DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application is a Continuation of application 17/812,133 filed 12 July 2022, which is a Continuation of application 16/915,017 filed 29 June 2020, which is a Continuation of application 16/132,857 filed 17 September 2018, which is a Continuation of application 14/949,454 filed 23 November 2015, which is a Continuation of application 13/922,482 filed 20 June 2013, which is a Continuation of application 13/797,230 filed 12 March 2013, which is a Continuation of application 13/213,473 filed 19 August 2011, which is a Divisional of application 11/932,101 filed 31 October 2007, which is a Continuation-in-Part of application 10/918,597 filed 13 August 2004.
The examiner notes that the earliest filed application which appears to provide written description support for the instant claims under 35 U.S.C. 112, first paragraph, is the 10/918,597 application filed 13 August 2004.
Status of the Claims
Claims 1-19 are pending, presented for examination, and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to methods of making implantable compositions combining the steps of milling a hydrophobic ended PLGA copolymer, milling a hydrophilic ended PLGA copolymer, blending the milled copolymers with a particulate steroidal anti-inflammatory agent having a defined particle size, extruding the resultant mixture and pelletizing the extrudate, then extruding the pelletized composition to provide an implantable composition having a defined weight. Claim 1 recites diseases which can then be treated by the use of the resultant composition. Dependent claims specify the steroid is to be dexamethasone having defined degrees of impurities, represents a defined percentage of the weight of the implant, or is present in defined weights of the implant. Claim 8 indicates that the hydrophobic and hydrophilic PLGA copolymers are to be present in defined weight percentages of the implant. Claim 9 specifies particular hydrophobic and hydrophilic PLGA copolymers to be used. Independent Claim 10 combines the limitations of Claim 1 with different implant weights, and specifies concentrations of each of the dexamethasone and PLGAs present in the implant. Dependent claims 11-18 specify the steroid is to be dexamethasone having defined degrees of impurities, represents a defined percentage of the weight of the implant, or is present in defined weights of the implant. Claim 19 specifies particular hydrophobic and hydrophilic PLGA copolymers to be used.
Claim Rejections - 35 USC § 112 Second Paragraph
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 1-19 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.
Here, each of independent claims 1 and 10 incorporate not only language identifying particular process steps which are to be followed to provide an implantable steroid/polymer composition, but also include language describing diseases to be treated. A single claim which recites multiple statutory classes of invention, such as claims directed to both method steps of making and method steps of using a product, is indefinite under 35 USC 112, second paragraph. IPXL Holdings, L.L.C. v. Amazon.com, Inc. 430 F.3d 1377, 1384 (2005), citing Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990). As it is unclear from the language presented whether the treatment of a medical condition recited in the terminal “wherein” clause of each of the independent Claims represents an additional method steps, applicants are required to amend the claims to provide needed clarity. For purposes of compact prosecution, this language will be treated as a recitation of an intended use to which the products resulting from the manufacturing steps recited may be put.
Claims 9 and 19 contains the trademark/trade names “RESOMER 502H PLGA” and “RESOMER 502H PLGA.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe certain types of PLGA copolymers and, accordingly, the identification/description is indefinite.
Owing to the indefiniteness of Claims 9 and 19, they will not be treated further on the merits. See In re Steele, 305 F.2d 859,134 USPQ 292 (CCPA 1962) (it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions).
Claim Rejections - 35 USC § 103
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 of this title, 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 negatived 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-8 and 10-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cheikh (U.S. PGPub. 2002/0111603) as evidenced by Wong (U.S. PGPub. 2002/0182185).
Cheikh describes implantable solid rods of dexamethasone phosphate contained in a 50/50 PLGA matrix. [0173]. Cheikh indicates that the dexamethasone phosphate is incorporated into a 50/50 PLGA matrix by pulverizing the solid dexamethasone phosphate to a particulate size of less than 100 microns and extruding the combination of PLGA and dexamethasone phosphate. [0307-11]. Concerning the dexamethasone particle sizes claimed, applicants are reminded that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Cheikh indicates that the solid implantable dosage forms advantageously have a diameter of less than 1mm, even envisioning implants with a diameter as small as 0.1mm. [0094]. Implant lengths are explicitly described as less than 2cm and “suited to the space in the depot zone.” [0096]. Wong indicates that the vitreous of the eye is capable of accommodating fairly large implants, having dimensions of up to 3mm, informing the skilled artisan that the implants of Cheikh are indeed “sized for implantation in an ocular region” such as the vitreous cavity. [0057]. Cheikh indicates that the implants preferably contain more than 50% of the active principle, with preferably less than 49% of the implant being the biodegradable excipient, such as the exemplary 50/50 PLGA. [0238-47]. Cheikh indicates that the PLGAs used in the implants may be either hydrophobic or hydrophilic, thereby suggesting combinations of each required by the instant claims. [0245-46]. While not specifying the 30% hydrophilic and 10% hydrophobic combination recited by Claims 8 and 10, it must be remembered that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.). As such, it would have been a matter of optimization of the amounts of hydrophilic and hydrophobic PLGA through little more than routine experimentation to arrive at the concentrations of each claimed. Cheikh indicates that the processes used in manufacturing these implants depend on mixing, compression, extrusion, and grinding techniques conventionally used in the delayed-release pharmaceutical arts. [0269]. Cheikh describes producing a homogeneous mixture of the active and excipients which is then compacted, ground, which the examiner considers equivalent to the “milling” step recited by the claims (see [0283]), and extruded, then cut to the desired length. [0274-87]. Chiekh indicates that the homogenization, compaction, and pulverization serves to improve the quality of the powder mixture flow during extrusion. [0284]. In addition, Chiekh describes a second embodiment where after homogenization, compaction, and pulverization, a second step of pulverization and extrudation prior to the implants being cut to a desired size and weight sufficient to provide 7.5mg dexamethasone is described. [0306-11]. Because Chiekh indicates that milling the components of the implant improves the quality of powder mixture flow during extrudation, and also describes multiple milling and extrudation steps to provide the extrudate to be cut into sizes desired for obtaining a desired implant weight, the skilled artisan would consider the milling of the PLGA used, homogenization of the micronized components with the active agent, a first extrusion, second comminution, and second extrusion to provide implants of desired dosage and weight to be obvious modifications of the steps described by Chiekh. This is because simply duplicating elements has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Furthermore, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Because Chiekh indicates that the milling of the implant components coveys benefits to the manufacturing process, the skilled artisan has a motivation to employ such a process prior to homogenization and extrudation steps. In addition, which the specific weights and dosages of the implant and dexamethasone recited by Claims 1, 7, and 10-16 are not specified by Cheikh, it must be remembered that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of the process steps of milling the PLGA used, homogenization of the micronized components with the active agent, a first extrusion, second comminution, and second extrusion to provide implants of desired dosage and weight as recited by the Claims, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected the process steps of milling the PLGA used, homogenization of the micronized components with the active agent, a first extrusion, second comminution, and second extrusion to provide implants of desired dosage and weight as recited by the Claims, to arrive at methods “yielding no more than one would expect from such an arrangement.”
Examiners Note
Record is made of the following patents which are not being relied on for double patenting rejections owing to the fact that the compositions or methods of treatment recited by the claims of these issued patents do not reasonably suggest the milling and extruding processes of the present claims.
U.S. Patent No. 8,034,370.
U.S. Patent No. 8,034,366.
U.S. Patent No. 8,506,987.
U.S. Patent No. 9,192,511.
U.S. Patent No. 10,076,526.
U.S. Patent No. 10,702,539.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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