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 .
Status of Application
The Preliminary Amendment filed on 04/11/24 is acknowledged.
Claims 5, 8-10, 12-13, and 16-18 were amended.
New claim 20 was added.
Claims 1-20 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/11/24 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
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 5-6, 8-9, 12-13, 17, and 20 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 pre-AIA the applicant regards as the invention.
Claims 5-6, 8-9, 12-13, 17, and 20 recite the limitation "the linezolid composition." Claims 5, 8-9, and 12-13 are dependent on claim 3, and are ultimately dependent on claim 1. Claim 6 is dependent on claim 5. Claim 17 is dependent on claim 12. Claim 20 is dependent on claim 4, which is dependent on claim 3. However, none of claims preceding claims 3 or 5 recite a “linezolid composition.” There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
Claim 1 recites “A method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient …” It is recommended that claim 1, line 2, should be amended to insert the phrase “in need thereof” after the term “patient” in order to state the intentional purpose for which the method must be performed. Please see MPEP 2111.02(II).
Notice for all US Patent Applications filed on or after March 16, 2013
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5-10, 12-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Czaplewski et al. (WO 2019/097242 A1 – “Czaplewski”).
The claimed invention is a method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient; wherein the antibiotic is administered to one or more targeted sites in the spine.
Czaplewski teaches discloses a method of administering an injectable, thermosensitive hydrogel pharmaceutical composition comprising the antibiotic linezolid to a diseased site (or sites) for treating lower back pain (Abstract, [0029]-[0030], claims 1-25). Example 11 discloses the in vivo intradiscal disc injection of the linezolid suspension (PP353) in sheep ([00190]-[00192], Figure 6). The linezolid is linezolid Form II ([0010], [0043], [0065], Example 4, claims 2, 11, and 15). The thermosensitive hydrogel delivery carrier is composed of poloxamer 407 and iohexol ([0015], [0056], [0072], claims 1, 3-4, 11, and 15). The linezolid particles may be sterilized for preparing sterile injectable formulations ([0044], [0065], [0074], section 9.2 [00174]-[00175], [00179], and claim 16). Linezolid form II was air jet milled to provide micronized-linezolid form II ([0016], Figures 1A and 1B, Example 4 [00142]-[00143], Table 5, [00155], [00172]-[00173], and [00183]). Linezolid was loaded to the delivery vehicle to form a suspension ([0010], [0034], [0064], [00166], Table 14). The poloxamer-iohexol solution is sterilized and packed into separate vials ([0059], [00164]). The injectable pharmaceutical formulation is administered to an intervertebral disc, intervertebral space, intra-articular space, ligament, tendon, tendon and bone junction, joint, epidural space, facet joint, site adjacent to bone edema, or other spinal compartment ([0014], [0034], claims 12 and 23). Needles are positioned into adjacent discs and the formulation injected ([0017], Figure 2, [0077], [0089]-[0090], [00116], [00119]-[00120]). A 5 inch (127mm) 18 French gauge needle that represents a guide needle and another 7 inch (178mm) 22 French gauge needle which represents the administration needle are disclosed ([00188]). The linezolid suspension is used to prime a 1 ml luer lock syringe ([00170]). A single administration (e.g., a single injection) is used to deliver a desired dosage of linezolid to the infected disc ([0083], [0084]). A total treatment dose that is a single unit dose is disclosed ([00104]). A split dose which is the division of a single dose or total treatment dose into two doses is disclosed ([00101]). A second dose is administered 5 days after the previous dose ([0083]). The compositions deliver about 5 mg to 450 mg, about 50 mg to about 200 mg of linezolid, including a dose of 150 mg of linezolid to obtain the desired therapeutic effect ([0081]). Modic Type 1 patients are disclosed ([0038], claims 21-24).
