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 .
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 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.
DETAILED ACTION
Claims 31-48 are pending, claims 1-30 are canceled in this application. This application is a continuation of 17/160,588, filed on 01/28/2021, now U.S. Patent 11,938,218, which
is a continuation of 15/502,166, filed on 02/06/2017, now U.S. Patent 10,980,744, which is a National Stage entry of PCT/US15/44515, filed on 08/10/2015, which claims priority to provisional application 62/035,313, filed on 08/08/2014.
Election/Restrictions
Applicants’ election without traverse of group I, claims 31-46, and subsequent species election of blend copolymer in claim 33 among claims 32 and 33, anti-tumor or anti-cancer peptide in claim 38 among claims 34, 35 and 38-42, and substituted or unsubstituted alkylene as L1 in claim 31 among claims 31 and 43-46, filed on 02/04/2026 is acknowledged.
Applicant’s election of anti-tumor or anti-cancer peptide in claim 38 among claims 34, 35 and 38-42 as ONE SINGLE SPECIES of therapeutic polypeptide is a clear admission of the species in claims 34, 35 and 38-42 being obvious variants of anti-tumor or anti-cancer peptide and applicant’s election of substituted or unsubstituted alkylene in claim 31 among claims 31 and 43-46 as ONE SINGLE SPECIES of L1 is a clear admission of the species in claims 43-46 being obvious variants of substituted or unsubstituted alkylene according to the restriction requirement dated 12/10/2025 page 9. Thus, if the examiner finds one of the inventions unpatentable over the prior art, the admissions may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 32, 47, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 31 and 33-46 will presently be examined to the extent they read on the elected subject matter of record.
Claim Objections
Claim 39 is objected to because of the following informalities: “Insulin recombinant” is recited twice. Appropriate correction is required.
Claim 31 is objected in the recitation the acronym “ROMP”. Use of the full terminology at the first occurrence would obviate this objection.
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.
Claims 31, 34, 35, 38, 41, and 42 are rejected under 35 U.S.C. 112(a) for failure to comply with the written description requirement.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.’)
Mere indistinct terms (such as “therapeutic”, “capable of treating a disease”, “anti-tumor or anti-cancer” (elected species) used herein), however, may not suffice to meet the written description requirement. This is particularly true when a polypeptide is claimed in purely functional terms. See Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886 (CAFC 2004) at 1892, stating:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
Conversely, a description of a polypeptide genus will usually comprise a recitation of amino acid sequence common to the members of the genus, which features constitute a substantial portion of the genus. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under Section 112, ¶ 1, by showing the enablement of a representative number of species within the genus.
A “therapeutic”, “capable of treating a disease”, “anti-tumor or anti-cancer” polypeptide genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP 2163.
Here, the specification does not provide a reasonably representative disclosure of useful “therapeutic”, “capable of treating a disease”, “anti-tumor or anti-cancer” polypeptides generally, a potentially huge genus inclusive of many different polypeptides having widely divergent sequences and functions (different types of cancer) including future, undiscovered polypeptides (reach-through). Specifically, the specification discloses only a limited number of species in paragraph 202 and 203 (also not all of them are therapeutic: Ceruletide is not therapeutic), and these are not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of the second paragraph 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.
Claims 31 and 33-46 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitations of "copolymer" being R1-[M(O)]n-R2 in claim 31 and “blend copolymer” in claim 33 and the disclosure of “polymer” being R1-[M(O)]n-R2 and "copolymer" as block copolymer and blend copolymer being R1-[M(O)]n-[M(P)]m-R2, R1-([M(O)]n-[M(P)]m)z-R2 or R1-([M(P)]m-[M(O)]n)z-R2, respectively, in the instant specification paragraph 9-11 render claim 31 indefinite. Since R1-[M(O)]n-R2 is defined in the disclosure of the instant specification as “polymer” while "copolymer" is defined as block copolymer R1-[M(O)]n-[M(P)]m-R2 and blend copolymer R1-([M(O)]n-[M(P)]m)z-R2 or R1-([M(P)]m-[M(O)]n)z-R2; it is unclear and indefinite as to how the "copolymer" and R1-[M(O)]n-R2 herein are interpreted thereby.
To expedite the prosecution "copolymer" and “blend copolymer” being R1-[M(O)]n-R2 in claims 31 and 33 are given their broadest reasonable interpretations by the examiner in light of the specification in the prior art rejections as a “homopolymer”, not a “copolymer”, being R1-[M(O)]n-R2.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 31 and 33-46 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lu et al. (One-Pot Synthesis of Brush-Like Polymers via Integrated Ring-Opening Metathesis Polymerization and Polymerization of Amino Acid N-Carboxyanhydrides, Journal of the American Chemical Society, Vol 131, Issue 38, Article, page 13582-13583, 09/02/2009) in view of Gaspar et al. (From antimicrobial to anticancer peptides. A review, Frontiers in Microbiology, Antimicrobials, Resistance and Chemotherapy, 09/30/2013).
Lu et al. teach, in abstract and the last paragraph in the left column and the first paragraph on the right column, scheme 2 and table 1 and 2, a brush-like polymer via integrated ring-opening metathesis polymerization (ROMP) via approach 3 in scheme 2
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(the left repeating unit M2 with grafted polypeptide, without the right repeating unit M4, also P2-P5 in table 1, i.e., a homopolymer having a polypeptide and TMS as a protecting group (will be removed after the polymerization, the claimed homopolymer in the instant claims 31 and 33 as discussed above)
from 5-norbornene-endo-2,3-dicarboximide (M1) (the claimed ROMP monomer M in the formula in the instant claim 31) catalyzed by Grubbs catalyst (results in phenyl terminal groups (unsubstituted aryl, the claimed R1 and R2 in the formula in the instant claims 31, 36, and 37) with
only left part of the repeating unit, M2 with grafted polypeptide (the portion within the parenthesis having “n” repeating unit in the pendant, the claimed O in the formula in the instant claim 31), without the right part of the repeating unit, M4, which is the P2-P5 in table 1, i.e., a homopolymer having a polypeptide and TMS as a protecting group (will be removed after the polymerization) (the claimed M(O) in the instant claim 31),
-CH2-CH2-NH- between the cyclic -N- on norbornene and the polypeptide (substituted alkylene, the elected species of the claimed L1 in M(O) in the instant claims 31 and 43-46 as discussed above), and
exemplified P2-g-Glu50 in table 2 with x=9 (degree of polymerization, the claimed n in the formula in the instant claim 31) having 50 Glu (50 amino acids).
Lu et al. do not specify the polypeptide including anti-tumor or anti-cancer peptide (the elected species in the instant claims 31, 34, 35 and 38-42.
This deficiency is cured by Gaspar et al. who teach peptides with anticancer are known (abstract, the paragraph bridges left and right column on page 3 and table 1).
In KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), the Supreme Court has held that when there is market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person has good reason to pursue known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. Under these conditions, “obviousness to try” such options is permissible. In this instance, Lu et al. utilize monomer 5-norbornene-endo-2,3-dicarboximide to produce a polymer with polypeptide side chain while Gaspar et al. teach anticancer peptides. Thus, it would have been obvious to one of ordinary skill in the art to try to use anticancer peptides taught by Gaspar et al. as the polypeptide side chain in the polymer taught by Lu et al. because all amino acids in any polypeptide have both an amine functional group and a carboxylic functional group that is needed in functionalization the repeating unite M2 taught by Lu et al.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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