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 .
Claims 1-13, 17, and 18 are pending and currently under investigation.
Claim Objections
Claim 4 is objected to because of an apparent illustration and/or typographical issue. Formula I and Formula II of the claim illustrate a dashed vertical line between “Chain” of each formula and the claim recites a solid vertical line (“I”) represents a disulfide bond between a heavy chain and light chain. It is suspected Applicant intended the dashed vertical line in each figure to be a solid vertical line. Proper correction is required.
Claim 4 is objected to because of an apparent illustration and/or typographical issue. Claim 4 illustrates two formulas with numerous horizontal lines and dashes (including between “H” and “Chain”, “V” and “Chain”, and “Chain” and “CCL”. Further, the claim contains many dashed lines between terms. Claim 4 further recites “…”-“ represents a peptide bond or a peptide linker.” It is suspected Applicant intended only the horizontal lines between “Chain” and “CCL” in the figures to represent a peptide bond or a peptide linker. Proper correction is required.
Claim 5 is objected to because the claim contains three sentences (see the periods before “(2)” and “(4)”. Claims are required to be a single sentence. Proper correction is required.
Claim 12 is objected to because of an apparent typographical error. The term “The” at the beginning of the second line of the claim should not be capitalized. Proper correction is required.
Claim 18 is objected to because of an apparent typographical error. The term “or” appears to be missing prior to “melanin tumors” in the claim. Proper correction is required.
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.
Claims 2, 4-13, 17, and 18 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.
Claims 2 and 9 are rejected because claim 2 recites “…wherein the chemokine is selected from….” There is insufficient antecedent basis for “the chemokine” in the claims.
Claims 4-8, 10-13, 17, and 18 because claim 4 recites “The fusion protein composed of the fusion protein single chain of claim 1, wherein the fusion protein has….” There is insufficient antecedent basis for “The fusion protein composed of the fusion protein single chain of claim 1” and “the fusion protein” in the claims.
Claims 5-8, 10-13, 17, and 18 because claims 5-6, 10-12, and 17 each recite “the fusion protein of claim 4”. Claim 4 awkwardly recites two fusion proteins (“The fusion protein composed of the fusion protein single chain of claim 1” and “the fusion protein single chain of claim 1”). It is unclear which is “the fusion protein of claim 4”. There is insufficient antecedent basis for “the fusion protein of claim 4” in the claims.
Claims 4-8, 10-13, 17, and 18 because claim 4 recites “…H-chain is none…V-chain is none…..” The metes-and-bounds of the claims are unclear because it is unclear what is meant by an H-chain or V-chain being “none”.
Claim 5 is rejected for reciting a fusion protein according to claim 4 “wherein the sequence of the fusion protein is selected from the following group:” wherein the “group” comprises combinations of light chain and heavy chain sequences. Fusion proteins according to claim 4 require more than light chain and heavy chain sequences. Fusion proteins according to claim 4 also require chemokine CC family sequences. Therefore, it is unclear how a sequence lacking a chemokine CC family sequence can be “the sequence” of a fusion protein according to claim 4.
Claims 7-9 are rejected because 7-8 both recite “…wherein it contains…” and claim 9 recites “…wherein it comprises…..” There is insufficient antecedent basis for “it” in the claims.
Claim 9 recites “…culturing the host cell of the fusion protein under….” There is insufficient antecedent basis for “the host cell of the fusion protein” in the claim.
Claims 12-13 are rejected because claim 12 recites “…or the immune cell expressing thereof….” There is insufficient antecedent basis for “the immune cell expressing thereof” in the claims.
Claim 13 is rejected because it is unclear how, or if, possible limitations following “preferably” and the possible limitations found in parenthesis limit the claim.
Claims 17-18 are rejected because claim 17 recites “or the pharmaceutical composition thereof.” There is insufficient antecedent basis for “the pharmaceutical composition thereof” in the claims.
Claim 18 recites “…the tumor comprises….” There is insufficient antecedent basis for “the tumor” (singular) in the claims.
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.
Claim(s) 1, 3, 4, 6-10, 12, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Challita-Eid et al (The Journal of Immunology, 1998, 161: 3729-3736).
