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 .
The Group and/or Art Unit location of your application in the PTO has changed. All correspondence regarding this application should be directed to Examiner Lori Mattison in Group Art Unit 1619.
DETAILED ACTION
Election/Restrictions
Applicant's election without traverse of the following species:
A) Treatment- method of reducing VEGF;
B) Composition-17-alpha-hydroxyprogesterone caproate (17-OHPC) as the first active agent and budesonide as the second active agent;
C) Administration- the second agent is administered after the first; -and-
D) Disease- Glucocorticoid insensitivity is associated with a disease; in the reply filed on 16 December 2025 is acknowledged.
Claims 31-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 December 2025.
Claim Status
Applicant’s claim amendments in the response filed 16 December 2025 are acknowledged.
Claims 21-41 are pending.
Claims 1-20 are cancelled.
Claims 31-40 are withdrawn.
Claims 21-30 & 41 have been examined on the merits.
Effective Filing Date
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Provisional Application No. 62,195,649, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application.
The prior-filed application does not disclose the concept of reducing vascular endothelial growth factor (VEGF) expression recited in claim 21.
The earliest date available to the pending claims is September 21, 2015 which is contemplated in US SN 14/860,680.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 August 2021 and 28 October 2021 have been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Drawings
The drawings were received on 16 August 2021. These drawings are accepted.
Objections/Rejections
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at paragraph [0008]. 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.
Applicant may wish to consider whether a specification amendment to state:
“http://emedicinedotmedscapedotcom/article/920713-differential” would obviate the objection.
Claim Objections
Claims 28 & 29 are objected to because of the following informalities:
Claim 28 recites “the 17-OHPC “comprises” an amount of from 0.03 mg/L to 0.3 mg/L” (emphasis added). “Mg/L” is a concentration, not an amount. Also, the term “comprising” means “including” (See MPEP 2111.03.I). “the 17-OPHC includes an amount of 0.03 mg/L to 0.3 mg/L” does not make grammatical sense.
Applicant may wish to consider whether an amendment to recite “the 17-OHPC is present in a concentration of 0.03 mg/L to 0.3 mg/L” would obviate the rejection.
Claim 29 recite “the BUD comprises 0.2 g/ml” (emphasis added). The transitional phrase “comprising” means “including” (MPEP 2111. 03 I). What Applicant’s representative appears to be conveying is the concentration of the BUD. Applicant may wish to consider whether a recitation of “the BUD is present in a concentration of 0.2 g/ml” would obviate the objection.
Appropriate correction is required.
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 24-26 & 29 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 pre-AIA the applicant regards as the invention.
Claim 24 recites “a second treatment agent”; this does not make sense because no “first treatment agent” is recited.
If Applicant intended for the “progesterone or a derivative thereof” to be the “first treatment agent”, Applicant should recite it as so in claim 21.
Claims 25, 26 & 29 are rejected under 35 USC 112 (b) because they depend from indefinite claim 24.
Claim 25 recites the limitation "the first treatment agent" in line 2. There is insufficient antecedent basis for this limitation in claim.
Applicant may wish to consider reciting a “first treatment agent” in either claims 21 or 24 from which claim 25 ultimately depends.
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 25 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 25 depends from claim 24. Claims 21 and 24 permit the second treatment agent to be administered at any time relative to the first treatment agent (i.e. before, coincident, or after the administering of the first treatment agent). Claim 25 recites “wherein the second treatment agent is administered before, coincident, or after the administering of the first treatment agent”. Since claim 25 also permits the second treatment agent to be administered at any time relative to the first treatment agent; claim 25 fails to further limit claims 21 and 24. 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 § 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 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim [(Published: 2013); as evidenced by Hong (Published: 10/01/2014)].
Claim 25 Analysis: There are no time limitations which establish the start of the protocol and the time between the first treatment and second treatment.
