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 .
Detailed Action
This action is in response to the papers filed August 21, 2026.
Election/Restrictions
Applicant’s reply filed 08/21/2026 to the Requirement for Restriction/Election mailed 05/21/2026 is acknowledged.
Applicant elected with traverse of the invention of Group 5 (drawn to a method of contacting stem cells in vitro with an inhibitor of PI3K/ Akt/ mTOR signaling), GSK-690693 (inhibitor of PI3K/Akt/mTOR signaling), Activin A (growth factor from TGF-β superfamily), CHIR99021 (activator of WNT signaling) and Polyvinyl alcohol (water-soluble synthetic polymer).
The traversal is on the grounds that restriction requirements A, B, C and D should have been provided under the “election-of-species” procedure rather than restriction as “separate inventions” because the instantly pending claims include claims that are generic to the alternative embodiments identified by restriction requirements A, B, C and D.
The traversal is not persuasive. As explained during the interview on 08/20/2026, the term "species election" or "election of species" refers to restriction under domestic U.S. practice (MPEP Chapter 800). However, the instant application is a national stage application under 35 U.S.C. 371, and, therefore, the instantly pending claims are subject to restriction under the international practice of "unity of invention" (PCT Rule 13.1), which does not distinguish between "group restrictions" (restriction between separate claims) and "species elections" (restriction within a singular claim) in the manner provided under domestic U.S. practice. See, attached interview summary. Further, PCT Rule 13.3 states:
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim.
Accordingly, the Regulations under the Patent Cooperation Treaty (PCT) clearly provide for restriction not only between separate claims but also between alternatives within a single claim. The terms "species election" or "election of species" are not found in the Regulations under the PCT.
The Examiner has previously acknowledged that rejoinder of nonelected embodiments would be considered should a generic claim be found allowable. Further, restriction requirements A, B, C and D do not preclude examination of generic claims that encompass the elected embodiments.
The requirement is still deemed proper and is therefore made FINAL.
Claims 83, 85 and 89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/21/2026.
Noncompliance with 37 CFR 1.52
Applicant's amendments to the claims filed 08/21/2026 fail to comply with the requirements of 37 CFR 1.52. 37 CFR 1.52(a)(1)(iv-v) states that all papers that are submitted on paper or by facsimile transmission must be plainly and legibly written either by a typewriter or machine printer in permanent dark ink or its equivalent and presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition. In this case, the markings provided in Applicant's amendments are presented in a low-resolution, grainy and faint grey-scale ink or type that lacks sufficient clarity and contrast between the paper and the writing thereon so as to render the changes introduced by the amendments difficult to read and understand. If applicable, it is recommended that applicant avoid submitting amendments containing color text that is converted to grey-scale upon submission. Applicant is respectfully notified that any future submission of an amendment to the application that is too difficult to read so as to raise any degree of uncertainty regarding the specific text or language submitted will delay prosecution of the application.
Claim Amendments
Applicant’s amendment to the claims filed 08/21/2026 is acknowledged.
Claims 1-79, 86, 90-92, 95-96, 100-106, 109-130, 134-135, 137-159 have been cancelled.
Claims 80-85, 87-89, 93-94, 97-99, 107-108, 131-133, and 136 are pending.
Claims 83, 85 and 89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 80-82, 84, 87-88, 93-94, 97-99, 107-108, 131-133, and 136 are under examination.
Priority
The instant application 18707756 was filed on 05/06/2024. This application is a national stage of international application PCT/US2022/079398 filed 11/07/2022, claiming priority based on U.S. Provisional Patent Application No. 63/277,092 filed 11/08/2021.