Figure 1 of Challita-Eid et al teaches RANTES.her2.IgG3 fusion protein comprising the CC chemokine family member RANTES and anti-HER-2 antibody:
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Challita-Eid et al further teaches an isolated polynucleotide encoding RANTES.her2.IgG3 fusion protein, a vector containing said polynucleotide, a host cell comprising said vector, and a method of generating the fusion protein comprising culturing a host cell with the fusion protein under conditions suitable for expression (Figure 1 and left column on page 3730, in particular). The flow cytometry method taught at the left column on page 3730 generates an immunoconjugate containing the fusion protein and a detectable label. The purification of the fusion protein described at the left column on page 3730 requires compositions, including those comprising glycine, equivalent to those of instant claims 12-13.
Claim Rejections - 35 USC § 102
Claim(s) 1, 3, 4, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenblatt et al (J Immunother, 1999, 22(5): 456).
Rosenblatt et al teaches treating subjects with HER2+ tumors comprising administering to the subjects RANTES.her2.IgG3 fusion protein of Challita-Eid et al (The Journal of Immunology, 1998, 161: 3729-3736), resulting in localization of the fusion protein to the HER2+ tumor cells, increased macrophage and CD8+ T-cell infiltration within the tumors (Abstract, in particular).
The abstract of Rosenblatt et al further teaches recruitment of such effector cells within the tumor vicinity can provide an enhanced repertoire of T-cell capable of being activated and generating a systemic anti-tumor immune response. The abstract of Rosenblatt et al further teaches T cell activation can occur through direct effect of the RANTES domain in the fusion protein on T cells or through the recruitment of antigen-presenting cells by the fusion protein.
Claim Rejections - 35 USC § 102
Claim(s) 1, 3, 4, 6-9, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN108864289A (11/23/18; 5/9/23 IDS).
CN108864289A teaches the chimeric antigen receptor (CAR) “Igkappa-iRGD-EpCAMscFv-(G4S)5-Her-2scFv-CD8α-CD28-CD137-CD3ζ-2A-CCL19” fusion protein (Abstract and claim 2, in particular). CN108864289A further teaches T cells (“CAR-T cells”) expressing the CAR (Abstract, in particular). CN108864289A further teaches virally expressing polynucleotide vectors encoding the CAR fusion protein in the cells (see “Third purpose of the present invention” in google English translation of CN108864289A at: https://patents.google.com/patent/CN108864289A/en, in particular).
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 1-4, 6-9, 12, 13, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Penichet et al (US 2003/0187225 A1; 10/2/2003).
Penichet et al teaches antibody-immunostimulant fusion proteins that are to function as adjuvants (Abstract, in particular). At figure 1 and [0064], Penichet et al further teaches exemplary structures of the fusion proteins where the immunostimulant is linked to variable (VH or VL) domains of the antibody (such as the anti-HER2 antibody Trastuzumab). Penichet et al further teaches methods of administering the immunostimulant fusion proteins to a subject along with a disease-related antigen ([0018], in particular). Penichet et al further teaches the fusion proteins are administered in compositions comprising pharmaceutically acceptable carriers ([0087], in particular). Penichet et al further demonstrates methods of administering the immunostimulant fusion proteins comprising Trastuzumab fused to an immunostimulant along with HER2 ECD therapeutically reduced tumor (HER2+ lobular carcinoma cells) volume (Figure 3, in particular). Penichet et al further teaches their invention is based on the use of antibody-immunostimulant fusion proteins not to directly target specific cells to destroy them, etc.(e.g., tumor cells, or infectious bacteria, etc.) but instead, their invention is based upon targeting a soluble safe form of an antigen. The antigen, along with antibody-immunostimulant fusion protein acting as its adjuvant, elicits an immune response (humoral and/or cellular) within the subject against the antigen (e.g., the disease related antigen such as those present on tumor cells, on infectious organisms, etc.) (see [0045], in particular). Penichet et al further teaches methods of making the fusion proteins by expressing vectors encoding the fusion proteins in host cells and culturing the host cells ([0084], in particular).
Penichet et al does not specifically teach making or using an antibody-immunostimulant fusion protein wherein the antibody binds HER2 and the immunostimulant is CCL2 (“MCAF” of Penichet et al). However, Penichet et al further teaches the antibody of the fusion protein can be HER2-binding antibody and the immunostimulant can be MCAF ([0020], in particular, which is the same as CCL2. Therefore, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to make and use the antibody-immunostimulant fusion protein of Penichet et al wherein the antibody binds HER2 and the immunostimulant is CCL2 (“MCAF” of Penichet et al). This is an example of xome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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