DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 15-32 are pending. Claims 1-14 and 33-122 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/CN2021/134828, filed on December 1, 2021. This application also claims the benefits of foreign priority to CN202011388458.0, filed on December 1, 2020 and CN202111428491.6 filed on November 29, 2021.
It is noted, however, that applicant has not provided English translated versions of the certified foreign priority documents.
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.
Information Disclosure Statement
The information disclosure statement filed on July 9, 2025 lists the following references:
CN103582484A
CN108367012A
CN102811730A
WO2017053416A1
Examiner did not consider the three China patent applications because no English-translated version was provided. Examiner could not locate the WIPO document in the file wrapper and, hence, did not consider this reference. All other references were considered.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 15-17 and 23-27 are objected to because of the following informalities:
In claim 15:
“Method of treating pulmonary disease” should read “A method of treating pulmonary disease”
In claim 16:
“wherein said method does not comprise the step of” should read “wherein said method does not further comprise a step of”
In claim 17:
“wherein said method comprises the step of” should read “wherein said method further comprises a step of”
For consistency, claim 23 should read:
“The method according to claim 15, wherein the hydroxyprogesterone caproate is administered 1-7 times per week.”
Claims 24-27 should read:
“… wherein said treating pulmonary disease further comprises…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
When the “treating pulmonary disease” is c) inhibiting pro-fibrotic factors and inflammatory cytokines, and/or type I collagen; and/or increasing levels of anti-fibrotic factors, the instant specification only provides written support for instant claims 15-23 (see instant specification, para. 0106-0116).
There is no written description support for instant claims 24-31 when the “treating pulmonary disease” is c) inhibiting pro-fibrotic factors and inflammatory cytokines, and/or type I collagen; and/or increasing levels of anti-fibrotic factors.
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 19-23, and 28-31 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.
Regarding claim 19, the phrases "preferably" and “particularly preferred” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 19 further recites “wherein the dosage form of hydroxyprogesterone caproate…” Claim 19 is dependent on claim 15 which does not disclose “a dosage form of hydroxyprogesterone caproate.” Thus, there is insufficient antecedent basis for this limitation in claim 19. To avoid a 112(b) issue, claim 19 should recite “The method according to claim 15, wherein the hydroxyprogesterone caproate is in a dosage form selected from the group consisting of an injectable, oral or topical formulation”
Claim 20, which is dependent on claim 19, is also rejected for further requiring and/or reciting the indefinite limitation of claim 19.
Claim 21 recites “wherein the dose of hydroxyprogesterone caproate…” Claim 21 is dependent on claim 15 which does not disclose “a dose of hydroxyprogesterone caproate.” Thus, there is insufficient antecedent basis for this limitation in claim 21. To avoid a 112(b) issue, claim 21 should recite “The method according to claim 15, wherein the hydroxyprogesterone caproate is administered at a dose of 30-100 mg/day, or 250-750 mg/week.”
Regarding claims 22, 23, 28, and 29, the phrases "preferably" and/or “more preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 22 further recites “wherein the daily dose of hydroxyprogesterone caproate…” Claim 22 is dependent on claim 15 which does not disclose “a daily dose of hydroxyprogesterone caproate.” Thus, there is insufficient antecedent basis for this limitation in claim 22. To avoid a 112(b) issue, claim 22 should recite “The method according to claim 15, wherein the hydroxyprogesterone caproate is administered at a daily dose of 20-80 mg/kg.”
Claim 30 recites the limitation "wherein said treatment of abnormalities of lipid metabolism during pulmonary disease is reduced.” Claim 30 is dependent on claim 17 which does not disclose a “treatment of abnormalities of lipid metabolism during pulmonary disease.” Thus, there is insufficient antecedent basis for this limitation in claim 30.
Claim 31, which is dependent on claim 30, is also rejected for further requiring and/or reciting the indefinite limitation of claim 30.
Note on 35 USC § 102 and § 103 Rejections
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.
