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 .
Double Patenting
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-10 and 20-26 of copending Application No. 17/507,733 (‘733).
This rejection has been withdrawn in view of the Remarks filed 08/21/2025. The composition taught in the ‘733 application does not comprise carbonate.
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 2-18 and 20 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.
This rejection has been withdrawn in view of the Amendment filed 08/21/2025.
Claim Rejections - 35 USC § 103
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.
Claims 1-12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Walsdorf et. al. US Patent No. 4, 904, 478, in view of Spielberg et al. 20190388353 A1.
This rejection has been withdrawn in view of the Remarks filed 08/21/2025.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. US 20010043947 A1, in view of Johnson et al. US 20020164398 A1 and Spielberg et al. 20190388353 A1.
Robinson teaches a compressed, chewable tablet containing at least one active ingredient, a water-disintegratable, compressible carbohydrate and a binder. These components are dry blended and compressed into a convex-shaped tablet having a hardness of about 2 to about 11 kp/cm.sup.2. The tablet has a friability of less than 1%. See Abstract. Active includes supplements, vitamins and acetaminophen is found in paragraph 0017. Tablet further comprises sweeteners, such as aspartame, acesulfame potassium, sucralose and saccharin; and lubricants, such as magnesium stearate, stearic acid, talc, and waxes. The dosage form may also incorporate pharmaceutical acceptable adjuvants. Such adjuvants, include, for example, preservatives, flavors, antioxidants, surfactants, and/or colors. See paragraph 0029. Tablets having hardness between about 5 and about 8.5 kP (5N-85N) is found in paragraph 0035. Chewable acetaminophen tablet is disclosed in Examples 1-3.
Robinson does not expressly teach the claimed tablet excipients including the base material such as rice bran, gum, wax, and maltodextrin.
Johnson teaches a chewable tablet comprising active ingredient and a base material comprising: gum, wax, filler, binder, sweetener, and the like. The base materials constitute up to about 95% by weight of the total tablet composition is found in paragraphs 0054 and 0066. Filler such as calcium carbonate, softener such as lecithin, sweetener such as dextrose, maltodextrin and the like is found in paragraphs 0060-0075. Coating film including essential oil is found in paragraphs 0078-0079.
Spielberg teaches a chewable tablet comprising maltodextrin, rice bran oil, and carnauba wax. See Abstract, Examples and Claims.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the chewable tablet taught in Robinson to include the tablet base materials in view of the teachings of Johnson and Spielberg with the expectation to obtain a chewable tablet having superior hardness and friability useful for the delivery of acetaminophen. This is because both Johnson teaches the use of the claimed tablet base materials is known in the art and useful for the preparation of tablet for the delivery of acetaminophen. This is because Spielberg teaches the use of the claimed tablet base material to obtain chewable tablet having superior tablet hardness and friability suitable for the delivery of any drug by oral route.
Response to Arguments
Applicant's arguments filed 08/21/2025 have been fully considered but they are not persuasive.
Applicant argues that Johnson discloses a "coated chewing gum product." The product includes "a chewing gum center; a chewing gum coating containing at least one medicament; and a water-soluble alkaline material incorporated into the chewing gum center, the coating, or both." A person skilled in the art would not have combined the disclosures of Robinson, Johnson and Spielberg to arrive at the subject matter of claim 1 and its dependent claims, especially the solid tablet as claimed "wherein the active material is mixed with the base material." To the contrary, Johnson discloses separating the medicament from the chewing gum center, noting that "it is particularly advantageous to formulate a medicinal gum product as a chewing gum product with the pharmaceutical agent in the coating to overcome the tendency for the agent to be entrapped in the gum base." Johnson at [0019]. A person skilled in the art therefore would not have been motivated to contradict this teaching and instead combine this disclosure with other references to mix the medicament with a base material to form a solid tablet as is claimed. Applicant also does not agree that a person skilled in the art would have been motivated to so freely pick and choose between various components of the cited references and combine them in a way needed to arrive at the pending claims. Robinson and Spielberg relate to tablets while Johnson instead relates to a chewing gum. The proposed combination of references does not appear to take into consideration significant differences between the two types of dosage forms, including differences in their administration. It is not appropriate in the obviousness analysis to use the pending claims as a template and, only after finding deficiencies in a reference, search without appropriate guidance for solutions to approximate the claims. See MPEP §2142 ("impermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art."). The proposed combination of references, despite the significant differences between those disclosures, relies extensively on hindsight and should not be a basis for rejecting the pending claims.
However, Applicant’s arguments are not persuasive for the following reasons:
In response to applicant's argument that Johnson discloses a "coated chewing gum product." The product includes "a chewing gum center; a chewing gum coating containing at least one medicament; and a water-soluble alkaline material incorporated into the chewing gum center, the coating, or both." A person skilled in the art would not have combined the disclosures of Robinson, Johnson and Spielberg to arrive at the subject matter of claim 1 and its dependent claims, especially the solid tablet as claimed "wherein the active material is mixed with the base material, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, Johnson is relied upon solely for the teaching of pharmaceutically acceptable excipients that are known in the art for chewable composition, namely, chewable composition suitable for the delivery of active agent typically for oral administration;
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Robinson teaches a chewable tablet suitable for chewing and delivery of active agent in the mouth. The Robinson reference teaches the desirability for using conventional chewable excipients to provide a chewable composition with improved product tase, mouthfeel, and ease of chewing. Similarly, Johnson teaches that active medicaments may have a low quality off-taste or bitterness, if added to a chewing gum coating. In most cases, this off taste may be masked with high-intensity sweeteners, but in other instances, a bitterness inhibitor may be needed to reduce a bitter taste of a medicament (0045-0048). Johnson further teaches chewability and mouth feel can be improved with known pharmaceutical excipients (0065). Therefore, one of ordinary skill in the art would have been motivated to, by routine experimentation select the excipients disclosed in Johnson; and
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Thus, for at least the above reasons, the above 103 rejection is maintained.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615