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 .
Status
Applicant’s response dated 15 October 2024 to the previous Office action dated 01 August 2024 is acknowledged. Pursuant to amendments therein, claims 1-19 are pending in the application.
The claim objection made in the previous Office action is withdrawn in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 112 made in the previous Office action is withdrawn in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is maintained.
Election/Restrictions
Claims 5-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 July 2024.
Claims 1-4 and 17-19 are under current consideration.
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.
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) 1-4 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cassatt et al. (US 2006/0128672 A1; published 15 June 2006; of record) in view of Budzai et al. (UA 14527 C2; published 15 September 2000; of record; citations herein to English machine translation made 26 July 2024; of record).
Cassatt et al. discloses administration of amifostine (title) to a subject to protect against toxicity associated with ionizing radiation (paragraph [0002]) wherein amifostine can be delivered to a patient using a wide variety of routes or modes of administration (paragraph [0050]) wherein for oral administration amifostine can be formulated by combining with pharmaceutically acceptable carriers well known in the art and can be formulated as liquids for oral ingestion by a patient to be treated (paragraphs [0055]-[0057]) wherein active ingredient may be in powder form (i.e., of micrometer scale) for constitution with a suitable vehicle for example sterile pyrogen-free water before use (paragraph [0062]) wherein amifostine may be administered in the form of a pharmaceutical composition comprising amifostine and a pharmaceutically acceptable diluent for example normal saline (i.e., a solvent) (paragraph [0012]) wherein amifostine may be combined with other therapeutic agents (paragraph [0053]) wherein for use as a radioprotectant the dose is preferably at least about 500 mg, preferably about 500 mg to 1500 mg (paragraph [0079]) wherein usual patient doses for administration of amifostine range from about 0.6 to 100 mg/kg/day (paragraph [0072]) wherein suitable excipients include sugars (paragraph [0055]).
Cassatt et al. does not disclose spirulina as claimed.
Budzai et al. discloses a radioprotective composition (title) comprising biologically active substances including spirulina and inert excipients (abstract) wherein spirulina protects against adverse radiation (page 4 sixth full paragraph) wherein the spirulina is crushed to particle size of not more than 1 mm (i.e., of micrometer scale) (page 4 eighth full paragraph) wherein an oral dose range of spirulina is 500-1000 mg/kg (page 7 last paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Cassatt et al. and Budzai et al. by adding the crushed spirulina (i.e., of micrometer scale) of Budzai et al. to the composition of Cassatt et al. as discussed above as another therapeutic agent therein for radioprotection, wherein such composition comprises amifostine from powder (i.e., of micrometer scale) and saline (i.e., a solvent, a pharmaceutically acceptable additive, a diluent, an excipient, a filler), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because Cassatt et al. suggests adding other therapeutic agents therein, and both Cassatt et al. and Budzai et al. are directed to radioprotective compositions, and it is prima facie obvious to combine equivalents known for the same purpose (i.e., radioprotective agents) per MPEP 2144.06(I).
Such mixture of the amifostine composition of Cassatt et al. and the crushed spirulina of Budzai et al. is at least substantially identical to the claimed composition and thus is presumed to exhibit the claimed properties per MPEP 2112(V), including formation of a complex with osmotic pressure-driven binding as claimed, given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Regarding the claimed mass ratio of spirulina to amifostine of 1:0.5 to 1:8, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize radioprotection in the composition of Cassatt et al. in view of Budzai et al. as discussed above by varying the amounts of spirulina and amifostine radioprotectant active agents therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that active agent amounts are known result-effective variables. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Regarding claim 4, the crushed spirulina of Budzai et al. has particle size of not more than 1 mm (i.e., less than 1000 µm), which overlaps the claimed range of 100-500 µm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claim 19, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Cassatt et al. as discussed above and to include in the composition of Cassatt et al. in view of Budzai et al. as discussed above sugars (i.e., flavoring/sweetener), with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 15 October 2024 regarding obviousness have been fully considered but they are not persuasive.
Applicant argues that Budzai et al. does not teach the use of spirulina as a carrier for drugs (remarks pages 2-3). In response, the mixture of the amifostine composition of Cassatt et al. and the crushed spirulina of Budzai et al. is at least substantially identical to the claimed composition and thus is presumed to exhibit the claimed properties per MPEP 2112(V), including formation of a complex with osmotic pressure-driven binding as claimed, given that compositions that are physically the same must have the same properties per MPEP 2112.01(II). Applicant’s specification indicates that merely combining the amifostine drug and spirulina results in the formation of a complex with osmotic pressure-driven binding, and thus combining the compositions of Cassatt et al. and Budzai et al. naturally results in such formation of a complex, and nonobviousness is not conferred to such combination merely by referring to the spirulina as a “carrier”.
Applicant argues that the claimed mass ratio of 1:0.5 to 1:8 is crucial for achieving binding and is not obvious (remarks page 3). In response, applicant points to no data/evidence indicating that such mass ratio is critical, in that mass ratios outside such range do not achieve such binding. See, e.g., MPEP 2144.05(III)(A), 716.02, 716.02(b), 716.02(d)(II).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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, Johann Richter can be reached on (571)272-0646. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