Regarding instant claim 1, the limitation of a method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient; wherein the antibiotic is administered to one or more targeted sites in the spine is anticipated by the method of administering an injectable, thermosensitive hydrogel pharmaceutical composition comprising the antibiotic linezolid to a diseased site (or sites) for treating lower back pain (Abstract, [0029]-[0030], Example 11 – [00190]-[00192], claims 1-25, particularly claim 12), as taught by Czaplewski.
Regarding instant claim 2, the limitation of linezolid form II is anticipated by the linezolid Form II ([0010], [0043], [0065], Example 4, claims 2, 11, and 15), as taught by Czaplewski.
Regarding instant claim 3, the limitation of a thermosensitive hydrogel delivery carrier composed of poloxamer 407 and iohexol is anticipated by the thermosensitive hydrogel delivery carrier composed of poloxamer 407 and iohexol ([0015], [0056], [0072], claims 1, 3-4, 11, and 15), as taught by Czaplewski. The limitation of the linezolid prepared as sterilized micronized powder in a dose unit is anticipated by the linezolid particles which are sterilized for preparing sterile injectable formulations ([0044], [0065], [0074], section 9.2 [00174]-[00175], [00179], and claim 16), and linezolid form II which was air jet milled to provide micronized-linezolid form II ([0016], Figures 1A and 1B, Example 4 [00142]-[00143], Table 5, [00155], [00172]-[00173], and [00183]), as taught by Czaplewski. The limitation of the linezolid loaded to the poloxamer 407 based thermosensitive hydrogel delivery carrier prior to administration is anticipated by the linezolid loaded to the delivery vehicle to form a suspension ([0010], [0034], [0064], [00166], Table 14). The limitation of the thermosensitive hydrogel delivery carrier pre-prepared as a sterilized solution is anticipated by the poloxamer-iohexol solution that is sterilized and packed into separate vials ([0059], [00164]), as taught by Czaplewski.
Regarding instant claims 5 and 20, the limitations of the linezolid composition administered to at least one intervertebral disc, intervertebral space, intra-articular space, ligamentum flavum, ligament associated with the spine, epidural space, tendon associated with the spine, site adjacent to bone oedema, bone junction, facet joint, and/or other spinal compartments are anticipated by the injectable pharmaceutical formulation administered to an intervertebral disc, intervertebral space, intra-articular space, ligamentum flavum, ligament associated with the spine, epidural space, tendon associated with the spine, site adjacent to bone oedema, bone junction, facet joint, and/or other spinal compartments ([0014], [0034], claims 12 and 23), as taught by Czaplewski.
Regarding instant claim 6, the limitation of one or more intervertebral discs is anticipated by the intervertebral disc ([0014], [0034], [0054], [0081], claims 12 and 23), as taught by Czaplewski.
Regarding instant claim 7, the limitation of about 150 mg linezolid per intervertebral disc is anticipated by the dose of 150 mg of linezolid ([0081]), as taught by Czaplewski.
Regarding instant claims 8 and 9, the limitations of an introducer needle and an administration needle are anticipated by the needles positioned into adjacent discs and the formulation injected, ([0017], Figure 2, [0077], [0089]-[0090], [00116], [00119]-[00120], [00188]), the 5 inch (127mm) 18 French gauge needle that represents a guide needle and another 7 inch (178mm) 22 French gauge needle which represents the administration needle that would be inserted into the disc to be injected ([00188]), as taught by Czaplewski.
Regarding instant claim 10, the limitation of the administration needle connected to a luer-lock syringe is anticipated by the linezolid suspension used to prime a 1 ml luer lock syringe ([00170]), as taught by Czaplewski.
Regarding instant claim 12, the limitation of the patient receiving a single dose of the linezolid composition in each of the one or more targeted sites in the spine is anticipated by the single administration (e.g., a single injection) that is used to deliver a desired dosage of linezolid to the infected disc ([0083], [0084]) and a total treatment dose that is a single unit dose ([00104]), as taught by Czaplewski.
Regarding instant claim 13, the limitation of the patient receiving two doses of the linezolid composition in each of the one or more targeted sites in the spine is anticipated by the split dose which is the division of a single dose or total treatment dose into two doses ([00101]), as taught by Czaplewski.
