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 .
Status of the claims
NOTE: it is noted that a notice of non-complaint amendment was filed 10/30/25 and that the Applicant did not respond to the amendment within the two-month time frame noted in the notice of non-compliance. The Examiner called Kay Yang, attorney 01/12/25 and Kay Yang stated that no response was submitted. Therefore, the Examiner has proceeded with the set of claims filed 05/23/25. Claims 2 and 4-29 have been canceled. Claim 1 and claim 3 are pending.
Information Disclosure Statement
The information disclosure statement (IDS), filed 01/05/23 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the citations no. 1 to GENBANK and no. 2 to GENBANK lacks an author and title. It has been placed in the application file, and the information referred to therein has been considered as to the merits, but the citation has been lined through on the said IDS. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The use of the term Tween 20 (e.g. pages 96-97), 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 lengthy 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 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 and 3 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
The claims are directed to a naturally occurring correlation between Globo-H levels in breast cancer patients and eligibility for therapy.
Step 2A, Prong 2
The additional elements of providing a tissue sample, contacting the sample with Globo-H antibody, forming a plurality of complexes, contacting the complex with detectable antibody; generating detectable signal and detecting the detectable signal do 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 “selecting patients with a level of Globo-H higher than a threshold”. The “selecting” 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 Globo-H being correlated with breast cancer and therapy eligibility. No active method steps are invoked or clearly required; the “selecting” statement does 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 contact a sample with Globo-H antibody, forming a plurality of complexes, contacting the complex with detectable antibody; generating detectable signal and detecting the detectable signal.
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 and 3 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, step (d) is vague and indefinite in reciting “contacting the complex with a detectably labeled second antibody” because it is unclear if the applicant is referring to the first complex or the second complex recited in step (c) or if the applicant intends another complex. Please clarify.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (PNAS, August, 19, 2008, vol. 105, no. 33, pages 11667-11672) (submitted in the IDS filed 03/11/22) in view of NIH (Clinicaltrials.gov, Study of Adagloxad Simolenin (OBI-822) and OBI-821 Versus Placebo Treatment for High Risk Early Stage Triple Negative Breast Patients) (submitted in the IDS filed 03/11/22).
Chang discloses a method of detecting the level of Globo-H in a tissue sample from a patient (immunohistochemical staining of patient tumors (a method of detecting the level of Globo-H in a tissue sample from a patient); page 11667, second column, first paragraph; Table 3; page 11670, first column, first paragraph), the method comprising: (a) providing or having provided the tissue sample from the patient (providing or having provided the tissue sample from the patient; Table 3, page 11671, second column, third paragraph; supporting information, first column, fourth paragraph - second column, first paragraph); (b) contacting the tissue sample with a Globo-H antibody (contacting the tissue sample with a Globo-H antibody; supporting information, first column, fourth paragraph – second column, first paragraph); (c) forming a complex comprising a Globo-H antigen-antibody (detecting the presence of Globo-H (forming a complex comprising a Globo-H antigen-antibody); Figure S3); (d) contacting the complex with a detectably labeled second antibody that binds to the Globo-H antibody thereby forming a labeled complex (contacting the complex with a detectably labeled second antibody that binds to the Globo-H antibody thereby forming a labeled complex; supporting information, first column, fourth paragraph – second column, first paragraph); (e) generating a detectable signal (generating a detectable signal; Figure S3); (f) detecting the detectable signal (detecting the detectable signal; Figure S3) and relating the units of detactable signal to the level of Globo-H antigens in the tissue sample (relating the units of detectable signal to the level of Globo-H antigens in the tissue sample; table 3) and administering Globo-H therapy to patients (page 116689, first column, second paragraph; page 11670, first column, third paragraph).
Chang differs from the instant invention in failing to teach selecting patients with a level of Globo-H antigens higher than a threshold.
NIH discloses (g) selecting patients with a level of Globo-H antigens higher than a threshold (Eligibllity criteria including Globo H IHC score greater than or equal to 15 (selecting patients with a level of Globo-H antigens higher than a threshold); pages 3-4, eligibllity section); and (h) selected patients (pages 3-4, eligibility section).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the to modify the disclosure of Chang, to include (g) selecting patients with a level of Globo-H antigens higher than a threshold; and (h) administering a Globo-H therapy to patients, as disclosed by NIH, in order to provide a superior method for identifying patients to receive Globo-H therapy for the effective treatment of breast cancer. Thus, absent evidence to the contrary one of ordinary skill in the art would have a reasonable expectation of success to incorporate selecting patients with a level of Globo-H antigens higher than a threshold; and administering a Globo-H therapy to patients, as disclosed by NIH.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al (US 2020/0109435) discloses antibodies for Globo-H (e.g. para 0204).
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