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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6-16-26 has been entered.
Claims 1, 2, 4-16 are pending.
Claims 1, 2, 12-15 are under examination as they read on a peptide comprising SEQ ID NO: 1, wherein said peptide is not a full-length polypeptide.
Claims 4-11 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11-6-25.
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 1, 2, 12, 14 and 15 are 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.
Claim 1 is drawn to “[a] peptide comprising an amino acid sequence of SEQ ID NO: 1…; and a pharmaceutical acceptable salt thereof…”
The skilled artisan would not be certain what exactly is meant by the “and a pharmaceutical acceptable salt thereof” portion of this phrase.
On the one hand, at paragraph 0029 the specification teaches that a "peptide" includes "salts of a series of amino acid residues, connected one to the other typically by peptide bonds between the alpha-amino and carbonyl groups of the adjacent amino acids. Preferably, the salts are pharmaceutical acceptable salts of the peptides, such as, for example, the chloride or acetate (trifluoroacetate) salts.”
On the other hand, the phrasing of claim 1, “…; and a pharmaceutical acceptable salt thereof” could be interpreted to suggest that the pharmaceutical acceptable salt thereof is, e.g., present in the context of the claimed peptide but somehow not integral to the claimed peptide? For example a mixture of a non-salt form of a peptide comprising SEQ ID NO: 1; and a peptide comprising an amino acid sequence of SEQ ID NO: 1 bound to a pharmaceutically acceptable salt?
One way to clarify the meaning of the claim would be for it recite, for example, “[a] peptide comprising an amino acid sequence of SEQ ID NO: 1…, wherein said peptide further comprises
a pharmaceutical acceptable salt thereof and wherein said peptide is not a full-length polypeptide.”
An alternative way to clarify the meaning of the claim would be for it recite, for example, “[a] composition comprising a peptide comprising an amino acid sequence of SEQ ID NO: 1…, said composition further comprising a pharmaceutically acceptable salt, wherein said peptide is not a full-length polypeptide.”
Given the uncertainty as to the meaning of base claim 1, dependent claims 2, 12, 14 and 15 are indefinite for the same reason.
Additionally, the kit of claim 15 at parts (b) and (c) is additionally indefinite for a variety of reasons.
First, “the lyophilized formulation” of part (b) lacks antecedent basis in part (a) of base claim 1.
Second, the ordinarily skilled artisan further would not understand the meaning of claim 15 at parts (c)(i) and (c)(ii as they relate to part (b) of claim 15: “…(b)…containing a diluent or reconstituting solution for the lyophilized formulation, and (c) instructions for (i) use of the solution or (ii) reconstitution…”
In particular, since the referenced “solution” of part (c)(i) is set forth as a “reconstituting solution for the lyophilized formulation” in part (b) of claim 15, what, if anything, should be understood to distinguish between “instructions for (i) use of the solution or (ii) reconstitution…?”
Moreover, the ordinarily skilled artisan would not understand what is meant by “…and (c) instructions for…use of the lyophilized formulation.” While the specification appears to describe uses for the reconstituted lyophilized formulation, e.g., subcutaneous administration, beyond reconstitution the specification does not appear to describe uses for the lyophilized formulation, per se.
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.
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.
Claim(s) 1, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Uchimura et al. (J. Biochem. 124, 670-678 (1998)) or, in the alternative, claims 1, 12, 14 and 15 are rejected under 35 U.S.C. 103 as obvious over Uchimura et al. (J. Biochem. 124, 670-678 (1998)) in view of Weinschenk et al. (WO2016102272)(all cited herewith).
Uchimura teaches the sequences of murine and human GlcNAc-6-O-sulfotransferase (see Fig. 2), and notes the remarkable homology of a 363-amino acid segment at page 673, left col., 2nd full paragraph:
"The human protein is highly homologous to mouse GlcNAc-6-O-sulfotransferase (Fig. 2). Although the region corresponding to the stem region is less homologous, the expected catalytic regions are nearly identical; in the 363 amino acid segments, only 3 amino acid residues are different, and all the changes are conservative ones."
Similarly, at page 676, left col., 2nd full paragraph Uchimura concludes:
"Human GlcNAc-6-O-sulfotransferase was found to exhibit extensive sequence similarity to mouse GlcNAc-6-0-sulfotransferase. In particular, in the putative catalytic domain encompassing 363 amino acid residues, 99% amino acids were identical between the human and mouse enzymes, and all the amino acid changes were conserved ones. This high degree of homology is unusual. For example the mouse and human (Fukuta, M., Kobayashi, Y., Uchimura, K., Kimata, K., and Habuchi, 0., submitted for publication) chondroitin 6-sulfotransferases are 90% identical in the corresponding region. The primary sequence of fucosyltransferase IV, which forms the Lewis X antigen, is also 90% conserved in the catalytic regions in man and mouse (32). The high degree of evolutional conservation of the human and mouse GlcNAc-6-O-sulfotransferases implies the rigid requirement of the protein structure for the transferase action."
