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 1-5 and 13-25 are currently pending in the instant application. Applicants have amended claims 1-5 and 13, added new claims 13-25 and cancelled claims 6-12 in an amendment filed on January 20, 2026. Claims 17-20 are rejected, claim 3 is objected and claims 1-2, 4, 5, 13-16 and 21-25 are considered allowable in this Office Action.
I. Response to Arguments/Remarks
Applicants’ amendment, filed on January 20, 2026, has overcome the rejection of claims 1-2, 4 and 5 under 35 USC 102(a)(1) as being anticipated by WO 2019/078246 A1; the rejection of claims 1-2, 4 and 5 under 35 USC 102(a)(1) as being anticipated by Fadeyeva, et al. (Khimiko-farmatsevticheskii Zhurnal, Vol. 26, No. 9-10, 31 October 1992, pages 677-679); the rejection of claims 1, 2 and 4-13 under 35 USC 112(b) as being indefinite for the phrase “preferably”, “more preferably” or “most preferably”; the rejection of claim 2 under 35 USC 112(b) as being indefinite for the phrase “such as” ; the rejection of claims 6-12 under 35 USC 101 as being directed to non-statutory subject matter for the phrase “Use of a compound”; the objection of claim 3 as being dependent upon a rejected based claim and the objection of claim 3 for not containing the term “and” in between the last two compounds.
The above rejections and objection have been withdrawn.
The objection to claim 3 for containing structures that are illegible and/or too small has not been addressed. This part of the objection has been maintained.
II. Rejection(s)
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 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 17-20 are rejected under 35 U.S.C. 112 (a), because the specification, while being enabling for a method of treating diseases related to outside-in signaling mediated by the interaction of integrin β3 with Src kinase does not reasonably provide enablement for a method of preventing diseases related to outside-in signaling mediated by the interaction of integrin β3 with Src kinase. 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.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case
The nature of the invention
The nature of the invention is a method of treating diseases related to outside-in signaling mediated by the interaction of integrin β3 with Src kinase. Support for the intended use is in vitro data for Binding constants of compound and protein SH3 and the Inhibition of platelet stretching on fibrinogen on pages 182-195 of the specification.
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 statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects of any condition mediated by inhibiting platelet stretching on fibrinogen, whether or not the condition is affected by the instant compounds’ activity would make a difference.
For example, Applicants’ claim is drawn to a method of preventing tumors. It is well known in the art that tumors include 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. Cancer is a disease characterized by a population of cells that grow and divide without respect to normal limits, invade and destroy adjacent tissues, and may spread to distant anatomic sites through a process called metastasis. Most cancers are named for where they start. For example, lung cancer starts in the lung, and breast cancer starts in the breast. Symptoms and treatment depend on the cancer type and how advanced it is (URL: https://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). Treatment may include surgery, radiation, chemotherapy, immunotherapy, monoclonal antibody therapy, etc. 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 example shows that there are different cellular mechanisms, the unpredictability in the art and the different treatment protocols. Because "cancer" refers to a class of diseases, it is unlikely that there will ever be a single "treatment for cancer".
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 amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is minimal. There are no working examples present for preventing all diseases related to outside-in signaling mediated by the interaction of integrin β3 with Src kinase.
Test assays and procedure are provided in the specification such as in vitro data for Binding constants of compound and protein SH3 and the Inhibition of platelet stretching on fibrinogen on pages 182-195.
Receptor activity is generally unpredictable and the data provided is insufficient for one of ordinary skill in the art in order to extrapolate to the other compounds of the claims. It is inconceivable as to how the claimed compounds can treat the extremely difficult diseases embraced by the instant claims.
Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds. 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 breadth of the claims
The breadth of the claims is a method of preventing and/or treating diseases related to outside-in signaling mediated by the interaction of integrin β3 with Src kinase.
The quantity of experimentation needed and the level of the skill in the art
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases would be benefited by the effects of inhibiting platelet stretching on fibrinogen and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment or prevention of the diseases.
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 or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
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 “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 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 diseases can be treated by the compound encompassed in the instant claims, with no assurance of success.
This rejection can be overcome, for example, by amending the claim to read on the subject matter that Applicants' specification are enabled for as indicated above.
III. Objections
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 contains structures that are illegible and/or too small. Appropriate correction is required.
IV. Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is (571)272-9043. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached on (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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