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 .
Claim Status
Claims 1-7 are pending.
Claims 2-7 are withdrawn.
Claim 1 is under examination.
Remark on Priority
The instant application is a national stage entry under 35 USC 371 of PCT/CN2021/077088 (filed 2/20/2021). Acknowledgement is made of Applicants’ claim for priority to CN 202110109540.3 (filed 1/25/2021). It is noted that Applicant filed a certified translation of CN 202110109540.3 (filed 1/25/2021) on 8th, May, 2026.
Moot Claim Rejections - 35 USC § 101
The rejection of claims 8-9 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as set forth in the previous office action is moot in view of the cancellation of these claims.
The rejection of claims 8-9 under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more as set forth in the previous office action is moot in view of the cancellation of these claims.
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 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more.
The claim recites a cell line which is not markedly different from its naturally occurring counterpart. This judicial exception is not integrated into a practical application because the natural product is not linked to a particular technology. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are well understood, routine and conventional in cell biology.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
Step 1
In regard to step 1, the claims are directed to a malignantly transformed cell line of human keratinocytes, which is a product and is a statutory class of invention. Accordingly, the requirements of step 1 are met.
Step 2A Prong One
In regard to Step 2A prong one, as stated above, the claims are directed to a malignantly transformed cell line of human keratinocytes. A cell line is cells in culture which is a nature-based product.
Applicant is additionally directed to the art of Martinez et al. (J Skin Cancer. 2011 Dec 6;2011:454157.; henceforth “Martinez”). Martinez evidences malignant human keratinocytes that naturally occurred in response to arsenic exposure (Human Squamous Cell-Type Carcinomas by Arsenic in drinking water; abstract; see also Table 1) which are a naturally occurring product.
As claimed, the cells are not markedly different from the naturally occurring malignant human keratinocytes evidenced by Martinez above. More specifically the cells are made by exposure to dimethylmonothioarsinic acid which is a toxic metabolite of inorganic arsenic and therefore the resulting cells would be structurally the same as naturally occurring cells that had been exposure to inorganic arsenic, such as those evidenced by Martinez above.
Step 2A Prong Two
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application.
Specifically, claim 1 recites the additional elements of:
“cell line”
A “cell line” means that the cells are in culture. Merely taking the cells out of their natural state and putting them in culture does not structurally change the cells as they are the same genotype and phenotype. Further, placing the cells in culture on its own does nothing to improve a technology, effect a particular treatment, or implement with a particular device to provide a meaningful limitation on the judicial exception. Therefore, recitation of a “cell line” does not integrate into a judicial exception.
“dimethylmonothioarsinic acid-induced malignantly transformed” and
“wherein the dimethylmonothioarsinic acid-induced malignantly transformed cell line is exposed and incubated in a medium containing 0.5-1.0 μM dimethylmonothioarsinic acid.”
These are product-by-process limitations. Product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps (see MPEP 2113). The structure implied by the dimethylmonothioarsinic acid-induction is malignant transformation of the cells, which means that the resulting cells are malignant (cancer) cells. As stated above, these would be not markedly different than cells that had been naturally exposed to arsenic.
Therefore, exposing the cells to dimethylmonothioarsinic acid or the specific amounts recited does not integrate into a practical application.
“and is adapted for studying a carcinogenic mechanism of dimethylmonothioarsinic acid and screening or evaluating drugs for treating cancers caused by inorganic arsenic”
This recitation does not integrated into a practical application because it merely describes an intended use. The recitations of an intended use does not integrate the claims into a practical application.
Therefore, because it is the structure of the product that is limiting, and not how it is made, the process of making (the recited elements above of “dimethylmonothioarsinic acid-induced malignantly transformed,” “line is exposed and incubated in a medium containing 0.5-1.0 μM dimethylmonothioarsinic acid” and “is adapted for studying a carcinogenic mechanism of dimethylmonothioarsinic acid and screening or evaluating drugs for treating cancers caused by inorganic arsenic”) does not result in a structural difference and does not integrate the claims into a practical application.
“deposited in China General Microbiological Culture Collection Center (CGMCC, Address: Building #3, NO. 1 Beichen West Road, Chaoyang District, Beijing) under CGMCC Accession No. 21419 on December 30, 2020”
Merely depositing the cells does not structurally change the cells and also does not integrate the claims into a practical Application.
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As stated above, instant claims are directed to a cell lines that is not markedly different than its naturally occurring counterpart (naturally occurring malignant human keratinocytes that result from arsenic exposure). The additional elements recited above do not impart markedly different characteristics and do not integrate the claims into a practical application as discussed above.
The additional elements do not amount to significantly more for the reasons stated below.
Regarding claim 1, the additional element of the “cell line,” does not amount to significantly more because it merely indicates the cells are in culture, which is well-understood, routine and conventional in cell-biology and does not impart a structural change onto the cells.
Regarding claim 1, the additional elements of the “dimethylmonothioarsinic acid-induced malignantly transformed,” the specific “is exposed and incubated in a medium containing 0.5-1.0 μM dimethylmonothioarsinic acid” and deposit of claim 1 merely describe how the cells are made and where they are located and do not amount to significantly more.