Elsewhere, Uchimura highlights differential expression of human GlcNAc-6-O-sulfotransferase in various human tumor cell lines (see paragraph bridging pages 674-76); moreover, Uchimura describes differences in the expression of human and murine GlcNAc-6-O-sulfotransferase (see page 676, left col., last full paragraph).
Given the teachings of Uchimura, it would have been obvious to one of ordinary skill in the art to prepare the fragment corresponding to amino acid residues 122-484 of the human GlcNAc-6-O-sulfotransferase set forth in Fig. 2 for the purpose of raising antibodies capable of binding murine and human GlcNAc-6-O-sulfotransferase.
One of ordinary skill in the art would have been motivated to identify antibodies capable of binding the 122-484 amino acid residue fragment of the human GlcNAc-6-O-sulfotransferase set forth in Fig. 2 of Uchimura since such antibodies would be reasonably expected to cross-react with, not only murine and human GlcNAc-6-O-sulfotransferase, but also with GlcNAc-6-O-sulfotransferase from additional animal model systems such as rats and non-human primates given the conservation of this fragment across the human and murine enzymes. A reason the ordinarily skilled artisan would have been motivated to identify antibodies that bind the 122-484 amino acid residue fragment of the human GlcNAc-6-O-sulfotransferase is because such antibodies would facilitate facile detection of the expressed enzyme, which may reveal additional features relevant to its biological function in cancer cells and/or in the brain.
The instant specification does not define what is meant by a “pharmaceutical composition,” and when this phrase is given its broadest reasonable interpretation consistent with the knowledge of the prior art it would be understood to encompass in its breadth compositions of the peptide of claim 1 in any carrier which can be safely administered to an animal, such as, e.g., water, phosphate buffered saline, sodium citrate buffer, etc. Likewise, the instant specification does not define what is meant by a “pharmaceutical composition…which is a vaccine,” and thus claim 14 will be considered as an equivalent of claim 12.
In making the fragment corresponding to amino acid residues 122-484 of the human GlcNAc-6-O-sulfotransferase set forth in Fig. 2 for the purpose of raising antibodies capable of binding murine and human GlcNAc-6-O-sulfotransferase, the skilled artisan would necessarily be making a pharmaceutical composition comprising this fragment and water or PBS such that the fragment can be safely administered, e.g., to a mouse in order to generate a humoral immune response.
Thus, the teachings of Uchimura anticipate claims 1, 12 and 14.
Insofar as applicant wishes the argue that the teachings of Uchimura are not anticipatory, the claimed invention is also obvious over the teachings of Uchimura in view of Weinschenk.
The teachings of Uchimura are given above.
Weinschenk teaches peptides comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 300, and pharmaceutically acceptable salts thereof, wherein said peptide is not the underlying full-length polypeptide (see page 3, last paragraph; page 75, last paragraph). Weinschenk also teaches polypeptides (which “is meant to refer to molecules containing more than about 30 amino acid residues”), including pharmaceutical compositions thereof, and describes how said polypeptides can be immunogenic (see page 76, 1st - 2nd paragraphs; page 82, 1st full paragraph).
At page 130, 2nd – 5th paragraphs, the specification further teaches kits comprising said peptides and pharmaceutically acceptable salts thereof:
“The present invention is further directed at a kit comprising:
(a) a container containing a pharmaceutical composition as described above, in solution
or in lyophilized form;
(b) optionally a second container containing a diluent or reconstituting solution for the
lyophilized formulation; and
(c) optionally, instructions for (i) use of the solution or (ii) reconstitution and/or use of the
lyophilized formulation.
The kit may further comprise one or more of (iii) a buffer, (iv) a diluent, (v) a filter, (vi) a
needle, or (v) a syringe. The container is preferably a bottle, a vial, a syringe or test
tube; and it may be a multi-use container. The pharmaceutical composition is preferably
lyophilized.
Kits of the present invention preferably comprise a lyophilized formulation of the present
invention in a suitable container and instructions for its reconstitution and/or use.
Suitable containers include, for example, bottles, vials (e.g. dual chamber vials),
syringes (such as dual chamber syringes) and test tubes. The container may be formed
from a variety of materials such as glass or plastic. Preferably the kit and/or container
contain/s instructions on or associated with the container that indicates directions for
reconstitution and/or use. For example, the label may indicate that the lyophilized
formulation is to be reconstituted to peptide concentrations as described above. The
label may further indicate that the formulation is useful or intended for subcutaneous
administration.”
Continuing at page 131, last paragraph and a page 132, penultimate paragraph, Weinschenk teaches various way in which their pharmaceutical composition could include, e.g., an adjuvant, and could be used as a vaccine.
Given the reference teachings it would have been obvious to one of ordinary skill in the art to package the fragment corresponding to amino acid residues 122-484 of the human GlcNAc-6-O-sulfotransferase set forth in Fig. 2 of Uchimura in the form of a pharmaceutical composition for vaccination of an animal in order to raise antibodies capable of binding human GlcNAc-6-O-sulfotransferase and orthologs thereof. The ordinarily skilled artisan would have been motivated to do so because such a kit provides a convenient format for shipping and organizing the components required, e.g., for inducing a humoral immune response in an animal.
In view of the reference teachings it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
No claims are allowed. However, claims 2 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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