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
This is the Non-Final Action for application 18/277424 response dated 05/26/2026.
Claims 1, 3-9, 11-14,16-18 are pending and have been fully considered.
Claims 2, 10,15 are cancelled.
Claims 16-18 are newly added.
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, 3-9, 11-14,16-18 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 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.
With respect to Claims 1, 9, & 14 and the claims which depend therefrom, the broadest reasonable interpretation (BRI) for the claim, includes an immunoassay with a monoclonal antibody that binds to residues immediately prior to SEQ ID NO:1 and includes ONLY “G” of SEQ ID NO:1, since the rest of SEQ ID NO:1 is SEQ ID NO:2, which is not recognized by the claimed monoclonal antibody.
An antibody with such property is possible, however the specification does not describe how it is done and therefore lacks written description.
The instant claims directed to an antibody/ies that binds to a specific epitope lack written description. While the term, “antibody,” does impart some structure, the structure that is common to antibodies is generally unrelated to antigen binding function. Further, correlation between structure and function is less likely for antibodies than for other molecules. Therefore, given the highly diverse nature of antibodies, one generally cannot envision the structure of the claimed antibody by knowing its binding characteristics, which is all that is instantly claimed.
While indicating the binding properties of an antibody or antigen it would/could bind was shown by District Court in Amgen F.3d at 1376 to be sufficient, the Federal Circuit remanded the case and noted that one cannot describe an invention by pointing to something else and a method of making the invention.
See the February 22, 2018 memo to the Patent Examining Corps:
https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf
“The Amgen court expressly stated that the so-called ‘newly-characterized antigen’ test…should not be used in determining whether there is adequate written description…for a claim drawn to an antibody.”
Therefore, with respect to written description, the claimed monoclonal antibody is treated like claims reciting any other molecule.
While many antibody claims recite some structure and some function the instant antibody claim/s focus only functions other than very generally reciting that it is a monoclonal antibody, and the functions are the sequence/s it recognizes versus does not recognize.
Instant Claims 1, 9 & 14 (and 17-19) all contain limitations drawn towards a genus of antibodies that bind and don’t bind to specific SEQ ID NO epitopes, and no structure is claimed. As disclosed, one cannot envision the structure of members of the genus. Even though all members of the genus are antibodies and share certain structure that structure is unrelated to the claimed function. Applicant does disclose some specific antibodies including S25206 and S25207 S25210 and some other structure components as shown in specification paragraph 0013-0014, and possibly in paragraph 0018 and paragraphs 0054-0071. Therefore, while it is within the skill of the artisan to make and screen for such antibodies as claimed, one cannot envision their structure. Therefore, the claims do not comply with the written description requirement.
According to MPEP 2163 (II)(A)(3)(a)(ii) which says the written description of a claimed genus may be satisfied through description of:
a representative number of species…or
disclosure of relevant, identifying characteristics…
by functional characteristics coupled with a known or disclosed correlation between function and structure,
and from a review of the above written description of the claimed genus is not satisfied.
Claims 3-8, 11-13,16-18 are also rejected by virtue of being dependent on rejected claims.
Claims 16-18, though specific to a different sequence the monoclonal antibody does not recognize, carries the same issues as above and also lack written description.
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.
Claims 1, 3-9, 11-14,16-18 are rejected under 35 U.S.C. 101 because the claimed invention is drawn towards a product of nature without significantly more.
Step 1: Independent Claims 1 is directed towards a method.
Independent Claim 9 claim is directed towards a kit which only contains an antibody.
Independent Claim 14 is directed towards an antibody.
Step 2A, Prong One: Claims 1, 9, and 14 all contain a monoclonal antibody. While some monoclonal antibodies are manmade IgM and some others are naturally occurring. The instant specification says that the instant monoclonal antibodies can be IgM (paragraph 0013). Therefore, even when claimed that it recognizes one seq ID and not the other, as claimed since no specific actual structure is claimed, this reads on a naturally occurring antibody and therefore a product of nature.
SEE MPEP 2106.04(b).
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application. Nothing further is done.
Step 2B: Claims 1, 9 and 14 do not add significantly more. In claims 9 & 10, nothing further is added. In claim 1, all that is done is contacting with a c-terminal telopeptide, which is also a product of nature itself.
Claims 3-9, 11-14,16-18 recite elements directed towards further limiting the above claims however do not practically apply, add significantly more, or make the claims markedly different from what is found in nature.
With respect to Claims 3-4, labeling substances as generally claimed are WURC so does not add significantly more at step 2B, and also does not practically apply as step 2A/2.
With respect to Claim 5, measuring “signals,” are abstract idea judicial exceptions themselves.
With respect to Claims 6-7, 11-12, the biologic samples claimed are products of nature judicial exceptions themselves.
With respect to Claim 8, 13, applicant claims assay options, however at the level of generality claimed are WURC in the art and also do not practically apply.
With respect to Claims 16-18, claiming further sequence that the antibody doesn’t mind to does not change matters as the specification says the structure can be IgM, which again is still naturally occurring, so a product of nature and part of the claimed judicial exception.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-9, 11-14 & 16-18 are rejected under 35 U.S.C. 103 as being obvious over ROSENQUIST in US 20030148272 in view of SHUBER in US 20120309010 and even further in view of ESSLINGER in US 20180353603.
