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 .
DETAILED ACTION
This office action is in response to applicant’s filing dated November 15, 2023.
Status of Claims
Claims 1-11 are currently pending and are the subject of this office action.
Claims 1-11 are presently under examination.
Priority
The present application is a 371 of PCT/KR2022/007479 filed on 05/26/2022 and claims priority to foreign application KOREA KR10-2021-0067636 filed on 05/26/2021 and claims priority to foreign application KOREA KR10-2022-0064451 filed on 05/26/2022.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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)(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.
Claim(s) 1-5 and 8-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jung et. al. (US 2022/0387476).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
For claims 1 and 4, Jung teaches a formulation for injection (claim 12) comprising the following Chemical Formula 1:
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a cyclodextrin (see claim 1) and mannitol (an isotonizing agent, see claim 7), wherein the pH is 4.0 to 6.0 (see claim 15)
For claim 2, Jung teaches that the cyclodextrin can be 2-hydroxypropyl-beta-cyclodextrin (see claim 3).
For claim 3, Jung teaches that the cyclodextrin/compound 1 ratio is 4.5 to 15.0 parts by weight (see claim 5).
For claim 5, the prior art does not teach that the formulation has an osmolarity of 100 to 700 mOsmol/L.
However, the osmolality seems to be a property of the above formulation anticipated by Jung. “An osmolarity that ranges between 100 to 700 mOsmol/L” will inevitably flow from the teachings of Jung (see above rejection) since both have the same structural components (an injectable formulation comprising the Chemical Formula 1, a cyclodextrin and the isotonizing agent mannitol, wherein the pH is 4.0 to 6.0).
Apparently, Applicant has discovered a new property ("An osmolarity that ranges between 100 to 700 mOsmol/L”) of the composition anticipated by the prior art (an injectable formulation comprising the Chemical Formula 1, a cyclodextrin and the isotonizing agent mannitol, wherein the pH is 4.0 to 6.0).
MPEP 2112 I states: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112.01 further states: "When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions (in the instant case: the viscosity range of the nasal formulation) are presumed to be inherent”. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulation disclosed by Jung does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the instant formulation is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claim 8, Jung teaches the presence of freeze-drying agents like: mannitol, sucrose, sorbitol or trehalose (see claim 7).
For claim 9, Jung teaches that the freeze-drying aid is contained in an amount of 3.0 to 25.0 parts by weight with respect to 1 part by weight of the compound of Chemical Formula 1 (see claim 8).
For claim 10, Jung teaches that the solvent of the formulation for injection is distilled water, water for injection, acetate buffer or physiological saline (see claim 13).
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.
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.
Claims 1-11 is/are rejected under 35 U.S.C. 103 as being obvious over Jung et. al. (US 2022/0387476).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Jung teaches all the structural limitations of claim 6, except for the pH being 5.0 to 6.0. However, Jung teaches that the pH can be 4.0 to 6.0 (see claim 15), which overlaps with the instantly claimed range (5.0 to 6.0).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re
Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claim 6 with a reasonable expectation of success.
For claim 7¸ before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to formulate the composition without a pH adjusting agent, thus resulting in the practice of claim 7 with a reasonable expectation of success.
For claim 11, Jung teaches that the Chemical Formula 1 is contained in an amount of 5 to 25 mg/ml (see claim 17), which overlaps with the instantly claimed range (1 to 8 mg/ml).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re
Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claim 11 with a reasonable expectation of success.
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.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et. al. (US10,100,010) and (Kim et. al. (WO 2017/164575, September 28, 2017, cited by Applicant), in view of Mehmood et. al. (Open Science (2015) 3:19-27, cited by Applicant) and in view of Loftsson et. al. (Journal of Pharmaceutical Sciences (1996) 85:1017-1025, cited by Applicant).
For claims 1, 6 and 10, Lee teaches compounds of Formula I:
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and in particular compound of example 8 (see column 17):
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which is identical to the instant compound of Formula 1).
