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 .
Applicant's amendment and remarks, filed 10/28/25, are acknowledged.
Claims 1, 5-7, 11-12 have been amended.
Claims 1-2, 5-7, 11-12 are pending.
Claims 7, 11-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim 6 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
Claims 1-2 and 5 are being acted upon.
The rejection under 35 U.S.C. 101 is withdrawn in view of Applicant’s claim amendments.
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.
Claim(s) 1-2 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi, 2016 (of record).
Choi teaches a composition comprising a psoralea Semen water extract (WPS) and influenza virus (i.e. comprising influenza antigen, see page 3, Fig. 7, in particular). . Choi teaches that said WPS extract comprises bavachin and that the WPS extract induces cytokine production (i.e. “adjuvant” activity, or “immunogenic”, see Fig. 8, in particular). Choi teaches compositions comprising extracted, i.e. isolated bavachin. Furthermore the composition of Choi meets all the requirements of the claimed composition, and it would inherently be immunogenic. Additionally, bavachin is inherently an adjuvant that increases cellular and humoral immunity.
Applicant’s arguments filed 10/28/25 have been fully considered, but they are not persuasive.
Applicant argues that Choi teaches a virus, while the present claims relate to the use of an antigen as an immunogen for use in administration to a subject for inducing an antigen specific immune response. Applicant further argues that Choi does not recognize bavachin as an adjuvant, and that the extract of Choi contains bavachin along with psoralen, angelicin, and bavachiniin.
The present claims are directed to a product, an immunogenic composition comprising an isolated bavachin and an viral antigen, and not to an administration method for inducing an antigen specific immune response, as argued by Applicant. Furthermore, the term comprising is an open term that does not exclude unrecited elements, such as psoralen, angelicin, and bavachinin. Choi teaches a composition within the scope of the instant claims, since it comprises bavachin extracted i.e. isolated from psoralen semen, and influenza virus, which comprises numerous immunogenic viral antigens, such as HA.
Adjuvant function is an inherent property of bavachin. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.. Furthermore, “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)
Applicant cites data comparing the effect of bavachin and bavachinin on T cell activation, wherein bavachin increased T cell activation, but bavachinin did not.
As noted above, the prior art composition contains bavachin, and the effect on T cell activation is an inherent property in the prior art.
Applicant argues that Choi relates to inducing cytokine secretion from macrophages, i.e. innate immunity, while the present claims relate to the use of bavachin as an adjuvant to induce T cell based antigen specific acquired immunity.
As an initial matter, it is noted that an adjuvant can work by increasing innate immunity, i.e. stimulating APCs such as dendritic cells or macrophages, which thereby increase acquired B and T cell immunity. Regardless, as noted above, the composition of Choi is structurally identical to that of the instant claims, and the function of bavachin to increase T cells is inherent to the chemical composition itself.
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644