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 .
Receipt and entry of the response dated 7/6/2026 is acknowledged.
Newly amended claims 8-10, 13 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
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. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-3, 6, 7, 12, 15, 16, drawn to a reprogramming agent comprising a polypeptide consisting of a sequence represented by formula (1).
Group II, claim(s) 8-10, drawn to a method for producing a pluripotent stem cell by culturing a somatic cell in contact with the agent of Group I.
Group III, claim(s) 13, drawn to a method for producing a pluripotent stem cell by culturing a somatic cell in contact with the agent of Group I.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a reprogramming agent comprising a polypeptide consisting of a sequence represented by formula (1), this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Yu et al (US 20080287342 A1, of record). Yu et al teach collagen mimetic peptides (CMP) that comprise Z(ProHypGly)n repeats, wherein one exemplified repeat is n=6. See the abstract, Figure 2 and ¶ [0009]. The instant claim limitations of “reprogramming agents” are intended use limitations at best and do not add further structure to the claimed polypeptide products. If a prior art structure is capable of performing the intended use as recited, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). (MPEP 2111.02). Cells are not claimed as a component in claim 1, only the polypeptide is claimed. Regarding the “consisting of” phrase in instant claim 1, it is proceeded by “comprising” language; “…the…agent comprising a polypeptide consisting of…”. Thus, the agents of claim 1 can include additional components in addition to the (PHG) polymer. That is the case in Yu et al wherein Z can be any amino acid.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 8-10 and 13 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claims 11 and 14 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claims 11 and 14 have not been further treated on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new rejection necessitated by applicants' amendment of the claims in the response filed 7/6/2026. This is a New Matter rejection.
Claim 16 recites a polypeptide agent comprising a polypeptide of from 31-1000 repeats of the (PHG) sequence. The response indicates support for the amendment may be found in ¶[0016] and original claims 1 and 5. These passages do disclose that the integer n of formula 1 can be from 31 to 1000, but rather state the integer may be from 2 to 1000, 10 to 1000 or 500 to 1000. Applicants do not disclose any specific number for the integer in the working examples, and do not disclose the range “31 to 1000” anywhere in the specification as filed. Therefore, there appears to be no support for the limitation “an integer of 31 to 1000”, thus, the amended claims include impermissible New Matter.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 2, 3 and 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 2, 3 and 15 merely recite types of cells that may be modified by the composition of claim 1 by an intended use. Cells are not claimed as a component in claim 1, only the polypeptide is claimed. Thus, claims 2 and 3 do not alter the scope of claim 1 in any significant way.
Response to Arguments
Applicant's arguments filed 7/6/2026 have been fully considered but they are not persuasive. Applicants essentially assert that claims 2 and 3 have been amended to recite different target cells. Such is not convincing for reasons of record. The claim is directed to a polypeptide agent, and does not include any cell component. Thus, reciting intended uses for different cell types does not alter the scope of the claims in any significant way.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 6-7, 12, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al (US 20080287342 A1, of record). This rejection is maintained for reasons made of record in the Office Action dated 4/8/2026 and for reasons set forth below.
Regarding the “consisting of” amendment in instant claim 1, it is preceded by “comprising” language; “…the…agent comprising a polypeptide consisting of…”. Thus, the agents of claim 1 can include additional components in addition to the (Pro-Hyp-Gly) polymer (PHG). That is the case in Yu et al wherein Z can be any amino acid.
Response to Arguments
Applicant's arguments filed 7/6/2026 have been fully considered but they are not persuasive. Applicants essentially assert that Yu et al teaches (PHG) polypeptides comprising an additional amino acid, i.e. the “Z” component. Such is not convincing for the reasons set forth above addressing the “consisting of” language of claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
