Notice of Pre-AIA or AIA Status
1. 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
Status of Application, Amendments, and/or Claims
2. The preliminary amendment filed 05 March 2024 has been entered in full. Claims 1-6 have been canceled, and claims 7-16 have been added. Therefore, claims 7-16 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 05 March 2024 have been considered by the Examiner.
Drawings
4. The drawings are objected to because Figure 3 is too faint/blurred to read. 37 C.F.R. 1.52(a)(1)(v) requires that all papers be presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 10-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
7. Claim 10 is rejected as being indefinite because the claims do not have a step that clearly relates back to the preamble. For example, there is no step indicating that administration of the histidine-rich glycoprotein results in treatment, or what the intended outcome is, such as treatment of the infectious disease (i.e., therapeutically effective). Furthermore, it is unclear if the limitation ‘administering the agent to a subject” refers to any subject, or a subject with an infectious disease. It is thus unclear what the claimed method is intending to accomplish. Amending the claim to recite, for example, “A method for treating an infectious disease in a subject in need thereof, comprising administering to the subject an agent comprising histidine-rich glycoprotein and a pharmacologically acceptable carrier, wherein the treatment is due to enhancing phagocytosis ability of neutrophils” would be remedial.
8. Claims 11-16 are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
9. 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.
10. Claims 10-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a bacterial infection in a subject, does not reasonably provide enablement for the breadth of infectious diseases either recited or encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
11. Factors to be considered in determining whether a disclosure enables one skilled in the art to make and use the claimed invention in its full scope without resorting to undue experimentation include: (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the nature or complexity of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. See In re Wands, 8 USPQ2d. 1400 (Fed. Cir. 1988).
12. In the instant case, the claims are broadly drawn to a method for treating an infectious disease, comprising: preparing an agent containing a histidine-rich glycoprotein as an active ingredient and a pharmacologically acceptable carrier, and administering the agent to a subject, wherein the treatment is due to enhancing phagocytosis ability of neutrophils. The claims also recite wherein the infectious disease is caused by a pathogen derived from one or a plurality of species selected from bacteria, viruses, fungi, and parasites, or wherein the infectious disease is any one of infectious diseases selected from the group of a respiratory infectious disease, a urinary tract infectious disease, a biliary tract infectious disease, a gastrointestinal infectious disease and a central nervous system infectious disease. Thus the claims encompass complex and unpredictable subject matter, involving the effects of complex biological molecules on diseased physiological states.
13. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology”, Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert, denied, 502 U.S. 856 (1991).
14. The specification provides detailed direction and guidance regarding the effects of the histidine-rich glycoprotein on enhancing the phagocytosis of neutrophils and opsonin enhancing effect against Escheria coli and Staphylococcus aureus (See Examples 2-4 at pp. 17-21). However, the data presented in the Specification does not provide any guidance on the treatment of every infectious disease, or an infectious disease that is caused by a pathogen derived from one or a plurality of species of viruses, fungi, and parasites, or any respiratory infectious disease, a urinary tract infectious disease, a biliary tract infectious disease, a gastrointestinal infectious disease and a central nervous system infectious disease.
15. Therefore, while administration of the histidine-rich glycoprotein would be expected to treat a bacterial infection, one skilled in the art would not predict that administration of the recited histidine-rich glycoprotein would be sufficient to treat the breadth of diseases recited in the claims. There are no working examples provided in the instant application which demonstrate that the recited histidine-rich glycoprotein is capable of treating anything other than bacterial infection.
16. While the level of skill in the art is high, the amount of guidance provided regarding how to use the recited histidine-rich glycoprotein to effectively treat anything other than bacterial infection is completely lacking. Accordingly, the amount of experimentation required to determine how to use the recited histidine-rich glycoprotein in this manner is quite extensive.
17. Due to the large quantity of experimentation necessary to determine how to use the recited histidine-rich glycoprotein to treat every infectious disease, or an infectious disease that is caused by a pathogen derived from one or a plurality of species of viruses, fungi, and parasites, or any respiratory infectious disease, a urinary tract infectious disease, a biliary tract infectious disease, a gastrointestinal infectious disease and a central nervous system infectious disease, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to the same, the complex nature of the invention, the unpredictability of the effects of complex biological molecules on diseased physiological systems, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Claim Rejections - 35 USC § 102
18. 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.
19. 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.
20. Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shoji et al. (WO 2013/183494; published 12 December 2013; cited by Applicant). It is noted that the Examiner has provided an English translation of the reference as an Appendix to this Office action.
21. Shoji et al. teach a method of treatment which utilizes a histidine-rich glycoprotein as the active ingredient. While Shoji et al. does not teach enhancing phagocytosis ability of neutrophils, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)), as are their processes and yields (In re Von Schick, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Thus, Shoji et al. meets all the limitations of claim 7.
22. Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nishibori et al. (U.S. Pat. No. 9,504,731; issued 29 November 2019; cited by Applicant).
23. Nishibori et al. teach a method of treatment which utilizes a histidine-rich glycoprotein as the active ingredient. While Shoji et al. does not teach enhancing phagocytosis ability of neutrophils, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)), as are their processes and yields (In re Von Schick, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). Thus, Nishibori et al. meets all the limitations of claim 7.
Claim Rejections - 35 USC § 103
24. 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.
25. The factual inquiries 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.
26. 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.
27. Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoji et al. or Nishibori et al. as applied to claim 7 above, and further in view of (U.S. Pat. No. 5,116,964; issued 26 May 1992; cited by Applicant).
28. The teachings of Shoji et al. and Nishibori et al. are set for supra. Neither reference teaches wherein the histidine-rich glycoprotein is fused with an Fc region of an antibody, or wherein the Fc region is derived from IgG2.
29. However, Capon et al. teaches fusion proteins comprising immunoglobulin polypeptides fused to "ligand binding partners" (see column 2, lines 14-19). At column 4, lines 38-43, Capon states that the immunoglobulin (Ig) fusions of the invention, including the Fc portion, "serve to prolong the in vivo plasma half-life of the ligand binding partner...", "facilitate its purification by protein A" and “combine the adhesive and targeting characteristics of a ligand binding partner with immunoglobulin effector functions such as complement binding, cell receptor binding and the like.” Capon also Fc regions from IgG2 antibodies as a preferred embodiment (see column 14, lines 40-45).
30. At the time of the invention was filed, it would have been obvious to a person of ordinary skill in the art to modify the teachings of either Shoji et al. or Nishibori et al. and make a fusion protein comprising a histidine-rich glycoprotein as taught by both Shoji et al. and Nishibori et al. fused to Fc immunoglobulin polypeptides as taught by Capon et al. in view of Capon et al.’s suggestion that it would be desirable to do so, for the reasons cited above. The expectation of success is high since fusion proteins comprising an Fc polypeptide are well-known in the art. Thus at the time the invention was filed, claims 8-9 are prima facie obvious over the combined teachings of the art.
Double Patenting
31. 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.
32. Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,504,731. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘731 Patent recite a method of treatment which utilizes a histidine-rich glycoprotein as the active ingredient. While the claims of the ‘731 patent do not recite enhancing phagocytosis ability of neutrophils, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)), as are their processes and yields (In re Von Schick, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
33. Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,504,731 in view of Capon (U.S. Pat. No. 5,116,964; issued 26 May 1992).
34. The teachings of the ‘731 Patent are set for supra. The claims of the ‘731 Patent do not teach wherein the histidine-rich glycoprotein is fused with an Fc region of an antibody, or wherein the Fc region is derived from IgG2.
35. However, Capon et al. teaches fusion proteins comprising immunoglobulin polypeptides fused to "ligand binding partners" (see column 2, lines 14-19). At column 4, lines 38-43, Capon states that the immunoglobulin (Ig) fusions of the invention, including the Fc portion, "serve to prolong the in vivo plasma half-life of the ligand binding partner...", "facilitate its purification by protein A" and “combine the adhesive and targeting characteristics of a ligand binding partner with immunoglobulin effector functions such as complement binding, cell receptor binding and the like.” Capon also Fc regions from IgG2 antibodies as a preferred embodiment (see column 14, lines 40-45).
36. At the time of the invention was filed, it would have been obvious to a person of ordinary skill in the art to modify the teachings of ‘731 and make a fusion protein comprising the histidine-rich glycoprotein as recited in the claims of the ‘731 patent fused to Fc immunoglobulin polypeptides as taught by Capon et al. in view of Capon et al.’s suggestion that it would be desirable to do so, for the reasons cited above. The expectation of success is high since fusion proteins comprising an Fc polypeptide are well-known in the art.
Summary
37. No claim is allowed.
Advisory Information
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/JON M LOCKARD/Examiner, Art Unit 1647 April 3, 2026