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.
Claim 78 is 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.
The text “
PNG
media_image1.png
106
282
media_image1.png
Greyscale
” renders the claim indefinite as part of the text is “cut off”. Thus, one would not have been apprised of the metes and bounds of the depicted compound.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 14, 55, and 78 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Askew et al. US 6,784,190 B2 (Askew).
Askew discloses compounds
PNG
media_image2.png
186
512
media_image2.png
Greyscale
,
PNG
media_image3.png
256
508
media_image3.png
Greyscale
,
PNG
media_image4.png
198
518
media_image4.png
Greyscale
, and
PNG
media_image5.png
184
522
media_image5.png
Greyscale
.
See columns 111-114. At least compounds 14-17 are embraced by instant formula (A). Askew teaches all of the instantly claimed elements. Thus, claims 1-2, 14, 55, and 78 are anticipated.
Claim(s) 1-2, 13-14, 55, 92, and 95 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jiang et al. US 2018/0093984 A1 (Jiang).
Jiang discloses compounds
PNG
media_image6.png
168
714
media_image6.png
Greyscale
,
PNG
media_image7.png
198
710
media_image7.png
Greyscale
,
PNG
media_image8.png
164
702
media_image8.png
Greyscale
,
PNG
media_image9.png
132
708
media_image9.png
Greyscale
,
PNG
media_image10.png
126
708
media_image10.png
Greyscale
,
PNG
media_image11.png
200
590
media_image11.png
Greyscale
,
PNG
media_image12.png
206
572
media_image12.png
Greyscale
,
PNG
media_image13.png
240
546
media_image13.png
Greyscale
,
PNG
media_image14.png
246
556
media_image14.png
Greyscale
, and
PNG
media_image15.png
244
590
media_image15.png
Greyscale
.
Jiang teaches that one or several compounds described therein can be used in the preparation of a formulation , such as a pharmaceutical formulation, by combining the compound or compounds as an active ingredient with a pharmaceutically acceptable carrier [0235]. Depending on the therapeutic form of the system (e.g., transdermal patch vs. oral tablet), the carrier may be in various forms. In addition , pharmaceutical formulations may contain preservatives, solubilizers, stabilizers, re-wetting agents, emulgators, sweeteners, dyes, adjusters, and salts for the adjustment of osmotic pressure, buffers, coating agents or antioxidants.
In another aspect, Jiang provided a method of delaying the onset and/or development of a fibrotic disease in an individual (such as a human) who is at risk for developing a fibrotic disease [0241]. It is appreciated that delayed development may encompass prevention in the event the individual does not develop the fibrotic disease. An individual at risk of developing a fibrotic disease in one aspect has or is suspected of having one or more risk factors for developing a fibrotic disease. Risk factors for fibrotic disease may include an individual's age (e.g., middle-age or older adults), the presence of inflammation, having one or more genetic component associated with development of a fibrotic disease, medical history such as treatment with a drug or procedure believed to be associated with an enhanced susceptibility to fibrosis (e.g., radiology) or a medical condition believed to be associated with fibrosis, a history of smoking, the presence of occupational and/or environmental factors such as exposure to pollutants associated with development of a fibrotic disease.
Jiang further provides kits for carrying out the methods of the invention, which comprises one or more compounds described herein or a pharmacological composition comprising a compound described therein [0260]. The kits may employ any of the compounds disclosed therein. In one variation, the kit employs a compound described therein or a pharmaceutically acceptable salt thereof. The kits may be used for any one or more of the uses described therein, and, accordingly, may contain instructions for use in the treatment of a fibrotic disease. In some embodiments, the kit contains instructions for use in the treatment of liver fibrosis.
The IC50 values obtained for αvβ1 integrin inhibition for exemplary compounds are shown in Table B-1 [0733]. The compounds tested were compound samples prepared according to procedures described in the Synthetic Examples section, with the stereochemical purity as indicated in the Examples indicated for Example or Compound No. 1-62.
At least compounds 81-84, 86, 97-98, and 102-104 are embraced by instant formula (A). Jiang teaches all of the instantly claimed elements. Thus, claims 1-2, 13-14, 55, 92, and 95 are anticipated.
Claim(s) 93, 97-98, 100, 107, 110-111, and 115 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jiang et al. US 2018/0093984 A1 (Jiang) as applied to claims 1-2, 13-14, 55, 92, and 95 above.
Jiang teaches or reasonably suggests administration of a compound of the invention to an instant subject. Jiang teaches all of the instantly claimed elements. Thus, claims 93, 97-98, 100, 107, 110-111, and 115 are anticipated.
Conclusion
Claims 1-2, 13-14, 55, 74-75, 78, 84, 89-93, 95, 97-98, 100, 104-107, 110-111, and 115 are pending. Claims 1-2, 13-14, 55, 78, 92-93, 95, 97-98, 100, 107, 110-111, and 115 are rejected. Claims 74-75, 84, and 104-106 are 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. Claims 89-91 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Jiang et al. US 2018/0093984 A1 (Jiang) as applied to claims 1-2, 13-14, 55, 92, and 95 above is representative of prior art. Jiang does not teach or suggest an instantly claimed compound.
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).
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, Renee Claytor can be reached at (571) 272-8394. 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.
/PATRICK T LEWIS/Primary Examiner, Art Unit 1691