DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner Notes
Claim Summary
Claims 1, 12-14, 20-21, 23-24, and 26 are pending.
Claims 1, 12-14, 20-21 and 23 remain withdrawn.
Claims 25 and 27-28 remain cancelled.
Claim 24 is currently amended
Claims 24 and 26 remain under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/14/2026 has been entered.
Examiner of Record Has Changed
The Examiner of Record has changed from Shubo (Joe) Zhou to Amjad Abraham.
Claim Objections
Claim 24 is objected to because of the following informalities: Line 6 recites, “the subject,” but should be amended to recite, “the human subject” to remain consistent with line 3 of the claim. Appropriate correction is required.
Response to Arguments - Claim Rejections - 35 USC § 103
Applicants' amendments presented within the 14 April 2026 reply have overcome the rejection of record. In particular, the limitation of being “not in the form of melanized nanoparticles” is the limitation that the prior art fails to teach. The claims are now rejected over new art.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 24 and 26 are 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 pre-AIA the applicant regards as the invention.
Claim 24 recites, “wherein the composition is an edible composition or a drinkable composition that comprises at least 8mg of synthetic melanin per kg of bodyweight of the subject.” It is unclear how this recitation is intended to limit the claimed composition. It is an intended use. Even if an attempt was made to give this recitation patentable weight, the limitation could vary widely based on subject weight and there is no indication in what time period the 8mg per kg bodyweight would need to be consumed. As such, the metes and bounds of the claim cannot be determined.
Dependent claim included.
Claim 26 is indefinite as it refers to “the drinkable suspension”. In claim 24, there are two “drinkable compositions” in lines 5 and 6 that both have their own antecedent basis. It is unclear if the limitation for claim 26 is intended to be applied to both drinkable compositions in lines 5 and 6. For the sake of compact prosecution the examiner will interpret that the limitation of claim 26 is intended to further limit the second recitation of “a drinkable suspension”.
Claims 24 and 26 are also indefinite as line 2 of claim 24 states that the melanin is not in the form of melanized nanoparticles. The claim is limited to a species (synthetic eumelanin) and the reference to “melanin” in line 2 is unclear as it is a genus. Do you mean that the synthetic eumelanin is not in the form of melanized nanoparticles?
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 are rejected under 35 USC 103 (a) as being unpatentable over Ghisalberti (WO 0118125-A1) in further view of Berliner et al (US 5210076) and Haywood et al. (Synthetic melanin is a model for soluble natural eumelanin in UVA photosensitized superoxide production).
Ghisalberti teaches methods of treating or preventing disease caused by radiation exposure or an oxidative environment by administering synthetic vegetal melanin (lines 4-7, p. 15). They further teach that these may be provided in foods or beverages (lines 8-10, p. 15). They teach that melanins including eumelanins are a broad class of photoabsorbing biopolymers (lines 24-26, p. 1). A person of ordinary skill in the art knows that genotoxic radiation includes the photon classes of UV-rays, X-rays, and Gamma-rays.
Ghisalberti does not teach to provide eumelanin in a beverage or specified volumes or concentrations nor does it teach that the eumelanin is made from tyrosine.
Berliner et al teach that eumelanins can be prepared by isolation from natural sources or prepared synthetically (columns 13-14; especially lines15-23, column 14). The Examiner notes that many of the biosynthesized eumelanin is made from a tyrosine precursor (See Haywood below). They teach that in the process of purifying eumelanin was washing in sterile water multiple times and the yields that they obtains far exceeded the 500mg required by the claims (lines 45-61, column 28, and Examples 1-5).
Haywood et al. teaches that synthetic eumelanin is synthesized from tyrosine. (See Page 230 left columns 1st full paragraph).
At the time of filing, it would have been prima facie obvious for a person of ordinary skill in the art to follow the suggestion of Ghisalberti to use a food or beverage comprising melanin to protect against radiation damage. Given that Ghisalberti teaches that that melanins including eumelanins are a broad class of photoabsorbing biopolymers, a person of ordinary skill in the art would have been motivated to use any known melanin including eumelanins to protect against radiation. Berliner et al teach several means to obtain eumelanin and in the process of doing so they generated amounts far exceeding the claimed at least 500mg. They also suspended the eumelanin in sterile water and in doing so may have made a eumelanin suspension comprising greater than 500mg in greater than 100mL. Even if they did not, the simple process of scaling up their synthesis could lead them to making the claimed amounts. Accordingly, claims 24 and 26 are rejected as being obvious over Ghisalberti in further view of Berliner et al. Note that there is no upper limit to the size of the drinkable suspension in the claims.
Furthermore, it was well known in the art that synthetic eumelanin made from tyrosine was known in the art and known to be a substitute for natural melanin/eumelanin. Because Berliner suggests synthetic melanin/eumelanin and it is was known to produce these synthetic materials it would have been obvious to one having the ordinary skill in the art to utilize Haywood’s method to produce the synthetic eumelanin called for by Ghisalberti/Berliner.
The combination of references does not suggest using eumelanin/melanin in the form of melanized nanoparticles.
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 in view of Ghisalberti/Berliner/Haywood as described above. 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. The application of synthetic eumelanin from tyrosine as described by Ghisalberti/Berliner/Haywood would have been an obvious substitution for the melanin of Dadachova.
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 in view of Ghisalberti/Berliner/Haywood as described above. 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.
The application of synthetic eumelanin from tyrosine as described by Ghisalberti/Berliner/Haywood would have been an obvious substitution for the melanin of Dadachova.
Response to Arguments – Double Patenting
Applicant’s arguments presented on 14 April 2026 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.
Additional notes: Squid ink sauce on pasta and squid ink cocktails which are popular around Halloween can contain significant amounts of eumelanin. There is great concern that a bartender mixing up their stock bottle of squid ink for making seasonal black cocktails (which first became popular around 2009, Bender 2009 (https://cocktailjourney.wordpress.com/2009/02/28/dont-try-this-at-home/), before the instant priority date) or a chef making a classic pasta dish (read: invented long before the instant priority date) could be infringing the instant claims. These are composition claims. The means by which the compositions are made and the intended use of the compositions does not matter unless it structurally limits what is being claimed. Please explain why these food and beverage are not considered within or equivalent to embodiments within the scope of the examined claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
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, Amjad A Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
Prosecution Insights