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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted June 19, 2020 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 2, 13 and 21 are objected to because of the following informalities:
In claims 1, 2 and 21 the examiner respectively requests a space between the number and unit, i.e., between ‘5’ and ‘nm’ and ‘25’ and ‘nm’ in claim 1; between ‘10’ and ‘nm’, ‘15’ and ‘nm’, ‘1’ and ‘nm’, ‘3’ and ‘nm’ in claim 2; between ‘5’ and ‘nm’, ‘25’ and ‘nm’, ‘1’ and ‘nm’ and ‘5’ and ‘nm’ in claim 21.
In claim 13, it is suggested to amend ‘linker’ to ‘linker molecule’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-23 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. This is a written description rejection.
The claimed invention is directed to a genus of cell penetrating β helical protein conjugates, that encompasses a species of β helical protein with pentapeptide-repeat, with the consensus sequence (STAV)1(DN)2(LF)3(STR)4(G)5, that is SEQ ID NO: 18. The instant specification [00120] line 12, states SEQ ID NO: 1-2, 6-8 are examples of pentapeptide repeat proteins. Thus, the examiner interprets SEQ ID NO: 3-5 and 9-12 as not pentapeptide-repeat proteins. Applicant reduced to practice SED ID NO: 2 representing the β helical protein in a cell penetrating conjugate. Consequently, one of ordinary skill in the art would not conclude Applicant was in possession of the claimed genus in view of the single species described.
Claim 1 is drawn to a genus of cell penetrating β helical protein conjugates, wherein “a cell penetrating conjugate comprising a recombinant β helical protein…range from 5 nm to 25 nm, and width is in the range of from 1 nm to 5 nm” . The specification defines the term “β helical protein” as “a protein forming a β helical secondary structure. β helical proteins are formed from a generally parallel association between adjacent β strands of a peptide chain. A β helical protein can be a right handed or a left handed b helical depending on the direction of coiling on the helix structure” [0053].
Claim 1 lacks written description because the instant application does not provide sufficient guidance to one of ordinary skill in the art to determine the sequences falling within the scope of the genus or of a recitation of structural features common to the members of the genus.
Regarding claim 10, the Applicant has reduced to practice SEQ ID NO: 2 and Applicant states that SEQ ID NO: 1-2, 6-8 are examples of pentapeptide repeat proteins [00120]. In the case of SEQ ID NO: 3-5, 9-12, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. A “representative number of species” means that the species are adequately described are representative of the entire genus. See MPEP §2163.
The claimed genus of β helical protein is very structurally diverse whereas the species reduced to practice are not as diverse. To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention. The description must clearly allow persons of ordinary sill in the art to recognize that [the inventor] invented what is claimed”.
While the general knowledge and level of skill in the art for peptide amino acids is evident, this knowledge and level of skill does not supplement the omitted description because specific, not general guidance is needed for the one or more sequences forming the β helical protein, for which guidance is not provided at all. Since the disclosure fails to describe the common attributes or core sequence that represent all members of the genus, and because the genus of β helical protein is vast and variant, the limited example in the specification is insufficient to teach the entire genus. One would only conclude that Applicant was in possession of a cell penetrating conjugate comprising a β helical protein represented by SEQ ID NO: 2.
Claims 2-23 which depend from claim 1 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112(pre-AIA ), first paragraph, as these claims incorporate by dependency the lack of adequate written description of claim 1.
Regarding claim 10, the Applicant satisfies the written description requirement for SEQ ID NO: 1, 2, 6, 7, and 8.
