DETAILED ACTION
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 .
Status of the Application
Claims 23, 25, 28-46 are pending and under current examination.
Amendment necessitated new claim rejection as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 23, 25, 29-46 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is because the specification, while being enabling for treating thrombocytopenia, does not reasonably provide enablement for the prevention of thrombocytopenia aHIT and VITT. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. As a general rule enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)”. The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(1) The breadth of the claims
(2) The nature of the invention
(3) The state of the prior art
(4) The level of one of ordinary skill
(5) The level of predictability in the art
(6) The amount of direction provided by the inventor
(7) The existence of working examples
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) The breadth of the claims:
The presently claimed invention is directed to a method of treating and/or preventing thrombocytopenia aHIT and VITT comprising administering the compound of the instant claims. While such “prevention” might theoretically be possible under strictly controlled laboratory or in vitro conditions, as a practical matter it is extremely risky and nearly impossible to achieve in the “real world” in which patients live.
(2) The nature of the invention:
The presently claimed invention is directed to a method of treating and/or preventing thrombocytopenia comprising administering the compound of the instant claims. That is, in order to be enabled to practice the present invention, the skilled artisan would have to accept that by administering the compound that such therapeutic objectives could actually be achieved. However, in light of the fact that the specification fails to provide the skilled artisan with any direction or guidance as to how the prevention of thrombocytopenia could be achieved, the present specification is viewed as lacking an enabling disclosure of the entire scope of the claimed invention.
(3) The state of the Prior Art:
Prior art exists with respect to treating thrombocytopenia. For example, Lassila (US 20170266299 A1).
(4) The skill of those in the art:
The skill of those in the art is expected to be high, requiring advanced training in chemistry, medicine, or pharmacology.
(5) The level of predictability in the art:
With specific reference to thrombocytopenia, treatment of thrombocytopenia is known. For example, Lassila (US 20170266299 A1).
(6) The amount of direction provided:
While the treatment of thrombocytopenia is discussed and demonstrated with examples, the necessary specifics for preventing thrombocytopenia is completely absent.
(7) Working examples:
The examples and guidance provided is limited to the treatment of thrombocytopenia. However, no guidance or experimental data is provided for prevention of thrombocytopenia.
(8) The quantity of experimentation needed:
Given the fact that, historically, the development of new drugs for treatment and especially for has been difficult and time consuming, and, the quantity of experimentation needed is expected to be great.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 23, 25, and 29-46 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lassila (US 20170266299 A1).
Lassila discloses a method of treating thrombotic thrombocytopenia purpura (reads on thrombocytopenia) (can be caused by infection, autoimmune disease and certain medications (reads on heparin independent thrombocytopenia and vaccine-induced thrombocytopenia), thrombotic complications caused by thrombolytic therapy etc. comprising administering an anti-thrombotic molecule having both antiplatelet and anticoagulant (APAC) activity, wherein anti-thrombotic molecule comprises human plasma protein, preferably recombinant, such as human serum albumin, alpha-2macroglobulin, fibrinogen attached to a plurality of heparin chain having MW of 10-21KDa, ideally 15, or 16 or 17 KDa e.g., unfractionated heparin, preferably recombinant, such as 4,5---15, 16 chains, preferably 4-6 chains, through a linker SPDP, thereby treating thrombotic thrombocytopenia purpura (entire application, especially abstract, paragraphs 0020, 0025-0040, 0045-0066, 0108-0118, 0147-0230, Examples and claims)
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The cited prior art further discloses method of making such APAC compounds, wherein linkers are amine linkers and links with serine on the heparin chain and lysine on the plasma protein (entire application, especially 0109-0118 and claims). The cited prior art discloses dose of APAC as 1microgram/ml, 2microgram/ml, 4microgram/ml and 5microgram/ml (entire application, especially paragraphs 0105-0106) (reads on instant claims 25 and 34).
Since the cited prior art reads on all the limitations of the instant claims 23, 25, and 29-46, these claims are anticipated.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 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.
Claims 23, 25, 28-46 are rejected under 35 U.S.C. 103 as being unpatentable over Lassila (US 20170266299 A1).
Determining the scope and contents of the prior art
Lassila discloses a method of treating thrombotic thrombocytopenia purpura (reads on thrombocytopenia) (can be caused by infection, autoimmune disease and certain medications (reads on heparin independent thrombocytopenia and vaccine-induced thrombocytopenia) comprising administering an anti-thrombotic molecule having both antiplatelet and anticoagulant (APAC) activity, wherein anti-thrombotic molecule comprises human plasma protein, preferably recombinant, such as human serum albumin, alpha-2macroglobulin, fibrinogen attached to a plurality of heparin chain having MW of 10-21KDa, ideally 15, or 16 or 17 KDa e.g., unfractionated heparin, preferably recombinant, such as 4,5---15, 16 chains, preferably 4-6 chains, through a linker SPDP, thereby treating thrombotic thrombocytopenia purpura (entire application, especially abstract, paragraphs 0020, 0025-0040, 0045-0066, 0108-0118, 0147-0230, Examples and claims)
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The cited prior art further discloses method of making such APAC compounds, wherein linkers are amine linkers and links with serine on the heparin chain and lysine on the plasma protein (entire application, especially 0109-0118 and claims). The cited prior art discloses dose of APAC as 1microgram/ml, 2microgram/ml, 4microgram/ml and 5microgram/ml (entire application, especially paragraphs 0105-0106) (reads on instant claims 25 and 34).
