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 without traverse of SEQ ID# 34 in the reply filed on May 11, 2026 is acknowledged.
Claims 431-434 are withdrawn as drawn top a non-elected invention because they do not include SEQ ID# 34. It is noted that the SEQ ID# 47 is related to SEQ ID# 34 but is not included in claim 431 (the independent claim). Claim 432 does contain SEQ ID# 34 but would be rejected under 112 4th if included at this point.
Claim Rejections - 35 USC § 112
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.
Claims 417 and 424 are 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. For the claims, the percent identity includes peptides less than 30 residues. 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.
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 416-420 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.
For claims 416-420, it is not clear how the non-native complex is formed. The polypeptide is 30 or more residues corresponding to a sequence of the target. This includes the target itself and homodimers can form that are not non-native. There is nothing about the polypeptide that makes the complex non-native.
For claim 417, without a specific reference sequence, the percent identity limitation is not clear as to what it encompasses.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 416-420 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims include all possible polypeptides that bind a target protein that regulate the target protein.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of all possible polypeptides that bind a target protein.
The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
There are insufficient structural features common to all members of the genus of all possible polypeptides that bind a target a protein.
The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus.
One of ordinary skill in the art would not be able to identify the broad claimed genus of all possible polypeptides that bind a target protein.
Thus, the specification does not provide an adequate written description of the genus of all possible polypeptides that bind a target a protein that regulate the target protein that is required to practice the claimed invention. Applicants have not described the genus of all possible polypeptides that bind a target a protein to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Claims 416-430 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the 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.
The claims are drawn to preventing any disease or condition in a subject or preventing infection in a subject.
The specification does not teach this.
The are recognizes that not all vaccines prevent infection:
Vaccines are available for reduction of disease due to CPiV, CAV-2, CDV, and CIV. With the exception of CDV vaccines, none of the available vaccines completely prevent infection and shedding, but they can lessen the severity of disease, provided other factors such as overcrowding and appropriate disinfection and reduction of other stressors are also addressed. (page 177, top left) and other disease-causing agents include canine pneumovirus (page 170 top left). (Jane E. Sykes, Canine Viral Respiratory Infections, Chapter 17,
Thus, the art recognizes that there are not vaccines against all viruses and that some vaccines do not prevent infection.
For some virus, there is no vaccine despite years of effort:
Bekker, et al. (abstract only, Nature Reviews Disease Primers volume 9, Article number: 42 (2023)) teach that there is no vaccine or cure for HIV “The AIDS epidemic has been a global public health issue for more than 40 years and has resulted in ~40 million deaths. …Intense research efforts continue for therapeutic and/or preventive vaccines, novel immunotherapies and a cure. (abstract).
Thus, with lack of success, unpredictability, and lack of teaching in the specification, the one of ordinary skill in the art would not be able to make and use the invention as claimed.
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) 416-430 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kim et al. WO 2005/002500 A2).
