DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of group I, claims 1-11, in the reply filed on 10/22/25 is acknowledged. Applicant has further elected a combination of SEQ ID Nos: 1, 4, 7, 9-12 as the species of peptides, and a composition comprising isolated peptides as the species of composition. Upon reconsideration, compositions comprising APCs carrying the peptides are also being included in the examination. Claims 14-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 2-4, 7-9 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species of peptide combinations.
Claims 1, 5-6, and 10-11 read on the elected invention and are being acted upon.
Claim 11 is objected to for the following informality: The claim recites “a biologicals”. Correction is required to, for example, “a biological”.
Claim interpretation
The claims recite the limitation of one or more tumor-associated “peptides” comprising an amino acid sequence selected from the group consisting of SEQ ID Nos. 1-4 and 6-13, fragments of said amino acid sequences SEQ ID NOS: 1-4 and 6-13 of at least 3 amino acids in length, and any combination thereof. The specification does not define the term peptide. Therefore, the term is given its broadest reasonable interpretation of a polymer of amino acid residues of any length (see US 12,188,096 or 11,319,344, for example, where the terms peptide and polypeptide are used interchangeably and refer to polymers of amino acid residues of any length). Furthermore, the claims recite peptides “comprising” said amino acid sequences, which is an open term. Therefore, the claims would encompass a tumor associated peptide of any length as long as it comprises an amino acid sequence selected from the group of sequences defined in the claim. For example, a 200 amino acid peptide comprising SEQ ID NO: 1 would be within the scope of the claimed tumor associated peptides. The claims recite that the peptides comprise an amino acid sequence “selected from the group consisting of SEQ ID Nos. 1-4 and 6-13, fragments of said amino acid sequences SEQ ID NOS: 1-4 and 6-13 of at least 3 amino acids in length, and any combination thereof”. Thus, the claims encompass one or more tumor associated peptides that comprise either SEQ ID NO: 1-4 or 6-13, or a fragment of SEQ ID NO:1-4 or 6-13 of at least 3 amino acids, or any combination thereof. For example, a 100 amino acid peptide comprising a sequence “SKVP” would be within the scope of the instant claims, since SKVP is an amino acid sequence that is a fragment of SEQ ID NO: 10 of at least 3 amino acids. Regardless of the sequence of the remaining residues in said 100 amino acid peptide, said peptide would be considered a “tumor-associated peptide” within the scope of the instant claims, since it comprises a fragment of a tumor-associate peptide of at least 3 amino acids.
It is also noted that claim 6 is directed to an immunogenic composition “comprising” the one or more tumor associated peptides, which is an open term, and therefore the composition encompasses unrecited elements (i.e. such as additional peptides). Claim 1 is also interpreted as encompassing other peptides in addition to the one or more tumor associated peptides (i.e. the APC can carry other peptides, so long as it carries the one or more tumor-associated peptides comprising an amino acid selected from the recited group of sequences).
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.
Claims 6, 10-11 are 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 6 is directed to a composition comprising (i), (ii), (iii) “or” (iv), wherein only element (iv) depends from claim 5. For example, claim 6 would encompass a composition comprising only a peptide of part (i), and therefore would not require all the limitations of claim 5, from which it depends. In other words, claim 6 is broader in scope than claim 5, from which it depends. 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.
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 6 and 10-11 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 6 is indefinite, since it is unclear whether the limitation of “a pharmaceutically acceptable vehicle” as recited in the last line, is intended to limit each of options i)-iv), or whether it only applies to option iv). The scope of the claim is unclear and indefinite.
Claim 11 is indefinite in the recitation of the immunogenic composition for use as a vaccine according to claim 10, “in combination therapy with an immune checkpoint inhibitor, a chemotherapeutic agent, a biologicals, target therapy and/or an oncolytic virus”. The scope of the claim is unclear and indefinite. Does the claim intend that the composition further comprises the immune checkpoint inhibitor (i.e. “combination therapy), or does the limitation refer to an intended use of the claimed composition in combination therapy with a checkpoint inhibitor. For the purposes of examination, the claim limitation is being interpreted as encompassing an intended use of the immunogenic composition, i.e. it can be used as a vaccine in combination with an immune checkpoint inhibitor, for example.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-6, and 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) one or more tumor-associated peptides comprising an amino acid sequence selected from the group consisting of SEQ ID Nos. 1-4 and 6-13, fragments of said amino acid sequences SEQ ID NOS: 1-4 and 6-13 of at least 3 amino acids in length, and any combination thereof. This judicial exception is not integrated into a practical application because said peptides are products of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including “physical phenomena,” “scientific principles”, “natural laws,” and “products of nature.” Product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g.,Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g.,In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart. See MPEP 2106.04(b).
