DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/03/2026 has been entered.
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 of the Claims
Claims 1-13 and 35-40 are pending (claim set as filed on 04/03/2026).
Applicant’s election with traverse of Group I directed to the composition is again acknowledged. Claims 35-40 stand withdrawn as being directed to the non-elected method claims.
Therefore, only product/composition claims 1-13 are under examination.
Priority
This application is a 371 of PCT/JP2020/046426 filed on 12/11/2020, which has a foreign application to JP 2019-225959 filed on 12/13/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/30/2025, 04/03/2026, 04/09/2026, and 04/24/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Claim Interpretation
Regarding claim 2’s recitation of the phrase “wherein the protein fraction is obtained from a frozen extract … immortalized megakaryocytes”, the claimed invention, as a whole, is directed to a product or composition of matter. However, said phrase invokes the interpretation of a product-by-process limitation where the patentability of a product does not depend on its method of production (MPEP 2113(I)).
Maintained Rejection
Claim Rejections - 35 USC §101, Subject Matter Eligibility
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-13 are rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter.
Broadest reasonable interpretation (BRI) of base claim 1: the broadest scope of claim 1 is drawn to a composition comprising portion of a protein (i.e., a “fraction” or piece of protein from an immortalized megakaryocytes’ metabolites or products thereof). The phrase “of immortalized megakaryocytes that have released platelets, wherein the immortalized megakaryocytes each comprise an exogenous BMI1 gene, an exogenous MYC gene, and an exogenous Bcl-xL gene” does not impart a distinctive structural characteristic to the product of “a protein fraction”. The MPEP 2103(C) states that “Examiners should begin claim analysis by identifying and evaluating each claim limitation … For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter”. Thus, the emphasis for product/composition is primarily based upon definitive physical structure.
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a composition of matter.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
YES, the claims are considered to be “product of nature” exceptions (i.e., a mixture of naturally occurring products). The courts have held that “products of nature” fall under the laws of nature and/or natural phenomena exceptions.
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the additional elements or a combination of elements in the claims does not impose a meaningful limit on the judicial exception. Note that the markedly different characteristics analysis is used to determine if a nature-based product is a “product of nature” exception. Thus, the markedly different characteristics analysis is part of Step 2A, i.e., it helps answer the question of whether a claim is directed to an exception as further explained below.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to a law of nature and/or natural phenomena (i.e., a product of nature) without significantly more. Note that the claims must be interpreted under the broadest reasonable interpretation (BRI) standard when evaluating for a marked difference. Under BRI, the claims broadly describe the cell’s natural metabolite, protein, cytokine, or growth factors thereof.
Applicant is claiming the resultant end product of a piece of protein from the cell (i.e., the protein fraction) and it does not matter if the source cell is non-natural, synthetically engineered, or artificially altered where “the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart” (MPEP 2106.04(C)(I)(B)). Turning to the dependent claims which describes the protein fraction to be, e.g., bFGF, IGFBP-2, PIGF, SCFR, VEGF, et. al., these fractions are naturally occurring or at least resembles proteins found in nature as shown in the previously cited Burnouf prior art.
There is no indication that the claimed composition has any markedly different characteristic (e.g., structure, function, phenotype, etc.) that is different than what is found in nature. Thus, it appears that Applicant is claiming a naturally occurring product or one that substantially resembles a naturally occurring product.
Therefore, the claims are interpreted under the BRI standard, wherein the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
Therefore, the claims, as a whole, are considered as products of nature which are directed to judicially recognized exceptions without amounting to significantly more from what occurs in nature and thus, are not eligible subject matter under 35 U.S.C. §101.
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 04/03/2026 have been fully considered but they are not persuasive and deemed insufficient to overcome the subject matter eligibility.
