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 14-31 are pending.
Claims 16-17 and 19-31 are withdrawn.
Claims 14-15 and 18 are under examination.
Election/Restrictions
Applicant’s election without traverse of the following invention
Invention
Group I, claims 14-15 and 18, drawn to human non-small cell lung carcinoma cell line LDI- 0025-200717, deposited under CCTCC No. C2020103, and a kit comprising the cell line of claim 14.
in the reply filed on 7th, November, 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-17 and 19-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Objection to Abstract
The abstract is objected to because it contains legal phraseology (“said” line 7).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Objections to Specification
Browser-executable Code
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg. 2) . Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Objection to Drawings
Sequence Compliance
The Drawings are objected to because they does not conform to sequence rules, requiring the use of “SEQ ID NO:” (37 CFR 1.821-1.825) (see also MPEP 2422.01)
Figures 2A and 2B contain sequences which are not labeled with a corresponding sequence identifier. The sequences at issue are labeled below for reference.
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Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. 37 CFR 1.821 (d).
The applicant is reminded that the claims and specification must be amended in order to comply with regulations cited above. All references to sequences in claims and specification should be referred to as “SEQ ID NO:1”, for example. To avoid all doubts of the examiner and to ensure correct interpretation of the claims and specification, the identification of sequences with proper sequence identifiers is required.
Objection to Drawings
Drawings Quality
The Drawings are also objected to due to poor quality. Not all the features of the drawings are decipherable.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 uses the abbreviation “CCTCC”, which has not been spelled out upon first use. Although claims are allowed abbreviations, if an abbreviation is not spelled out upon first use in a claim, MPEP §2429 states that Applicant only use abbreviations that are specifically defined in "WIPO Standard ST.25 (2009)” or that are well known and would be clear to someone who had not read the invention description.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 14-15 and 18 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.
Instant claims require “Human non-small cell lung carcinoma cell line LDI-0025-200717, deposited under CCTCC No. C2020103.”
Since the human non-small cell lung carcinoma cell line 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 Human non-small cell lung carcinoma cell line is not so obtainable or available, the requirements of 35 USC 112 may be satisfied by a deposit of the human non-small cell lung carcinoma cell line that can be used to make the cells, 37 CFR 1.802.
The specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed cell line (“CCTCC No. C2020103”; instant claim 14) 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.
Regarding (1), because a search of the CCTCC databases did not return any results for No. C2020103, 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 does describe the method of obtaining LD1-0025-200717 (Example 1; pg. 13-14), which appears to be the same as the CCTCC No. C2020103 line, the methods are not reproducible because the cell line “was established from biopsy sample obtained from patient who received a diagnosis of NSCLC and became resistant to Osimertinib(AZD9291)” and furthermore the specific patient was an “EGFR triple-mutant (19del/T790M/C797S).” The specification further evidences the development of the mutations in the patient (pg. 13) and evidences “The influence of the treatment history could not be mimicked by any other artificial models.” Furthermore, it is unclear whether the mutations in question arose from the treatment regimen or were coincidental in the patient. Without access to this specific patient which has a specific genetic makeup with specific mutations and underwent a treatment regimen that may or may not have had an effect on the cells, the cells cannot be made and additionally even with access to the exact patient used by Applicant, a cell-line established from a different cell than that of the examples would be different line.
Therefore, regarding (2), one of ordinary skill would not be able to reproduce the cell line from the written description.
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 human non-small cell lung carcinoma cell line has been deposited under the Budapest Treaty and that the Human non-small cell lung carcinoma cell line, 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 (CCTCC No. C2020103”; instant claim 14). However, as stated above, this deposit number cannot be found upon search at CCTCC.
Regarding 37 C.F.R. § 1.809(d) (2), Applicant discloses the date of the deposit (3rd, June, 2020, pg. 6 and pg. 7).
Regarding 37 C.F.R. § 1.809(d) (3), Although Applicant discloses the cells are “Human non-small cell lung carcinoma cell line” (claim 14), and Applicant discloses the cells are triple mutant triple-mutant (19del/T790M/C797S) (Example 1) this is not sufficient to specifically identify the cells and permit examination because it is not apparent whether the cell line of CCTCC No. C2020103 has additional structural requirements as it is derived from a specific patient tumor with a specific genetic makeup that has undergone a specific treatment regimen.
