DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 3 August 2026, in the matter of Application N° 18/710,561. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added or canceled.
Claims 1 and 10 have been amended. Claim 1 has been amended to add that the one or more API’s is present in a concentration ranging from 250 mg/mL to 500 mg/mL (25.0-50.0 wt%). Claim 10 has been amended to remove the “preferably” language from the claim.
No new matter has been added.
Thus, claims 1-15 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 112
Applicants’ amendment to claim 10 successfully overcomes the previously raised indefiniteness rejection. Said rejection is withdrawn.
Rejection under 35 USC 102
Applicants’ amendment to claim 1 successfully overcomes the previously raised anticipation rejection. Said rejection is withdrawn.
New Rejections
Applicants’ amendments have necessitated the following grounds of rejection:
Claim Rejections - 35 USC §112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As discussed above, claim 1 has been amended recite an API concentration range of 250 mg/mL to 500 mg/mL. Due to this amendment, claim 5 is now broader in scope, reciting a concentration range of 1 mg/mL to 500 mg/mL for the API component. As such, the claim now fails to further limit its predecessor.
Applicants may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC §103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5, 7-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Beyernick et al. (US Pre-Grant Publication Nº 2010/0062073 A1).
The instantly amended composition is directed to a suspension comprising nanoparticles of one or more active pharmaceutical ingredients (APIs) selected from peptides and proteins, and one or more pharmaceutically acceptable oils, wherein the APIs are present in an amount ranging from 250-500 mg/mL (i.e., 25-50 wt%).
Beyernick discloses preparing an aqueous suspension comprising nanoparticles comprising: a) a poorly water-soluble drug and an enteric polymer, b) casein (protein), and c) water (see e.g., claims 1 and 24). Claim 11 discloses that the nanoparticles may further comprise a surface stabilizer, which is defined further in claim 14 as being selected from polyethylene castor oil. Claim 15 discloses that the composition will comprise 1-60 wt% of said poorly aqueous soluble drug.
The nanoparticles are defined as having a diameter of less than 500 nm and less than 300 nm (see e.g., claims 1 and 25).
Here, casein is defined as being a small protein have a molecular weight ranging from about 10,000 Daltons to about 50,000 Daltons (10-50 kDa). See ¶[0064]. According to a preferred embodiment, casein is present in the practiced nanoparticles in an amount ranging from 5-50 wt%. See ¶[0034].
The foregoing is considered to teach the limitations of claims 1, 2, 5, 7, 8, and 15.
Disclosure of the enteric polymer as part of the nanoparticles is considered to meet the limitations recited by instant claims 9-12.
Disclosure of the surface stabilizer as being polyethylene castor oil is considered to meet the limitations of the recited oil component of claim 1.
Claim 22 discloses that the poorly water-soluble drug may be an inhibitor of cyclooxygenase-2 (aka an enzyme inhibitor), thereby meeting the limitations of claim 9 again.
Based on the foregoing teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition.
MPEP §2144.05(I) state that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In the instant case, the Examiner submits that Applicants’ amendment to claim 1 continues to be rendered prima facie obvious over the teachings of the reference.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 1 May 2026 since the art that was previously cited continues to read on the amended and previously recited limitations.
Claim Rejections - 35 USC §103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Merisko-Liversidge et al. (WO 2003/024425 A1; ISR/IDS reference of record).
The limitations of the claimed composition are discussed above. Claims 3 and 4 further define the oil component (e.g., fish or olive oil), while claim 6 further defines the at least one API.
Merisko-Liversidge discloses a nanoparticulate composition comprising insulin particles and at least one non-crosslinked stabilizer adsorbed on the surface thereof (see e.g., claim 1). The insulin particles are taught as having an effective average particle size of less than five microns and most preferably less than 50 nm (see e.g., claims 1 and 2). Claim 3 discloses that the concentration of insulin in the composition ranges from about 0.5% to about 90% by weight of the total weight of the insulin particles, at least one surface stabilizer, and not including other excipients. Converting weight percentage to concentration (mg/mL), the foregoing concentration is disclosed as ranging from about 5 mg/mL to about 900 mg/mL, thereby necessarily encompassing the instantly recited range. See MPEP §2144.05(I), wherein it states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”
Regarding the remainder of the compositional and “structural” limitations of the composition of claim 1, the reference additionally discloses that the practiced pharmaceutical composition may be formulated as a suspension, and that examples of non-aqueous carriers include such vegetable oils as olive oil (see pg. 15, Section D, first paragraph).