With respect to Claim 1, ROSENQUIST teaches of a method for measuring type I collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP, so teaching that sequence ID NO :1 in claim 1 can be detected.
ROSENQUIST further teaches that the type I collagen is forming in an organism as C-terminal propetide sequences and that after removal of the propeptide molecules the remaining molecules a terminal telopeptides (C-terminal) (paragraph 0053, 0032, 0068-0069).
ROSENQUIST does not teach of specifically detecting/contacting the C-terminal telopeptides with a monocloncal antibody, and also does not teach of not detecting sequence ID NO: 2, FDFSFLP.
SHUBER teaches of a method for detecting a target nucleic acid and/ or a target protein in a single assay (abstract). SHUBER further teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065). SHUBER does not teach of not recognizing FDFSFLP, but only teaches of SHUBER teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
If it is still unclear that ROSENQUIST and SHUBER teach of not teach of not detecting sequence ID NO: 2, FDFSFLP, ESSLINGER is used to remedy this.
ESSLINGER teaches of a method of using tumor associated antigen binding antibodies (abstract), the antibodies being monoclonal (paragraph 0004, 0015, 0044, 0069). ESSLINGER further teaches that the antibodies or binding fragments thereof bind to the CT antigens of Table 1, which include CSAG1 and CSAG2 (Table 1), and the protein expressed by it(paragraph 0077, 0080). As ROSENQUIST taught of protein/peptide sequence, CSAGFDFSFLPQPPQE (paragraph 0069), and antibody that detects SEQ ID 1, which has a G added to the front of seq 2 but not the sequence ID NO: 2, FDFSFLP, in the instance of ROSENQUSIT would be CSAG1 or CSAG2.
It would have been obvious to one of ordinary skill in the art to use a specific binding antibody as is done in ESSLINGER in the methods of ROSENQUIST and SHUBER due to the advantage this offers in targeting tumor selective antigens (ESSLINGER, paragraph 0004, 0069, 0079-0080, Table 1).
With respect to Claim 3, ROSENQUIST teaches of the antibodies being bound directly or indirectly to a label (paragraph 0068, 0080, 0082).
With respect to Claim 4, ROSENQUIST teaches of the antibodies being bound directly or indirectly to a label can be bound or conjugated to an enzyme (paragraph 0080, 0082).
With respect to Claim 5, ROSENQUIST teaches of the antibodies being bound directly or indirectly to a label can be bound or conjugated to an enzyme and of detecting (meaning there is a signal) from the label (paragraph 0080, 0082, 0084).
With respect to Claim 6, ROSENQUIST teaches of measuring a body fluid sample (paragraph 0057) such as a serum or plasma sample (paragraph 0105, 0112).
With respect to Claim 7, ROSENQUIST teaches of the sample being from a subject with cancer (paragraph 0074), but does not teach of one of the claims cancers nor of metastasis to the bones.
SHUBER is used to remedy this and teaches of the claims as shown above for Claim 1. SHUBER further teaches of detecting cancer with the invention (paragraph 0014, 0025, 0027), and that the cancer can be associated with breast or bone cancer (meaning metastasis if in multiple areas) (paragraph 0030, 0093).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect cancer with the invention/biomarkers as is done in SHUBER in the method of ROSENQUIST due to the fact that the techniques/biomarkers of SHUBER have been found to be especially useful in screening for cancer (SHUBER, paragraph 0014).
With respect to Claim 8, ROSENQUIST teaches of the assay being ELISA (paragraph 0080).
With respect to Claim 9, ROSENQUIST teaches of a kit and method for using kit to measure type I collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP.
ROSENQUIST further teaches of the assay being for C-terminal (teleopeptides) (paragraph 0053, 0032) and that the antibodies and monocloncal antibodies for type I collagen (paragraphs 0068-0069).
Specifically, ROSENQUIST teaches that the kit can contain the monoclonal antibody with sequence CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP (paragraph 0080).
ROSENQUIST does not teach of “not,” recognizing FDFSFLP.
SHUBER is used to remedy this. SHUBER teaches of the instant claims as shown above for Claim 1. SHUBER does not teach of not recognizing FDFSFLP, but only teaches of SHUBER teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides (not recognizing FDFSFLP) using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
If it is still unclear that ROSENQUIST and SHUBER teach of not teach of not detecting sequence ID NO: 2, FDFSFLP, ESSLINGER is used to remedy this.
ESSLINGER teaches of a method of using tumor associated antigen binding antibodies (abstract), the antibodies being monoclonal (paragraph 0004, 0015, 0044, 0069). ESSLINGER further teaches that the antibodies or binding fragments thereof bind to the CT antigens of Table 1, which include CSAG1 and CSAG2 (Table 1), and the protein expressed by it(paragraph 0077, 0080). As ROSENQUIST taught of protein/peptide sequence, CSAGFDFSFLPQPPQE (paragraph 0069), and antibody that detects SEQ ID 1, which has a G added to the front of seq 2 but not the sequence ID NO: 2, FDFSFLP, in the instance of ROSENQUSIT would be CSAG1 or CSAG2.
