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, 2, 4, 5, 7, 9, 13, 15, 17, 19, 20, 22 and 31-34 are presented for examination.
Applicants’ drawings, information disclosure statement, and preliminary amendment filed January 13, 2023 have been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms ABRAXANE®, Vidaza, Afinitor®, Revlimid®, Cyramza®, Stivarga®, Synovir®, Thalomid®, Caprelsa®, and Zaltrap®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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, 4, 5, 7, 13, 15, 17, 19, 20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad term: metastasis. The mere fact that Applicant may have discovered one type of metastasis is treated or prevented with the administration of an effective amount of carbon monoxide at a low dose of about 100 ppm to about 300 ppm is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 1, 4, 5, 7, 13, 15, 17, 19, 20 and 22 are not allowed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 22, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 22 contains the trademark/trade name ABRAXANE®, Vidaza, Afinitor®, Revlimid®, Cyramza®, Stivarga®, Synovir®, Thalomid®, Caprelsa®, and Zaltrap®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe albumin-bound paclitaxel, azacitidine, everolomus, lenalidomide, ramucirumab, regorfenib, thalidomide, vandetanib, and ziv-aflibercept and, accordingly, the identification/description is indefinite.
Claim 22 is not allowed.
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)(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.
Claim(s) 1, 2, 4, 5, 9 and 31-34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 03/103585 A2, hereby known as Otterbein et al., and taken in evidence with Kourti, “Combining carbon-monoxide-releasing molecules with anti-VEGF therapy for triple-negative breast cancer therapy”, Cardiff University, (August 01, 2013)(A5 of PTO-1449).
Otterbein et al. teach a method of treating cancer or unwanted angiogenesis, tumor growth and metastasis in a patient with a pharmaceutical composition that includes carbon monoxide to the patient (see the abstract). Note page 8, lines 11-26 teaches the effective amounts of carbon monoxide in the composition falls in the range of about 0.0000001% to about 0.3% by weight. Note the conversion of percent weight to ppm is 1% = 10000 ppm, thus 0.010% to about 0.03% converts to 100 ppm to about 300 ppm. Note page 10, lines 3-8 teaches the various cancers treated with the carbon monoxide, for example, breast, lung, stomach, liver, pancreas, ovary, bone, bladder, and others.
The Kourti reference is taken in evidence to show that carbon-monoxide molecules such as carbon monoxide is effective in treatment of triple-negative breast cancer wherein the patient exhibits one mutation gene, BRAC1.
As to the carbon monoxide, a product of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 709, 15 USPQ 2d 1655, 1658 (Fed. Cir. 1990)). In the instant application, the aforesaid to treated a subject that is diagnosed with breast cancer that is an estrogen receptor negative (ER⁻) breast cancer, an estrogen receptor positive (ER⁺) breast cancer, a progesterone receptor negative breast cancer (PR), a progesterone receptor positive (PR⁻) breast cancer, a Her2⁺ breast cancer, or a triple negative (ER:/PR:/Her2*) breast cancer is anticipated by Otterbein et al. since the active agent, carbon monoxide, possesses the same identical chemical structure.
As to the carbon monoxide, a product of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 709, 15 USPQ 2d 1655, 1658 (Fed. Cir. 1990)). In the instant application, the aforesaid to administration of the effective amount of carbon monoxide results in decreased levels of one or more tricarboxylic acid (TCA) cycles metabolites in cancer cells compared to untreated cancer cells is anticipated by Otterbein et al. since the active agent, carbon monoxide, possesses the same identical chemical structure.
Clearly, the cited reference anticipates the applicants’ instant invention; therefore, applicants’ instant invention is unpatentable.
Claims 1, 2, 4, 5, 9 and 31-34 are not allowed.
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.
Claim(s) 1, 2, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wegiel et al., “Carbon Monoxide Expedited Metabolic Exhaustion to Inhibit Tumor Growth”, Cancer Research, Vol. 73, No. 23, pages 7009-7021 (2013), A6 of PTO-1449.
Wegiel et al. teach on page 7010, column 2, Animal tumor models, that 250 ppm of CO was administered to nu/nu mice for prostate cancer. Note on page 7019, under Discussion, the administrated of CO inhibited prostate and lung tumor growth alone, and amplifies tumor cell death when treated with either doxorubin or camptothecin (both topoisomerase inhibitors).
Clearly, the cited reference anticipates the applicants’ instant invention; therefore, applicants’ instant invention is unpatentable.
Claims 1, 2, 20 and 22 are not allowed.
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.
Claim(s) 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vitek et al., “Antiproliferative effects of carbon monoxide on pancreatic cancer”, Digestive and Liver Disease, Vol. 46, No, 4, pages 369-375 (2014).
Vitek et al. teach administration of 500 ppm of carbon monoxide to treat pancreatic cancer, a metastasis.
Clearly, the cited reference anticipates the applicants’ instant invention; therefore, applicants’ instant invention is unpatentable.
Claim 7 is not allowed.
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, 2, 4, 5 , 9, 19, 15, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 03/103585 A2, hereby known as Otterbein et al., and taken in evidence with Kourti, “Combining carbon-monoxide-releasing molecules with anti-VEGF therapy for triple-negative breast cancer therapy”, Cardiff University, (August 01, 2013)(A5 of PTO-1449) in view of Kourti et al., “Aspects of Carbon Monoxide in Form of CO-Releasing Molecules Used in Cancer Treatment: More Light on the Way”, Oxidative Medicine and Cellular Longevity, Vol. 2017, No. 1 (2017) and/or Yan et al., “Emerging Delivery Strategies of Carbon Monoxide for Therapeutic Applications: from CO Gas to CO Releasing Nanomaterials:, Nano-Micro Small, Vol. 15, No. 49, pages 1-22 (2019).
Otterbein et al., taken in evidence with Kourti et al. were discussed above supra for the administration of about 100 ppm to about 300 ppm for the treating or preventing metastasis in a subject in need thereof.
The instant invention differs from the cited references in that the cited references do not teach other type of carbon monoxide type active agents used too. However, one secondary reference, Kourti et al., teaches carbon monoxide in the form of CO-releasing molecules used in cancer treatment are well-known. Note page 2, under 2. Carbon Monoxide-Releasing Molecules (CORMs), to page 3 in Figure 2, shows the classic and novel CORMs (same as applicants’ claim 15). Now the other secondary reference, Yan et al., teaches on page 9, Table 1, that Lipid nanoparticles can be used in as CO.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute CORMs for carbon monoxide with a predictable expectation of successful treatment due to the functional similarities.
Claim(s) 1, 2, 4, 5 , 9, 19, 15, 17 and 19 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629