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 .
Claims 1-7, 9, and 23 are pending. Claims 1-7, 9 and 23 are examined herein on the merits.
Claim Rejections - 35 USC § 112
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.
Claims 1-7 and 9 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method of increasing the antigenicity of any plant-produced membrane-bound polypeptide, which reads on any membrane-bound polypeptide native to a plant or expressed in a plant, which reads on literally hundreds of thousands if not millions of polypeptides. The claimed method appears to rely on a comparison between an unspecified method of extraction with another unspecified method of extraction wherein one method has a lower amount of phospholipids associated with the membrane-bound polypeptide in order to establish an increase of antigenicity.
In contrast, the specification describes increasing antigenicity in mice from booster administrations of cornmeal comprising defatting cornmeal from transgenic maize expressing Hepatitis B surface antigen (HBsAg) by specifically using supercritical fluid extraction as compared to hexane extraction. Regarding the dependent claims, it is noted that wherein processes are specified and/or the relati9ve amount of phospholipid removal is specified, no plant species are specified and no membrane-polypeptide is specified.
The specification does not describe any other comparison methods of extraction, nor does the specification describe what levels of phospholipids are required to be maintained in order to achieve this claimed function of increased antigenicity other than as relative between the two described treatments. The specification does not describe using any other plants or plant materials other than maize, nor does the specification describe any other membrane-bound polypeptide other than HBsAg. While the claims appear to indicate that any partial removal of lipids would have the effect of increased antigenicity, it is notable that the results in Example 6, Table 5 show that a simple comparison amount of phospholipids is insufficient to increase antigenicity as Table 5 shows little difference in response between the full fat extraction vs the hexane extraction even though there is a difference in the amount of phospholipids associated with the membrane-bound polypeptide.
Accordingly, the claims are not adequately described over their full breadth.
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
Applicant’s urge that although the specification exemplifies hepatitis B surface antigen that the process is a general process by which the antigenicity of membrane-bound polypeptides is enhanced.
This is not persuasive because the claimed methods require an increased antigenicity which is not established structurally and functionally with regard to which polypeptides would be expected to work within the instantly claimed method. Not so much as one additional embodiment has been reduced to practice to illustrate that this effect is generic and not due to properties of the hepatitis B surface antigen. The spectrum of possible membrane bound polypeptides encompassed by the claims is quite large, and some are more integral to the membrane than others, such that it is not clear which polypeptides would have the properties required by the claims. Furthermore, the specification states “the phospholipid content in wafers is here believed to alter the immunogenic and structural properties of the protein” (see page 57 of the specification) indicating the mechanism of the change in the antigenicity is not known at the time of filing such that one of skill in the art would be able to determine if any given membrane bound polypeptide would be encompassed by the instantly claimed methods or not. Accordingly the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9 and 23 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10150970. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a species of the instantly claimed genus and would therefore anticipate in the instantly claimed genus.
Applicants requested the rejection to be held in abeyance, but the rejection is maintained.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663
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