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
Claims 1-19 are pending in the application. Claims 1-14 and 16-19 are rejected. Claims 4 and 16-19 are objected to. Claim 15 is withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of Group I, encompassed by claims 1-14 and 16-19, in the reply filed on June 22, 2026 is acknowledged. The absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse. See MPEP § 818.01.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/EP2022/087700, filed on December 23, 2022, which claims priority to EPO Application No. EP21217704.2, filed on December 24, 2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on October 18, 2024 and June 22, 2026 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Specification
(1 of 2) The amendment filed on June 20, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the phrase “the contents of which is hereby incorporated by reference in its entirety.”
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-08.2017]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7, a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18, accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a), (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a), a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i), 20.5(b) or 20.5(c), as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b), 20.4, 20.5(a), (b) and (c), and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) or 20.5(a), as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) or a part of the description, claims or drawings referred to in Rule 20.5(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6, incorporated by reference in the international application for the purposes of Rule 20.6. Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of December 23, 2022.
Specifically, PCT/EP2022/087700 was filed without an “incorporation by reference” statement to the earlier EPO application. Then, Applicant filed a 371 of the PCT and attempted to amend the specification to include the “incorporation by reference” statement via a preliminary amendment filed June 20, 2024, which is after the instant application's International filing date of December 23, 2022. This is considered new matter. MPEP 201.06(c): “An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).”
Applicant is required to cancel the new matter in the reply to this Office Action.
This objection to the specification can be overcome by deleting the phrase “the contents of which is hereby incorporated by reference in its entirety” from the instant specification.
(2 of 2) The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 1, line 26. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawings
The drawings are objected to because the Examiner is unable to differentiate between data provided in the figures. To further improve the clarity and reproducibility of the aforementioned figures, Applicant should submit replacement drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 4 and 16-19 are objected to because of the following informalities:
Claim 4 should be amended to replace the word “and” appearing at the end of the second to last line of the claim with the word “or” for sake of clarity.
Claim 4 and 16-19 should each be amended to replace “the amount” with “the effective amount” for sake of consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3, 4, 7, 13, 14 and 16-19 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 3 recites the limitation “the dihydrochloride salt” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim as parent claim 1 does not provide for a dihydrochloride salt. It is suggested Applicant amend claim 3 to replace “the dihydrochloride salt” with “a dihydrochloride salt” to overcome this issue of indefiniteness.
Claims 4, 7, 13, 14 and 16-19 recite the term “about” and are rejected as indefinite. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how one of ordinary skill could reasonably determine the objective boundaries of the scope of the claims based on the term “about.” A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). For the purposes of examination, each instance of the term “about” is being interpreted as being drawn towards the exact numerical value associated with the recited term in the claim. For instance, “about 10% to about 20% w/v” as recited in claim 14 is being interpreted as a numerical value between 10-20% w/v.
Claim 7 recites the limitation “the amount of the surfactant” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim as parent claim 6 does not provide for any amount of surfactant. It is suggested Applicant amend claim 7 to replace “the amount of the surfactant” with “an amount of the surfactant” to overcome this issue of indefiniteness.
Claim 18 recites the limitation “the amount of the compound of Formula (I) is between about 20% w/v of the composition” and is rejected as indefinite. It is unclear whether Applicant intended “the amount” to be limited to a) about 20% w/v of the composition or b) an undefined % w/v range which includes 20% w/v.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4, 6, 8, 10, 11 and 16-19 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Meyer et al. (PCT Publication No. WO 2018/115432 A2; June 28, 2018).
Meyer et al. teach the following prior art genus (see e.g., page 179):
PNG
media_image1.png
172
472
media_image1.png
Greyscale
.
With respect to the above prior art genus, Meyer et al. teach Compound No. 316 having the following variable definitions (see e.g., page 188) and chemical structure:
PNG
media_image2.png
4
1001
media_image2.png
Greyscale
PNG
media_image2.png
4
1001
media_image2.png
Greyscale
PNG
media_image3.png
177
510
media_image3.png
Greyscale
.