In the instant case, the claims are directed to compositions of matter as set forth in Step 1 of the subject matter eligibility test (see MPEP 2106). Regarding step2A, prong 1, the claims recite one or more tumor associated peptides comprising an amino acid sequence selected from the group consisting of SEQ ID Nos. 1-4 and 6-13, fragments of said amino acid sequences SEQ ID NOS: 1-4 and 6-13 of at least 3 amino acids in length, and any combination thereof. Said peptides are products of nature. For example, each of SEQ ID Nos: 1-4 and 6-13 are sequences found within naturally occurring proteins such as osteopointin, ribosomal proteins, etc. (see Figure 2 of the instant specification). The claims encompass peptides “comprising” said sequences, which would read on the full length naturally occurring proteins (see claim interpretation regarding the breadth of a “peptide” as set forth above). Furthermore, even if the claims were limited to peptides consisting of, for example, SEQ ID NO: 1, for example, this would still be a product of nature, since the fact that a peptide is isolated from a larger peptide or protein (e.g. chemical bonds on either end of the peptide have been “broken”) does not rise to the level of a marked difference, because there is no change to the sequence of the peptide.
Regarding step 2A prong two and step 2B, the claims do not recite additional elements that integrate the judicial exception into a practical application, nor do the claims recite any additional elements that amount to significantly more than the judicial exception. In claims 6 and 10-11, the only other limitation is the recitation of an immunogenic composition, a pharmaceutically acceptable vehicle, and an intended use as vaccine, or use in combination with other therapies. However, these limitations, recited at a high level of generality amount to nothing more than field of use or insignificant extra-solution activity.
Claim 1 and 5 recites an additional element of an APC or dendritic cell which carries on the cell surface the one or more of the tumor associated peptides. However, naturally occurring APCs, such as dendritic cells, naturally carry “peptides” having at least 3 amino acids from, for example SEQ ID NO: 10. See GenBank Accession AAK20997.1, wherein a DC-SIGN protein (which is within the scope of a “peptide”, see claim interpretation) comprises a 4 amino acid fragment SKVP (see residues 61-64 of said Accession). Said SKVP is a fragment of SEQ ID NO: 10 of the instant application. Thus, the claims read on naturally occurring dendritic cells which carry cell surface “peptides” having the same amino acid sequences of the instant claims, i.e. a peptide comprising SKVP which represent at least 3 amino acids of SEQ ID NO: 10
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, 5-6, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Melacarne, published 2018, as evidenced by Nair, 2015.
Melacarne teaches an immunogenic composition comprising tumor associated peptides that are secreted from salmonella infected 62438 melanoma tumor cells (see pages 41, 44, 71, in particular). Melacarne teaches that the peptides secreted from said salmonella infected 62438 melanoma cells comprise a peptide RSGPTDDGEEEMEEDTVTNGS, which is identical to SEQ ID NO: 11 of the instant claims (See Fig. 4-24). Melacarne also teaches that said secreted peptides also comprise a peptide VIYTRNTKGGDAPAAGEDA, which comprises AAG, which represents three amino acids from SEQ ID NO: 4 of the instant application (i.e. a tumor associated peptide comprising a three amino acid fragment of SEQ ID NO: 4). Melacarne also teaches said secreted peptides include a peptide comprising SASSE, for example, which represents a 5 amino acid fragment of SEQ ID NO: 7 of the instant application. Melacarne also teach said secreted peptides include a peptide comprising, EEEEGISQ, which is an 8 amino acid fragment of SEQ ID NO: 9 of the instant application. Melacarne also teach said secreted peptides include a peptide having MGES, which is a 4 amino acid fragment of SEQ DIN NO: 1 of the instant application. Melacarne also teach said secreted peptides comprise a peptide RSAPGGGSKVPQK, which is identical to SEQ ID NO: 10 of the instant application. Melacarne also teach said secreted peptides include a peptide TVAGGAWTYNTTSAVTVK, which is identical to SEQ ID NO: 12 of the instant application. (see Fig. 4-24). Melacarne teaches that the peptides are in a composition comprising cell culture supernatant that has been filtered to remove bacteria, which is physiologically compatible vehicle and meets the limitation of a “pharmaceutically acceptable vehicle” (see page 41, 44, in particular).
