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 1-9 are pending.
Claims 2-7 are withdrawn.
Claims 1 and 8-9 are under examination.
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). A certified copy of the foreign priority application is present in the application file, but a certified translation is not present.
Election/Restrictions
Applicant’s election without traverse of the following invention
Invention
Group I, claims 1 and 8-9 drawn to a dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes
in the reply filed on 26th, August, 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter (see MPEP 2173.05(q)).
Claim 8 recites a use “as a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid,” and claim 9 recites a use “in screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” and therefore these claims recite a use, but fail to recites steps (see MPEP 2173.05(q) (I)). Therefore, it is not apparent whether instant claims are directed to a product with intended uses or a method, and instant claims 8-9 do not fall within at least one of the four categories of patent eligible subject matter.
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 and 8-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claims recite 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).
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.
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 directed to the art of Nagarajan et al. (Clin Cancer Res. 2018 Dec 6;25(8):2379–2391.; henceforth “Nagarajan”). Nagarajan evidences malignant human keratinocytes (Cutaneous squamous cell carcinoma (cSCC) and basal cell carcinoma (BCC); abstract; Figure 1).
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).
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”
The recitation of “dimethylmonothioarsinic acid-induced malignantly transformed” is a product-by-process limitation. 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 claimed, these cells are not markedly different from the naturally occurring malignant human keratinocytes evidenced by Nagarajan or Martinez above.
Therefore, because it is the structure of the product that is limiting, and not how it is made, the process of making (“dimethylmonothioarsinic acid-induced malignantly transformed”) 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.
Claim 8 recites the additional element of:
Use “as a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid”
Claim 9 recites the additional element of:
Use “in screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic”
Regarding claims 8-9, these each recite a “use,” which is interpreted as an intended use. The recitation of these intended uses does not create a marked difference and 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). 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,” 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 claims 8-9, these claims merely recite uses which are interpreted as intended uses and do not amount to significantly more.
Therefore, the claims are directed to a naturally occurring product (malignant human keratinocytes) 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.
Claim Rejections - 35 USC § 112a
Enablement
Biological deposit
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 8-9 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes are not so obtainable or available, the requirements of 35 USC 112 may be satisfied by a deposit of the dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes that can be used to make the cells, 37 CPR 1.802.
The specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed cell line (“CGMCC Accession No. 21419”; instant claim 1) is
(1) known and readily available to the public;
(2) reproducible from the written description; or,
(3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809.
The specification does not clearly disclose a repeatable process to obtain the cell line and it is not apparent if the cell line is readily available to the public. The only reference to CGMCC Accession No. 21419 is made on pg. 2 in the specification, and in instant claim 1. Instant claim 1 states the cell line “is 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.)” However, a search of the CGMCC databases did not return any results for Accession No. 21419.
Regarding (1), because a search of the CGMCC databases did not return any results for Accession No. 21419, the cell line is not known and readily available to the public.
Regarding (2), because the instant specification does not clearly disclose a repeatable process to obtain the cell line, the cell line is not reproducible from the written description. Although the specification describes methods of making dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes (Examples 1-3; see also pg. 2-3), it is not apparent which specific method steps are required to make the specific claimed CGMCC Accession No. 21419 in a reproducible manner.
Regarding (3), the requirements of C.F.R. §§ 1.801 through 1.809 have not been met for the reasons stated below.
The following is a quotation of 37 C.F.R. § 1.809(d):
"For each deposit made pursuant to these regulations, the specification shall contain: (1)
The accession number for the deposit; (2) The date of the deposit; (3) A description of the
deposited biological material sufficient to specifically identify it and to permit examination; and (4) The name and address of the depository."
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or
declaration by applicants, or a statement by an attorney of record over his or her signature and
registration number, stating that the specific dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes has been deposited under the Budapest Treaty and that the dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes, will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. 37 CPR 1.808.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CPR 1.808, applicants may provide assurance of compliance by an affidavit or declaration, or by 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.
Applicant is further reminded that, as required under 37 CPR 1.809(d), the specification shall contain: (1) the accession number for the deposit; (2) the date of deposit; (3) a description of the deposited biological material sufficient to identify it and to permit its examination; and (4) the name and address of the depository.
Regarding 37 C.F.R. § 1.809(d) (1), Applicant discloses the accession number for the deposit (CGMCC Accession No. 21419; claim 1). However, as stated above, this deposit number cannot be found upon search at CGMCC.
