DETAILED ACTION
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
Applicant’s election without traverse of Group I, claims 1-8 in the reply filed on 10/17/25 is acknowledged. Currently, claims 1-9 and 11-12 are pending. Claims 9 and 11-12 are withdrawn as being directed to a non-elected invention. Accordingly, claims 1-8 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term Tween 20 (e.g. para’s 0032, 0034, 042), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 the preamble of the claim recites for diagnosing pancreatic cancer or malignant intraductal papillary mucinous neoplasm (IPMC) and the body of the claim does not provide any specific method steps in the claim other than measuring the amount of fucosyl residues of a1-acid glycoprotein. The body of the fails to provide any diagnostic steps or any correlation of the amount with pancreatic cancer or IPMC. The body of the claim doesn’t even provide obtaining a sample from a patient. Thus, the preamble fails to correlate with the body of the claim. Method claims should clearly set forth the various method steps in a positive, sequential manner using active tense verbs such as mixing, reacting and detecting. Method claims should also clearly state each component used in the method and the relationship of the various components, and should not be a mere cataloging of parts. The claims should also conclude with a step relating the method result to the purpose of the method, preferably to the purpose as also set forth in the preamble of the claim. Appropriate correction is required.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 describes an abstract idea, law of nature, or natural phenomenon in the preamble of the claim by requiring diagnosing disease comprising the active method step of measuring a biomarker. The claims are directed to a naturally occurring correlation between the levels of the recited biomarkers in a subject with pancreatic cancer or malignant intraductal papillary mucinous neoplasm as compared to a reference or to an abstract idea of calculating the amount of fucosyl residues of AGP.
Step 2A, Prong 2
The additional elements of measuring the amount of fucosyl residues of a1-acid glycoprotein and a1-acid glycoprotein by EIA and ELISA does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “calculating the amount of the fucosyl residues of AGP” and diagnosis is based on a criterion that a pancreatic cancer or IPMC is present when the amount of the fucosyl residues of AGP in a specimen is greater than a reference value or the amount of the fucosyl residues of AGP in a specimen collected from a healthy subject or a patient with a benign intraductal papillary mucinous neoplasm”. The “calculating” and “diagnosis” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited markers being correlated with pancreatic cancer or IPMC or calculating a value. No active method steps are invoked or clearly required; the “calculating” or “diagnosis” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by the art below it is well known routine and conventional in the art to measure the amount of fucosyl residues of a1-acid glycoprotein and a1-acid glycoprotein by EIA and ELISA
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
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 1-8 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 1 the recitation “a specimen” is vague and indefinite. The specification does not provide a precise definition for the term and it is unclear if the applicant is referring to a sample from a patient, if the applicant is referring to a subject such as a patient or if the applicant intends something else. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims. Please clarify.
Claim 3, line 2, the recitation “(ug/ml)” is vague and indefinite because it is unclear if the recitation contained within the parenthesis () are a part of the claim or not.
Claim 3, line 3, the recitation “(U/ml)” is vague and indefinite because it is unclear if the recitation contained within the parenthesis () are a part of the claim or not.
Claim 6, line 3, the recitation “(ug/ml)” is vague and indefinite because it is unclear if the recitation contained within the parenthesis () are a part of the claim or not.
Claim 6, line 4, the recitation “(U/ml)” is vague and indefinite because it is unclear if the recitation contained within the parenthesis () are a part of the claim or not.
Claim 7 the recitation “the diagnosis” there is insufficient antecedent basis for this limitation because claim 1 does not have a step wherein a diagnosis is made. Further, it is unclear if the applicant intends a diagnosis of pancreatic cancer or something else. Please clarify.
Claim 8 the recitation “the diagnosis” there is insufficient antecedent basis for this limitation because claim 1 does not have a step wherein a diagnosis is made. Further, it is unclear if the applicant intends a diagnosis of pancreatic cancer or something else. Please clarify.
Claim Rejections - 35 USC § 102
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 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 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yazawa et al (Clinica Chimica Acta, 2018, 478, pages 120-128) (submitted in the IDS filed 01/26/23).
Yazawa et al discloses a method for measuring the amounts of fucosyl residues of a1-acid glycoprotein and a1-acid glycoprotein (e.g. abstract, page 122). Yazawa et al discloses that the fucosyl residues of a1-acid glycoprotein are detected with an EIA assay wherein an immobilized anti-AGP antibody that has been periodate oxidized is contacted with a serum sample (e.g. page 122). Yazawa et al discloses contacting the complexes with labeled Aleuria aurantia lectin (AAL) and detecting the complexes and quantifying and calculating the amount (e.g. page 122). Yazawa et al discloses that the a1-acid glycoprotein is detected with a sandwich ELISA wherein a serum sample that has been desialylated is contacted with immobilized anti-human AGP and then contacted with horseradish peroxidase-conjugated ant-AGP and complexes are detected (e.g. page 122). Yazawa et al discloses that the biomarkers can be used as a potential biomarker of cancer initiation, progression and response to treatment in cancer patients (e.g. abstract) and diagnosis of prognosis of cancer treatment (e.g. page 125).
With respect to the recitations “for diagnosing pancreatic cancer or malignant intraductal papillary mucinous neoplasm (IPMC)” as recited in claim 1. This limitation occurs in the preamble of the claim and thus has not been given patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case, Yazawa et al discloses the method step of measuring the amount of fucosyl residues of a1-acid glycoprotein in a specimen. Thus, Yazawa et al performs every active method step and when every active method step has been performed the prior art method is met. Therefore, for the reasons stated supra Yazawa et al reads on the instantly recited claim.
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.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yazawa et al (Clinica Chimica Acta, 2018, 478, pages 120-128) (Yazawa et al 1) in view of Yazawa et al (PLOS ONE 11(6). June 13. 2016. pages 1-20) (submitted in the IDS filed 01/26/23) (Yazawa et al 2).
See above for the teachings of Yazawa et al 1.
Yazawa et al 1 differs from the instant invention in failing to comparing the amount of the fucosyl residues of a1-acid glycoprotein to a reference and determining greater values as correlated with pancreatic cancer.
Yazawa et al 2 teaches an association of fucosylated AGP in pancreatic cancer subjects and teaches that levels are greater in pancreatic cancer patients as compared to healthy controls (e.g. abstract, Fig. 2, page 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate healthy controls and to compare amounts of fucosyl residues of a1-acid glycoprotein in subjects suspected of pancreatic cancer because Yazawa et al 1 specifically teaches the biomarker can be used in cancer diagnosis and Yazawa et al 2 shows that it is known in the art that fucosyl residues of a1-acid glycoprotein amounts are greater in pancreatic cancer patients than that of healthy controls. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating healthy controls and to compare amounts of fucosyl residues of a1-acid glycoprotein in subjects suspected of pancreatic cancer.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Balmana et al. (Journal of Proteomics, 132, 2016, pages 144-154) discloses a directed correlation of a1-2 fucosylation of a-1-acid glycorprotein in pancreatic cancer (e.g. abstract and throughout the publication).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678