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 .
Election/Restrictions
In Applicant’s election, the objected to the restriction requirement. They did not expressly state the term, “traverse”. However, the response provides rationale as to why the groups should be considered together. As such, Examiner will be interpreting their objection, as a statement of traversal. Applicant's election with traverse of Group VI in the reply filed on 12/2/2025 is acknowledged. The traversal is on the ground(s) that follow: Applicant acknowledges differences in protected subject matter and IPC classification among the different group. They believe that these inventions are not “independent or distinct” from each other. Instead they represent multiple interdependent and inseparable aspects of a single, coherent inventive concept. This is not found persuasive because each claim is written as an independent claim, meaning all of the limitation cited in the claim are not dependent upon the other claims and thus stand alone. While it might be Applicant’s intent that the claims be interdependent, there is no express interdependence between them. So from a claim construction stand point, each claim stands alone and thus is independent. Distinctness means that the structural/function limitations are different. For example, claim 5 recites coagulation mechanism and claim 6 recites a preparation of an enucleated erythrocyte. Coagulation mechanism require materially different steps and starting materials from preparation of an erythrocyte without a nucleus. The chemicals used to make the erythrocyte without a nucleus and the steps taken are completely different from a coagulation mechanism. Further, a end product a coagulation mechanism is organic chemicals. The end product of preparation of nucleated erythrocytes is a living cell. Cell are structurally and functionally different from coagulation causing chemicals. As such, while Applicant may intend one coherent inventive concept through out the claims, in actuality they have written 6 independent product or methods that have structurally and functionally different limitations, thus are distinct. As per search burden, Applicant submits that due to the high degree of technical and logical interconnection among these inventions, a prior art search directed to the final product of claim 6 will inevitably touch upon and assess the novelty and non-obviousness of its foundational mechanisms in claims 1-5. In response, search burden is determine as the degree in which the searches across the grouping are coextensive. Coextensive searches use terms that are not divergent in the field of art and CPC symbols that are same. The restriction requirement demonstrates that the CPC classification is different between the different groups. Search terms for preparation of a nucleated erythrocyte (for example nucleated erythrocyte) do not require for example any terms regarding coagulation (for example coagulation factors) and vice versa. As such the terms and CPC symbols collectively used for searching claims 5 and 6 are divergent and thus would require independent searches each in multiple database. The same rational exist for all of the other claims and has been provided in the restriction requirement. As such, a consideration of all the claims would require at least six independent searches that in multiple database and independent review of each of relevant prior art. This amount of is burdensome and potentially compromises the integrity of the quality of the examination of the application. As such it is a serious search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/2/2025.
Claim 6 is under consideration in this office action.
Specification
The disclosure is objected to because of the following informalities: The specification is objected to because it lacks the first paragraph providing Cross-References to Related Application.
Appropriate correction is required.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it appears to be either a product or a method but does not state that it either. As stated above the statutory categories for patent are process, machine, manufacture or composition of matter. Applicant’s response to the restriction requirement states that claim 6 is a production. However, the claims does not state that it is a preparation of nucleated erythrocytes, which would make claim indicative of a product, but rather “preparation of nucleated erythrocytes” which possibly can be indicative of a process. Further, the claim also recites “genetic engineering universal nucleated erythrocytes”. “Engineering” is an active process step, which is indicative of a process or claiming a method. However, this is recited in conjunction with a possible product or method. As such, the claim does not delineate that type of inventive entity claim 6. Therefore the claim is patent ineligible because it does not meet the requirement of reciting one of the four statutory categories of invention.
If Applicant intends for claim 6 to be a product as indicated in their response to the restriction requirement. Reciting “a preparation of nucleated erythrocytes…” would be remedial. Also if applicant intends to claim a product made by the process of engineering as claimed. Reciting “a preparation of nucleated erythrocytes…by the process of genetically engineering” would be remedial.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
(1) As discussed in the 101 rejection above, it is not clearly recited if the claim is a product or process. As such, the claims are also indefinite because one does not known from the claim language if the intended invention of claim is a product or a method.
