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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-11; drawn to a membrane rupture solution) in the reply filed on May 15, 2026, is acknowledged.
Claims 12-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II-IV), there being no allowable generic or linking claim.
Applicant further elected the following species:
a. TDA9 as the ethoxylated alcohol
b. polysorbate 20 as the sorbiton ethoxylate
c. poloxamer 188 as the triblock copolymer
DETAILED ACTION
The amended claims filed on July 16, 2021, have been acknowledged. Claims 3-5, 10, 12-14, 16, 18, 21-36, 40, 42, and 47-50 were cancelled. Claims 1, 6-9, 15, 17, 19, 37-39, 41, 43, 46, and 51 were amended. In light of the Applicant’s elected species, claims 6, 8, 17, 19-20 (the limitations of claims 6, 8, 17, and 19-20 are not clearly present in SEQ ID NO: 1), 39, 41, 43, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2, 7, 9, 11, 15, 37-38, 44, 46, and 51 are pending and examined on the merits.
Notice of Non-responsive Amendment
The reply filed on April 12, 2023, is not fully responsive to the prior Office Action because of the following omission(s) or matter(s): the claims are not considered to be in compliance with 37 CFR § 1.121, recited here:
§ 1.121(c) Manner of making amendments in applications.
Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of "canceled" or "not entered" may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(c)(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn— currently amended.”
The claim amendment submitted April 12, 2023, does not list claim 1 as having been amended compared to the original claim set submitted on October 14, 2021, nor does it identify the changes that were made even though claim 1 has been amended. While it would be appropriate to reject entry of the present amendment for noncompliance with 37 CFR § 1.121, applicant is instead respectfully reminded to properly note the status of each and all claims previously presented in order to avoid the issuance of a Notice of Non-Compliant Amendment, which would delay prosecution and potentially have an adverse effect on any patent term adjustment should the claims proceed to issue.
Priority
The applicant claims domestic priority from U.S. provisional application No. 63/091,718, filed on October 14, 2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-11 receive domestic benefit from U.S. provisional application No. 63/091,718, filed on October 14, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on July 27, 2023, and April 15, 2025, have been considered.
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 1-11 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.
Claims 1, 5-6, and 8 recite the limitation "the nonionic detergent" in line 1 while claim 1 recites “one or more purified non-ionic detergents”. There is insufficient antecedent basis for this limitation in the claim. As claim 1 recites “one or more purified non-ionic detergents”, the claims can be interpreted to require a single purified non-ionic detergent or multiple purified non-ionic detergent. Therefore, it is unclear whether the non-ionic detergent of claims 1, 5-6, and 8 involve a single non-ionic detergent or multiple non-ionic detergent, thus, rendering the claims indefinite. Furthermore, the limitation "the nonionic detergent" does not identify whether it is a purified non-ionic detergent while claim 1 recites “one or more purified non-ionic detergents”. Therefore, it is unclear whether the non-ionic detergent is the purified detergent(s) or a separate non-ionic detergent that is not required to be purified.
Claims 2-11 are also rejected because of their dependency on claim 1.
Claim 1 recites that “a scavenger, in a concentration in a range of 0% to about 2%”. This language encompasses 0% scavenger in the solution. However, claim 1 does not recite that the scavenger is optional. Therefore, it I unclear whether the scavenger is required as identified by the “A membrane rupture solution comprising: … a scavenger” language or is optional as identified by the 0% language.
Claims 2-11 are also rejected because of their dependency on claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 7, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chinese Patent Application No. CN111721705 (Machine Translation provided).
As initial matters, regarding the limitation in claim 1 “A membrane rupture solution”, this limitation is considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. See MPEP 2111.02. Furthermore, as per the 112b above, the claim language “a scavenger, in a concentration range of 0% to about 2%” is considered to encompass solutions without scavenger as the claim includes 0% scavenger. As such, the claim is considered to only require a solution comprising one or more of the claimed purified non-ionic detergents, wherein the detergent is in a concentration range from about 0.01% (w/v) to about 2.0% (w/v).
‘705 teaches a solution comprising the following components in percentage by mass: a 0.01 to 1% of buffer solution; 0.01 to 0.5% of organic solvent; 0.1 to 0.8% of surfactant; 0.005 to 0.05% of chelating agent; 0.01 to 1% of stabilizer; and 0.02 to 1% of bacteriostatic agent. ‘705 teaches that the surfactant is poloxamer 188, that the chelating agent is EDTA, and that the stabilizer is magnesium chloride and sodium chloride (abstract and page 3, paragraphs 3-5 of the Machine Translation).
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by United States Patent No. 8071667 (Furman).
As initial matters, regarding the limitation in claim 1 “A membrane rupture solution”, this limitation is considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. See MPEP 2111.02. Furthermore, as per the 112b above, the claim language “a scavenger, in a concentration range of 0% to about 2%” is considered to encompass solutions without scavenger as the claim includes 0% scavenger. As such, the claim is considered to only require a solution comprising one or more of the claimed purified non-ionic detergents, wherein the detergent is in a concentration range from about 0.01% (w/v) to about 2.0% (w/v).
Furman teaches that the composition of this invention includes one or more surfactants to emulsify the poly alpha olefins in water and form a stable dispersion. Furman teaches that the surfactants can be Tween-20 (also known as polysorbate 20) and TDA-9. Furman teaches that the composition can comprise about 75 wight percent of the alpha olefins and 25 weight percent of the one or more surfactants. The composition is diluted with water to prepare an aqueous composition comprising about 0.01 to about 2 percent by weight of the poly alpha olefin-surfactant composition (column 3, line 26-column 4, line 32). A 1% poly alpha olefin-surfactant composition with 25% surfactant would equate to a surfactant concentration of 0.25% in the aqueous solution. The surfactant concentration of 0.25% in the aqueous solution can include more than one surfactant and would also encompass wherein the TDA-9 concentration is 0.05% and polysorbate 20 concentration is 0.2% as these concentration fall within the range of identified surfactant concentrations of Furman.
