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
1. Claims 2, 6-8, 14, 17, 21, 24, 25, 29, 30, 31, 32, 34 are amended. New claims 37-40 are added. Claims 3-5, 9-13, 15, 16, 19, 20, 22, 23, 26-28, 36 are canceled. Claims 1, 2, 6-8, 14, 17, 18, 21, 24, 25, 29-35, 37-40 are under consideration.
2. Due to the new rejection below, this Action is a Non-Final Action.
Sequences
3. It is noted applicant has amended Figures 3, 11 to insert sequence identifiers.
Claim Rejections - 35 USC § 103
4. (previous rejection, withdrawn) Claims 1, 6, 14, 17, 18, 21, 25 were rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. (WO2014100913)(cited in applicant's IDS submitted 1/30/2023) in view of Anderson et al. (WO2021198769; previously cited).
Applicant contends: the polypeptides in Qian et al. are small polypeptides; viral surface antigens are not expected to mimic natural molecules; a person skilled in the art would not view a viral surface antigen as a therapeutic polypeptide as described in Qian et al.; Qian et al. is directed to increasing plasma half life of therapeutic polypeptides; polypeptides of Qian et al. are small; viral surface antigens are larger than 50 kDa; a person of skill in the art would have no motivation to combine the teachings of Qian et al. and Anderson et al..
Applicant’s arguments are considered and found persuasive, and the rejection is withdrawn.
5. (previous rejection, withdrawn) Claims 2, 37, 38 were rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. as applied to claims 1, 6, 14, 17, 18, 21, 25 above, and further in view of Renner et al. (WO02056907A2; previously cited).
In view of the withdrawal of the rejection over Qian et al. in view of Anderson et al. on which the instant rejection depends, the instant rejection is also withdrawn.
6. (previous rejection, withdrawn) Claims 39, 40 were rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. and further in view of Renner et al. as applied to claims 2, 37, 38 above, and further in view of Tan et al. (WO2004109289A1; previously cited)
In view of the withdrawal of the rejection over Qian et al. in view of Anderson et al. on which the instant rejection depends, the instant rejection is also withdrawn.
7. (previous rejection, withdrawn) Claim 7 was rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. as applied to claims 1, 6, 14, 17, 18, 21, 25 above, and further in view of De Groot et al. (WO2021163427; previously cited).
In view of the withdrawal of the rejection over Qian et al. in view of Anderson et al. on which the instant rejection depends, the instant rejection is also withdrawn.
8. (previous rejection, withdrawn) Claims 29, 31-35 were rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. as applied to claims 1, 6, 14, 17, 18, 21, 25 above, and further in view of Tan et al. (cited above).
In view of the withdrawal of the rejection over Qian et al. in view of Anderson et al. on which the instant rejection depends, the instant rejection is also withdrawn.
9. (previous rejection, withdrawn) Claim 30 was rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. in view of Anderson et al. and further in view of Tan et al. as applied to claims 29, 31-35 above, and further in view of De Groot et al. (WO2021163427) (cited above).
In view of the withdrawal of the rejection over Qian et al. in view of Anderson et al. on which the instant rejection depends, the instant rejection is also withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
10. (new rejection) Claims 1, 2, 6, 7, 14, 17, 18, 21, 25, 29-35, 37-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 1, 2, 6, 7, 14, 17, 18, 21, 25, 29-35, 37-40 as submitted 11/17/2022.
Each of the claims is drawn, inherently or explicitly, to a resistin trimerization domain. Thus, the claims are drawn to compositions comprising a genus of resistin trimerization domains.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification teaches: complete SEQ ID NOs: 1, 2 [0008, 0011]; as well as complete sequences SEQ ID NOs: 5, 6, 17; 7, 8, 18.
As to the state of the art, the art teaches: variations and complicated structural conditions for resistin. For example, Aruna et al. (“Biophysical Analyses of Human Resistin: Oligomer Formation Suggests Novel Biological Function,” Biochemistry 47:12457-12466 (2008))(See PTO-892: Notice of References Cited): teaches: resistin, a small peptide hormone; wherein significant differences in the structural organization, both at the gene and at the protein level exist (p. 12458); wherein mouse resistin reveals a complex hexameric and trimeric structure (p. 12458); human resistin forms oligomers involving covalent as well as noncovalent linkages (p. 12458); if covalent linkages are critical for maintaining the structure of human resistin, what then is the role of noncovalent interactions in stabilizing human resistin structure? (p. 12459); human resistin undergoes a concentration-dependent oligomerization (p. 12459); human resistin requires ionic forces for trimerization and ionic and hydrophobic forces for oligomerization (p. 12460). Further, it is also well known in the art that protein structure determines function, and even minor changes can alter function. For example, Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982))(See PTO-892: Notice of References Cited) teaches: that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (p. 1979). Further, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References Cited) teaches: a single amino acid change may alter the immunological information of a peptide (title).
However, while the specification as indicated above identifies SEQ ID NOs: 1, 2 and complete sequences SEQ ID NOs: 5, 6, 17; 7, 8, 18, in view of challenges known in the art as indicated above, it does not identify a representative sample of resistin trimerization domains, especially in view of the breadth of the claims. Thus, the application does not identify a representative sample of resistin trimerization domains clearly within the breadth of the claimed genus.
There is no apparent common conserved structure to the different resistin trimerization domains that distinguishes those resistin domains that trimerize as compared to those that do not. There is therefore a high level of uncertainty as to which resistin trimerization domains fall within the scope of the indicated genus.
Further, the specification has identified resistin trimerization domains only by function.
The specification does not provide a specific structure of resistin trimerization domains within the genus that correlates with the required function. Because there is no identification of structures common to each resistin trimerization domain, nor sufficient representative examples of the resistin trimerization domain by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of resistin trimerization domains through identification of a structure and function. While the resistin domains are required to trimerize, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a resistin domain does not demonstrate that a such a domain would be able to trimerize.
For the reasons above, and in view of the uncertainty as to which resistin domains would be able to trimerize, the application has not provided sufficient written description support for the genus of resistin trimerization domains identified in claim 1. The application therefore fails to provide adequate support for methods of using this genus of resistin trimerization domains.
Conclusion
11. Claims 8, 24 are objected to for depending on rejected claims.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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