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
Election/Restrictions
Applicant's election with traverse of Group I, SEQ ID NO: 3, and the linker GTGGGGSGGGGSGGGGS in the reply filed on 6/25/2026 is acknowledged. The traversal is on the ground(s) that there should be no undue burden on the Examiner to consider all claims in the single application. This is not found persuasive because Inventions I and II are related as product and process of use. Since the method of invention II can be practiced with another materially different product, the restriction requirement is proper under 35 U.S.C. 121 (see MPEP 806.05(h)).
The requirement is still deemed proper and is therefore made FINAL.
Applicants elected species (i.e. SEQ ID NO: 3) was deemed to be free of the prior art. The search was extended to another species (i.e. HHHHHH (Hx(G/S/P/A/T)y(R/K)z, wherein x is 6, y is 0 and z is 0)). As a result, claims 1, 4 and 6 have been examined and claims 2-3, 5 and 7-12 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time.
Status of the Claims
Claims 1-12 are pending in this application.
Claims 2-3, 5 and 7-12 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1, 4 and 6 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 should be amended to recite “The p53 variant according to claim 1, wherein the p53 variant has transactivation activity”. Appropriate correction is required.
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.
Claims 1, 4 and 6 are 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.
The claims are drawn to a p53 variant with enhanced liquid-liquid phase separation ability, wherein the p53 variant comprises an amino acid sequence rich in positive charges and histidine at one terminus of a p53 sequence, which has stronger liquid-liquid phase separation ability and stronger transactivation activity in cells and in vitro than the p53 sequence; and a general formula of the amino acid sequence rich in positive charges and histidine is Hx(G/S/P/A/T)y(R/K)z, where H represents histidine; (G/S/P/A/T) represents a sequence composed of one or more of glycine, serine, alanine, proline, and threonine; and (R/K) represents arginine or lysine, where x, y and z represent numbers of respective amino acids; x and z range from 0 to 20; y ranges from 0 to 100, and x+z>5.
When referring to the “amino acid sequence rich in positive charges and histidine”, the specification does not provide any structural attributes.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe what part of Hx(G/S/P/A/T)y(R/K)z correlates with the required activity (i.e. having stronger liquid-liquid phase separation ability and stronger transactivation activity in cells and in vitro than the p53 sequence alone).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the “amino acid sequence rich in positive charges and histidine” can be any peptide encompassed by the general formula Hx(G/S/P/A/T)y(R/K)z.
However, the specification fails to provide a representative number of examples for the claimed general formula Hx(G/S/P/A/T)y(R/K)z.
The specification teaches only 6 specific peptides (i.e. C-terminal residues of SEQ ID NOs: 3-8) encompassed by the general formula Hx(G/S/P/A/T)y(R/K)z. It is noted that SEQ ID NOs:3-8 comprise stretches of glycine residues.
However, many peptides encompassed by the general formula Hx(G/S/P/A/T)y(R/K)z do not.
For instance, since y can be 0, peptide such as RRRRR, KKKKK, HHHHH, etc. are encompassed by said formula. Would these peptides, when linked to the C-terminus of a p53 sequence, have stronger liquid-liquid phase separation ability and stronger transactivation activity in cells and in vitro than the p53 sequence alone?
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 is drawn to the p53 variant according to claim 1, wherein the p53 variants have transactivation activity. The p53 variants of claim 1 already has transactivation activity (see lines 3-4 of claim 1). Therefore, claim 4 fails to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryu et al. (Mol. Cells, Vol, 17, No. 2, pp. 353-359, 2004).
With respect to claims 1 and 4, Ryu et al. teach a p53 fusion protein with the HIV-1 Tat basic domain at its N-terminus (Tat-p53) (abstract; passim), wherein the HIV-1 Tat basic domain is RKKRRQRRR (page 353, right column, 2nd para).
The fusion protein of Ryu et al. comprises a p53 sequence linked at its N-terminus with RKKRRQRRR (i.e. a sequence comprising an amino acid sequence rich in positive charges and histidine of formula Hx(G/S/P/A/T)y(R/K)z, wherein x is 0, y is 0, z is 5, and (R/K) is RKKRR).
With respect to: 1) the claimed stronger liquid-liquid phase separation ability and transactivation activity in cells and in vitro than the p53 sequence; and 2) the claimed activation of transcription of CDKN1A and improvement of mRNA levels of one or more of CDKN1A, MDM2, PUMA, NOXA and RRM2B, the MPEP 2112.01 states that “'Products of identical chemical composition cannot have mutually exclusive properties.’ A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In the instant case, the Tat-p53 of Ryu et al. has the same structure of the p53 variant instantly claimed, thus it will necessarily: 1) have stronger liquid-liquid phase separation ability and transactivation activity in cells and in vitro as compared to the p53 sequence alone; and 2) activates transcription of CDKN1A and improves mRNA levels of one or more of CDKN1A, MDM2, PUMA, NOXA and RRM2B.
Furthermore, since the Office does not have the facilities for examining and comparing applicants’ p53 variant with the p53 variant of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the p53 variant of the prior art does not possess the same material structural and functional characteristics of the claimed p53 variant). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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