DETAILED ACTION
Receipt of Arguments/Remarks filed on March 23 2026 is acknowledged. Claims 1-111 and 122 were/stand cancelled. Claims 112, 114-121, 123-124, 129 and 135 were amended. Claim 136 was added. Claims 112-121 and 123-136 are pending. Claims 130-133 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 9 2025. Claims 112-121, 123-129 and 134-136 are directed to the elected invention.
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 .
Withdrawn Objections/Rejections
The amendments to the drawings and specification filed March 23 2026 are sufficient to overcome the nucleotide and/or amino acid sequence disclosure issues. The incorporation by reference paragraph has been added to the specification, replacement drawings have been submitted indicating SEQ ID NO:. The appropriate statement has been provided (12/13/2022) and repeated with the response filed March 23 2026.
The amendments filed March 23 2026 are sufficient to overcome the objection of claim 135. The acronyms are now spelt out the first time they appear.
The arguments filed March 23 2026 are sufficient to overcome the rejection of 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 arguments (page 10-11) establish that mere administration of the SDF-1 inhibitor results in the claimed function. Specifically, as argued the formation of the SDF-1 gradient which happens upon exposing the desired area with a compound that inhibits signaling between SDF-1 and CSCR4 and/or CXCR7 produces the claimed function.
The arguments filed March 23 2026 are sufficient to overcome the rejection of 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. The arguments (page 11) make it clear that these features occur on exposing an inhibitor of interest to a tumor or structure associated therewith.
New and Modified Rejection Based on amendments
in the reply filed on March 23 2026
Claim Rejections - 35 USC § 112-failure to further limit
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 114-121 and 123-125 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.
Claims 114-121 and 123-125 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.
Response to Arguments
Applicants’ arguments filed March 23 2026 have been fully considered but they are not persuasive.
Applicants argue (page 10) that (1) the claimed invention, in part, relates to establishing an SDF-1 gradient. Surprisingly the inventors found a molecule that inhibits SFD-1 from engaging the receptor paradoxically enhances elimination of tumor and tumor cells. Mass action of the inhibitor of interest and tumor-produced soluble SDF-1 results in a gradient of SDF-1 about the tumor and associated stroma. The gradient directs leukocytes to the tumor and associated vascular. Adding an inhibitor of interest to the spheroid culture, induced infiltration of leukocytes into the spheroids. Therefore, the inventors identified the SDF-1 gradient that surrounds tumors and revealed the surprising observation that an inhibitor molecule preventing the chemokine, SDF-1, from engaging the receptor can act to facilitate cytotoxic activity in tumors enhancing infiltration of leucocytes into tumors. Applicants argue (page 11) that the claims describe specific action and features that occur on exposing an inhibitor of interest to a tumor or structure associated therewith. Applicants argue (page 12) that the claims are species of activities or process that occur under the ambit of the general method of claim 112. These do not relate or require additional steps but instead are specific actions or features that occur on exposing an inhibitor of interest to a tumor or structure associated therewith.
Regarding Applicants arguments, while the rejections under 112(a) and 112(b) were withdrawn, they were withdrawn because the arguments make it clear that the features in these claims flow from claim 112 such that practicing the method of claim 112 would necessarily result in the specific actions or features claimed. Thus, claims 114-118, 120-121 and 123-125 all recite features which occur following exposing a tumor, metastases of a tumor, vasculature of a tumor or vascular of a metastases of a tumor to a molecule that inhibits signaling between SDF-1 and CXCR4 and/or CXCR7 as confirmed by Applicants in the response filed. Claim 119 is slightly different as it requires administration of a therapeutically effective compound of a L-nucleic acid. However, claim 112 recites exposing to an L-nucleic acid already. Thus, claim 119 does not appear to further limit.
Claim Rejections - 35 USC § 112-Indefinitness
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 112-121, 123-129, 134-136 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 112 as currently written is vague and indefinite. The claim in lines 2-3 recites (a), (b), (c) and/or (d). However the exposing step in lines 5-6 recites “and” said vasculature of metastases of a tumor which corresponds to (d). This creates confusion to the exposing step (the only active method step). The recitation “and” is not in the alternative but the preamble of the claim recites and/or. Therefore, it isn’t clear if all those areas (a)-(d) have to be exposed to the inhibitor at the same time (i.e. limiting the patient population/cell type) to only those that would have a tumor in all those areas or if the claim should be in the alternative and at least one of those areas need to be exposed to the inhibitor. For art purposes the examiner is interpreting the claim as only requiring one to have exposure, i.e. and/or.
Claim 136 as currently written is vague and indefinite. The claim recites comprising an SDF-1 binding L-nucleic acid molecule concentration of 10 nm with a tumor/stroma spheroid. It isn’t clear if the 10 nM includes the tumor/stroma or is just the concentration of the L-nucleic acid molecule. The “with a” creates confusion of the scope. Page 29 of the instant specification, which applicants point to for support, states an optimal NOX-A12 concentration around 10 nM when added to the microtissue. But the claim as written does not use that language instead the claim recites “with a” indicating accompanied or association. Additionally, the claim just recites the method comprises. It does not indicate that the concentration is the concentration of the nucleic acid exposed to the site. Therefore, this additional feature creates further confusion to the scope.
