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 1-17 are pending in the instant application. Claims 1-16 are rejected. Claim 17 is objected.
Information Disclosure Statements
The information disclosure statements filed on November 1, 2024 and January 14, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
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 1-16 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 method of treating a metastatic or chemoresistant cancer wherein ALDH1a3 is implicated in the cancer or treating type 2 diabetes in a subject in need thereof, or inhibiting the proliferation of a metastatic or chemoresistant cancer cell wherein ALDH1a3 is implicated in the cancer cell, does not reasonably provide enablement for a method of treating every known (in the art) type of metastatic or chemoresistant cancer, or inhibiting the proliferation of every known (in the art) metastatic or chemoresistant cancer cell. 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.
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 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 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 inhibition of ALDH1a3 or the administration of a compound of the claims would make a difference.
With regards to the treatment of cancer, the state of the prior art is that cancer therapy remains highly unpredictable. There are many known (in the art) types of cancer. 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 various types of cancers claimed as capable of treatment through the administration of a compound of the claims, one of skill in the art is unable to fully predict possible results from the administration 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 by the administration of a compound of the claims or the inhibition of ALDH1a3 (e.g., see [0008] and [0051]), an ALDEFLUORTM assay and assays involving ALDH1a3 (see pages 39-54 of the specification). However, the specification does not contain any evidentiary support that the administration would be able to treat the many various diseases listed. Furthermore, there are no working examples to support the treatment of the instantly claimed diseases besides the assays which are drawn to the treatment of cancers wherein ALDH1a3 is implicated.
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 diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the administration of a compound of the claims for the treatment of the various claimed diseases, as a result necessitating one of skill to perform an exhaustive search for which diseases can be treated by the administration of a compound of the 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 a compound of the claims.
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 specification. 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 by the administration of a compound of the claims.
This rejection can be overcome, for example, by amending the claims to be drawn to a method of treating a metastatic or chemoresistant cancer wherein ALDH1a3 is implicated in the cancer or treating type 2 diabetes in a subject in need thereof, or inhibiting the proliferation of a metastatic or chemoresistant cancer cell wherein ALDH1a3 is implicated in the cancer cell.
Claim Objections
Claim 17 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.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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