DETAILED ACTION
Election/Restrictions
Applicant’s election of SEQ ID NO: 22 (type B molecule) in the reply filed on August 29 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Claims 112-135 are pending in the application. Claims 130-133 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(species), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 9 2025. Accordingly, claims 112-129 and 134-135 are being examined on the merits herein.
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 .
Priority
This application is a CON of 16/093,645 (10/14/2018; PAT 11371045) which is a 371 of PCT/EP2017/000495 (04/18/2017) which claims benefit to EUROPEAN PATENT OFFICE (EPO) 16 000 861.1 (04/15/2016) and EUROPEAN PATENT OFFICE (EPO) 16 002 168.9 (10/07/2016) as reflected on the filing receipt issued January 30 2023.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16093645, filed on October 14 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 1 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 135 is objected to because of the following informalities: The acronym “HES” is not defined in the claims. When an acronym is used in a claim set, it should be defined the first time it appears in the claims. For the purposes of examination, the term “HES” is interpreted to mean hydroxyethyl starch. Appropriate correction is required.
Claim 135 is objected to because of the following informalities: The acronym “PEG” is not defined in the claims. When an acronym is used in a claim set, it should be defined the first time it appears in the claims. For the purposes of examination, the term “PEG” is interpreted to mean polyethylene glycol. 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 114-119 and 120-125 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses administration of a SDF-1 inhibitor which is an SDF-1 binding L-nucleic acid. Specific L-nucleic acid molecules disclosed include SEQ ID NO: 52, 108, 74, 144, 53, 5-20, 22, 28, 109-11, 95-107, 112-137, 223-224, 75-77, 60-73, 78-82, 84-87, 89-94 and 145-146. The specification and claims teaches the administration includes a therapeutically effective amount.
Page 1 of the instant specification states that molecules that bind the CSC chemokine stromal cell-derived factor-1 (SDF-1) thereby modulate the number and the distribution of tumor-infiltrating leukocytes in tumors.
Page 29 suggest that CXCL12 inhibition to the microtissue during the incubation phase, T cells or peripheral blood mononuclear cells, the inventions have found a dose-dependent increase in lymphocyte infiltration.
Page 36 teaches that administering a diffusible inhibitor of SDF-1, CXCL12 around the vasculature is partially bound and neutralized. The inhibitor thereby creates or at least enhances microgradients around the vasculature into the solid tumor and metastasis which leukocytes can follow. Thereby more leukocytes can come into contact with more tumor cells. This can enhance T cell and NK cell attack, ADCC, leukocyte engagement and tumor cell killing by multi-valent drugs and also promote B cell driven anti-tumor response.
Page 68 teaches that the therapeutic agent can be effected by any appropriate route including, but not limited to, topical routes, oral routes, intravenous routes, intramuscular routes and direct absorption through mucous membrane tissue.
Therefore, while the specification discloses a representative number of species of a molecule that inhibits signaling between SDF-1 and CXCR4 and/or CXCR7 and describes various ways the molecule can be administered, the specification does not describe the specifics to the administration step that allow for the functions recited in claims 114-119 and 120-125. The specification merely teaches that administration of the molecule achieves these effects. Claim 120 is further complicated because the claim recites various effects separated by “and/or”. This seems to suggest the effects may or may not be present. But the specification never describes how to achieve some of the effects but not the others.
Note: MPEP 2163.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993), claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 (Fed. Cir. 1997) held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
If the wherein clause is intended to limit the method process, then the specification must describe how the wherein clause would give meaning and purpose to the manipulative step, administering in the instant claims. Note: MPEP 2111.04.
Therefore, since the instant specification fails to describe how the wherein clauses limit the process step, the specification fails to provide written description support for the claims.
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 114-119 and 120-125 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.
Claims 114-119 and 120-125 all recite various effects that are achieved following administering a molecule that inhibits signaling between SDF-1 and CXCR4 and/or CXCR7. However, it isn’t clear how the administration steps are modified to achieve the different effects. It isn’t clear if the recited effects merely happen after administration of the molecule and thus would not further limit or if there is some other manipulation of the administration step that occurs in order to achieve the claimed effect. Neither the claims nor the specification clarify.
Therefore, for art purposes, the claims are interpreted as merely reciting the effect that is achieved when one of the specifically taught SDF-1 binding L-nucleic acid molecule is administered.
Claim Rejections - 35 USC § 112
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 114-119 and 120-125 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.
As set forth above, the specification fails to describe how the administering step is manipulated in order to achieve the instantly claimed functions. Therefore, one interpretation is that merely administering the molecule as recited in claim 112 would necessarily leads to the claimed effects. In that case, claims 114-119 and 120-125 would all fail to further limit claim 112 as they merely recite the effect achieved by performing the method of claim 112.
