to arrive at the presently claimed range.
However, this argument is not persuasive because, 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).” By teaching a range a range of amounts, Day demonstrates that the concentrations of colostrum and fucoidan can be optimized. Thus, varying the concentration of the ingredients within the pharmaceutical composition is not considered to be inventive unless the concentrations are 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.
8. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
