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 .
Response to Amendment
The amendment filed 10/1/2025 has been entered. Any previous rejection not reiterated herein has been withdrawn.
New grounds of rejection
Claim Rejections - 35 USC § 112
Claim 40 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 term "chemical stapling" as used in claim 40 is unclear. The term is indefinite because the specification does not clearly define the term and the term is not a term of art generally recognized by the prior art. While the specification does discuss chemical staples, etc. this discussion adds more confusion to the term rather than a clear definition. For example, para [0010] appears to suggest that chemical stapling is accomplished merely by having the polypeptide enter the pore of the chaperone while para [0054] appears that it is accomplished with click chemistry. Since there is no clear definition in the specification and the term is not known in the art, it is unclear what is encompassed or excluded by the term “chemical stapling” and thus the metes and bounds of the term are undefined.
Claim Rejections - 35 USC § 103
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 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) 23-30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Won (US 2017/0172923 A1; "Won") in view of Verdine US 20160244494 and/or Ploegh US 20150086576 and Kajihara US 20110262945.
Won teaches a composition and methods for delivering a bioactive material comprising: a porous silica nanoparticle containing pores with an average pore diameter ranging from 1 nm to 100 nm, a surface of the porous silica nanoparticle comprising a pore surface forming the pores and an outer surface; at least one of (i) a functional group that binds to the inner or outer surface of the pore of the porous silica nanoparticle and to give a negative charge or a positive charge (implies hydrophilic if functional group present; hydrophobic if not), (ii) a ligand which binds to the pore surface of the porous silica nanoparticle and specifically binds to the bioactive material, and (iii) a combination of the functional group and the ligand; and a bioactive material having a size to be accommodated within the pores of the porous silica nanoparticle, the bioactive material bound to said at least one of the functional group and the ligand bound to the pore surface of the mesoporous silica nanoparticle and accommodated within the pores of the porous silica nanoparticle (Abstract; 1 0012, 0015, 0052-0056, 0060-0077, 0085-0086, 0098, 0115-0134, and 0140; Example 1; and Tables 4-5). Won further teaches that the composition is prepared in a simple and cost effective way since the protein or the bioactive material may be introduced into a pore of the mesoporous silica nanoparticle by just mixing a solution containing the mesoporous silica nanoparticle and the protein or the bioactive material (1 0015). The porous silica maintains high stability and the function of the bioactive material, and thereby can play a role as a delivering agent acceptable for a therapeutic research (T 0205). Won further teaches a method for delivering a protein to a recipient (e.g., an animal subject) by administering the composition (T 0012, 0051). The bioactive material may be proteins and peptides, and anti-tumor agents (1 0052-0056). The average diameter of the porous silica nanoparticle may be 100 nm - 100 µm, such as 239 nm or 267 nm, and may be controllable (1 0085, 0098, and 0115; and Table 4). The BET surface area may be 388 m²/g, and volume per gram of the pores may be 1.47 mL/g (Tables 3-4). The porous silica nanoparticles are prepared by reacting silica particles having 2 nm pores with ethanol, water, and TMB (swelling agents) at 160°C for 48 hrs., then calcining the porous silica nanoparticles at 120°C for 20 hrs. (Example 1). Regarding claim 27, a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01. In the instant case, because the particles of Won have the identical structure and chemical composition as the claimed artificial chaperone particles, the particles of Won must necessarily have the same chemical and physical characteristics as claimed, absent evidence to the contrary.
Won fails to specifically disclose performing a click reaction to further stabilize the polypeptide to an alpha helix structure as set forth in claim 23.
Won also fails to teach “chemical stapling” or the use of a random coil tertiary structure as set forth in claim 40.
However, the use of a click reaction or “click chemistry” is a very well-known method of stabilizing polypeptides to form an alpha helix as shown by Verdine US and/or Ploegh.
The “chemical stapling” appears to be met by Won (as described in para [0010] or the specification or at least by the click chemistry see [0054], as disclosed hereinbelow).
Verdine teaches that click chemistry can be used to stabilize polypeptides to an alpha helix, see at least [0076], [0106-0107], [0110], [0134], [0177], [0253-0255].
Ploegh teaches that click chemistry or a click reaction is a known means to modify peptides for various reasons, see entire document, especially [0004-0015] and [0073-0100] and can be used to form an alpha helix [0106]. Ploegh also teaches that click chemistry can be used on any polypeptide, see at least [0212].
The limitations of claim 40 are met since the “chemical stapling” (while it is unclear what is meets and bounds or this term encompass) appears to be met by either carrying the polypeptide in the pore of the chaperone as taught by Won and/or by using a chemical click reaction as taught by Verdine and/or Ploegh. This is supported by the following recitations in the spec. see [0010] “The composition according to the above 1, wherein the particles are used to staple the polypeptide supported inside of pores thereof or [0054] “FIG. 13 is diagrams schematically illustrating stapling the polypeptide to porous artificial chaperone particles. As soon as the polypeptide is carried therein, click reaction is performed whereby the polypeptide is stapled to form an irreversible alpha helix structure”.
Further, the limitation of a random coil is a known higher or structure of polypeptides as taught by Kajihara, see [0153]: As used herein, the "higher order structure" of a protein refers to a conformation of a protein encompassing the secondary structure such as a .alpha.-helix and a .beta.-sheet structure or a structure such as a random coil, the tertiary structure in which the secondary structure is spatially folded by a hydrogen bond, a disulfide bond, an ionic bond, a hydrophobic interaction, and the like so as to form a stable conformation, and the quaternary structure which is formed by assembling a plurality of polypeptide chains as subunits.
It would have been obvious before the effective filing date of the claimed invention to modify the methods disclose by Won to include a step of performing a click reaction to further stabilize the polypeptide to an alpha helix structure because the use of a click reaction or “click chemistry” (e.g., chemical stapling) is a very well-known method of stabilizing polypeptides to form an alpha helix as shown by Verdine US and/or Ploegh.
One or ordinary skill in the art would have had a reasonable expectation of success since the click reaction method is well known for modifying and/or stabilizing polypeptides including forming an alpha helix and may be used for any polypeptide as taught by Ploegh including those known to have a random coil tertiary structure which is a known higher structure of a polypeptide, as shown by Kajihara.
Response to Arguments
Applicant’s arguments filed 10/1/2025 have been fully considered but are not found persuasive since what is alleged as missing in the Won reference is addressed in the new grounds of rejection set forth hereinabove.
Conclusion
No claims are allowed at this time.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618