With regard to the claims 21-26, Kim teaches a patient with a history of asthma that is controlled by budesonide as well as weekly injections of 17 alpha-hydroxyprogesterone caproate for prevention of recurrent preterm birth (i.e. 17 alpha-hydroxyprogesterone caproate is injected weekly followed by later administration of budesonide; pg. 2, col. 1). Note that “a method for reducing vascular endothelial growth factor(VEGF) expression” occurs in the preamble. The claim also does not recite “a patient in need thereof” in the body of the claim to limit the patient to having the disease; this should be recited after the transitional phrase. Furthermore, as evidenced by Hong, amniotic fluid VEGF level (i.e. VEGF expression) is an effective predictor of preterm delivery with increased VEGF levels linked to preterm delivery (pg. 267; Table 1-pg. 267). With regard to claim 21, “Her pregnancy remained uneventful, and she went on to spontaneously vaginally deliver a… male infant… without any complications” (i.e. VEGF reduced and an effective amount of 17 alpha-hydroxyprogesterone caproate was administered; pg. 2, col. 2).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 21-26, 28, 30 & 41 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kim [(Published: 2013); as evidenced by Hong (Published: 10/01/2014)] in view of Du (US 2011/0195031; Published: 08/11/2011; IDS-08/18/2021).
Claims Analysis of Claim 25: As above under 35 USC 102(a)(1).
The teachings of Kim are described above under 35 USC 102(a)(1). Kim teaches the patient received weekly injections of 17 alpha-hydroxyprogesterone caproate (pg. 2, col. 1). The budesonide taught by Kim is a glucocorticoid. With regard to claim 41, Kim teaches the patient had a history of asthma that is controlled by budesonide (pg. 2, col. 1)
Kim does not teach the concentration of the 17 alpha-hydroxyprogesterone caproate nor does Kim teach the patient exhibits symptoms of glucocorticoid insensitivity which is associated with a disease which may be asthma.
With regard to claims 28 & 30, Du teaches methods of using progestogen as a glucocorticoid sensitizer to restore corticosteroid sensitivity or reverse the glucocorticoid insensitivity or enhance glucocorticoid sensitivity (title; abstract). The progestogen may be 17 alpha-hydroxyprogesterone caproate and the glucocorticoid may be budesonide (Du’s claim 20; [0061] & [0070]). With regard to claims 30 & 41, Du teaches the disease for treatment include corticosteroid refractory asthma and glucocorticoid resistant asthma ([0051]; Du’s claim 4). Du teaches injection is a suitable administration mode (Du’s claim 14). With regard claim 28, Du in Fig. 4 teaches 17 alpha-hydroxyprogesterone caproate in a concentration of 10-7 M (i.e. 0.4 mg/L) was most effective in reversing steroid resistance ([0080]; Figure 4; Math: 10-7 mol/L * 428.6 g/mol = 0.4 mg/L).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
With regard to claims 28, 30 & 41, at least rationale (G) may be employed in which it would have been prima facie obvious before the effective filing date to have modified Kim’s method by adjusting the concentration of 17 alpha-hydroxyprogesterone caproate to be 0.4 mg/L (i.e. 10-7 M) and applying the method to a patient having glucocorticoid insensitivity including corticosteroid refractory asthma and glucocorticoid resistant asthma as suggested by Du because Kim and Du are directed to treatment of asthma that is treated with glucocorticoids and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to reverse corticosteroid resistance and treat patients having glucocorticoid insensitivity including corticosteroid refractory asthma and glucocorticoid resistant asthma.
With regard to concentration of 17 alpha-hydroxyprogesterone, the combined teachings of Kim and Du teach a value for the 17 alpha-hydroxyprogesterone concentration which falls within the claimed range. 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).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Du as applied to claims 21-26, 28, 30 & 41 above, and further in view of Service (Published: 08/29/1997).
The teachings of Kim and Du are described above. Kim and Du teach administration of 17 alpha-hydroxyprogesterone caproate to treat asthma. Kim teaches the 17 alpha-hydroxyprogesterone caproate is injected. With regard to claim 27, Du also teaches an inhalation route of administration may be used including an aerosol spray or powder mixture in a pressurized pack or a nebulizer or in an inhaler ([0056]; Du’s claims 17 & 47).
