DETAILED ACTION
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 the Claims
Claims 16 and 18-35 are presented for examination and rejected, as set forth below.
Claim Interpretation
Applicants claims are directed to kits which contain an aspirin and a COX-2 inhibitor which has at least a partial enteric coating, and the other which is partitioned for sequential absorption when orally administered. Claim 18 specifies that the aspirin also possess the enteric or partial enteric coat. Claim 19 specifies components of the enteric or partial enteric coat. Claim 20 indicates the coating is solvent or aqueous based. Claim 21 indicates the COX-2 coating provides for release in the small intestine or colon. Claims 22 and 23 indicate that the aspirin is configured to be released in the gastric or duodenal areas. Claim 24 narrows the identity of the COX inhibitor, and Claim 25 that of the aspirin component. Claim 26 indicates the COX inhibitor enteric coating is an acrylic or methacrylic polymer. Claim 27 specifies the dosage of each of the COX and aspirin components. Claims 28-31 specify that the COX and aspirin components are either a single or separate dosage units. Claims 32-35 specify that the aspirin component is to have no enteric coating.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is 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 claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 24 recites as potential COX-2 components of the kits claimed each of celecoxib and PC-celecoxib “analogues” as falling within the scope of the invention. Nothing of either the claim or the specification provides any guidance as to what an “analogue” of either of these components may be. As applicants have failed to particularly explain or indicate what might be considered an “analogue” of either celecoxib or PC-celecoxib, the disclosure provides an inadequate written description of celecoxib “analogues” as set forth in the claims.
Claim Rejections - 35 USC § 112(b)
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.
Claim 24 is 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.
As set forth above, applicants disclosure fails to identify what modifications to celecoxib or PC-celecoxib would constitute an “analogue” of either, making it impossible for a skilled artisan to grasp the metes and bounds of the invention claimed. Furthermore, applicants provide no definition as to what a “PC-celecoxib” is. As this is not a term widely known in the art, in the absence of such a definition the disclosure provides insufficient guidance to permit a skilled artisan to ascertain the metes and bounds of the invention being claimed.
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.
Claims 16, 18-20, 22, 24-28, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gimona (WO03/033001) in view of Soula (WO2007/036809).
Gimona describes combinations of aspirin, synonymous with the acetylsalicylic acid of Claim 25, and COX-2 inhibitors including celecoxib of Claim 24, for sequential use. (Abs., Pg.1, 3). Gimona indicates these dosage forms may suitably be used for the treatment of gastrointestinal cancers including cancer of the colon. (Pg.2). Separate or combined orally-deliverable pharmaceutical compositions containing each of the aspirin and COX-2 inhibitor suited for sequential administration are described, suggesting the kits containing each of the aspirin and COX-2 inhibitor of the present claims. (Pg.6-7). Film or enteric coatings for oral dosage forms such as tablets are contemplated by the teachings of Gimona. (Pg.8). Aspirin in these compositions should be present in amounts of less than 75mg, (Pg.3), while the COX-2 inhibitors should be present in amounts of between 100-500mg, ranges overlapping and therefore rendering obvious the limitations of Claim 27. (Pg.9), 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.”).
Soula also describes oral dosage forms of acetylsalicylic acid (aspirin) which in certain embodiments are combined with COX-2 inhibitors in controlled release forms, to provide for each of immediate and slow-release phases of each component. (Pg.9-11). In some embodiments the aspirin is provided in immediate release form. (Pg.13). Soula indicates that enteric coatings may serve as the release-controlling coating of the dosage forms, (Pg.17), with each of the polyvinyl acetate and methacrylic acid copolymers known as EUDRAGIT described as suitable enteric coatings provided as, for example, a sprayed solvent solution of the polymer. (Pg.23-24, 27, 32).
The art at the time of the instant application therefore established the desirability of providing sequentially administrable pharmaceutical dosage forms, either combined or distinct dosage forms, containing each of aspirin and a COX-2 inhibitor for sequential administration. That art also establishes that immediate release aspirin, lacking an enteric coating, and enteric coatings such as polyvinyl derivatives or methacrylic acid copolymers for modified release of active agents so coated, were ways of providing COX-2 inhibitors for ASA/COX-2 combination therapy. It therefore would have been prima facie obvious to have provided a COX-2 inhibitor such as celecoxib as an enteric coated dosage forms in combination with immediate release aspirin, respectively, to provide kits for use in providing combination ASA/COX-2 therapy. That is because such kits simply represent a means of providing the kind of therapeutic combinations advocated by the art, utilizing technology known to the skilled artisan for providing such therapeutics. This is because “[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.).