Lee further teaches pharmaceutical compositions of the above compounds, wherein the compositions are suitable for parenteral administration such as injection. The pH of the formulations should be suitable adjusted. The composition may be in the form of an aqueous solution containing pharmaceutically acceptable carriers. For intravenous administration, the total concentration of solutes should be controlled in order to render the preparation isotonic (see column 13, line 4-45).
Kim also teaches the above compound and shows that the free base has very low solubility in water (see Table 4 on page 16).
Neither Lee nor Kim teaches the presence of cyclodextrin or a pH of 4.0 to 6.0 (Claim 1) or 5.0 to 6.0 (claim 6). However, Mehmood teaches that pharmaceutical excipients like isotonic agents (see section 3.1 on page 21) and cyclodextrins (see section 3.4 on page 21) are commonly used in injectable formulations. Further, Mehmood teaches that for parenteral preparations, it is desirable that the product pH be close to physiologic pH (see page 22, bottom of the page). Ph between 7.3 and 7.5 is considered a physiological pH.
Finally, Loftsson teaches that cyclodextrins help the solubilization of low water-soluble drugs and their stabilization (see entire document).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to formulate the above compound of Formula 1 as an injectable formulation (as disclosed by Lee and by Kim) with isotonic agents (as disclosed by Lee and by Mehmood) and with cyclodextrin (as disclosed by Mehmood and Loftsson) in order to improve the poor water solubility of the above compound (as disclosed by Kim).
Finally, knowing that the pH of injectable solutions should be close to physiological pH (7.3-7.5), the skilled in the art should be able to optimize the pH of the solution in order to achieve better solubility and stability as taught by Mehmood. Further the pH of 4.0 to 6.0 (Claim 1) or 5.0 to 6.0 (Claim 6) claimed is very close to the physiological pH (7.3-7.5).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claims 1, 6 and 10 with a reasonable expectation of success.
For claim 2, Loftsson teaches that the cyclodextrin could be (2-hydroxypropyl)-beta-cyclodextrin (see page 1018, left column8, lines before the bottom), thus resulting in the practice of claim 2 with a reasonable expectation of success.
For claim 3, Loftsson teaches the solubility enhancement of different cyclodextrin for different drugs at different cyclodextrin concentrations (see table 5 on page 1021 and under Drug Solubilization on page 1020), and since dose formulation is routine practice in the pharmaceutical art, before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to achieve the optimal cyclodextrin/drug ratio in order to obtain an injectable formulation with the best solubility and stability, thus resulting in the practice of claim 3 with a reasonable expectation of success.
For claim 4, Mehmood teaches glycerin and mannitol among the isotonic agents that can be present in injectable formulations (see section 3.1 on page 21), thus resulting in the practice of claim 4 with a reasonable expectation of success.
For claim 5, Lee teaches that for intravenous administration, the total concentration of solutes should be controlled in order to render the preparation isotonic (see column 13, line 4-45). Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to control the osmolarity of the injectable formulation in order to render the preparation isotonic as required by Lee, thus resulting in the practice of claim 5 with a reasonable expectation of success.
For claim 7, none of the references requires the absolute presence of pH adjusting agents, thus resulting in the practice of claim 7 with a reasonable expectation of success.
For claim 8, Mehmood teaches that mannitol is an important agent for lyophilization of formulations (see section 2.1 on page 20), thus resulting in the practice of claim 8 with a reasonable expectation of success.
For claim 9, the prior art does not teach the exact freeze-drying aid to chemical formula 1 ratio. However, optimizing the amount of each excipient to obtain the best possible formulation is no more than routine experimentation, thus resulting in the practice of claim 9 with a reasonable expectation of success.
For claim 11, the prior art does not teach the exact concentration of the chemical formula 1. However, optimizing the amount of drug present in a formulation to obtain the best possible formulation is no more than routine experimentation, thus resulting in the practice of claim 11 with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1) Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/774,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both, the instant application and the co-pending application claim similar or identical formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/560,955 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both, the instant application and the co-pending application claim similar or identical formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February17, 2026.