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 .
Examiner of Record Has Changed
The Examiner of Record has changed from Randall O. Winston to Shubo (Joe) Zhou.
Claim Status
Claims 1, 12-14, 20-21, 23-24, and 26 are pending.
Claims 1, 12-14, 20-21, and 23 are withdrawn from consideration.
Claims 24 and 26 are examined on the merits.
Information Disclosure Statement
The information Disclosure Statement filed on 4/14/25 is acknowledged. The submissions are compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, all documents submitted therein have been considered. A copy of the PTO-1449 is attached.
Response to Arguments - Indefiniteness
Applicants' arguments presented within the 11 March 2025 reply concerning the previous indefiniteness rejection of record have been considered. In Applicant’s remarks, they have made clear that the claim should be interpreted that the synthetic eumelanin has the structure below. The claims are interpreted as such.
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Claim Rejections - 35 USC § 103
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 24 and 26 remain rejected under 35 USC 103 (a) as being unpatentable over Dadachova et al. (WO 2006124056 A2).
Dadachova teaches a composition comprising synthetic melanin is synthetic eumelanin from tyrosine (see e.g. abstract, paragraph 0019 and claims, especially claims 1,3, 8, and 41-44) for administration to a subject therein and/or a composition comprising the synthetic melanin is synthetic eumelanin from tyrosine within water therein (see e.g. abstract, paragraph 0019 and also paragraphs 0045, 0046, 0052 and especially paragraph 0057 (claimed within water) and claims, especially claims 1,3, 8, and 41-44) for administration to a subject therein [Please note that the cited reference’s composition is used for the protection against radiation see e.g. abstract]. (see entire document including e.g. title, abstract, paragraphs and claims).
It would have been obvious to one of ordinary skill to provide a composition comprising synthetic melanin is synthetic eumelanin from tyrosine for administration to a subject and/or composition comprising the synthetic melanin is synthetic eumelanin from tyrosine within water therein based upon the beneficial teachings provided by Dadachova (as fully discussed above). Furthermore, the adjustment of particular conventional working conditions therein (e.g. determining an effective amount of the claimed active ingredient (the claimed product) therein within the claimed composition/solution and the volume of water amount and/or packaging therein) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
In addition, the cited reference is relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teaching provided therein with respect to the claimed intended use in the manner disclosed therein, the adjustment of a particular conventional working condition therein (e.g. determining one or more suitable ranges, including dosing, amounts, and proportions, in which to provide therapeutically effective amounts in the composition), is deemed merely a matter of judicious selection and routine optimization that are well within the purview of the skilled artisan. From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention effective filing date, as evidenced by the references, especially in the absence of evidence to the contrary.
Examiner’s comment regarding claim interpretation of “synthetic melanin is synthetic eumelanin from tyrosine”: As readily admitted by Applicants, a composition comprising the synthetic melanin is synthetic melanin is synthetic eumelanin from tyrosine is admitted state of the art. For example, Examiner’s comment regarding claim interpretation of “synthetic melanin”: it is further noted that the admission by applicant in the specification in paragraph 0061 that the “synthetic melanin” comprising composition (including as within an edible oral) remains inclusive of “Commercial synthetic eumelanin made from tyrosine was obtained from Sigma-Aldrich.” Applicant’s specification readily admits in paragraph 0061 that melanin sources and physico-chemical analyses, and commercially synthetic eumelanin made from tyrosine, was obtained from Sigma-Aldrich, and accordingly, it would have been obvious to one of ordinary skill to provide a composition (as an edible oral) comprising “synthetic melanin” based upon the beneficial teachings provided by over the prior admitted by applicant in the specification in paragraph 0061 (as fully discussed above). [Also Please note that Paragraph 0061 title Melanin sources and physico chemical analysis states “Commercial synthetic eumelanin made from tyrosine was obtained from Sigma-Aldrich.” A search by Applicants of the Sigma-Aldrich site reveals that this compound is synthetic melanin made from tyrosine is CAS Reg. No. 8049-97-6, “ melanin.”]. Furthermore, the adjustment of particular conventional working conditions therein (e.g. determining an oral (drinkable) effective amount of the “synthetic eumelanin from tyrosine (such as of the compound of CAS Reg. NO. 8049-97-6) ” within the claimed composition) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Thus, the invention as a whole is prima facie obvious over the cited reference, especially in the absence of evidence to the contrary.
Please Note that the patentability of a product (i.e. the claimed synthetic eumelanin) does not depend upon the method of production (i.e., the method of production of obtaining a synthetic eumelanin from tyrosine in a particular manner as claimed in claims 24 and 26). If the product in a product by process claim is the same as or obvious from a product of the prior art, then the claim is unpatentable even though the prior art product was made by a different process (see, e.g. MPEP 2113).
