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United States Patent and Trademark Office 



UNITED STATES DEPARTMENT OF COMMERCE 
United States Patent and Trademark Office 
Address: COMMISSIONER FOR PATENTS 
P.O. Box 1450 

Alexandria, Virginia 223 1 3- 1 4S0 
www.uspto.gov 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



ATTORNEY DOCKET NO. CONFIRMATION NO. 



09/864,621 



05/23/2001 



25226 7590 04/14/2005 

MORRISON & FOERSTER LLP 

755 PAGE MILL RD 

PALO ALTO, CA 94304-1018- 



H. Ralph Snodgrass 



441472000110 



3487 



EXAMINER 



CHEN, SHIN LIN 



ART UNIT 



PAPER NUMBER 



1632 

DATE MAILED: 04/14/2005 



Please find below and/or attached an Office communication concerning this application or proceeding. 



PTO-90C (Rev. 10/03) 



Office Action Summarv 


Application No. 

09/864,621 


Applicant(s) 

SNODGRASS, H. RALPH 


Examiner 

Shin-Lin Chen 


Art Unit 

1632 





The MAILING DATE of this communication appears on the cover sheet with the correspondence address - 
Period for Reply 



A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) FROM 
THE MAILING DATE OF THIS COMMUNICATION. 

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). in no event, however, may a reply be timely filed 
after SIX (6) MONTHS from the mailing date of this communication. 

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely. 

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. 

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133). 
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any 
earned patent term adjustment. See 37 CFR 1.704(b). 

Status 

1)S Responsive to communication(s) filed on 30 December 2004 . 
2a)D This action is FINAL. 2b)S This action is non-final. 

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is 

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 O.G. 213. 

Disposition of Claims 

4) M Claim(s) 1-28 is/are pending in the application. 

4a) Of the above claim(s) 12-28 is/are withdrawn from consideration. 

5) D Claim(s) is/are allowed. 

6) S Claim(s) 1-11 is/are rejected. 

7) D Claim(s) is/are objected to. 

8) D Claim(s) are subject to restriction and/or election requirement. 

Application Papers 

9) D The specification is objected to by the Examiner. 

10)D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner. 

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a). 

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d). 
1 1 )□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152. 

Priority under 35 U.S.C. § 119 

12)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f). 
a)D All b)D Some * c)D None of: 

1 .□ Certified copies of the priority documents have been received. 

2. D Certified copies of the priority documents have been received in Application No. . 

3. D Copies of the certified copies of the priority documents have been received in this National Stage 

application from the International Bureau (PCT Rule 17.2(a)). 
* See the attached detailed Office action for a list of the certified copies not received. 



Attachment(s) 

1) □ Notice of References Cited (PTO-892) 4) D Interview Summary (PTO-413) 

2) □ Notice of Draftsperson's Patent Drawing Review (PTO-948) Pa P er No(s)/Mail Date. . 

3) ^ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08) 5 ) D Notice of Informal Patent Application (PTO-152) 

Paper No(s)/Mail Date 2-26-04 . 6) □ Other: . 



U.S. Patent and Trademark Office 
PTOL-326 (Rev. 1-04) 



Office Action Summary 



Part of Paper No./Mail Date 2005041 1 



Application/Control Number: 09/864,62 1 Page 2 

Art Unit: 1632 

DETAILED ACTION 

Applicants' amendment filed 12-30-04, which was filed in accompany with a petition to 
revive the abandoned application and the petition was granted on 2-17-05, has been entered. 
Claim 1 has been amended. Claims 1-28 are pending and claims 1-11 are under consideration. 



Claim Rejections - 35 USC §101 

1. 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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed 
to non-statutory subject matter. The claims are drawn to a library of molecular profiles of 
chemical compositions. On page 3, lines 23-24, the specification discloses "The library can be in 
the form of a database. A database may comprise more than one library for chemical 
compositions of different toxicity categories." A database is not considered patentable subject 
matter. Therefore, the instantly claimed invention is directed to a non-statutory subject matter. 