Effective filing dates: Claims 131, 133 and 136 are not found to possess sufficient written support in applicant’s priority document, U.S. Provisional Patent Application No. 63/277,092. For example, the priority document does not describe (i) the first composition as comprising a “water-soluble synthetic polymer” nor (ii) where the water-soluble synthetic polymer comprises polyvinyl alcohol that is “less than 85% hydrolyzed.” For these reasons, claims 131, 133 and 136 are not found to receive benefit of applicant’s priority claim, and, therefore, the effective filing date of claims 131, 133 and 136 is 11/07/2022 based on the U.S. filing date of the present application. If Applicant believes that claims 131, 133 and 136 possess sufficient written support in U.S. Provisional Patent Application No. 63/277,092, then Applicant may reply by specifically identifying where said written support is found by page and line number.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/06/2024 and 08/21/2026 have been considered.
The IDS filed 10/01/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 for the following reasons. 37 CFR 1.98(a)(2) requires a legible copy of each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications. In this case, NPL citation #2 is defective for one or more of these requirements because the submitted paper copy of the publication is not a legible copy.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or by applicant in an information disclosure statement (IDS), they have not been considered.
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.
Claims 80-82, 84, 93-94, 97-99, 107-108 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0327719 A1 to Osafune et al.
Osafune discloses a process for generating pancreatic bud cells by inducing differentiation of pluripotent stem cells in vitro. See, Abstract. The process comprises contacting stem cells with an Akt inhibitor, Activin and a GSK3 inhibitor, wherein the Akt inhibitor is GSK690693, wherein the Activin is Activin A, and wherein the GSK3 inhibitor is CHIR99021. See, e.g., par. 21-26, 46 and 73. The contacting is performed for 2 days or more. See, e.g., par. 63. The pluripotent stem cells may be embryonic stem cells or induced pluripotent stem cells. See, e.g., par. 8, 92-93.
For these reasons, claims 80-82, 84, 93-94, 97-99 and 107-108 are anticipated by Osafune.
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 patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 87-88, 131-133 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0327719 A1 to Osafune et al., as applied above; and Claim 136 is rejected under 35 U.S.C. 103 in further view of US 2003/0008396 A1 to Ku, David N.
Regarding dependent claims 87-88, Osafune does not disclose the concentration of GSK690693.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See, MPEP 2144.05.
In this case, Osafune teaches that Akt inhibitors, including GSK690693, are useful for making pancreatic bud cells from stem cells. Accordingly, one of ordinary skill in the art would have recognized that the concentration of GSK690693 is a result-effective variable and been led to optimize the concentration by routine experimentation. Therefore, absent a secondary consideration, the concentration ranges found in claims 87-88 would have been prima facie obvious over the prior art.
Regarding dependent claims 131-133 and 136, Osafune discloses culturing stem cells with an Akt inhibitor, Activin and a GSK3 inhibitor, wherein the Akt inhibitor is GSK690693, wherein the Activin is Activin A, and wherein the GSK3 inhibitor is CHIR99021. See, e.g., par. 21-26, 46 and 73. The contacting is performed for 2 days or more. See, e.g., par. 63.
Osafune further discloses the pancreatic bud cells are encapsulated with polyvinyl alcohol prior to administration to a subject in need thereof. See, e.g., par. 94-95. Therefore, it would have been prima facie obvious to further culture the stem cells with polyvinyl alcohol with a reasonable expectation of success in order to provide for the encapsulated pancreatic bud cells used in therapy.
Osafune does not disclose the polyvinyl alcohol is less than 85% hydrolyzed, as instantly claimed in claim 136. Nu is relevant prior art for disclosing polyvinyl alcohol hydrogels for human tissue replacement. See, Abstract. The preferred polyvinyl alcohol typically has a degree of saponification (or hydrolysis) in excess of 80% (par. 26), which overlaps with the instantly claimed range of less than 85% hydrolyzed. Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to select a degree of hydrolysis within the range recited in claim 136 with a reasonable expectation of success because one of ordinary skill in the art, in view of Nu, would have recognized that 80-84% hydrolyzed polyvinyl alcohol is suitable for cellular encapsulation in human tissue replacement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 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, James D Schultz can be reached at (571)272-0763. 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.
/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
Prosecution Insights