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 present application U.S. Appln. Ser. No.: 18/320,082, Filed: May 18, 2023 is a US By-Pass Continuation of WO 2022/112537 A1 (i.e., PCT/EP2021/083253, Intern.’l Filing Date: November 26, 2021), which claims foreign priority to GB2018667.2, Filed: November 26, 2020.
Status
This is in response to the September 26, 2023 Information Disclosure Statement and other documents filed in the above-identified application.
Claims 57-84 are pending, new and under examination and claims 1-56 are cancelled in the above identified application.
Information Disclosure Statement
An Information Disclosure Statement (IDS) submitted on September 26, 2022 is in compliance with the provisions of 37 CFR 1.97.
Accordingly, Information Disclosure Statements have been considered by the Examiner.
Drawing Objections
The drawings in the application are objected to for failure to meet the requirements of 37 C.F.R. 1.81(a). See 37 C.F.R. 1.153.
Drawings are objected to under 37 CFR 1.84 for being of poor quality and/or not acceptable for publication purposes, because photographs in Figures 5-9 lack necessary clarity rendering key structural details or features difficult to discern/identify in photographs; i.e., e.g., due to blurriness, pixelation, low-resolution, being too dark, etc. (also see MPEP 608.02(b) Acceptability of Drawings).
Replacement drawings in compliance with 37 CFR 1.84 are required for submission within two (2) months from the mailing date of this action and must show the same figures as the original submission, but they must be clear, well-defined, and of sufficient quality to permit examination.
Claim Objections
Claims are objected to for typographical, grammatical, punctuations inadvertent errors and/or minor informalities.
With regard to claims 57-68, it is suggested that the preamble of dependent claims be amended to recite “the compound of Formula (I) or complex of Formula (II)”, instead of “the compound or complex of claim “. Likewise for claims 69, it is suggested that the claim be amended to recited “a pharmaceutical composition comprising a compound of Formula (I) or a complex of Formula (II) . . .”
Claims 57, 60, 62, 66, 75, 77 and 79, respectively, are objected to because of the following informalities:
missing punctuation, which includes missing semicolons between chemical compound structures or species and no appropriate inclusion of an alternative term “or” -or conjunctive term “and” before recitation of the last chemical compound structure in a list appropriately set forth in above-identified claims.
claim 66 does not recite a compound number or a corresponding or identifier alongside the last 5 chemical structures in this claim (i.e., the first 25 or so chemical compounds have defined chemical names).
Claim 83 is objected to as being dependent upon canceled claim 1. To overcome the objection, the applicant must rewrite claim 83 to be dependent on claim 57 so it is no longer dependent on the canceled claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 57-84 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd para., 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 Applicants), regards as the invention.
In general, the claims of the present invention fail to define the metes and bounds of the claimed invention due to use of indefinite, vague, ambiguous or unclear or poorly defined functional terms and/or language (i.e., such that exact scope of the claimed invention cannot be ascertained) without support from the specification within the claim itself. Claims must particularly point out and distinctly the claimed invention. Moreover, claims identified above also lack clarity, due to unnecessary use of repetitive and/or redundant terms.
Claims 57, 66-69, 73, 75 and 77-82 are rejected for being indefinite, vague, ambiguous or unclear or poorly defined functional terms and/or language, because:
While the pharmaceutical composition claim of claim 69, recites the open ended transitional term “comprising, claim 70 would be more accurately be amended to recite:
“The pharmaceutical composition according to claim 69, further comprising the pharmaceutically acceptable carrier or diluent which is polyvinylpyrrolidone”
because identifies that that polyvinylpyrrolidone represents a pharmaceutically acceptable carrier or diluent and shows that claim 69 has proper antecedent basis from claim 70.
Claim 73 is rejected for having 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 recites the broad recitation below
and
also recites terms below, which is the narrower statement of the range/limitation
parenteral
and
i intravenous, subcutaneous, intramuscular, intradermal, intratracheal, intraperitoneal, intratumoral, intraarticular, intraabdominal, intracranial and epidural
airway
and
aerosol
topical
and
buccal, mucosal and sublingual
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 75, 76 and 78, respectively, are rejected under 35 U.S.C. § 112(b) as being indefinite and for ambiguity in scope for containing an improper Markush grouping of diseases, which does not meet the requirements of proper Markush practice because:
members do not share a "single structural similarity" or a "common use"; i.e., e.g.,
group(s) improperly aggregates conditions with completely different etiologies and treatments, such as bacterial infections, cardiovascular blockages, and forms of cancer. These alternatives are not functionally equivalent in the context of the claimed invention. As such, the boundaries of the claim are unclear to one of ordinary skill in the art, rendering the claim indefinite;
claim language, specifically the list of diseases, fails to particularly point out and distinctly claim the invention, by combining very specific diseases (e.g., Hodgkin's lymphoma, carotid artery stenosis) with broad, non-specific disease descriptions (e.g., "a cardiovascular disease," "a benign or malignant tumor," "a dermatological condition") such that disease scope is indeterminate and unclear where it is unclear the broad term encompasses a wider range of conditions or is limited by the specific disease examples;
In addition, claims 75, 76 and 78, respectively recite, broad range(s) or limitation(s) 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).