In response to Applicant’s argument (addressing pages 6-7 of the remarks) that amended claim 1 is not a product of nature “since the gene expression profile of the immortalized megakaryocytes by overexpression of BMI1, Bcl-xL, and c-MYC does not exist in nature, and the protein expression profile would generally reflect the gene expression profile, the protein fraction of claim 1 also should not exist in nature”: this argument is not persuasive because, as indicated on page 3 of the prior office action, the claims are given their broadest reasonable interpretation (BRI). Again, the claim is a product or composition matter, where the emphasis of analysis is primarily based upon its definitive physical structure. With respect to claim 1, the physical characteristic or structural feature is “a protein fraction” and not the source material of immortalized megakaryocytes after release of that have released platelets nor the gene expression profile thereof. In other words, Applicant is claiming the resultant end product of a piece of protein from the cell (i.e., the protein fraction) and it does not matter if the source cell is non-natural, synthetically engineered, or artificially altered where “the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart” (MPEP 2106.04(C)(I)(B)). Turning to the dependent claims which describes the protein fraction to be, e.g., bFGF, IGFBP-2, PIGF, SCFR, VEGF, et. al., these fractions are naturally occurring or at least resembles proteins found in nature as shown in the Burnouf prior art. Said differently, Applicant needs to show how the proteins of bFGF, IGFBP-2, PIGF, SCFR, or VEGF are markedly different (i.e., a difference that arises to patentably level) from those that are found in nature. Again, it is not the “immortalized megakaryocytes” that is being claimed but the protein fraction and it does not matter how said protein is obtained regardless of whether it is made via non-natural means because it is a comparison of a marked difference between the end product versus a similar protein found in nature (i.e., a naturally occurring counterpart). For instance, MPEP 2113(I) states that “The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product”. Accordingly, the claims stand rejected as being directed to ineligible subject matter because the analysis pertains to the end product based upon what the “a protein fraction” is comprised of in terms of structure.
New Grounds of Rejection
Claim Rejections - 35 USC § 102, Anticipation
The text of those sections of Title 35, U.S. Code not included in this action can be found
in a prior Office action.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eto (US 2018/0016597 A1).
Eto’s general disclosure relates to a method for efficiently polyploidizing megakaryocytes before polyploidization, a method for producing platelets from such megakaryocytes (see ¶ [0002]).
Eto discloses “immortalized megakaryocytic progenitor cell line is the one which is imparted with enhanced proliferative potential and is established (immortalized) by inducing expression of an oncogene such as MYC or a gene such as BMI1 in the megakaryocyte progenitor cells derived from pluripotent stem cells” (see ¶ [0021]-[0026]). Eto discloses the apoptosis suppressor gene is a BCL-XL gene and wherein the c-MYC gene is used as the oncogene (see ¶ [0027]-[0039]); and expression of an exogenous apoptosis suppressor gene (see ¶ [0154]).
Eto teaches a “method of producing platelets according to the present invention, on the other hand, produces platelets in vitro from the polyploidized megakaryocytes and the like obtained using the method of the present invention” (see ¶ [0146]-[0147]). Eto teaches culturing of immortalized megakaryocytes using a conditioned medium and the platelets contained in the supernatant of the medium were analyzed with a flow cytometer (see ¶ [0204]-[0209]).
The cited reference is silent with regards to “a protein fraction” but there is a reason to believe that said protein fraction is an inherent feature of said reference because Eto teaches the culturing of immortalized megakaryocytes that have released platelets wherein the immortalized megakaryocytes each comprise an exogenous BMI1 gene, MYC gene, or BCL-XL gene. The technical reasoning is because the instant application discloses the culturing of immortalized megakaryocytes where the protein is present in the supernatant as a protein fraction (see ¶ [0107]) and the prior art of Eto also discloses the culturing of immortalized megakaryocytes that have released platelets in the supernatant (see ¶ [0209]). Therefore, “a protein fraction” of immortalized megakaryocytes that have released platelets should be inherently contained in the supernatant portion of the culture conditioned medium.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirose (US 2018/0282697 A1).
Hirose’s general disclosure relates to a method for producing purified platelets from a culture of megakaryocytes (see abstract & ¶ [0001]-[0006]).
Hirose teaches the method comprises centrifugal separation step and a liquid component is recovered and “wherein the culture of megakaryocytes is obtained by the steps of: overexpressing a cancer gene and a Polycomb gene in cells less differentiated than megakaryocytes; overexpressing a Bcl-xL gene in the cells; and terminating all the overexpression” (see ¶ [0009]-[0020], [0047]-[0054], [0076]-[0087] for the production of immortalized megakaryocytes). Hirose teaches culturing the megakaryocytes in a medium and platelets were produced and purified (see ¶ [0064]-[0065], [0113]-[0129])
The cited reference is silent with regards to “a protein fraction” but there is a reason to believe that said protein fraction is an inherent feature of said reference because Hirose teaches the culturing of immortalized megakaryocytes that have released platelets wherein the immortalized megakaryocytes each comprise an exogenous BMI1 gene, MYC gene, or BCL-XL gene. The technical reasoning is because the instant application discloses the culturing of immortalized megakaryocytes where the protein is present in the supernatant as a protein fraction (see ¶ [0107]) and the prior art of Hirose also discloses the culturing of immortalized megakaryocytes that have released platelets for recovery. Therefore, “a protein fraction” of immortalized megakaryocytes that have released platelets should be inherently contained in the liquid component of the culture conditioned medium.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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