It would have been obvious to one of ordinary skill in the art to use a specific binding antibody as is done in ESSLINGER in the methods of ROSENQUIST and SHUBER due to the advantage this offers in targeting tumor selective antigens (ESSLINGER, paragraph 0004, 0069, 0079-0080, Table 1).
With respect to Claim 11, ROSENQUIST teaches of measuring a body fluid sample (paragraph 0057) such as a serum or plasma sample (paragraph 0105, 0112).
With respect to Claim 12, ROSENQUIST teaches of the sample being from a subject with cancer (paragraph 0074), but does not teach of one of the claims cancers nor of metastasis to the bones.
SHUBER is used to remedy this and teaches of the claims as shown above for Claim 1. SHUBER further teaches of detecting cancer with the invention (paragraph 0014, 0025, 0027), and that the cancer can be associated with breast or bone cancer (meaning metastasis if in multiple areas) (paragraph 0030, 0093).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect cancer with the invention/biomarkers as is done in SHUBER in the method of ROSENQUIST due to the fact that the techniques/biomarkers of SHUBER have been found to be especially useful in screening for cancer (SHUBER, paragraph 0014).
With respect to Claim 13, ROSENQUIST teaches of the assay being ELISA (paragraph 0080).
With respect to Claim 14, ROSENQUIST teaches of a monoclonal antibody used in a kit and method for measuring type I collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP.
ROSENQUIST further teaches of the assay being for C-terminal (teleopeptides) (paragraph 0053, 0032) and that the antibodies and monocloncal antibodies for type I collagen (paragraphs 0068-0069).
Specifically, ROSENQUIST teaches that the kit can contain the monoclonal antibody with sequence CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP (paragraph 0080).
ROSENQUIST does not teach of “not,” recognizing FDFSFLP.
SHUBER is used to remedy this. SHUBER teaches of the instant claims as shown above for Claim 1. SHUBER does not teach of not recognizing FDFSFLP, but only teache that the biomarker whsich is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides (not recognizing FDFSFLP) using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
If it is still unclear that ROSENQUIST and SHUBER teach of not teach of not detecting sequence ID NO: 2, FDFSFLP, ESSLINGER is used to remedy this.
ESSLINGER teaches of a method of using tumor associated antigen binding antibodies (abstract), the antibodies being monoclonal (paragraph 0004, 0015, 0044, 0069). ESSLINGER further teaches that the antibodies or binding fragments thereof bind to the CT antigens of Table 1, which include CSAG1 and CSAG2 (Table 1), and the protein expressed by it(paragraph 0077, 0080). As ROSENQUIST taught of protein/peptide sequence, CSAGFDFSFLPQPPQE (paragraph 0069), and antibody that detects SEQ ID 1, which has a G added to the front of seq 2 but not the sequence ID NO: 2, FDFSFLP, in the instance of ROSENQUSIT would be CSAG1 or CSAG2.
It would have been obvious to one of ordinary skill in the art to use a specific binding antibody as is done in ESSLINGER in the methods of ROSENQUIST and SHUBER due to the advantage this offers in targeting tumor selective antigens (ESSLINGER, paragraph 0004, 0069, 0079-0080, Table 1).
With respect to Claims 16-18, ROSENQUIST and SHUBER teach of the above, but do not teach of not recognizing the claimed epitope.
ESSLINGER is used to remedy this and teaches of a method of using tumor associated antigen binding antibodies (abstract), the antibodies being monoclonal (paragraph 0004, 0015, 0044, 0069). ESSLINGER further teaches that the antibodies or binding fragments thereof bind to the CT antigens of Table 1, which include CSAG1 and CSAG2 (Table 1), and the protein expressed by it(paragraph 0077, 0080), which would recognize seq id no 1, but also teaches of many other antigen/ protein expressions that the antibody/ies would detect which are not the sequence of sequence 3.
It would have been obvious to one of ordinary skill in the art to use a specific binding antibody as is done in ESSLINGER in the methods of ROSENQUIST and SHUBER due to the advantage this offers in targeting tumor selective antigens (ESSLINGER, paragraph 0004, 0069, 0079-0080, Table 1).
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner notes that a new reference was used in addition to the priorly used references, which changes the basis of the rejection.
A 101 rejection was added to the record as well after further consideration and search into the specification.
Further, after consultation with a SPE in 1600, a written description rejection under 112a was made as well, and this is the reason this office action is a Non-Final.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ROSENQUIST2 in US 20040224375
With respect to Claim 1, ROSENQUIST2 teaches of a method for measuring type II collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST2 further teaches that the antibody can also be used which is reactive with a peptide sequence of the collagen molecule upstream, and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0070), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP.
ROSENQUIST2 further teaches of the assay being for C-telopeptides and that the monocloncal antibodies to C-telopeptides can be monoclonal antibodies prepared for type I collagen (paragraphs 0117-0118).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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, Maris Kessel, can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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