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 .
Priority
The priority date is the filing date of the instant application, February 16, 2024.
Drawings
The drawings were received on February 16, 2024. These drawings are acceptable.
Claims 1-16 are pending.
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.
Claims 12-16 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.
In claim 12, it is unclear what the phrase “creating a standardized assay” encompasses. What is the assay? Clarification is requested. Suggest, identifying the assay used to measure inhibition of replication of the herpesvirus.
Claims dependent on the rejected claim are rejected for failing to cure the indefiniteness.
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.
Claim 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” MPEP § 2163.
Level of Skill and Knowledge in the Art:
The MPEP indicates:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
The specification does not clearly teach a specific composition for effectively inhibiting the replication of herpes virus and how to make that composition. A number of examples are provided but are incomplete as to how to make and use the invention. The most specific composition is shown in page 67, Table 3, however is not the complete list of the composition as stated in claim 1. It is noted that there are six different herpes type viruses that are pathologic for humans. It is not seen that the present invention can effectively treat all six types of viruses, some of which are well known to be difficult to treat. There are 26 different genus's of plants listed in claim 1 many of which have hundreds of species. It is not seen that any extract of any of the plethora of plants claimed would be effective to treat any and all of the human herpes viruses in the claimed invention. It is noted that there are more than one hundred different known types of herpes viruses.
This disclosure is actually a very few number in comparison to the vast number of extracts which could be obtained from Glycyrrhiza and Hypericum. The reason for this large amount of permutations is because extraction techniques are often coupled in order to obtain a product; for example;
1) a water extraction followed by an alcoholic extraction: the product obtained is an extract.
2) a supercritical extraction (CO2 ) followed by an alcoholic and then a non-polar solvent extraction (e.g., chloroform): the product is an extract.
3) a benzene extraction followed by a water extraction and chromatographic separation: the product is an extract.
4) a water/chloroform extraction (e.g., in a seperatory funnel), followed by collection of the water layer, chromatographic separation and crystallization of an isolate: the product is an extract.
5) squeezing the plant to obtain a juice: the product is an extract.
6) dipping the plant in an organic solvent to remove the waxy layer: the product is an extract.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
The specification does not provide sufficient evidence that any liquid extract of either any species Glycyrrhiza or Hypericum could effectively inhibit replication of any herpesvirus including human herpes virus-2 infection as encompassed by the pending claims. The evidence provided indicates that a particular extract of G. glabra and H. performatum prepared by a particular method could have potency against HV2.
Partial Structure, Physical and/or Chemical Properties:
Applicants have only disclosed extraction techniques for obtaining a particular extract as disclosed in paragraph [0146] – [0151]. Applicants have not elucidated any particular phytochemicals in their recovered extracts that possesses anti-viral properties. Therefore, no structure or physical/chemical properties of the extracts have been disclosed.
Functional Characteristics Alone or Structure/Function Correlation:
Again, Applicants have not elucidated any phytochemicals in their extracts. Therefore, Applicants have not demonstrated any correlation between the structure of any component which resides in the extract(s) to any particular function.
Method of Making the Claimed Invention:
Applicants have disclosed only techniques as disclosed in paragraphs [0146] – [0151] of the specification which provide for extracts which were found to inhibit replication of herpes virus.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
There is no known means for predicting the capability of other extracts, besides the extract(s) specifically described in the Instant disclosure, with regard to [e.g., anti-viral effect]. The skilled artisan could not even relatively predict what other extracts would perform this function. Absent any discussion regarding correlation between structure and function, even the most skilled of artisans would need to guess what other extracts could potentially have the effect(s) listed in the claim(s).
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) 1-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Langland et. al. (US 10842838 B2) .
The applied reference has a common Applicant/Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The instant claims are drawn to a method for inhibiting replication of a herpes virus by exposing the herpesvirus to an extract from a plant material.
Langland et.al. ‘838 however anticipates the claims by teaching, “a method of inhibiting the replication of herpes virus family members comprises exposing said herpes virus to at least one extract (Summary [para 52]); comprises the use of a botanical extract composition comprising at least one botanical extract of Sarracenia, Nepenthes, Melissa, Lavandula, Glycyrrhiza, Eleutherococcus, Hypericum, Darlingtonia, Heliamphora, Roridula, Drosera, Dionaea, Aldrovanda, Drosophyllum, Triphyophyllum, Catopsis, Brocchinia, Paepalanthus, Utricularia, Genlisea, Pinguicula, Ibicella, Byblis, Philcoxia, Stylidium or Cephalotus…(Summary [para 20]); a method for preparing a liquid extract from a plant material…method comprising, obtaining fresh plant material; washing and air drying said plant material: combining said plant material with a liquid comprising at least one of water, ethanol and glycerol; allowing said liquid to extract said plant material at from about room temperature to simmering temperatures to form said liquid extract; and separating said liquid extract from said plant material, is provided…(Summary [para 34]),” as in instant claim 1.
Regrading instant claims 2,3 and 4; Langland et.al. ‘838 however anticipates the claims by teaching, “a method for extracting the roots or leaves from the botanical… a method for extracting the flowering stems of the botanical…(Summary [ 35-37])”, as in instant claim the plant material consist of leaves, roots, and flowers.
Regarding Claims 5, 6, and 7; Langland et. al. ‘838 however anticipates the claims by teaching, “said herpes viruses is selected from the group consisting of herpes simplex 1, herpes simplex 2, varicella-zoster virus, Epstein-Barr virus, cytomegalovirus and human herpes 8 (Summary [para 052]), as in instant claim 5 and 15); said herpes virus is an animal herpes virus. In yet further embodiments, said animal herpes virus is equine herpes virus-1 (Summary [52]), as in instant claim 6 and 7.
Regarding Claims 8 and 9, Langland et. al ‘838 however anticipates the claims by teaching, “The extracts of the present disclosure may be combined and/or formulated with any food-grade or pharmaceutically acceptable excipient, such as to provide various therapeutic compositions (Summary [para 16 and 22]), a pharmaceutically acceptable transdermal driving carrier/gel (Summary [para 23])” as recited in instant claim 8 and 16 and 9.
Regarding claims 12-14, Langland et.al. ‘838 however anticipates the claims by teaching, “a botanical extract may be standardized based on in vitro antiviral activity against a virus such as such as HSV1, HSV2, VZV, SV-40 (Summary [para 76]), as instant claim 12; an aqueous botanical extract mixture comprises: 50% extract of Sarracenia purpurea (equating to 50 viral inhibitory units (VIU)/ml); 12% Melissa officinalis (equating to 80 viral inhibitory units (VIU)./ml); 20% Lavandula officinalis (equating to 20 viral inhibitory units (VIU)/ml) (Summary [para 44]), as in instant claim 13 and 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alpa Amin whose telephone number is (571)272-0562. The examiner can normally be reached 8:30 - 6:00.
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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655