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 .
The amendment filed 20 May 2026 is acknowledged and has been entered.
Status of the Claims
Claims 1-11, 15, 16 have been cancelled.
Claims 12-14 and 17-21 are presented for examination 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.
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 12-14 and 17-21 stand 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 treatment of inflammation with an parsnip extract obtained by pretreatment a drying at 55C~-65C and heat-dried for at least 10 days and extracted with 30% alcohol for 24 hours and filtration and removal of the solvent (see Example 1), does not reasonably provide enablement for any and all treatments of promoting respiration with any and all extract of “heat-treated” parsnip extract. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to a respiratory treatment with an extract of heat-treated parsnip. However, the specification provides only one working example, that of an extract of parsnip obtained in a particular extraction with particular extraction conditions (Example 1), which was found to possess antioxidant and anti-inflammatory properties. Regarding the extraction solvent used to obtain the claims product with anti-inflammatory properties, it is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his/her best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Oftentimes, unless the constituents in a particular natural product extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a natural product or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in an attempt to isolate particular ingredient(s) that have medicinal efficacy. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. For example, unpredictability with regard to natural extracts due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction. Thus, the functional properties of an extract of parsnip is not considered to be predictable because the type of extraction used to produce the extract would have a significant impact on the chemical characteristics of the extract.
It would appear from the description of the specification that the critical factor distinguishing the parsnip extract of the instant Application is the pretreatment by heating. As applicant points out in specification: , it was observed that after a certain period of time (e.g., 20 days), the physiological activity of the processed parsnip did not increase linearly even if additional dry heating processing was conducted. The specification does not provide any specific guidance to show that any and all extracts of parsnip pre-treated (i.e., aged) by heating with any heat for any amount of time would have the claimed functionality. An artisan would have to test every potential extraction technique with the virtually limitless number of solvents, temperatures, durations, and other extraction conditions in order to determine if it is able to inhibit inflammation. This degree of experimentation clearly places an undue burden on the artisan of ordinary skill. Given the wide range of possible resulting extracts that could potentially result from various extraction methods, the presence of a single example of an extract that possesses anti-inflammatory properties in an in vitro model provides insufficient guidance to the person to practice the invention.
Consequently, given the unpredictability of the art, the lack of guidance from the specification and the quantity of experimentation needed to practice the claimed invention, the claims are not considered to be enabled for the full scope of the claim.
Claims 12-14 and 17-21 stand 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 pre-AIA 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.
Applicant has provided evidence of only a single example of an extract of parsnip with the anti-inflammatory properties to treat respiratory disorders. This product with the specific composition was produced by a specific method of extraction from a specific, which as stated previously could vary considerably. This disclosure is actually a very few number in comparison to the vast number of extracts which could be obtained from parsnip. 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.
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-inflammatory 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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-14 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steglemeier et al. (2019) and Kenari et al. (2021).
Stegelmeier et al. (2019) Discloses extraction of furanocoumarins from parsnips and for analysis and extract production the plant was lyophilized and ground in a Wiley mill to pass through a 1mm screen. Accurately weighed samples (ca 100 mg) of the lyophilized ground plant were extracted with methanol (10 mL) at room temperature with gentle, inversion mixing for 6 h. After settling, the green supernatant was removed, filtered (0.45 m) and replaced with fresh methanol (10 mL) and the extraction continued overnight for a further 15 h for qualitative assessment of extraction efficiency. The
combined extracts from each sample were evaporated (to less than 10 mL) under a flow of nitrogen and diluted accurately to 10 mL with methanol. An aliquot (10 μL) of each crude extract was added to 0.1% aqueous formic acid/methanol (1:1, v/v) (80 μL) and an internal standard solution (10 μL of 700 μg quercetin/mL methanol). This was then analysed using HPLC-esi(+)MS and MS/MS as described. To assess possible degradation of the furanocoumarins, samples of the bulk, lyophilized plant were subjected to three additional treatments for up to 7 days: 1. Heating in an oven at 40 °C; 2. Exposed to sunlight and warmth on a window sill; and 3. Simulated sun exposure by incubating material in a plant growth chamber at 40 °C (Thermo Fisher Scientific,
Pittsburg PA). Sub-samples from each treatment were extracted and analysed after 48 h and 7 days of treatment.
Kenari et al. (2021): provides a review of the pharmacological properties and phytochemicals of parsnip, including furanocoumarins used in the treatment of various disorders including bronchospasm.
In addition, Applicant points out in the Specification that:
A process of pretreating raw parsnips was reported in Plant Foods for Human
Nutrition (2020) 75:292-297), but the process takes too much time (4 weeks) to complete and requires high temperature (80oC) heat treatment and a high level of humidity (95%), which limits its application in industrial sites. There is an urgent need for a new method of pre- treating raw parsnips with a shorter period of time and milder process conditions.
Though given the indefiniteness of the claims as drafted it is difficult to determine the precise scope of the claims, it would appear that the claimed method in which no temperature is recited nor humidity limited, the previous reference, which was not included in the Applicant’s filed IDS, would cover the claimed method of preparing the parsnip extract. It is further known to treat respiratory disorders with parsnip extract, as well as inflammation.
It would appear that Applicants invention is predicated on an unexpected result, that is – pretreatment by heat drying at a specific temperature for a specific amount of time of parsnip before extraction, results in a higher total polyphenol content, exhibits enhanced 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical scavenging activity, and exhibits enhanced 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulphonic acid) (ABTS) radical scavenging activity. However, with respect to such unexpected results, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Response to Arguments
Applicant's amendments/arguments filed with respect to 35 USC 112(a) rejection have been fully considered but they are not persuasive.
Applicant asserts that claim 12 has been amended to specify the precise "heat-drying" parameters, including a temperature of "55*C to 90*C" and a duration of "3 to 21 days." By narrowing the claim to these specific conditions supported by the specification, Applicant has provided a clear standard that enables one of ordinary skill in the art to practice the invention without undue experimentation.
This is unpersuasive, since the specification does not support the claims in that the extract used to show efficacy in treatment of “respiratory inflammation” was obtained in a specific method with a specific extraction solvent. The amended claims do not specify these variables, but rather include any extraction solvent of any alcohol or water.
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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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