Regarding instant claims 1, 2, 4, 6, 8, 10, 11 and 16-19, the above prior art Compound No. 316 corresponds to the instantly claimed compound of Formula (I). Meyer et al. further teach “a stereoisomer, pharmaceutically acceptable salt...thereof.” See e.g., page 16. Meyer et al. further teach “dosage forms... referred to herein as formulations or pharmaceutical composition[s]...[and] [o]ne dosage route (administration route) is the parenteral, especially injection administration (e.g. subcutaneous injection, intravenous injection, intramuscular injection, etc.).” See e.g., page 152. Meyer et al. further teach “the concentration for injectable... administration is from about...10 to about 50% (by weight)” which encompasses, for instance, the instantly claimed about 15% to about 30% w/v range (instant claims 4 and 16) and also the %w/v values recited in instant claims 16-19. See e.g., page 154. Meyer et al. further teach physiologically acceptable adjuvants [i.e., pharmaceutically acceptable carriers] ... necessary to keep the compound suspended in suspension compositions... [and that] [m]any surfactants are also useful as suspending agents.” See e.g., page 154. Meyer et al. also teach lecithin as a suspending agent/surfactant. See e.g., page 154. Meyer et al. also teach water as a suspending medium for injectable suspension compositions. See e.g., page 154.
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 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.
(1 of 2) Claim 3 is rejected under 35 U.S.C. § 103 as being unpatentable over Meyer et al. (PCT Publication No. WO 2018/115432 A2; June 28, 2018) in view of Berge et al. (J. Pharm. Sci., 1977, 66(1):1-19).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Meyer et al. teach Compound No. 316 having the following chemical structure (see e.g., page 188):
PNG
media_image2.png
4
1001
media_image2.png
Greyscale
PNG
media_image2.png
4
1001
media_image2.png
Greyscale
PNG
media_image3.png
177
510
media_image3.png
Greyscale
.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 3, Meyer et al. does not specifically teach a dihydrochloride salt of the prior art Compound No. 316 [i.e., instant compound of Formula (I)]. However, Meyer et al. does teach suitable pharmaceutically acceptable salts including a “hydrochloric acid salt.” See e.g., page 23. In addition, Berge et al. teach “[s]alt formation is a means of altering the physical, chemical, and biological characteristics of a drug without modifying its chemical structure.” See e.g., page 16.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 3, it would, therefore, have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed dihydrochloride salt of the prior art Compound No. 316 based on the teachings of the prior art. Considering that Berge et al. teach “[d]ifferent salts of the same drug rarely differ pharmacologically; the differences are usually based on the physical properties,” a person of ordinary skill in the art would have good reason to pursue known salt formation options within his or her technical grasp. See e.g., page 5 (quotations omitted). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
(2 of 2) Claim 5, 7, 9, 12 and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over Meyer et al. (PCT Publication No. WO 2018/115432 A2; June 28, 2018) in view of Buss et al. (J Appl Toxicol, 2028, 38:1293-1301), Scheller et al. (MethodsX 1, 2014, 212-216) and Kollisolv P124 data sheet (BASF Technical Information, 2011; retrieved online September 11, 2026).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Meyer et al. teach Compound No. 316 having the following chemical structure (see e.g., page 188):
PNG
media_image2.png
4
1001
media_image2.png
Greyscale
PNG
media_image2.png
4
1001
media_image2.png
Greyscale
PNG
media_image3.png
177
510
media_image3.png
Greyscale
.
Meyer et al. further teach “dosage forms... referred to herein as formulations or pharmaceutical composition[s]...[and] [o]ne dosage route (administration route) is the parenteral, especially injection administration (e.g. subcutaneous injection, intravenous injection, intramuscular injection, etc.).” See e.g., page 152. Meyer et al. further teach “the concentration for injectable... administration is from about...10 to about 50% (by weight)” which encompasses, for instance, the instantly claimed about 10% to about 35% w/v range. See e.g., page 154.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 5 and 13, Meyer et al. does not teach a medium chain triglyceride as a pharmaceutically acceptable carrier. However, Buss et al. teach “Miglyol 812, a mixture of medium chain triglycerides (MCTs)...is a safe excipient for use in subcutaneously administered therapeutics.” See e.g., page 1293.