Regarding 37 C.F.R. § 1.809(d) (2) Applicant discloses the date of the deposit (December 30, 2020).
Regarding 37 C.F.R. § 1.809(d) (3), Although Applicant discloses the cells are “A dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes” this is not sufficient to specifically identify the cells and permit examination because it is not apparent whether the cell line of CGMCC Accession No. 21419 has additional structural requirements.
Therefore, because the claimed cell line (“CGMCC Accession No. 21419”; instant claim 1) is not (1) known and readily available to the public; is not (2) reproducible from the written description; and is not (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809, the specification fails to provide an enabling disclosure.
Claim Rejections - 35 USC § 112b
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 8-9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites a use of a product “as a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid,” and claim 9 recites a use of a product “in screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” and therefore these claims recite a use, but fail to recites steps (see MPEP 2173.05(q) (I)). Because instant claims recite both a product (cell line of human keratinocytes according to claim 1) and a use, it is unclear whether the claims are directed to a product or a method, and the scope of the claims is indefinite (see MPEP 2173.05(q)).
Claim Interpretation
Due to the 112a and 112b issues identified above, for the sake of compact prosecution, the claims identified with 112 issues above are being examined against the prior art and double-patenting as follows:
Claim 1 is interpreted as a dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes.
Instant claims 8-9 are interpreted as intended uses of the claimed cell line of claim 1
It is additionally noted that claim 1 recites a product-by-process (“dimethylmonothioarsinic acid-induced malignantly transformed”). Applicant is reminded that product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113)
Examiner’s Remark
As stated above, instant claims 8-9 are not clearly part of a statutory category (see rejections under 35 USC § 101 above) and are therefore also indefinite (see rejections under 35 USC § 112b above). As stated above (see claim interpretation above), instant claims 8-9 are being interpreted as intended uses of the claimed cell line of claim 1. Because instant claims 8-9 are being interpreted as intended uses of the claimed cell line of claim 1, they are currently grouped with the product of elected Group I. Applicant is advised that amendments to instant claims 8-9 may result in election by original presentation or the necessitation of a new restriction requirement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 8-9 are rejected 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”).
Regarding claim 1, Sun discloses an arsenic-induced malignantly transformed cell line (“arsenic-exposed HaCaT cells” abstract) of human keratinocytes (see also Figures 2, 4; Materials and methods “Cell Culture” pg. 163 col. 2 3rd para.).
Regarding claim 1, although Sun does not disclose the cell line is “dimethylmonothioarsinic acid-induced,” this is a product-by-process limitation. As stated above (see claim interpretation above), product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps. In the instant case, the cell line of Sun is a malignantly transformed cell line of human keratinocytes and therefore meets the structural requirements of instant claims.
Regarding claims 8-9, although Sun does not recite an intended use of “a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid” (instant claim 8), or the intended use of “screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” (instant claim 9), the cell line of Sun meets the structural requirements of instant claims, and is therefore capable of meeting the claimed intended uses.
Accordingly, Sun anticipates instant claims.
Claims 1 and 8-9 are rejected 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”).
The applied reference has a common Inventors with the instant application. Based upon the earlier publication date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(1). Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Regarding claim 1, Mao discloses a dimethylmonothioarsinic acid-induced (DMMTAV) malignantly transformed cell line of human keratinocytes (abstract; see also Materials and methods “Cell culture and treatment”; HaCaT cells treated with 10 μM DMMTAV Figure 5).
Regarding claims 8-9, although Mao does not recite an intended use of “a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid” (instant claim 8), or the intended use of “screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” (instant claim 9), the cells of Mao meets the structural requirements of instant claims, and are therefore capable of meeting the claimed intended uses.
Accordingly, Mao anticipates instant claims.
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
Regarding claim 1, Applicant claims the cell line “is 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). The date cited by Applicant pre-dates the filing date of Chinese Application 202110109540.3 filed on 25th, January, 2021, which is the earliest priority date claimed by Applicant. Therefore, the claimed invention, which is CGMCC Accession No. 21419 was publicly available before the effective filing date of the claimed invention.
Regarding claims 8-9, the publicly available cells of CGMCC Accession No. 21419 meet the structural requirements of instant claims, and are therefore capable of meeting the claimed intended uses of “a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid” (instant claim 8), or the intended use of “screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” (instant claim 9).
Accordingly, the claimed invention was publicly available.