Ascertaining the differences between the prior art and the claims at issue
Lassila discloses a method of treating thrombotic thrombocytopenia purpura (reads on thrombocytopenia) (can be caused by infection, autoimmune disease and certain medications (reads on heparin independent thrombocytopenia and vaccine-induced thrombocytopenia) comprising administering an anti-thrombotic molecule having both antiplatelet and anticoagulant (APAC) activity, wherein anti-thrombotic molecule comprises human plasma protein, preferably recombinant, such as human serum albumin, alpha-2macroglobulin, fibrinogen attached to a plurality of heparin chain having MW of 10-21KDa, ideally 15, or 16 or 17 KDa e.g., unfractionated heparin, preferably recombinant, such as 4,5---15, 16 chains, preferably 4-6 chains, through a linker SPDP, thereby treating thrombotic thrombocytopenia purpura but fails to teach other thrombocytopenia, such as heparin induced.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference- Lassila discloses a method of treating thrombotic thrombocytopenia purpura (reads on thrombocytopenia) (can be caused by infection, autoimmune disease and certain medications (reads on heparin independent thrombocytopenia and vaccine-induced thrombocytopenia) comprising administering an anti-thrombotic molecule having both antiplatelet and anticoagulant (APAC) activity, wherein anti-thrombotic molecule comprises human plasma protein, preferably recombinant, such as human serum albumin, alpha-2macroglobulin, fibrinogen attached to a plurality of heparin chain having MW of 10-21KDa, ideally 15, or 16 or 17 KDa e.g., unfractionated heparin, preferably recombinant, such as 4,5---15, 16 chains, preferably 4-6 chains, through a linker SPDP, thereby treating thrombotic thrombocytopenia purpura. Since Lassila teaches treating thrombocytopenia using same APAC molecule as in the instant claims, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that thrombocytopenia caused by any reason, such as heparin -induced or heparin-independent may be treated using APAC of the cited prior art.
Based on the above established facts, it appears that the teachings of above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modified the elements as claimed by known methods with no change in their respective functions, and the modification would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Lassila Lassila discloses a method of treating thrombotic thrombocytopenia purpura (reads on thrombocytopenia) (can be caused by infection, autoimmune disease and certain medications (reads on heparin independent thrombocytopenia and vaccine-induced thrombocytopenia) comprising administering an anti-thrombotic molecule having both antiplatelet and anticoagulant (APAC) activity, wherein anti-thrombotic molecule comprises human plasma protein, preferably recombinant, such as human serum albumin, alpha-2macroglobulin, fibrinogen attached to a plurality of heparin chain having MW of 10-21KDa, ideally 15, or 16 or 17 KDa e.g., unfractionated heparin, preferably recombinant, such as 4,5---15, 16 chains, preferably 4-6 chains, through a linker SPDP, thereby treating thrombotic thrombocytopenia purpura.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that thrombocytopenia caused by any reason may be treated using compound of the cited prior art and can be made by teaching of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
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 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 23, 25, 28-46 in the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11-14 of U.S. Patent No. 11446361 B2, since the claims, if allowed, would improperly extend the “right to exclude" already granted in the patent.
Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application and claims 11-14 of U.S. Patent No. 11446361 B2 are drawn to a process of treating thrombocytopenia, such as thrombotic thrombocytopenia purpura (reads on thrombocytopenia) (can be caused by infection, autoimmune disease and certain medications (reads on heparin independent thrombocytopenia and vaccine-induced thrombocytopenia) comprising administering an anti-thrombotic molecule having both antiplatelet and anticoagulant (APAC) activity, wherein anti-thrombotic molecule comprises human plasma protein, preferably recombinant, such as human serum albumin, alpha-2macroglobulin, fibrinogen attached to a plurality of heparin chain having MW of 10-21KDa, ideally 15, or 16 or 17 KDa e.g., unfractionated heparin, preferably recombinant, such as 4,5---15, 16 chains, preferably 4-6 chains, through a linker SPDP, thereby treating thrombotic thrombocytopenia purpura. Since patent claims teaches treating thrombocytopenia using same APAC molecule as in the instant claims, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that thrombocytopenia caused by any reason, such as heparin -induced or heparin-independent may be treated using APAC of the cited prior art.
Thus, the difference, however, does not constitute a patentable distinction, because the claims in the present invention simply fall within the scope/or are obvious over claims 11-14 of U.S. Patent No. 11446361 B2 . For the foregoing reasons, the instantly claimed process is made obvious.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See also MPEP § 804.
Response to Arguments
Applicant’s remarks and amendment, filed on 11/05/2025, have been fully considered but not found persuasive.
Applicant argue over rejection under 112a:
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This is not found persuasive as the instant claims are not restricted to heparin-induced but also to heparin-independent as well as vaccine-induced.
Applicant argue that TTP taught by Lassila is a blood disorder and does not suggest treating or preventing HIT, ---aHIT and VITT. Applicant argue that TTP is pathologically different from diseases of the instant claims. Applicant argue that it was surprising and unexpected APAC is effective in preventing by disrupting PF4 complex. Applicant similarly argue over ODP rejection.
This is not found persuasive and the instant claims stand rejected. This is because (1) Lassila not only teaches treating TTP but also drug induced etc. thrombocytopenia, which are all heparin-independent and reads on the instant claims; (2) applicant only argued but provided no evidence how TTP is different from broad heparin-independent thrombocytopenia; (3) the instant claims are not restricted to preventing and thus results are not unexpected; (4) the instant claims are not restricted to heparin-induced thrombocytopenia under which according to the applicant such PF4 complex forms; (5) with similar logic as explained in points 1-4, Applicant’s argument over ODP rejection is also not persuasive.
Rest of applicant’s argument is moot in view of new rejection as set forth above.
Applicant's 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.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Milligan Adam can be reached at 571-2707674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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