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 .
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 5-6 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.
These claims include (e.g.) which renders the claim indefinite.
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 person shall be entitled to a patent unless –
(a)(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.
Claims 1-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang “In situ imagining of tissue remodeling with collagen hybridizing peptides” American chemical society, 11:9825-9835 (2017).
Regarding claim 1, Hwang discloses a method of measuring a total collagen content in a sample, comprising denaturing collagen in the sample by heat or antigen retrieval to produce a denatured sample (prior to staining pathologic tissues with CHPs, ligament cryosections are heated to 80c to purposefully denature collagen in the sample; abstract, page 9826, second column, second and fourth paragraph; page 9827 first column first paragraph),
contacting labeled collagen hybridizing peptides (CHPs) to the denatured collagen (fluorescein labeled collagen hybridizing peptides F-CHP are added to the heat-denatured collagen sample wherein F-CHP binds to the heat denatured collagen, page 9826, second column second and fourth paragraph, page 827, first column, first paragraph), and
measuring a signal from the labeled CHPs to determine the total collagen content in the sample (measurement of the fluorescence signal of F-CHP bound to the heat denatured collagen (total collagen content); abstract, page 9826, second column, second and fourth paragraph, page 9827, first column, first paragraph).
Regarding claim 2, the method according to claim 1, wherein the denaturing comprises heating the sample at a temperature from 60 °C to 160 °C (80c is disclosed above).
Regarding claim 3, the method according to claim 1, further comprising contacting labeled collagen hybridizing peptides (CHPs) to the sample without prior to denaturing collagen, and measuring a signal from the labeled CHPs to determine the total denatured collagen content in the sample (without prior to denaturing collagen, abstract, page 9826, heading results and discussion).
Regarding claim 4, the method according to claim 1, the CHPs are labeled with fluorescent or biotin dyes (see claim 1 rejection above, fluorescent dyes).
Regarding claim 5, the method according to claim 1, wherein the sample is a solution (e.g., homogenizing tissue sample, ECM, etc) (the sample is a solution, abstract; staining solution is added).
Regarding claim 6, the method according to claim 1, wherein the sample is a tissue section (e.g., bone section) (a tissue sample is extracted and examined, abstract, Results and discussion).
Regarding claim 7, the method according to claim 1, wherein the sample is an artificial tissue section (Results and discussion, tissue sample).
Regarding claim 8, the method according to claim 6, wherein the tissue section has a thickness of at least 1-100 um (results and discussion).
Regarding claim 9. (currently amended): The method according to claim 1, wherein each of the labeled CHPs comprises a sequence represented by Formula I (SEQ ID NO: 352): L-Sm-(GIy-X-Y)20 (Formula I) in which L is one or more detectable moieties; S is a spacer molecule and m is an integer from 0 to 10; Gly is glycine; and at least one of X and Y is proline, modified proline, and/or hydroxyproline (page 9867 right column top).
Regarding claim 10, the method according to claim 1, wherein each of the CHPs comprises the sequence of any one of SEQ ID NOs: 1-118 (page 9832 left column).
Regarding claim 11, the method according to claim 1, wherein the sample is from a patient with liver fibrosis (abstract).
Regarding claim 12, the method according to claim 1, wherein the method excludes trypsin-hydroxyproline assay (the assay is not disclosed as being used).
Regarding claim 13, the method according to claim 1, wherein the method excludes picrosirius red with polarized light (fluorescence is used).
Regarding claim 14, the method according to claim 1 wherein the method takes less than three days (page 9827 right column).
Regarding claim 15, the method according to claim 1, wherein the method takes less than two days (page 9827 right column).
Regarding claim 16, Hwang discloses a method of determining presence or progression of a condition in a patient, comprising
detecting total collagen content in a sample from the patient by the method according to claim 1 (See rejection of claim 1 above), wherein the condition is one or more selected from the group consisting of fibrosis (Abstract), wound healing, idiopathic pulmonary fibrosis (IPF), aged skin, liver fibrosis, nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), alcoholic fatty liver disease (AFLD), kidney fibrosis, myocardial infarction (MI), age-related macular degeneration (AMD), osteoarthritis (OA), and keratoconus.
Regarding claim 17, the method according to claim 16, wherein the total collagen content and the damaged collagen content are combined as a ratio for an objective measure of damaged collagen that is normalized to the specific sample group (Results and discussion, measured damage via fluorescence).
Regarding claim 18, the method according to claim 17, wherein the ratio is used as predictive biomarker of progression or resolution in a diseased state (progression tissue development is monitored with the method).
Regarding claim 19, the method according to claim 16, wherein the condition is liver fibrosis (abstract), nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD) or alcoholic fatty liver disease (AFLD).
Regarding claim 20, the method according to claim 16, further comprising detecting total collagen content in another sample from the patient (fig. 3, total CHP fluorescence signal is measured in each group).
Regarding claim 21, the method according to claim 16, further comprising detecting non-triple helical collagen in another sample from the patient by contacting the labeled CHPs to the non-triple helical collagen (results and discussion).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday, Tuesday, Thursday, Friday, 8-6.
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 at 571-270-7698. 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.
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
Prosecution Insights