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 .
Election/Restrictions
Applicant's election with traverse of Groups I and II in the reply filed on 03/04/2026 is acknowledged. The traversal is on the ground(s) that Kim et al. (Korean J Parasitol, 2021) was published after the PCT filing date of December 6, 2021 and the claimed priority date January 22, 2021. This is found persuasive and the restriction requirement is therefore withdrawn.
Claims 1 – 12 are under consideration.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/KR2021/018383, filed December 06, 2021. This application also claims priority to Korean application KR10-2021-0009692, filed on January 22, 2021.
Claim Objections
Claim 8 objected to because of the following informalities: the claim reads “characterized in that a level of autoantibody”. The claim should read “wherein a level of autoantibody”. Appropriate correction is required.
Claim Interpretation
Claims 6 and 7 were interpreted as product-by-process claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) See MPEP 2113.
Here, claims 6 and 7 are drawn to virus-like-particles (VLPs), and not a method for preparing VLPs. As such, for purposes of applying prior art, claims 6 and 7 were broadly interpreted herein encompass any VLPs having all the recited structural limitations of the claimed VLPs.
Claim 8 is drawn to a VLP composition comprised of M1 and T. gondii derived surface antigen and further recites an intended use of characterizing levels of autoantibody. A recitation of the intended use of the claimed invention must result 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. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81; and MPEP § 2111.02.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 3 and 4 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.
Claims 3 and 4 recite the phrase “has an amino acid sequence set forth as SEQ ID NO…”. It is not clear whether the Applicants intend this limitation to read on only the full sequence, a partial sequence, or at least the full sequence. For purposes of compact prosecution and applying prior art, claims 3 and 4 were interpreted herein to require AMA1, ROP4, and ROP18 to comprise the amino acid sequences of SEQ ID NOs: 2, 3, and 4, respectively.
The term “autoantibody” in claim 8 is used by the claim to mean an antibody produced from an individual, while the accepted meaning is that targets an individual’s own cells and is produced by the individual The term is indefinite because the specification does not clearly redefine the term. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
Claim Rejections - 35 USC § 112 – Improper Dependent Claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 is drawn to virus-like-particles (VLPs), and not a method for characterizing autoantibodies. The recitation of the intend use does not, absent evidence to the contrary, result in an additional structural limitations that further limit the claimed invention.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 2, 4, 6, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (KR101964751B1, hereinafter, “Lee”).
Lee discloses a toxoplasmosis VLP which is comprised of M1 and rhoptry antigen 18 (ROP18) (Abstract). Lee discloses that this VLP can react with M1 antibodies (Figure 1, ¶0027). Lee also discloses that Rop18 specific T cells are produced upon VLP administration (Figure 2).
Regarding claim 1, Lee discloses a composition of VLP comprised of T. gondii derived surface antigen protein and M1 (Claim 1, ¶0014, Figure 1).
Regarding claim 2, Lee discloses the T. gondii derived surface antigen protein is Rop18 (Abstract, Claim 1, ¶0014).
Regarding claim 4, Lee discloses the Rop18 sequence that is 100% identical with SEQ ID NO: 4 (reproduced below, Sequence1 is Lee M1 Seq 2; Sequence2 is SEQ ID NO: 4).
PNG
media_image1.png
824
773
media_image1.png
Greyscale
As discussed above, claim 6 is interpreted as a product-by-process claim. As such, the product of claim 6 is a VLP comprised of a T. gondii derived surface antigen and M1. Lee discloses a composition of VLP comprised of T. gondii derived surface antigen protein and M1 (Claim 1, ¶0014, Figure 1).
Regarding claims 9 and 10, Lee discloses using western blot to detect ROP18 and M1 to detect VLPs comprised of Rop18 and M1.
Accordingly, the claimed invention was anticipated by Lee.
Claims 1, 2, 6, and 8 – 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (Korean J Parasitol, 2017, hereinafter, “Lee 2”).
Regarding claim 1, Lee 2 discloses a composition of VLP comprised of T. gondii derived surface antigen protein and M1 (Abstract).
Lee 2 teaches the generation of VLPs comprised of M1 and rhoptry antigen 4 (ROP4) generated using a baculovirus expression system (Abstract). Lee 2 teaches the VLPs are spherical shaped and that the ROP4 are exhibited as spikes on the VLP surface (Abstract). Lee 2 teaches that this VLP elicits an in-vivo immune response (Figure 7).
Regarding claim 2, Lee 2 discloses the T. gondii derived surface antigen protein is Rop4 (Abstract).
As discussed above, claim 6 is interpreted as a product by process claim. As such, the product of claim 6 is a VLP comprised of a T. gondii derived surface antigen and M1. Lee 2 discloses a composition of VLP comprised of T. gondii derived surface antigen protein and M1 (Abstract).
As discussed above, claim 8 is drawn to a VLP composition comprised of M1 and T. gondii derived surface antigen with its intended use of characterizing levels of autoantibody. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Therefore, a prior art reference that teaches a VLP comprised of M1 and T. gondii derived surface antigen would anticipate the claim.
Regarding claims 9 – 12, Lee 2 discloses coating 96 well plates with VLPs comprised of Rop4 and M1 and applying p.Berghei-infected mouse sera (Figure 7 caption). Lee 2 then teaches the characterization of IgG levels using ELISA (Figure 7 caption).
Accordingly, the claimed invention was anticipated by Lee 2.
Claim Rejections - 35 USC § 103
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 3 is rejected under 35 U.S.C. 103 over Lee as applied to claims 1, 2, 4, 6, 9, and 10 above, and in further view of Quan et al (Vaccine, 2008, hereinafter, “Quan”).
As discussed above, claims 1, 2, 4, 6, 9, and 10 were anticipated by the teachings of Lee.