The foregoing is considered to teach and suggest the limitations of claims 1-6 and 15.
The same Section D passage is also considered to teach and suggest the limitations of claims 7-11.
The inclusion of a surfactant is taught as one of several difference pharmaceutically acceptable excipients that may be added to the nanosized particles. Furthermore, the inclusion of the excipients with the nanoparticles such as lecithin as a coating is considered to meet the limitations recited by claims 9-10. The limitations of claim 10, are considered to be met since the reference discloses coating the nanosized particles with a lecithin coating. Said coating is additionally, broadly and reasonably considered as providing a barrier to the practiced nanosized particles which stands in the way of external stimuli that would degrade the particles, thereby meeting the limitations of claim 11.
The limitations of instant claim 13 recite that the composition of claim 1 consists of a suspension consisting of the nanosized particles of one or more API selected from proteins and peptides, and one or more pharmaceutically acceptable oils.
The limitations of instant claim 14 recite that the composition of claim 1 comprising a suspension consisting of the nanosized particles of one or more API selected from proteins and peptides, and one or more pharmaceutically acceptable oils.
Here, the Examiner notes that both claims require a suspension consisting of the API and oil components.
As discussed above, the reference discloses a nanoparticulate composition comprising insulin particles and at least one non-crosslinked surface stabilizer adsorbed on the surface thereof, and that said particles most preferably have an average diameter of less than 50 nm (see e.g., claim 1). The at least one surface stabilizer is further defined as being selected from such compounds as gelatin, casein, and polyoxyethylene castor oil (see e.g., claim 13). Added definitions for the practiced compositions disclose forming suspensions that also contain such oils as olive oil (see pg. 15, Section D, first paragraph).
Based on the combined teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment. Though primarily directed to nanosized particles, the reference also discloses that formulations prepared using said particles includes other such forms as suspensions. The reference also teaches combining the particles with excipients and carriers (i.e., olive oil, lecithin, etc.) in order to produce coated nanoparticles in an oil as instantly claimed.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1-11 and 13-15 under 35 USC 103(a) as being unpatentable over the combined teachings of Merisko-Liversidge et al. have been fully considered, but they are not persuasive.
Applicants’ opening remarks against the rejection attest to the amended limitations of claim 1 being novel over the teachings of the reference.
Here, the Examiner agrees, but points out that novelty is not at issue with respect to the cited reference.
Applicants next assert that the reference fails to render the amended invention obvious since it does not teach or suggest suspending the nanosized API (insulin) to one or more pharmaceutically acceptable oils would be from 250-500 mg/mL.
The Examiner, in response, respectfully disagrees and maintains the rejection for the reasons already of record.
Weighing the remarks of record, the Examiner submits that Applicants’ concede that the amount of API is present in the composition in an amount ranging from about 0.5-90 wt%, based on the total combined dry weight of the insulin particles and at least one surface stabilizer, not including other excipients. [emphasis added]
Here, the Examiner further points out that the other excipients that are excluded from this disclosure are inclusive of the oils that are used as carriers to facilitate suspension of the API, as discussed above (see pg. 15, Section D, first paragraph).
Thus, it is respectfully maintained that the ordinarily skilled artisan, considering the teachings of the reference would understand that adding the oil excipient to the composition (e.g., claim 32) would reduce the weight percent contribution of the active insulin. Such a recalculation based on the amount of oil used would be well within the purview of said artisan.
Regarding Applicants’ alleged advantages, the Examiner lastly points out that Merisko-Liversidge aligns with and discloses these as well. The practiced compositions are taught as protecting insulin from degradation (see e.g., pg. 8, Section A, first paragraph), as well as providing increased bioavailability (see e.g., Abstract).
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
All claims have been rejected; no claims are allowed.
Conclusion
Applicants’ amendments 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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