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 .
Election/Restriction Requirement
Applicant’s election of Group III, claims 71-73, without traverse in the reply filed on 10/22/25 is acknowledged. Claims 1-3, 5, 8, 9, 13-15, 17, 18, 25, 38, 41, 47, 48, 49, 54, 55, 59, 62, and 65 are withdrawn.
Claim Interpretation
Claim 73 has a wherein clause that optionally limit the lysophospholipid GPCR to LPA receptor or S1P receptor. MPEP 2111.04 state:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed.
MPEP 2143.03 state:
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation.
Considering this guidance, these optional limitations do not further limit the claims.
Claim Rejections - 35 USC § 112
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 72 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.
The phrase “the GPCR signaling pathway is considered abnormally active when the signaling pathway is ultra sensitive to the agonist”. The limitation “ultra sensitive to the agonist” reads as a relative term. The Specification does not provide a threshold where the measuments of the pathway become ultra sensitive. It is unclear what values this term encompasses.
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.
Claim(s) 71-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. US 2017/0343554 (in IDS 9/21/22 #57) in light of support by Sun et al. (Cell Signal, 2010).
Sullivan et al. teach a method of measuring the signaling pathway with the following method:
Obtaining a viable cell sample from a subject diagnosed with a disease associated with abnormal signaling pathway [0010-0011]. This disease includes cancer [0019];
Culturing the viable cell sample in media [0012-0013];
Contacting the cell sample with a perturbing agent know to selectively affect the signaling pathway associated with the disease and either upregulate or downregulate the cell adhesion or attachment when compared to cells not contacted with the perturbing agent [0013];
Continuously measure the cell adhesion or attachment of the cells contacted with the perturbing agent [0014];
Determining by mathematically analysis of the continuous measuments the amount of change in the cell adhesion or attachment occurring in the cells contacted with the perturbing agent [0015] compared to a suitable control [0018];
The subject is diagnosed for a disease associated with an abnormal signaling pathway when the measurement is greater than (e.g. abnormally active or sensitive) a cut-off value derived from a normal reference for the signaling pathway activity [0016-0018].
They teach the perturbing agent is known to agonize the cellular pathway [0308]. They teach agents specific for GPCR which include the agonists dopamine, 5-HT, [Table 6] or lysophosphatidic acid [Table 12]. They teach that the perturbing agents can be applied to portions of the sample [0040]. In an alternative embodiment they teach the cell adhesion measurement can be between 1) a portion of cells exposed to the perturbing agent and 2) an unperturbed portion of cells [0046]. Considering this embodiment, it would be obvious for one of ordinary skill in the art to apply the perturbing agent in step c) to a portion of cells in the sample and then continuously measure the cell adhesion (step d) against an unperturbed portion of cells. This would mean that the measurement can be performed on a single cell sample, which simplifies the method by not requiring a separate control sample. Also if one portion is exposed to a perturbing agent while the control is not exposed, then this control is exposed to a lower concentration of agonist than the perturbed portion.
Since one of the perturbing agents is lysophosphatic acid for the NF-κB pathway (Table 12). Then this lysophosphatic acid is an agonist for the GPCRs called LPA1, LPA2, and LPA3 in the NF-κB pathway as supported by Sun et al. (see Introduction, 1st paragraph and Figure 1). Since these LPA-CPCRs activate the NF-κB pathway then the method of Sullivan et al. will also detect abnormally active GPCR in the NF-κB pathway when lysophosphatic acid is the perturbing agent.
While Sullivan et al. does not expressly teach all the claim limitations in a single embodiment, it would be obvious for one of ordinary skill in the art to perform the claimed method after reviewing the entire disclosure. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699