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 .
Priority
The instant application is a National Stage entry of International application PCT/EP2021/075902 filed 21 September 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to European application 20382835.5 filed 22 September 2020..
Status of the Claims
Claims 1-20 are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Interpretation
Applicants claims are directed to methods of treating or preventing peripheral neuropathy by the administration of a product containing a C-phycocyanin component in a manner to provide between 0.1-4.5 mg/kg of body weight per day. Dependent claims require the inclusion of excipients or carriers with the product, or specify the C-phycocyanin component is C-phycocyanin, or indicate that the C-phycocyanin is an extract obtained from cyanobacteria, more specifically Spirulina platensis, in further dependent claims present in a concentration in the composition of at least 40% by weight, as either an oral or injectable composition. Dependent Claim 9 indicates that he composition is to be in the form of a solution of a defined concentration of C-phycocyanin in deionized water that demonstrates a particular ratio of absorbance at 616nm/650nm. The examiner notes that this ratio of absorbance at 616 vs 650 nm appears to reflect the absorbance of C-phycocyanin itself. Donald S. Berns & Robert MacColl, Phycocyanin in Physical-Chemical Studies, 89 Chem. Rev. 807, “Figure 1,” Sec. IV(A), (1989). Art suggesting the use of deionized water as a carrier for the delivery of c-phycocyanin will be considered, given the understanding of the absorption spectrum of C-phycocyanin, sufficient to address the limitations of Claim 9. Additional dependent claims specify the type of peripheral neuropathy to be treated or prevented, ultimately indicating that chemotherapy-induced peripheral neuropathy caused by any of a variety of chemotherapeutic agents recited in a Markush-type alternative format, including paclitaxel, define the patient population to be treated. Additional dependent claims specify the timing of the C-phycocyanin administration.
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.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez-Rojas (Berenice Fernandes-Rojas, et al, C-Phycocyanin Prevents Cisplatin-Induced Mitochondrial Dysfunction and Oxidative Stress, Mol. Cell Biochem. 2015)), in view of Canta (Annalisa Canta, et al, Mitochondrial Dysfunction in Chemotherapy-Induced Peripheral Neuropathy (CIPN), 3 Toxics 198 (2015)), and Liu (Qian Liu, et al, Medical Application of Spirulina platensis Derived C-Phycocyanin, Evidence-Based Complementary and Alternative Medicine (2016)).
Rojas indicates that administration of C-phycocyanin, one of the main pigments from the algae Spirulina, possess antiinflammatory and antioxidant activity and demonstrates protection from and prevention of cisplatin-induced mitochondrial dysfunction. (Pg.1, 9-10; 12-13). Rojas describes tests where 30 mg/kg of body weight was administered intraperitoneally in an aqueous solution prior to and concurrently with cisplatin administration. (Pg.2).
Canta indicates that peripheral neuropathy observed as a side effect of the administration of a number of chemotherapeutic agents including the cisplatin and paclitaxel of the instant claims arises from mitochondrial dysfunction arising from, among others, oxidative damage caused by the administration of these agents. (198, 201-06).
Liu indicates that C-phycocyanin obtained from Spirulina platensis is known to be useful as an antioxidant, neuroprotective, and antiinflammatory COX-2 inhibitory agent with antitumor activity. (Pg.1, 3-4; 6-7).
The art available at the time applicants filed the instant application therefore establishes that an injectable solution of 30 mg/kg C-phycocyanin in an aqueous carrier was shown to prevent mitochondrial damage in cisplatin treated animals when administered prior to or concurrently with exposure to the chemotherapeutic agent. The art also establishes that mitochondrial dysfunction in patients treated with cisplatin or paclitaxel gives rise to peripheral neuropathy in patients undergoing chemotherapy. The art also establishes that C-phycocyanin used as a nutraceutical is ordinarily obtained as an extract of Spirulina platensis. It therefore would have been prima facie obvious to have injected an aqueous solution of C-phycocyanin obtained as an extract of S. platensis to a subject being treated with cisplatin with the expectation that such treatment would prevent or reduce the likelihood of developing peripheral neuropathy subsequent to the chemotherapeutic treatment. While the concentrations and dosages of C-phycocyanin obtained from S. platensis suggested by the art and those recited by the claims differ, the art indicates that the C-phycocyanin obtained from provides antioxidant, antiinflammatory, neuroprotective, and mitochondria-sparing activity to subjects treated by chemotherapeutic agents including cisplatin. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts and concentrations of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the methods suggested by the art of record. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.), see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015) (indicating that every ordinary artisan in medicine performs "merely routine optimization of drug dosage to maximize therapeutic effect.").
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rojas, Canta, and Liu as applied to claims 1-8 and 10-20 above, and further in view of Katsnelson (Boris Katsnelson, et al, Subchronic Systemic Toxicity and Bioaccumulation of FE3O4 Nono- and Microparticles Following Repeated Intraperitoneal Administration to Rats, 30 Int’l. J Toxicol. 59 (2011), and Berns (Donald S. Berns & Robert MacColl, Phycocyanin in Physical-Chemical Studies, 89 Chem. Rev. 807 (1989)).
Rojas, Canta, and Liu, discussed in greater detail above, suggest that an injectable solution of 0.1-4.5mg/kg C-phycocyanin obtained as an extract of S. platensis in an aqueous carrier to a subject being treated with cisplatin with the expectation that such treatment would prevent or reduce the likelihood of developing peripheral neuropathy subsequent to the chemotherapeutic treatment.
None of Rojas, Canta, and Liu suggest providing such a solution by using deionized water, nor does the art of record establish the understanding that such a solution would demonstrate the UV absorption spectrum recited by Claim 9. However, applicants are reminded that this ratio of absorbance at 616 vs 650 nm appears to reflect the absorbance of C-phycocyanin itself, as Berns demonstrates. See “Figure 1,” Sec. IV(A). The use of deionized water to formulate solutions for injection not only represents the use of a material understood by the skilled artisan as suitable as a carrier for injection, but which also provides certain advantages, as the absence of ions helps contribute to the stability of solutions made employing it. See pg.63.
It therefore would have been prima facie obvious to have used deionized water to dissolve C-phycocyanin for injection and, having done so, observed a ratio of absorbance at 615nm vs. 650 nm in excess of 3. This is because deionized water was known to be useful in the formulation of injectable solutions, and generally it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). In addition, the art establishes that the use of deionized water in injectable solutions may contribute to the increased stability of solutions formulated in such a manner. See In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.”). Finally, the ratio of absorbance recited by the claims appears to be a property C-phycocyanin possess naturally, as Berns demonstrates.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614