DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of Application No. 17/589162 (filed on 1/31/2022), which is a continuation of Application No. 16/368159 (filed on 3/28/2019), which is a continuation of Application No. 15/260286 (filed on 9/08/2016), which is a continuation of 14/491792 (filed on 9/19/2014), which in turn is a divisional of Application No. 13/993919 (filed on 6/13/2013). The latter application is a national stage entry of PCT/JP2011/006938 (filed on 12/13/2011).
Foreign priority is claimed under 35 U.S.C. 119(a)-(d) based on application JP2010-277490 filed in Japan on 12/13/2010. Certified copy of the foreign priority document was received in the national stage application and its English translation was received in Application No. 15/260286.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/20/2024 is in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all references cited in the IDS have been fully considered.
However, the listing of references in the specification (par. [0007]-[0008]) is not a proper IDS. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Thus, unless the references have been cited by the applicant or examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities:
(i) “anulus fibrosus” (par. [0003]) is a misspelling of the term “annulus fibrosus”;
(ii) “glucosaminoglycan” (par. [0004]) appears to be a typographical error for “glycosaminoglycan”; and
(iii) “Proteus vulgaris” (par. [00012], [00015], [00019]) is a species name but is not written in italics.
Appropriate corrections are required.
It is also recommended that the abstract be amended to more accurately describe the claimed method.
Claim Objections
Claim 1 is objected to because of the following informality: incorrect syntax. To resolve this issue, the phrase “a human disc of a patient” should be amended to “a disc of a human patient”.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Masuda et al. (Pub. No. US 2002/0106362 A1).
According to Masuda et al., lumbar intervertebral disk herniation is one of the most common causes of lower back pain. It is initially treated with physical therapy and sometimes followed by other treatments including chemonucleolysis, which dissolves intervertebral tissue using a locally injected enzyme (par. [0009]). Performing chemonucleolysis with proteolytic enzymes like chymopapain and collagenase, however, can lead to complications such as paraplegia, anaphylaxis, and neurologic deficits (par. [0010]). And since physical therapy and chemonucleolysis often do not relieve sciatica associated with disc herniation, many patients undergo surgery which is not always satisfying and can lead to adverse side effects (par. [0011]). Hence, there is a need for a chemonucleolysis treatment that not only provides relief from symptoms of intervertebral disk herniation but also avoids invasive surgery, improves stability, and repairs the nucleus pulposus and annulus fibrosus in the disc (par. [0014]).
To address this need, Masuda et al. discloses a treatment method comprising administering to a mammal in need of chemonucleolysis an effective amount of a proteoglycan-degrading enzyme and growth factor in an amount effective for stimulating the formation of a matrix component like collagen (par. [0015]), wherein said enzyme and growth factor are administered simultaneously or sequentially (par. [0052]-[0053]) in one or more doses (par. [0049], [0054]). The administration is preferably performed by direct injection into the intervertebral disc space (par. [0055]). Applicable mammals include primates like humans (par. [0056]).
An example of a suitable proteoglycan-degrading enzyme is chondroitinase, preferably chondroitinase ABC (par. [0018], [0040]). Chondroitinase ABC degrades mucopolysaccharides likes chondroitin sulfate, dermatan sulfate, chondroitin, and hyaluronic acid (par. [0012]). An effective proteoglycan cleaving amount of the proteoglycan-degrading enzyme is about 0.01 U/disc to about 10 U/disc, preferably from about 0.05 U/disc to about 5 U/disc (par. [0041]).
The treatment method of Masuda et al. is comparable to the instant application’s method for treating disc herniation as explained below:
Regarding claim 1: administering one or more doses of a proteoglycan-degrading enzyme like chondroitinase ABC (par. [0018], [0040]), which can be provided as a pharmaceutical composition in a single dosage form (par. [0057], [0061]), is the same as the step “administering a single dose formulation containing chondroitinase ABC”.
The preferred embodiment of administering via direct injection into the intervertebral disc space of a mammal such as a human having a condition requiring treatment like disc herniation (par. [0038], [0055]-[0056]) meets the requirement that the formulation is administered “into a human disc of a patient with disc herniation”.
The proteoglycan-degrading enzyme being administered in the preferred amount of about 0.05 U/disc to about 5 U/disc is similar to “an effective amount of 1-3 units per disc”. Although the disclosed amount is not identical to 1-3 U/disc, a prima facie case of obviousness is considered to exist when the claimed range overlaps or lies inside the range disclosed by the prior art. See MPEP § 2144.05(I) and 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). In this case, Masuda et al.’s proteoglycan-degrading enzyme amount of about 0.05-5 U/disc overlaps with the claimed amount of 1-3 U/disc.
