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 .
Claim Status
Claims 1-20 are pending.
Claims 1-5 and 15-16 are examined herein.
Claims 6-14 and 17-20 are withdrawn (see restriction/election below).
Priority
This application is filed 03/04/2024, and claims the benefit of domestic priority as below:
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Information Disclosure Statements
One IDS(s) received on 7/31/2024 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant elects Group I, claims 1-8 and 15-16, is drawn to a composition comprising a cannabinoid and an anticancer agent, with traverse in the reply field on 06/25/2026 is acknowledged.
However, claim 20 was inadvertently omitted from the method of use group (e.g., Group II). This error is corrected herein as follows:
Claims 1-8, and 15-16, are drawn to a composition comprising a cannabinoid and an anticancer agent, classified in CPC A61K 31/658.
Claims 9-14, and 17-20, are drawn to a method of treating lung cancer by administering a composition comprising a cannabinoid and an anticancer agent, classified in CPC A61P 35/00.
In view of this correction, the restriction requirement is not made final in this Office Action to allow Applicants an opportunity to respond to the revised grouping.
Accordingly, non-elected Group II, claims 9-14 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicants argue that the restriction is improper because Office Action has not shown that a serious burden would be required to examine all of the claims. This argument is not persuasive because the claims encompass patentably distinct species within a broad genus. In particular, as explained in the restriction Office action, the two groups above require different fields of search as evidenced by their different classifications. Examination of the composition claims requires a search directed to cannabinoid and anticancer agent combinations, including the identity, structure, and compatibility of the selected cannabinoid and anticancer agent. In contrast, examination of method of use claims requires as additional searching burden directed to therapeutic use, lung cancer treatment, dosage, administration route, treatment regimen, clinical efficacy, and pathway specific us of the selected anticancer agent. In addition, the claims include compositions and methods involving EGFR inhibitors, such as Osimertinib and Gefitinib, and a different class of anticancer agents, KRAS inhibitors, such as MRTX 1133. EGFT inhibitors and KRAS inhibitors involve different molecular targets, mechanism of action, compounds, and prior art. Thus, examination of both distinct groups, including all claimed species, would require separate searches in different fields and separate patentability analyses, thereby imposing a serious search and/or examination burden. Accordingly, the serious burden requirement is satisfied for the restriction under MPEP 803.
Applicants also argues that the present genus of 2 claimed inhibitor classes and 29 claimed individual anticancer agents (and 1 claimed cannabinoid, if relevant) represents a finite number of species and that claims 1-2 and 9-14 are generic.
This argument is not persuasive because the relevant question is not merely whether the species are finite or whether generic claims are present, but whether the species are patentably distinct and whether examination of all species would impose a serious search and /or examination burden. The generic claims will be examined with the elected species, but the presence of generic claims does not require examination of all non-elected species at this stage. See MPEP 808.01(a) and 809.02(a).
Applicants’ reliance on 37 CFR 1.141(a) and 1.143 is acknowledged, but does not render the restriction/election requirement improper. Any later consideration or rejoinder of non-elected species will be addressed if and when a generic claim is found allowable.
Accordingly, the restriction requirement is deemed proper.
Applicant elects EGFR inhibitors, Osimertinib and CBD (if required), as the species, with traverse in the reply field on 06/25/2026 is acknowledged.
The claims 1-5 and 15-16 read on the elected species in Group I. Claims 6-8 from Group I are withdrawn from consideration because these claims do not read on the elected species.
If the elected specie is not identified in the prior arts, the elected specie would be allowable if
an independent claim were drafted with that specie alone. (see MPEP 802.03)
The elected specie was identified in the prior art. Accordingly, claims 1-5 and 15-16 read on the elected species, and will be examined on their merits, and no further claims are withdrawn.
With respect to the elected species, the art is rejected under 35 USC 102 and 35 USC 103 below.
Abstract
The abstract of the disclosure is objected to because the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. Currently, the abstract has 22 words.
The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The current submitted abstract is the front pages of PCT application. Examiner requests to bring in narrative form to satisfy the abstract requirement.
Correction is required. See MPEP § 608.01(b).
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
The lines, numbers and lettering are not clean, well-defined, sufficiently dense and dark, and uniformly thick and well defined in Figure(s) 1, 2 and 4A-4C. See 37 CFR 1.84(l) and (q). The text and characters, in particular, have significant blurry and spread out, making them difficult to read.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
With respect to claim 1, the term "an anticancer agent" is interpreted as "any molecule capable of treating cancer."
With respect to claims 1 and 15, the phrase “a composition comprising a cannabinoid and an anticancer agent” in claim 1 and the phrase “a composition comprising a CBD and an EGFR inhibitor” in claim 15 are interpreted to encompass a therapeutic composition or combination inhibitor. The transitional term “comprising” is open ended and does not require the recited cannabinoid/CBD and anticancer agent/EGFR inhibitor to be the only active ingredients.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 is objected to because “erlotinib ”, and “neratibib” are duplicated.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The Examiner has followed the guidance set forth in MPEP 2106 and has concluded that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter.
