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 .
The amendment filed 29 September 2025 is acknowledged and has been entered.
Claims 2-8, 10-17 and 19-29 have been cancelled.
Claim 9 was previously withdrawn.
Claims 1 and 18 and 30-38 are submitted for examination on the merits.
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.
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.
Claims 1, 18 and 30-38 stand rejected under 35 U.S.C. 103 as being unpatentable over being unpatentable over Kott (US 2010/0137433) in view of Zhou (2010 3 International Conference on Biomedical Engineering and Informatics (2010), pp 1723-1726 - cited by applicant in the IDS of 6/17/2015) and Reagan-Shaw (The FASEB Journal (2007) vol. 22, pp. 659-661).
Kott teaches a method for improving memory or impairing memory loss in a subject by administering a composition comprising a spearmint extract comprising rosmarinic acid (RA) to the subject. The reference teaches that the spearmint extract can be in the form of water extract (see claims 1, 8-11, 16, and 29 and paragraphs 35-37 and 80). It is specified that the spearmint extract contains RA in a range from 77.5 to 150 mg/g, which is 7.7 to 15%. In addition, the reference teaches administering the extract so that a dosage of 300 mg or more of rosmarinic acid/day is administered (see paragraphs 36 and 40) but does not explicitly teach a dosage of 900 mg/d. However, Kott teaches administering the extract so that a dosage of 90 mg, 100 mg, 250, or 300 mg of rosmarinic acid/day is administered (see paragraphs 36 and 40). This dosage overlaps with the dosages claimed by applicant. For example, for a 68 kg patient, a dosage between 1.6 to 32 mg/kg is 72 to 1440 mg/day. In addition, “at least about 900 mg/day water extract” as claimed in claim 1 encompasses 72 mg/kg/day (for a 68 kg subject) and any dosage amount above that.
Zhou teaches that rosmarinic acid has cognitive enhancing effects that are useful in treating an aging individual. The reference teaches that rosmarinic acid improves learning memory (see page 1723), synonymous with working memory which is an executive function as defined by applicant in the specification at paragraph [0012] of the published application. Zhou teaches using a dosage of 100, 200, or 400 mg/kg/day in the mouse model (see page 1724).
Reagan-Shaw teaches that conversion of mouse dosage to human dosage is calculated by multiplying the mouse dosage by the Km factor for a mouse (3) and then dividing by the Km factor for a human (37) (see first paragraph of page 660). Thus, the human dosages suggested by the mouse dosages in Zhou are 16 mg/kg/day for the 200 mg/kg dosage and 32 mg/kg/day for the 400 mg/kg dosage.
Furthermore, Applicant, argues that Kott does not teach the claimed dosages of rosmarinic acid. However, Kott teaches administering the extract so that a dosage of 90 mg, 100 mg, 250, or 300 mg of rosmarinic acid/day is administered (see paragraphs 36 and 40). This dosage overlaps with the dosages claimed by applicant. For example, for a 68 kg patient, a dosage between 1.6 to 32 mg/kg is 72 to 1440 mg/day. In addition, “at least about 900 mg/day water extract” as claimed in claim 1 encompasses 72 mg/kg/day (for a 68 kg subject) and any dosage amount above that. Therefore, Kott clearly teaches utilizing dosage amount of rosmarinic acid that fall within the broadly claimed range.
Therefore, it was known in the art at the time of the invention that spearmint extracts comprising rosmarinic acid improve memory or impair memory loss and that rosmarinic acid is useful in enhancing cognition in aging individuals. Thus, an artisan of ordinary skill would reasonably expect that the rosmarinic acid containing spearmint extract of Kott would be useful for specifically improving the cognitive health or function in an individual experiencing normal aging cognitive changes using the dosages suggested by Zhou. This reasonable expectation of successful results would motivate the artisan to modify Kott to include modifying the method for improving memory or impairing memory loss to include the selection of an individual experiencing normal aging cognitive changes as the subject treated in the method and using the dosages suggested by Zhou.
Zhou teaches administering the rosmarinic acid for 10 weeks (70 days) (see page 1724). However, the references do not specifically teach administering the extract for a time period of at least 90 days. However, "[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). Zhou specifically states that long- term administration is beneficial for producing an improvement in the age-related impairments (see page 1725). Thus, an artisan of ordinary skill would by motivated to modify the length of time in which the extract is administered in order to determine the optimal amount of time for administration. Given that Zhou teaches that prolonged administration is advantageous, an artisan would be motivated to optimize the dosage schedule for a long period of time such as that claimed by applicant. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
The cited references do not explicitly disclose the claimed dosage regimen (i.e., at least 900 mg/day of spearmint extract containing at least 13% rosmarinic acid). However, the reference does teach that the rosmarinic acid obtained from spearmint can administered in varying dosages. Furthermore, it would be customary and well within the purview of the skilled practitioner to vary dosages of a medication depending on specific conditions varying from patient to patient (e.g., size, age, condition, etc.). Such adjustment of particular conventional working conditions (e.g., determining an appropriate daily dose thereof and how long to continue the treatment) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. In the instant case, the cited reference teaches that the bioactive component of the spearmint extracts is rosmarinic acid (RA) and discloses that the RA content of the of the spearmint extract can range from about 8-15% RA. Thus one of ordinary skill in the art would alter the amount of the active ingredient spearmint extract applied to maximize the amount of RA (i.e., including anything above 13% as claimed) to obtain the optimum effective amount of RA administered to the patient.
See e.g., MPEP 2144.05
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.