Claim Rejections - 35 USC § 112 

2. The following is a quotation of the first paragraph of 35 U.S.C. 1 12: 

The specification shall contain a written description of the invention, and of the manner and process of making 
and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it 
pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode 
contemplated by the inventor of carrying out his invention. 

3. Claims 1-11 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with 
the written description requirement. The claim(s) contains subject matter which was not 



described in the specification in such a way as to reasonably convey to one skilled in the relevant 



Application/Control Number: 09/864,62 1 Page 3 

Art Unit: 1632 

art that the inventor(s), at the time the application was filed, had possession of the claimed 
invention. 

Claims 1-11 read on a library of molecular profiles of chemical compositions having 
predetermined toxicities by contacting an isolated mammalian embryoid body with the chemical 
compositions, recording alterations in gene expression or protein expression in said mammalian 
embryoid body and compiling a library of molecular profiles for at least two chemical 
compositions. 

The chemical compositions encompass therapeutic agents, neurotoxins, renal toxins, 
hepatic toxins, toxins of hematopoietic cells, myotoxins, agents that are toxic to cells of 
reproductive organs, teratogenic agents, carcinogens, agricultural chemicals, cosmetics, and 
environmental contaminants. The specification only discloses the protein expression profiles of 
mouse embryoid body treated with troglitazone or erythromycin compared to the control having 
no treatment of troglitazone or erythromycin. The chemical compositions set forth above include 
numerous different chemical compounds having different chemical structures, physical 
properties, and biological functions. They don't have common chemical structures, chemical 
activities, and biological functions. Common structural feature of the chemical compositions 
that would have a certain effect on the gene expression or protein expression pattern in a 
mammalian embryoid body has not been disclosed in the present invention. Further, different 
embryoid bodies derived from various mammal, such as humans, mice, rats, pigs, sheep, cows, 
whales, primates, dogs etc., would differ from each other physiologically, and their response to 
same chemical composition, not to mention different chemical compositions, could vary. 
Therefore, the pattern of alterations in gene expression or protein expression in various 



Application/Control Number: 09/864,62 1 Page 4 

Art Unit: 1632 

mammalian embryoid bodies responding to numerous different chemical compositions would not 
be predictable at the time of the invention. One skilled in the art at the time of the invention 
would not be able to anticipate the gene expression or protein expression pattern in the 
mammalian embryoid body treated with various chemical compositions other than the disclosed 
protein expression pattern of mouse embryoid body treated with either troglitazone or 
erythromycin. The general knowledge and level of skill in the art do not supplement the omitted 
description because specific, not general, guidance is what is needed. 

The limited information disclosed in the present invention is not sufficient to reasonably 
convey to one skilled in the art that applicants were in possession of the claimed libraries of 
molecular profiles of numerous different chemical compositions. Thus, it is concluded that the 
written description requirement is not satisfied for the libraries of molecular profiles of numerous 
different chemical compositions as claimed. 

Applicant cites Atlantic Thermoplastics v. Faytex Corp., and argues that claims 1-1 1 are 
products by process claims, therefore, there is no need to define the products in terms of 
structural characteristics (amendment, p. 6-7). This is not found persuasive because of the 
reasons set forth above and that applicant only states "e.g. Atlantic thermoplastics v. Faytex 
Corp." but fails to point out how it is related to the product by process claims and there is no 
need to define the structural characteristics of products. The claimed invention is a library of 
molecular profiles, i.e. the patterns of gene expression or protein expression, of numerous 
different chemical compositions when said chemical compositions contact with an isolated 
mammalian embryoid body. As discussed above, the chemical compositions include numerous 
different chemical compounds having different chemical structures, physical properties, and 



Application/Control Number: 09/864,62 1 Page 5 

Art Unit: 1632 

biological functions. They don't have common chemical structures, chemical activities, and 
biological functions. Further, different embryoid bodies derived from various mammal, such as 
humans, mice, rats, pigs, sheep, cows, whales, primates, dogs etc., would differ from each other 
physiologically, and their response to same chemical composition, not to mention different 
chemical compositions, could vary. Therefore, the pattern of alterations in gene expression or 
protein expression in various mammalian embryoid bodies responding to numerous different 
chemical compositions would not be predictable at the time of the invention. One skilled in the 
art at the time of the invention would not be able to anticipate the gene expression or protein 
expression pattern in the mammalian embryoid body treated with various chemical compositions 
other than the disclosed protein expression pattern of mouse embryoid body treated with either 
troglitazone or erythromycin. Thus, the written description requirement is not satisfied for the 
libraries of molecular profiles of numerous different chemical compositions as claimed. 

