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 .
Claim 1 is examined on the merits.
Claim Objections
Objection Withdrawn in view of Amendment Claim 4 objected to because of the following informalities: “drugdelivery” in line 2 appears to require a space between drug and delivery. Appropriate correction is required.
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.
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.
Rejection Withdrawn in view of Amendment Claims 6-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing an immune response when a pharmaceutical composition or health functional food composition that comprises nanovesicles which deliver a hepatitis B virus (HBV) surface antigen in vivo, does not reasonably provide enablement for a pharmaceutical composition that comprises nanovesicles of grapefruits or mandarin oranges that comprise a HBV treatment drug, such as a surface antigen of HBV, which prevents or treats hepatitis B. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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.
Rejection Withdrawn in view of Amendment-Claims 1-8 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Rejection Withdrawn in view of Amendment-Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejection Withdrawn in view of Amendment-Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013) (hereafter “Myriad”).
Claim Rejections - 35 USC § 102
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.
Rejection withdrawn in view of amendments Claim(s) 1, 2 and 4 are rejected under 35 U.S.C. 102a1 as being anticipated by Murphy et al. (Food and Nutrition Research, 2014, Vol. 58).
Rejection withdrawn in view of amendments Claim(s) 1, 3 and 4 are rejected under 35 U.S.C. 102a1 as being anticipated by Goldenberg et al. (J Sci Food Agric, 2018, Vol. 98, pages 18-26).
Claim Rejections - 35 USC § 103
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.
(New Rejection Necessitated by Amendments) Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chien et al. US PGPub 2003/0044982) and Pocsfalvi et al. (Journal of Plant Physiology, 2018, Vol. 229, pages 111-121).
The claimed invention is drawn to a drug-delivery composition comprising nanovesicles derive from Citrus x paradisi or Citrus reticulata as an active ingredient, wherein the nanovesicles are loaded with a drug, and the drug is a hepatitis B surface antigen or an influenza virus antigen.
Chien et al. teach the generation of a vesicle (non-viral) that encapsulates (is loaded with) a hepatitis env L protein, which comprises the S (surface) protein. [see paragraph 12] However, Chien et al. do not teach the use of a nanovesicle from Citrus x paradisi as the vesicle.
Pocsfalvi et al. teach the formulation of vesicles derived from Citrus x paradisi and tested the vesicles for encapsulated proteins. [see left column of page 112] Table 1 provides a list of proteins identified in nanovesicles of Citrus x paradisi and Pocsfalvi et al. teach that characterization of protein cargo of plant-derived vesicles is important in their exploitation as potential vectors for cellular delivery. [see right column, page 120]
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Chien et al. in order to employ nanovesicles from Citrus x paradisi in their loading of hepatitis surface proteins. One would have been motivated to do so, given the suggestion by Chien et al. that vesicles can be used to encapsulate hepatitis B virus surface antigen. There would have been a reasonable expectation of success, given the knowledge that nanovesicles from Citrus x paradisi have been confirmed to encapsulate proteins and that they should be investigated as delivery vectors towards cells, as taught by Pocsfalvi et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
(Rejection Maintained) Claim 1 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 5 of copending Application No. 18/988,213 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Applicants have filed to expressly abandon application ‘213. However, at the time of drafting this Office action, application ‘213 is still a copending application. Therefore, this rejection maintained.
Conclusion
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 BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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