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 – Retained for the Record
Applicant’s election without traverse of Group I, claims 1-9 and 14, in the reply filed on 6/10/25 is acknowledged.
Claims 15, 16, 22, 23, 28, 29, 33-35, 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/25.
Applicant elected the following species in the reply filed on 6/10/25:
Applicant hereby elects the peptide amphiphile (C16)VVAAEEGGRGAAPPKQEFLDIE (SEQ ID NO:1), as shown in Table 1, p. 21 of the specification. Applicant also notes that the hydrophobic non-peptidic segment is a C16 group; the B-sheet-forming peptide segment is VVAA; the charged peptide segment is EE; and the targeting moiety is RGAAPPKQEFLDIE (SEQ ID NO: 7).
Applicant’s election of the above species in the reply filed on 6/10/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Based on the specification, Table 1, page 21, the elected species SEQ ID NO:1 targets MMP2 and not MT1-MMP nor fragmented elastin.
Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/25.
Claim Status
Claims 1-6, 8, 9, 14-16, 22, 23, 28, 29, 33-35, 43 are pending.
Claims 7, 10-13, 17-21, 24-27, 30-32, 36-42 are cancelled.
Claims 15, 16, 22, 23, 28, 29, 33-35, 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/25.
Claims 5-7 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/25. Claim 7 is cancelled 12/5/25.
Claims 1-4, 8, 9 and 14 are pending and under examination.
Claims 1-4, 8, 9 and 14 are rejected.
Priority
The instant application, filed 07/29/2022 is a National Stage entry of PCT/US2021/015776 , International Filing Date: 01/29/2021
PCT/US2021/015776 Claims Priority from Provisional Application 62968896 , filed 01/31/2020.
Specification – Objections
Response to Arguments
Applicant’s arguments, see page 7, filed 12/5/25, and amendment of title, with respect to the objection to the title have been fully considered and are persuasive. The objection regarding the title has been withdrawn.
Applicant's arguments filed 12/5/25 with respect to the color drawings have been fully considered and are persuasive. In view of grant of the Petition for color drawings, the objection regarding the specification has been withdrawn.
Drawings
Response to Arguments
Applicant’s arguments, see page 7, filed 12/5/25, and grant of petition following submission of color drawing, with respect to the color drawings objection have been fully considered and are persuasive. The color drawings objection has been withdrawn.
Further in this regard, the examiner has reviewed the color drawings and finds them acceptable, comprising no new matter and otherwise in conformance with requirements.
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.
Response to Arguments
Applicant's arguments filed 12/5/25 have been fully considered but they are not persuasive.
As to page 8 of Remarks, the examiner does not dispute any statement in Ariad v. Lilly, however the facts there differ from those directed to the instant claims and the paucity of support in the application as filed for the claimed genus. A single species for what is claimed, combined with the lack of guidance in any forms, are considered in the instant application rejection under this section.
On page 9 applicant makes a general statement that one of ordinary skill in the art “would understand “the structure required to achieve the claimed functions of a targeting moiety that localizes to MMP-2” from the application as filed and the state of the art,” then sets forth para 76. This is a statement without sufficient support to be persuasive. The genus is large and as noted there is a single embodiment in the application as filed that is shown to associate with/localize to MMP-2. As to para 76, this even expands the genus to small molecules, for which no guidance is found. Also as to para 76, notwithstanding its general statements Table 1, page 21 of the specification reveals that only one of two peptides were evaluate for the MMP-2 target, which did target aneurism, and a single peptide targeted MT1-MMP.
Applicant pursues the argument that “there is no need to show” more than one specific PA that localizes to MMP-2 because of knowledge in the art, including that these are “easily derivable based on the known structure of MMP-2.” This, again, is not found persuasive at least because applicant has not provided evidence of the knowledge in the art that would so readily lead one of ordinary skill in the art to understand such structures commensurate with what is claimed.
Both of these, apparently, were based on regions of surface contact from X-ray crystallographic structures of TIMP-2 in complex with MMP-2 and MT1-MMP, respectively, para 170. Even considering the state of knowledge in the art, this, along with other disclosures in the application as filed, is not supportive of possession of the entire genus of peptide amphiphiles that comprise a targeting moiety that localizes to MMP-2, nor of the entire genus of peptide amphiphiles that comprise a targeting moiety that localizes to MT1-MMP. Other than this limited approach using TIMP-2, nowhere has applicant disclosed properties or requirements of sequences required to achieve the claimed functions of a targeting moiety that localizes to MMP-2 or a targeting moiety that localizes to MT1-MMP, nor key portions of its sequences that are critical to retaining desired targeting properties. The claimed genus is large, and applicant has not set forth by any combination of examples, disclosures of key or required components, structure/function teachings, or other relevant disclosures, that demonstrates that applicant is in possession of a sufficient number and diversity of species to support possession of the large and diverse genus now claimed.
