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 .
Applicant’s response and amendments received February 12, 2026 are acknowledged.
Claims 14, 19, and 20 have been canceled.
Claim 1 has been amended.
Claim 22 has been added.
Claims 1-13, 15-18, 21, and 22 are pending in the instant application.
Claim 21 stands withdrawn from consideration as being drawn to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03, for reasons of record set forth in the restriction requirement mailed July 2, 2025.
Claims 1-13, 15-18, and 22 are under examination in this office action.
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.
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 1, 2, 4-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. in view of Kim et al. (US 9,523,683).
Abrams et al. disclose methods for the direct detection of activated platelets in human blood samples (see entire document, particularly the title and abstract). Such methods utilize antibodies in flow cytometric assays utilizing blood from normal volunteers as well as patients undergoing cardiopulmonary bypass operations (see most particularly the Materials and Methods section as well as Figures 1 and 4). Antibodies used in their methods include PAC1 which binds the activated form of GPIIb/IIIa, 9F9 which binds fibrinogen bound to the surface of activated platelets, and S12 which binds alpha-granule membrane protein that is found on the surface of platelets following granule secretion (see most succinctly in the abstract). They teach that monitoring activated plates is essential to identifying if a patient is in a prethrombotic or thrombotic state and that such knowledge would allow clinicians to undertake strategies to minimize platelet activation which in conditions including unstable angina, stroke, and after angioplasty is highly undesirable (ibid). Such teachings differ from that which is presently claimed in that the antibodies of Abrams et al. are not disclosed as being conjugated to polydiacetylene liposomes in an array.
Kim et al. disclose and claim sensors comprising diacetylene monomers coupled to an affinity component, wherein the sensor exhibits a change in fluorescence or conductivity when the affinity component interacts with its target, and wherein the affinity component is an antibody (see entire document, particularly the abstract, Figure 1A, and claims, most particularly claims 4 and 11). Notably the diacetylene is recited as comprising 10,12-pentacosadiynoic acid (see particularly claim 6) and as comprising epoxy groups (see particularly claim 14). Figure 1A explicitly shows that PDA forms liposomes and that antibodies capable of binding antigen are attached thereto (see said figure as well as its legend (lines 55-63 of column 2) the paragraph spanning columns 7 and 8, and the first full paragraph of column 9). Microarrays comprising solid substrates to which immobilized antibodies are attached are explicitly disclosed (see for example column 8), and note that such immobilization is disclosed as occurring via PDA liposomes on said substrate (see particularly column 10). Glass is disclosed as a suitable substrate upon which to build such arrays (see particularly column 11 as well as working example 1) as are amine-modified substrates (see working example 3 which explicitly used liposomes comprising a 4:1 ratio of PCDA-epoxy to PCDA immobilized on an amine glass slide). The assays of Kim et al. are disclosed as providing the advantages of allowing for highly selective and sensitive quantitative analysis (see particularly column 36).
Therefore it would have been obvious to an ordinary artisan at the time of the invention to modify the activated platelet detection assays of Abrams et al. to use the formats and reagents disclosed by Kim et al. Artisan would be motivated to do so in order to gain the advantages of high selectivity and sensitive quantitative analysis offered by the assay systems of Kim et al. which provide fluorescent readout upon antigen binding. Given that Kim et al. disclose using immobilized antibodies to detect antigens, artisans would reasonably expect that immobilizing the 9F9 antibody used in the methods of Abrams et al. and part of a PDA-liposome comprising antibodies as disclosed by Kim et al. would improve the sensitivity and quantifiability of such an assay to detect activated platelets as compared to the assays of Abrams et al. alone.
Applicant's arguments filed February 12, 2026 have been fully considered but they are not persuasive. Applicant argues that the independent claim has been amended to recite that whole blood comprising platelets with an anti-coagulation agent is used in the claimed method and that such a limitation is not taught or reasonably suggested by the references of record alone or in combination. Applicant then points out why neither Abrams et al. nor Kim et al. anticipate what is presently claimed. Applicant also asserts that there is no motivation to combine the cited references to arrive at that which has been claimed.
These arguments have been considered and are not persuasive. It should be noted that the assay of Abrams et al. was performed on both normal humans (i.e. patients who were not on anti-platelet medication) as well nine patients undergoing open heart surgery who did receive the extremely well known anti-coagulant heparin (see particularly both the abstract as well as the right column of page 129). Thus whole blood samples tested by Abrams et al were exposed to anticoagulant drugs prior to testing. In response to applicant's arguments against the references individually, applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). With regard to motivation to combine the teachings, as was set forth the in rejection of record, “Artisan would be motivated to do so in order to gain the advantages of high selectivity and sensitive quantitative analysis offered by the assay systems of Kim et al. which provide fluorescent readout upon antigen binding. Given that Kim et al. disclose using immobilized antibodies to detect antigens, artisans would reasonably expect that immobilizing the 9F9 antibody used in the methods of Abrams et al. and part of a PDA-liposome comprising antibodies as disclosed by Kim et al. would improve the sensitivity and quantifiability of such an assay to detect activated platelets as compared to the assays of Abrams et al. alone.”