Regarding instant claims 7, 9, 12 and 13, Meyer et al. does not teach polyethylene glycol (15)-hydroxystearate as a surfactant. Meyer et al. also does not teach benzyl alcohol, a poloxamer 124, a citric acid or mixtures thereof as a surfactant. However, Meyer et al. teach surfactants, such as 10% Poloxamer 188, present in a pharmaceutical formulation. See e.g., page 236. In addition, Scheller et al. teach Kolliphor® HS 15 (i.e., polyethylene glycol (15)-hydroxystearate) as a non-ionic surfactant “that can assist in delivering poorly water-soluble compounds.” See e.g., page 216. In addition, with respect to poloxamer 124, the Kollisolv P124 data sheet discloses that “poloxamers are readily soluble in polar and non-polar organic solvents which allows a wide range of dosage forms to be formulated with these Excipients.” See e.g., page 3.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 5 and 13, it would, therefore, have been obvious to a person of ordinary skill in the art to incorporate medium chain triglycerides, such as the Miglyol 812 taught by Buss et al., in the pharmaceutical composition of Meyer et al. Considering that Meyer et al. teach “[i]njectable suspension compositions employ a liquid suspending medium, with or without adjuvants, as a vehicle” (see e.g., page 154), it would be within the ability of a skilled artisan to form a suspension of the prior art Compound No. 316 in Miglyol 812. At least in the interest of improving pharmacokinetic properties, a person of ordinary skill would be motivated to include a pharmaceutically acceptable carrier such as Miglyol 812 medium chain triglycerides to a pharmaceutical formulation.
Regarding instant claims 7, 9, 12 and 13, it would, therefore, have been obvious to a person of ordinary skill in the art to add a surfactant, such as Kolliphor® HS 15 (i.e., polyethylene glycol (15)-hydroxystearate) or poloxamer 124 to the pharmaceutical formulation of Meyer et al. to, for instance, improve the water solubility of Compound No. 316 or enhance the physical properties of the formulation. In addition, it would have been obvious for a person of ordinary skill in the art to arrive at the instantly claimed about 0.01% to about 1% w/v of polyethylene glycol (15)-hydroxystearate based on the teachings of the prior art. The optimization of result-effective variables, i.e., variables that achieve a recognized result, such as % w/v values, are considered to be within the ability of the skilled artisan. “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.” In re Williams, 36 F.2d 436, 438 (CCPA 1929). Therefore, a skilled artisan would have been motivated to optimize the aforementioned result effective parameters as part of a routine optimization process. “[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).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. 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 1-14 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11/406,617 (“the ‘617 patent”) in view of Berge et al. (J. Pharm. Sci., 1977, 66(1):1-19), Meyer et al. (PCT Publication No. WO 2018/115432 A2; June 28, 2018), Buss et al. (J Appl Toxicol, 2028, 38:1293-1301), Scheller et al. (MethodsX 1, 2014, 212-216) and Kollisolv P124 data sheet (BASF Technical Information, 2011; retrieved online September 11, 2026). Claims 1 and 2 of the ‘617 patent are drawn towards the instantly claimed compound of Formula (I) and are, therefore, generic to subject matter discussed above under 35 U.S.C. § 103 as being obvious. Moreover, Meyer et al. teach “compounds for use in the treatment of respiratory diseases of animals, especially Bovine or Swine Respiratory disease.” See e.g., the abstract. Therefore, instant claim 1-14 and 16-19 would have been obvious in view of claims 1 and 2 of the ‘617 patent for the reasons discussed under 35 U.S.C. § 103, which rationale is incorporated here by reference.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM 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.
/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
Prosecution Insights