Applicant indicated that claim 6 may be intended to be the final product of a method. As such, the above suggest language discussed above in the 101 rejection would be remedial in this point of indefiniteness as well.
(2) Further, claim 6 recites, “nucleated erythrocyte artificial blood of different blood types”. This recitation is indefinite because the relationship between artificial blood type of different blood types and nucleated erythrocyte is not apparent. It appears maybe some conjunctive terms may be missing. Does it mean that the erythrocytes are prepared from artificial blood? Is intended to be preparation steps using artificial blood? The metes and bound of the recitation cannot be discerned in this recitation. Thus, it is indefinite.
Claim Interpretation
For purposes of identifying relevant prior art, claim 6 will be interpreted as “A preparation nucleated erythrocytes prepared by the method comprising genetically engineering nucleated erythrocyte obtained from artificial blood to remove antigen, wherein the artificial blood is from different blood types”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(1) Claim(s) 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iodice (Iodice et al. European Journal of Cancer (2010) 46:3345-3350) as evidenced by Red Blood Cells form Wikipedia).
The claim is being interpreted as a product by process. The product is nucleated erythrocytes. The structural limitation that the process appears to impart to the nucleated erythrocyte is that it is “universal”. Universal in the blood typing art means that it lacks A and B antigen. When one lack A and B antigen, the blood type is called type O because not A and B antigens are present. As such, the process ultimately seems to impart the structural limitation that the nucleated erythrocyte is type O or lack A and B antigens in at least one embodiment. The claims do not specify that the “preparation” is a preparation of “isolated” nucleated erythrocytes. As such, the breadth of the claimed preparation encompasses a preparation of isolated or in vivo erythrocytes from a person with type O blood.
Iodice discloses a patient comprising type O blood (for example, see page 3348, col 2, paragraph 1). Iodice is silent as to the whether the patient has nucleated erythrocytes. However, nucleated red blood cells are normally found in the bone marrow of humans of all ages (see excerpt from Wikipedia below). As such, a disclosure by Iodice of a patient comprising type O blood inherently discloses nucleated erythrocytes that are without antigen because the patient disclosed by Iodice inherently has nucleated erythrocytes that lack antigen in their bone marrow.
In conclusion, the prior art of Iodice anticipates the claim because it inherently discloses nucleated erythrocytes lacking A and B antigen found normal in the patient disclosed by Iodice.
PNG
media_image1.png
587
1032
media_image1.png
Greyscale
Claim(s) 6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chou (US 11,708,559 publication date 7/25/2023; effectively filed October 2017).
Chou discloses a plurality of antigenically distinct engineered red blood cells produced from included pluripotent stem cells that were genetically engineered with CRISPR to remove blood antigens (col 77 claim 1). Chou further discloses In yet another embodiment, there is provided a plurality of antigenically distinct engineered erythroblasts (i.e. immature nucleated erythrocytes) , wherein said plurality of erythroblasts exhibit distinct blood antigen group profiles, including at least two rare blood antigen groups. The plurality of erythroblasts may exhibit at least three, four, five, six, seven, eight, nine, ten or fifteen distinct blood antigen groups. The plurality of erythroblasts may be produced from induced pluripotent stem cells. The plurality of erythroblasts may comprise two or more of the following blood antigen group profiles: Rh null, D −/−, U/S/s antigen negative (glycophorin B null), RHCE negative, positive for low prevalence RhD antigens, Dombrok (Do) null, and Lutheran null, and optionally further comprise one or more of Kell positive, Kidd positive, Duffy positive and MNS antigen positive. The plurality of erythroblasts may comprise three, four, five or all six blood antigen group profiles (col 3, lines 14-30).
As such, Cho expressly discloses the limitations of claim 6.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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, Peter Paras can be reached at 571-272-4517. 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.
MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632