Regarding instant claim 14, the limitation of the dosing interval between the first dose and second dose of from about 72 hours (3 days) to about 132 hours (5.5 days) is anticipated by the second dose which is administered 5 days after the previous dose ([0083]), as taught by Czaplewski. According to MPEP 2131.03(I), a specific example in the prior art which is within a claimed range anticipates the range.
Regarding instant claim 15, the limitation of the dosing interval between the first dose and second dose of 120 hours (5 days) is anticipated by the second dose which is administered 5 days after the previous dose ([0083]), as taught by Czaplewski.
Regarding instant claim 17, the limitation of about 150 mg linezolid is anticipated by the dose of 150 mg of linezolid ([0081]), as taught by Czaplewski.
Regarding instant claims 18-19, the limitations of the patient with low back pain having vertebral body endplate bone edema (Modic change) (instant claim 18) and Modic change Type I (instant claim 19) are anticipated by the Modic Type 1 patients ([0038], claims 21-24), as taught by Czaplewski.
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 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Czaplewski et al. (WO 2019/097242 A1 – “Czaplewski”), as applied to claims 1-3, 5-10, 12-15, and 17-20 above.
Instant claim 4 is drawn to the method of claim 3 wherein linezolid is pre-prepared in a dose unit of about 250 mg and loaded to about 5 ml of the thermosensitive hydrogel delivery carrier prior to administration.
The teaching of Czaplewski is discussed above.
Although Czaplewski teaches that the compositions deliver about 5 mg to 450 mg of linezolid ([0081]), they do not exemplify an embodiment that delivers about 250 mg of linezolid.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of administering an injectable, thermosensitive hydrogel pharmaceutical composition comprising the antibiotic linezolid to a diseased site(s) for treating lower back pain, as taught by Czaplewski, in view of the compositions that deliver about 5 mg to 450 mg of linezolid, also as taught by Czaplewski, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because according to MPEP 2144.05, “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 the present case, the claimed dose of about 250 mg lies within the range of about 5 mg to 450 mg disclosed by Czaplewski. One of ordinary skill in the art would have found it obvious to use various dosages within the dosage range taught by Czaplewski and have a reasonable expectation of successfully treating low back pain.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 4, the limitation of about 250 mg of linezolid would have been obvious over the compositions that deliver about 5 mg to 450 mg of linezolid ([0081]), as taught by Czaplewski. Please see MPEP 2144.05. The limitation of about 5 ml of the thermosensitive hydrogel delivery carrier would have been obvious over the 5 ml of the linezolid suspension administration ([0082]) as taught by Czaplewski.
Regarding instant claim 16, the limitation of the first and second doses containing the same amount of linezolid would have been obvious over the division of a single dose or total treatment dose into two doses ([00101]), as taught by Czaplewski. One of ordinary skill in the art would have found it obvious to split the single dose in equal parts, thereby providing the same amount of linezolid in each part.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Czaplewski et al. (WO 2019/097242 A1 – “Czaplewski”), as applied to claims 1-3, 5-10, 12-15, and 17-20 above, in view of Hinderer et al. (US 2019/0038772 A1 – “Hinderer”).
Instant claim 11 is drawn to the method of claim 10 wherein the administration needle and the luer-lock syringe are connected via a flexible connector.
The teaching of Czaplewski is discussed above.
Although Czaplewski teaches needles positioned into adjacent discs and the formulation injected, ([0017], Figure 2, [0077], [0089]-[0090], [00116], [00119]-[00120], [00188]), a 5 inch (127mm) 18 French gauge needle that represents a guide needle and another 7 inch (178mm) 22 French gauge needle which represents the administration needle that would be inserted into the disc to be injected ([00188]), and a 1 ml luer lock syringe ([00170]), Czaplewski does not expressly teach a flexible connector.
