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 .
DETAILED ACTION
Status of Claims
Claims 1-9 are pending and the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Claim Rejection - 35 USC § 112- Indefiniteness
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.
Claims 4 and 9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The metes and bounds of claim 4 are unclear because Applicants use the term “namely,” which creates confusion whether the limitation that follows is required or not. Claim 4 states “The method according to claim 1, wherein said immunoglobulins are clonal, namely cancerous.”
In claim 9, the following phrase is confusing: “mapping of proteolytic peptides from serum and/or urine proteins in a urine sample.” The specification simply never explains what this means. Specifically, mapping what exactly? And how is this mapped? Moreover, how are the “immunoglobulin heavy and/or light chains” used to perform this “mapping”? Although it is known that proteolytic peptides can cleave immunoglobins, yet this simple fact says nothing about techniques to “map[] [] proteolytic peptides.” Neither the claims nor the specification provide any detail. A skilled artisan is left to guess what this means, much less what it encompasses.
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)Novelty; Prior Art.—A person shall be entitled to a patent unless—
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 8-9 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by LOONEY (US20230212689, effective filing 07/06/2021).
As to claim 1, LOONEY teaches a method for identification of a whole sequence of a variable region of a heavy and/or light chain of one or more isotypes of immunoglobulin in a biological sample, comprising the following steps:
i) extracting intact RNA from said biological sample (Fig. 1);
ii) conducting reverse transcription of RNA obtained in step i) and circularization of ds cDNA thus obtained (Fig. 1);
iii) conducting two-step reverse PCR with high-fidelity DNA polymerase for amplification with primer pairs directed against a constant region of the circularized ds cDNA transcribed by genes of said one or more immunoglobulin light and/or heavy chain isotypes (Figs. 1 & 7 in view of paras. 0109, 0208, 0274, 0382 & 0387 describing analyzing immunoglobulin constant regions);
iv) sequencing of DNA single molecules in real time1 in order to obtain a complete sequence of the variable region of one or more isotypes of the heavy and/or light chains of the immunoglobulins present in the biological sample (para. 0373- “A variety of suitable sequencing platforms are available for implementing methods disclosed herein (e.g., for performing the sequencing reaction)” such as “SMRT (single-molecule real-time sequencing)”).
As to claim 2, LOONEY teaches a step v) for classification of the isotypes identified in step iv) based on their relative quantity (paras. 0011, 0102, 0117, 0176-77, 0376 for example).
As to claim 3, LOONEY teaches isotypes are α, γ, μ, δ, ε, κ and λ (paras. 0098, 0217, for example).
As to claim 4, LOONEY teaches said immunoglobulins are clonal (paras. 0016, 0377, 0382, 0387, for example).
As to claim 5, LOONEY teaches biological sample derives from a patient affected by monoclonal gammopathy (multiple myeloma; para. 0091, for example).
As to claim 6, LOONEY teaches monoclonal gammopathy is selected from the group consisting of multiple myeloma, Waldenström's macroglobulinemia, and monoclonal gammopathy of clinical significance (MGCS) or undetermined significance (MGUS) (id.).
As to claim 8, LOONEY teaches biological sample is peripheral blood (para. 0075, for example).
As to claim 9, LOONEY teaches a verification step vi) wherein a list of immunoglobulin heavy and/or light chains obtained from the analysis according to steps i)-v) is used for a mapping of proteolytic peptides from serum and/or urine proteins in a urine sample (paras. 0047, 0074-75, 0374-75, describing determining peptidases in serum or urine samples).
Claim Objection/Allowable Subject Matter
Claim 7 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The primers of claim 7 are unknown in the art, nor suggested.
Prior Art
The following prior art is also pertinent: US 20230287515; US 20120328612; US 20170342405; WO1996015238; WO2010094040; US 20100151470; art cited in IPRP 01/18/2024.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/ Primary Examiner, Art Unit 1681
1 This is interpreted to mean Pacific Bioscience SMRT sequencing using zero mode waveguides.
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