Claim Rejections - 35 USC § 112
Claims 1-23 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 pentapeptide repeat-containing protein of SEQ ID NO: 2, does not reasonably provide enablement for the genus of β helical proteins. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Claim 1 is directed to cell penetrating conjugates comprising a genus of β helical protein of SEQ ID NO: 1-SEQ ID NO: 12, which encompasses a species of pentapeptide repeat containing proteins of SEQ ID NO: 1, 2, 6, 7 and 8 [00120]. While the instant specification is enabling for β helical protein of SEQ ID NO: 2, which contains the pentapeptide repeat sequence of SEQ ID NO: 18, the embodiments of the instant specification is not enabling for SEQ ID NO: 3, 4, 5, 9, 10, 11 and 12 that does not contain the pentapeptide repeats [00120]. 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
the claims.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether
there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement
requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5.The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the
disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands
factors are applied to claims 9-13 as follows:
The breadth of the claims and the nature of the invention
Claims 1-23 are directed to β helical protein conjugates wherein the β helical protein length is in the range of from 5 nm to 25 nm, and width is in the range from 1 nm to 5 nm. As such, the genus of “β helical protein”, encompasses pentapeptide-repeat, with the consensus sequence (STAV)1(DN)2(LF)3(STR)4(G)5. The instant specification discloses SEQ ID NO: 1, 2, 6, 7 and 8 as pentapeptide repeat containing proteins [00120]. The specification does not provide evidence that SEQ ID NO: 1, 3-12 can form cell penetrating conjugates. The instant specification provides no evidence that SEQ ID NO: 1, 3-12, are of protein length ranging from 5 nm to 25 nm and width in the range of 1 nm to 5 nm. Accordingly, claims 1-23 are unduly broad with respect to forming cell penetrating conjugates.
The State of the Prior Art
Prior art, U.S. Patent No. 11,583,589, teaches cell penetrating conjugates comprising β helical protein of SEQ ID NO: 1-5, 7, 9-12, 18. The prior art is enabled for sequences in instant Claims 9 and 10, except for SEQ ID NO: 6 and SEQ ID NO: 8. It is noted that there is no prior art that teaches all β helical proteins, wherein protein lengths ranging from 5 nm to 25 nm and width in the range of 1 nm to 5 nm can form cell penetrating conjugates.
The Level of Skill in the Art
Practitioners in this art (structural biologists, chemists) would presumably be highly skilled in the art for generating cell penetrating conjugates.
The Level of Predictability in the Art
It is noted that the molecular biology art it unpredictable, requiring each embodiment to be individually assessed for physiological activity. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). This is because it is not obvious from the disclosure, of a specific structure that can achieve the cell penetrating properties of the conjugate.
In the instant case, the specification provides SEQ ID NO: 2, a pentapeptide repeat protein ranging in length from 5 nm to 25 nm and width in the range of 1 nm to 5 nm, that forms a cell penetrating conjugate. The size of SEQ ID NO: 2 was determined from the published crystal structure pdb id: 2w7z.pdb. [00287] line 11. The specification does not demonstrate that peptide composition with SEQ ID NO: 1, 3-12 exhibit β helical structure of length and width as stated above, and does not provide data that it forms cell penetrating conjugates. Without any experimentation demonstrating the claimed size or function, the level of unpredictability remains high. Therefore, it is unpredictable that the SEQ ID NO: 1, 3-12 will function as cell penetrating conjugates.
The amount of Direction Provided by the Inventor and The Presence or Absence of Working Examples
The instant specification does not provide adequate guidance with regard to the genus of β helical proteins that function as cell penetrating conjugates. Applicant’s limited disclosure is noted but is not sufficient to justify claiming the β helical proteins broadly.
Absent a reasonable a priori expectation of success for using SEQ ID NO: 1, 3-12, as β helical proteins in the cell penetrating conjugate, one skilled in the art would have to extensively test the peptides, determine each structure to ascertain the lengths and widths, create conjugates and establish cell penetrating functions. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he Level of Predictability in the Art” section supra, the specification teaches working examples with SEQ ID NO: 2 and the cell penetrating function of SEQ ID NO:2-containing conjugate. Prior art teaches SEQ ID NO: 1, 2, 3, 4, 5, 7, 9-12, 18 as forming cell penetrating conjugates. However as noted in the “Breadth of the Claims and Nature of Invention” section, the genus of “β helical protein” encompasses β helical proteins in the length ranging from 5 nm to 25 nm, and width in the range from 1 nm to 5 nm. As such, the examples used in the specification are not indicative broadly of β helical proteins with the desired result of cell penetration properties.
