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 2, 8-9, 12-19, 21-30, and 36-38 are pending.
Applicant’s arguments, filed 09/26/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 8-9, 12-19, 21-30 and 36-38 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.
Claim 2 now reads:
Claim 2 (Currently Amended) A polypeptide formulation consisting of:
a core comprising a polypeptide component consisting of the pharmaceutically active polypeptide; and
a pharmaceutically acceptable shell consisting essentially of lactose, cane sugar, or xylitol that dissolves when placed buccally or sublingually, so that the pharmaceutically active crystallized polypeptide component is released into mouth tissue and is absorbed through such mouth tissue into the bloodstream, such that once in the blood stream, at least 5% bioavailability of administered polypeptide is achieved. (Underlining for emphasis).
The claim is indefinite because its scope is unclear.
Specifically, the recitation of “consisting of” (a closed term) at the first line conflicts with the later recitations of “comprising” (an open term) at line 2 and “consisting essentially of” (a partially open term) at line 4.
Claim 8 is similarly unclear in scope.
Claim 2, , line 2, “the pharmaceutically active” polypeptide lacks antecedent basis; the recitation of “polypeptide” in line 1 does not support the later recitation of “pharmaceutically active”.
Claim 2, line 5, the pharmaceutically active “crystallized” polypeptide lacks antecedent basis; there is no earlier recitation of the polypeptide being crystallized.
Claim Rejections – 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 8-9, 12-16, 19, 21-24, 26, 29-30, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0166914 A1 (Herron et al., 07/01/2010) (hereinafter Herron) in view of US 2014/0162965 A1 (Maggio, 06/12/2014) and US 2006/0178296 A1 (Goldberg et al., 08/10/2006) (hereinafter Goldberg).
The text of previous rejections not included in this action can be found in a prior Office action dated 03/26/2025.
Regarding claims 2 and 8 reciting wherein the pharmaceutically acceptable shell consists essentially of lactose, cane sugar, or xylitol, the Examiner notes that the transitional phrase "consisting essentially of,” absent an otherwise clear indication in the specification or claims of what the basic and novel characteristics actually are, will be construed as equivalent to "comprising." See MPEP § 2111.03(III).
Response to Arguments
Applicant asserts that Herron teaches a shell with multiple ingredients in its examples. Thus, Herron’s shell does not essentially consist of any single ingredient. Nowhere does Herron teach, suggest, or provide motivation to abandon its shell containing a plurality of segments and distinct ingredients to create a shell that is purely one ingredient.
The Examiner does not find the argument persuasive. The present claims do not exclude a shell containing a plurality of segments. Moreover, a prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments and working examples. See MPEP § 2123(I). Therefore the teaching of Herron is not limited to its examples. Herron discloses in para. [0053] where any segments may contain one ingredient, and in para. [0054] that sugars may be included alone. In addition, Herron discloses in para. [0055] where a sugar alcohol such as xylitol may also be used, alone. As such, Applicant’s argument is unpersuasive.
The Examiner notes again that while factual evidence of unexpectedness has been provided by the instantly filed working examples (as was previously acknowledged and discussed during the interview), the probative value of that evidence as compared to the invention as claimed must nevertheless than be determined, i.e., the claims must be “commensurate in scope” with the showing of unexpected results. MPEP § 716.02(d). See also MPEP § 2145.
Commensurateness in scope (see MPEP § 716.02(d)) does not require evidentiary data for every claimed species of the invention; an exemplary showing may be sufficient to establish a reasonable correlation between the showing and the entire scope of the claim, when viewed by a skilled artisan. See MPEP § 2145. Applicant must, however, explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention and to represent the appropriate comparison between the invention claimed and the prior art each as a class”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP § 716.02, citing same. See also In re Greenfield, 571 F.2d 1185, 1189, 197 USPQ 227, 230 (CCPA 1978) (evidence of superior properties in one species insufficient to establish the nonobviousness of a subgenus containing hundreds of compounds).