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.
(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.
102 Rejection – Part 1:
Claims 15-17, 19, 20, 23-25, 28, 29, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Du et al. (Du) (US20160045517A1; published February 18, 2016).
Du discloses a study on a mouse model system for chronic obstructive pulmonary disease (COPD) (para. 0085-0088). In this study, the mice were either in a control group or exposed to:
O3 only
O3 + hydroxyprogesterone caproate (herein, referred to as 17-HPC) (either at a low or high concentration)
O3 + Budesonide (herein, referred to as BUD) or
O3 + BUD + 17-HPC (wherein the 17-HPC is at a low or high concentration).
“The study drugs were given daily with concurrent ozone exposure” (para. 0085, 5th to last sentence).
The study demonstrated that 17-HPC “has a dramatic effect in lowering IL-17 levels in both BALF [i.e., bronchoalveolar lavage fluid] and [blood] serum” of the mice model for COPD. Also, increasing doses of 17-HPC results in a corresponding reduction of IL-17 and IL-17 levels gradually returning to within the range of the control mean values under the combined treatment of 17-HPC and BUD (para. 0088 and Table 2).
Note:
BUD is a glucocorticoid (see Szefler, pg. S181, “Conclusions” section, first sentence).
Szefler (Szefler, Z. J. Pharmacodynamics and pharmacokinetics of budesonide: A new nebulized corticosteroid. J Allergy Clin Immunol 1999, 104, S175-S183.)
IL-17 (i.e., interleukin-17) is a pro-inflammatory cytokine (see Moseley, abstract, 1st sentence), a pro-fibrotic factor (see Gurczynski, pg. L9, left col., 2nd paragraph, sentences 1-3), and induces collagen deposition (see Vroman, Fig. 1 caption, last sentence).
Moseley et al. (Moseley) (Moseley, T. A. et al. Interleukin-17 family and IL-17 receptors. Cytokine and Growth Factor Reviews 2003, 14, 155-174.)
Gurczynski et al. (Gurczynski) (Gurczynski, S. J. et al. IL-17 in the lung: the good, the bad, and the ugly. Am J Physiol Lung Cell Mol Physiol 2018, 314, L6-L16.)
Vroman et al. (Vroman) (Vroman, H. et al. Mode of dendritic cell activation: The decisive hand in Th2/Th17 cell differentiation. Implications in asthma severity? Immunobiology 2015, 220, 254-261.)
In other words, Du discloses a method of treating pulmonary disease wherein the method comprises daily administration of:
17-HPC without a glucocorticoid (i.e., a drug comprising only 17-HPC), or
17-HPC with a glucocorticoid (i.e., BUD)
(wherein the medicine was aerosolized and inhaled by subject; similar function as a nasal spray)
to pulmonary disease patients (i.e., mice) wherein the treating pulmonary disease comprises (c) inhibiting pro-fibrotic factors and inflammatory cytokines (i.e., IL-17). As stated above, since it is known that IL-17 induces collagen deposition, inhibiting IL-17 would also result in reducing collagen deposition in the lungs and symptoms of inflammation and fibrosis in the lungs (reads on instant claims 15-17, 19, 20, 23-25, 28, 29, and 32).
102 Rejection – Part 2:
Claims 15-17, 19-26, 28, 29, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Du et al. (Du – 660A) (CN113616660A; published November 9, 2021)
US patent application no. US20230181599A1 corresponds to CN113616660A. Hence, Examiner will refer to the former document for the English-translation.