Neither Kim nor Du teach a motivation to select inhalation as the administration method.
With regard to claim 27, Service teaches “drug company executives worry…the complication and expense of injection-not to mention needle phobia-will stunt sales and hurt their bottom line” (pg. 1). “[d]rug companies …are now exploring the possibility of having patients inhale their medicine” (pg. 2).
Here, at least rationale (B) may be employed in which it would have been prima facie obvious before the effective filing date to have modified the method suggested by Kim and Du by substituting injection administration step with an inhalation step as suggested by the combined teachings of Service and Du because Kim, Service and Du are directed towards methods of administering pharmaceuticals and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to “avoid needle phobia” and potential stunting of drug sales as suggested by Service.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Du as applied to claims 21-26, 28, 30 & 41 above, and further in view of Caponetti [(EP 1,683,514; Published: 07/26/2006); as evidenced by Wang (Published: 2011)].
The teachings of Kim and Du are described above. In brief, Kim teaches the patient took budesonide to treat asthma.
Neither Kim nor Du teach the concentration budesonide (BUD) is 0.2 g/L.
In the same field of invention of budesonide, Caponetti teaches inhalatory formulations which may comprise budesonide ([0004] & [0021]). Caponetti teaches “typical inhalatory suspensions of budesonide have a concentration of 0.25…g/L” [0024].
Here, at least rationale (G) may be employed in which it would have been prima facie obvious before the effective filing date to have modified the method suggested by Kim and Du by adjusting the concentration of budesonide to be 0.25 g/L as suggested by Caponetti’s teachings because Kim, Du and Caponetti are directed towards methods of administering budesonide and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to administer budesonide at concentrations “typical” for drug and art recognized as suitable by Caponetti.
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). In the instant case, 0.2 g/L budesonide and 0.25 g/L are expected to have the same property of treating asthma and reduction of IL-17. This assertion is supported by evidentiary reference, Wang which teaches “activation of the IL-17-producing cells may be associated with the neutrophilic inflammatory response and the development of severe forms of asthma” (pg. 6) and the instant specification at Table 2 teaches 0.2 g/L budesonide decreased IL-17 levels in mice (pg. 31). 0.25 g/L is close to 0.2 g/L and there is no reason to assume that the higher concentration of 0.25 g/L would be less effective than 0.2 g/L, particularly since 0.25 g/L rounds down to 0.2 g/L. Further, Caponetti teaches 0.25 g/L is a typical concentration of budesonide used in inhalatory formulations, budesonide is used to treat asthma as taught by Kim, and 0.25 g/L is close to 0.2 g/L.
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 §§ 706.02(l) (1) - 706.02(l) (3) 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).
Claims 21-30 & 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,231,976 (hereinafter ‘976) in view of Kim (Published: 2013), Du (US 2011/0195031; Published: 08/11/2011) and Caponetti (EP 1,683,514; Published: 07/26/2006). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘976 recites a method for the treatment of asthma with glucocorticoid insensitivity condition of administering to a patient, 17 alpha-hydroxyprogesterone caproate and budesonide. The ‘976 recites the composition is an aerosol which reasonably embraces inhalation administration because that is how aerosols are used. The ‘976 does not recite the concentration of 17 alpha-hydroxyprogesterone caproate and budesonide or that the second treatment agent is administered before, concurrent, or after the first treatment agent. The teachings of Kim are described above under 35 USC 102(a)(1) with regard to the order of administration of the first treatment agent/17 alpha-hydroxyprogesterone caproate and second treatment agent/budesonide. The teachings of Du are described above under 35 USC 103(a) with regard to the 17-alpha-hydroxyprogesterone caproate in a concentration of 10-7 M (i.e. 0.4 mg/L) was most effective in reversing steroid resistance ([0080]; Figure 4). The teachings of Caponetti are described above under 35 USC 103(a) with regard to the concentration of budesonide typically used being 0.25 g/L which is close to the recited 0.2 g/L, rendering the 0.2 g/L concentration obvious. It would have been prima facie obvious to the ordinary skilled artisan before for the effective filing date to have modified the method recited by the ‘976 patent by adjusting the amount of 17-alpha-hydroxyprogesterone caproate to be 0.4 mg/L as taught by Du, the concentration of budesonide to be 0.25 g/L as taught by Caponetti and administering the budesonide after administration of 17-alpha-hydroxyprogesterone as taught by Kim because the ‘976, Kim, Du and Caponetti are directed to methods of administering 17-alpha-hydroxyprogesterone and budesonide and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to have art recognized starting points as a place to start dose optimization and art recognized protocol for the order of administering 17-alpha-hydroxyprogesterone caproate and budesonide. With regard to the amount of 17-alpha-hydroxyprogesterone caproate, the combined recitations/teachings of ‘976, Du and Caponetti teach the recited concentration at a value that falls within the claimed range. 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). With regard to the amount of budesonide, the combined recitations/teachings of ‘976, Du and Caponetti teach the typical concentration of budesonide is 0.25 g/L which is close to the claimed range of 0.2 g/L. 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).
