DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s correspondence and preliminary amendment filed April 12, 2024, is acknowledged. Claims 3-10 are amended. Claims 1-14 are pending and presently subject to examination.
Information Disclosure Statement
3. The listing of references in the specification (e.g., pg. 57-65) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The references should be placed on an information disclosure statement if Applicant would like them considered.
Objection to the Specification
4. The instant specification is objected to for the following reasons:
a. There are trademarks in this application that do not meet the requirements.
The use of the term (e.g., “FACS” at para. [0117]), which is a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology whenever possible; furthermore the terms 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. Please, review the specification for other improper trademarks and correction is required.
b. There are also what appears to be claims under an addition embodiment section at para. [0267]-[0278]; the embodiments appear to be claims, and if they are claims they should be placed on a separate page. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112
5. 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.
Written Description
6. Claims 1-14 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 claims contain 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that:
"applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
No Written Description for the Breath of the Claims: methods for reducing metastasis in subjects with “cancer” in general or genus “gynecological” cancer: Applicant is in possession of methods for reducing metastasis in subjects with ovarian cancer.
Claim 1 recites a method for reducing metastasis in subjects having any type of cancer. The remaining claims depend therefrom, with claims 3 and 4 further specify the cancer is breast, gynecological, lung, or neuroendocrine cancer.
The claims therefore broadly encompass that metastasis may be reduced by the BMP-9 in a subject having any type of cancer, or e.g., gynecological cancer at claims 3-4.
The specification teaches in vitro and in vivo effects of BMP-9 using various ovarian cancer (OC) cell lines at FIGs. 1 and 15, and gene expression changes (particularly SOX2) in the OC cells at FIGs. 2-10 and 16-22. The specification explains at para. [0142] that TGF-β1 but not BMP-9 is enriched in ascites, and so OC cells are primarily exposed to TGF-β1 that stimulates SOX2 and suppresses anoikis (a form of apoptosis that prevents metastasis). The specification shows that BMP-9 inhibits SOX2, thereby counteracting the harmful effects of TGF-β1 in OC context.
The specification does not disclose any metastasis or cancer models other than OC.
The claims require that metastasis is reduced in subjects with any kind of cancer, or more specifically, breast, gynecological, lung, or neuroendocrine cancer. The specification only discloses results obtained in the context of OC. Therefore, the breath of the claims is not commensurate with the specification’s disclosure. To address this issue, a brief assessment of the state of the art of BMP-9 and SOX2 in cancer contexts is presented herein, which shows that it is very unpredictable how the instant findings regarding BMP-9 in OC context may translate into the reduction of metastasis associated with other disparate forms of cancer.
Shonibare et al. ("Reciprocal SOX2 regulation by SMAD1-SMAD3 is critical for anoikis resistance and metastasis in cancer." Cell reports 40.4 (2022)) is the companion journal article to the instant application. Shonibare et al. explains that “Ascites accumulation in the abdomen is associated with diseases of the peritoneal cavity, with 30% related to ovarian cancer (OC). More than 90% of stages III and IV OC patients present malignant ascites, which harbor cancer cell clusters in suspension that contribute to metastasis.” Shonibare et al. at introduction, first sentence. “Our findings implicate the use of a subset of BMPs as a therapeutic strategy and demonstrate a critical role of context-specific SOX2 regulation in controlling anchorage-independent survival and metastasis in ovarian cancer.” Shonibare et al. at introduction, last sentence. Shonibare et al. concludes: “Overall, our findings suggest that both intrinsic cellular states and the growth factor environment strongly influence SOX2, providing information on the effects of changing the balance in growth factors in the ovarian cancer ascites environment, which may inform therapeutic targeting of these pathways in ovarian cancer.” Accordingly, Shonibare et al. discusses how the results obtained are specific to OC, and the relationship between ascites exposure in the abdomen and OC through the unique growth factor environment’s effect on SOX2. Ovaries are in the abdomen—however, not all the cancers encompassed by the claims relate to ascites exposure in the abdomen. For example, breasts and lungs are not in the abdomen. Nor is the rest of the gynecological anatomy. Therefore, SOX2 for example is not expected to be regulated in the same way in other forms of cancer, promoting metastasis the same way, and therefore necessarily treatable by BMP-9.
