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 Non-Final Office Action is responsive to the communication received 4/27/2026.
Election/Restrictions
Applicant’s election in the Reply filed on 9/2/2025 of group I, claims 16-24 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicant has elected in the Reply filed on 9/2/2025 and the interview summary filed 4/6/2026 the following species:
A. the species of onocological medicament is temozolomide (claim 19)
B. the species of at least 9 non-onocological medicament is minocycline (claim 20)
C. the species of at least 100 non-oncological medicaments is withdrawn due to the Applicant stating that there are no patentable distinctions among the at least 100 non-oncological medicaments
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 16-30 are pending.
Claims 25-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 9/2/2025.
Claims 16-24 are under examination in this Office Action.
Claim Objections
The claims are objected to because of the following informalities:
A. Claims 16, 17, 18 and 22 recite “tumour”. Correction of the typographical/grammatical error is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 16-24 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims 17-24 depend from claim 16.
Claim 16 is indefinite and unclear in their recitation for being incomplete by omitting essential steps or ingredients, such omission amounting to a gap between the steps. See MPEP § 2172.01.
For example, there appears to be insufficient steps and ingredients to carry out the methods c) selecting at least one further medicament from a list of at least 100 non-oncological medicaments because no such list is provided by the Applicant in the Specification and no such list is generated by the method steps in claim 16.
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 16-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea (mental processes), without significantly more. Claims 17-24 depend directly or indirectly from claim 16.
The claim 16 limitations directed to an abstract idea (mental processes) are c) selecting at least one further medicament from a list of at least 100 non-oncological medicaments; and d) combining the combination of medicaments provided in step b) with the at least one medicament identified in step c) into a medicament combination; wherein the selection of the at least one further medicament in step c) is based on the result of the molecular in-vitro characterization in step a).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 16 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are method for providing a medicament combination, comprising the steps: a) performing a molecular in-vitro characterization of tumour tissue of a glioblastoma of a patient, with a result of the molecular in-vitro characterization being obtained; b) providing a combination of medicaments, the combination comprising an oncological medicament for the treatment of glioblastoma and at least nine non-oncological medicaments. Ryu et al. (2012) Journal of Biomedicine and Biotechnology article 987594 pages 1 to 9 cited in the 9/30/2025 IDS (hereinafter known as "Ryu") teaches a) performing a molecular in-vitro characterization of tumour tissue of a glioblastoma of a patient, with a result of the molecular in-vitro characterization being obtained (see entire document especially Abstract and pages 1 to 5). Kast et al. (2014) Oncotarget volume 5 pages 8052 to 8082 cited in the 1/19/2023 IDS (hereinafter known as "Kast") teaches b) providing a combination of medicaments, the combination comprising an oncological medicament for the treatment of glioblastoma and at least nine non-oncological medicaments (see entire document especially Abstract, Table 4 and pages 8052 to 8057 and 8067).
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the Examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the Examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 16-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kast et al. (2014) Oncotarget volume 5 pages 8052 to 8082 cited in the 1/19/2023 IDS (hereinafter known as "Kast") in view of Ryu et al. (2012) Journal of Biomedicine and Biotechnology article 987594 pages 1 to 9 cited in the 9/30/2025 IDS (hereinafter known as "Ryu").
With regards to claims 16-24, Kast teaches:
a) as in claims 16-24, a method for providing a medicament combination, comprising the steps: b) providing a combination of medicaments, the combination comprising an oncological medicament for the treatment of glioblastoma and at least nine non-oncological medicaments; and d) combining the combination of medicaments provided in step b) with the at least one medicament identified in step c) into a medicament combination; wherein the selection of the at least one further medicament in step c) is based on the result of the molecular in-vitro characterization in step a); wherein the molecular in-vitro characterization of tumour tissue of a glioblastoma of a patient is in-vitro characterization of the genome; wherein the in-vitro characterization of tumour tissue of a glioblastoma of a patient includes a determination of whether, in the tumour tissue of the patient, a molecule of DNA shows an abnormality; wherein the oncological medicament comprises temozolomide; wherein the at least nine particular non-oncological medicaments comprise aprepitant; wherein the list of non-oncological medicaments comprises medicaments for which an inhibitory effect on an oncogene associated with glioblastoma is known; wherein the selection of the at least one further medicament comprises the following steps: i) comparing the result for the characterized tumour tissue from the patient with the results of a large number of molecular in-vitro characterizations of tumour tissues of glioblastomas in a large number of other patients, the results for the large number of other patients being stored on a data carrier; ii) determining whether, following the comparison, there are abnormalities present; iii) matching the abnormalities to at least one non-oncological medicament from the list of non-oncological medicaments, there being a correlation available from the data carrier between abnormalities and the non-oncological medicaments on the list; and iv) selecting the at least one further medicament from the list of non-oncological medicaments on the basis of this match; wherein the data carrier is updatable; wherein in step c) i) a selection is made of at least 2 medicaments from the list of non-oncological medicaments (see entire document especially Abstract, Table 4 and pages 8052 to 8057 and 8067).
Kast does not explicitly teach:
a) as in claim 16, a) performing a molecular in-vitro characterization of tumour tissue of a glioblastoma of a patient, with a result of the molecular in-vitro characterization being obtained; c) selecting at least one further medicament from a list of at least 100 non-oncological medicaments.
With regards to claim 16, Ryu teaches:
a) as in claim 16, a) performing a molecular in-vitro characterization of tumour tissue of a glioblastoma of a patient, with a result of the molecular in-vitro characterization being obtained; c) selecting at least one further medicament from a list of at least 100 non-oncological medicaments (see entire document especially Abstract and pages 1 to 5).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. Ryu teaches the advantages of using a combination treatment for malignant glioma for improved treatment (see entire document especially Abstract and pages 1 to 5). One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of combining Kast's treatment of a patient with glioblastoma with Ryu's combination oncological and non-oncological medicaments for the improved treatment of a patient with glioblastoma. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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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 .
/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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