It is further noted that Applicant provides no data, examples, figures, etc. demonstrating that β helical proteins in the length ranging from 5 nm to 25 nm, and width in the range from 1 nm to 5 nm are capable of cell penetrating properties. In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “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).
After applying the Wands factors and analysis to claims 1-23, in view of the Applicant’s entire disclosure, it is concluded that the practice of the invention as claimed in claims 1-23 would not be enabled by the written disclosure for β helical proteins. Therefore claims 1-23 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to generate cell penetrating conjugates as claimed.
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, 8-16, 18-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 14 of U.S. Patent No. 11,583,589 (reference patent).
Reference patent claims:
1. A cell penetrating conjugate comprising a recombinant β helical protein linked to a functional molecule, wherein the β helical protein length is in the range of from 5 nm to 25 nm, and width is in the range of from 1 nm to 5 nm; wherein the β helical protein comprises a sequence selected from the group consisting of SEQ ID NO: 18, SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, and SEQ ID NO: 12, and combinations thereof.
2. The cell penetrating conjugate as claimed in claim 1, wherein the recombinant β helical protein is linked to the functional molecule via a linker molecule selected from the group consisting of: polyethyleneglycol (PEG); peptide; metal conjugate, drug-metal conjugate, DNA binding domain, nucleic acid intercalating molecule and combinations thereof.
3. The cell penetrating conjugate as claimed in claim 2, wherein when the linker molecule is a peptide, the peptide comprises amino acids selected from the group consisting of: aliphatic amino acids; aromatic amino acids; and combinations thereof.
4. The cell penetrating conjugate as claimed in claim 1, wherein the recombinant β helical protein is linked to the functional molecule by one or more of the group consisting of: covalent bonds, non-covalent bonds, and combinations thereof.
5. The cell penetrating conjugate as claimed in claim 1, wherein the recombinant β helical protein is linked to the functional molecule by a linkage selected from the group consisting of an ester linkage and an amide linkage.
6. The cell penetrating conjugate as claimed in claim 1, wherein the functional molecule is selected from the group consisting of dyes, drugs, metal, drug-metal conjugate, proteins, enzymes, antibodies, nucleic acids, polysaccharides, nuclear localizing signals, nanoparticles, and combinations thereof.
7. The cell penetrating conjugate as claimed in claim 1, wherein the conjugate further comprises a signal sequence wherein the signal sequence directs the conjugate to a particular cell or part of a cell.
9. The cell penetrating conjugate as claimed in claim 1, wherein the conjugate further comprises a phosphatidyl choline molecule.
10. The cell penetrating conjugate as claimed in claim 7, wherein the conjugate transfers the functional molecule to a location selected from the group consisting of: cell organelles; nucleus; endoplasmic reticulum; mitochondria; cell membrane; and P-cadherin overexpressing breast cancer cells.
11. The cell penetrating conjugate as claimed in claim 10, wherein the cell organelles are selected from the group comprising actin filaments, golgi bodies, cell membrane, and microtubulins.
12. A process for transferring a functional molecule into at least one cell, said process comprising:
a) linking the functional molecule to a recombinant β helical protein to obtain a conjugate;
b) contacting the conjugate with at least one cell;
wherein contacting the conjugate of step (b) transfers the functional molecule into the at least one cell; and
wherein the β helical protein length is in the range of from 5 nm to 25 nm and width is in the range of from 1 nm to 5 nm; wherein the β helical protein comprises a sequence selected from the group consisting of SEQ ID NO: 18, SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, and SEQ ID NO: 12, and combinations thereof.
13. The process as claimed in claim 12, wherein the process comprises after step (b):
c) detecting the transfer of the conjugate inside the at least one cell.
14. The process as claimed in claim 12, wherein the at least one cell is selected from the group consisting of eukaryotic cells, prokaryotic cells, and combinations thereof.