Therefore the peptide composition of Melacarne comprises a tumor associated peptide comprising SEQ ID NO: 10, a tumor associated peptide comprising SEQ ID NO: 11, a tumor associated peptide comprising SEQ ID NO: 12, as well as tumor associated peptides comprising at least three amino acid fragments of each of SEQ ID NO: 1, 4, 7, and 9 of the instant claims.
Alternatively, the instant specification on page 17 discloses that the peptides of SEQ ID NO: 1, 4, 7, and 9-12 were sequenced from the secretome of melanoma cell line 624.38 following Salmonella infection. Therefore, the peptide compositions taught in Melacarne, which are isolated in an identical manner (i.e. from the secretome of salmonella infected 62438 cells), would inherently comprise peptides comprising each of SEQ ID NO: 1, 4, 7, and 9-12 of the instant application.
Regarding the limitations in claim 10-11 reciting an intended use as a vaccine, or for use as a vaccine in combination with, for example, a checkpoint inhibitor, it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Regarding the limitations of claim 1, wherein the peptides are carried on the cell surface of an isolated APC, Melacarne also teaches pulsing and loading the peptides onto isolated PBMC, which would comprise APC. The instant specification discloses on page 7 that in order to generate APC carrying the claimed peptides, APCs may be pulsed with the peptides. Therefore, the pulsed PBMC of Melacarne would inherently be carrying the peptides, i.e. they would be presented at the cell surface of the APC in the context of HLA. Melacarne teach that the PBMC are isolated by Ficoll density gradient centrifugation (see page 43-44, 71-72). Regarding claim 5, as evidenced by Nair, PBMC isolated by Ficoll density centrifugation inherently comprise dendritic cells, and the isolated PBMC of Melacane would therefore comprise isolated dendritic cells.
The rejection is made as a combined 102/103 to the extent that some of the limitations relied upon (for example the presence of each of SEQ ID NO 1, 4, 7, 9-12, and the fact that the peptides are carried on the cel surface) are inherent. See MPEP 2112, a rejection under 35 U.S.C. 102 and 103 can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic.
Claim(s) 1, 5-6, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2018/0346513.
The ‘513 publication teaches an immunogenic composition comprising tumor associated peptides, wherein the composition comprises a peptide of SEQ ID NO: 30, TEEEKNFK, which comprises a 3 amino acid fragment of SEQ ID NO: 11 of the instant claims (i.e. EEE, see pages 2-4 paragraphs 25, 149-151, and Fig. 13, in particular). The ‘513 publication teaches another embodiment of an immunogenic composition comprising tumor associated peptides that are secreted from salmonella infected 624.38 melanoma tumor cells (see paragraphs 145, 198, and 2187in particular). The instant specification on page 17 discloses that the peptides of SEQ ID NO: 1, 4, 7, and 9-12 were sequenced from the secretome of melanoma cell line 624.38 following Salmonella infection. Therefore, the peptide composition taught in the ‘513 publication, which is produced in an identical manner (i.e. from the secretome of salmonella infected 624.38 cells), would inherently comprise peptides comprising each of SEQ ID NO: 1, 4, 7, and 9-12 of the instant application. The ‘513 publication teaches the use of said composition as a vaccine in combination with an immune checkpoint inhibitor and said composition and a pharmaceutically acceptable vehicle (See paragraphs 25, 53, 58-59, in particular). The ‘513 publication teaches loading said peptide compositions on dendritic cells on cell surface MHC molecules (i.e. the peptides are carried on the cell surface of the dendritic cells, See page 2, in particular).
The rejection is made as a combined 102/103 to the extent that since some of the limitations relied upon (for example the presence of each of SEQ ID NO 1, 4, 7, 9-12,) are inherent. See MPEP 2112, a rejection under 35 U.S.C. 102 and 103 can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644