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 1-25 are pending in the instant application. Claims 24 and 25 are rejected. Claims 1-23 are allowed.
Information Disclosure Statements
The information disclosure statements filed on March 30, 2026 and May 26, 2026 have been considered and signed copies of form 1449 are enclosed herewith.
Response to Amendment and Arguments/Remarks
The amendment and arguments/remarks filed on March 30, 2026 have been fully considered and entered into the application. With regards to the 35 U.S.C. 112(b) and 35 U.S.C. 112(a) rejections, the grounds for rejection are moot in view of Applicant’s amendment and the rejections have been withdrawn.
It is noted that previously withdrawn claims 21-25 have been rejoined.
New 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 24 and 25 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 non-small cell lung cancer does not reasonably provide enablement for a method of treating every known 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 make an/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 administration of a conjugate comprising a structure of Formula X10 or X20 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 cancer claimed as capable of treatment through the administration of a conjugate of Formula X10 or Formula X20, 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 conjugate of Formula X10 or Formula X20 (see [0159]), an assay measuring lutetium accumulation in tumor, plasma and healthy tissues of NCI-H460 tumor-bearing mice (see example 2), an in vitro assay measuring HSP90 binding (see example 3), and an assay measuring the permeability of conjugates (see example 4). 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 involving NCI-H460 tumors or non-small cell lung 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 diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the administration of a conjugate of Formula X10 or Formula X20 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 conjugate of Formula X10 or Formula X20 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 conjugate of Formula X10 or Formula X20.
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 formulation and 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 by the administration of a conjugate of Formula X10 or Formula X20.
This rejection can be overcome, for example, by amending the claims to be drawn to a method of treating non-small cell lung cancer.
Allowable Subject Matter
Claims 1-23 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
Prosecution Insights