Here is a specific example in claims 75, 76 and 78, respectively, where a broad recitation of a disease, i.e., e.g., “cardiovascular diseases” is followed by recitation of the corresponding terms "coronary artery stenosis" and "carotid artery stenosis", which represent narrower statements of the range/limitation.
There are other diseases defined in each of the claims 75, 76 and 78, which represent use of both broad, genus-level language and specific examples of same disease type that renders the boundaries of the aforementioned claims unclear:
Therefore, Applicants are requested to review the identified claims to provide clarification, identify broad/narrow grouping of disease types/disease states and make appropriate claim amendments.
These 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.
Claim 78 also is indefinite for failure to distinctly and particularly claim the invention due to recitation of the term “and/or” after list of diseases in (a), (b) and (c), respectively; i.e., this would indicate that the treatment method of claims 77-78 would be used to treat all diseases all combinations of (a), (b), (c) in light of the term “and/or”.
Based on the above, an ordinary artisan could not determine with reasonable certainty the full range of conditions falling under this category without resorting to excessive and subjective analysis, thereby requiring undue experimentation.
Claims 80 to 82, respectively, are rejected under 35 U.S.C. § 112(b) as being indefinite, vague and ambiguous for recitation of the phrase "optionally wherein", because:
while U.S. patent claims generally must recite required features, not optional ones, the term "optional" in claims 80 and 81 can be interpreted to represent two (2) distinct limiting alternative embodiments or sub-embodiments; i.e., e.g.,
where “the irradiation is electromagnetic radiation with a wavelength in the range of from 500nm to 1000nm”; or
where “the irradiation does not have an electromagnetic radiation with a wavelength in the range of from 500nm to 1000nm.”
Clarification and amendments to the claims is/or required accordingly.
Based on the foregoing with regard to [1] to [7] supra, appropriate clarification, correction and amendment is required accordingly.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
WRITTEN DESCRIPTION REJECTION
The specification fails to provide an adequate written description to support the full scope of the claimed invention, i.e., e.g., with regard to incomplete, missing definitions and/or details in the originally filed disclosure (inc. specification and claims) which includes:
[1] Claims 73, 75 and 78, respectively are rejected under 35 U.S.C. § 112(a), because the specification does not provide sufficient written description or enabling disclosure for the full range of claimed diseases. The wide array of distinct and unrelated diseases requires a level of support and enablement that is not present in the application.
The claim encompasses a method for treating distinct and unrelated diseases disparate list of disease set forth in the specification ranging from infectious diseases and benign tumors to cardiovascular conditions and multiple types of cancer. While the specification may describe an effective treatment for a single, or a few related, only specific human conditions:
(e.g., ovarian cancers (inc. ovarian adenocarcinoma (OVCAR23, CaOV3), ovarian clear cell (inc. SKOV3)), breast cancer (inc. breast adenocarcinoma (MDA-MB-468, triple negative)) lung cancers (inc. lung adenocarcinoma), skin cancers (inc. melanoma (B16F10)), T-cell lymphoma (HH), colorectal adenocarcinoma (DLD-1), kidney (inc. renal carcinoma), human mesothelial cells (i.e., immortalized mesothelial cells)
it provides no basis for one of ordinary skill in the art to conclude that the invention is applicable to all the other listed diseases without undue experimentation.
It is not evident from the specification that the inventor was in possession of a method for treating all of the diseases listed, particularly the broad categories, at the time of filing. Furthermore, a single disclosure cannot reasonably enable a person of ordinary skill to practice the invention for every condition on the extensive list without requiring undue experimentation. For example, the skills and techniques required to treat a cardiovascular disease are vastly different from those needed to treat a viral infectious disease. The specification's failure to provide specific details on how to treat the myriad diseases, including the general categories, means that the disclosure is not commensurate in scope with the claims.