Claim 1 is therefore obvious over Masuda et al..
Regarding claim 2: the working example involving direct injection of the enzyme into lower lumbar intervertebral discs (par. [0109]) indicates that the treatment method is suitable for treating lumbar disc herniation, thereby satisfying “wherein the disc herniation is a lumbar disc herniation”.
Regarding claim 3: the proteoglycan-degrading enzyme being formulated as an injectable preparation that can be a single dosage form (par. [0058], [0061]) fulfills “wherein the formulation is single-dose injection”.
Regarding claim 4: the effective amount of chondroitinase ABC in the method of claim 3 is further limited to “1.25 units per disc”.
Masuda et al. differs from the instant claim in that it only teaches using the proteoglycan-degrading enzyme in the preferred amount of about 0.05-5 U/disc.
Nevertheless, Masuda et al. states that the amount of active ingredient to produce a single dosage form varies depends on various factors such as the mammal being treated and the particular mode of administration (par. [0050], [0061]). A person with ordinary skill in the art at the time of invention would have thus found the recited amount through routine experimentation and optimization. In addition, the courts have held that differences in concentration typically do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Claim 4 is thus obvious over Masuda et al..
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,463,225.
U.S. 9,463,225 teaches a method for treating lumbar disc herniation, which comprises administering a single dose formulation containing chondroitinase ABC into a human lumbar disc of a patient with lumbar disc herniation in an effective amount of 1-3 units per disc. In one embodiment, the effective amount of chondroitinase ABC is further limited to 1.25 units per lumbar disc. In another embodiment, the single dose formulation is specified to be an injection product.
Similarly, the claims of the instant application are drawn to a method for treating disc herniation comprising administering a single dose formulation containing 1-3 units of chondroitinase ABC into a disc of a human patient with disc herniation.
The U.S. patent therefore anticipates the claimed invention.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,286,046 in view of Masuda et al. (Pub. No. US 2002/0106362 A1).
The U.S. patent discloses a method for treating disc herniation by administering a formulation consisting essentially of chondroitinase ABC in an effective amount of 1-3 units per disc into a human disc of a patient with disc herniation. The effective amount of chondroitinase ABC is further defined as 1.25 units per disc in an embodiment.
The claimed invention is directed to a method for treating disc herniation comprising administering a single dose formulation containing 1-3 units of chondroitinase ABC into a disc of human patient with disc herniation.
The U.S. patent differs from the claimed method in that it does not specify the formulation as a single dose formulation.
Single dose formulations, however, are well-known and routine in the art. For example, Masuda et al. teaches preparing a non-proteolytic proteoglycan-degrading enzyme like chondroitinase ABC as a single dosage form (par. [0061]) for use in the treatment of a mammal in need of chemonucleolysis (par. [0039], [0056]). A person with ordinary skill in the art at the time of invention would have combined the teachings of Masuda et al. with the U.S. patent’s method and arrive at the claimed invention. Such combination would be advantageous because single dose formulations are more convenient, improve accuracy by minimizing dosing errors, ensure product integrity, and increases patient compliance. Obviousness is based on the rationale that combining prior art elements according to known methods yields nothing more than predictable results.
The claims of the instant application are therefore obvious over U.S. patent 10,286,046 in view of Masuda et al..
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,266,725.
U.S. 11,266,725 is directed to a method for treating disc herniation. The method comprises injecting a formulation consisting essentially of chondroitinase ABC in an effective amount of 1-3 units per disc in a single dose into a disc of a human patient where a nucleus pulposus is present and where the disc herniation occurs. This method is capable of achieving significant reduction in pain evaluated by Visual Analog Scale compared to placebo at 13 weeks after the injection. In some embodiments, the effective amount is specified to be 1.25 units per disc and the disc herniation is specified to be a lumbar disc herniation.
The U.S. patent reads on the instant application, which entails administering a single dose formulation containing chondroitinase ABC in an effective amount of 1-3 units per disc.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,944,670.
U.S. 11,944,670 teaches a method for treating lumbar disc herniation by injecting a formulation consisting essentially of chondroitinase ABC in an effective amount of 1-3 units per disc in a single dose into a disc of a human patient with disc herniation. The effective amount in some embodiments is limited to 1.25 units per disc.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is directed to a method for treating disc herniation using the same composition (i.e., a single dose formulation containing chondroitinase ABC in an effective amount of 1-3 units per disc).
Hence, the U.S. patent anticipates the instant application’s method.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651