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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2023, were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Priority
This application filed on 12/18/2023, is a 371 of PCT/CN2022/108432, filed on 07/28/2022, which claimed priority to Chinese application Nos: i) 202210416287.0, filed on 04/20/2022; and ii) 202110879406.1, filed 08/02/2021.
Status of the Claims
Claims 1-17 are pending.
Improper Markush Grouping Rejection
Claims 1-11 and 13-17 are rejected on the basis that it contains an improper Markush grouping of alternatives. The nonstatutory Markush grouping rejection is based on a judicially approved “improper Markush grouping” doctrine. Please see In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Please see MPEP § 2117.
The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the claimed Markush grouping lack the required combination of a shared substantial structural feature and a common use that flows from that shared substantial structural feature because they lack a substantial shared structural feature.
In the present case, at least (1), it cannot be said that all members of the Markush grouping of a compound of Formula (I) have a single structural similarity from which the activity flows. The improper Markush groups are R1, R2, R3, R4, R5, R6, R9, X1, X2, Z and m. The compound(s) of Formula (I), where choices for Markush groups, for example, Markush groups R1, R2, R3, R4, R5, R6, R9, X1, X2 and m, are selected from the group consisting of the list disclosed in instant claim 1, are so diverse that they do not share substantial structural features. The claim is very broad encompassing heterocycles, carbocycles and other groups bearing multiple substitutions on all the numerous varying variables. Every variable varies having substituents with voluminous complex meanings and seemingly endless permutations and combinations.
To overcome this rejection, Applicants should either amend the claims to recite only individual species or a grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative do in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Claim Rejections - 35 USC § 112-2nd Paragraph
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 1-11 and 13-17 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. Claims 2-11 and 13-17 depend from claim 1 and are therefore, also rejected under 35 USC 112, second paragraph for the reasons set forth below.
Claim 1 is rendered indefinite because a person of the ordinary skill in the art cannot determine the metes and bounds of the Markush claim due to an inability of a skilled artisan to envision all of the members. Please see MPEP § 2173.05(h). Appropriate correction is required.
Claim Rejections - 35 USC § 112-Scope of Enablement
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 15-17 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 a method for treating lung and skin cancer with compounds 1-18 (see Table 1, page 57 of the specification), does not reasonably provide enablement for treating cancers or diseases recited in claims 15-17, with a compound of formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Applicants’ claimed invention (e.g., claim 15) is directed to a method of treating cancer, tumor or metastatic disease, with a compound of formula (I).
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) The nature of the invention;
2) The breadth of the claims;
3) The predictability or unpredictability of the art;
4) The amount of direction or guidance presented;
5) The presence or absence of working examples;
6) The quantity of experimentation necessary;
7) The state of the prior art; and,
8) The relative skill of those skilled in the art.
The relevant factors are addressed below in the basis of comparison of the disclosure, the claims, and the state of the prior art in the assessment of undue experimentation.
Note that the specification must be enabling as of the filing date. MPEP §2164.05(a). In the instant case, the filing date is 06/19/2015, the date of U.S. provisional application No. 62/182,219.
The standard for determining whether the specification meets the enablement test was first stated in Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916), and asks if the experimentation needed to practice the invention is undue or unreasonable.
The claimed invention is enabled if any person skilled in the art can make and use the invention without undue experimentation. The focus is on ‘undue’ rather than on ‘experimentation’ (In re Wands, at 737, 8 USPQ2d at 1404; see also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988)).
A patent need not teach what is well known in the art (In re Buchner, 929 F.2d 660, at 661, 18 USPQ2d 1331, at 1332 (Fed. Cir. 1991); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, at 231 USPQ 81, at 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, at 1463, 221 USPQ 481, at 489 (Fed. Cir. 1984)).
Determining whether claims are sufficiently enabled by the specification is based on underlying findings of fact. In re Vaeck, 947 F.2d 488, at 495, 20 USPQ2d 1438, at 1444 (Fed. Cir. 1991); Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, at 576, 224 USPQ 409, at 413 (Fed. Cir. 1984).
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The Nature of the Invention
The nature of the invention is the treatment of these diseases or conditions through the use of a compound of formula (I). Currently, there is(are) no known agent(s) that treat all plethora of diseases or conditions recited in for example, claims 15-17, inclusively.
The Breadth of the Claims:
Applicants’ invention (e.g., claim 15), is drawn a method of using a compound of formula (I), in order to treat cancer, tumor or metastatic disease. A compound of formula (I), encompasses a plethora of compounds of varying chemical structural features. The claims are very broad and inclusive of: i) a plethora of compounds; and ii) a plethora of diseases or conditions with wide varying pathologic features.
The level Predictability or Unpredictability of the Art:
The instant invention (e.g., claim 15), claims a method of using a compound of formula (I), in order to treat cancer, tumor or metastatic disease. Support for the Applicants’ invention is only in the form of inhibiting the growth of lung and skin cancer cell lines with compounds 1-18 (see Table 1, page 57 of the specification).
However, as of the time of filing, the Examiner is not aware of any evidence in the art which teaches, for example, treating a plethora of diseases or conditions with wide varying pathologic features, with a compound of formula (I). Furthermore, no evidence has been provided by the instant disclosure to show that a compound of formula (I), can treat a plethora of diseases or conditions with wide varying pathologic features.
MPEP § 2164.05(a), states: “The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.” Emphasis added.
In the instant case, the Examiner is not aware of any evidence in the art for the degree of predictability, wherein a person skilled in the art would readily predict that a compound of formula (I), can treat a plethora of diseases or conditions with wide varying pathologic features.Therefore, one skilled in the art could not predict, from the evidence of record that, a compound of formula (I), can treat a plethora of diseases or conditions with wide varying pathologic features.
The Amount of Guidance, and the Existence of Working Examples
MPEP §2164.03 states:
"The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The 'amount of guidance or direction' refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004)...In applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required."
"Nascent technology…must be enabled with a 'specific and useful teaching'. The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology." Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). See MPEP §2164.03.
The specification only provides evidence that compounds 1-18, can be used to inhibit the growth of lung and skin cancer cell lines (see Table 1, page 57 of the specification). Considering the state of the art as discussed above and the lack of guidance provided in the specification, one skilled in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states:
“The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
The Quantity of Experimentation Necessary:
Genentech Inc. vs. Novo Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997).
In the instant case, Applicants have presented a general idea that because compounds 1-18, can be used to inhibit the growth of lung and skin cancer cell lines (see discussions above), then a compound of formula (I), which encompasses a plethora of compounds of varying chemical formula or structure types, can treat a plethora of diseases or conditions of varying pathologic features.
Determining if a compound of formula (I), can be used to treat a plethora of diseases or conditions of varying pathologic features, would require the formulation of a compound of formula (I), which encompasses a plethora of compounds of varying chemical formula or structure types, and subjecting it to preparation trials or to testing in an assay known to correlate to the treatment of a plethora of diseases or conditions of varying pathologic features. This is undue experimentation given the limited guidance and direction provided by Applicants, lack of working examples, and unclear mechanism of action of a compound of formula (I), in the treatment of a plethora of diseases or conditions of varying pathologic features.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusions
Claims 1-11 and 13-17 are rejected.
Claim 12 is objected to.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629