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 .
Claim Status
Claims 1-2, 4-8, and 10-20 are pending. Claims 2, 4-8, and 10-14 are withdrawn. Claims 1 and 15-20 are rejected.
Election/Restrictions
Applicant's election with traverse of Group I and the combination of oxaliplatin and rheumatoid arthritis in the reply filed on July 13th, 2026 is acknowledged. The traversal is on the ground(s) that “the pending claims are sufficiently related that examination of the elected and non-elected subject matter would not require a search or examination imposing the type of burden contemplated by 35 USC 121 or applicable USPTO practice.” This is not found persuasive because restriction under 35 USC 371 is not contingent upon the burden of examination. The instant claims lack unity because they do not possess a special technical feature that makes a contribution over the prior art as discussed in the requirement for restriction filed May 13th, 2026 and as set forth in the 35 USC 103 rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s elected combination is not allowable. Search and examination have been restricted to claims embracing the elected species. Any subject matter presented beyond this scope was discovered incidental to the search and presented in the interest of compact prosecution.
Claims 2, 4-8 and 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 13th, 2026.
Claim Rejections - 35 USC § 112(b)
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 15-20 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.
Regarding claim 1, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Likewise, the term “optimally” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 15 recites the limitation "the pharmaceutical composition containing oxaliplatin" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 is further rejected as the claim recites a method of treating disease in a subject in need, which includes administering to the subject… “the pharmaceutical composition containing the cocrystal according to claim 2 or the pharmaceutical composition containing oxaliplatin” wherein… “the pharmaceutical composition has a therapeutically effective dose.” The claim recites two separate pharmaceutical compositions, one comprising the cocrystal of claim 2 and one comprising oxaliplatin, however the limitation wherein the pharmaceutical composition has a therapeutically effective dose is generic. It is unclear which pharmaceutical composition the limitation applies to. Likewise, claims 18-20 contain the same reference to “the pharmaceutical composition” without specifying the pharmaceutical composition containing the cocrystal according to claim 2 or the pharmaceutical composition containing oxaliplatin.
Claims 16-17 are rejected for failing to obviate the indefiniteness of claim 15.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 recites a method of treating a disease in a subject comprising administering to the subject oxaliplatin or a pharmaceutical composition comprising oxaliplatin however claim 2 from which it depends only provides for pharmaceutical cocrystals.
Claims 16-20 are rejected as they embrace the improper dependent subject matter of claim 15.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 and 15-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over KR 101367516 B1. (citations refer to the machine translation).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches “combinations of therapeutic agents for treating cancer” and disclose a combination therapy for treating patients suffering from diseases associated with persistent angiogenesis wherein the patient is treated with a camptothecin derivative and one or more chemotherapeutic agents selected from a platin compound (title; abstract).
Regarding instant claims 1 and 15-16, the prior art suggests oxaliplatin as a platin compound and arthritis as a disease associated with persistent angiogenesis (page 3, paragraph 3; page 9).
Regarding instant claim 20, the prior art discloses pharmaceutical formulations comprising a pharmaceutically effective amount of oxaliplatin wherein the composition is an aqueous solution or suspension (page 8, paragraphs 10 and 13).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses a method of treating arthritis comprising administering oxaliplatin but does not include and embodiment wherein the compound is administered to a subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
A person of ordinary skill seeking to implement the pharmaceutical composition of the prior art would have been motivated to administer the composition to subjects with arthritis as disclosed in the suggested utilities.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over KR 101367516 B1 as applied to claims 1, 15-16 and 20 above, and further in view of Elshabrawy et al. “The pathogenic role of angiogenesis in rheumatoid arthritis.” Angiogenesis vol. 18,4 (2015): 433-48.
KR 101367516 B1 discloses a method of treating diseases triggered by persistent angiogenesis such as arthritis comprising administering oxaliplatin but do not specify that the arthritis is rheumatoid arthritis.
Elshabrawy et al. discuss “the pathogenic role of angiogenesis in rheumatoid arthritis” and explain (abstract):
Angiogenesis is the formation of new capillaries from pre-existing vasculature, which plays a critical role in the pathogenesis of several inflammatory autoimmune diseases such as rheumatoid arthritis (RA), spondyloarthropathies, psoriasis, systemic lupus erythematosus, systemic sclerosis and atherosclerosis. In RA, excessive migration of circulating leukocytes into the inflamed joint necessitates formation of new blood vessels to provide nutrients and oxygen to the hypertrophic joint. The dominance of the pro-angiogenic factors over the endogenous angiostatic mediators triggers angiogenesis.
Accordingly, a person of ordinary skill performing the method of treating angiogenesis-related conditions such as arthritis in the method of KR 101367516 B1 would be motivated to treat subjects with rheumatoid arthritis as angiogenesis plays a critical role in the pathogenesis of the disease as taught by Elshabrawy et al.
Claim(s) 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over KR 101367516 B1 as applied to claims 1, 15-16 and 20 above, and further in view of Nair et al. “A simple practice guide for dose conversion between animals and human.” Journal of basic and clinical pharmacy vol. 7,2 (2016): 27-31.
KR 101367516 B1 discloses a method of treating arthritis comprising administering oxaliplatin wherein the suggested dose is 50 to 85 mg/m2 but does not provide dosages in mg/kg (page 8, paragraph 9).
Nair et al. provide a guide for dose conversions between animals and humans and between units of mg/kg and mg/m2 in Table 1 below (page 29):
PNG
media_image1.png
676
1288
media_image1.png
Greyscale
.
The corresponding dosage range for 50 to 85 mg/m2 would be about 1.4 to 2.3 mg/kg which is embraced by the about 0.01 to about 5 mg/kg or about 0.01 to about 10 mg/kg ranges of instant claims 18 and 19.
Accordingly, the claimed method of treatment is obvious in view of KR 101367516 B1 as person of ordinary skill practicing the method of treating arthritis comprising administering oxaliplatin within the disclosed range of the prior art would administer dosages which overlap with the pharmaceutically effective doses of the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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, James H Alstrum-Acevedo can be reached at (571)272-5548. 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.
/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Prosecution Insights