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 .
Claims 1-13 filed 28 August 2024 are pending in the application.
Priority
This application is a continuation of PCT/CN2023/096530 filed 05/26/2023. This application claims foreign priority to CHINA 202210638893.7 filed 06/07/2022, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-13 are rejected under 35 U.S.C. 101 because it is not clear what statutory class the claims fall into. Specifically, by reciting application and use, the claim could be drawn to a process or it could be drawn to a product. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 1-13 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.
In claim 1 it is not clear what ‘alkaline inclusion’ means. The said recitation is also seen in claims 3, 10-11, and claim 9 recites the term ‘inclusion’. If applicant intends an alkaline drug, the claims should recite ‘an alkaline drug’. Applicant is requested to check for support for the recitation ‘an alkaline drug’ in the specification and reword the claim for clarity.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation phosphate, and the claim also recites hydrogen phosphate, magnesium ammonium phosphate which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 12-13 provide for the application/use of the gel according to claim 1, but, since the claim does not set forth any steps involved in the method/process of application/use, it is unclear what method/process of application/use applicant is intending to encompass. A claim is indefinite where it merely recites an application/use without any active, positive steps delimiting how this use is practiced.
Claims 4-8, which depend from a rejected base claim that is unclear/indefinite are also rendered unclear/indefinite and are rejected for the same reasons. All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claim Rejections - 35 USC § 102
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 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) 1-3 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al (KR 101901649 B1, machine English translation, pages 1-9).
Ho teaches a sustained-release gel comprising doxorubicin, calcium phosphate, PBS (has water) and alginate polymer (Abstract; page 6, 10th full para; page 7, Example 1; limitations of claims 1-3 and 9). Therefore, Ho et al anticipates claims 1-3 and 9.
Claim(s) 1-3 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (Materials Science and Engineering C, 2017, 80, 688-697).
Li et al teaches doxorubicin loaded polyacrylic acid/calcium phosphate nanogel (page 689, part 2.2; limitations of claims 1-3 and 9). Therefore, Li et al anticipates claims 1-3 and 9.
Claim(s) 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al (KR 101901649 B1, machine English translation, pages 1-9).
Ho teaches a method of making the sustained-release gel wherein a polymer solution (alginate) is prepared in aqueous solution and blended and compounded with the doxorubicin solution (page 7, Example 1; method of claim 10). Therefore, Ho et al anticipates claim 10.
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 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, 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 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.
Claim(s) 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al (KR 101901649 B1, machine English translation, pages 1-9) in view of Li et al (Materials Science and Engineering C, 2017, 80, 688-697) and further in view of Ding et al (CN 102204881 A, machine English translation, pages 1-12).
The teachings of Ho et al are set forth above. In addition, Ho also teaches drug release from the gels (Examples 1-7). This means that the sustained-release gels can be used as a formulation to release drugs in a sustained manner as in claims 12-13. Ho et al does not teach the use of all the salts and drugs recited in claims 2-3 and does not teach the limitations of claims 4-8 and 11.
Li et al teaches doxorubicin loaded polyacrylic acid/calcium phosphate nanogels (limitations of claims 1-3 and part of the limitation of claim 8-acrylic acid/acrylate; limitations of claims 1-3 and part of the limitations of claims 4-6, 8, 9).
Ding et al teaches a sustained release gel injection comprising an alkaline drug which can be 10-hydroxycamptothecin and irinotecan in a polymer which can be a block copolymer of polyethylene glycol and polyester (Abstract; paras 0006, 0008-0010; part of the limitations of claims 1, 3, 8, 9, and limitations of claims 4-5). It is an aqueous system (paras 0010; as in claim 1). The polymers used can be of different types (paras 0017-0018; limitations of claims 5 and 7). The molecular weight of the polymers can be in the range of 400-8000; paras 0015-0016; part of the limitation of claim 6).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, sustained-release polymer gels having an alkaline component, a polymer and an insoluble salt as claimed are known in the art. The use of block copolymers with alkaline drug components is also known, as well as the method of making them. The gels are also shown to release the drug in a sustained manner.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. According to there is need for drug delivery system for stably maintaining concentration of the anticancer drug (page 2, last para), and Ding teaches the need for gel flexibility, biocompatibility, good degradability with reversible temperature sensitive sustained-release injection (para 0006).
It would be obvious to one of ordinary skill in the art to make the claimed gel using the other insoluble salts as pH adjuster as in claim 2, the other alkaline components as in claims 3 and 13, the polymers as in claims 4-8 to look for other gels that have ideal properties for sustained release of the alkaline drugs. From the teachings of Ho, Li and Ding regarding the method of preparation the artisan can arrive at the method of claim 11 for making the sustained-release gel. Ding teaches preparation of the gels by adjusting the temperature of dissolution (para 0025). This can be used as a starting point to adjust the temperature as in claim 11.
It is well established that merely selecting proportions and ranges and modifying the process conditions such as temperature, reaction time and concentration is not a patentable modification absent a showing of criticality (In re Aller, 220 F.2d, 454, 105 U.S.P.Q 233 C.C.P.A, 1995 and In re Becket, 33 U.S.P.Q 33, C.C.P.A, 1937 and In re Russell, 439 F. 2d 1228, 169 U.S.P.Q. 426, C.C.P.A 1971).
Conclusion
Pending claims 1-13 are rejected
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693