III. REBUTTAL OF PRIMA FACIE CASE OF OBVIOUSNESS
A. Showing That the Range Is Critical
Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916) (a patent based on a change in the proportions of a prior product or process (changing from 4-10% oil to 1% oil) must be confined to the proportions that were shown to be critical (1%)); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205 (CCPA 1946) ("Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies."); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) ("It is well established that, while a change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such changes must be critical as compared with the proportions used in the prior processes, producing a difference in kind rather than degree."); In re Wells, 56 F.2d 674, 675 (CCPA 1932) ("Changes in proportions of agents used in combinations . . . in order to be patentable, must be critical as compared with the proportions of the prior processes."); E.I. DuPont de Nemours & Company v. Synvina C.V., 904 F.3d 996, 1006, 128 USPQ2d 1193, 1201 (Fed. Cir. 2018.)("[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 was prima facie obvious to one of skill in the art at the time the invention was made, as evidence 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 § 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 1 and 18 and 30-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 13, 15, 18-24, 51 and 52 of copending Application No. 14/962,537 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method for improving cognitive function, including executive function, by administering an extract from a Lamiaceae plant which can contain rosmarinic acid. Thus, the current claims are anticipated by the claims of the reference application despite some differences in scope between the two sets of claims.
In addition, please note that the instant claims encompass and/or are encompassed by the “537 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant has requested that the Double Patenting rejections be held in abeyance until allowable subject matter is indicated. The request is noted. The rejection is currently still considered valid at this time for the reasons set forth above.
No claim amendments have been made and Applicant arguments are those that have been made many times before and remain unpersuasive for all of the reasons previously set forth repeatedly.
The claimed method is broadly directed to supplementation of anyone with a spearmint extract.
Applicant asserts that Kott does not teach administering spearmint extract to such a "healthy human”. Kott describes the use of a plant tissue comprising more than 77.5 mg/g rosmarinic acid "to protect memory impairments observed in Alzheimer's Disease." [Para. 0012]. Applicant asserts that Kott does not teach or suggest the use of rosmarinic acid for treatment of memory loss that it not due to dementia or Alzheimer's disease, contrary to the specific teachings of the claimed invention. Further, as already noted, Kott does not teach administration of rosmarinic acid for a time period of at least 30 days as required by the claimed invention.
Zhou describes the study of, “the protective effects of Rosmarinic acid (RosA), on age-related behavior in senescent mice induced by consecutive injection of D- galactose (D-gal) and to explore in-brain mechanism of its effects.” (Abstract)(Emphasis supplied). Contrary to the Examiner’s assertion, the senescent mice induced by injection of D- gal are not models for “normal aging”. Instead, such mice are the accepted animal model for Alzheimer’s disease. Applicant asserts that, while Zhou mentions treatment of Alzheimer's disease through treatment of mice models for Alzheimer's disease, it does not teach or suggest the use of spearmint extract in the treatment of individuals experiencing normal aging cognitive changes. There is therefore no reason for persons skilled in the art to look to the cited references for such teachings.
As discussed in the previous Office action, Zhou teaches that rosmarinic acid has cognitive enhancing effects that are useful in treating an aging individual. Zhou does not teach that the aging individual has dementia; thus, this reference is considered to teach the limitations in claim 1. Therefore, it was known in the art at the time of the invention that spearmint extracts comprising rosmarinic acid improve memory or impair memory loss and that rosmarinic acid is useful in enhancing cognition in aging individuals without dementia. Thus, an artisan of ordinary skill would reasonably expect that the rosmarinic acid containing spearmint extract of Kott would be useful for specifically improving the cognitive health or function in an individual experiencing normal aging cognitive changes using the dosages suggested by Zhou. This reasonable expectation of successful results would motivate the artisan to modify Kott to include modifying the method for improving memory or impairing memory loss to include the selection of an individual experiencing normal aging cognitive changes as the subject treated in the method and using the dosages suggested by Zhou. Therefore, given that rosmarinic acid and spearmint are known to enhance cognition, an artisan of ordinary creativity would expect that the cognitive enhancing effect would be useful in health patients and well as patients with an underlying pathology.
Zhou specifically states “The aim is to study the protective effects of Rosmarinic acid (RosA) on age-related behavior in senescent mice...(abstract, emphasis added).” Zhou also states “Brain senescence played an important role in aging tissues... (First paragraph, introduction section);” and “The aim of this study was to investigate the effect and mechanism of RosA on aging-related behavior...(emphasis added, Last paragraph, introduction section). Furthermore, Zhou states “In conclusion, these results and above other reported indicated that RosA may have potential value in the treatment of aged- related behavior...(emphasis added, last paragraph Discussion section). Thus, Zhou clearly teaches the treatment of an individual experiencing normal aging related changes to cognition and does not only teach the treatment of Alzheimer’s disease as asserted by applicant. This normal aging population would not necessarily have an underlying pathology and is considered “healthy.” Therefore, the treatment of the claimed subject population is specifically suggested by Zhou. Consequently, applicant’s argument is not persuasive.
Thus, applicant’s invention is considered to be properly rendered obvious by the combination of the references.
In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Thus, an ordinary person of skill in the art of herbal supplements would be motivated to include spearmint extract with rosmarinic acid in a supplement to prophylactically treat cognitive decline based on the evidence of its efficacy provided by the cited references.
The amendments made to the claims have actually broadened the claim scope as the subject group is not limited and the new claims are directed to the same supplementation method wherein the subject group is a mammal.
THIS ACTION IS MADE FINAL. 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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, Terry McKelvey can be reached at 5712720775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUSSELL G FIEBIG/Examiner, Art Unit 1655
Prosecution Insights