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 .
Claims 1-14 are pending as amended 6/28/24, and are considered herein.
Formalities:
The drawings of 6/28/24 are accepted.
The specification as amended 6/28/24 is accepted.
The IDS and references therein of 6/28/24 have been considered. Attached is a signed copy of the same IDS.
Applicant’s priority is noted to be:
The present Application is a 371 of PCT/EP2022/087998, filed 12/29/2022, which claims priority to NL 2030378, filed 12/31/2021 and EP 22173305.8, filed 5/13/2022.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 3 states when the applied force is a force ramp (which is required to be a force ramp in Claim 2, anyway), the different forces applied as first, second, and optional more, including providing each force ramp a loading rate and an end force. However, if it starts at a first force and ends at a second, third, or whatever force, and it is a force ramp, the loading rate and end force is necessarily present. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 4 limits the applied force (to the cells in Claim 1) to being acoustic, shear flow, or centrifugal. These are the only options. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 6 requires the force selection to be chosen from a predetermined rate and end force, or a predetermined rate and a lower end force. However, the step is mental and not measurable, and the scope of forces and rate of change remain the same. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim 7 recites “preferably a glass surface in a chip”. Because the specification does not define the embodiments where it is preferable, the scope is not clear.
Claim 10 is objected to because of the following informalities: Claim 10 recites “after the step of applying the force the presence of a marker …”. As the latter portion is an action, it is appropriate to separate it with a comma, i.e., “after the step of applying the force, the presence of a marker …”. Appropriate correction is required.
Double Patenting, Non-Statutory
It is noted for the record that Applications 18/725,340; 18/863,877; 18/863,913; and 18/863,923 were considered for NSDP rejections, but for the similar reasoning as the written description rejection below, the Artisan would not have made the invention.
Claim Rejections - 35 USC § 112
Claims 2, 5, and 10-11 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 2 recites “preferably a linear force ramp”. Because the specification does not list the embodiments that are preferably a linear force ramp, the claim is not clear for its metes and bounds.
Claim 5 recites “the control cells and of the cells of interest”, in Claim 1. It is not clear what applicant is claiming. Is applicant claiming the control cells of the cells of interest, the cells of interest, or both?
Claim 10 recites “the presence of a marker … is determined”. The scope is not clear. Is this simply a mental process, i.e., a declaration that a marker is present, or is there a required physical manipulation to ascertain if such marker is present? Applicant needs to provide a mechanism to determine the presence of such.
Claim 11 is not clear for the same reasoning as Claim 10, as if you simply declare it is present, it makes no sense that a cellular avidity can be determined.
Claim Rejections - 35 USC § 112
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.
Claims 13-14 are 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 13 requires the target cells are “optionally attached to a surface”. However, Claim 1, from which it depends requires the target cells are “attached to a surface”. Thus, Claim 13 contains a scope which is larger than that of Claim 1. 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.
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.
Claims 1-14 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are generic for “agent(s) capable of modulating the cellular avidity between the cell of interest and the target cell” (e.g., Claim 1).
The specification describes identifying candidate agents capable of modulating the cellular avidity between a cell of interest and a target cell (p. 23, paragraph 2). This is basically a screen for finding agents that increase/decrease binding avidity between the cells. However, Claim 1 is not a screen for identifying these agents, but selecting or sorting cells of interest. Thus, the agent needs to be described for the Artisan to know what is to be used. Also, in the same paragraph (p. 23, paragraph 2), it is described that “in case agents are present that are known to modulate a desired interaction between a cell of interest and a target cell, receptor/ligand interactions may be selected that are not affected by such agents, or conversely, are aided by such agents.” However, no single agent is described for any cell-cell interaction.
The art recognizes that almost every compound affects the chemical potential of the interactions between the cells, at some level. For example, simple salt concentrations can alter the avidity of protein-protein interactions (e.g., Chen, et al. (2020) “Investigation of the effect of salt additives in Protein L affinity chromatography for the purification of tandem single-chain variable fragment bispecific antibodies”, MABS, 12(1): e1718440 (10 pages), e.g., ABSTRACT).
Given that any compound can have an influence on the interaction of chemical binding, and Applicants generic description without any examples, the Artisan would not have understood Applicant to have been in possession of the invention as presently claimed.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638