4. Claims 1-11 are rejected under 35 U.S.C 1 12, first paragraph, because the specification, 
while being enabling for the library of protein expression profile of troglitazone and 
erythromycin in the mouse embryoid body, does not reasonably provide enablement for libraries 
of molecular profiles of numerous different chemical compositions in various mammalian 
embryoid bodies. The specification does not enable any person skilled in the art to which it 
pertains, or with which it is most nearly connected, to make and/or use the invention 
commensurate in scope with these claims. 

Claims 1-11 read on a library of molecular profiles of chemical compositions having 
predetermined toxicities by contacting an isolated mammalian embryoid body with the chemical 



Application/Control Number: 09/864,62 1 Page 6 

Art Unit: 1632 

compositions, recording alterations in gene expression or protein expression in said mammalian 
embryoid body and compiling a library of molecular profiles for at least two chemical 
compositions. Claim 2 specifies the embryoid body is of human. Claims 6 and 7 specify the 
embryoid body is of non-human mammals, such as rodents. Claims 3-5 and 8-10 specify the 
chemical compositions are therapeutic agents, neurotoxins, renal toxins, hepatic toxins, 
teratogenic agents, carcinogens, agricultural chemicals, cosmetics, environmental contaminants 
etc. 

As discussed above, the chemical compositions encompass therapeutic agents, 
neurotoxins, renal toxins, hepatic toxins, toxins of hematopoietic cells, myotoxins, agents that 
are toxic to cells of reproductive organs, teratogenic agents, carcinogens, agricultural chemicals, 
cosmetics, and environmental contaminants. The specification only discloses the protein 
expression profiles of mouse embryoid body treated with troglitazone or erythromycin compared 
to the control having no treatment of troglitazone or erythromycin. The chemical compositions 
set forth above include numerous different chemical compounds having different chemical 
structures, physical properties, and biological functions. Further, different embryoid bodies 
derived from various mammal, such as humans, mice, rats, pigs, sheep, cows, whales, primates, 
dogs etc., would differ from each other physiologically, and their response to same chemical 
composition, not to mention different chemical compositions, could vary. Therefore, the 
alterations in gene expression or protein expression in various mammalian embryoid bodies 
responding to numerous different chemical compositions would not be predictable at the time of 
the invention. One skilled in the art at the time of the invention would not be able to anticipate 
the gene expression or protein expression pattern in the mammalian embryoid body treated with 



Application/Control Number: 09/864,621 Page 7 

Art Unit: 1632 

various chemical compositions other than the disclosed protein expression pattern of mouse 
embryoid body treated with either troglitazone or erythromycin. Applicants were not in 
possession of the claimed libraries of molecular profiles of numerous different chemical 
compositions. Thus, the present invention does not enable the use of the broadly claimed 
libraries of molecular profiles of numerous different chemical compositions. 

Applicant cites Atlantic Thermoplastics v. Faytex Corp., and argues that claims 1-11 are 
products by process claims, therefore, there is no need to define the products in terms of 
structural characteristics (amendment, p. 6-7). This is not found persuasive because of the 
reasons set forth above and the reasons set froth above under 35 U.S.C. 1 12, first paragraph, 
written description rejection. 

Conclusion 

No claim is allowed. 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Shin-Lin Chen whose telephone number is (571) 272-0726. The 
examiner can normally be reached on Monday to Friday from 9:30 am to 6 pm. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Ram Shukla can be reached on (571) 272-0735. The fax phone number for this 
group is (571) 273-8300. 

Any inquiry of a general nature or relating to the status of this application or proceeding 
should be directed to (571) 272-0547. 



Application/Control Number: 09/864,621 
Art Unit: 1632 



Page 8 



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Shin-Lin Chen, Ph.D.