MPEP 2131.03(II) discloses that: When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with "sufficient specificity to constitute an anticipation under the statute." What constitutes a "sufficient specificity" is fact dependent. If the claims are directed to a narrow range, and the reference teaches a broader range, other facts of the case, must be considered when determining whether the narrow range is disclosed with "sufficient specificity" to constitute an anticipation of the claims. Compare ClearValue Inc. v. Pearl River Polymers Inc., 668 F.3d 1340, 101 USPQ2d 1773 (Fed. Cir. 2012) with Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006). Furman is considered to provide sufficient specificity regarding the range of concentrations for the surfactant and is considered to anticipate the claimed concentrations of TDA-9 and polysorbate 20.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8288348 (Chang).
As initial matters, regarding the limitation in claim 1 “A membrane rupture solution”, this limitation is considered to be an “intended use” of the claimed composition, and not found to add any structural limitations. See MPEP 2111.02. Furthermore, as per the 112b above, the claim language “a scavenger, in a concentration range of 0% to about 2%” is considered to encompass solutions without scavenger as the claim includes 0% scavenger. As such, the claim is considered to only require a solution comprising one or more of the claimed purified non-ionic detergents, wherein the detergent is in a concentration range from about 0.01% (w/v) to about 2.0% (w/v).
Chang teaches an emulsion comprising cyclosporin A, an oil, and a surfactant. Chang teaches that the surfactant may be selected from TDA-9 (column 5), polysorbate 20 (column 21), and poloxamer 188 (column 3) (column 1, line 21-column 21, line 19).
Chang does not teach the concentrations used for TDA-9, polysorbate 20, and poloxamer 188 in their composition.
However, Chang does teach using 0.2% polysorbate 80 in a representative composition (column 25, lines 25-31).
As Chang identifies that polysorbate 80 and polysorbate 20 are known alternative sorbitan esters (column 21, lines 7-19), it would have been well understood that a similar concentration could be used for both compounds. As such, it would be reasonable to use 0.2% polysorbate 20 in the cyclosporin composition. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Furthermore, as Applicant does not define about, a reasonable definition for about would be ±20% as it is a routinely used definition for about. About 0.25% (±.05) would encompass 0.2%.
16. Claims 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8288348 (Chang) as applied to claim 1 above and further in view of United States Patent No. 5858401 (Bhalani).
The teachings of Chang are as discussed above.
Chang does not teach wherein the cyclosporin emulsion composition comprises more than one surfactant.
However, Bhalani teaches a mixture of cyclosporin, a polar lipid, and at least one surfactant to form a fine emulsion. Bhalani teaches that the one of the surfactants can be polysorbate 20. The surfactants may be used singly or in combination. However, any surfactant, and any concentration of surfactant, can be utilized that enables self-emulsification of the composition when the composition is added to an aqueous solution (column 2, line 29-column 4, line 13).
As Chang teaches that TDA-9, polysorbate 20, and poloxamer 188 are all viable alternative surfactants to create an emulsified cyclosporin composition and Bhalani teaches that more than one surfactant, including polysorbate 20, can be used to generate a fine emulsion of a cyclosporin composition, it would have been obvious that TDA-9, polysorbate 20, and poloxamer 188 could be added together as part of the cyclosporin emulsified composition. Regarding the concentrations of the individual surfactant components, Bhalani teaches that any concentration of surfactant can be used that leads to an emulsified cyclosporin composition. Chang already identifies that 0.2% polysorbate 80 can be used to generate an emulsified cyclosporin product and identifies that the polysorbate 80 concentration can be readily adjusted according to the example formulations in the table seen in columns 23-26. Therefore, it would be reasonable to generate a combined surfactant concentration that is also about 0.2%. As Chang identifies that polysorbate 80 and polysorbate 20 are known alternative sorbitan esters (column 21, lines 7-19), it would have been well understood that similar concentrations could be used for both compounds. Regarding the concentrations of TDA-9 and poloxamer 188, although concentrations for these compounds are not identified in Chang, one of ordinary skill in the art would envision the possibility of using about 0.05% TDA-9 and 0.005% poloxamer 188 as part of the combined surfactant concentration as there are a finite number of combined concentrations of the three surfactants to reach a concentration of about 0.2% in the emulsified cyclosporin composition.
Furthermore, MPEP 2144.05 discloses that generally, 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. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); 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."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8288348 (Chang) and United States Patent No. 5858401 (Bhalani) as applied to claims 1 and 8 above, and further in view of United States Patent Application No. 20060148982 (Uchegbu).
Uchegbu teaches a pharmaceutical composition comprising cyclosporin, polyethylenimine, and a pharmaceutically acceptable carrier, such as an emulsion. Uchegbu teaches that their polyethylenimine can mitigate some of the slubility issues associated with cyclosporin. Uchegbu teaches that the polyethylenimine can be at a concentration of 0.1 w/v (paragraphs 0001-0090).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the polyethylenimine of Uchegbu with the cyclosporin emulsion composition of Chang and Bhalani to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because Chang, Bhalani, and Uchegbu are all interested in increasing the solubility of cyclosporin to use as a pharmaceutical composition. Furthermore, Uchegbu directly identifies that their polyethylenimine can be used with emulsions and cyclosporin. As the emulsion and the polyethylenimine are known to improve the solubility of cyclosporin, it would be obvious to use them together to further improve solubility. Furthermore
MPEP 2144.06 states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631
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