Regarding the Budapest Treaty, it is not clear under what conditions the deposit was made; there is no indication that the deposit was made under the Budapest Treaty. 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 strains have been deposited under the Budapest Treaty and that the deposited material 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.
Therefore, because the claimed cell line 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, and it because it is unclear whether the deposit was made under the Budapest Treaty, the specification fails to provide an enabling disclosure.
Claim Rejections - 35 USC § 112(b)
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 15 is 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 15 recites “comprises the EGFR mutations in Exon 20.” However, claim 14 upon which claim 15 depends, does not recite “EGFR mutations in Exon 20.” Therefore, it is unclear what the scope of “the EGFR mutations in Exon 20” encompasses and there is improper antecedent basis for this term.
Claim 15 recites the mutations “T790M,” “C797S,” and “746_750del” which appear to refer to mutations in amino acid sequences of EGFR. However, there are multiple variants in amino acid sequences of EGFR. A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). In the instant case “T790M,” “C797S,” and “746_750del” are dependent on amino acid positions in an EGF amino acid sequence which is not sufficiently defined (see MPEP 2173.05(b)).
Claim 15 recites “the cell line of claim 14, which comprises the EGFR mutations in Exon 20 encoding T790M and C797S as well as Exon 19 deletion 746_750del.” Claim 14, upon which claim 15 depends, recites the cell line is “LDI-0025-200717, deposited under CCTCC No. C2020103.” The instant specification appears to evidence that the hNSCLC cell line LD1-0025-200717 has “EGFR mutations in Exon 20 encoding T790M, C797S and the Exon 19 deletion 746_750de1 ("19 deletion")” (pg. 3, 6, 13 and 17). Therefore, it is unclear whether claim 15 further limits claim 14 because the recited mutations already appear to be required by the cell line LDI-0025-200717 recited in claim 14.
Claim 15 recites “Exon 19 deletion 746_750del.” However, 746_750del describes the deletion of the protein product, not the deletion in Exon 19. Therefore, it is unclear what the scope of the “Exon 19 deletion 746_750del” encompasses.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 recites “the cell line of claim 14, which comprises the EGFR mutations in Exon 20 encoding T790M and C797S as well as Exon 19 deletion 746_750del.” Claim 14, upon which claim 15 depends, recites the cell line is “LDI-0025-200717, deposited under CCTCC No. C2020103.” The instant specification appears to evidence that the hNSCLC cell line LD1-0025-200717 has “EGFR mutations in Exon 20 encoding T790M, C797S and the Exon 19 deletion 746_750de1 ("19 deletion")”(pg. 3, 6, 13 and 17) and therefore the mutations recited in claim 15 are already a structural requirement of the cell line recited in claim 14, and cannot further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Examiner’s Remark
Instant claims are directed to a human non-small cell lung carcinoma cell line LDI-0025-200717, deposited under CCTCC No. C2020103, which a cell line derived from a human tumor and is a nature-based product.
Although the cell line is derived from a human tumor, it is not a judicial exception because the C797S mutation is an acquired mutation in response to EGFR TKIs such as Osimertinib and omulitinib.
Specifically, the instant specification evidences the cell line LDI-0025-200717, deposited under CCTCC No. C2020103 comprises “the EGFR mutations in Exon 20 encoding T790M and C797S and the Exon 19 deletion 746_750del” (pg. 9). This cell line appears to be derived from a patient tumor sample (see Example 1; pg. 14). However, Applicant’s specification indicates the C797S mutation appears to occur in response to treatment regimen (see pg. 13 last para.) and it not naturally occurring.
Applicant is additionally directed to the art of Lee et al. (J Thorac Oncol. 2017 Nov;12(11):e179-e181.; henceforth “Lee”). Lee evidences the C797S mutation altering the compound contact site has been presented as an acquired resistant mutation against third-generation EGFR TKIs such as Osimertinib and omulitinib (pg. e180 col. 1 2nd para.).
It is additionally noted that the art of Lee evidences the C797S mutation can occur naturally in a human non-small cell carcinoma (“This is the first case report of de novo C797S mutation detected incidentally in the early stage before exposure to EGFR TKIs”; pg. e180 col. 1). However, because Lee is silent to whether the patient with the de novo C797S mutation also has the mutations in Exon 20 encoding T790M and the Exon 19 deletion 746_750del, the claimed cell line, which requires the structural elements of these three specific mutations, does not appear to be a product of nature exception.
