DETAILED CORRESPONDENCE
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 claim set filed on 12/19/2024 is acknowledged.
Claim 1 is pending.
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 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 set for th 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Ozawa et al. (US Pat 5409709 A) hereinafter Ozawa in view of First et al. (US 20100286100 A1) hereinafter First.
Regarding claim1, Ozawa is drawn to an ibuprofen-containing antipyretic analgesic preparation blending 0.01-30 parts by weight of acetaminophen based on 1 part by weight of ibuprofen (abstract, claims 1-5).
Ozwawa discloses an ibuprofen-containing antipyretic analgesic preparation which synergistically improves antipyretic analgesic action, comprising ibuprofen, acetaminophen and magnesium-based antacids, wherein the acetaminophen content is 0.01-30 parts by weight based upon 1 part by weight of ibuprofen (encompasses a composition comprising 21-23 wt% ibuprofen and 73-75 wt% acetaminophen) (col. 2, ln 51-67; col. 3, ln 13-24). Ozawa discloses the antipyretic analgesic preparation is effective against pain (col. 4, ln 14-18) and can be administered orally to in the amount of 100-6000 mg as the total amount of ibuprofen, acetaminophen (encompasses a combination of 325 mg acetaminophen with 97.5 mg ibuprofen or 500 mg acetaminophen with 150 mg of ibuprofen) (col. 4, ln 19-22). Ozawa discloses antipyretic analgesic preparation is used in various forms including tablets (col. 4, ln 28-30), that can be coated (col. 4, ln 45-46).
Ozawa does not explicitly disclose the particle size of the ibuprofen between 1 to 9 microns.
However, First is drawn to a tablet with an enhanced dissolution profile for a medicinally active ingredient and methods for making the tablet. The tablet comprises a blend of crystals of the medicinally active ingredient and a dissolution aid such as sodium or calcium carbonate or bicarbonate that coats the crystals upon co-milling. The blend is then compressed to form tablets that have an enhanced dissolution profile for the medicinally active ingredient (abstract).
First discloses the blend should be milled to reach an average particle size for the medicinal ingredient of less than about 10 microns measured by a scanning electron microscopy (SEM) using laser diffraction on a MS 2000 Hydro S machine ([D50] between 1-9 microns, [D10] between 1-3 microns, [D90] between 3-16 microns) [0048].
First discloses a milled NSAID selected from the group consisting of acetaminophen, ibuprofen, milled in combination with a solubility aid that has an improved dissolution profile when compared to an NSAID that has not been milled with a solubility aid [0021].
First's disclosure in Figures 4 and 5 show the dissolution rate of blends prepared as disclosed by First have a dissolution rate of at least 80, 85, and 95% in less than 10 minutes [0030-0031].
First discloses medicinal ingredient such as acetaminophen and ibuprofen in combination [0042].
First discloses tablets can comprise a therapeutic amount of the medicinally active ingredient, for example from about 37 mg-500 mg [0045].
The pre-blend of the medicinal ingredient and the dissolution aid is milled by air-jet milling [0046].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dosage form of Ozawa, wherein particle size of ibuprofen is less than 10 microns, as taught by First, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because First discloses one promising avenue of investigation is reducing the particle size of the medicinal ingredient in the tablet. Due to surface area effects, smaller particle sizes, theoretically, should improve solubility, particularly for less soluble materials. In general there is a correlation between reducing particle size and dissolution rate; the smaller the size the faster the dissolution profile [0012], and the tablet itself offers several benefits over conventional tablets. The decrease in particle size following a precise milling time reduces transit time of the active ingredient from GI to bloodstream, thus improving time to onset of action and decreases local GI irritation (due to reduced contact time) [0061]. One of ordinary skill in the art would have had a reasonable expectation of success in making the dosage form as disclosed by the combined teachings of Ozawa and First, by applying a known technique to a known product ready for improvement to yield predictable results.
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.
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 §§ 706.02(l)(1) -
706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Parent Patent No. 11,197,830 B2.
The instant claim differs from the claims of the ‘830 Patent because claim 1 of the ‘830 Patent requires a tablet and wherein the ibuprofen has a [D50] between 2 and 8 μm and wherein “the [D90] to [D50] ratio is between 4:1 and 1.5:1”.
However, instant claim 1 and claim 1 of the ‘830 Patent both require the overlapping limitations of a dosage form comprising 325 mg of acetaminophen and 97.5 mg of ibuprofen or 500 mg of acetaminophen and 150 mg of ibuprofen. Instant claim 1 requires wherein the ibuprofen has a [D50] between 1 and 9 μm. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to make the solid dosage form because the instant claims and claims of the ‘830 Patent overlap as described above.
This is a nonstatutory double patenting rejection.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Parent Patent No. 11,534,407 B2.
The instant claim differs from the claims of the ‘407 Patent because claim 1 of the ‘470 Patent requires a tablet and wherein the ibuprofen has a [D50] between 2 and 8 μm.
However, instant claim 1 and claim 1 of the ‘407 Patent both require the overlapping limitations of a dosage form comprising 325 mg of acetaminophen and 97.5 mg of ibuprofen or 500 mg of acetaminophen and 150 mg of ibuprofen. Instant claim 1 requires wherein the ibuprofen has a [D50] between 1 and 9 μm. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to make the solid dosage form because the instant claims and claims of the ‘407 Patent overlap as described above.
This is a nonstatutory double patenting rejection.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Parent Patent No. 11,872,317 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to solid dosage form comprising 325 mg of acetaminophen and 97.5 mg of ibuprofen or 500 mg of acetaminophen and 150 mg of ibuprofen, and wherein the ibuprofen has a [D50] between 1 and 9 μm.
Furthermore, there is no apparent reason why applicant would be prevented from presenting claims corresponding to those of the instant application in the other copending application. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a solid dosage form comprising 325 mg of acetaminophen and 97.5 mg of ibuprofen or 500 mg of acetaminophen and 150 mg of ibuprofen, and wherein the ibuprofen has a [D50] between 1 and 9 μm.
This is a nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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