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 .
Response to Amendment
Acknowledgement is made of receipt and entry of the amendment filed on 10/07/2024.
Any rejection found in the previous OFFICE ACTION and not repeated herein has been withdrawn based upon Applicant’s amendments to the claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior OFFICE ACTION.
Amended claims 1-2 have been examined on the merits.
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 1-2 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the term “purified.” No objective criterion is provided in the specification or claims to apprise one of skill in the art of the meaning “purified.” Examiner is unclear of what the term means and/or of what “purified” encompasses. Clarification or Correction is required.
All other claims depend directly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112, second paragraph for the reasons set forth above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-2 are directed to a natural product (i.e., a law of nature/a natural phenomenon-e.g. step 1 (MPEP 2106.03)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception (i.e. do not recite additional elements/steps that integrate the exception into a practical application and/or do not recite additional elements that amount to significant more than the exception of the claimed naturally-occurring ingredients-e.g. step 2A2 (MPEP 2106.04(d) and 2B (MPEP 2106.5))– i.e., as drafted, the cited claims read upon a product of nature for the following reasons:
Claims 1-2 are drawn to a composition comprising (please note that comprising and/or consisting essentially of language is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein (please note that the claimed natural compounds are found within the natural plant of Mitragyna speciose (Kratom)) and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) (i.e. all the claimed active ingredients are naturally-occurring ingredients). [Please note that where the claim is to a nature-based product in combination with non-nature based elements (e.g. a claim to “a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt”), the markedly different characteristics analysis should be applied only to the nature-based product limitation (MPEP 2106.04(c)(I)(A))]. Moreover, the claimed composition comprising (please note comprising language is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine, etc. therein (please note that the claimed natural compounds are found within the natural plant of Mitragyna speciose (Kratom)) and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) is not markedly different from its/their naturally-occurring counterpart(s) because there is no adequate indication and/or sufficient evidence/support within Applicant’s specification that the claimed composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein)-i.e., there is no adequate indication and/or sufficient evidence/support within Applicant’s specification that the instantly claimed preparatory steps (i.e. demonstrated evidence of the preparatory step of whereas the purification process steps of purifying the claimed compounds within the claimed composition/plant to have caused the resulting claimed composition to have any markedly different characteristics (i.e. structural and/or functional characteristics or properties) that are different from the naturally-occurring counterpart. Please note also that there is no adequate evidence/support within Applicant’s specification that the claimed composition is markedly different in terms of having a change in structure of having an unexpected functional difference (i.e. a difference in properties and/or characteristics) as compared to its/their naturally-occurring counterpart(s)) and/or no adequate evidence/support within Applicant’s specification that its claimed composition (as a whole) is markedly different by having a change in the composition’s overall functional properties as compared to its/their naturally-occurring counterpart(s) and/or there is no adequate evidence/support within Applicant’s specification that its claimed composition/product is markedly different in terms of having a change in structure (by demonstrating “synergism”) that produced an unexpected/synergistic functional effect as compared to its/their naturally-occurring counterpart(s)] and that the composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein)-e.g. step 2A1(MPEP 2106.04 (a-c))]. Moreover, the cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements (i.e. do not recite additional elements/steps that integrate the exception into a practical application and/or do not recite additional elements that amount to significant more than the exception of the claimed naturally-occurring ingredient- e.g. step 2A2 (MPEP 2106.04(d) and 2B (MPEP 2106.5).
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural products does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because again there is no sufficient evidence/support of a marked difference brought about by combining the instantly claimed natural products. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
Response to Arguments
Applicant’s arguments presented on March 07, 2024 have been carefully considered but are not deemed persuasive.