Claims 16 and 18-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gimona and Soula as applied to claims 16, 18-20, 22, 24-28, and 31-35 above, and further in view of Lerner (U.S. 6,231,888), and Nikam (Vikrant K Nikam, et al, Eudragit A Versatile Polymer: A Review, 1 Pharmacologyonline 152 (2011)).
Gimona and Soula, discussed in greater detail above, suggest kits which combine dosage forms of aspirin lacking an enteric coat combined with EUDRAGIT enteric coated COX-2 inhibitors such as celecoxib.
Neither Gimona nor Soula describe providing the enteric coat for the COX-2 inhibitor in a manner configured to deliver the inhibitor to the small intestine or colon as is required by Claim 21.
However, Lerner indicates that formulating NSAIDS for direct delivery to the colon permits the use of effective concentrations of NSAIDS including COX-2 selective inhibitors without risking the side effects associated with systemic administration. (Col.5, L.5-24; Col.6, L.45-50; Col.7, L.14-16; Col.9, L.5-9; Col.10, L.17-27, 36-42). Eudragit polymers are identified as suitable for achieving such colonic targeting, (Col.13, L.10-48). This is reinforced by the teachings of Nikam, which indicates that a variety of EUDRAGIT polymers are known to be useful for targeted colonic delivery of active agents for the treatment of intestinal disorders. (Pg.155).
It would have been prima facie obvious to one having ordinary skill in the art at the time the instant application was filed to have utilized a colon-targeting enteric coating such as a colon-targeting EUDRAGIT polymer as the enteric coating for the celecoxib dosage form suggested by Gimona and Smith. This is because not only does Gimona and Soula suggest enteric coatings for the COX-2 inhibitors, but the artisan would have been aware of the benefits associated with colonic targeting of COX-2 inhibitors in the treatment of GI diseases and disorders through the teachings of Lerner. Lerner and Nikam go on to establish a variety of EUDRAGIT polymers are known to be useful in formulating dosage forms targeting the colon. The selection of such an enteric polymer appears little more than the predictable use of prior art elements according to their established functions, and obvious thereby. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)).
Response to Arguments
Applicant's arguments filed 23 February 2026 have been fully considered but they are not persuasive.
Applicants assert that Gimona fails to describe an enteric coating of the present claims, and that Soula fails to address this deficiency. Applicants indicate that in a related case, with a different record, a different Examiner relying on Soula was informed that that combination of art failed to address configurations whereby aspirin is delivered to the proximal GI tract and the COX-2 inhibitor to the small intestine or colon.
As a threshold matter, applicants are reminded that patentability decisions made during previous proceedings before the Office concerning the claims of any given patent have no bearing on patentability decisions made with respect to future proceedings concerning different patents having different claims. The Office, including the Board, must decide each case on its own merits, and the similarity of claims found patentable by another Examiner is not material to this proceeding. See In re Wertheim, 541 F.2d 257, 264 (CCPA 1976) (“it is immaterial in ex parte prosecution whether the same or similar claims have been allowed to others”); see also In re Nett Designs, 236 F.3d 1339, 1342 (Fed. Cir. 2001) (“The Board must decide each case on its own merits [and] the PTO’s allowance of prior registrations does not bind the Board or this court”).
In addition, applicants are reminded that their claims simply require that the aspirin component and COX-2 component be “configured for sequentially partitioned bioabsorption when orally administered in combination.” It is not until newly added Claim 21 that a limitation concerning small intestine or colonic delivery of the COX-2 inhibitor is introduced, a limitation addressed by the Examiner’s newly required reliance on the teachings of Lerner and Nikam owing to the introduction of these limitations.
Applicants assert the Examiner provided no explanation as to why a skilled artisan would choose an immediate release aspirin and an enteric coated COX-2 inhibitor from the teachings of Soula, when exemplified embodiments employ a combination of enteric coated aspirin and immediate release COX-2 inhibitor, while also asserting that embodiments of Soula which contain non-enteric coated aspirin are distinct from the invention claimed. Applicants are reminded that art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Here, Soula describes as alternative embodiments of the invention dosage forms utilizing immediate release ASA. (Pg.13). Soula describes dosage forms employing controlled release COX-2 inhibitors. (Pg.11). The selection of these alternative embodiments amounts to little more than following the guidance provided by the art to obtain an alternative embodiment envisioned by the authors. Applicants assertion that there would have been no expectation that this modification to the art would be successful is unsupported by evidence, and therefore unpersuasive. "[A] prior art publication cited by an Examiner is presumptively enabling barring any showing to the contrary by a patent applicant." In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012).
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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