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/Restrictions
Claims 1-2 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected a prostate cancer monitoring reagent, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/29/2026.
Applicant's election with traverse of claims 3-5 in the reply filed on 7/29/26 is acknowledged. The traversal is on the ground(s) that Group 1 and 2 constitute a special technical feature over Chen in view of Li . This is not found persuasive because it would be obvious to one of ordinary skill in the art to use the reagent taught by Chen and modify it with Li because Li teaches a method of protein glycosylation which is known to be correlated with various diseases such as cancer (para n0003).
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “incubated for 1~6 h” in “step 1”. The “~” should be a hyphen to clarify a range of time between 1-6 h.
Appropriate correction is required.
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.
Claim 3 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 3 is narrative in form and replete with indefinite language. The claim must be in one sentence form only. Please note the format of claims in related US Patents.
Claims 3-5 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 3 recites the limitation "the inactivated 2uL serum sample" in step 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is being interpreted “an inactivated 2uL serum sample” corresponding to a test sample from prostate cancer patients or health patients (Specification, pg 4, Section: Methods and materials).
Claim 3 recites the limitation "the liquid" in step 2 and 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is being interpreted as a liquid mixture obtained in step 1 (Specification, pg 5).
Claim 3 recites the limitation "the analyzer" in step 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is being interpreted as a capillary electrophoresis analyzer (Specification, pg 6, Section: Methods and materials).
Claim 3 recites the limitation "the spectrum" in step 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is being interpreted as a spectrum from the capillary electrophoresis analyzer (Specification, pg 6, Section: Methods and materials).
Claim 5 recites the limitation "the fluorescent label". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is being interpreted as Reagent C (Specification, pg 3).
Claim 4 is rejected as being dependent on claim 3.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO 2018157832 A1) as cited in the previous office action filed on 07/24/2026, and further in view of non-patent literature "Glycosylation-Based Serum Biomarkers for Cancer Diagnostics and Prognostics" by Kirwan et al and non-patent literature "LC-MS determination of glycosylation pattern on glycoproteins as critical quality attribute for biopharmaceuticals and potential markers for diseases" by Zhang.
Regarding claim 3, Chen teaches a method for detecting changes in the glycosidic content of blood glycoprotein linked to oligosaccharides (pg 5, para 0009). Chen further teaches
Step 1 Preparation of oligosaccharide: 3uL of reagent A (‘10mM ammonium bicarbonate with 5% SDS’, pg 5, para 0011) was added to the inactivated 3uL serum sample (pg 5, para 0018), denatured, cooled to room temperature, added 3uL of reagent B, and incubated for 1-6 h (‘react at 37°C for 4 hours’) (pg 5, para 0018);
Step 2 Labeling of oligosaccharide: 4 uL of reagent C (‘20mM APTS in DMSO’) was added to the liquid obtained in step 1 for fluorescence labeling, and then 100 uL of reagent D (‘water’) was added to terminate the labeling reaction (pg 5, para 0019-0020);
Step 3 Oligosaccharide separation analysis: Take 10 uL of the liquid treated in step 2, use the analyzer (‘ABI sequencer’) to separate the oligosaccharide, and get the spectrum (pg 5, para 0021).
Chen teaches this method of for detecting changes in the glycosidic content blood glycoprotein linked to oligosaccharides for gastric cancer (pg 5, para 0009). Chen does not teach the method for preparing prostate cancer detection reagent.
However, Kirwan teaches that specific cancer associated carbohydrate alterations can be detected using the separation of oligosaccharides release from glycoproteins using capillary electrophoresis (pg 3, Section: Introduction). Kirwan further teaches using serum glycosylation as a potential diagnostic biomarkers in gastric cancer (pg 10, Subsection: 4.2 Gastric Cancer). Kirwan further teaches using serum glycosylation as a potential diagnostic biomarkers in prostate cancer (pg 11, Subsection: 4.7 Prostate Cancer). Thus, it would be obvious to modify the method taught by Chen with a method for preparing prostate cancer detection reagent as taught by Kirwan for the benefit of detecting various cancers in serum samples.
Chen further teaches the enzyme that can act on N-linked glycans to be glycoside exonuclease for gastric cancer detection. Chen further teaches use a reagent to remove the sialic acid from the sample (pg 5, para 0020). Chen in view of Kirwan does not teach the enzyme that can act on N-linked glycan to be glycoamidase for prostate cancer detection and use sialidase to remove the sialic acid from the sample.
However, Zhang teaches that glycosylation patterns were link with specific disease and glycoprotein play crucial roles in the clinical discovery for glycan-based biomarkers for detecting disease. Glycoproteins have higher chances to serve a disease marker especially for biomarkers because glycosylation is a non-template based synthetic process with a series of enzymatic pathways (pg 17-18, Section: 1.2.4 Glycoproteins in disease biomarker discovery). Zhang further teaches various enzymes such as glycoamidases, endoglycosidases and exoglycosidases are used for removal of glycan from glycoproteins (pg 37, Section: 1.3.2.1 Enzyme strategy). Zhang further teaches Sialidase is used for removal of terminal sialic acid with all types of linkages (pg 37, Section: 1.3.2.1 Enzyme strategy). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Chen and Kirwan with the enzyme that can act on N-linked glycan to be glycoamidase as taught by Zhang for the benefit of removing glycans from glycoproteins (pg 37, Section: 1.3.2.1 Enzyme strategy). Furthermore, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Chen and Kirwan with using sialidase to remove the sialic acid from the sample as taught by Zhang for the benefit of converting negatively charges glycan to neutral glycans (pg 37, Section: 1.3.2.1 Enzyme strategy).
Regarding claim 4, Chen in view of Kirwan teaches the invention of claim 5. Chen further teaches the denaturation temperature in preparation of oligosaccharide in step 1 is not less than 75°C heating (‘95°C’, pg 5, para 0022), and the incubation temperature is not less than 25°C (‘37°C’, pg 5, para 0018).
Regarding claim 5, Chen in view of Kirwan teaches the invention of claim 5. Chen further teaches the temperature of the fluorescent label in step 2 is 50~90 0C (’60-70°C’, pg 5, para 0023).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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, Charles Capozzi can be reached at (571) 270-3638. 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.
/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights