DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
2. Applicant’s election without traverse of Group I, claims 1-11 and 14 in the reply filed on 02/03/2026 is acknowledged.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Status of the claims
3. Claims 1-14 are pending. Claims 1-11 and 14 are currently examined. Claims 12 and 13 are currently withdrawn.
Priority
4. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN 202311045174.5, filed on 08/17/2023.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 10/06/2023 complies with the
provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered on the merits. See attached copies of PTO-1449.
Claim Objections
6. Claim 5 is objected to because of the following informalities: recitation of “the phospholipids is lecithin or soya lecithin” which is improper grammar and should instead recite “the phospholipids are lecithin or soya lecithin”. Appropriate correction is required.
Claim Interpretation
7. Claims 1-11 are drawn to a composition and an intended use of the composition. The recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the limit of the claim (see MPEP §2111.02 II). Therefore, the intended uses of:
“nose-to-brain delivery” recited in the preamble of claims 1-11
“nose to brain delivery” recited in the body of claim 14
“acts as drug reservoirs” recited in the body of claim 11
are not afforded patentable weight when considering the structural limitations of the claimed composition.
Claim Rejections - 35 USC § 112
8. 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 6, 9-11 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 6, which depends from claim 1, recites the limitation "… the formulation of nimodipine of claim 1, characterized in that, the lecithin…", however, claim 1 does not recite the limitation of a lecithin. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, claim 6 will be examined as interpreted to depend from claim 5.
Claim 9, which depends from claim 1, recites the limitation "… parts by weight ethyl oleate", however, claim 1 does not recite the limitation of ethyl oleate. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, claim 6 will be examined as interpreted to depend from claim 2. Claim 10 is included as it depends from claim 9.
9. 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 11 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. Claim 11, which depends from claim 1, recites only an intended use of the composition of claim 1 and therefore does not provide any further structural limitation of the claimed invention. Claim 11 is not further examined. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
10. 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.
The factual inquiries 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. Applicant is 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.
11. Claims 1-10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gizurarson et al., (WO 2008/089426 A2, published July 24, 2008) and in further view of Zuo et al., (WO 2022/068585 A1, published 07/04/2022).
12. Regarding claims 1, 2, 5, and 14, Gizurarson et al., teaches pharmaceutical compositions comprising
(1) one or more therapeutic agents (see pg. 11, para. [0037- pg. 12, para. [0040], including anti-hypertensive agents (see pg. 11, line 14), such as nimodipine (see pg. 12, line 26);
(2) “additional compounds that enhance the solubility of the therapeutic agent” including,
(2a) “other solubilizers” (see pg. 20, lines 22-23), including diethylene glycol monoethyl ether (i.e., the solvent of the instantly claimed invention) (see pg. 20, lines 24-25);
(2b) esters, including ethyl oleate (i.e., the diluent of the instantly claimed invention) (see pg. 20, lines 19-20); and
(3) absorption promoters, including the phospholid lecithin (see pg. 19, lines 9-11).
13. Regarding claims 3, 4, 9, 10, Gizurarson et al., teach that the therapeutic agent (e.g., nimodipine) can comprise “about 0.001% (w/v)[weight by volume] to about 20% (w/v) of the composition (see pg. 8, lines 10-12). Gizurarson et al. further teaches the solubilizer diethylene glycol monoethyl ether (i.e., the solvent of the instantly claimed invention) can be “present in an amount of from about 0.1% (w/v) to about 50% (w/v)” (see pg. 20, lines 30-31). The amount of nimodipine required by instant claim 3 is 4-50 parts by weight, which can overlap with the range of amounts taught by Gizurarson et al. The amount the solvent required by instant claim 3 is 5-300 parts by weight, which can overlap with the range of amounts taught by Gizurarson et al. For example, a composition based on the teachings of Gizurarson et al. may comprise 4mg nimodipine and 20mg of diethylene glycol monoethyl ether out of 100mL volume (i.e., 4% w/v and 20% w/v, respectively) which reads on 4 parts by weight and 20 parts by weight, respectively, of the instantly claimed invention.
Therefore, it would be prima facia obvious to one of skill in the art at the time of filing of the instant application to make a composition comprising an amount of nimodipine and diethylene glycol monoethyl ether according to the teachings of Gizurarson et al. that read on the claimed range of the instant application where the ranges overlap and where there is no showing of criticality of the higher end point of the instantly claimed range. See MPEP 2144.05 (I) and In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
14. However, Gizurarson et al. is silent with respect to the concentrations (e.g., the parts by weight) of the diluent (i.e., ethyl oleate), and absorption enhancer (i.e., lecithin).
MPEP 2144.05 (II) states “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” and, the instant application fails to provide evidence that the claimed 500-900 parts by weight of diluent and 20-200 parts by weight of absorption enhancer required by claim 3 is critical.
See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382, “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”
Thus, based on the teachings of Gizurarson et al., it would be prima facia obvious to one of skill in the art at the time of filing of the instant application to make a composition comprising amounts of a diluent and an absorption enhancer that read on the claimed weight ratios of the instant application.
15. Regarding claims 6, as discussed above, Gizurarson et al. teach compositions which comprise lecithin but is silent on the specific lecithin agents recited in the instant claim 6. However, Zuo et al., (WO 2022/068585 A1, published 07/04/2022) is directed to pharmaceutical phospholipid complexes for improved stability and fat solubility of medicines and discloses the use of phospholipid egg yolk lecithin E80 (see paras. [0009] –[0011] and Examples 1-3). Zuo et al. further discloses the substitution of lecithin E80 with egg yolk lecithin PL-100M (see para. [0095] and Example 4).
Where a single prior art reference discloses a genus encompassing the claimed species or subgenus but does not expressly disclose the particular claimed species or subgenus, an additional prior art reference can be used to show the differences between the primary reference and the claimed invention is obvious (see MPEP § 2144.08). Therefore, the use of lecithin E80 and lecithin PL100M of instant claim 6 are obvious based on the of the compositions comprising lecithin as taught by Gizurarson et al. and in further view of the use of lecithin E80 and lecithin PL100M in pharmaceutical compositions as taught by Zuo et al.
16. Regarding claims 7 and 8, compositions based on the teachings of Gizurarson et al. “may also include a sweetener or flavoring agent” (see pg. 21, para. [0052]). For example, the composition may include an aromatic or aromatic elixir, or lemon oil, orange oil, cherry juice, raspberry juice, citric acid syrup, wild cherry syrup, or combinations thereof. Based on the teachings of Gizurarson et al., it would be prima facia obvious to one of skill in the art to substitute one fruit flavoring agent additive (i.e., grape essence) for anther flavoring agent additive (e.g., the aromatics, elixirs, oils, juices, or syrups disclosed in Gizurarson et al.) of a different fruit (e.g., orange, lemon, cherry, raspberry) for the same purpose (i.e., adding an aroma or a fruit flavor to the composition) with a reasonable expectation of success (see MPEP § 2144.06 II). Therefore, the compositions taught by Gizurarson et al. read on instant claims 7-8.
Conclusion
17. Claims 1-11 and 14 are rejected. No claims are allowed in this action.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN JEROME FOWLER whose telephone number is (571)272-0195. The examiner can normally be reached Monday - Friday 9-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALAN J FOWLER/ Examiner, Art Unit 1691
/RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691