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naranmandura et al. (Chem Res Toxicol. 2007 Aug;20(8):1120-5. Epub 2007 Jul 13.; henceforth “Naranmandura”).
Regarding claim 1, Naranmandura discloses a cell line of human keratinocytes (Human Epidermoid Carcinoma A431 Cells; abstract; pg. 1121 col. 1 2nd para., last para. col. 2 2nd para; Figure 1; Materials and Methods “Culture of A431 Cells”). Naranmandura discloses the cell line of human keratinocytes was treated are treated with dimethylmonothioarsinic acid for 24 hours (pg. 1121 col. 2 1st para.). Therefore, because the cell line of human keratinocytes of Naranmandura was contacted with dimethylmonothioarsinic acid, it meets the broadest reasonable interpretation of a dimethylmonothioarsinic acid-induced malignantly transformed cell line of human keratinocytes.
Regarding claims 8-9, although Naranmandura does not recite an intended use of “a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid” (instant claim 8), or the intended use of “screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” (instant claim 9), the cells of Naranmandura meets the structural requirements of instant claims, and are therefore capable of meeting the claimed intended uses.
Accordingly, Naranmandura anticipates instant claims.
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 and 8-9 are rejected 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”).
Regarding claim 1, Sun discloses an arsenic-induced malignantly transformed cell line (“arsenic-exposed HaCaT cells” abstract) of human keratinocytes (see also Figures 2, 4; Materials and methods “Cell Culture” pg. 163 col. 2 3rd para.).
However, regarding claim 1, Sun does not disclose the cell line is dimethylmonothioarsinic acid-induced.
Nevertheless, regarding claim 1, Shimoda teaches a dimethylmonothioarsinic acid-induced malignantly transformed cell line of human hepatocytes (HepaRG cells) (Materials and methods “Cell Culture”).
Therefore, regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the cell line of Sun, and simply substitute the known prior art element of the dimethylmonothioarsinic acid-induction of Shimoda for the arsenic-induction of Sun to obtain the predictable result of a malignantly transformed cell line of human keratinocytes. One of ordinary skill would have been motivated to do so as taught by Shimoda because Shimoda teaches dimethylmonothioarsinic acid as a metabolite of trivalent dimethylated arsenic, and Shimoda teaches the metabolites are considered to be the ultimate substances responsible for arsenic carcinogenesis (pg. 189 col. 1 para. 1-2). Regarding the reasonable expectation of success, Shimoda evidences making a malignantly transformed human cell line by applying dimethylmonothioarsinic acid (Materials and methods “Cell Culture”).
Regarding claims 8-9, although Sun and Shimoda are silent to an intended use of “a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid” (instant claim 8), or the intended use of “screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” (instant claim 9), the cell line suggested by Sun in view of Shimoda meets the structural requirements of instant claims, and is therefore capable of meeting the claimed intended uses.
Hence, the claimed invention as a whole was prima facie obvious.
Non-Statutory 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Co-pending Application No. 17625740
Claims 1 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending application No. 17625740.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. A notice of allowance has been mailed for Co-pending Application No. 17625740. Once the allowed patent has issued, this rejection will no longer be provisional, and will be an actual double patenting rejection.
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the cell line of U.S. Co-pending App ‘740 anticipates the cell line of instant application.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
Regarding claim 1, U.S. Co-pending App ‘740 claims a dimethylarsinous acid-induced malignantly transformed cell line of human keratinocytes (claim 1).
Regarding claim 1, although U.S. Co-pending App ‘740 does not disclose the cell line is “dimethylmonothioarsinic acid-induced,” this is a product-by-process limitation. As stated above (see claim interpretation above), product-by process claims are not limited by the manipulation of the recited steps, only the structure implied by the steps. In the instant case, the cell line of U.S. Co-pending App ‘740 is a malignantly transformed cell line of human keratinocytes and therefore meets the structural requirements of instant claims.
Regarding claims 8-9, although U.S. Co-pending App ‘740 does not claim an intended use of “a cell model in the study of carcinogenic mechanism of dimethylmonothioarsinic acid” (instant claim 8), or the intended use of “screening or evaluating drugs for the treatment of cancers caused by inorganic arsenic” (instant claim 9), the cell line of U.S. Co-pending App ‘740 meets the structural requirements of instant claims, and is therefore capable of meeting the claimed intended uses.
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Conclusion
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
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632