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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07 Oct 2025 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 07 Oct 2025 has been entered.
Claims 1-3, 7-18 and 22 remain pending in the application.
Claims 1, 2, 7, 9, 10 and 12-15 are amended.
Claims 4-6 and 19-21 are cancelled.
Claims 9-17 are withdrawn
Claims 1-3, 7, 8, 18 and 22 are under examination
Rejections Maintained
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.
The following rejection is maintained, and is updated as necessitated by Applicant’s amendment filed 10 September 2024:
Claims 1-3, 7, 8, 18 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a composition comprising an aqueous extract of Alerce cells (Fitzroya cupressoides) cultured in vitro, and further comprising at least one skin care excipient and an additional component such as a vitamin (claim 1 as amended). This judicial exception is not integrated into a practical application because the claims only recite natural products (i.e., aqueous extract of Alerce cells), without any additional elements recited that are sufficient to amount to significantly more than the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (i.e., excipient, which may be a simple solvent such as water; vitamins) do not change the structure, function, or other properties of the natural product as to integrate the judicial exception into a practical application. A detailed analysis follows.
The active ingredient of the composition (i.e., aqueous extract of Alerce cells, cultured in vitro) is derived from the plant itself (Fitzroya cupressoides; note the cultured cells may be derived from the plant, e.g., see Durzan, col. 1, lines 62-63; col. 6, lines 13-14). Alerce cells are already known to be useful for cell regeneration, as in wound healing repair, and have been used in traditional medicine for different skin lesion treatments (e.g., see Carvajal, abstract; also see Examiner’s Note regarding Carvajal at end of paragraph 9, below). Additional components such as vitamins (e.g., vitamin C) are also naturally occurring (e.g., see Cui et al., col. 1, lines 16-17) and also known to be necessary for proper wound healing (e.g., see Lerner, col. 2, lines 35-37). Therefore, the extract recited in independent claim 1 is presumed to not be markedly different from the plant, and may contain the same active component(s) as the plant itself.
Under the 101 analysis for patent eligibility:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The claims are drawn to a composition of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-3, 7, 8, 18 and 22 recite an aqueous extract of Alerce cells. The extract is derived from the plant itself (Fitzroya cupressoides), and can be isolated using standard isolation techniques (e.g., extraction with distilled water; e.g., see Carvajal, page 1255). Therefore, the aqueous extract of Alerce cells is a natural product from the Fitzroya cupressoides plant. The extract does not require any additional elements, and may contain the same elements which do not differ in structure, function, or other properties present in the plant. As noted above, the plant has been used in traditional medicine for different skin lesion treatments (e.g., see Carvajal, abstract), and Alerce cells are already known to be useful for cell regeneration, as in wound healing repair (id.). Therefore, the extract is not markedly different from the plant, and may contain the same active component(s) as the fruit itself.
Step 2A, Prong 2: Does the claim recite additional elements that integrated the Judicial Exception into a practical application?
Claim 1 recites the additional elements of water (being an aqueous extract), a skin care excipient (note that the as-filed specification does not specifically define the term “excipient”, and the thus the term is given its broadest reasonable interpretation, to include simple solvents, such as water itself), and additional components such as vitamins (Applicant’s elected species; see claim 1 as amended). When considering the claimed composition as a whole, the composition does not have markedly different properties from the closest corresponding product of nature.
When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP 2106.04(c) II.A. The naturally occurring plant (in this case, the Fitzroya cupressoides plant) is known for being used in traditional medicine for different skin lesion treatments, and Alerce cells are already known to be useful for cell regeneration, as in wound healing repair (e.g., see Carvajal, abstract). Therefore, the extract is not markedly different from the plant, as the extract may contain the same active component(s) as the plant itself. The additional element of water, acts as carrier material(s) for the extract itself, and does not change the structure, function, or other properties of the extract in such a way as to integrate the judicial exception into a practical application.
The additional elements recited (water; skin care excipient; vitamin) do not integrate the judicial exception into a practical application, as the properties of the composition recited in the claims are already known (e.g., see Carvajal and Lerner, cited above) and/or would be inherent or innate characteristics in the naturally occurring counterpart. Inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. See MPEP 2106.04(c)II.C.
Step 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
Each of the elements recited in the claims are natural products and additional elements which do not integrate the judicial exception into a practical application. No other limitations are recited in instant claims 1-3, 7, 8, 18 and 22 that would add significantly more to the Judicial Exception.
Accordingly, the claimed composition recites a natural product that is not markedly different in structure from naturally occurring elements and hence reads on patent ineligible subject matter under the above guidelines.
To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature. Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The Court provides long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U .8.C.§ 101. A claim that recites a law of nature or natural correlation, with additional steps that involve well- understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation for the reasons cited above.
Response to Arguments
Applicant's arguments filed 07 Oct 2025 have been fully considered but they are not persuasive. The applicant argues that data presented in two declarations submitted under 37 CFR 1.132 which indicate that the claimed extract is different from the extract that comes from Alerce branches in nature. The examiner does not find the data in the declarations to be persuasive.
