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 .
Claims 1-11 are pending in the instant application. Claims 2-9 are rejected. Claim 1 is allowed.
Information Disclosure Statement
The information disclosure statement filed on November 16, 2023 has been considered and a signed copy of form 1449 is enclosed herewith.
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.
Claim 9 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 9 contains the trademarks/trade names Glivec, Tasigna, etc. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names are used to identify/describe imatinib mesylate and nilotinib, respectively, and, accordingly, the identification/description is indefinite. This rejection can be overcome by replacing all the trade names listed in claim 9 (i.e., all 11 trade names) with the chemical compound names they are used to identify/describe.
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 2-9 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 a pharmaceutical composition for treating prostate cancer, breast cancer or lung cancer and a method for treating prostate cancer, breast cancer or lung cancer, does not reasonably provide enablement for a pharmaceutical composition for preventing prostate cancer, breast cancer or lung cancer and a method for preventing prostate cancer, breast cancer or lung cancer nor does it reasonable provide enablement for a pharmaceutical composition for preventing or treating every known (in the art) type of cancer and a method for preventing or treating every known (in the art) type of cancer. 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.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include: nature of the invention, breadth of the claims, guidance of the
specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The state of the prior art and the predictability or lack thereof in the art
The term “prevention” actually means to anticipate or counter in advance, to keep from happening, etc. and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds can be administered in order to have the "preventative" effect.
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e., what compounds can prevent or treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statue. In the instant case, the claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects, whether or not the disease is affected by the administration of a compound of Chemical Formula 1 would make a difference.
With regards to the treatment of cancer, the state of the prior art is that cancer therapy remains highly unpredictable. The various types of cancers have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. Symptoms and treatment depend on the cancer type and how advanced it is (see URL: http://www.nlm.nih.gov/medlineplus/cancer.html). It is known that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, that cancer classification has been based primarily on morphological appearance of the tumor and that tumors with similar histopathological appearance can follow significantly different clinical courses and show different responses to therapy (Golub et al., page 531). Furthermore, it is known that chemotherapy is most effective against tumors with rapidly dividing cells and that cells of solid tumors divide relatively slowly and chemotherapy is often less effective against them. It is also known in the prior art (Lala et al., page 91) that the role of NO in tumor biology remains incompletely understood with both the promotion and inhibition of NO mentioned for the treatment of tumor progression and only certain human cancers may be treated by selected NO-blocking drugs. These examples show that there are different cellular mechanisms, the unpredictability in the art and the different treatment protocols.
Also, with specific reference to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the "general unpredictability of the field [of] ...anti-cancer treatment." In re Application of Hozumi et al., 226 USPQ 353 notes the "fact that the art of cancer chemotherapy is highly unpredictable".
Hence, in the absence of a showing of correlation between all the diseases claimed as capable of treatment or prevention through the administration of a compound of Chemical Formula 1, one of skill in the art is unable to fully predict possible results due to the unpredictability.
The amount of direction or guidance present and the presence or absence of working examples
A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that the compounds which fall within the scope of a claim will possess the alleged activity. The only direction or guidance present in the instant specification is the listing of diseases Applicant considers as treatable or preventable by administration of a compound of Chemical Formula 1 which results in the inhibition of STAT3 activity, various non-patent literature citations that discuss the relationships between inhibition of STAT3 activity and (treatment of) cancer (see page 3) and assays measuring the confirmation of STAT3 phosphorylation inhibitory effect in prostate, breast and lung cancer cell lines, the confirmation of cancer cell growth inhibitory effect due to STAT3 phosphorylation inhibition in prostate, breast and lung cancer cell lines, the confirmation of effect of the compounds on normal cells, the confirmation of inhibition of expression and apoptotic effect of STAT3 target proteins in cancer cell lines, the confirmation of STAT3 phosphorylation inhibitory effect in natural killer cells and bone marrow-derived macrophages, the confirmation of growth inhibitory effect of cancer tissue in nude mice using transplant models of human-derived prostate cancer, and the verification of single oral dose toxicity in mice (see Examples 1-10 on pages 30-39). However, the disclosure does not provide how the assays correlate to treatment or prevention of the assorted diseases claimed as treatable or preventable. In other words, the specification does not contain any evidentiary support that these compounds would be able to treat or prevent every known (in the art) type of cancer. Furthermore, there are no working examples to support the treatment or prevention of the instantly claimed diseases except the assays which are drawn to breast cancer, prostate cancer and lung cancer (i.e., they involve DU-145, MDA-MB-468 and HCC827 cells and transplant models of human-derived prostate cancer).
Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds and pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved." See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The level of skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of the instant claims for the treatment or prevention of the various claimed diseases, as a result necessitating one of skill to perform an exhaustive search for which diseases can be treated or prevented by what compounds of the instant claims in order to practice the claimed invention.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what specific diseases are benefited by the administration of the compounds of the instant claims and would furthermore have to determine which of the claimed compounds would provide treatment or prevention of which diseases.
Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed method. In view of the chemical nature of the invention and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and ”[p]atent 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 and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which specific diseases can be treated or prevented by the compounds encompassed in the instant claims, with no assurance of success.
This rejection can be overcome by amending the claims to be drawn a pharmaceutical composition for treating prostate cancer, breast cancer or lung cancer and a method for treating prostate cancer, breast cancer or lung cancer.
Allowable Subject Matter
Claim 1 is allowed. No prior art was found. The closest prior art is Kim et al. (Bioorganic & Medicinal Chemistry Letters 28 (2018) 2566-2572) which discloses the compounds CG-01 and CG-02, for example, (see Scheme 1 on page 2567) which have three -OCH3 groups attached to a phenyl ring which corresponds to the phenyl ring in instant Chemical Formula 1 which only has one R1 group attached. Therefore, the compounds disclosed in the reference do not fit within the scope of those of the claims nor are they obvious variants.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622