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. Power of Attorney The Examiner was unable to contact Applicant prior to this Office action. Telephone interview practice is not permitted because it appears applicant has legal representation but a valid power of attorney has not been filed in the present application. Providing representative information in an Application Data Sheet (ADS) does not constitute a power of attorney. See 37 CFR 1.76(b)(4) and MPEP § 408. For information on appointing a power of attorney, see MPEP § 402.02 Claim Objections Claim 4 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim s hould refer to other claims in the alternative only . See MPEP § 608.01(n). Accordingly, the claim 4 not been further treated on the merits. Claim 4 should be amended to “any one of claims 1-3”. Currently the claim states “any of” which could be more than one. Claim s 5 and 10-14 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim . See MPEP § 608.01(n). Accordingly, the claim s 5 and 10-14 have not been further treated on the merits. In summary, claims 4-5 and 10-14 have not been further treated on the merits. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim s 1-3 and 6-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Regarding claims 1-3 and 6-9, BRI of the claims is a composition comprising human albumin. All other limitations in the claims are an intended use. Step 1: Claims 1-3 and 6-9 are to a composition of matter. Step 2A, Prong 1: Claims 1-3 and 6-9 are directed to a product of nature, the protein human albumin. The closest counterpart to the nature-based product is human albumin. T he claimed protein is structurally identical to the natural protein , e.g., it has the same peptide backbone and amino acid sequence as human albumin in nature. Although isolated and purified for its intended use, this difference is not a marked difference in view of MPEP § 2106.04(c)(II)(C)(2) and the Supreme Court decision in Myriad. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977. In addition, the function of the claimed protein, regulating B-cell function, is innate to the protein itself, and was not created or altered by the inventor, including by gathering the peptide in an amount sufficient to carry out the function. See A mbry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244 . In sum, the claimed proteins are different, but not markedly different, from their naturally occurring counterparts (human albumin ), and thus ar e natural phenomenon exceptions Step 2A, Prong 2: The claim only recites the peptide, which is a natural phenomenon exception. Because the additional limitation s in claims 1-3 and 6-9 are intended use limitations, they do not actually provide a treatment or prophylaxis, e.g., they are merely an intended use of the claimed invention or a field of use limitation, then they cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (MPEP § 2106.04(d)(2)) . Step 2B: Because the additional limitation s in claims 1-3 and 6-9 do not actually provide a treatment or prophylaxis, e.g., they are merely an intended use of the claimed invention or a field of use limitation , the claim s do not amount to significantly more than the judicial exception (MPEP § 2106.05) . Therefore, claim s 1-3 and 6-9 are patent ineligible. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. C laims 1-3 and 6-9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ling et al. (US 2011/0124566 A1). Ling et al. teach compositions comprising human serum albumin effective for the treatment of cancer (para. [0002]-[0003]). Regarding the requirement that the composition regulate B-cell function in claims 1-3 and treat defective B-cell function in claims 6-9, these limitations are intended use limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art composition meets all of the structural limitations of the claimed composition and therefore must be capable of the intended use. Regarding claim 8 , Ling et al. teach that the cancer is a kidney, breast, lung, prostate, liver, cervical, or ovarian cancer (para. [00 37 ]). Regarding claim 9, Ling et al. teach that the composition may be administered by intravenous injection, subcutaneous injection, intraperitoneal injection, intraarterial injection, intramuscular injection, intralesional injection into the tumor, intralesional injection adjacent to the tumor, intravenous infusion, and intraarterial infusion (claim 4, para. [0048]). C laims 1-3 and 6-9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Fern á ndez et al . (NPL 4, IDS 9/18/2025) , as evidenced by Romero-Grimaldo et al. ( WED-087 Exploring the potential of human serum albumin to reprogram B cell function . Journal of Hepatology, Volume 80, Supplement 1, 2024, Page S185 ) . Fernández et al. teach compositions comprising human serum albumin (20% solution) effective for the treatment of decompensated liver cirrhosis ( abstract ). M PEP § 2131.0 1(III) states: A rejection under 35 U.S.C. 102 over multiple references is proper when the extra reference or other evidence can be used to show an inherent characteristic of the thing in the primary reference. "To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill." Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) . T he critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP § 2124. In the instant case, Fernández et al. teach compositions comprising human serum albumin (20% solution) are effective for the treatment of decompensated liver cirrhosis (abstract) but are silent regarding the effect of the composition on B-cells . Romero-Grimaldo et al. teach that albumin is capable of reprogram ing B cell function and boost ing the production of immunoglobulins by these adaptive immune cells (abstract) . Therefore, the compositions taught by Fernández et al. inherently possess the characteristic s recited in instant claims 1-3 and 6-9 . In addition, r egarding the requirement that the composition regulate B-cell function in claims 1-3 and treat defective B-cell function in claims 6-9, these limitations are intended use limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art composition meets all of the structural limitations of the claimed composition and therefore must be capable of the intended use. Regarding claim 9, Fernández et al. teach compositions comprising human serum albumin (20% solution) , which is suitable for injection. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CHRISTINA MARCHETTI BRADLEY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9044 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday, 7 am - 3 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, FILLIN "SPE Name?" \* MERGEFORMAT Lianko G Garyu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-7367 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHRISTINA BRADLEY/ Primary Examiner, Art Unit 1654