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 14-15 and 18 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 14, Applicant claims the cell line is “deposited under CCTCC No. C2020103.” The instant specification evidences “Human NSCLC cell line of the present invention, LD1-0025-200717, deposited with China Center for Type Culture Collection (CCTCC) under CCTCC No. C2020103 on June 3, 2020. Address: Wuhan University, Wuhan, China, 430072.” (pg. 6 and pg. 7). The date cited by Applicant pre-dates the filing date of PCTCN2020094778 filed on 5th, June, 2020, which is the earliest priority date claimed by Applicant. Therefore, the claimed invention, which is CCTCC No. C2020103, was publicly available before the effective filing date of the claimed invention.
Applicant is directed to MPEP 2152.02 for information on Prior Art Under AIA 35 U.S.C. 102(a)(1) that falls under “in Public Use, on Sale, or Otherwise Available to the Public.” Specifically, Applicant is directed to MPEP 2152.02 (e) which states that even if a document or other disclosure is not a printed publication, or a transaction is not a sale, either may be prior art under the "otherwise available to the public" provision of AIA 35 U.S.C. 102(a)(1), provided that the claimed invention is made sufficiently available to the public. In the instant case, because the China Center for Type Culture Collection (CCTCC) is an international depository authority, with a catalog that can be ordered from, the preponderance of the evidence is that the claimed invention, the cell line of deposited under CCTCC No. C2020103 would have been sufficiently available to the public as of the deposit date of 3rd, June, 2020.
Regarding claim 15, further to the discussion of claim 14 above, the cell line deposited under CCTCC No. C2020103 comprises the EGFR mutations in Exon 20 encoding T790M and C797S as well as Exon 19 deletion 746_750del (see instant specification pg. 7 1st para.).
Regarding clam 18, further to the discussion of claim 14 above, as stated above (see claim 14 rejection above), the cell line deposited under CCTCC No. C2020103 was publicly available prior to the effective filing date of the claimed invention.
Regarding the preamble “a kit” of claim 18, the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). Therefore, because the structural limitation of the cell line of CCTCC No. C2020103 was publicly available this cell line meets the structural limitations of claim 18.
Accordingly, the claimed invention was publicly available.
Examiner’s Remark
As discussed above (see rejection under 35 U.S.C. 112a above), it is unclear whether the deposit of CCTCC No. C2020103 was made under the Budapest Treaty. The instant rejection under 35 U.S.C. 102 due to the public availability of the invention could be overcome by evidence that the deposit was made under the Budapest treaty and was held secret. Furnishing copies of the BP/4 and BP/9 forms as evidence of the Budapest treat deposit, would overcome the rejection under 35 U.S.C. 102 as evidence that the deposit was held in secret and was not publicly available.
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the public availability of the invention in view of Ahern (The Scientist Magazine, 1995 Archive accessed at https://www.the-scientist.com/technology/biochemical-reagents-kits-offer-scientists-good-return-on-investment-58425). The discussion of the public availability of CCTCC No. C2020103 above is hereby incorporated in its entirety.
Regarding claim 18, further to the discussion of claim 15 above, there is no evidence of public availability of a kit comprising the cell line CCTCC No. C2020103.
Nevertheless, regarding claim 18, Ahern teaches preparing kits to allow the product to be readily used in research by other scientists to accelerate the research process and allow them to spend more time on their primary research focus, rather than preparing reagents, (pg. 3-5).
Therefore, regarding claim 18, 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 publicly available cell line CCTCC No. C2020103, and make it into a kit as suggested by Ahern with a reasonable expectation of success. One of ordinary skill would have been motivated to do so as taught by Ahern because making the cell line CCTCC No. C2020103 into a kit would allow the product to be readily used in research by other scientists to accelerate the research process and allow them to spend more time on their primary research focus, rather than preparing reagents, as taught by Ahern (pg. 3-5). Regarding the reasonable expectation of success, Ahern evidences Kits (pg. 3-4).
Hence, the claimed invention as a whole was prima facie obvious.
Pertinent Art
Wang
The prior art of Wang et al. (Cancer Med. 2021 Oct 6;10(23):8328–8337.; see IDS filed 17th, November, 2025; henceforth “Wang”) made of record but not relied upon, is considered pertinent to Applicant’s disclosure.
Wang discloses patient tumors comprising EGFR mutations in Exon 20 encoding T790M and C797S as well as Exon 19 deletion encoding 746_750del (EGFR 19del-T790M-cis-C797S mutations).
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.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632