For claims 416-420, 423-424, Kim et al. teach a method for regulating a target protein or biological function thereof in vivo in a subject comprising contacting the target protein with an effective amount of a polypeptide having an amino acid sequence corresponding to a sequence of the target protein (claim 1; "1. A coronavirus inhibitor which is selected from the group consisting of a) a Five-Helix protein, b) an HR2 peptide, c) an HR1 peptide"; Pg 2 In 1-3; "In particular embodiments, the present invention relates to C-peptides, N-peptides, Five-Helix proteins, Heptad Repeat 2 (HR2) peptides, and Heptad Repeat 1 (HR1) coiled-coil peptides, all of which target HR1 or HR2 regions of the coronavirus Spike protein"; claim 9; "9. A method of inhibiting coronavirus infection of cells in an individual, comprising administering to the individual the inhibitor of claim 1 in sufficient quantity and by an appropriate route, whereby infection of cells in the individual is inhibited"; pg 4 In 1-6; "The method comprises the step of administering to the patient an effective amount of an inhibitor of coronavirus to the patient. Another aspect of the present invention describes a method of inhibiting the ability of a human coronavirus to infect a cell in vitro. The method comprises the step of providing an inhibitor of coronavirus to a cell culture infected with the coronavirus."), wherein the length of the polypeptide is greater than 30 amino acids (claims 12-13; "12. The inhibitor of claim 1 which is an HR2 peptide comprising at least 20 amino acid residues from coronavirus HR2 and is an inhibitor of coronavirus infection of eukaryotic cells. 13. The inhibitor of claim 12 wherein the HR2 peptide has a sequence selected from the group consisting of: amino acid residues 5-50, 9-41, 21- 57, 5-41, 30-57, and 1-57 of SEQ ID NO:2, and 1148- 1182 and 1148-1185 of SEQ ID NO: 1"corresponding sequence), and wherein: the polypeptide and the target protein form a non-native protein complex upon contact of the target protein with the polypeptide, thereby regulating the target protein or biological function thereof in vivo (claim 12; "12. The inhibitor of claim 1 which is an HR2 peptide comprising at least 20 amino acid residues from coronavirus HR2 and is an inhibitor of coronavirus infection of eukaryotic cells"; pg 9 In 1-7; pg 9 In 1-7; "HR1 Peptides: HR1 (Heptad Repeat 1) peptides or inhibitors, also referred to as N-peptide inhibitors, are a further subject of this invention. HR1 peptides are thought to bind to HR2 region in the pre-hairpin intermediate of S protein in a dominant- negative manner, block formation of the fusion-active hairpin structures, and consequently inhibit infection of coronaviruses such as SARS -CoV"). It is noted that claims 416-420 only refer to contacting but the step is comprising and thus includes administering.
For claim 418, Kim et al. teach that it is a SARS CoV spike protein. (page 9, lines 1-7).
For claims 420 and 422, because Kim et al. teach the same products in the same method, the proteasomal degradation is the natural outcome of the structure formed.
For claim 421, Kim et al. teach the sequence of figure 1 that is at least 10% identical to SEQ ID# 4 (compare carboxy terminal region). Also, for claim 421, Kim et al. teach that the oligomerization of the polypeptide and the coronavirus spike protein regulates the coronavirus spike protein or biological function (pg 9 In 1-7) thereof to treat or prevent the coronavirus infection (claim 9).
For claims 425 and 426, Kim et al. teach that the vaccine can be used in treatment (abstract). It is inherent that to treat, the subject must have symptoms or be diagnosed to know to be treated. Further comprising as the claims is written, the claimed step can be carried out before or after the other step.
For claim 427, an immune modulator can be used for example adjuvant can be used (page 31 lower and para spanning 31-32).
For claim 428, the dose can be 0.01 to 1000 micrograms per dose. While the dose is not given in amount per Kg, the dose ranges overlap. (page 30 lower).
For claim 429, the method can use pharmaceutical acceptable carriers (page 30, line 23).
For claim 430, the dose is administered once or over multiple days (page 31 top).
Thus, Kim et al. anticipate the claimed invention.
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(s) 421 and 424 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. as applied to claims 416-430 above, and further in view of fusion protein [human respiratory syncytial virus] GenBank: AFX60169.1.
Kim et al. is discussed above. Kim et al. additionally teach that their invention relies on viral fusion proteins and the structures therein that are found in other viruses as well including heptad repeats, trimeric structure, and involved in fusion (cell entry). (page 5 lower half)
Kim et al. does not teach RSV.
GenBank: AFX60169.1 teach a known RSV F sequence.
One of ordinary skill in the art before the effective time of filing would have known that the RSV F has the features pointed out as part of the fusion protein including heptad repeats, trimeric structure, and involved in fusion (cell entry). One of ordinary skill in the art before the effective time of filing would have had the expectation of success knowing that the proteins shared structure elements and been able to choose any known sequence.
Thus, it would have been obvious before the effective filing date to modify the antiviral of Kim et al. and use an RSV F corresponding to SEQ ID# 34.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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