[2] Claims 77 & 81 and 79 & 82 are rejected under 35 U.S.C. 112(a) for failure to provide adequate written description to support the full scope of the claimed invention, i.e. where the following method steps omit necessary steps, elements and/or details for how to achieve either:
a method of photodynamic therapy (PDT) or cytoluminescent therapy, which comprises administering a therapeutically effective amount of a compound of formula (1) or complex of formula (I) to a human or animal in need thereof (i.e., claims 77 and 81); or
a method of photodynamic diagnosis (PDD) of a human or animal disease, which comprises administering a diagnostically effective amount of a compound of formula (I) or a complex of formula (II) to a human or animal in need thereof (claims 79 and 82); and.
there are NO definitions in the originally filed disclosure, specification or claims that set forth the definition of therapeutically effective amount or diagnostically effective amount, which is understood in the art as distinct terms (i.e., where a therapeutically effective amount is the quantity of a substance used to treat a disease, while a diagnostically effective amount is the quantity needed to detect or identify a condition. The key difference lies in the purpose and function of the substance in the body.)
For example, method steps and specific details that define and distinguish photodynamic diagnosis (PDD) or photodynamic therapy (PDT) (or cytoluminescent therapy (CTA), an unproven alternative form of PDT) such as identified below are not defined in the specification or set forth in the claims or original disclosure:
PDD: Uses low-intensity, non-thermal light to excite the photosensitizer and cause it to fluoresce, providing a visual diagnosis without destroying tissue.
PDT: Uses a higher-powered, thermal light dose to activate the photosensitizer, which then produces toxic reactive oxygen species to destroy the targeted cells.
A typical photodynamic diagnosis (PDD) method administering a photosensitizer drug absorbed by diseased cells, then activated with a specific wavelength of light. The photosensitizer fluoresces, causing abnormal tissue to glow, allowing to identify/differentiate healthy tissue.
Photodynamic therapy (PDT) is a 2-step medical trmt that uses light-sensitive drug (photosensitizer) and a specific wavelength of light to destroy abnormal or diseased cells.
(CLT) is a debunked, unconventional form of photodynamic therapy (PDT) that was promoted for treating advanced cancer
Procedure consists of three main stages:
1. Administration of a photosensitizing agent to a patient, where delivery method is det. by disease type and admin location (i.e., e.g., oral, topical, (IV) injection)
2. Incubation periods after admin allowing for photosensitizer absorption
3. Light exposure and fluorescence visualization of photosensitizer to fluoresce.
4. Diagnosis (inc. critical diagnostic from fluorescence imaging from exam with specialized endoscope or cystoscope scopes with blue or violet light source to view tissue, detection. intervention) and trmt planning procedures as guide therapeutic steps (i.e., such as photodynamic therapy (PDT) or other trmts)
Process typically involves three main steps: sensitization, incubation, and light activation.
1. Sensitization: Photosensitizer admin depending on type and location of target tissue ((i.e., e.g., oral, topical, (IV) injection admin)
2. Incubation periods after admin.allowing for photosensitizer absorp
3. Light activation exposure to different light sources wavelengths: Targeted cell destruction via Chem. rxn with oxygen species toxic to cells
4. Patient Sensation (stinging, tingling, or burning) Recovery and aftercare
5. Targets superficial tumors/ones reachable with a fiber optic cable, such as in lungs or esophagus.
Process typically involves three main steps:
Photosensitizer activation: Claimed whole-body illumination, often using low-penetration light such as infrared lamps for at-home treatment
Drug accumulation: Promoters claimed the chlorophyll-derived drug selectively accumulated in tumor cells.
Light penetration: wavelengths used in CLT (including infrared) are not capable of penetrating tissue more than a few millimeters
With regard to [1] and [2] above, the Federal Circuit has established that a disclosure of a genus requires either a representative number of species or relevant identifying characteristics to show the inventor was in possession of the full scope of the claim. Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010). In the field of deuterated drugs, the properties of the deuterated analog, such as metabolism and pharmacokinetic profile, are often unpredictable and can be significantly different from the non-deuterated parent compound. Simply demonstrating possession of the non-deuterated compound does not automatically establish possession of the deuterated counterparts.
Without specific examples, structural data, or a recognized correlation between the non-deuterated compounds and the entire genus of deuterated compounds, the specification does not reasonably convey to one skilled in the art that the inventor was in possession of the claimed deuterated genus at the time of filing.