Claims 113-121, 123-129, 134-135 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
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, cited in the Office Action mailed on 09/23/2025).
The instant application claims a method for establishing an SDF-1 gradient (a) in and/or around a tumor, (b) in and/or around metastases of a tumor, (c) around vasculature of a tumor and/or (d) around a vasculature of metastases of a tumor, wherein the method comprises exposing said tumor, said metastases of a tumor, said vasculature of a tumor and said vascular of metastases of at tumor to 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 to 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).
Unnecessary exposure of other tissues to the nucleic acid agent is taught (page 51). Subcutaneous injection is exemplified (page 109). Effective plasma levels of nucleic acid include 1 nM to 20 µM, more preferably 5 nM to 20 µM (page 62).
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 as disclosed reducing unnecessary exposure to other tissues is desired, this suggest exposing to said tumor specifically the molecule that inhibits anticipating claims 112-113, 119 and 126-129. It is noted that the recitation “for establishing an SDF-1 gradient 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 exposing which is taught by Purschke et al.
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.
The examiner is of the position that Purschke et al. still anticipates the claims as amended. However, in the event exposing is not determined as anticipated, the claims are obvious for the reasons set forth below.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 112-121, 123-129 and 134-136 are rejected under 35 U.S.C. 103 as being unpatentable over Purschke et al. in view of Dolznig et al. (Drug Discovery Today, 2011).
Applicant Claims
The instant application claims a method for establishing an SDF-1 gradient (a) in and/or around a tumor, (b) in and/or around metastases of a tumor, (c) around vasculature of a tumor and/or (d) around a vasculature of metastases of a tumor, wherein the method comprises exposing said tumor, said metastases of a tumor, said vasculature of a tumor and said vascular of metastases of at tumor to 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.
The instant application claims comprising an SDF-1 binding L-nucleic acid molecule concentration of 10 nM with a tumor/stroma spheroid. This claim is interpreted as being directed to the concentration of the nucleic acid exposed to a tumor/stroma spheroid.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Purschke et al. In vitro cell culture assays are taught (see example 1 or 4).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Purschke et al. clearly suggest reducing unnecessary exposure to other tissues is desired, this suggest exposing to said tumor specifically the molecule that inhibits Purschke et al. does not expressly state “exposing said tumor to a molecule” or spheroids. However, this deficiency is cured by Dolznig et al.
Dolznig et al. is directed to organotypic spheroid cultures to study tumor-stroma interaction during cancer development. The benefit of employing spheroids is that by introducing small avascular tumor spheroids of defined size into an organism one can dissect the early events of tumor angiogenesis. Spheroid implantation has also proven beneficial in studying choroidal melanoma (paragraph bridging pages 113-114). Cells grown as compact 3D aggregates (multi-cellular spheroids0 are more similar to tumors in vivo. They better mirror the in vivo structure of normal tissues and tumors (page 114, left column). Shown in Figure 1 is a schematic representation of in vitro spheroid-stroma interaction assays. Cells of different origin (tumor cells and stromal cells) are taught in Figure 1. See also Table 1.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 112 and 136, 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 Purschke et al. and Dolznig et al. and expose the SDF-1 binding molecule (i.e. SEQ ID NO 52, 53 and 22 which are L-nucleic acid molecules) in a therapeutically effective amount (1 nM to 20 µM, more preferably 5 nM to 20 µM) to spheroids with tumor/stromal cells. One skilled in the art would have been motivated to expose these cells as they are taught by Dolznig et al. as similar to tumors in vivo. Thus, when desiring to examine the effects of SDF-1 binding molecule in cancer, which is a desire of Purschke et al., one skilled in the art would have been motivated to utilize this cell culture for the reasons taught by Dolznig et al. Regarding the claimed concentration, Purschke et al. teaches an overlapping range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05. The examiner notes that page 29 of the instant specification indicates the claimed 10 nM is the optimal concentration. This does not establish an unexpected effect.
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.
Response to Arguments
Applicants’ arguments filed March 23 2026 have been fully considered but they are not persuasive.
Applicants argue that Purschke et al. does not teach an SDF-1 gradient at and about a tumor, at or about metastases of a tumor or at or about vasculature associated therewith and how to establish such a gradient. The SDF-1 gradient is not an intended use, creating that gradient enables treatment of tumors.
Regarding Applicants arguments, Although the reference is silent about an SDF-1 gradient, 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. Purschke et al. expressly teaches the exact same SDF-1 inhibitors as instantly claimed. It teaches administration to a subject with cancer (aka tumor) and clearly suggests administration at a site in which the tumor is present. Nothing in the arguments or the claim language results in a manipulative difference in the method steps. Therefore, contrary to Applicants assertion the instant claims are not structurally or functionally distinguished from the prior art.