In Applicant’s response, Applicant argues that the dosage formulation comprising an active component consisting essentially of two or more purified kratom compounds having little to no deviation across and between samples is not found in nature. In contrast, at the time of Applicant’s disclosure, “kratom compounds were only available within complex mixtures comprising other compounds or matter from their natural sources, i.e. plant matter and other compounds. All data indicate that the presence and amounts of psychoactive compounds within naturally occurring samples are considered highly variable. Further, Applicant argues that a mixture of natural products varies greatly in the composition and concentration of the active ingredients making it nearly impossible to use as a dosage form. The claimed dosage composition solves this longstanding scientific problem by providing precision, accuracy, and internal consistency. Therefore, the claimed dosage composition is markedly different than a naturally occurring composition. Because the claimed invention is patent eligible, Applicant respectfully requests that the Office withdraw this rejection.
In response, Examiner, however, disagrees because the claims do not set forth a marked difference in terms of structural (especially in terms of a different structured composition) and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Since Applicant’s claimed invention of the composition comprising (please note that comprising language and/or consisting essentially of is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein (please note that the claimed natural compounds are found within the natural plant of Mitragyna speciose (Kratom)) and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) (i.e. all the claimed active ingredients are naturally-occurring ingredients), Examiner also maintains that combining natural products does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because again there is no adequate indication and/or sufficient evidence/support within Applicant’s specification that the claimed composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein)-i.e., there is no adequate indication and/or sufficient evidence/support within Applicant’s specification that the instantly claimed preparatory steps (i.e. demonstrated evidence of the preparatory step of whereas the purification process steps of purifying the claimed compounds within the claimed composition/plant to have caused the resulting claimed composition to have any markedly different characteristics (i.e. structural and/or functional characteristics or properties) that are different from the naturally-occurring counterpart. Also, please also note that modifying the concentration/ratios of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)). Moreover, please note also that there is also no adequate evidence/support within Applicant’s specification that the claimed composition is markedly different in terms of having a change in structure of having an unexpected functional difference (i.e. a difference in properties and/or characteristics) as compared to its/their naturally-occurring counterpart(s)) and/or no adequate evidence/support within Applicant’s specification that its claimed composition (as a whole) is markedly different by having a change in the composition’s overall functional properties as compared to its/their naturally-occurring counterpart(s) and/or there is no adequate evidence/support within Applicant’s specification that its claimed composition/product is markedly different in terms of having a change in structure (by demonstrating “synergism”) that produced an unexpected/synergistic functional effect as compared to its/their naturally-occurring counterpart(s)] and that the composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein)-e.g. step 2A1(MPEP 2106.04 (a-c))].
Furthermore, Examiner also maintains that the cited claims [each of the individual claimed active ingredients is natural active ingredients] do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements (i.e. do not recite additional elements/steps that integrate the exception into a practical application and/or do not recite additional elements that amount to significant more than the exception of the claimed naturally-occurring ingredients-e.g. step 2A2 (MPEP 2106.04(d) and 2B (MPEP 2106.5)). For example, although Applicant has claimed its composition is in the oral form of a dosage formulation (see e.g. Applicant’s specification in paragraph 0028), the physical embodiment of a general type of this oral formulation would not be considered an additional element/step that would integrate the exception into a practical application.
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 1-2 remain rejected under 35 U.S.C. 103 as being unpatentable over Kariman (US 20180169172).
Although unclear as drafted, a composition comprising (please note that comprising and/or consisting essentially of language is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) is apparently claimed.
[Please note regarding amended claim 1, it appears to Examiner that Applicant is claiming a composition using the term “comprising” whereas the term “comprising” is defined as open language. Moreover, it is noted that Applicant claims state "comprising" which is open language and therefore allows for the incorporation of non-claimed, non-disclosed elements. Applicant's argument would be pertinent if the claims stated closed language; i.e. "consisting of," however, Applicant's claims do not state "consisting of” but rather, state “consisting essentially of" which allows for the incorporation of other process steps recited by the prior art. Thus, Examiner maintains In PPG Industries, 156 F.3d at 1355, 48, USPQ2d at 1355, it discloses that for the purpose of searching for and applying prior art under 35 USC 102 and 103, absent clear indication in the specification or claims of what the basic and novel characteristics actually are "consisting essentially of" will be constructed as equivalent to "comprising." (see, e.g. MPEP 2111. 03).]