Hinderer teaches: “After confirming correct placement of the needle by observation of the contrast agent in the cisterna magna, a syringe containing the test article or vehicle (volume of 1.4 mL, equivalent to 1 mL plus the volume of syringe and linker dead space) was connected to the flexible linker and slowly injected over 20 - 60 seconds” ([0404]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of administering an injectable, thermosensitive hydrogel pharmaceutical composition comprising the antibiotic linezolid to a diseased site(s) for treating lower back pain by using an administration needle and a luer-lock syringe, as taught by Czaplewski, in view of the flexible linker or connector, as taught by Hinderer, and produce the instant invention. Furthermore, applying a known technique to a known method ready for improvement to yield predictable results is obvious. Please see MPEP 2141(III)(D).
Regarding instant claim 11, the limitation of a flexible connector would have been obvious over the flexible linker ([0404]), as taught by Hinderer.
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 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,517,574 B2 (“the ‘574 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient; wherein the antibiotic is administered to one or more targeted sites in the spine, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claims of the ‘574 Patent recite an injectable pharmaceutical formulation comprising linezolid form II whereas instant claims recite a method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient. However, instant claim 2 recites the same active ingredient, i.e., linezolid form II. Furthermore, claim 8 of the ‘574 Patent recites that the injectable pharmaceutical formulation is prepared for administering to an intervertebral disc, an intervertebral space, an intra-articular space, a site adjacent to bone edema, a ligament, bone, joint, or tendon associated with the spine, or a tendon and bone junction. One of ordinary skill in the art would have found it obvious to administer the same injectable pharmaceutical formulation containing the same active ingredient and the same thermosensitive hydrogel delivery carrier in the same target site of a patient as recited in claims of the ‘574 Patent and successfully treat low back pain as recited in the instant claims.
Therefore, instant claims are obvious over claims of the ‘574 Patent and they are not patentably distinct over each other.
Claims 1-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,161,750 B2 (“the ‘750 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient; wherein the antibiotic is administered to one or more targeted sites in the spine, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claims of the ‘750 Patent recite that the linezolid is present in an amount of from about 2.5% to about 20% by weight of the injectable pharmaceutical composition whereas instant claims don’t recite this limitation.
However, one of ordinary skill in the art would have found it obvious to include the linezolid in a therapeutically effective amount, including the doses of about 250 mg, as recited in instant claim 4; and about 150 mg administered per intervertebral disc, as recited in instant claims 7 and 17, and modify the dosage range based on the optimal dose. The range recited in claim 1 of the ‘750 Patent would have been an obvious variant.
Therefore, instant claims are obvious over claims of the ‘750 Patent and they are not patentably distinct over each other.
Claims 1-10 and 12-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 46-48 of copending Application No. 19/025,236 (“the ‘236 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for treating low back pain comprising administering a therapeutically effective amount of an antibiotic to a patient; wherein the antibiotic is administered to one or more targeted sites in the spine, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 46 of the ‘236 Application recites 1% to 20% of linezolid Form II by weight of the formulation; and claim 48 of the ‘236 Application recites linezolid Form II in an amount of from about 2.5% to about 20% by weight of the injectable pharmaceutical formulation, whereas instant claims don’t recite this limitation.
However, one of ordinary skill in the art would have found it obvious to include the linezolid in a therapeutically effective amount, including the doses of about 250 mg, as recited in instant claim 4; and about 150 mg administered per intervertebral disc, as recited in instant claims 7 and 17, and modify the dosage range based on the optimal dose. The range recited in claims 46 and 48 of the ‘236 Application would have been obvious variants.
Another difference is that claims 46 and 48 of the ‘236 Application recite specific percentage ranges of poloxamer 407 and iohexol whereas instant claims don’t recite these ranges. However, one of ordinary skill in the art would have found it obvious to use various percentage ranges of poloxamer 407 and iohexol in order to efficaciously treat low back pain in a patient.
Therefore, instant claims are obvious over claims of the ‘236 Application and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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