Eligibility Step 1: The Four Categories of Statutory Subject Matter
Step 1 asks if the claim is to a process, machine, manufacture or composition of matter. The claims 1 and 2 are drawn to a composition comprising a cannabinoid and an anticancer agent. Therefore, the answer to the question of Step 1 for claims 1 and 2 is Yes, because the claims are considered directed to a composition of matter, which is eligible subject matter.
Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception
Prong One asks if the claim recites a natural phenomenon. The specification identifies naturally occurring phytocannabinoids, including THC, CBD, CBG, CBC, and CBN, as cannabinoids within the scope of the claims (paragraph [0033]). As discussed the claim interpretation above, claim 1 does not limit an anticancer agent, and the cannabinoid and anticancer agent to belong to different chemical classes. Under BRI, one naturally occurring cannabinoid may satisfy the “cannabinoid” limitation, while a second naturally occurring cannabinoid having anticancer activity may satisfy the “anticancer agent” limitation.
Blasco-Benito et al.,(Appraising the "entourage effect": Antitumor action of a pure cannabinoid versus a botanical drug preparation in preclinical models of breast cancer, Biochem. Pharmacol., 157, 285-293, pub’d 06/27/2018) disclose that a THC rich botanical preparation derived from Cannabis produced antitumor effects in breast cancer models and is more potent than purified THC (abstract). In addition, Hinz et al. (Cannabinoids as anticancer drugs: current status of preclinical research, Br. J. Cancer, 127(1), 1-13, pub’d 03/11/2022) discloses the anticancer activity of THC, CBD, and other cannabinoids that are exerted at multiple levels of tumor progression via different signal transduction mechanisms (abstract, and Fig 1 and 2). In view of Blasco-Benito and Hinz, the anticancer activity of CBD, THC or other cannabinoid is an inherent property of the natural molecule and does not create a markedly different characteristic.
Accordingly, claims 1 and 2 encompass a natural occurring or naturally derived cannabis composition (i.e., CBD as a cannabinoid and THC as an anticancer agent), that lack markedly different structural, functional, physical, or chemical characteristics from its natural counterpart. Therefore, the answer to the question of Step 2A in Prong One is Yes.
Prong Two asks if the claim recites additional elements that integrate the judicial exception into a practical application. In the instant case, claims 1 and 2 are directed to the composition itself, and it does not require a practical application. Therefore, the answer to the question of Step 2A in Prong Two is No, claims 1 and 2 do not include an additional element that meaningfully applies the product of nature or integrates it into a practical application.
Eligibility Step 2B: Whether a Claim Amounts to Significantly More
Step 2B asks if claims recite additional elements that amount to significantly more than the judicial exception. In the instant case, under the BRI, the cannabinoid and anticancer agent limitations (i.e., CBD as a cannabinoid and THC as an anticancer agent) may be satisfied two distinct naturally occurring cannabinoids present together in a cannabis extract. The claims does not add a non-natural ingredient, chemical modification, delivery vehicle, treatment step, manufacturing limitation or non-natural concentration or ratio.
Therefore, the claimed composition is not deemed to be different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303 (1980)). Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)).
Accordingly, the answer to the question of Step 2B is No, and claim 1 and 2 are ineligible under 35 USC 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by SÁEZ et al. (US 2022/0226259 A1, pub’d 7/21/2022).
SÁEZ discloses a pharmaceutical composition comprising at least one compound selected from the group consisting of (-)-CBD, (-)-CDBV, and (+)-CBDV; at least one pharmaceutically acceptable excipient; and further comprising at least one additional active compound or therapeutic ingredient for use in the treatment of a cancer (claims 19, 20 and 23). SÁEZ identifies numerous active compound or therapeutic ingredient suitable for such cancer therapy, including well known EGFR inhibitors such as Erlotinib or Gefitinib (claim 24 and paragraph [0066]).
With respect to claim 1, SÁEZ teaches a cannabinoid containing pharmaceutical composition for cancer treatment and further teaches use of the composition may comprising with additional anticancer agents (claims 19 and 23), as required by claim 1.
With respect to claim 2, SÁEZ teaches a pharmaceutical composition comprises cannabidiol (CBD) (claim 19), as required by claim 2.
With respect to claims 3-5, SÁEZ teaches anticancer agents including EGFR inhibitors. Although, SÁEZ does not separately define the term “EGFR inhibitor”, the list agents, Erlotinib and Gefitinib, are well-known targeted cancer therapies that inhibit EGFR signaling (claim 24 and paragraph [0066]). Thus, SÁEZ discloses the anticancer agent class required by claim 3, the EGFR inhibitor species required by claim 4, and the specific anticancer agents, including Erlotinib and Gefitinib, recited in claim 5.
With respect to claims 15-16, as discussed above, SÁEZ discloses a therapeutic composition comprising CBD and an EGFR inhibitor, as required by claim 15, and the specific EGFR inhibitor required by claim 16 (claims 19, 23, 24 and paragraph [0066]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over SÁEZ et al. (US 2022/0226259 A1, pub’d 7/21/2022), in view of Bertenshaw et al., (US 2022/0339257 A1, pub’d 10/27/2022).