Kariman teaches a composition comprising (please note that comprising and/or consisting essentially of language is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) to be administered to a subject for a medicinal purpose such as to treat neurological diseases (see e.g. entire document including title, abstract, Figure 1, paragraphs 0015 and 0026 and claims). Please note also that the cited reference’s claimed natural compounds could be purified (see e.g. paragraph 0014 and claims 12 and 24).
It would have been obvious to one of ordinary skilled to provide a composition comprising (please note that comprising language is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) to be administered to a subject for a medicinal purpose such as to treat neurological diseases therein based upon the beneficial teachings provide by Kariman as discussed above. The adjustment of particular conventional working conditions therein (e.g. determining the various amount/ranges of each claimed active ingredient within the composition) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Thus, the invention as a whole is prima facie obvious over the cited reference, especially in the absence of evidence to the contrary.
Regarding the above art rejections, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
Response to Arguments
Applicant’s arguments presented on March 07, 2024 have been carefully considered but are not deemed persuasive.
In Applicant’s response, Applicant argues that Kariman is solely concerned with compounds comprising of a Mitragyna extract further comprising “at least trace amounts of 7-hydroxymitragynine and/or pseudoindoxyl; and where said compound contains at least a trace amount of one or more other of plurality of indole or oxindole alkaloids.” Additionally, Kariman’s only use the term “purified” in the description of the invention. Further descriptions of the safer and more efficacious purified compounds are missing from Kariman, and it is not clear how the term “purified” as used by Kariman relates to Kariman’s claimed compound composition containing at least trace amounts of 7-hydroxymitragnine, pseudoindoxyl, and/or plurality of other indole or oxindole alkaloids. In additionally, Applicant argues that the compounds comprising of a Mitragyna extract further comprising at least trace amounts of other indole or oxindole alkaloids reads against the active component consisting essentially of two or more purified kratom compounds of the claimed formulation. The transitional phase “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristics of the claimed invention. For these reasons, there is no case of prima facie obviousness, and Applicant respectfully requests the Office reconsider and withdraw the rejection of claims 1 and 2 as unpatentable over Kariman.
In response, Examiner, however, disagrees because since Kariman teaches (see e.g. entire document) a composition comprising (please note that comprising language and/or consisting essentially of is open language whereas other active ingredients could be included within the claimed composition) which comprises or may comprise (often within various preferred embodiments) of two or more kratom natural compounds (see e.g. entire document, especially claims 1, 6 and 30-31) selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) to be administered to a subject for a medicinal purpose such as to treat neurological diseases (see e.g. entire document including title, abstract, Figure 1, paragraphs 0015 and 0026 and claims). Please note also that the cited reference’s claimed natural compounds could be purified (see e.g. paragraph 0014 and claims 12 and 24), Examiner still maintains that it would have been obvious to one of ordinary skilled to provide a composition comprising (please note that comprising and/or consisting essentially of language is open language whereas other active ingredients could be included within the claimed composition) of two or more kratom natural compounds selected from the group consisting of compounds such as 7-Hydroxymitragynine, Mitragynine, Paynantheine, Speciogynine, Speciociliatine and/or Corynantheidine etc. therein and further comprising a pharmaceutically acceptable excipient (the excipient could just be natural water) to be administered to a subject for a medicinal purpose such as to treat neurological diseases therein based upon the beneficial teachings provide by Kariman as discussed above. The adjustment of particular conventional working conditions therein (e.g. determining the various amount/ranges of each claimed active ingredient within the composition) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL O WINSTON whose telephone number is (571)272-0972. The examiner can normally be reached M-T 8am-5pm.
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.
Applicant is advised to participate in the after-final consideration pilot program. Applicant is reminded of the PTO’s policies and procedures in this program for responding to final Office actions, changes in effect since May 18, 2013. These policies and procedures are described at http://www.uspto.gov/patents/init_events/afcp.jsp, After-Final Consideration Pilot 2.0 (AFCP 2.0). Of particular importance are the mandatory request form, form PTO/SB/434, and the policy that at least one independent claim must be amended in a way that does not broaden that claim.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached on 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL O WINSTON/Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655