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 .
Claims 1-22 are pending and examined on the merits as drawn to the elected peptide SEQ ID NO: 1 (e.g. in claim 10) and the only peptide (anticancer active peptide) found in possession at the time of filing (see also 35 U.S.C. 112(a) Written Description and (b) Indefiniteness rejections below). (Note: A 35 USC 101 judicial exception is not applied though elected peptide SEQ ID NO: 1 is an isolated fragment of naturally occurring peptide, as the peptide is bound to silica, which such is not so modified/found in nature as, rising to something more than the judicial exception of the naturally occurring peptide fragment in-and-of-itself).
Election/Restrictions - Species
Applicant’s election without traverse of species peptide SEQ ID NO: 1 (e.g. in claim 10) in the reply filed on 5/9/25 is acknowledged. The remaining species elections are withdrawn.
Allowable Subject Matter
Elected peptide SEQ ID NO: 1 (e.g. in claim 10) and the only sequenced/supported peptide found in possession at the time of filing; see also 35 U.S.C. 112(a) Written Description rejection below). Were claims 1-22 amended thereto along with amendments and/or arguments addressing all other rejections of record, the application would be in condition for allowance.
Closest Prior Art of Record - Prior Art Made of Record But Not Relied Upon
The closest prior art of record to the elected 20mer peptide SEQ ID NO: 1 (e.g. in claim 10) is deemed that of Majdoul et al. (U.S. Patent No. 11,371,061), teaching a 31mer peptide (peptide SEQ ID NO: 101) of 92.9% identity, a larger peptide fragment of the naturally occurring source peptide and the closest peptide identified. There is no motivation found to isolate the instant peptide SEQ ID NO: 1 as smaller functional peptide fragment thereof.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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.
Claims 1-22 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.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: where on the peptide the silica molecule is bound to peptide SEQ ID NO: 1 via disulfide bond; where the nitrogen-containing group of an aminopropyl and silanol group are each respectively attached on the outer surface of the silica; and where the folic acid – when present since can be as little as 0% technically – is bound on the nitrogen containing group. In other words, how all the parts fit together as a whole so that PHOSITA is apprised as to what falls inside v. outside the metes and bounds of the intended claim scope.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description
The following is a quotation 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.
Claims 1-22 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
1. In this case, there is only possession for elected peptide SEQ ID NO: 1 (e.g. claim 10) as the anticancer peptide drug. The claims are not so amended.
2. In this case, the genus of any configuration is not found in possession as to the peptide bound to silica which is then bound on its outer surface to the remaining elements. Namely, possession is only present for that described as to where on the peptide the silica molecule is bound to peptide SEQ ID NO: 1 via disulfide bond; where the nitrogen-containing group of an aminopropyl and silanol group are each respectively attached on the outer surface of the silica; and where the folic acid – when present since can be as little as 0% technically – is bound on the nitrogen containing group. In other words, how all the parts fit together as a whole so that PHOSITA is apprised as to that which was in applicant’s possession at the time of filing.
as-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
With the exception of that fully described, the skilled artisan cannot envision the detailed chemical structure of the encompassed variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovinesequence.
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654