Weina et al. ("SOX2 and cancer: current research and its implications in the clinic." Clinical and translational medicine 3.1 (2014): 19) is a review article of SOX2 in cancer and is presented to corroborate that SOX2 is differentially regulated in different cancers. For example, FIG 2 of Weina et al. shows how SOX2 not only regulates—but is regulated by—diverse signaling pathways, and therefore it is unpredictable how SOX2 may respond to BMP-9 or regulate metastasis in all cancer contexts. FIG. 2 of Weina et al. also shows that the results were contradictory as to SOX2’s role in breast cancer metastasis. FIG. 2 of Weina et al. is presented below for Applicant’s convenience:
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Therefore, without performing any the required experiments, it is unpredictable how BMP-9 will reduce metastasis in forms of gynecological cancer other than OC, let alone any of the other forms of cancer encompassed by the claims. Neither the art nor the specification provides a sufficient representative number of examples of other cancers wherein metastasis is reduced by BMP-9 to meet the written description requirement for instant claims directed to reducing metastasis in all forms of cancer. It is therefore unknown how BMP-9 would reduce metastasis in breast, gynecological, lung, or neuroendocrine cancers, or cancer in general. Applicant has only demonstrated possession for reducing metastasis in OC context.
No Written Description for the Breath of the Claims: administering “agonists” of BMP-9: Applicant is in possession of administering BMP-9 or recombinant BMP-9.
Claims 1 and 10 recite administering BMP-9 “or an agonist thereof.” The claims therefore encompass administering anything that agonizes the BMP-9 signaling pathway. However, the Specification provides no examples of administering any BMP-9 agonists other than BMP-9 itself.
The claims recite functional language of BMP-9 agonist, such as reduces metastasis; however a definition by function does not suffice to define the genus of BMP-9 agonists because it is only an indication of what the BMP-9 agonist does, rather than what it is. Therefor it is only a definition of a useful result rather than a definition of what achieves that result. In addition, because the genus of BMP-9 agonists is highly variable (i.e., each would necessarily have a unique structure; see MPEP 2434), the generic description of the substance in insufficient to describe the genus. Thus, the encompassed BMP-9 agonists have no correlation between their structure and function.
The specification only sets forth BMP-9 or recombinant BMP-9 as potentially having the claimed functionality; however, these species are not sufficiently representative of the genus “BMP-9 agonist” because: BMP-9 agonists do not have the same properties as BMP-9, and therefore it is unknown how well they may reduce metastasis in cancer or OC context. To address this issue, a brief assessment of the state of the art of BMP-9 agonists is made herein, which shows it is very unpredictable what biological activity the encompassed agonists will have, and therefore how they may reduce cancer metastasis.
Tong et al. ("A bone morphogenetic protein (BMP)-derived peptide based on the type I receptor-binding site modifies cell-type dependent BMP signaling." Scientific reports 9.1 (2019): 13446) is a report on BMP-9 mimetics. Tong et al. designed BMP-9 agonist “P3,” and surprisingly found “Although showing no baseline activity, P3 significantly enhanced BMP9-induced Smad1/5 phosphorylation as well as ID1, BMPR2, HEY1 and HEY2 gene expression in pulmonary artery endothelial cells (hPAECs), and this activity is dependent on its alpha helix propensity. However, in human dermal microvascular endothelial cells, P3 did not affect BMP9-induced Smad1/5 phosphorylation, but potently inhibited ALK3-dependent BMP4-induced Smad1/5 phosphorylation and gene expression. In C2C12 mouse myoblast cells, P3 had no effect on BMP9-induced osteogenic signaling, which is primarily mediated by ALK2. Interestingly, a previously published peptide from the knuckle region of BMP9 was found to inhibit BMP4-induced Smad1/5 phosphorylation. Together, our data identify a BMP9-derived peptide that can selectively enhance ALK1-mediated BMP9 signaling in hPAECs and modulate BMP9 and BMP4 signaling in a cell type-specific manner.” Tong et al. at abstract. Therefore, Tong et al. demonstrates that it is unpredictable what effects BMP-9 agonists will have from cell type to cell type, since P3 had different activity in pulmonary artery endothelial cells, dermal microvascular endothelial cells, and myoblasts. It is therefore unpredictable which of the encompassed BMP-9 agonists may reduce metastasis in OC context, let alone with all the other encompassed cancer types. Applicant has not performed any of the required experiments to determine which may work.
Neither the art nor the specification provides a sufficient representative number of BMP-9 agonists the met the written description requirement for instant claims encompassing BMP-9 “agonists” and having the required function of reducing cancer metastasis.
It is therefore unknown how the genus of BMP-9 agonists would reduce cancer metastasis. Applicant has not shown possession of a representative number of species that have the claimed function(s). The specification therefore provides insufficient written description to support the genera of BMP-9 agonists encompassed by the claims.
Given all of the above, Applicant does not have possession for: a method for reducing metastasis in a subject with cancer by administering BMP-9 agonists. Applicant is in possession of: a method for reducing metastasis in a subject with ovarian cancer by administering BMP-9.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
8. 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.