Claim(s) 1-5 and 15-16 is/are rejected by SÁEZ, as discussed above. Nevertheless, this rejection is made to the extent to the listed alternative EGFR inhibitors, including Osimertinib.
With respect to independent claim 1, the claim recites that a composition comprising a cannabinoid and an anticancer agent.
As discussed above under 35 USC 102, SÁEZ discloses a pharmaceutical composition comprising at least one compound selected from the group consisting of (-)-CBD, (-)-CDBV, and (+)-CBDV; at least one pharmaceutically acceptable excipient; and further comprising at least one additional active compound or therapeutic ingredient for use in the treatment of a cancer (claims 19, 20 and 23). SÁEZ further teaches numerous active compound or therapeutic ingredient suitable for such cancer therapy, including well known EGFR inhibitors such as Erlotinib or Gefitinib (claim 24 and paragraph [0066]).
SÁEZ fails to teach the alternative EGFR inhibitor, Osimertinib, even though SÁEZ discloses Erlotinib and Gefitinib.
Bertenshaw teaches using one or more modulator or enhancer molecules to enhance the response of a biological sample or cancer subject to one or more anticancer therapies and/or to reverse or overcome resistance to such anticancer therapies (claims 1, 19, 20, and abstract). Bertenshaw further teaches that the modulator or enhancer molecules may be a cannabinoid including CBD, and anticancer therapies may be a molecularly targeted therapy, including Gefitinib and Osimertinib as an EGFR inhibitor (claims 1, 19, 20, and abstract). In addition, Bertenshaw teaches that the anticancer agent and/or modulator may be formulated with a pharmaceutically acceptable carrier (paragraph [0015] and [0071]). It supports the use of CBD/cannabinoid modulator with EGFR inhibitor anticancer therapy, including in pharmaceutically acceptable compositions or formulations.
It would have been obvious to a PHOSITA at the time of the invention to provide the CBD containing cancer treatment composition of SÁEZ with an EGFR inhibitor, including Gefitinib or Osimertinib, in order to cannabinoids, including CBD, may be used as modulator or enhancer molecules with anticancer therapies, including EGFR inhibitors, to enhance therapeutic response and/or overcome resistance, as taught by Bertenshaw. SÁEZ already teaches a CBD containing pharmaceutical composition comprising an additional anticancer active compounds such as Erlotinib or Gefitinib. Bertenshaw identifies that Gefitinib or Osimertinib as EGFR inhibitors with CBD/cannabinoids are suitable for anticancer therapy. Thus, combining SÁEZ’s CBD containing pharmaceutical composition together with an EGFR inhibitor, including Gefitinib or Osimertinib , to obtain the expected benefit of enhanced response to EGFR inhibitor therapy and/or overcoming resistance to such therapy taught by Bertenshaw. Accordingly, the combination would have involved the predictable use of known therapeutic agents according to their established functions.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Constantly, applying KSR example rationale (A) in the independent claim 1, it would have been prima facie obvious to combine CBD containing cancer composition and EGFR inhibitors such as Gefitinib and Osimertinib are known, and Bertenshaw teaches using CBD/cannabinoids with EGFR inhibitor therapy to enhance response or overcome resistance represents the predictable use of known elements according to their established functions, yielding predictable results. (see MPEP 2141)
With respect to claims 2-5, the claims recite that the composition of claim 1, wherein the cannabinoid is CBD; wherein the anticancer agent is an EGFR inhibitor; wherein the EGFR inhibitor is recited active drugs or a combination thereof; and wherein the EGFR inhibitor is Osimertinib , Gefitinib, or a combination thereof.
SÁEZ teaches 1) CBD containing pharmaceutical composition for cancer treatment (claim 19); 2) the composition may comprise at least one additional active compound or therapeutic ingredient (claim 23); 3) therapeutic ingredient suitable for such cancer therapy, including well known EGFR inhibitors such as Erlotinib or Gefitinib (claim 24 and paragraph [0066]).
SÁEZ fails to teach that the alternative EGFR inhibitor, Osimertinib, and using the term ”EGFR inhibitor”.
Bertenshaw teaches the anticancer therapy is an inhibitor of epithelial growth factor receptor
(EGFR) selected from the group consisting of Erlotinib , Cetuximab, Osimertinib , Necitumumab, Gefitinib and Afatinib (claim 20) that overlap with SÁEZ’s list and recited list in the instant claim 4.
With respect to claims 15-16, the claims recite that a composition comprising CBD and an EGFR inhibitor, wherein the EGFR inhibitor is Osimertinib , Gefitinib, or a combination thereof.
For the same reasons discussed above with respect to claims 1, the combination of SÁEZ and Bertenshaw teaches a composition comprising CBD and an EGFR inhibitor, wherein the EGFR inhibitor is Osimertinib , or Gefitinib.
Conclusion
Claim 4 is objected to.
Claims 1-5 and 15-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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