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 .
Response to Amendment
The amendment filed 1/14/2025 has been entered.
Claim Rejections - 35 USC § 112
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 1, 4, 6, 9 and 10 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.
The instant claims have been amended to recite that the fluorogenic substrate “binds to the active site of thrombus and, once bound, is cleaved by thrombin to release a fluorophore” see instant claim 1. Thus, claim 1 now defines the fluorogenic substance as having a very specific functional limitation. It is noted that the fluorogenic substrate is defined in the claims by function only. However, there is no corresponding structure related to this specific function set forth in the claims or described in the specification. The specification neither defines any structural/functional relationship nor provides a reasonable number of species that would provide for a fluorogenic substrate which has the specific function that it binds to the active site of thrombus and, once bound, is cleaved by thrombin to release a fluorophore. While the specification does mention this function, it does not appear to define any fluorogenic substrates that clearly have this function. Also, it is noted that no specific fluorogenic substrates are claimed. While it is noted that some specific fluorogenic substrates that may have this function are known in the prior art, these are specific structures, and such a limited number of compounds does not support a large genus based on a reasonable number of species and/or a clear structure/function relationship. Since the instant claims define this substrate by function only, it would include a vast number of possible fluorogenic substances and thereby is drawn to a large genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 USC 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 USC 112a.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 4, 6, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Karp (US 20080167544) in view of Ghai US 2007/0077610 (IDS filed 11/19/2025) and Hemker US 8916356 (IDS filed 9/20/2022).
Karp teaches a method for localizing an internal bleeding site in the body of an animal, comprising: a) introducing a labeled component configured to associate with a clot or damaged portion of a blood vessel in said animal, wherein the labeled component is not an endogenous clotting factor to said animal; and b) detecting an internal bleeding site in said animal by detecting localization of said labeled component [0011]. Karp teaches that the labeled component can be an optical label, and specifically that the optical label can be a fluorophore [0017] and [0031]. Karp also teaches that Factor lla (aka thrombin) is a targeting component that the labeled component can associate with that is associated with a clot or damaged portion of a blood vessel [0013]. Karp teaches that this invention is used as part of surgery [0010], thus meeting the limitation of claim 6. This component is associated with Factor lla or thrombin, which thus can be a substrate of thrombin.
Karp fails to specifically teach the fluorogenic substrate is immobilized on a membrane or porous matrix and/or the specifically that the fluorogenic substrate binds thrombin and is cleaved to release the fluorophore. However, this is known in the art as shown by Ghai and Hemker, see hereinbelow.
Ghai teaches a fluorogenic substrate which is immobilized on a membrane or porous matrix and is a substrate for thrombin which is used for blood coagulation testing including during surgery, see [0003], [0008] and the examples, which provides an effective means for coagulation testing.
Hemker teaches a fluorogenic substrate that is immobilized on a membrane or porous matrix or the specifically that the fluorogenic substrate binds thrombin and is cleaved to release the fluorophore (see col. 8, lines 39+). The fluorogenic substrates are taught for detecting thrombin that is important for the detection of bleeding (see col. 1). Hemker teaches the substrates provide added benefits in the detection of thrombin, see col. 12, lines 35+.
It would have 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 to modify the methods disclosed by Karp to include a fluorogenic substrate that is immobilized on a membrane or porous matrix or the specifically that the fluorogenic substrate binds thrombin and is cleaved to release the fluorophore because both Ghai and Hemker teach that such fluorogenic substrates provide an effective means of measuring coagulation for bleeding such as, surgery.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 6, 9 and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed at this time.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
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/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
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