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 .
Claim Rejections - 35 USC § 112
Notice of AIA Status
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.
This rejection is directed to claims which encompass prophylactic administration.
Claims 9-20 are rejected under 35 U.S.C. 112(a), because the specification does not reasonably provide enablement for preventing metastatic diseases (claim 9); tumor recurrence (claim 13); at least one of radiation therapy resistance, chemotherapy resistance, and hormone therapy resistance (claim 17); by administering the compound as defined in each independent claim. 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.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by 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 quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method for preventing metastatic diseases; for preventing tumor recurrence; for preventing at least one of radiation therapy resistance, chemotherapy resistance, and hormone therapy resistance; and for preventing proliferation of at least one of cancer cells, cancer stem cells, and circulating tumor cells, the methods comprising administering to a patient in need thereof, a pharmaceutically effective amount of the depicted agent and a pharmaceutically acceptable carrier. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant stated in the specification that the compound of the instant invention increases inhibition of cancer stem cell proliferation, can inhibit growth of in vitro lung cancer cell line, can reduce cancer resistance to treatment, treat cancer, prevent metastatic diseases and tumor recurrence, nowhere in the specification did applicant demonstrate prevention of any disease or treatment of any disease for that matter by administering the claimed compound. Additionally, the examiner contends that cancer is characterized by genetic factors that cannot be prevented and thus prevention of any cancer is therefore highly unlikely. In fact, the specification fails to demonstrate treatment of any disease, let alone cancer. While Applicant describes how the compound of claim 1 may be useful, nowhere in the specification did applicant demonstrate prevention of any disease or disorder. Consequently, the examiner maintains that applicant has yet to enable the breadth of the claims.
2. The breadth of the claims
The claims are thus very broad insofar as they recite the “prevention of metastatic diseases or tumor recurrence by administering the aforementioned compound”. While “treatment” of cancer might theoretically be possible, as a practical matter it is nearly impossible to achieve prevention of various diseases with the same compound.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the compound to prevent tumor recurrence or metastatic diseases and subtypes. No reasonably specific guidance is provided concerning useful preventative protocols for the disclosed compound, other than what said compound could possibly be useful for. The latter is corroborated by the specification on page 15 and paragraph 0048.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed compound of claim 1 could be predictably used for the prevention of metastatic diseases, tumor recurrence, radiation therapy resistance and proliferation of at least on cancer cells as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 112
Notice of AIA Status
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.
This rejection is directed to claims encompassing treatment of cancer, metastatic diseases.
Claims 1-20 are rejected under 35 U.S.C. 112(a), because the specification does not reasonably provide enablement for treating cancer; reducing treatment resistance of a cancer; treating metastatic diseases; treating tumor recurrence; treating at least one of radiation therapy resistance, chemotherapy resistance or hormone therapy resistance by administrating the pyrrolo[2,3-d]pyrimidine compound (the compound) delineated in claims. 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.
The instant claims are drawn to a method for treating cancer; for reducing treatment resistance of a cancer; for treating or preventing metastatic diseases; for treating or preventing tumor recurrence; for treating or preventing at least one of radiation therapy resistance, chemotherapy resistance, and hormone therapy resistance; and for preventing or reducing the proliferation of at least one of cancer cells, cancer stem cells, and circulating tumor cells, the methods comprising administering to a patient in need thereof, a pharmaceutically effective amount of a compound of claim 1 and a pharmaceutically acceptable carrier. The instant specification fails to provide information that would allow the skilled artisan to practice the treatment of cancer, of metastatic diseases, tumor recurrence or treatment of the proliferation of cancer cells as recited in the claims.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by 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 quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates a method for treating cancer; for reducing treatment resistance of a cancer; for treating or preventing metastatic diseases; for treating or preventing tumor recurrence; for treating or preventing at least one of radiation therapy resistance, chemotherapy resistance, and hormone therapy resistance; and for preventing or reducing the proliferation of at least one of cancer cells, cancer stem cells, and circulating tumor cells, the methods comprising administering to a patient in need thereof, a pharmaceutically effective amount of a compound of claim 1 and a pharmaceutically acceptable carrier. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant stated in the specification that the compound of the instant invention increases inhibition of cancer stem cell proliferation, can inhibit growth of in vitro lung cancer cell line, can reduce cancer resistance to treatment, treat cancer, prevent metastatic diseases and tumor recurrence, nowhere in the specification did applicant demonstrate actual treatment of any disease, let alone cancer, by administering the compound of claim 1. Additionally, the examiner contends that it is known (see Golub et al., Science, Vol. 286, October 15, 1999, pages 531-537) in the current art that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, to maximize efficacy and minimize toxicity. 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., Science, Vol. 286, October 15, 1999, pages 531-537 cited in IDS 12/15/23). While Applicant describes how the compound may be useful, nowhere in the specification did applicant demonstrate treatment of any cancer or treatment of tumor recurrence or metastatic diseases. Given that applicant has yet to provide any data demonstrating treatment of any disease, the examiner contends that applicant has yet to enable the breadth of the claims.
2. The breadth of the claims
The claims are thus very broad insofar as they recite inter alia the “treatment of every single cancer by administering the aforementioned compound”. Likewise, Applicant does not demonstrate treatment of any of the diseases or disorders delineated in claims 1-20. While “treatment” of cancer might theoretically be possible, as a practical matter it is nearly impossible to achieve treatment of every single cancer in existence with the same compound.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the compounds to treat any cancer, to treat tumor recurrence or metastatic diseases and subtypes. No reasonably specific guidance is provided concerning useful therapeutic protocols for the disclosed compound, other than that said compound could possibly be useful for. The latter is corroborated by the specification on page 15 and paragraph 0048.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed compound could be predictably used for treatment of every single cancer, the treatment of metastatic diseases, tumor recurrence, radiation therapy resistance and treatment of proliferation of at least on cancer cells as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,965,983. Although the claims at issue are not identical, they are not patentably distinct from each other because. Claims of the ‘983 patent are directed to a compound and a pharmaceutical composition while current claims are directed to methods of treating metastatic disorders comprising administration of a composition comprising the same compound. The description of the ‘983 patent lists treatment of currently claimed disorders as the only utility of the pharmaceutical composition comprising the compound. A skilled artisan would have found it obvious to use the pharmaceutical composition of claim 5 of the ‘983 patent in treatment of disorders for which it has been designated by the description, thereby arriving at the currently claimed invention.
Conclusion
Claims 1-20 are pending
Claims 1-20 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.