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 .
Election/Restrictions
Applicant’s election without traverse of:
40-60% ethanol elution fraction LRCW-B in claim 1,
LRCW-B2 in claim 2, (now recited in amended claim 1, 11)
B2-16 in claim 3 (now recited in claims 1, 4, 11),
B2-16-1 in claims 4, 6 (now recited in claim 11); and
lung cancer, claim 5 (now recited in claim 1),
in the reply filed on 7/2/2025 remains acknowledged.
Double Patenting
In view of the abandonment of Application No. 19/058,112 (reference application), effective 1/22/2026, the provisional double patenting rejection has been withdrawn.
Terminal Disclaimer
The terminal disclaimers filed 11/25/2025 have been disapproved:
The applicant cited on the TD should be cited exactly as cited on the ADS form, in its entirety. The applicant can be provided on a separate sheet.
When using PTO/AIA /25 (4-13) the reference application number should have forward slash: (19/058,112)
Please resubmit the td. No fee required. Thanks
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 1, 4, 6, 11 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.
Examiner notes that the labels “LRCW-B”, “LRCW-B2”, “B2-16”, “B2-16-1” in context with amended claim 1 language clarifies the meanings of some of the recited terms. Together with the steps for extraction of Monochasma savatieri and details now recited in amended claim 1, including recited antitumor effect of portions of Monochasma savatieri (in view of disclosed Table 3), for Inhibition rates of A549, there are some clarifications for the fractions B2-2, B2-3, B2-6, B2-16-1, B2-16-3 and B2-16-4.
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The specification clearly states that B2-2, B2-3, B2-6, B2-16-1, B2-16-3 and B2-16-4 had obvious inhibitory effect on the proliferation of lung cancer cell A549; thus, the meaning of an effective amount of any one of these 6 fractions has been clarified, but only with respect to anti-A549 type of lung cancer. None of the other Samples (shown with 0 inhibition rates in the table; i.e., these tests show no activity for the assay) had any inhibition of A549; none of these can be considered effective parts nor are they associated with any effective amounts. The Examiner failed to identify any other examples of specific types of lung cancer or any generic lung cancer data; thus, the meaning of “effective part” or “effective amounts” of any other named fraction is confusing, with respect to either A547 or generic lung cancer recited.
There is no disclosure of any other effective amounts or effective parts of generic lung cancer (apart from the species A547) or any other species of lung cancer types.
There is no disclosure of effective amounts of effective parts of any antitumor comprising both breast cancer and lung cancer as currently recited in amended claim 1.
Applicant argues that the claimed effective part extract is not a vague or subjective concept but is clearly defined by an objective process comprising specific extraction and separation parameters recited in the claims. The Examiner acknowledges some clarification by the specific extraction and separation parameters included in amended claim 1. However, the separation process results in many fractions named, but when evaluated based on Table 3 assay for A549, are not active. It is confusing how, for instance LRCW-A, B2-113, B16-6, etc, shown to have 0% activity in the A547 inhibition assay of Table 3, satisfy the recited effective amount or effective part extract language.
Additionally, there is no disclosure of any tumor considered to be both breast and lung cancer. Accordingly, there is no clarity about which, if any, fraction of any separation, can be considered effective part or having effective amount to treat such a tumor
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 1, 4, 6, 11 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 amendments to claim 1, and the date from Table 2 functions to place the public in possession of the fractions B2-2, B2-3, B2-6, B2-16-1, B2-16-3 and B2-16-4, in context of the anti-tumor effect of the specific lung cancer A547 for these fractions only. However, none of the other named fractions are not disclosed to be active; there are no disclosures of activity for any other lung cancer, let alone for a generic lung cancer.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. 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, not 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
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 and 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. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims are drawn to a method for treating tumor (including Applicant elected lung cancer, amended claim 1), comprising contacting inflamed tissue with a drug comprising an effective amount of an effective part extract of Monochasma savatieri, wherein the effective part extract of Monochasma savatieri comprises one or a series of fractional extracts named in claims 1, 4, 6, 11. Even claim 6, limited to the fractions B2-2, B2-3, B2-6, B2-16-1, B2-16-3 and B2-16-4, is not considered supportive for the generically recited “lung cancer”, considering there is no additional anti-lung cancer activity disclosed, aside from A547.