Regarding claim 1, the recitation of “adapted for studying a carcinogenic mechanism of dimethylmonothioarsinic acid and screening or evaluating drugs for treating cancers caused by inorganic arsenic” merely recites an intended use and does not amount to significantly more.
Therefore, the claims are directed to a naturally occurring product (malignant human keratinocytes from inorganic arsenic exposure) that is not integrated into a practical application, does not include elements that amount to significantly more than the judicial exception, and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
Response to Arguments
Applicant arguments, filed 8th, May, 2026, have been fully considered but are not found persuasive.
Applicant argues “Claim 1 recites, "the dimethylmonothioarsinic acid-induced malignantly transformed cell line is exposed and incubated in a medium containing 0.5-1.0 μM dimethylmonothioarsinic acid, and is adapted for studying a carcinogenic mechanism of dimethylmonothioarsinic acid and screening or evaluating drugs for treating cancers caused by inorganic arsenic." Claim 1 now is directed to patent eligible subject matter” (pg. 5).
In response, this is not found persuasive because the preponderance of the evidence is that the dimethylmonothioarsinic acid-induced malignantly transformed cell line as claimed does not have markedly different characteristics than the malignant human keratinocytes that occur naturally in response to inorganic arsenic exposure (Martinez; Human Squamous Cell-Type Carcinomas by Arsenic in drinking water; abstract; see also Table 1, cited above). Applicant is directed to MPEP 2106.04(b) (II) which states that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 and the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart. (MPEP 2106.04(b) (II))
Withdrawn Claim Rejections – 35 USC § 112a
Enablement
Biological deposit
The rejection of claim 1 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement as set forth in the previous office action is withdrawn in view of Applicant’s filing of a statement by an attorney of record over his or her signature and registration number, showing that
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a viability statement in accordance with the provisions of 37 CPR 1,807; and
(e) the deposit will be replaced if it should ever become inviable (see remarks filed 8th, May, 2026 pg. 5).
Moot Claim Rejections – 35 USC § 112a
Enablement
Biological deposit
The rejection of claims 8-9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement as set forth in the previous office action is moot in view of the cancellation of these claims.
Moot Claim Rejections - 35 USC § 112b
The rejection of claims 8-9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is moot in view of the cancellation of these claims.
Withdrawn Claim Rejections – 35 USC § 102
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (Toxicology. 2009 Aug 3;262(2):162-70. Epub 2009 Jun 12.; henceforth “Sun”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Mao et al. (J Trace Elem Med Biol. 2020 Sep:61:126544. Epub 2020 May 6.; see IDS filed 30th, January, 2022; henceforth “Mao”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments and in view of Applicants filing of a Declaration under 37 CFR 1.130 that indicates that the cited areas of the Mao reference were made solely by the inventor Yan An.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as set forth in the previous office action is withdrawn in view of Applicants filing of a Declaration under 37 CFR 1.130 that indicates that the deposit of the cell line before the effective filing date, but within the 1-year grace period, was made by the inventor Yan An.
Moot Claim Rejections – 35 USC § 102
The rejection of claims 8-9 under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (Toxicology. 2009 Aug 3;262(2):162-70. Epub 2009 Jun 12.; henceforth “Sun”) as set forth in the previous office action is moot in view of the cancellation of these claims.
The rejection of claims 8-9 under 35 U.S.C. 102(a)(1) as being anticipated by Mao et al. (J Trace Elem Med Biol. 2020 Sep:61:126544. Epub 2020 May 6.; see IDS filed 30th, January, 2022; henceforth “Mao”) as set forth in the previous office action is moot in view of the cancellation of these claims.
The rejection of claims 8-9 under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as set forth in the previous office action is moot in view of the cancellation of these claims.
Response to Declaration under 37 CFR 1.130
The Declaration under 37 CFR 1.130 filed 8th, May, 2026 is sufficient to overcome the rejection of claim 1 based on 35 U.S.C. 102(a)(1) as being anticipated by Mao and the rejection of claim 1 based on 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as set forth in the previous office action.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Sun et al. (Toxicology. 2009 Aug 3;262(2):162-70. Epub 2009 Jun 12.; henceforth “Sun”) in view of Shimoda et al. (J Trace Elem Med Biol. 2018 Dec:50:188-197. Epub 2018 Jul 10.; henceforth “Shimoda”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Claim Rejections - 35 USC § 103
The rejection of claims 8-9 under 35 U.S.C. 103 as being unpatentable over Sun et al. (Toxicology. 2009 Aug 3;262(2):162-70. Epub 2009 Jun 12.; henceforth “Sun”) in view of Shimoda et al. (J Trace Elem Med Biol. 2018 Dec:50:188-197. Epub 2018 Jul 10.; henceforth “Shimoda”) as set forth in the previous office action is moot in view of the cancellation of these claims.
Withdrawn Non-Statutory Double Patenting
The provisional rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending application No. 17625740 as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Non-Statutory Double Patenting
The provisional rejection of claims 8-9 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending application No. 17625740 as set forth in the previous office action is moot in view of the cancellation of these claims.
Conclusion
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 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.
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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, Peter Paras can be reached at (571) 272-4517. 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.
/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
Prosecution Insights