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 1-17 as filed January 31, 2024, are pending in the application and are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 5-10 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The claims are indefinite in the recitation of parentheses in claim 1 such as “(e.g., estradiol (and its esters), ethinylestradiol, conjugated estrogens, diethylstilbestrol)”, “(e.g., goserelin, leuprorelin)”, “(e.g., cetrorelix)”, and “(e.g., chlormadinone acetate, cyproterone acetate, gestonorone caproate, medroxyprogesterone acetate, megestrol acetate)” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examples and preferences in a claim may lead to confusion over the intended scope of the claim. The description of examples or preferences is properly set forth in the specification rather than the claims.
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.
Claims 2-3 and 5-10 are 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. In this case, claims 2-3 and 5-10 depend from claim 1 which recites an “AR cellular signaling pathway inhibitor” … “selected from the group consisting of Steroidal antiandrogens, Nonsteroidal antiandrogens, Androgen synthesis inhibitors, CYP17A1 inhibitors, CYP11A1 (P450scc) inhibitors, 5a-Reductase inhibitors and Antigonadotropins or combinations thereof, or wherein the AR cellular signaling pathway inhibitor is selected from the group consisting of Bicalutamide, (R)-Bicalutamide (HY-14249), Enzalutamide (MDV3100), N- desmethyl Enzalutamide, Proxalutamide (GT0918), Apalutamide (ARN-509), N-Desmethyl- Apalutamide, Darolutamide (ODM-201;BAY-1841788), Ketodarolutamide (ORM-15341), Galeterone (TOK-001), D4-abiraterone, A-485, Dexamethasone, Mifepristone (RU486), Cyproterone acetate, Chlormadinone acetate, Cyproterone acetate, Megestrol acetate, Osaterone acetate, Nomegestrol acetate, Dienogest, Oxendolone, Drospirenone, Spironolactone, Medrogestone, Bicalutamide, Flutamide, Nilutamide, Apalutamide, Cimetidine, Topilutamide, Abiraterone acetate, Ketoconazole, Seviteronel, Aminoglutethimide, Dutasteride, Alfatradiol, Dutasteride, Epristeride, Finasteride, A-485, ARCC-4, ARD-266, Saw palmetto extract, Leuprorelin, Estrogens (e.g., estradiol (and its esters), ethinylestradiol, conjugated estrogens, diethylstilbestrol), GnRH analogues, GnRH agonists (e.g., goserelin, leuprorelin), GnRH antagonists (e.g., cetrorelix), and Progestogens (e.g., chlormadinone acetate, cyproterone acetate, gestonorone caproate, medroxyprogesterone acetate, megestrol acetate), etanercept, resatorvid, filgotinib or combinations thereof” with claim 1 further reciting intended use(s) for the inhibitor(s), while claims 2-3 and 5-10 merely recite additional intended use(s) for the inhibitor(s) without structurally or materially limiting the inhibitor(s) of claim 1. Therefore, claims 2-3 and 5-10 fail to further limit claim 1 because it merely recites intended use(s) without further limiting the inhibitor(s) of claim 1.
Claims 12-13 and 15-16 are 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. In this case, claims 12-13 and 15-16 depend from claim 11 which recites a “TGFbeta cellular signaling pathway inhibitor” … “selected from the group consisting of Small molecule kinase inhibitors, Anti-TGF-3 ligand antibodies, Anti-TPR receptor antibodies or Antisense oligonucleotides or combinations thereof, or wherein the TGFbeta cellular signaling pathway inhibitor is selected from the group consisting of Vactosertib (EW-7197), Galunisertib (LY2157299), LY3200882, (E)-SIS3, Fresolimumab, XPA681, XPA089, LY2382770, LY3022859, ISTH0036, ISTH0047, Pyrrole- imidazole polyamides, etanercept, resatorvid, filgotinib or combinations thereof” with claim 11 further reciting intended use(s) for the inhibitor(s), while claims 12-13 and 15-16 merely recite additional intended use(s) for the inhibitor(s) without structurally or materially limiting the inhibitor(s) of claim 11. Therefore, claims 12-13 and 15-16 fail to further limit claim 11 because it merely recites intended use(s) without further limiting the inhibitor(s) of claim 11.
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 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paller et al (Prostate, 79(1):31-43, 2019, pages 1-24).
With respect to claims 1-10, Paller et al disclose an AR cellular signaling pathway inhibitor which is the antiandrogen enzalutamide (see abstract, page 4 and Figure 1). With respect to claims 11-16, Paller et al disclose an TGFbeta cellular signaling pathway inhibitor which is galunisertib (see abstract, page 4 and Figure 1). With respect to claim 17, Paller et al disclose an AR cellular signaling pathway inhibitor which is the antiandrogen enzalutamide and an TGFbeta cellular signaling pathway inhibitor which is galunisertib (see abstract, page 4 and Figure 1).
With respect to claim interpretation, while the claims recite the intended use of the “inhibitors” for use in the prevention or treatment of sepsis in a subject along with other intended uses, the intended uses do not structurally or materially limit the claimed “inhibitors” from those in Paller et al which are structurally and materially identical and which therefore could also be used in the prevention or treatment of sepsis.
See MPEP § 2103 “Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use”.
Therefore, the products of Paller et al are deemed to anticipate the claims absent a showing otherwise.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
February 18, 2026