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.
Claim(s) 112-129 and 134-135 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Purschke et al. (WO2012031773).
The instant application claims a method for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases, wherein the method comprises administering to the subject a molecule that inhibits signaling between SDF-1 and CXCR4 and/or CXCR7, wherein said molecule comprises an SDF-1 binding L-nucleic acid molecule. As elected the SDF-1 binding nucleic acid is SEQ ID NO: 22, which is type B and encompasses SEQ ID NO: 52 and 53.
Purschke et al. is directed to SDF-1 binding nucleic acids and the use thereof in cancer treatment. Claimed is a nucleic acid molecule capable of binding to SDF-1 that is capable of inhibiting SDF-1 and used in the treatment and/or prevention of cancer (claim 1). Cancers specifically claimed are solid tumors (claim 5). The nucleic acid molecule is capable of blocking the interaction between SDF-1 and an SDF-1 receptor wherein the SDF-1 receptor is selected from the group comprising CXCR4 and CXCR7 (claim 14). Claimed (claim 17) is a nucleic of SEQ ID NO: 52 which has 100% sequence identity to instantly claimed SEQ ID NO: 52 which is taught as an L-RNA (page 67).
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Another nucleic acid molecule claimed (claim 18) is SEQ ID NO: 53 which is taught as an L-RNA (page 67) which has 100% sequence identity ot instantly claimed SEQ ID NO: 53.
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The nucleic acid molecule is of type B and more preferably SEQ ID NO: 22 (claim 25) which is taught as an L-RNA (page 66) and has 100% sequence identity to instantly claimed SEQ ID NO: 22.
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The nucleic acid molecule comprises a modification which is selected group comprising a HES moiety, a PEG moiety, biodegradable modifications and combinations thereof (claim 45).
Specifically claimed is a method for the treatment of a subject suffering from or being at risk of developing cancer wherein the method comprises administering to the subject a pharmaceutically effective amount of a nucleic acid molecule capable of binding to SDF-1 as defined in any of the previous claims (claim 93). The method includes solid tumor cancers (claim 106).
Therefore, Purschke et al. teaches administration of the same SDF-1 binding molecule (i.e. SEQ ID NO 52, 53 and 22 which are L-nucleic acid molecules) in a pharmaceutically effective amount (aka therapeutically effective amount) to a subject with a solid tumor anticipating claims 112-113, 119 and 126-129. It is noted that the recitation “for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases is directed to the intended use of the method. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the only method step is administering which is taught by Purschke et al. As set forth in the 112a rejection above, the instant specification only ever teaches administering of the SDF-1 binding L-nucleic acid molecule to achieve the intended use.
Regarding claims 134-135, Purschke et al. claims the exact same modifications (see claim 45).
Regarding claims 114-118, 120-125, although the reference is silent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Thus, Purschke et al. teaches, either expressly or inherently implied, each and every limitation of the instant claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11371045. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a method for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases, wherein the method comprises administering to the subject a molecule that inhibits signaling between SDF-1 and CXCR4 and/or CXCR7, wherein said molecule comprises an SDF-1 binding L-nucleic acid molecule. As elected the SDF-1 binding nucleic acid is SEQ ID NO: 22, which is type B and encompasses SEQ ID NO: 52 and 53.
Patent ‘045 claims a method for modulating number and/or spatial distribution of NK cells that infiltrate a tumor in the treatment of a subject suffering from the tumor, wherein the method comprises administering to the subject a molecule that inhibits signaling between SDF-1 and CXCR4 and/or CXCR7 thereby modulating number and/or the spatial distribution of NK cells that infiltrate the tumor; and at least one checkpoint inhibitor, wherein said molecule comprises an L-nucleic acid and is selected from the group consisting of an SDF-1 binding nucleic acid molecule of type B, an SDF-1 binding nucleic acid molecule of type C, an SDF-1 binding nucleic acid molecule of type A and an SDF-1 binding nucleic acid molecule of type D. The type B includes a central stretch of SEQ ID NO 52 which is the same as instantly claimed. SEQ ID NO: 53 is claimed which is the same as instantly claimed. SEQ ID No 22 is claimed which is the same as instantly claimed. The same modifications are claimed (see claims 13-14).
Regarding claims 114-118, 120-125, Patent ‘045 claims the same limitations in claims (see claims 1-4).
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as both claim administration of the same compounds to the same subject. It is noted the instant claim language of comprising does not exclude the checkpoint inhibitor of patent ‘045.