The reference does not teach SEQ ID NO: 4.
However, regarding claim 3, Lee teaches the M1 sequence that is 99.2% identical with SEQ ID NO: 1 (reproduced below, Sequence1 is Lee M1 Seq 1; Sequence2 is SEQ ID NO: 1).
PNG
media_image2.png
425
777
media_image2.png
Greyscale
Additionally, Von der Muelbe teaches compositions contained stabilized mRNA that are optimized for translation to be used for medical applications (Title, ¶0011). This includes an optimized sequence for M1 (Figure 1) that is the exact sequence as SEQ ID NO:4 (reproduced below, Qy is SEQ ID NO: 4, Db is Von der Muelbe).
PNG
media_image3.png
536
691
media_image3.png
Greyscale
Lee and Von der Muelbe are considered to be analogous to the claim invention because they both teach a use for M1. Lee discloses a VLP comprised of M1 core and Rop18 antigen (Abstract). Von der Muelbe teaches the exact sequence of M1 as claimed by SEQ ID NO:4 of the instant application.
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to create a VLP comprised of Rop18 and M1, as taught by Lee, at a with the exact sequence taught by Von der Muelbe because doing so result in a M1 that is optimized for translation within an individual. One of ordinary skill in the art would have had a reasonable expectation of success in using the optimized sequence given that it is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 5 is rejected under 35 U.S.C. 103 over Lee as applied to claims 1, 2, 4, 6, 9, and 10 above, and in further view of Quan et al (Vaccine, 2008, hereinafter, “Quan”).
As discussed above, claims 1, 2, 4, 6, 9, and 10 were anticipated by the teachings of Lee.
The reference does not teach a T. gondii derived surface antigen and M1 at a ratio of 3:1 in an VLP.
However, Quan teaches an producing a bivalent influenza VLP vaccine comprised of hemagglutinin (HA) antigen and M1 (Abstract). Quan teaches the use of this VLP in mice to detect changes in the immune response (Abstract). Regarding claim 5, Quan teaches a near 3:1 ratio of HA protein to M1 (Figure 1A, Lane 3). To determine the ratio of HA protein to M1, examiner used ImageJ.JS, an online repository of the program ImageJ. Western blot quantification was done according to routine practice as evidenced by Davarinejad (Quantifications of Western Blots with ImageJ, Steps 3 to 4). Figure 1 of Quan was uploaded and using the rectangle function, the four regions of interest were measured with each region the exact same size. The pixel intensity measurements recorded by the examiner were HA, which was subtracted by lane background, compared to M1, which was subtracted by the lane background resulting in a 2.91:1 ratio (Shown below, Figure 1 [AltContent: textbox ([img-media_image4.png]
Figure 2)][AltContent: textbox ([img-media_image5.png]
Figure 1)]shows an example of how pixel intensity was calculated, Figure 2 shows two repeated iterations for calculations (A and B)).
Lee and Quan are considered to be analogous to the claim invention because they teach VLPs as therapeutic and diagnostic methods. Lee discloses a VLP comprised of M1 core and Rop18 antigen (Abstract). Quan teaches the ratio of VLP antigen to core, HA to M1, of 2.92:1 (Figure 1A, Lane 3).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to create a VLP comprised of Rop18 and M1, as taught by Lee, at a ratio of 3:1, as taught by Quan, because doing so would produce more antigens on the VLP allowing for a stronger antibody binding. One of ordinary skill in the art would have had a reasonable expectation of success in using a 3:1 ratio of Rop18 to M1 in a VLP given that a 3:1 ratio for antigen to core proteins in VLP is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 7 is rejected under 35 U.S.C. 103 over Lee and Quan as applied to claim 5 above, and in further view of Xue et al (Arch Virol, 2014, hereinafter, “Xue”).
As discussed above, claim 5 was rendered prima facie obvious by the teachings of Lee and Quan.
The references do not teach co-infecting a host cell with a recombinant baculovirus comprising a gene encoding a T. gondii derived surface antigen and a recombinant baculovirus comprising a gene encoding M1.
However, Xue teaches engineering chimeric influenza VLPs comprised of GP5, HA, and M1 proteins (Abstract). This VLP is used to detect the binding of antibodies within the sera of individuals (Abstract). Regarding claim 7, Xue teaches Sf9 cells were co-infected with recombinant baculoviruses encoding NA/GP5-M1, chimeric protein, and HA, an antigen, at different rations including at ratios of 0.5, 1, 3, 5, and 6 (Section: Protein expression).
Lee, Quan, and Xue are considered to be analogous to the claim invention because they teach VLPs as therapeutic and diagnostic methods. Lee discloses a VLP comprised of M1 core and Rop18 antigen (Abstract). Quan teaches the ratio of VLP antigen to core, HA to M1, of 2.92:1 (Figure 1B, Lane 3). Xue teaches the ratio of antigen and core proteins within VLPs can be modified by changing the recombinant baculovirus ratios during co-infection (Section: Protein expression).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to create a VLP comprised of Rop18 and M1, as taught by Lee, at a ratio of 3:1, as taught by Quan, by changing the recombinant baculovirus ratios during co-infection, as taught by Xue, because doing so would produce more antigens compared to the core on the VLP allowing for a stronger antibody binding. One of ordinary skill in the art would have had a reasonable expectation of success in altering the ratio of recombinant baculoviruses encoding the antigen or core protein to alter VLP antigen to core ratio given that the method is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
The prior art made of record and not relied upon is considered pertinent to applicant'sdisclosure:
Pan et al (BioMed Research International, 2010)
Quan et al (Virology, 2017)
Quan et al (J Virol, 2007)
Sokolenko (Biotech Advances, 2012)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
Prosecution Insights