The pending claims are therefore an obvious variant of the conflicting, patented claims.
Claims 21-30 & 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,987,361 (hereinafter ‘361). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘361 recites a method for the treatment of a disease with symptoms of glucocorticoid insensitivity including asthma comprising of administering to a patient/subject, 0.03 mg/L to 0.3 mg/L 17 alpha-hydroxyprogesterone caproate and 0.2 g/L budesonide. The ‘361 recites the administration is by inhalation. The ‘361 recites the second treatment agent is administered before, concurrent, or after the first treatment agent. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have looked to the recitations of the ‘361 for guidance for appropriate method steps for administering alpha-hydroxyprogesterone caproate and budesonide and their amounts. With regard to the amount of 17-alpha-hydroxyprogesterone caproate and budesonide, the ‘361 recites the concentrations of these reagents with values which fall within the claimed range. 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). The pending claims are therefore an obvious variant of the conflicting, patented claims.
Claims 21-23, 30 & 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 19-23 of copending Application No. 17/623,331 (hereinafter the ‘331; claims filed 01/15/2026) in view of Du (US 2011/0195031; Published: 08/11/2011). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘331 recites a method of administering hydroxyprogesterone caproate (i.e. 17-alpha-hydroxyprogesterone caproate). The ‘331 does not recite the amount of 17-alpha-hydroxyprogesterone caproate. The teachings of Du are described above in the 35 USC 103 (a) rejections. Du teaches administration of 17-alpha-hydroxyprogesterone (i.e. hydroxyprogesterone) caproate in a concentration of 10-7 M (i.e. 0.4 mg/L) was most effective in reversing steroid resistance ([0080]; Figure 4). It would have been prima facie obvious to the ordinary skilled artisan before for the effective filing date to have modified the method recited by the ‘331 by adjusting the amount of 17-alpha-hydroxyprogesterone caproate to be 0.4 mg/L as taught by Du because the ‘331 and Du are directed to methods of administering 17-alpha-hydroxyprogesterone caproate and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to have art recognized starting points as a place to start dose optimization for administering 17-alpha-hydroxyprogesterone caproate. With regard to the amount of 17-alpha-hydroxyprogesterone caproate, the combined recitations/teachings of ‘331 and Du teach the recited concentration with a value that falls within the claimed range. 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).
The instant claims are therefore an obvious variant of the conflicting, copending claims.
Claims 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 12, 15 & 59-77 of copending Application No. 17/923,539 (hereinafter the ‘539; claims filed 12/18/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘539 recites a method of modulating a cytokine release syndrome by administering 17-alpha-hydroxyprogesterone caproate to a patient/subject and the step of administering a glucocorticoid. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have looked to the recitations of the ‘539 for guidance for administration of the 17-alpha-hydroxyprogesterone caproate to a patient/subject. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to administer 17-alpha-hydroxyprogesterone caproate using methods appropriate to the field. The instant claims are therefore an obvious variant of the conflicting, copending claims.