(1) Level of skill and knowledge in the art:
The typical skilled artisan preparing herbal extracts would have knowledge in techniques of separation science. However, this is mitigated by lack of detail of specific considerations set forth above. The TLC characteristics required to define the boundaries of any of the elected “LRCW-B”, “LRCW-B2”, “B2-16”, and “B2-16-1” fractions are not disclosed.
The knowledge in the art includes the fact, that extracts often have variations in specific components extracted from plants, and can vary with specific plant, the age, health, time of year, growing conditions, etc. of the plant being extracted, harvest techniques. See discussion of the complexity of herbal medicines and the critique that pharmacological research on medicinal plant extracts lack reproducibility. Heinrich et al. (“Best Practice in the chemical characterization of extracts used in pharmacological and toxicological research—The ConPhyMP—Guidelines”; 2022; Frontiers in Pharmacology; DOI 10.3389/fphar.2022.953205; cited in the parent application) includes the statement,
“Overall, two herbal extracts can differ significantly in their composition, although they are prepared from the same plant species and based on a superficially similar protocol” (p. 04, 2nd from last paragraph). Heinrich indicates that a medicinal plant extract or product used for research studies should be authenticated and characterized in terms of active ingredients/marker compounds, of sufficient quality and consistency, and it should be stable (p. 05, 2nd paragraph). The instant application has no such discussion of active ingredients or marker compounds in any of “LRCW-B”, “LRCW-B2”, “B2-16”, and “B2-16-1”. Heinrich has many other specific suggestions; the instant disclosure does not have sufficient description to satisfy the requirements for characterization of a plant medicinal extract, apart from the singular assay with A547 activity while separating the parts according to claim 1. Compare the brief discussion in the specification to the Table 3 of Heinrich. For instance, there is no fingerprinting; see Table 5. There is no showing the disclosed procedure is reproducible. In fact, the instant disclosure relies on two unique separation methods, one to extract anti-inflammatory elements, the other to extract anti-cancer elements. The two have no relationship.
(2) Partial structure:
A general scheme for separation of components of Monochasma savatieri is depicted in Figure 1, and now recited in amended claim 1; a broad discussion, without the specific details discussed in the above rejection is set forth. However, claim 1 requires a drug, an effective amount, and an effective part. Because the specifics do not precisely claim the drug material, the general approach discussed does not set forth specific enough details place the public in possession of the specific materials of claim 1, even for a generic lung cancer. Examiner notes that limiting claim 6 to activity in A549 type lung cancer would be considered to overcome this rejection basis.
(3) Physical and/or chemical properties and (4) Functional characteristics:
The disclosure indicates the drug is capable of significantly inhibiting secretion of an inflammatory factor TNF-α (See Test Example 1). However, it is not clear how this is related to efficacy for treating a lung cancer tumor, or the disclosed A549 tumor cell line. The claims recite treating a tumor, lung cancer amended claim 1, was elected. Test Example 2 utilizes the specific lung cancer cell line A549. For this tumor, only 6 of the claimed extracts have efficacy in inhibiting rate of tumor cell proliferation (Table 3).
There is no sample ID for LRCW-B in the results. It cannot be ascertained what part of Monochasma savatieri has lung cancer tumor effective part (One can assume that the 0% inhibition rates for LRCW-B1 through LRCW-B4 is indicative that LRCW-B also has 0% inhibition rate for A549. For the elected LRCW-B2, inhibition rate is 0%. Thus, it cannot be ascertained what part of Monochasma savatieri is effective for the elected lung cancer for this elected fraction. Regarding B2-16, the inhibition rate is 0%. Regarding B2-16-1, the table indicates 60.76% inhibition rate. Thus, this is the only fraction among those elected having any efficacy in the disclosed example. While many of the instant claims recite many fractions, for the elected fractions, only one can be said to comprising an effective amount of an effective part extract. Written description is clearly lacking for other recited fractions in the many claimed lists.
Thus, the functional characteristics are mostly lacking with respect to even the elected fractions.
