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 18/455,930 (now US 12,226,486) filed 25 August 2023 which is a continuation of application 17/732,983 (now US 11,771,768) filed 9 June 2021 which is a continuation of 16/394,877 (now US 11,058,774) filed 25 April 2019, which is a continuation of 15/793,257 filed 25 October 2017, which is a continuation of application 15/456,028 filed 10 March 2017, which is a continuation of application 15/165,948 filed 26 May 2016, which is a continuation of application 14/963,616 filed 9 December 2015, which is a continuation of application 13/708,430 filed 7 December 2012. Acknowledgement is made of the Applicant’s claim of domestic priority to US provisional application 61/568,131 filed 7 December 2011.
Status of the Claims
Claims 1-23 are pending.
Claims 1-23 are rejected.
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barras et al. (US 7,169,381 B2) in view of Capitanio et al. (Journal of Sensory Studies 26 (2011) 54-61) in view of Kurihara et al. (Nature, (1969) 222, 1176-1179) as evidenced by Kumler (J. Am. Chem. Soc., 1935, 57 (10), pp 1929-1930).
Barras teaches bowel preparation compositions useful for cleansing the gastrointestinal tract before colonoscopy, barium enema, or colon surgery and is also useful for preventing infection in the lower intestine (col 1, lns 9-18). One such composition comprises polyethylene glycol, sodium bicarbonate, sodium chloride, potassium chloride, ascorbic acid, and sodium sulfate (col 15, lns 20-67, Table 3 Form. C). It is disclosed that inclusion of ascorbic acid contributes to the function of the preparation while also facilitating digestion due to its pleasant acidic taste that masks the salty taste of the solution (col 2, lns 50-62). As such, ascorbic acid can be considered a “taste-modifying substance” as it imparts a change in the taste of the composition. The combination of ascorbic acid and sodium sulfate leads to a statistically significant increase in stool weight and volume, which is desired for bowel preparations (col 16, lns 44-47). Barras teaches that that based on reference Borody, as incorporated by reference in their disclosure, while ascorbic acid certainly helps the taste, it is taught that it does not completely remove the unpleasantness of drinking large volumes of liquids (col 3, lns 16-24). The composition can further comprise magnesium or calcium metals (col 6, lns 47-49). Also, it is preferred that the compositions of Barras comprise a non-sugar sweetener such as citric acid (col 8, lns 21-31). In the composition of formulation C, described above, it is taught that regarding the pH, it is assumed to be such that “ascorbic acid [is] essentially completely associated.” Kumler et al. teaches that the first pKa of ascorbic acid is 4.85, thus at a pH less than 4.85, the ascorbic acid would be assumed to be completely associated (pg 1929, table I). Conversely, over pH 4.85, ascorbic acid will be partially or fully dissociated. Thus, it would have been obvious to the skilled artisan that Barras requires the composition to be pH adjusted to a pH of less than 4.85, which necessarily would require a pre-pH adjustment assessment of the existent pH, thereby addressing the pH limitations of the instant claims. Regarding the volume of the composition, it is taught that the salt solution is prepared in 3 L of water prior to drinking (col 29, lns 38-43). In another embodiment, the composition is dissolved in only 1 L of water and resulting in citric acid being present in about 0.02 M (col 30, lns 50-67; col 31, lns 65-67). Regarding sodium phosphate-containing solutions, Barras teaches that they carry out the same function as the disclosed invention and have equal safety and compliance properties (col 33, lns 5-10).
Barras does not teach administering a taste-modifying substance prior to administering the bowel preparation nor does it teach reducing the salty taste of the liquid. Barras does not teach determining or adjusting the pH.
Capitanio teaches that miraculin is effective at not only replacing sour with sweet taste but also reducing saltiness (abstract; pg 55, ¶3). It is noted, however, that to achieve a reduction in saltiness, a sour tastant (such as citric acid) is necessary to be present (pg 54, ¶1). Tests were run wherein a subject was administered miraculin 2 minutes prior to administration of the liquid solution (pg 56, ¶1). Figure 1 shows that a salty solution (comprising NaCl) tasted only salty prior to miraculin but had a reduction in overall saltiness (by about 3-4%) upon administration of miraculin (pg 56, Fig 1). In the next experiment, Capitanio mixed citric acid with NaCl and showed that the initial solution tasted both sour and salty but after administration of miraculin, the sour-salty composition tasty mostly sweet with an approximately 20% reduction in perceived saltiness (pg 58, Fig 2). It was concluded that miraculin results in a suppressive interaction between miraculin sweetness and NaCl and it was hypothesized by Capitanio that one possible explanation could be ascribed to the fact that NaCl also tastes sour (pg 60, ¶4).