Du – 660A discloses an in vivo study on a rat model system for chronic obstructive pulmonary disease (COPD) (Example 1 – Pharmacodynamic Study of 17-HPC in Smoke Exposure-Induced COPD Rats). Du discloses the following results:
“17-HPC, BUD, and 17-HPC+BUD all reduced the percentage of neutrophils in rat BALF” (i.e., inflammatory cell counts in BALF is reduced) (para. 0167)
“different doses of 17-HPC and BUD can downregulate TNF-a, IL-1ẞ, IL-6 and IL-17 levels in the BALF. Serum TNF-a, IL-1ẞ, IL-6 and IL-17 levels were also downregulated in the treatment groups in a dose-dependent manner” (i.e., pulmonary disease in a rat was treated by inhibiting pro-fibrotic factors and inflammatory cytokines upon administration of 17-HPC to the rat) (para. 0168)
Du – 660A also discloses oral formulations of 17-HPC (Example 3) and 17-HPC formulation dosing guides (e.g., Table 12 and 13).
Hence, Du – 660A reads on instant claims 15-17, 19-26, 28, 29, and 32.
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.
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.
103 Rejection – Part 1:
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over:
Du et al. (Du) (US20160045517A1; published February 18, 2016) and
Lee et al. (Lee) (US20110262502A1; published October 27, 2011)
The teachings of Du as they apply to claims 15-17, 19, 20, 23-25, 28, 29, and 32 are as discussed in “102 Rejection – Part 1” and incorporated herein.
Du does not disclose the administration of 17-HPC and a glucocorticoid to a subject to treat pulmonary disease in said subject wherein the glucocorticoid is dexamethasone. Lee is relied upon for this disclosure.
The invention of Lee relates to 17-HPC pulmonary formulations for administration by inhalation comprising 17-HPC and a pharmaceutically acceptable excipient (abstract). “Inhalation formulations may be used for the treatment of glucocorticoid-insensitivity related diseases or disorders, or conditions, including, but not limited to, … interstitial lung disease…, interstitial pulmonary fibrosis, … desquamative interstitial pneumonia refractory to corticosteroid, and other inflammatory diseases, autoimmune diseases, hyperproliferative diseases, and other such disease when glucocorticoid-insensitivity is implicated (para. 0069).
Lee also discloses positive results from multiple in vitro studies that involve combining peripheral blood mononuclear cells (i.e., PBMCs) from male smokers with 17-HPC and/or dexamethasone (See Examples 1-7). For example, Example 7 discloses how “the combination of 17-HPC with dexamethasone consistently increases dexamethasone’s anti-inflammatory effects [in PBMCs), and is better than their uses individually” (para. 0140).
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to administer 17-HPC and/or dexamethasone (instead of BUD as the glucocorticoid) to the COPD mouse model. One of ordinary skill in the art would have been motivated to make such a modification since Lee has demonstrated that there is synergy between 17-HPC and dexamethasone in increasing the anti-inflammatory effects in PBMCs of male smokers.
103 Rejection – Part 2:
Claims 19-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over:
Du et al. (Du) (US20160045517A1; published February 18, 2016) and
(Makena) (Makena® FDA drug label; revised August 2013).
The teachings of Du as they apply to claims 15-17, 19, 20, 23-25, 28, 29, and 32 are as discussed in “102 Rejection – Part 1” and incorporated herein.
Du does not disclose the dosing of 17-HPC. Makena is relied upon for this disclosure.
Makena® is a branded formulation of 17-HPC and teaches the typical dosing regimen of 250 mg administered intramuscularly once weekly. This dosage, frequency, and route of administration are encompassed by instant claims 19-21 and 23.
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to administer 17-HPC to pulmonary disease patients using the typical dosing regimen taught by Makena as a method of treating pulmonary disease in said patient. One of ordinary skill in the art would have found it obvious to try this dosing regimen since it is an FDA-approved regimen and would have been understood to be safe for administration in humans.
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.
Claims 15-26, 28, 29, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-16 of U.S. Patent No. 10231976B2 (‘976B2)
claims 1-10 of U.S. Patent No. 10987361B2 (‘361B2)
claims 1-8 of U.S. Patent No. 10993879B2 (‘879B2)
claims 1, 2, 4, 6, 7, 9, 15-25, 28-36, 40-42, 66, 80-82, and 91 of U.S. Patent Application No. 17923532 (‘532).
