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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 34-46, in the reply filed 6/26/2023, and in the election of species requirement, applicant stated that claims 34-43, 45 and 46 read upon the elected species. It is also noted that claim 65 is also drawn to a “preservative” as in claim 44, thus claim 65 is also withdrawn from further consideration.
Thus, claims 44 and 65 are withdrawn from further consideration by the Examiner as being drawn to non-elected inventions.
Therefore, the restriction/election is hereby made FINAL.
Claim Rejections - 35 USC § 102
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.
Claims 34-43, 45, 46, 54-64, 66 and 67 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by WO 2005/025319.
WO teaches that Eragrostis (Teff-which inherently contains the claimed compound) is well known in the prior art to be used in food and beverage (oral liquid) to feed celiac patients (they have a chronic gastrointestinal disorder) since they are allergic to gluten which teff does not contain, see entire reference, especially pages 1-2.
Applicant admits on the record in paragraphs 94-95 of the instant specification, that the claimed extract (which inherently contains the claimed compound) can be made by an extraction with water. Thus, WO teaches the claimed method since the Eragrostis (Teff) is extracted with water and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claims 46 and 67-see also Table 4 of the instant specification). Note the carrier of “excipient” (liquid form such as alcoholic drink, see page 12). Note oral administration with drink (liquid). Note that humans eat teff which is in injera and are in need of improved digestive function and regulating gut permeability since they have celiac disease. Once the Eragrostis (Teff) grain is processed it has clearly been isolated and is therefore not crude anymore since it is used in a drink for administration to someone having celiac disease. Inherently, the compound of Formula (I) comprises between 10 % to 99 % w/w of the oral composition since the Eragrostis (Teff) is prepared in an oral drink such as an alcoholic beverage.
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.
Claims 34-43, 45, 46, 54-64, 66 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/025319.
WO teaches that Eragrostis (Teff-which inherently contains the claimed compound) is well known in the prior art to be used in food and beverage (oral liquid) to feed celiac patients (they have a chronic gastrointestinal disorder) since they are allergic to gluten which teff does not contain, see entire reference, especially pages 1-2.
Applicant admits on the record in paragraphs 94-95 of the instant specification, that the claimed extract (which inherently contains the claimed compound) can be made by an extraction with water. Thus, WO teaches the claimed method since the Eragrostis (Teff) is extracted with water and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claims 46 and 67-see also Table 4 of the instant specification). Note the carrier of “excipient” (liquid form such as alcoholic drink, see page 12). Note oral administration with drink (liquid). Note that humans eat teff which is in injera and are in need of improved digestive function and regulating gut permeability since they have celiac disease. Once the Eragrostis (Teff) grain is processed it has clearly been isolated and is therefore not crude anymore since it is used in a drink for administration to someone having celiac disease. Inherently, the compound of Formula (I) comprises between 10 % to 99 % w/w of the oral composition since the Eragrostis (Teff) is prepared in an oral drink such as an alcoholic beverage.
In the event it is seen that the compound of Formula (I) does not inherently contain between 10 % to 99 % of the oral composition (which is NOT being admitted) then it would have been obvious to one having ordinary skill in the art to do so since 10 % to 99 % is a very broad range. Clearly, it would have been well within the purview of the ordinary artisan in an effort to optimize the desired results to use such an amount as the range of 10 % to 99 % is so broad and encompasses amounts which are routinely used in the art. Note that the compound of Formula (I) is clearly a results effective variable and it was clearly obvious at the time the invention was made for one of ordinary skill in the art to use an amount from such a broad range as claimed.
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
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 § 2146 et seq. 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.
Claims 34-43, 45, 46, 54-64, 66 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,173,136. Although the claims at issue are not identical, they are not patentably distinct from each other because 17/828,627 claims a process using the same compound as used in US 11,173,136 and the instant application can be used on anyone thus it is obvious to use the compound in either case.
Applicant did not respond to the rejection other than to say it should be held in abeyance, thus the rejection is maintained for the reasons of record.
Claims 34-43, 45, 46, 54-64, 66 and 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,382,880.
Although the claims at issue are not identical, they are not patentably distinct from each other because 17/828,627 claims a process using the same compound as used in US 11, 382,880 and the instant application can be used on anyone thus it is obvious to use the compound in either case.
Applicant did not respond to the rejection other than to say it should be held in abeyance, thus the rejection is maintained for the reasons of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655
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