(5) Method of making the claimed invention:
While a general separation procedure has been disclosed, it lacks specific details defining the metes and bounds of and of “LRCW-B”, “LRCW-B2”, “B2-16”, and “B2-16-1”. Additionally, there is no disclosure (fingerprinting) of which active compound(s) are present in each of “LRCW-B”, “LRCW-B2”, “B2-16”, and “B2-16-1”, that equips the skilled artisan to reproduce drug/the effective part of this specific fraction. While a statement that TLC data is used to combine fractions, there is no showing of what the TLC characteristics are for each of “LRCW-B”, “LRCW-B2”, “B2-16”, and “B2-16-1”.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 1-11 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any ordered extract, without knowledge of how this extract material is defined or verified. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus. The specification does not provide sufficient descriptive support for the myriad of varying potential extracts embraced by the claims, required to define “LRCW-B”, “LRCW-B2”, “B2-16”, and “B2-16-1”.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claims 1, 4, 6, 11 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 treating the lung cancer A549 with the extracts B2-2, B2-3, B2-6, B2-16-1, B2-16-3 and B2-16-4, does not reasonably provide enablement for any other elected fraction being effective for treating A549, nor any fractions being effective for lung cancer generically (outside of A549), let alone fractions being effective for treating any tumor, whichever of 28 disclosed fractions are utilized. 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.
Applicant claims A method for treating a tumor, comprising contacting the tumor with a drug comprising an effective amount of an effective part extract of Monochasma savatieri, wherein the effective part extract of Monochasma savatieri comprises a water elution fraction LRCW-A, a 40% to 60% ethanol elution fraction LRCW-B, or both, that are separated by macroporous resin from a Monochasma savatieri crude extract; additional details of fractions separation steps are now recited in claim 1.
The steps result in a series of fractions being obtained, most of which are shown not to be active against A547 cancer cells (see Table 3, also reproduced above), which shows only the 6 extracts B2-2, B2-3, B2-6, B2-16-1, B2-16-3 and B2-16-4 having anticancer activity against A547; no other activity is disclosed for these 6 extracts, or any others, for any other lung cancer type or lung cancer generically.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). These factors include the following:
a) Breadth of the claims. These claims are broad in terms of all possible lung cancerous tumor; while claim 1 limit cancers to breast cancer or lung cancer (in claim 2, confusingly, and breast and lung cancer in the same embodiment is recited, which is confusing, whatever the meaning). Regarding the extracts of Monochasma savatieri, 28 unique fractions, a fairly broad assortment of drugs, are discussed in the examples. As discussed in the above rejections; there is some clarification by the claim 1 amendment reciting specific steps of separation
b) Nature of the invention. The invention involves treating lung, breast or both cancerous tumors, with alternate extracts (at least 28) from Monochasma savatieri.
c) State of the prior art. The art in the field of cancer treatments is highly unpredictable, until either a mechanism for treating a given cancer is identified, or demonstration of anticancer activity is shown.
d) Level of one of ordinary skill. The level of skill in the art is high however, this is offset by the unpredictability of cancer treatments, until demonstration of said activity is shown.
e) Level of predictability in the art. The art in the field of cancerous treatments is unpredictable, until a showing of efficacy with each unique cancer for each unique drug is shown. As discussed above, plant extracts are also highly unpredictable.
f) Amount of guidance presented by applicant. Applicant presents Example 2, demonstrating inhibition rate of tumor cell proliferation for a single lung cancer and a single breast cancer. There are 6 active fractions effective for A549, only one of which was elected. All other samples tested show 0 % activity.
g) Number of working examples. Applicant presents a working example demonstrating activity by 6 extracts against one lung cancer line. This is insufficient to provide evidence for the broader generic lung cancer, or for effective amounts or parts of the claimed method for treating a tumor. There is no working example for treating both lung and breast cancer type tumor
Given the analysis of the above factors which the Courts have determined are critical in determining whether a claimed invention is enabled, it must be concluded that the skilled artisan would have needed to have practiced undue and excessive experimentation, with little guidance from applicants, in order to practice the claimed invention.
Applicant argues that the claims have been amended in response to both the written description and enablement rejections, by language defining a detailed and reproducible chromatographic separation process. The examiner agrees that some of the meaning of fractions is clarified by the amendment to claim 1. However, with respect to the elected lung cancer, only 6 of the about 28 fractions are shown to have activity in treating a single lung tumor A547. None of the others are active in this specific assay. The lack of evidence in any other lung tumor demonstrates there is no generic written description nor enablement support for lung cancer generically. In view of failure of 22 fractions tested in one assay, most of the claimed method fractions is shown not to be active in the single assay tested. Clearly the 6 samples that are active fail to provide written description or enablement type support for the full breath even of the elected lung cancer. There is no support for both lung and breast cancer types, whatever the meaning of this recited combination. Because of the unpredictability both of reliability of plant extracts and alternative cancer types, the claims still are rejected under both written description and lack of enablement.
Conclusion
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 TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614