The claim set of ‘976B2 is directed towards a method for the treatment of pulmonary diseases (i.e., asthma or chronic obstructive pulmonary disorder) and/or glucocorticoid insensitivity conditions in a patient wherein the method comprises administering to said patient a pharmaceutical composition comprising 17-HPC.
The specification of ‘976B2 also recites:
“Yet other embodiments of the present invention are directed to methods for… treating one or more conditions selected from the group consisting of corticoid resistant diseases, corticosteroid refractory, corticosteroid-dependent immune-inflammatory disorders, and combinations thereof. Certain exemplary glucocorticoid resistant conditions include, but are not limited to… interstitial pulmonary fibrosis” (col. 6, lines 31-43).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to administer 17-HPC to patients with pulmonary fibrosis, for example, as encompassed by the instant claim set.
The claim set of ‘361B2 is directed towards a method for the treatment of pulmonary diseases (i.e., asthma, obliterative bronchitis, or chronic obstructive pulmonary disorder) in a patient wherein the method comprises administering to said patient a pharmaceutical composition comprising a first treatment agent comprising 17-HPC and a second treatment agent comprising budesonide, and wherein the disease is mediated by interleukin-17.
The specification of ‘361B2 also recites:
“IL-17 has also been implicated in other diseases. B cell activating factor is central to bleomycin- and IL-17-mediated experimental pulmonary fibrosis” (col. 4, lines 17-20).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to administer 17-HPC to patients with pulmonary fibrosis, for example, as encompassed by the instant claim set since pulmonary fibrosis is also mediated by interleukin-17.
Since the claim set of ‘879B2 is directed towards a method of preparing a composition comprising 17-HPC, it is implied that the inventors had access to a drug comprising 17-HPC (which is encompassed by instant claim 32) before the effective filing date of the instantly claimed invention as the drug would be the product of the method.
Further, the specification of ‘879B2 also recites:
“For instance, the present invention also contemplates formulations for systemic delivery, including for instance parenteral, oral, or intravenous delivery, or for local or topical application, for the treatment of glucocorticoid-insensitivity related diseases or disorders, or conditions, including, but not limited to, glucocorticoid resistant conditions (e.g., … interstitial pulmonary fibrosis…); glucocorticoid refractory conditions (e.g.,… desquamative interstitial pneumonia refractory to corticosteroid…)” (col. 13, lines 5-18).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to administer 17-HPC to patients with pulmonary fibrosis or interstitial pneumonia, for example, as encompassed by the instant claim set.
Since the claim set of ‘532 is partly directed towards a method of preparing a composition comprising 17-HPC, it is implied that the inventors had access to a drug comprising 17-HPC (which is encompassed by instant claim 32) before the effective filing date of the instantly claimed invention as the drug would be the product of the method.
The claim set of ‘532 is also directed towards a method of administering 17-HPC to a subject or treating a disease or condition in a subject in need thereof, comprising administering to the subject the composition comprising 17-HPC. According to the specification of ‘532:
“In some embodiments, the disease or condition is idiopathic interstitial pneumonias (IIPs)… In some instances, the IIPs are further classified into four groups: chronic fibrosing IIPs: idiopathic pulmonary fibrosis (IPF), and idiopathic non-specific interstitial pneumonia (NSIP)… desquamative interstitial pneumonia (DIP); acute and subacute IIPs: acute interstitial pneumonia (AIP) and cryptogenic organizing pneumonia (COP); and rare IIPs: idiopathic pleuroparenchymal fibroelastosis (IPPFE) and lymphoid interstitial pneumonia (LIP)” (para. 0137).
Therefore, one of ordinary skill in the art would have found it prima facie obvious to administer 17-HPC to patients with pulmonary fibrosis or interstitial pneumonia, for example, as encompassed by the instant claim set and the claim set of ‘532.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624