The rejection is maintained.
Claims 3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. in view of Kim et al. (US 9,523,683) as applied to claims 1, 2, 4-13, and 15-20 above, and further in view of WO 2021/035030.
The inventions rendered obvious by the combined teachings of Abrams et al. and Kim et al. have been discussed above and differ from that which is presently claimed in that the cited art does not appear to disclose liposomes which also comprise DMPA (1,2-dimyristoyl-sn-glycero-3-phosphate).
The ‘303 document discloses the use of the phospholipid DMPA in liposomes comprising PCDA-epoxy when making liposomes that are to be immobile on derivatized surfaces such as those comprising amine or carboxylic acid (see entire document, particularly paragraph [0049] and working example 2).
Therefore it would have been obvious to ordinary artisans at the time of filing that DMPA could be included in the PCDA liposomes as the use of liposomes comprising this phospholipid in making microarray devices was known and successfully used in the art as taught by the ‘303 document.
Applicant's arguments filed February 12, 2026 have been fully considered but they are not persuasive. Applicant argues that the base obviousness rejection is not tenable and that the additional teachings of the ‘030 WIPO document do not rectify its deficiencies.
This argument is not persuasive as applicant’s arguments against the inventions rendered obvious by the combined teachings of Abrams et al. in view of Kim et al. was not found persuasive as discussed above.
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 1, 2, 4-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,523,683 in view of US 2015/0268232 and in view of Abrams et al.
The issued claims recite sensors comprising diacetylene monomers coupled to an affinity component, wherein the sensor exhibits a change in fluorescence or conductivity when the affinity component interacts with its target, wherein the affinity component is an antibody, and wherein the diacetylene is recited as comprising 10,12-pentacosadiynoic acid and as comprising epoxy groups (see all claims, particularly claims 4, 6, 11, and 14). Such claims differ from that which is presently claimed in that while antibodies are claimed as being present in the sensor, the antibodies are not recited as specifically binding activated platelets in blood samples.
The ‘323 document discloses sensors comprising diacetylene joined to an affinity component, wherein the sensor exhibits a change in fluorescence or conductivity when the affinity component interacts with its target, and wherein the affinity component is an antibody (see entire document, particularly the abstract, Figure 1A, and claims, most particularly claims 18 and 25). Notably the diacetylene is recited as comprising 10,12-pentacosadiynoic acid (see particularly claim 21) and as comprising epoxy groups (see particularly claim 29). Figure 1A explicitly shows that PDA forms liposomes and that antibodies capable of binding antigen are attached thereto (see said figure as well as paragraphs [0016], [0057], and [0063-0066]). Microarrays comprising solid substrates to which immobilized antibodies are attached are explicitly disclosed (see for example paragraphs [0056-0077]), and note that such immobilization is disclosed as occurring via PDA liposomes on said substrate (see particularly page 5). Glass is disclosed as a suitable substrate upon which to build such arrays (see particularly paragraph [0074] as well as working example 1) as are amine-modified substrates (see working example 3 which explicitly used liposomes comprising a 4:1 ratio of PCDA-epoxy to PCDA immobilized on an amine glass slide). These assays are disclosed as providing the advantages of allowing for highly selective and sensitive quantitative analysis (see particularly paragraph [0187]).
Abrams et al. disclose methods for the direct detection of activated platelets in human blood samples (see entire document, particularly the title and abstract). Such methods utilize antibodies in flow cytometric assays utilizing blood from normal volunteers as well as patients undergoing cardiopulmonary bypass operations (see most particularly the Materials and Methods section as well as Figures 1 and 4). Antibodies used in their methods include PAC1 which binds the activated form of GPIIb/IIIa, 9F9 which binds fibrinogen bound to the surface of activated platelets, and S12 which binds alpha-granule membrane protein that is found on the surface of platelets following granule secretion (see most succinctly in the abstract). They teach that monitoring activated plates is essential to identifying if a patient is in a prethrombotic or thrombotic state and that such knowledge would allow clinicians to undertake strategies to minimize platelet activation which in conditions including unstable angina, stroke, and after angioplasty is highly undesirable (ibid).
Therefore it would have been obvious to an ordinary artisan at the time of the invention to modify the sensors claimed in the ‘683 patent to include antibodies that bind activated platelets, such as 9F9, so that the can be used in clinical tests for activated platelets such as those disclose by Abrams et al. which are to be used to determine appropriate clinical courses of action for patients at risk of thrombosis such as heart attack and stroke patients. Artisans would be motivated to modify the assays of Abrams in order to gain the advantage of high selectivity and quantifiability that are provided by PCDA-liposome array systems as taught by the ‘232 document and which are claimed in the ‘683 patent.
Applicant's arguments filed February 12, 2026 have been fully considered but they are not persuasive. Applicant’s arguments concerning NSDP rejections essentially mirror that set forth by applicant as to why the obviousness rejection under 35 USC 103 is improper (an unsurprising argument as the ‘683 patent originally published as US 2015/0268232 and thus all are “Kim et al.”).