Claims 3-4 are rejected under 35 U.S.C 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claims 3-4 recite that that the cancer may be “gynecological” cancer. The specification does not indicate what cancers are encompassed by the genera “gynecological” cancer other than ovarian cancer. Therefore, the metes and bounds of the term “gynecological” are unclear. For example, does the term “gynecological” cancer include cervical cancer and uterine cancer? Appropriate clarification and/or correction is requested.
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. Claims 1-12 are rejected under 35 U.S.C 103 as obvious over Sampath et al. (WO 2000029012 A2, published May 25, 2000) in view of Varadaraj et al. ("Epigenetic regulation of GDF2 suppresses anoikis in ovarian and breast epithelia." Neoplasia 17.11 (2015): 826-838) and further in view of Jung et al. ("Bone morphogenetic protein-9 is a potent growth inhibitor of hepatocellular carcinoma and reduces the liver cancer stem cells population." Oncotarget 7.45 (2016): 73754).
Claim 1 is drawn to a method for reducing metastasis in a subject with cancer, the method comprising administering an effective amount of BMP9 or an agonist thereof, to the subject with cancer.
Claim 2 is drawn to the method according to claim 1, wherein the BMP9 is recombinant BMP9 (rBMP9).
Claim 3 is drawn to the method according to claim 1, wherein the cancer is selected from the group consisting of breast cancer, gynecological cancer, lung cancer, neuroendocrine cancer, and combinations thereof.
Claim 4 is drawn to the method according to claim 1, wherein the cancer is a gynecological cancer.
Claim 5 is drawn to the method according to claim 1, wherein the BMP9 is rhBMP that is administered for a period of at least 7 days.
Claim 6 is drawn to the method according to claim 1, wherein the BMP9 is rhBMP that is administered in an amount from 0.01 mg/kg to 50 mg/kg.
Claim 7 is drawn to the method according to claim 1, wherein the subject is a mammal.
Claim 8 is drawn to the method according to claim 1, wherein the subject is a human.
Claim 9 is drawn to the method according to claim 1, wherein administering the BMP9 or an agonist thereof suppresses three dimensional spheroid cell invasion.
Claim 10 is drawn to the method according to claim 1, wherein the BMP9 or an agonist is administered in a pharmaceutical composition comprising the BMP9 or an agonist and a pharmaceutically acceptable carrier.
Claim 11 is drawn to the method according to claim 10, wherein the pharmaceutical composition further comprises an additional therapeutic agent.
Claim 12 is drawn to the method according to claim 11, wherein the additional therapeutic agent is an anti-cancer compound.
Sampath et al. disclose methods of reducing metastasis in subjects with cancer comprising administering morphogens including BMP-9.
Sampath et al. is directed to methods of treating cancer to alleviate the symptoms of the cancer by inhibiting unregulated proliferation of cancerous cells using BMP morphogens (Sampath et al. at page 2, last paragraph). Sampath et al. indicate BMP-9 is a morphogen useful in the invention at page 3, ln. 13-14; and that the compositions and methods of the invention may be applied to the treatment of any mammalian subject afflicted with cancer, which necessarily includes humans, at pg. 13, ln, 10-11. Sampath et al. indicate symptoms of cancer may be alleviated in, inter alia, breast cancer, cervix cancer, fallopian tube cancer, lung cancer, ovarian cancer, and metastatic forms thereof at page 4, ln. 14-23. Sampath et al. teach at pg. 14, ln. 10-19: “BMPRs mediate BMP signaling [… .] Hence, the determination of BMPRs expression on targeted malignant cells represents a novel means to pre-screen a subject to enable the selection of subjects with high probability of responding to a given morphogen.” Sampath et al. therefore teach to match the BMP with the cancer based on the BMP signaling associated with the cancer. Sampath et al. teach the effective dose and dosage strategy will vary depending on a number of factors including biological efficacy of the selected agent and administration route at page 17, ln. 17-24; and provides an example injecting 200 µL of 100 ng/ml BMP-6 intratumorally in mice every other day for three weeks at Example 8. Accordingly, Sampath et al. injected a total of at least ten 20 ng doses, or 200 ng into the mice over the three weeks. For example, if the mice weighed 20 g, Sampath et al. therefore administered an amount of about 200 ng / 20 g = 0.01 mg/kg. Said administration was intra tumor, however Sampath et al. also discuss administration may be systemic at page 14, ln. 29; which will necessarily result in higher doses. Sampath et al. discuss producing recombinant morphogens by morphogen-secreting mammalian cells transfected with nucleic acid at pg. 15, ln. 19-21 (i.e., recombinant morphogen); and that the morphogen may be a human morphogen at pg. 3, ln. 8-18. Sampath et al. discuss pharmaceutically acceptable carriers at pg. 3, ln. 24-32; and teach at page 17, ln. 25-27: “Morphogens of the invention may be administered alone or in combination with other molecules known to be beneficial in the treatment of cancer. For example, one can administer various well-known anti-tumor agents, analgesics, or anti-inflammatory compounds with a morphogen.” The BMP-9 treatment suggested by Sampath et al. will also necessarily suppress three-dimensional spheroid cell invasion.