Appropriate clarification and amendment required accordingly.
Claim Rejections - 35 USC § 112(a)
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 57-84 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 57-84 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for:
Compounds
A compound of Formula (I) or a complex of Formula (II):
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or
a pharmaceutically acceptable salt thereof”;
where M2+= Zn2+
Pharmaceutical Compositions
A pharmaceutical compositions which comprises a compound of Formula (I) or a complex of Formula (II) or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier or diluent (i.e., where pharmaceutically acceptable carrier or diluent is PVP); and/or
III. Methods
[a] where each of the methods described in this section are enabled for Compounds of Formula (I) and Complexes of Formula (II):
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or
a pharmaceutically acceptable salt thereof”;
where:
R1 = -C(O)-(NR3)2;
Ra = C₁-C6 alkylene;
R³ = Ra-SRb and Rb = a saccharidyl group (i.e., defined in claims 60-62);
M2+= = Zn2+;
where the above genus/subgenus is exemplified by compound Examples 3 and 6
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[b] methods for treatment for specific diseases; i.e.,
ovarian cancers (inc. ovarian adenocarcinoma (OVCAR23, CaOV3), ovarian clear cell (inc. SKOV3)),
breast cancer (inc. breast adenocarcinoma (MDA-MB-468, triple negative))
lung cancers (inc. lung adenocarcinoma),
skin cancers (inc. melanoma (B16F10)),
T-cell lymphoma (HH),
colorectal adenocarcinoma (DLD-1),
kidney (inc. renal carcinoma), human mesothelial cells (i.e., immortalized mesothelial cells) (i.e., defined in specification and Ex. 4);
which comprises administering compounds of Formula (I) or a complex of Formula (II) or a pharmaceutically acceptable salt thereof to a human subject in need thereof
[b] a method for treating breast and ovarian cancer, which comprises administering compounds of Formula (I) or a complex of Formula (II) or a pharmaceutically acceptable salt thereof to a human subject in need thereof
[c] a methods for photodynamic therapy for treatment of breast and ovarian cancer, which comprises:
administering compounds of Formula (I) or a complex of Formula (II) or a pharmaceutically acceptable salt thereof to a human subject in need thereof (i.e., see Ex. 6)
using fluorescence at 660m illuminated blue light of 400-460 nm with
photodynamic therapy steps or conditions exemplified in Example 6 and Fig 9
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. While the specification may describe an effective treatment for a single, or a few related, only specific human conditions:
(e.g., ovarian cancers (inc. ovarian adenocarcinoma (OVCAR23, CaOV3), ovarian clear cell (inc. SKOV3)), breast cancer (inc. breast adenocarcinoma (MDA-MB-468, triple negative)) lung cancers (inc. lung adenocarcinoma), skin cancers (inc. melanoma (B16F10)), T-cell lymphoma (HH), colorectal adenocarcinoma (DLD-1), kidney (inc. renal carcinoma), human mesothelial cells (i.e., immortalized mesothelial cells)
it provides no basis for one of ordinary skill in the art to conclude that the invention is applicable to all the other listed diseases without undue experimentation.
It is not evident from the specification that the inventor was in possession of a method for treating all of the diseases listed, particularly the broad categories, at the time of filing.
DOES NOT reasonably provide enablement for:
COMPOUNDS, where:
ALL or ANY compound(s) of Formula (I) or a ALL or ANY complexes of Formula (II), comprised of wherein . . .
Y is ALL or ANY counter ion(s); (i.e., as in claims 1, 75, 77 and)
M2+ is ALL or ANY metal ion (s) (i.e., as in claims 1, 75, 77 and)
Rb is ALL or ANY saccharide(s) (i.e., as in claims 59, 60, 62 and)
PHARMACEUTICAL COMPOSITIONS, where:
a pharmaceutical composition further comprising ANY or ALL immune checkpoint inhibitors (i.e., as in claim 71)
a pharmaceutical composition is in a form suitable for oral, parenteral (including intravenous, subcutaneous, intramuscular, intradermal, intratracheal, intraperitoneal, intratumoral, intraarticular, intraabdominal, intracranial and epidural), transdermal, airway (aerosol), rectal, vaginal or topical (including buccal, mucosal and sublingual) administration. (i.e., as in claim 73)
pharmaceutical composition is in ANY or ALL form(s) suitable for oral or parenteral administration. (i.e., as in claim 74)
pharmaceutical combination comprising: (a) a compound or complex according to claim 1; and (b) ANY or ALL immune checkpoint inhibitor(s). (i.e., as in claim 83)
METHODS, where:
A method for treating:
ANY or ALL human or animal disease(s) (i.e., as in claims 75 77, 78, 79, 80-82
ANY or ALL of the following diseases defined in these claims (i.e., as in claim 75, 76)
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A method for ALL or ANY photodynamic therapies or ALL or ANY cytoluminescent therapies of ANY or ALL human or animal disease(s) (i.e., as in claim 77)
A method of or for ALL or ANY photodynamic diagnosis of a human or animal disease, the method comprising administering a diagnostically effective amount of a compound or complex to a human or animal, wherein the compound or complex is a compound of formula (I) or a complex of formula (II): (i.e., as in claim 79)
the method comprising administering a therapeutically effective amount of a compound or complex to a human or animal, wherein the compound or complex is a compound of formula (I) or a complex of formula (II): (i.e., as in claim 75)
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 the invention commensurate in scope with these claims.