Kurihara teaches that the effects of miracle berry disappeared in as low as 20 min up to as long as 3 h, depending on the concentration of the taste modifying composition (pg 1177, ¶3).
The art teaches that citric and ascorbic acids, major components of citrus fruits such as lemons and oranges, impart a pleasant taste. Thus, the composition of Barras, which comprises citric and ascorbic acid and has an acidic pH of less than 4.85, would most likely have a pleasant and slightly sour taste, which reads on the method of providing a taste-modifying substance when the salty liquid is orally administered as required in instant claims 1-7, 11, 14-16, 18-20, and 22-23. Barras teaches that the inclusion of an acid (ascorbic or citric) renders the composition more palatable by increasing the sourness. This then masks or reduces the saltiness as perceived by the patient. However, Barras teaches that the addition of ascorbic acid only goes some way towards providing an improved bowel preparation. That being said, the person of ordinary skill in the art at the time of the invention would have found it prima facie obvious to find ways to further enhance the palatability and drinkability of said compositions. The inclusion of sugars is to be avoided due to the potential generation of intestinal gases that would have a negative impact during surgical procedures. Barras addresses this issue by utilizing citric acid to mask the bitter flavor and make it more acidic. To be sure, the five known tastes are sweet, sour, bitter, salty, and unami, thus sour and bitter are different from one another. However, since sweet flavor is more enjoyable, it would have been obvious for the skilled artisan to want to find a way to sweeten the already sour bowel preparation. Thus, it would have been prima facie obvious to the person of ordinary skill in the art at the time of the invention to have administered miraculin, a known agent for modifying sour tastes to sweet, to a patient followed by administering a bowel preparation of pH less than 4.85, as required in the instant claims. The skilled artisan would have found it obvious to apply miraculin and would have had a reasonable expectation of success that the sour-salty taste would be masked by sweet based on the teachings of Capitanio, thus addressing instant claims 8-10 and 13. The step of determining the pH in claim 1 is a routine lab procedure and would have accordingly been obvious. Moreover, Barras forces this adjustment by requiring that the ascorbic acid be fully associated, thus the pH cannot be greater than 4.85. That being said, the composition of Barras would have been adjusted to between pH 3-6.4, as required by instant claims 1 and 14-15, so as to provide a more effective composition comprising ascorbic acid.
Regarding claim 17, Barras teaches an alternative bowel preparation that comprises sodium phosphate and is useful for the same purpose of bowel cleansing. Generally, it is prima facie obvious to combine/substitute two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. (see MPEP § 2144.06; In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). Based on the common function, it would have been obvious to combine the two compositions to arrive at a third composition that comprises all the elements of instant claim 17. Similarly, it would have been obvious to further include a magnesium salt as taught by Barras, addressing instant claim 21.
Regarding claims 12-13, Kurihara teaches that the concentration of the taste modifier affects how long it lasts, but at a low end it can wear off in about 20 minutes. Capitanio teaches that miraculin is effective at least 2 minutes after administration to the tongue. Thus, it would have been obvious to administer miraculin and then administer the bowel preparation between 2 minutes and less than 20 minutes later. As such, it would have been obvious to the skilled artisan to have developed a method for cleansing the GI tract comprising the routine step of determining the pH of a preparation, adjusting the salty and unpleasant flavor to mildly acidic with citric or ascorbic acid as described by Barras, administering miraculin in advance to modify the sour taste to sweet, and finally administering the acidic bowel preparation.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9,238,075.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘075 claims are towards a method of cleansing the GI tract of a patient comprising determining the pH of a GI tract preparation and adjusting to 3-6.4, providing a taste modifying substance, and reducing the salty taste of the preparation as compared to the preparation had the taste modifying substance not been administered. Claim 9 requires the taste modifying substance to be miraculin. The remaining dependent claims closely match the dependent claims of the instant application. The instant claims are towards a method of reducing a salty taste of a liquid following the same steps and specifically using miraculin to modify the taste. Since reducing the salty taste is a required step/limitation of the ‘075 claims, it would have been obvious to apply the steps of '075 in a method of just reducing the salty taste of a liquid, as recited in the instant claims. As such, instant claims 1-23 are obvious over the claims of 9,238,075.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,352,044.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘044 claims are towards a method of cleansing the GI tract of a patient comprising determining the pH of a GI tract preparation and adjusting to 1-6.9, providing a taste modifying substance, and reducing the salty taste of the preparation as compared to the preparation had the taste modifying substance not been administered. Claim 9 requires the taste modifying substance to be miraculin. The remaining dependent claims closely match the dependent claims of the instant application. The instant claims are towards a method of reducing a salty taste of a liquid following the same steps and specifically using miraculin to modify the taste. Since reducing the salty taste is a required step/limitation of the ‘044 claims, it would have been obvious to apply the steps of ‘044 in a method of just reducing the salty taste of a liquid, as recited in the instant claims. As such, instant claims 1-23 are obvious over the claims of 9,352,044.
Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,629,917.
Although the claims at issue are not identical, they are not patentably distinct from each other. The 917 claims match those of the instant claims but differ in that they require the method to reduce the saltiness by at least 20%. This limitation, however, represents a description of the underlying mechanism rather than an active step of the claimed method. In addition, the 20% reduction limitation is included in instant claim 11. Thus, the parent 917 claims are nearly identical to the copending claims.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,433,660.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘660 claims are towards a method of cleansing the GI tract of a patient comprising determining the pH of a GI tract preparation and adjusting to 3-6.4, providing a taste modifying substance, and reducing the salty taste of the preparation by at least 20% as compared to the preparation had the taste modifying substance not been administered. Claim 5 requires the taste modifying substance to be miraculin. The remaining dependent claims closely match the dependent claims of the instant application. The instant claims are towards a method of reducing a salty taste of a liquid following the same steps and specifically using miraculin to modify the taste. Since reducing the salty taste is a required step/limitation of the ‘660 claims, it would have been obvious to apply the steps of '660 in a method of just reducing the salty taste of a liquid, as recited in the instant claims. As such, instant claims 1-23 are obvious over the claims of 9,433,660.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,585,937.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘937 claims are towards a kit for cleansing the GI tract of a patient comprising a GI tract composition having a salty taste, an amount of a pH modifying agent used to adjust the pH to 1-6.9, miraculin, and instructions teaching the steps of determining the pH, adjusting to 1-6.9, providing miraculin, and administering orally the GI tract preparation. The remaining dependent claims closely match the dependent claims of the instant application. The instant claims are towards a method of reducing a salty taste of a liquid following the same steps and specifically using miraculin to modify the taste. The method of the instant claims is the method that is taught as being suitable for use of the copending composition claims. Thus, it would have been obvious to use the composition of ‘937 in the method of the printed material of the kit which reads on the instant claims. As such, instant claims 1-23 are obvious over the claims of 9,585,937.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,980,653.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘653 claims are towards a kit for cleansing the GI tract of a patient comprising a GI tract composition having a salty taste, an amount of a pH modifying agent used to adjust the pH to 1-6.9, miraculin, and instructions teaching the steps of determining the pH, adjusting to 1-6.9, providing miraculin, and administering orally the GI tract preparation. The remaining dependent claims closely match the dependent claims of the instant application. The instant claims are towards a method of reducing a salty taste of a liquid following the same steps and specifically using miraculin to modify the taste. The method of the instant claims is the method that is taught as being suitable for use of the copending composition claims. Thus, it would have been obvious to use the composition of ‘653 in the method of the printed material of the kit which reads on the instant claims. As such, instant claims 1-23 are obvious over the claims of 11,980,653.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,377,129.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘129 claims are towards a kit for cleansing the GI tract of a patient comprising a GI tract composition having a salty taste, an amount of a pH modifying agent used to adjust the pH to 1-6.9, miraculin, and instructions teaching the steps of determining the pH, adjusting to 1-6.9, providing miraculin, and administering orally the GI tract preparation. The remaining dependent claims closely match the dependent claims of the instant application. The instant claims are towards a method of reducing a salty taste of a liquid following the same steps and specifically using miraculin to modify the taste. The method of the instant claims is the method that is taught as being suitable for use of the copending composition claims. Thus, it would have been obvious to use the composition of ‘129 in the method of the printed material of the kit which reads on the instant claims. As such, instant claims 1-23 are obvious over the claims of 12,377,129.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,058,774.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘774 claims are towards a method of reducing a salty taste of a liquid comprising determining the pH of the salty liquid and adjusting to 3-6.9, providing miraculin to the subject, and administering orally the liquid. While the pH range in ‘774 is narrower than the instant claims, it overlaps with the claimed range. The remaining dependent claims closely match the dependent claims of the instant application. As such, instant claims 1-23 are obvious over the claims of 11,058,774.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,771,768.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘768 claims are towards a method of reducing a salty taste of a liquid comprising determining the pH of the salty liquid and adjusting to 1-6.9, providing miraculin to the subject, and administering orally the liquid. The remaining dependent claims closely match the dependent claims of the instant application. As such, instant claims 1-23 are obvious over the claims of 11,771,768.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,226,486.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘486 claims are towards a method of reducing a salty taste of a liquid comprising determining the pH of the salty liquid and adjusting to 1-6.9, providing miraculin to the subject, and administering orally the liquid. The remaining dependent claims closely match the dependent claims of the instant application. As such, instant claims 1-23 are obvious over the claims of 12,226,486.
Conclusion
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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