Claims 21-23, 30 & 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40-42 & 80-82 of copending Application No. 17/923,532 (hereinafter the ‘532; claims filed 11/04/2022). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘532 recites a method of administering 17-alpha-hydroxyprogesterone caproate to a patient/subject to treat a disease or condition associated with glucocorticoid insensitive disease or condition including asthma and the step of administering a glucocorticoid. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have looked to the recitations of the ‘532 for guidance for administration of the 17-alpha-hydroxyprogesterone caproate to a patient/subject. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to administer 17-alpha-hydroxyprogesterone caproate using methods appropriate to the field. The instant claims are therefore an obvious variant of the conflicting, copending claims.
Claims 21-24, 27, 28, 30 & 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-32 of copending Application No. 18/549,968 (hereinafter the ‘968; claims filed 09/11/2023) in view of Du (US 2011/0195031; Published: 08/11/2011). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘968 recites a method of reducing inflammation and fibrosis in the lungs (i.e. pulmonary fibrosis) by administering hydroxyprogesterone caproate (i.e. 17-alpha-hydroxyprogesterone) to a patient and the step of administering a glucocorticoid. The ‘968 recites the oral formulation is a nasal spray (i.e. administering comprises inhalation). The ‘968 does not recite the concentration of hydroxyprogesterone caproate. The teachings of Du are described above in the 35 USC 103 (a) rejections. Du teaches administration of 17-alpha-hydroxyprogesterone (i.e. hydroxyprogesterone) caproate in a concentration of 10-7 M (i.e. 0.4 mg/L) was most effective in reversing steroid resistance ([0080]; Figure 4). It would have been prima facie obvious to the ordinary skilled artisan before for the effective filing date to have modified the method recited by the ‘968 by adjusting the amount of 17-alpha-hydroxyprogesterone caproate to be 0.4 mg/L as taught by Du because the ‘968 and Du are directed to methods of administering 17-alpha-hydroxyprogesterone caproate and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to have art recognized starting points as a place to start dose optimization for administering 17-alpha-hydroxyprogesterone caproate. With regard to the amount of 17-alpha-hydroxyprogesterone caproate, the combined recitations/teachings of ‘968 and Du teach the recited concentration with a value that falls within the claimed range. 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).
The instant claims are therefore an obvious variant of the conflicting, copending claims.
Claims 21-23, 28 & 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 12, 15, 18, 20, 24, 27-30, 33, 35, 39, 41, 50 & 51 of copending Application No. 18/568,788 (hereinafter the ‘788; claims filed 12/08/2023) in view of Du (US 2011/0195031; Published: 08/11/2011). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘788 recites a method for inhibiting tumors (i.e. a disease) by administering hydroxyprogesterone caproate (i.e. 17-alpha-hydroxyprogesterone) to a patient/subject. The ‘788 does not recite the concentration of hydroxyprogesterone caproate. The teachings of Du are described above in the 35 USC 103 (a) rejections. Du teaches administration of 17-alpha-hydroxyprogesterone (i.e. hydroxyprogesterone) in a concentration of 10-7 M (i.e. 0.4 mg/L) was most effective in reversing steroid resistance ([0080]; Figure 4). It would have been prima facie obvious to the ordinary skilled artisan before for the effective filing date to have modified the method recited by the ‘788 by adjusting the amount of 17-alpha-hydroxyprogesterone caproate to be 0.4 mg/L as taught by Du because the ‘788 and Du are directed to methods of administering 17-alpha-hydroxyprogesterone caproate and it is obvious to modify similar methods in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to have art recognized starting points as a place to start dose optimization for administering 17-alpha-hydroxyprogesterone caproate. With regard to the amount of 17-alpha-hydroxyprogesterone caproate, the combined recitations/teachings of ‘788 and Du teach the recited concentration with a value that falls within the claimed range. 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).
The instant claims are therefore an obvious variant of the conflicting, copending claims.
Conclusion
No claims are allowed.
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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