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. Teletronics 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:
Nature Of The Invention.
The nature of the invention relates to phyllochlorin analogues and pharmaceutically acceptable salts, corresponding pharmaceutical compositions and methods for photodynamic therapy, cytoluminescent therapy and photodynamic diagnosis (i.e., for treating or detecting a tumor or antiviral treatment).
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
2. Scope Of The Claims.
The scope of the claims relates to these classes exemplified by independent claim types:
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Thus, the scope of claims is very broad.
3 & 4) State of the Art and Predictability In The Art.
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally
considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
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 (i.e., see MPEP 2164.03)
Amount Of Guidance Provided By Applicants and 6. Working Examples.
Applicants provide guidance in the detailed specification and working examples demonstrate the practicality of the claimed invention, which include detailed examples exemplified by:
Synthetic compound Examples 1-25
Experimental In-Vitro Examples 1-4 (i.e., compound chemical & physical properties) and In-Vivo Examples 5-7 as shown below:
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Only 2 compound Examples 3 and 6 were tested for activity as shown in Examples 5 to 7 in the present invention
Regarding noted above, these cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However,...there is no evidence that such compounds exist...the examples of the '881 patent do not produce the postulated compounds...there is...no evidence that such compounds even exist.
The same circumstance appears to be true here. Hence, Applicants must show that the scope of claimed compounds and other requirements yields all the desired effects of scope claimed, other than those exemplified by the limited Experimental Example section of the present invention, where examples can be made/ used for the stated purpose in all situations across the board, not just in animals, but also in human subjects or limit the claims accordingly.
7. Level Of Skill In The Art (High)
An ordinary artisan in the area of drug development would have experience in screening chemical compounds for particular activities. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
An ordinary artisan with expertise in the biological areas of molecular biology, immunology, biopharma, biotech, pharmacology, medicinal chemistry organic, biological, organic, and /or related drug development technologies would recognize the significance of biological mechanisms of action involving use of tubulin polymerization inhibitors for treatment of various types of cancer.
The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known.
Additionally, while high throughput screening assays can often be employed, developing a therapeutic method for a complex invention as claimed, is generally not well-known or routine, given the complexity of certain biological systems. Screening of new drug candidates, while complex, is routine in the art.
MPEP §2164.01 (a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here as Applicants are not enabled for making or using all these compounds (i.e., as described in general terms, inc., but not limited to starting materials, intermediates, etc.) or pharmaceutical compositions thereof (i.e., e.g., by using not specifically reagents and/or, reactions conditions, etc. ) or treating the diseases taught in the specification.
The claims are directed to a method for treating a wide variety of cancers, including a method for inhibiting, suppressing, or reducing the severity of cancer. However, the specification provides only a single working example demonstrating the administration of Compound X to treat breast cancer in a mouse model. The application provides no evidence that the method is effective across the entire genus of cancer, which includes dozens of different disease types with distinct genetic and molecular pathways.
The specification does not establish that a person of ordinary skill in the art could apply this treatment to other cancer types numerous broad and specific disease types defined in the specification and in claims 75, 76 and 78 without resorting to undue experimentation. The application lacks any common structural or functional feature for all claimed cancers that would allow one to extrapolate the successful results from breast cancer to all other forms of the disease. The burden is on the applicant to show that the disclosure is enabling for the full scope of the claimed invention, but here, the disclosure of success in a single cancer model is not commensurate with the breadth of the claim.
Accordingly, above-identified claims of the instant invention are non-enabled under 35 U.S.C. § 112(a).
Conclusion
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/G.C.H./
Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624