These arguments are not persuasive as discussed under 35 USC 103 and will not be duplicated here for the sake of brevity.
Claims 1, 2, 4-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,633,140 in view of US 2015/0268232 and in view of Abrams et al.
The issued claims recite microarray sensors comprising diacetylene monomers in a liposome coupled to an affinity component and wherein the affinity component is an antibody (see all claims, particularly claims 5-10). Such claims differ from that which is presently claimed in that while antibodies are claimed as being present in the sensor, the antibodies are not recited as specifically binding activated platelets in blood samples.
The ‘323 document discloses sensors comprising diacetylene joined to an affinity component, wherein the sensor exhibits a change in fluorescence or conductivity when the affinity component interacts with its target, and wherein the affinity component is an antibody (see entire document, particularly the abstract, Figure 1A, and claims, most particularly claims 18 and 25). Notably the diacetylene is recited as comprising 10,12-pentacosadiynoic acid (see particularly claim 21) and as comprising epoxy groups (see particularly claim 29). Figure 1A explicitly shows that PDA forms liposomes and that antibodies capable of binding antigen are attached thereto (see said figure as well as paragraphs [0016], [0057], and [0063-0066]). Microarrays comprising solid substrates to which immobilized antibodies are attached are explicitly disclosed (see for example paragraphs [0056-0077]), and note that such immobilization is disclosed as occurring via PDA liposomes on said substrate (see particularly page 5). Glass is disclosed as a suitable substrate upon which to build such arrays (see particularly paragraph [0074] as well as working example 1) as are amine-modified substrates (see working example 3 which explicitly used liposomes comprising a 4:1 ratio of PCDA-epoxy to PCDA immobilized on an amine glass slide). These assays are disclosed as providing the advantages of allowing for highly selective and sensitive quantitative analysis (see particularly paragraph [0187]).
Abrams et al. disclose methods for the direct detection of activated platelets in human blood samples (see entire document, particularly the title and abstract). Such methods utilize antibodies in flow cytometric assays utilizing blood from normal volunteers as well as patients undergoing cardiopulmonary bypass operations (see most particularly the Materials and Methods section as well as Figures 1 and 4). Antibodies used in their methods include PAC1 which binds the activated form of GPIIb/IIIa, 9F9 which binds fibrinogen bound to the surface of activated platelets, and S12 which binds alpha-granule membrane protein that is found on the surface of platelets following granule secretion (see most succinctly in the abstract). They teach that monitoring activated plates is essential to identifying if a patient is in a prethrombotic or thrombotic state and that such knowledge would allow clinicians to undertake strategies to minimize platelet activation which in conditions including unstable angina, stroke, and after angioplasty is highly undesirable (ibid).
Therefore it would have been obvious to an ordinary artisan at the time of the invention to modify the sensors claimed in the ‘140 patent to include antibodies that bind activated platelets, such as 9F9, so that the can be used in clinical tests for activated platelets such as those disclose by Abrams et al. which are to be used to determine appropriate clinical courses of action for patients at risk of thrombosis such as heart attack and stroke patients. Artisans would be motivated to modify the assays of Abrams in order to gain the advantage of high selectivity and quantifiability that are provided by PCDA-liposome array systems as taught by the ‘232 document and which are claimed in the ‘140 patent.
Applicant's arguments filed February 12, 2026 have been fully considered but they are not persuasive. Applicant’s arguments concerning NSDP rejections essentially mirror that set forth by applicant as to why the obviousness rejection under 35 USC 103 is improper, specifically that Abrams et al. fail to disclose using an anticoagulation agent and that the ‘232 publication does not discuss platelets.
These arguments are not persuasive for the reasons already discussed earlier in this office action in conjunction with rejections set forth under 35 USC 103. See above.
Claims 3 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,523,683 in view of US 2015/0268232 and in view of Abrams et al. and/or as being unpatentable over claims 1-12 of U.S. Patent No. 8,633,140 in view of US 2015/0268232 and in view of Abrams et al. as applied to claims 1, 2, 4-13, and 15-20 above, and further in view of WO 2021/035030.
The inventions rendered obvious by the teachings of the issued in claim in combination with that of the cited art has been discussed above and differs from that which is presently claimed in that there does not appear to be a disclosure of liposomes which also comprise DMPA (1,2-dimyristoyl-sn-glycero-3-phosphate).
The ‘303 document discloses the use of the phospholipid DMPA in liposomes comprising PCDA-epoxy when making liposomes that are to be immobile on derivatized surfaces such as those comprising amine or carboxylic acid (see entire document, particularly paragraph [0049] and working example 2).
Therefore it would have been obvious to ordinary artisans at the time of filing that DMPA could be included in the PCDA liposomes as the use of liposomes comprising this phospholipid in making microarray devices was known and successfully used in the art as taught by the ‘303 document.
Applicant’s arguments of February 12, 2026 essentially mirror those discussed concerning the rejections under 35 USC 103 and are not persuasive for the reasons previously enunciated supra.
No claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641