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 .
Claims 1-8 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/20/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
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.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Nature of the invention/Breadth of the claims. The claims are drawn to a pharmaceutical composition or health functional food composition for preventing or treating hepatitis B, wherein these compositions possess a hepatitis B treatment drug loaded on a nanovesicle of grapefruit or mandarin oranges. An example of the hepatitis B treatment drug is HBV surface antigen.
State of the prior art/Predictability of the art.
Tajiri et al. (World J Gastroenterology, 25, Vol. 21, No. 23, pages 7074-7083) that while Hepatitis B virus surface antigens have prooved to be immunogenic, however, vaccines were not capable of preventing infection and due to S gene mutations, HBV can escape hepatitis B vaccination when only the surface antigen is employed. [see left column of page 7079]
Working examples. Working examples 7 and 8 tested the antibody response against hepatitis B surface antigen either injected into mice or administered orally with the surface antigen loaded into a nanovesicle composition from grapefruits or mandarin oranges. While figure 5B shows an increase in antibody titer after each vaccine is administered, these working examples do not determine if the nanovesicles loaded with a hepatitis B treatment drug (claims 6 and 8), such as HBV surface antigen (claim 7), would be capable of preventing or treating hepatitis B.
Guidance in the specification. The specification provides guidance towards using a nanovesicle obtained from grapefruits and mandarin oranges having been loaded with a hepatitis B treatment drug, including a HBV surface antigen, in the preventing or treatment hepatitis B.
Amount of experimentation necessary. Additional research is required in order to determine how effective an anti-influenza virus composition containing a Poncirus trifoliate seed extract as an active ingredient, wherein the composition is capable of preventing or treating diseases caused by influenza viruses.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
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.
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitations of “grapefruits” and “mandarin oranges”, and the claim also recites “(Citrus x paradisi)” and “(Citrus reticulata)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-8 are also rejected because they depend from claim 1, but do not remedy this deficiency.
Claim 4 recites, “wherein the nanovesicles improve drugdelivery efficiency into cells.” However, it is unclear what the nanovesicles are compared to in order to determine the improved efficiency.
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.
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 8 depends from claim 1, which appears to be drawn to nanovesicle composition from derived from grapefruits or mandarin oranges. However, claim 8 is drawn to a “health functional food composition” that comprises the nanovesicles of claim 1. Based on the specification at page 8, the following is stated relative to health functional food composition:
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Therefore, the definition of “health functional foods” includes the fruits of grapefruit and mandarin oranges, which would conflict with the “derived from” limitation in claim 1.
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.
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”).
Based upon an analysis with respect to the claims as a whole, claim(s) 104 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility)).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes the claims are directed to an ineligible product/process as further detailed below.
In this case, claim(s) 1-4 recite or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, a drug-delivery composition comprising nanovesicles from grapefruits or mandarin oranges, wherein the nanovesicles are naturally found in each of these fruits) that are directed to a judicial exception (in this case, a natural phenomenon)(Step 2A). This process of isolating these nanovesicles is detailed in working example 1 of the specification.
Thus the claimed product is not markedly different from its naturally occurring counterpart (see Part I.A.3 of the Interim Eligibility Guidance; Example 2, p. 29). Thus the claims also read a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception. In addition, the description of the nanovesicle size range in claims 2 and 3 and the ability of the nanovesicle to deliver a drug to a cell in claim 4 does not include additional elements that amount to significantly more than the interpretation of the instant invention as a product of nature.
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception. While the claimed invention also requires a characterization of the size of the nanovesicles, these additional limitations do not amount to significantly more than the judicial exception since the carrier does not provide any additional elements to change a property or function of the nanovesicles.
As pursuant to the Office’s interpretation of the Myriad decision, a recitation of a natural product of nature that does not have a substantial or marked difference from the natural product is not patent eligible subject matter. Therefore, claims 1-4 as written, read upon a non-naturally occurring grapefruit or mandarin orange nanovesicle that was found to have occurred naturally in nature without being subject to the "hand-of-person" and resulting in a substantial or markedly different product from that found in nature. Therefore, claim(s) 1-4 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter. This rejection is necessitated by expanded 35 USC §101 USPTO training in view of the USPTO’s interpretation of Myriad. Applicant is directed towards the USPTO memos, which support the analysis of the claims; please review the latest materials regarding 35 USC §101 rejections. It is suggested that applicant cancel the rejected claims, draw the rejected claims to read upon a non-naturally occurring nanovesicle, recite specific steps that are non-routine/non-conventional, and/or recite products/processes which are substantially or markedly different from the judicial exceptions. Applicant is cautioned to amend the claims according to these suggestions utilizing limitations for which the application would have support.
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.
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).
The claimed invention is drawn to a drug-delivery composition comprising nanovesicles derived from grapefruits as an active ingredient. The nanovesicle size is 30 nm to 60 nm and the nanovesicle improves drug delivery efficiency into cells.
Applicants have not provided a definition for “derived”, therefore, any composition that comprises a portion of a grapefruit is interpreted to be derived therefrom and possesses the claimed nanovesicles and any property observed by applicant of these nanovesicles is in inherently feature [see MPEP 2112 I. and II.].
Murphy et al. teach the benefits of consuming grapefruit as part of a human’s diet. By consuming half of a pink or red grapefruit, the daily value of vitamin C is consumed, 8% of the daily value of fiber, 35% of the daily value of vitamin A for example are also consumed. [see right column, page 1]
In addition, figure 3 provides the percentage male and female consumers and non-consumers of grapefruit that meet or exceed an adequate amount of dietary fiber and potassium. Grapefruit consumers routinely far exceed fiber intake compared to non-consumers. In view of teachings by Murphy et al. and the breadth of the claimed invention, they anticipate the nanovesicle composition.
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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).
The claimed invention is drawn to a drug-delivery composition comprising nanovesicles derived from mandarin oranges as an active ingredient. The nanovesicle size is 100 nm to 300 nm and the nanovesicle improves drug delivery efficiency into cells.
Applicants have not provided a definition for “derived”, therefore, any composition that comprises a portion of a mandarin orange is interpreted to be derived therefrom and possesses the claimed nanovesicles and any property observed by applicant of these nanovesicles is in inherently feature [see MPEP 2112 I. and II.].
Goldenberg et al. teach varieties of mandarin oranges and discusses the difference in taste, peelability and size. [see page 20] Goldenberg et al. also teach the color difference between mandarin oranges, as summarized in Figure 1 below. In view of teachings by Goldenberg et al. and the breadth of the claimed invention, they anticipate the nanovesicle composition.
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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.
Claims 1-8 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-8 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.
Conclusion
No claims are allowed.
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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