Note that the claims at issue in In re Greenfield (cited in MPEP § 2145) had a functional limitation which was not explicitly taught in the prior art, which is viewed as being analogous to the fact situation at hand.
The claims as currently drafted do not appear to be reasonably commensurate in scope with the factual evidence presented in the working examples since:
all the working examples use crystallized polypeptides and claim 2 is inconsistently worded with regard to that term as discussed in the indefiniteness rejection supra, such that it is unclear if the term is required (this can be rendered moot by amending the claim to consistently require the term);
all the working examples use truffles or globules which are made of 100% cane sugar, which does not appear to be “reasonably representative” for the other two species, lactose and xylitol (the latter is not even a sugar); see particularly paragraph [0283] of the instant specification; and
3) all the working examples demonstrate not merely at least 5% oral “bioavailability” per se as instantly claimed, but rather an increase of oral bioavailability of least 5% compared to that obtained by injection. See particularly paragraph [0277] of the instant Specification.
None of the independent claims (including neither claim 2 nor claim 8) are limited to 1) crystallized polypeptides, 2) 100 percent cane sugar truffles or globules, and 3) an increase of at oral bioavailability of least 5% as compared to injection, and applicant has not explained how compositions having these three specific features are “reasonably representative” of more generally recited compositions lacking them.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0166914 A1 (Herron et al., 07/01/2010) (hereinafter Herron) in view of US 2014/0162965 A1 (Maggio, 06/12/2014) and US 2006/0178296 A1 (Goldberg et al., 08/10/2006) (hereinafter Goldberg), further in view of “Recent advances in crystalline and amorphous particulate protein formulations for controlled delivery” (Puhl et al., 06/20/2016) (hereinafter Puhl).
The text of previous rejections not included in this action can be found in a prior Office action dated 03/26/2025.
Response to Arguments
Applicant does not present specific arguments with regards to Herron and Puhl. Since the Examiner has discussed Herron above, this rejection is maintained.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0166914 A1 (Herron et al., 07/01/2010) (hereinafter Herron) in view of US 2014/0162965 A1 (Maggio, 06/12/2014) and US 2006/0178296 A1 (Goldberg et al., 08/10/2006) (hereinafter Goldberg), further in view of US 2014/0135263 A1 (Pohl et al., 05/15/2014) (hereinafter Pohl).
The text of previous rejections not included in this action can be found in a prior Office action dated 03/26/2025.
Response to Arguments
Applicant does not present specific arguments with regards to Herron and Pohl. Since the Examiner has discussed Herron above, this rejection is maintained.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0166914 A1 (Herron et al., 07/01/2010) (hereinafter Herron) in view of US 2014/0162965 A1 (Maggio, 06/12/2014) and US 2006/0178296 A1 (Goldberg et al., 08/10/2006) (hereinafter Goldberg), further in view of US 2022/0211070 A1 (Liang, 07/07/2022) (hereinafter Liang).
The text of previous rejections not included in this action can be found in a prior Office action dated 03/26/2025.
Response to Arguments
Applicant does not present specific arguments with regards to Herron and Liang. Since the Examiner has discussed Herron above, this rejection is maintained.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0166914 A1 (Herron et al., 07/01/2010) (hereinafter Herron) in view of US 2014/0162965 A1 (Maggio, 06/12/2014) and US 2006/0178296 A1 (Goldberg et al., 08/10/2006) (hereinafter Goldberg), further in view of US 2006/0204626 A1 (Talbot, 09/14/2006) (hereinafter Talbot).
The text of previous rejections not included in this action can be found in a prior Office action dated 03/26/2025.
Response to Arguments
Applicant does not present specific arguments with regards to Herron and Talbot. Since the Examiner has discussed Herron above, this rejection is maintained.
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 LUCY M TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Friday 10:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/ Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612