Sampath et al. do not explicitly treat cancer subjects with BMP-9 to reduce metastasis.
Vardadaraj et al. is a research article exploring BMP-9 (GDF2) regulation in ovarian and breast cancer contexts (see the title). The abstract of Vardadaraj et al. teaches: “Consistent with a role for GDF2 in promoting anoikis susceptibility, the analysis of cell lines and patient data suggests epigenetic silencing of GDF2 in cancer cell lines and increased promoter methylation in patients. These findings collectively indicate an antimetastatic role for GDF2 in ovarian and breast cancer.” Vardadaraj et al. therefore teach that BMP-9 has antimetastatic properties in ovarian and breast cancer contexts.
Jung et al. is a research article regarding BMP-9 in hepatocellular carcinoma contexts (see the title). Jung et al. at page 73759, last paragraph, teach that IV administration of recombinant BMP-9 at a concentration of 1 mg/kg (in vivo) significantly reduced tumor growth.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to treat a subject with BMP-9 and reduce metastasis as suggested by Sampath because: Sampath et al. has demonstrated treating subjects having cancer with BMP-6 to reduce metastasis, suggests BMP-9 will work with other cancers and also matching the morphogen used based on the cancer—for example, by determining BMPR expression levels. Further, one of ordinary skill would reasonably conclude to use BMP-9 in a method of reducing metastasis because Vardadaraj et al. firmly link deficient BMP-9 signaling to ovarian and breast cancer and also suggests that BMP-9 also has antimetastatic properties in breast and ovarian cancers; and Jung et al. shows that BMP-9 can be administered to treat cancer. Thus, the ordinary skilled artisan would conclude with a reasonable expectation of success that BMP-9 could be used to treat metastatic cancers.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." The combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine the prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Accordingly, Sampath et al. in view of Varadaraj et al. and further in view of Jung et al. renders claims 1-12 obvious.
12. Claims 1-14 are rejected under 35 U.S.C 103 as obvious over Sampath et al. in view of Varadaraj et al. and Jung et al. as applied to claims 1-12, and further in view of McGuire et al. ("Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer." New England Journal of Medicine 334.1 (1996): 1-6).
Claim 13 is drawn to the method according to claim 12, wherein the anti-cancer compound is paclitaxel.
Claim 14 is drawn to the method according to claim 12, wherein the anti-cancer compound is cisplatin.
The teachings of Sampath et al. in view of Varadaraj et al. and Jung et al. are discussed above.
McGuire et al. is a report on the outcome of a successful clinical trial of combinations of cisplatin and paclitaxel in ovarian cancer (see the title). McGuire et al. teach at the second sentence of the introduction: “Cisplatin-based combination therapy has been found to be more effective than alkylating agents alone or combinations without cisplatin, when measured by clinical response rates and progression-free intervals.” McGuire et al. teach at the abstract’s conclusion: “Incorporating paclitaxel into first-line therapy improves the duration of progression-free survival and of overall survival in women with incompletely resected stage III and stage IV ovarian cancer.” Accordingly, McGuire et al. shows that both cisplatin and paclitaxel were well-known anti-cancer therapies and the state of the art for ovarian cancer combination therapies.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use combination therapy with cisplatin or paclitaxel because: Sampath et al. teach that “Morphogens of the invention may be administered alone or in combination with other molecules known to be beneficial in the treatment of cancer.” McGuire et al. shows that both cisplatin and paclitaxel were molecules well-known to be beneficial in the treatment of cancer, and in combination therapies (combination therapies with these two molecules were the state of the art). Therefore, one of ordinary skill in the art would be motivated to try combination therapy with a BMP-9 and either of cisplatin or paclitaxel. There was also a reasonable expectation of success that the combination therapy would work because McGuire et al. broadly teach that combination therapies with these two molecules is more effective than monotherapies in at least ovarian cancer context.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." The combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine the prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Accordingly, Sampath et al. in view of Varadaraj et al. and Jung et al., and further in view of McGuire et al. renders claims 1-14 obvious.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached M-Th 7-5 EST.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
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