DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 8/20/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 9, 12, 15, 18, 21, 24, 26, 29, 32, 35 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of a single species in the reply filed on 8/20/2026 is also acknowledged.
The elected species read upon claims 44, 57, 60, 63, 69 and 72. Claim 73 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 44, 57, 60, 63, 69 and 72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ino et al (World JL Gastroenterol 14:6382-6387, 2008).
Claim 44 is drawn to a pharmaceutical composition for treatment of aging or age-related conditions in a subject in need thereof, the pharmaceutical composition comprising a serine protease inhibitor (more specifically, gabexate mesilate (claim 57)), wherein the serine protease inhibitor reduces a pancreatic serine protease activity outside of a gastrointestinal (GI) tract of the subject.
Ino et al teach “[c]ontinuous regional arterial infusion therapy with gabexate mesilate for severe acute pancreatitis” (Title). That is, Ino et al teach an intra-arterial infusion formulation (i.e., a pharmaceutical composition) comprising gabexate mesilate.
Regarding the recitation that the composition is “for treatment of aging or age-related conditions in a subject in need thereof”, use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the recitation that the composition is “for treatment of aging or age-related conditions in a subject in need thereof” does not impose a structural limitation to distinguish the instantly claimed composition from the intra-arterial infusion formulation taught by Ino et al. Furthermore, the intra-arterial infusion formulation of Ino et al would be capable of performing the intended use of being administered for the treatment of aging or age-related conditions in a subject in need thereof.
And, regarding the recitation that “the serine protease inhibitor reduces a pancreatic serine protease activity outside of a gastrointestinal (GI) tract of the subject”, a prior art reference may anticipate without disclosing the claimed subject matter if the entire claimed subject matter is necessarily present, or inherent, in the single anticipating reference (see SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005) - discussing Continental Can Co. v. Monsanto Co., 948 F.2d 1264 (Fed. Cir. 1991) (“a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference”); see also Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed. Cir. 2003) (“the doctrine of inherent anticipation applies to the entire claimed subject matter just as it does to a single claimed feature")). As stated in SmithKline Beecham Corp. v. Apotex Corp, “the inherent disclosure of the entire claimed subject matter anticipates…” (quoting Schering Corp. v. Geneva Pharms., Inc) and said “anticipation does not require a person of ordinary skill in the art to recognize the inherent disclosure in the prior art at the time the prior art is created".
In the instant case, it is asserted, absent evidence to the contrary, that the intra-arterial infusion formulation taught by Ino et al necessarily reduces a pancreatic serine protease activity outside of a GI tract of the subject. As stated in In re Papesch, 315 F.2d 381 (CCPA 1963), “[f]rom the standpoint of patent law, a compound and all its properties are inseparable”.
Accordingly, claims 44 and 57 are anticipated.
Claim 60 is drawn to the composition of claim 44, wherein the serine protease inhibitor reduces the subject’s GI digestive enzyme activity by less than about 10%.
As discussed above, a prior art reference may anticipate without disclosing the claimed subject matter if the entire claimed subject matter is necessarily present, or inherent, in the single anticipating reference.
In the instant case, it is asserted, absent evidence to the contrary, that the intra-arterial infusion formulation taught by Ino et al necessarily reduces the subject’s GI digestive enzyme activity by less than about 10%. As stated in In re Papesch, 315 F.2d 381 (CCPA 1963), “[f]rom the standpoint of patent law, a compound and all its properties are inseparable”.
Accordingly, claim 60 is also anticipated.
Claims 63 and 69 are drawn to the composition of claim 44, wherein the serine protease inhibitor is intravenously administered (claim 63) and/or for at least three days (claim 69).
As discussed above, use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the recitations that the composition “is... intravenously administered” and/or “administered for at least three days” do not impose a structural limitation to distinguish the instantly claimed composition from the intra-arterial infusion formulation taught by Ino et al. Furthermore, the intra-arterial infusion formulation of Ino et al would be capable of being administered intravenously and/or administered for at least three days. Indeed, Ino et al specifically teach that “[g]abexate mesilate (2400 mg/d) was continuously administered for 3 to 5 d" (Abstract).
Accordingly, claims 63 and 69 are also anticipated.