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9387221 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘221 claims a method for the treatment of a subject suffering from cancer comprising: a) administering to the subject a cancer-treating amount of an L-nucleic acid molecule, or a an L-nucleic acid homolog thereof, wherein said L-nucleic acid molecule comprises SEQ ID NO:22, and said L-nucleic acid homolog comprises SEQ ID NO: 52 and a 5′ terminal stretch of nucleotides and a 3′ terminal stretch of nucleotides, wherein said 5′ stretch and said 3′ stretch can hybridize to each other, wherein 1) when said homolog is shorter than SEQ ID NO: 22, said homolog comprises homology of at least 85% to SEQ ID NO: 22 over the entire length of said homolog, and 2) when said homolog is equal in length to or longer than SEQ ID NO: 22, said homolog comprises homology of at least 85% to SEQ ID NO: 22 over the entire length of SEQ ID NO: 22, and wherein said L-nucleic acid molecule and said L-nucleic acid homolog bind SDF-1 and inhibit interaction of (a) SDF-1 and CXCR4 and (b) SDF-1 and CXCR7. SEQ ID NO: 22 is the same as instantly claimed (see below wherein instant SEQ ID NO: 22 is QY and patent ‘221 is Db) and thus encompasses instant SEQ ID NO: 52 and 53. Solid tumors are claimed (claim 7). The same modifications are claimed (see claims 8-9).
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Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as both claim administration of the same compounds to the same subject
Regarding claims 114-118, 120-125, although the reference is silent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8314223 in view of Purschke et al. (WO2012031773). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘223 claims an L-nucleic acid which has SEQ ID NO: 67 (claim 1). The nucleic acid includes a modification which can be a PEG molecule.
SEQ ID NO: 67 (Db) has 100% identity to instantly claimed SEQ ID NO: 22 (Qy):
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The difference between the instant application and Patent ‘223 is that Patent ‘223 does not teach administration to a patient with a tumor. However, this deficiency is cured by Purschke et al.
Purschke et al. is directed to SDF-1 binding nucleic acids and the use thereof in cancer treatment. Claimed is a nucleic acid molecule capable of binding to SDF-1 that is capable of inhibiting SDF-1 and used in the treatment and/or prevention of cancer (claim 1). Cancers specifically claimed are solid tumors (claim 5). The nucleic acid molecule is capable of blocking the interaction between SDF-1 and an SDF-1 receptor wherein the SDF-1 receptor is selected from the group comprising CXCR4 and CXCR7 (claim 14). Claimed (claim 17) is a nucleic of SEQ ID NO: 52 which has 100% sequence identity to instantly claimed SEQ ID NO: 52 which is taught as an L-RNA (page 67).
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Another nucleic acid molecule claimed (claim 18) is SEQ ID NO: 53 which is taught as an L-RNA (page 67) which has 100% sequence identity ot instantly claimed SEQ ID NO: 53.
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The nucleic acid molecule is of type B and more preferably SEQ ID NO: 22 (claim 25) which is taught as an L-RNA (page 66) and has 100% sequence identity to instantly claimed SEQ ID NO: 22 and as shown above to SEQ ID NO: 67 of patent ‘223.
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The nucleic acid molecule comprises a modification which is selected group comprising a HES moiety, a PEG moiety, biodegradable modifications and combinations thereof (claim 45).
Specifically claimed is a method for the treatment of a subject suffering from or being at risk of developing cancer wherein the method comprises administering to the subject a pharmaceutically effective amount of a nucleic acid molecule capable of binding to SDF-1 as defined in any of the previous claims (claim 93). The method includes solid tumor cancers (claim 106).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘223 and Purschke et al. and administer the nucleic acid to a subject suffering from or being at risk of developing cancer. One skilled in the art would have been motivated the nucleic acid of Patent ‘223 in this manner as it has the same sequence as nucleic acids taught in Purschke et al. and that is the end use taught by Purschke et al.
It is noted that the recitation “for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases is directed to the intended use of the method. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the only method step is administering which is taught by Purschke et al. As set forth in the 112a rejection above, the instant specification only ever teaches administering of the SDF-1 binding L-nucleic acid molecule to achieve the intended use.
Regarding claims 114-118, 120-125, although the reference is silent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10093934 (cited on PTO Form 1449) in view of Purschke et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘934 claims a method for the treatment of a subject suffering from cancer, wherein the method comprises a) administering to the subject a pharmaceutically effective amount of a type B L-nucleic acid, or a homolog thereof, that binds SDF-1, wherein said type B L-nucleic acid comprises, in order, a 5′ flanking sequence, SEQ ID NO:52 and a 3′ flanking sequence, wherein said 5′ and 3′ flanking sequences can hybridize to each other. A solid tumor is claimed (claim 3; 6). The same modifications are claimed (claim 16-17).