Regarding the above art rejections, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
Response to Arguments - Claim Rejections - 35 USC § 103
Applicants' arguments presented within the 14 April 2025 reply concerning the previous art rejection of record have been considered.
Applicant urges that Dadachova fails to disclose 8mg of synthetic melanin per kg of body weight or the drinkable suspension comprises at least 500mg of synthetic melanin in a volume of at least 10ml. Applicant urges that Dadachova fails to disclose oral administration the subject for alleviating and/or preventing one or more side effects associated with exposure of the subject to radiation. Applicant urges that Dadachova fails to teach any animal of in vivo studies to support the protective function of synthetic melanin.
These arguments are not persuasive for the following reasons:
1) The Federal Circuit Court found that “Obviousness does not require absolute predictability of success. Indeed, for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice.” In re O’Farrell, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Dadachova provided to a substantial amount of contemplation and suggestion that administration of synthetic melanin can provide protection from ionizing radiation.
2) The claims are not drawn to methods, but instead are drawn to compositions comprising synthetic melanin for oral administration wherein the composition comprises at least 8mg of melanin per kg of body weight or a drinkable suspension comprising at least 500mg of synthetic melanin in the volume of at least 10ml. Even in the process of making the composition to test its effectiveness, a person of ordinary skill would have practiced the claimed invention prior to ever administering the composition to any subject. The claims do not specify what type of subject (which species?) the composition will be administered to. The claim does specify that the composition is oral, so broadest reasonable interpretation requires that the subject has a mouth. A dose of 8mg for a mouse would actually be quite a small amount. But as addressed in the rejection above, optimizing the composition to provide the protection from the ionizing radiation (as taught by Dadachova) would allow for a person of ordinary skill to test a range of compositions having different concentrations of melanin.
3) A person of ordinary skill in the art would have determined the means by which the melanin in administered to the subject based upon the desired site of action. If a person of ordinary skill desired to protect the upper GI tract from radiation, they would have known that oral administration of the synthetic melanin would likely have been most effective. Applicant is reminded that “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 82 USPQ2d at 1396. See MPEP Section 2141.03. This limitation is only being addressed as the oral limitation requires that the liquid in which the melanin is provided is non-toxic enough that it may be consumed.
Applicant urges that Dadachova discloses that materials can be coated with melanin nanoshells such as clothing, protective gear, walls, buildings… Therefore, they fail to teach, suggest or motivate to use melanin nanoshells in animals.
This argument is not persuasive, because Dadachova clearly discloses using melanin to protect animals from ionizing radiation. See screen capture from Dadachova below.
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 24 and 26 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US Pat. No. 9,408,882. Although the claims at issue are not identical, the claims are drawn to the same and/or a similar edible composition for a method of use. For example, US Patent 9,408,882 now referred to as Dadachova reads on claims 24 and 26 of the claimed invention because both invention teaches a drinkable suspension comprising of a dried powdered edible source of melanin in a volume of at least 10 ml, wherein the edible source of melanin comprises Auricularia auricular-judae therein to be effectively orally administered to reduce radiation damage and/or alleviating one or more side effects associated with exposure to radiation in a subject in need thereof therein.
Claims 24 and 26 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of US Pat. No. 11,058,666. Although the claims at issue are not identical, the claims are drawn to the same and/or a similar edible composition for a method of use. For example, US Patent 11,058,666 now referred to as Dadachova reads on claims 24 and 26 of the claimed invention because both invention teaches a drinkable suspension comprising of a dried powdered edible source of melanin in a volume of at least 10 ml, wherein the edible source of melanin comprises Auricularia auricular-judae therein to be effectively orally administered to reduce radiation damage and/or alleviating one or more side effects associated with exposure to radiation (i.e. radiation damage from a computer tomography (CT) scan) in a subject in need thereof therein.
Response to Arguments – Double Patenting
Applicant’s arguments presented on 014 April 2025 have been carefully considered but are not deemed persuasive.
In Applicant’s response, Applicant argues that Applicants thank the Examiner for pointing out the potential obviousness-type double patenting issue between the claims of the present application and those of ‘882 and ‘666. In view of the possibility that claims in the present application will be further amended before allowance, Applicant’s will defer responding to this provisional rejection until claims in the present application are otherwise allowable, and it is determined whether this provisional rejection becomes an actual rejection.
In response, Examiner, however, disagrees because Examiner still maintain that claims 24 and 26 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-15 of US Pat. No. 9,408,882 and/or of claims 1-3 of US Pat. No. 11,058,666.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shubo (Joe) Zhou, Ph.D., whose telephone number is (571) 272-0724. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHUBO ZHOU/
/SHUBO (JOE) ZHOU/Supervisory Patent Examiner, Art Units 1661 and 1662