Claim 72 is drawn to the composition of claim 44, wherein the pharmaceutical composition is formulated to yield a systemic plasma concentration of serine protease inhibitor in the subject of less than about 10 µM.
As recited, the claim – which does not recite any structural or compositional features to provide the claimed systemic plasma concentration of serine protease inhibitor – is under to merely entail an intended use or property resulting from how the composition is administered. And, as discussed above, use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the recitation that the composition “formulated to yield a systemic plasma concentration of serine protease inhibitor in the subject of less than about 10 µM” does not impose a structural limitation to distinguish the instantly claimed composition from the intra-arterial infusion formulation taught by Ino et al. Furthermore, the intra-arterial infusion formulation of Ino et al would be capable of being administered so as “to yield a systemic plasma concentration of serine protease inhibitor in the subject of less than about 10 µM”.
Accordingly, claim 72 is also anticipated.
Claim 72 is ADDITIONALLY rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ino et al (World JL Gastroenterol 14:6382-6387, 2008) as applied to claims 44, 57, 60, 63 and 69 above, as evidenced by Murakami et al (Critical Care Medicine 24:1047-1053, 1996).
Claim 72 is drawn to the composition of claim 44, wherein the pharmaceutical composition is formulated to yield a systemic plasma concentration of serine protease inhibitor in the subject of less than about 10 µM.
As discussed above, Ino et al specifically teach that “[g]abexate mesilate (2400 mg/d) was continuously administered for 3 to 5 d" (Abstract) to “men, average age 48.0 + 13.4 years” (Page 6383, Column 1) which, based on an approximate weight of 65 kg equates to about 1.5 mg/kg/hr.
As evidenced by Murakami et al, “[t]he plasma concentration of gabexate mesilate in human subjects administered a therapeutic dose of gabexate mesilate (2 mg/kg/hr) was found to be 2.6 x 10-7 M” or 0.26 µM (Page 14 of 18).
Accordingly, it is asserted, absent evidence to the contrary, that the intra-arterial infusion formulation of Ino et al is necessarily formulated to yield a systemic plasma concentration of serine protease inhibitor in the subject of less than about 10 µM.
Accordingly, claim 72 is anticipated.
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).
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.
Claims 44, 57, 60, 63, 69 and 72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 6,534,283.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘283 claims are drawn to a method “comprising administering to an individual... a therapeutic dose of a serine protease inhibitor” (claim 1), wherein “the serine protease inhibitor is additionally administered orally” (claim 4) or “intravenously” (claim 5), and wherein “the serine protease inhibitor is gabexate mesilate (FOY)” (claim 8).
As such, the ‘283 Patent teaches an oral or intravenous formulation (i.e., a pharmaceutical composition) comprising gabexate mesilate. And, for the reasons discussed above, the ‘283 composition is not structurally different from and would be capable of performing the various intended uses of the instant claims, as well as providing the instantly claimed results.
Claims 44, 57, 60, 63, 69 and 72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,272,034.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘034 claims are drawn to a method “comprising administering to... [an] individual a therapeutic dose of a combination of a pancreatic digestive enzyme inhibitor” (claim 11), wherein “the pancreatic digestive enzyme inhibitor is gabexate mesilate” (claim 16), and wherein “the administering... is by oral administration” (claim 18) or “by direct injection” (claim 21).
As such, the ‘034 Patent teaches an oral or injectable formulation (i.e., a pharmaceutical composition) comprising gabexate mesilate. And, for the reasons discussed above, the ‘034 composition is not structurally different from and would be capable of performing the various intended uses of the instant claims, as well as providing the instantly claimed results.
Claims 44, 57, 60, 63, 69 and 72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45-64 of copending Application No. 19/149,294.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘294 claims are drawn to a method “comprising administering a therapeutic dose of a of a serine protease inhibitor” (claim 45) as “a composition” (claim 56), wherein “the serine protease inhibitor comprises gabexate mesilate (FOY)” (claim 48), as well as “[a] pharmaceutical composition for the treatment of aging or age-related conditions of skin tissue, the pharmaceutical composition comprising a serine protease inhibitor” (claim 63).
As such, the ‘294 Patent teaches a pharmaceutical composition comprising gabexate mesilate. And, for the reasons discussed above, the ‘294 composition is not structurally different from and would be capable of performing the various intended uses of the instant claims, as well as providing the instantly claimed results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights