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 .
DETAILED ACTION
Claims 1-18 are pending, and examined herein.
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 10, 18 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. The claims are drawn to a compound as described in claim 1, claim 12 for use in treatment or prevention of cancer. The specification fails to adequately teach how to use the herein claimed compounds to prevent a cancer as in instant claims 10, 18.
The instant specification fails to provide information that would allow the skilled artisan to practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The Nature of the lnvention:
The rejected claims are drawn to a compound as described in claim 1, and claim 12 for use in treatment or prevention of cancer.
(2) Breadth of the Claims:
The instant claim embraces a method for preventing a variety of cell proliferative disorders including but not limited to ependymoma, prostate cancer, esophageal cancer, thyroid cancer, hepatocellular carcinoma, testicular cancer, pediatric brain tumour, etc.
(3) Guidance of the Specification / Working Examples:
In the instant case, no working examples are presented in the specification as filed showing how to prevent a cancer in a human or animal totally, or permanently, not even occurring at the first time.
(4) State/predictability of the Art:
The relative skill of those in the art is high with regard to treating a specific cancer employing a specific compound.
The instant claims include a compound as described in claims 1, 12 for use in treatment or prevention of cancer, for example A 'cancer' or 'tumor growth' is anything that causes abnormal tissue growth. That can be growth by cellular proliferation more rapidly than normal, or continued growth after the stimulus that initiated the new growth has ceased, or lack (partial or complete) of structural organization and/or coordination with surrounding tissue. It can be benign or malignant.
Cell proliferative disorders for example cancers arise from a wide variety of sources, such as viruses (e.g. EBV, HHV-8, and HTLV-I), exposure to chemicals such as tobacco tars, genetic disorders, ionizing radiation, and a wide variety of failures of the body's cell growth regulatory mechanisms. Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities. Further, in order to prevent the occurrence of a cell proliferative disease such as cancer, one has to be able to determine a person susceptible to said disease. The state of the art is such that no method(s) is known for said determination. In essence, if one cannot determine a person in need of preventative therapy and/or the art nor the present specification teach how the skilled artisan could utilize the claimed compound to "prevent" the numerous diseases recited by the instant claims, applicant has not enabled the full scope of the claimed invention.
Thus, the skilled artisan would view that the ability to prevent a cell proliferative disorder in a human or animal totally, or permanently, not even occurring at the first time is highly unpredictable.
(5) The Quantity of Experimentation Necessary:
Applicant fails to provide information sufficient to practice the claimed invention, absent undue experimentation.
Genetech, 108 F.3d at 1366 states that “a patent is not a hunting Iicense. It is not a reward for search, but 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''.
Therefore, in view of the Wands factors, e.g., the amount of direction or guidance provided, absence of working examples, and the predictability of the art discussed above, to practice the claimed invention herein, a person of skill in the art would have to test various compounds in the instant claims to be administered to a host employed in the claimed methods of the particular treatments herein, with no assurance of success.
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, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18 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.
Regarding claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, the phrases " particularly, more particularly" in claims 1, 3, 4, 6, 7, 10, 12, 13, 14, 15, 18 render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The Applicant is encouraged to remove the indefinite language from the claims.
Claims 1-7, 9, 10, 11, 12, 13, 14, 15, 17, 18 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 1-7, 9, 10, 11, 12, 13, 14, 15, 17, 18 are not clear. The compounds of formula (500) and (700) in which X should represent O or S do not make chemical sense, as the valency of O or S would be exceeded to 3.
Claims 1, 2, 4, 5, 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.
It is not clear if the recitation “linear or branched” in claim 1 is part of the claim. If it is intended to be part of the claim as a limitation, it cannot be enclosed in the parenthesis.
Claims 2, 5 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.
Claim 2 recites the limitation wherein R1 is "-CH2-NH-CHR4R5, wherein - R4 and R5 together form an unsubstituted or OH-, halogen-, and/or CN- substituted cyclo-pentane or cyclo-hexane” in the claim. There is insufficient antecedent basis for this limitation in the claim, since claim 1 in its dependency chain does not encompass this recitation
Claim 3 is 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.
Claim 3 recites the limitation "formula (700)" in the claim. There is insufficient antecedent basis for this limitation in the claim, since claim 2 in its dependency chain recites R1 is -CH2-NH-CHR4R5.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1) Claims 1, 3, 6, 7, 8, 9, 10, 11, 12-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Library Supplier (See IDS filed on 02/03/2025).
The compound with RN: 1434129-57-3 is known in 2013. See structure below.
Entered STN: 04 Jun 2013
PNG
media_image1.png
234
374
media_image1.png
Greyscale
RN: 1434129-57-3
CN 6-Fluoro-2-[[[(1S)-1-(hydroxymethyl)-3-methylbutyl]amino]methyl]-4-quinolinol
2) Claims 1, 3, 6, 7, 8, 9, 10, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Library Supplier (See IDS filed on 02/03/2025).
The compound with RN: 1452968-68-1 is known in 2013. See structure below.
[AltContent: rect]
PNG
media_image2.png
201
434
media_image2.png
Greyscale
ED Entered STN: 22 Sep 2013
RN: 1452968-68-1
CN: 4-Quinolinol, 6-fluoro-2-[[[(1S)-1-(hydroxymethyl)-methylbutyl]amino]methyl]-
Prior Art Made of Record:
WO 2014018891;
WO 2011/017561.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627