Regarding the declaration of Contreras, the data is not presented with sufficient clarity needed to properly analyze the results. The declaration indicates in the purpose that two extracts were compared, Alerce C and Alerce R. There is no information presented as to what Alerce C and Alerce R represent and it is thus impossible to draw any conclusions about how the data presented relates to the instant application. It is further noted that the captions for Figures 4 and 5 are labeled as Rub2-1 and Rub4-1 which adds to the discrepancy of the data as these have not been identified.
Regarding the data presented in the Belchi declaration, the examiner acknowledges that the data appears to indicate that the aqueous extracts from cells of the invention and cells from branches and needles to be different. The examiner is not convinced, however, that the comparison made between the different aqueous extracts is pertinent to overcoming the rejection under 101. It is noted on page 6 of the declaration that the cultured cells are undifferentiated whereas the comparison cells were differentiated branch and needle cells. Thus, different types of cells were used for comparison and it is expected that the resulting chromatograms would show different polyphenol metabolites. This data does not show that the cells cultured per the claim are different from their natural counterpart, namely undifferentiated Alerce cells. Thus, there is insufficient evidence to indicate that the cultured cells of the claims are markedly different from their natural counterpart and the data is insufficient to overcome the rejection under 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-3, 7, 8, 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Carvajal et al. (“Carvajal”, J. Cosmet. Dermatol., 2020; 19:1254-1259, first published 05 September 2019) in view of Lerner (US Patent 5,470,874).
Regarding claims 1 and 3, Carvajal teaches cell cultures and aqueous extracts prepared from alerce needles (e.g., abstract). Alerce cell culture extracts at various concentrations demonstrate significantly increased wound closure rate (indicating cell regeneration; pharmaceutical/skin care use) with respect to control in scratch tests (e.g., page 1256, Figure 1 and Section 3.2). Regarding the presence of a skin care excipient (claim 1 as amended), it is noted that the term “excipient” is not specifically defined, and therefore is given its broadest reasonable interpretation, to include simple solvents, such as water itself, which is present in the composition of Carvajal (e.g., page 1255, Section 2.1). Regarding the various concentrations of alerce extract (claim 1 as amended; claims 7, 8), Carvajal discloses various concentrations of alerce extract concentrations ranging from 0.0005%-0.125% p/v (e.g., Figure 1), which are within the ranges claimed.
Regarding the presence of an additional ingredient (claim 1 as amended), Carvajal does not specifically teach the addition of a vitamin (Applicant’s elected species) to its composition. However, Lerner is in the field of topical compositions (e.g., abstract; claim 1) and generally teaches Vitamin C is known to be essential for collagen synthesis and wound healing (e.g., col. 2, lines 35-37). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to include vitamin C in the composition of Carvajal; thus arriving at the claimed invention. One skilled in the art would be motivated to do so because vitamin C is already known to be essential for wound healing, as taught by Lerner, and therefore it would be within the purview of the ordinarily skilled artisan to include vitamin C in the wound healing composition of Carvajal, with a reasonable expectation of success.
Regarding claims 2 and 22, it is noted that, since Carvajal discloses the same extract in the same amount as that instantly claimed (i.e., aqueous extract of alerce cell culture), the same components would be present in the extract, absent evidence otherwise.
Regarding claim 18, it is noted that this claim recites a product-by-process. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. Since the composition of the prior art comprises the same components (i.e., an aqueous alerce cell culture extract), it effectively reads on the claim.
Examiner’s Note: Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because an accurate translation of said foreign priority application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. While Applicant has submitted a translation of the foreign priority application, the translation contains inaccuracies which call into question the veracity of the translation, and thus the translation is not accepted as an accurate translation (see further discussion, below).
Response to Arguments
Applicant's arguments filed 07 Oct 2025 have been fully considered but they are not persuasive. Applicant states that a verified translation of the priority document CL 2863-2018 was filed with the 10 Sep 2025 amendment. The examiner acknowledges that a verified translation was provided, however, as was previously noted, there are discrepancies between the translation provided and the original document that call into question the veracity of the translation. For example: 1) the Certificate of Translation states “Application No. CL 2863-2018 dated October 10, 2018”, but the application actually has a filing date of October 8, 2018, as noted by Applicant (e.g., see page 8 of Remarks filed 10 September 2024); 2) the translation contains at least one paragraph which is left untranslated (e.g., see translation at page 1, third paragraph of description); and 3) claims 1 and 2 of the translation contain language which is not found in original claims 1 and 2 of application CL 2563-2018. For example, claim 1 of the translation recites, “cultured in vitro”, which is not found in claim 1 of CL 2563-2018, and claim 2 of the translation recites “comprises active compounds or compounds with properties complementary to those of the extract of the invention, such as vitamins, sunscreens, minerals or others”, which is not found in claim 2 of CL 2563-2018. For this reason the provided translation is not accepted as an accurate translation and is not sufficient to establish priority to overcome the rejection.
New Grounds of Objections
Claim Objections
Claims 1 and 22 are objected to because of the following informalities:
Claim 1 recites “curessoides.” This should be “cupressoides.”
Claim 22 recites in the sixth line “in arrange from.” This should be “in a range from.”
Appropriate correction is required.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, David Blanchard can be reached on (571)272-0827. 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.
/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600