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 an SDF-1 gradient (a) in and/or around a tumor, (b) in and/or around metastases of a tumor, (c) around vasculature of a tumor and/or (d) around a vasculature of metastases of a tumor, wherein the method comprises exposing said tumor, said metastases of a tumor, said vasculature of a tumor and said vascular of metastases of at tumor to 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 to 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 exposing which is taught by Purschke et al.
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 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 ‘636 claims a method for inhibiting the migration of leukocytes wherein the method comprises administering to a subject in need of treatment an L-nucleic acid that inhibits signaling between SDF-1 and SDF-1 receptor wherein the nucleic acid comprises a type B L-nucleic acid which comprises a core nucleotide sequence of SEQ ID No: 57 which has 100% sequence identity to instantly claimed SEQ ID NO: 52 (Qy):
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The nucleic acid comprises a modification which includes a HES moiety or PEG moiety.
The difference between the instant application and Patent ‘636 is that Patent ‘636 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 ‘636 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 ‘636 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 ‘636 teaches sequences which are the same as SEQ ID NO: 52 and the same in Purschke et al. which make up SEQ ID NO: 22. Since Patent ‘636 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.
Claim 136 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11371045, 9387221, 8314223, 10093934, 9035038, 8772257 OR 9988636 in view of Purschke et al. (WO2012031773) and Dolznig et al. (Drug Discovery Today, 2011). 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 the method comprising an SDF-1 binding L-nucleic acid molecule concentration of 10 nM with a tumor/stroma spheroid.
The teachings of Patent ‘045, ‘221, ‘223, ‘934, ‘038, ‘257 and ‘636 are set forth above.
None of the patents claim spheroids or a specific concentration. However, these deficiencies are cured by Purschke et al. and Dolznig 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). 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).Unnecessary exposure of other tissues to the nucleic acid agent is taught (page 51). Subcutaneous injection is exemplified (page 109). Effective plasma levels of nucleic acid include 1 nM to 20 µM, more preferably 5 nM to 20 µM (page 62).
Dolznig et al. is directed to organotypic spheroid cultures to study tumor-stroma interaction during cancer development. The benefit of employing spheroids is that by introducing small avascular tumor spheroids of defined size into an organism one can dissect the early events of tumor angiogenesis. Spheroid implantation has also proven beneficial in studying choroidal melanoma (paragraph bridging pages 113-114). Cells grown as compact 3D aggregates (multi-cellular spheroids0 are more similar to tumors in vivo. They better mirror the in vivo structure of normal tissues and tumors (page 114, left column). Shown in Figure 1 is a schematic representation of in vitro spheroid-stroma interaction assays. Cells of different origin (tumor cells and stromal cells) are taught in Figure 1. See also Table 1.
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 ‘045, ‘221, ‘223, ‘934, ‘038, ‘257 OR ‘636; Purschke et al. and Dolznig et al. and expose the SDF-1 binding molecule (i.e. SEQ ID NO 52, 53 and 22 which are L-nucleic acid molecules) in a therapeutically effective amount (1 nM to 20 µM, more preferably 5 nM to 20 µM) to spheroids with tumor/stromal cells. One skilled in the art would have been motivated to expose these cells as they are taught by Dolznig et al. as similar to tumors in vivo. Thus, when desiring to examine the effects of SDF-1 binding molecule in cancer, one skilled in the art would have been motivated to utilize this cell culture for the reasons taught by Dolznig et al. Regarding the claimed concentration, Purschke et al. teaches an overlapping range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05. The examiner notes that page 29 of the instant specification indicates the claimed 10 nM is the optimal concentration. This does not establish an unexpected effect.
Response to Arguments
Applicants’ arguments filed March 23 2026 have been fully considered but they are not persuasive.
Applicants argue (point 8) that none of Patent ‘045 teach an SDF-1 gradient. There is no teaching of the purpose of an SDF-1 gradient, why one would desire a gradient, how to make a gradient and how to use a gradient. The claims of Patent ‘045 do not render obvious the instant invention.
Regarding applicants arguments, while the patent is silent about an SDF-1 gradient, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to patent 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. Patent ‘045 expressly claims the exact same SDF-1 inhibitors as instantly claimed. Patent ‘045 administration to a subject with cancer (aka tumor). Nothing in the arguments or the claim language results in a manipulative difference in the method steps. Therefore, contrary to Applicants assertion the instant claims are not structurally or functionally distinguished from the patent.
Applicants argue (point 9) that none of Patent ‘221, ‘223, ‘934, ‘038, ‘257 and ‘636 teach an SDF-1 gradient. There is no teaching of the purpose of an SDF-1 gradient, why one would desire a gradient, how to make a gradient and how to use a gradient. The claims of Patent ‘045 do not render obvious the instant invention.
Regarding Applicants arguments, the arguments are not persuasive for the same reasons as set forth above. The mere silence of the verbiage SDF-1 gradient does not establish a difference between the instant claim and the Patents when the same SDF-1 inhibitor is claimed in all the patents. Administration to the same patient is taught (i.e. a tumor). Therefore, contrary to Applicants assertion the instant claims are not structurally or functionally distinguished from the patents.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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