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 .
Applicant’s response (new claim set amendments, arguments, submission of jumbo IDS’s) is acknowledged. New claims 63-71 are now pending after amendments and examined on the merits.
The examiner attempted to reach applicant’s representative (AR) multiple times to address the below objection and rejection, but was unable to reach AR.
The examiner is open to interview to address the below to advance prosecution.
Election/Restrictions – Maintained (Rejoinder After New Rejection Addressed)
Applicant’s election without traverse of the peptide species of SEQ ID NO: 1 (His Aib Gln Gly Thr Phe Thr Ser Asp Tyr Ser Lys Tyr Leu Asp Glu Lys Ala Ala Lys Glu Phe Ile Gln Trp Leu Leu Gln Thr) in the reply filed on 12/4/21 is acknowledged. Per standard species election practice should the species be found allowable the search and examination will proceed to the next species(s).
All of the pending claims read on the elected species and are examined on the merits.
Claim Objections
Claim 63 is objected to because of the following informalities: in line 1, the phrase “any one of” is repeated and one may be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description, New,
Necessitated by Amendment
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.
New claims 63-71 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.
In this case, the new claims recite that the specific “glycolipid surfactant” claimed, also referred to as Z17CO2H in the specification is recited as being open to attachment to any lysine side chain. However, per the specification support and sequence listing (see U.S. Patent Publication No. 20210290732), only certain Lys residues are open for such attachment; see by example peptide sequence listing definition for SEQ ID NOS: 9 and 10 where such may only be bound at the Lys24 or Lys17 respectively; which is mirrored through other sequences. Absent evidence to the contrary, based on the specification and sequence listing support it would appear that as to the specific peptide SEQ ID NOS: 1-10 and 12-27 only certain of these at certain Lys residues (e.g. 24 and 17) may be attached to the claimed glycolipid surfactant Z17CO2H, absent evidence to the contrary, which the examiner is open to weigh. That said, the claim scope would need to be amended to that supported as to the Lys residues for which Z17CO2H may be bound, rather than any Lys residue of any of the sequences, absent a showing of support thereto.
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
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.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 571-272-5548. 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
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