(Patent 11583589 claims 1-6, 7, 9, 11-14). Patent 11583589 is directed to a cell-penetrating conjugate comprising a recombinant β helical protein with a length in the range of 5 nm to 25 nm and width in the range of 1 nm to 5 nm; wherein the β helical protein comprises a sequence selected from the group consisting of SEQ ID NO: 18, SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 7, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, and SEQ ID NO: 12, and combinations thereof. The β helical protein is linked to a functional molecule by one or more of the group consisting of: covalent bonds, non-covalent bonds, and combinations thereof; and wherein the recombinant β helical protein is linked to the functional molecule by a linkage selected from the group consisting of an ester linkage and an amide linkage. The functional molecule is selected from the group consisting of dyes, drugs, metal, drug-metal conjugate, proteins, enzymes, antibodies, nucleic acids, polysaccharides, nuclear localizing signals, nanoparticles, and combinations thereof. The β helical protein is linked to the functional molecule via a linker molecule selected from the group consisting of: polyethyleneglycol (PEG); peptide; metal conjugate, drug-metal conjugate, DNA binding domain, nucleic acid intercalating molecule and combinations The linker molecule is a peptide, the peptide comprises amino acids selected from the group consisting of: aliphatic amino acids; aromatic amino acids; and combinations thereof. The conjugate comprises a phosphatidyl choline molecule and further comprises a signal sequence wherein the signal sequence directs the conjugate to a particular cell or part of a cell. Patent 11583589 claims 12-14 is directed to a process of transferring a functional molecule into at least one cell, by the conjugate, wherein the at least one cell is selected from the group consisting of eukaryotic cells, prokaryotic cells, and combinations thereof.
Claim 1 in the instant application, directed to a cell penetrating conjugate is not patentably distinct from the subject matter claimed in Patent 11583589. The claim under examination is not patentably distinct from the reference claim because, the claim under examination is anticipated by the reference claim. In the instant application, claim 1 is directed to a cell penetrating conjugate wherein the β helical protein can encompass a multitude of β helical proteins. This is a generic claim. Reference patent claim is directed to a species or sub-genus of β helical proteins. Here, the entire scope of the reference patent claim, falls within the scope of the examined claim. Therefore, a patent to the genus ofβ helical proteins would improperly extend the right to exclude granted by a patent to the species or sub-genus (SEQ ID Nos: 18, 1, 2, 3, 4, 5, 7, 9, 10, 11, 12), should the genus issue as a patent after the species or sub-genus. See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993).
Claim 10 which is dependent on claim 1, is directed to β helical proteins selected from a group consisting of SEQ ID NO 1 to SEQ ID NO: 12. The scope of claim 1 in the reference patent is directed to β helical proteins “selected from the group consisting of”. This is a Markush grouping and the examiner interprets the group to consist of obvious variants of each other. One or more sequences in claim 1 of the reference patent is 100% identical to the sequences in claim 10 in the instant application. Thus, the reference patent claim anticipates claim 10 in the instant application.
Claims 11-16, 18-23 are not patentably distinct from the reference claims because, the claims under examination are anticipated by the reference claims 2-7 and claims 9-14.Claim 2 is directed to β helical protein length in the range from 10 nm to 15 nm and width from 1 nm to 3 nm. While the reference patent, claims a length range from 5 nm to 25 nm and width range from 1 nm to 5 nm for the β helical protein, the reference does not claim the length and width ranges present in the instant claim. The claimed ranges overlap and lie inside ranges disclosed in the reference patent. See MPEP §2144.05. Thus, a prima facie case of obviousness exists.
Claims 8 and 9 are directed to the β helical protein, wherein the β helical protein is a pentapeptide with consensus sequence (STAV)1(DN)2(LF)3(STR)4(G)5. Reference patent claims β helical protein with a SEQ ID NO: 18. The reference patent specification describes SEQ ID NO:18 as a pentapeptide repeat protein having a consensus sequence (STAV)1(DN)2(LF)3(STR)4(G)5. A person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent.
Conclusion
No claim is allowed
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654