SEQ ID NO: 52 is the same as instantly claimed.
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The difference between the instant application and Patent ‘934 is that Patent ‘34 does not teach administration to a patient with a tumor and SEQ ID NO: 22. However, this deficiency is cured by Purschke et al
The teachings of Purschke et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘934 and Purschke et al. and administer the nucleic acid to a subject suffering from or being at risk of developing cancer. One skilled in the art would have been motivated the nucleic acid of Patent ‘934 in this manner as it has the same sequence as nucleic acids taught in Purschke et al. and that is the end use taught by Purschke et al. Since Patent ‘934 claims a subject with cancer there is a reasonable expectation of success.
It is noted that the recitation “for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases is directed to the intended use of the method. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the only method step is administering which is taught by Purschke et al. As set forth in the 112a rejection above, the instant specification only ever teaches administering of the SDF-1 binding L-nucleic acid molecule to achieve the intended use.
Regarding claims 114-118 and 120-125, although the reference is silent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9035038 in view of Purschke et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘038 claims an L-nucleic acid molecule that binds and SDF-1, the nucleic acid comprises a core nucleic acid sequence which is SEQ ID NO: 57 which as shown below is the same as instant SEQ ID NO: 52 (Qy):
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Another core claimed is SEQ ID No: 58 which is the same as instant SEQ ID NO: 53 (Qy):
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As claimed the L-nucleic acid includes a first stretch and a second stretch occurring before and after the core nucleotide sequence.
The difference between the instant application and Patent ‘038 is that Patent ‘038 does not expressly claim SEQ ID NO: 22 and does not teach administration to a patient with a tumor. However, this deficiency is cured by Purschke et al.
The teachings of Purschke et al. are set forth above.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘038 and Purschke et al. and administer the nucleic acid to a subject suffering from or being at risk of developing cancer. One skilled in the art would have been motivated the nucleic acid of Patent ‘083 in this manner as it has the same sequence as nucleic acids taught in Purschke et al. and that is the end use taught by Purschke et al.
It is noted that the recitation “for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases is directed to the intended use of the method. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the only method step is administering which is taught by Purschke et al. As set forth in the 112a rejection above, the instant specification only ever teaches administering of the SDF-1 binding L-nucleic acid molecule to achieve the intended use.
Regarding the claimed SEQ ID NO: 22, as set forth above, Patent ‘038 teaches sequences which are the same as SEQ ID NO: 52 and 53 and the same in Purschke et al. which make up SEQ ID NO: 22. Since Patent ‘038 claims an L-nucleic acid that binds SDF-1 and SEQ ID NO: 22 is taught by Purschke et al. is an L-nucleic acid that binds SDF-1 there is a reasonable expectation of success.
Regarding claims 114-118, 120-125, although the reference is silent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8772257 in view of Purschke et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘257 claims a method for mobilizing a cell that expresses a receptor for SDF-1 comprising exposing said cell to an L-nucleic acid antagonist of SDF-1 or a homolog thereof, each which binds SDF-1, wherein said L-nucleic acid comprises SEQ ID NO:67 and said homolog comprises at least 85% homology to the entire length of SEQ ID NO:67. The exposing is in a subject with a disease or a disorder. Diseases include cancer. SEQ ID NO: 67 has 100% sequence identity to instantly claimed SEQ ID No: 22:
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The difference between the instant application and Patent ‘257 is that Patent ‘257 does not expressly claim administration to a patient with a tumor. However, this deficiency is cured by Purschke et al.
The teachings of Purschke et al. are set forth above.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘257 and Purschke et al. and administer the nucleic acid to a subject suffering from or being at risk of developing cancer. One skilled in the art would have been motivated the nucleic acid of Patent ‘257 in this manner as it has the same sequence as nucleic acids taught in Purschke et al. and that is the end use taught by Purschke et al. There is a reasonable expectation of success as Patent ‘257 claim exposing a cell in a subject with a disease which can be cancer.
It is noted that the recitation “for establishing in the treatment and/or prevention of a tumor in a subject an SDF-1 gradient (a) in and/or around the tumor, (b) in and/or around metastases, (c) around the vasculature of the tumor and/or (d) around the vasculature of metastases is directed to the intended use of the method. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the only method step is administering which is taught by Purschke et al. As set forth in the 112a rejection above, the instant specification only ever teaches administering of the SDF-1 binding L-nucleic acid molecule to achieve the intended use.
Regarding claims 114-118, 120-125, although the reference is silent, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Regarding claims 134-135, Purschke et al. claims the exact same modifications (see claim 45).
Claims 112-129 and 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-14 of U.S. Patent No. 9988636 in view of Purschke et al. Although the conflicting claims are