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 .
DETAILED ACTION
Election/Restrictions
Claims 1-11, 14-17, and 20-23 are pending.
Applicant's election with traverse of Group I, claims -11, and 14-17, in the reply filed on 11/5/25 is acknowledged. The traversal is on the ground(s) that searching for all the invention groups is not a burden. This is not found persuasive because as indicated in the previous office action, the inventions of Group I-II are two distinct inventions for the reason of the record. They have different electronic resources and search queries, and searing for one subject matter will not necessarily lead to another. Applicant is reminded of the extensive literature search in biotechnology which is not co-extensive. Applicant also argues that the combination of the two references is a hindsight, which is not persuasive. Since both of the references teach treating skin disorder, one of the ordinary skill in the art would have been motivated to combine the teachings of the references together.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11, and 14-17 are examined on the merits.
Claim Rejections –35 USC § 112, 2nd
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.
Claim 9 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 9 recites “The combination according to claim 6, wherein the extract of Triptergium wilfordii is obtainable by…” (at lines 1-2). The recitation is confusing, as it is not clear wither the extract of Triptergium wilfordii is actually obtained by the claimed method or not. The correct recitation should be …obtained….
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under 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 1-8, 10, 11, and 14-17 are 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.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 1-8, 10, 11, and 14-17 is/are directed to a combination comprising a myrtle extract and an extract of Triptergium wilfordii.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, a myrtle extract and an extract of Triptergium wilfordii, because there is no indication that extraction has caused the components of myrtle and Triptergium wilfordii that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components in myrtle and Triptergium wilfordii..
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1-8, 10, 11, and 14-17 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claims 1-3, 6-8, and 14, since there is no absolute amounts of the active ingredients are claimed as compared to the whole composition, the claimed composition encompasses embodiments where the active ingredients are in such small amounts that none of them impart any characteristic or markedly different characteristic. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claims 4, 5, 10, 11, 15, and 16 require certain amounts of components being present in the composition. However, there is no indication that the amounts claimed in the compositions result in a markedly different characteristic for the composition as compared to the components that occur in the nature.
Regarding claims 14, the presence of water (one cosmetically or dermatologically acceptable excipient in the claimed composition does not result in a markedly different characteristic for the claimed composition because plant materials already comprise water and thus have that same characteristic.
Regarding claims 14-17, a cosmetic composition for topical administration does not result in a markedly different characteristic because plant harvest and plant extraction already involve contact of the plant materials with human skin.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The 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 beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claim Rejections –35 USC § 103
The following is a quotation of 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 through 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.
Claims 1-8, 10, and 14-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Puybaret et al (FR 2783425 A1) (see IDS filed on 11/30/23), in view of Duan (Duan, Triterpenoids from Tripterygium wilfordii. Phytochemistry, (2000 Apr) Vol. 53, No. 7, pp. 805-10) (see IDS filed on 11/30/23).
Puybaret et al et al teach the present invention relates to an extract of aerial parts of Myrtle (Myrtus communes L., Myrtaceae) (thus the claimed extract) and a process for preparing this extract. This extract is of interest in the treatment of inflammatory skin syndromes and skin differentiation syndromes such as psoriasis and keratinization disorders. The present invention also relates to a dermatological and/or cosmetic composition (thus claims 14 and 17 are met) and the use of this composition in particular for the treatment of psoriasis (page 1, lines 14-19). Puybaret et al teach the present invention relates more particularly to an extract of aerial parts of Myrtle, this extract is an apolar fraction which contains acylphloroglucinol compounds. Among the acylphloroglucinol compounds contained in this extract, there are myrtucommulones and in particular myrtucommulonesB'. Triterpenes and sterols are also present (page 1, lines 20-25). Puybaret et al teach the solvent most often used to carry out the extraction on the aerial parts of the plant is an alcohol preferably chosen from the group formed by ethanol, methanol, isopropanol, or a ketone preferably chosen from the group formed with acetone, methyl ethylacetone. However, hexane, methylene chloride, isopropyl ether and ethyl acetate (thus the same as the non-polar solvent in the specification, page 5, at line 19) (therefore, the non-polar solvent extracts the claimed components in claims 2 and 3). This extract contains 6.6% myrtucommulone B', 7% ursolic acid (page 8, at line 294).
Puybaret et al do not teach the incorporation of an extract of Triptergium wilfordii, or the claimed amounts of components in claims 4, 5, 10, 15, and 16.
Duan teaches the extract of Tripterygium wilfordii Hook f. afforded four triterpenoids: wilforic acid D (3beta,24-epoxy-2alpha-hydroxy-24R*-ethoxy- 29-friedelanoic acid); (E) 3beta,24-epoxy-2-oxo-3alpha-hydroxy-29- friedelanoic acid; (F) 2beta-hydroxy-3-oxo-friedelan-29-oic acid; 29-hydroxy-3-oxo-olean-12-en-28-oic acid and 17 known triterpenoids. Their structures were established on the basis of spectroscopic studies. In a bioactivity analysis, only the known dulcioic acid compound showed a significant inhibitory effect on cytokine production (see Abstract). Duan teaches we have described several interleukin-1 inhibitors celastrol (thus claims 6-8 are met) from Tripterygium wilfordii, and a water/chloroform extract of the roots of Tripterygium wilfordii was used in the clinical treatment of skin disorders, and other inflammatory disease (page 805, 1st column, last paragraph).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed the extract of Tripterygium wilfordii from Duan into the composition of Puybaret et al since Duan teaches Tripterygium wilfordii was used in the clinical treatment of skin disorders, and other inflammatory disease. Since both of the references teach treating skin disorder, one of the ordinary skill in the art would have been motivated to combine the teachings of the references together.
Regarding the claimed amounts of components in claims 4, 5, 10, 15, and 16, determining an appropriate amount of the components within the composition is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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