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 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 16-19, 21-26, and 28-30 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 16 and dependent claim(s) thereof, the clause “wherein R2a and R3a are independently selected from hydrogen, OH, or halogen” reads upon an improper Markush group as the last two members of the list are not separated by the term “and”. Thus, one of ordinary skill in the art would not have been apprised of the metes and bounds of variable “X”. When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if "wherein R is a material selected from the group consisting of A, B, C and D" is a proper limitation, then "wherein R is A, B, C or D" shall also be considered proper.
Regarding claim 30, the phrase “including HermanskyPudlak syndrome…mesothelioma” renders the claim indefinite because it is unclear whether the limitations following the term “including” are part of the claimed invention. Similarly, the term “e.g.” renders the claim indefinite because it is unclear whether the limitations following the term “e.g.” are part of the claimed invention. See MPEP § 2173.05(d). Additionally, the parenthetical phrase “(Post Contrast Agents)” renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Conclusion
Claims 16-30 are pending. Claims 16-19, 21-26, and 28-30 are rejected. Claims 20 and 27 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. GALECTO BIOTECH AB WO 2018/011093 A1 (GALECTO BIOTECH) is representative of prior art. GALECTO BIOTECH is drawn to alpha-d-galactoside inhibitors of galectins. GALECTO BIOTECH teaches D-galactopyranose compound of formula (1):
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wherein R1 is a five or six membered heteroaromatic ring selected from the group consisting of formulas 2 to 9, wherein the asterix * indicates the carbon atom of the heteroaromatic ring that is covalently attached to the triazole group of formula (1):
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.
GALECTO BIOTECH teaches that galectin-1 has been implicated in diverse phenomena and, hence, inhibitors may have multiple uses (page 2). It is easy to perceive this as a lack of specificity or lack of scientific focus. Therefore, the analogy with aspirin and the cyclooxygenases (COX-I and II) is useful. The COXs produce the precursor of a wide variety of prostaglandins and, hence, are involved in a diverse array of biological mechanisms. Their inhibitors, aspirin and other NSAIDs (non-steroid anti-inflammatory drugs), also have broad and diverse effects. Despite this, these inhibitors are very useful medically, and they have several different specific utilities.
GALECTO BIOTECH relates to compounds, the use of said compounds as medicament and for the manufacture of a medicament for the treatment of cancers; fibrosis; scarring; keloid formation; aberrant scar formation; surgical adhesions; pathological angiogenesis; eye diseases; HIV-1 diseases; inflammation or transplant rejection in mammals (page 1). In a further aspect GALECTO BIOTECH relates to a compound of formula (1) for use in a method for treating a disorder relating to the binding of a galectin-1 to a ligand in a mammal, such as a human (pages 16-17). In a further embodiment the disorder is selected from the group consisting of inflammation; fibrosis, such as pulmonary fibrosis, liver fibrosis, kidney fibrosis, ophthalmological fibrosis and fibrosis of the skin and heart; scarring; keloid formation; aberrant scar formation; scleroderma; sclerosis; surgical adhesions; septic shock; cancer, such as carcinomas, sarcomas, leukemias and lymphomas, such as T-cell lymphomas; metastasising cancers; neovascularization related to cancer; autoimmune diseases, such as psoriasis, rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, systemic lupus erythematosus; transplant rejection; metabolic disorders; heart disease; heart failure; pathological angiogenesis, such as ocular angiogenesis or a disease or condition associated with ocular angiogenesis, e.g. neovascularization related to cancer; and eye diseases, such as age-related macular degeneration and corneal neovascularization; atherosclerosis; metabolic diseases such as diabetes; obesity; asthma and other interstitial lung diseases, including Hermansky-Pudlak syndrome, mesothelioma; liver disorders, such as non-alcoholic steatohepatitis.
GALECTO BIOTECH differs from the instantly claimed invention in that GALECTO BIOTECH does not teach or reasonably suggest a compound wherein R1 (e.g., instant A1) is
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. It would not have been obvious to modify a compound of GALECTO BIOTECH in a manner to produce an instantly claimed compound of formula (1) based upon the prior art of record.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shaojia Jiang can be reached at (571) 272-0627. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/