DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group IV, claim 25, in the reply filed on 12 June 2026 is acknowledged. The traversal is on the ground(s) that the groups listed do not lack unity, and the subject matter of the claims is interrelated to the extent that a search and examination of the subject matter of those claims in the same application would not be over burdensome.
This is not found persuasive, because Applicant has not presented arguments relating to the lack of special technical feature. Additionally, while a lack of burdensome search does not negate the lack of a special technical feature in a Lack of Unity restriction requirement, it is further noted that the groups have acquired a separate status in the art in view of their different classifications, their recognized divergent subject matter, and the groups require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-6, 8-10, 14, 15, 19, 23, 24, and 26-28 have been withdrawn. Claim 25 is currently pending and under examination.
Priority
This application claims priority to International Application No. PCT/EP2022/076456, filed September 22, 2022; and claims priority to U.K. Patent Application No. 2404177.4, filed March 22, 2024, U.K. Patent Application No. 2210102.6, filed July 9, 2022, and U.K. Patent Application No. 2113747.6, filed September 27, 2021.
However, a cell line having ECACC Accession No. 24032101 was first presented in the amended claims of U.S. Application No. 18/695770, filed on March 26, 2024. It appears that the deposited cell line is PLTA58, which was first recited in U.K. Patent Application No. 2210102.6, filed July 9, 2022.
It is additionally noted that priority documents for U.K. Patent Application No. 2404177.4, filed March 22, 2024, have not been provided.
Claim Rejections - 35 USC § 112
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.
Claim 25 is 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 claims contain 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.
The invention appears to employ novel biological materials, specifically the cell line having ECACC Accession No. 24032101. Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials 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. 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 C.F.R. §§ 1.801-1.809, Applicant 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 test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Claim 25 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 25 recites a “cell line deposited under ECACC Accession No. 24032101.” This claim is indefinite, because no cell line deposited under ECACC Accession No. 24032101 is recited in the specification, and no deposit information is provided. It is unclear if this cell line is PLTA58 cells that have been deposited, or instead is a different cell line. For the purposes of examination, this limitation is deemed to refer to PLTA58 pig macrophage cells.
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.
Claim 25 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim recites a cell line deposited under ECACC Accession No. 24032101. This judicial exception is not integrated into a practical application because only a cell line is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the cell line with ECACC Accession No. 24032101, is claimed.
The cell line as claimed in claim 25 is a composition of matter.
Claim 25 encompasses a cell line deposited under ECACC Accession No. 24032101. Thus, claim 25 is generally directed to a cell line. While this deposited cell line is not specifically recited in the specification, cell lines recited include non-transformed pig macrophage cell lines, including PLTA58 (p. 4, line 4-36; p. 6, line 15-27). Thus, it appears that the cell line deposited under ECACC Accession No. 24032101 is a natural cell line. As such, the cell line of claim 25, which includes only the cell line deposited under ECACC Accession No. 24032101, is deemed to be a natural product.
Additionally, claim 25 does not recite any elements in addition to the cell line deposited under ECACC Accession No. 24032101. As such, there is no additional element in claim 25 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the natural cell line deposited under ECACC Accession No. 24032101, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Further, claim 25 does not recite any elements in addition to the cell line deposited under ECACC Accession No. 24032101. As such, the claim does not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
For the forgoing reasons, the cell line as claimed is not deemed to encompass patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim 25 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fejer et al. (IDS; WO 2014/012933; Published 2014).
With regard to claim 25, Fejer et al. teach a cell line comprising continuously replicating, non-transformed pig macrophage cells (Abs.; claims 1, 5).
Fejer et al. do not teach that the cell line is specifically the cell line deposited under ECACC Accession No. 24032101 or is cells named PLTA58. However, as Fejer et al. teach a cell line comprising continuously replicating, non-transformed pig macrophages, which are likewise produced by culturing a cell preparation from an organ obtained from a pig in culture medium to which GM-CSF has been added thereby differentiating the cell population into self-renewing, non-transformed macrophages, and are usable for in vitro development of treatments (Abs.; claim 1, 5; see also instant Specification, p. 1, line 4-6, line 15-17), the pig macrophage cells of Fejer et al. are deemed to be the cell line as claimed.
Alternatively, it would have been obvious to one of ordinary skill in the art from the teachings of Fejer et al. to provide and utilize an alternative cell line comprising continuously replicating, non-transformed pig macrophages. The use of an alternative cell line comprising pig macrophages amounts to the simple substitution of one known cell line for another, and would have been expected to predictably and successfully provide such a cell line for in vitro development of treatments.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm 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, Sharmila G. Landau can be reached at (571)272-0614. 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.
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
Prosecution Insights