Also, applicant states “the present application also discloses “structure/function teachings,”” but does not indicate where these are found nor how they provide for possession when all factors are considered. The examiner has not found relevant structure/function teachings in the application as filed to indicate possession when considering all factors.
Claims 1-4, 8, 9 and 14 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.
For compact prosecution this rejection extends beyond the elected species.
As previously stated, applicant has disclosed and demonstrated a single species that binds to MMP-2, and a single species that binds to MT1-MMP. Even considering the state of knowledge in the art, this, along with other disclosures in the application as filed, is not supportive of possession of the entire genus of peptide amphiphiles that comprise a targeting moiety that localizes to MMP-2, nor of the entire genus of peptide amphiphiles that comprise a targeting moiety that localizes to MT1-MMP. Nowhere has applicant disclosed the structure required to achieve the claimed functions of a targeting moiety that localizes to MMP-2 and a targeting moiety that localizes to MT1-MMP. Applicant has not set forth by any combination of examples, disclosures of key or required components, structure/function teachings, or other relevant disclosures, that demonstrates that applicant is in possession of a sufficient number and diversity of species to support possession of the large and diverse genus now claimed.
The above results in lack of possession of what is claimed in claim 1, so claim 1 is rejected under this section, and because dependent claims 2-4, 8, 9 and 14 do not overcome these bases, these claims also are rejected under this section.
Claim Rejections - 35 USC § 103
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.
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.
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.
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.
Response to Arguments
Applicant's arguments filed 12/5/25 have been fully considered but they are not persuasive.
As to arguments about the specificity of what Kibbe’s ‘teachings’ are directed to, please note how broad Kibbe’s claim 1 is. Plus as set forth in the rejection Kibbe teaches various prior art references teach a broad scope of uses for peptide amphiphiles having the same four-part structure. Overall the teachings in Kibbe extend broadly, far beyond what it focuses on regarding its particular advances in the field of therapeutic peptide amphiphiles, see the four paragraphs of the rejection, the first of which begins “Kibbe para 39 teaches …”. Its examples are not representative of its teachings, and given Kibbe’s claims, and broader teachings, there is no valid teaching away or “not work for its intended purpose” when considering the overall teachings of Kibbe.
Contrary to the statement on page 12, first sentence, the examiner in the rejection explicitly asserted that a person of ordinary skill would have a reasonable expectation of success. This is underlined below (for claims 8 and 9, which include all limitations in claims from which they depend). The examiner also directs applicant and representative thereof to MPEP 2143.02 I, which in part sets forth that a reasonable expectation of success can be implicitly shown via the prior art teachings or as part of the obviousness analysis. Applicant in this regard is further directed to the last sentence of the paragraph immediately preceding “Accordingly, claims 1, 4 and 14 when examining the elected species would have been obvious,” which the examiner considers one of the implicit showings of reasonable expectation of success.
The examiner is not persuaded by the “general approach …” arguments against Kibbe and Cathcart because what are taught are not that generalized, they are specific in many regards to the four configured components of the common PA structure. As to specific arguments against Cathcart, its teaching apart from specific embodiments or approaches stands and is relevant to the rejection, “Cathcart summarizes previous efforts to develop and evaluate pharmaceutical compounds to target MMPs,” including the importance of MMPs as targets such as for cancer cells.
Further regarding arguments against specific references and their alleged deficiencies, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim(s) 1-4, 8, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150151002, Kibbe et al, published 6/4/15 (Kibbe) in view of Cathcart et al., Genes & Diseases (2015) 2, 26-34 (Cathcart), US 20170051016, published 2/23/17 (Sharma), and Morgunova et al., PNAS, May 28, 2002, vol. 99, no. 11, pp 7414-7419 (Morgunova).
Kibbe claim 1 is compared with instant claims 1 and 14 in the following table:
Kibbe claim 1
Instant claim 1
1. A peptide amphiphile comprising:
(a) a hydrophobic non-peptidic segment;
(b) a .beta.-sheet-forming peptide segment;
(c) a charged peptide segment;
(d) a targeting moiety; and
(e) a therapeutic agent;1
wherein the hydrophobic non-peptidic segment is covalently attached to the N-terminus of the .beta.-sheet-forming peptide segment;
wherein the C-terminus of the .beta.-sheet-forming peptide segment is covalently attached to the N-terminus of the charged peptide segment; and wherein the C-terminus of the charged peptide segment is covalently attached to the N-terminus of the targeting moiety.
1. (Original) A peptide amphiphile comprising:
(a) a hydrophobic non- peptidic segment;
(b) a B-sheet-forming peptide segment;
(c) a charged peptide segment;
(d) a targeting moiety, wherein the targeting moiety localizes to MMP-2, MT1-MMP, or fragmented elastin;
and optionally (e) a therapeutic agent;
wherein the hydrophobic non-peptidic segment is covalently attached to the N-terminus of the B-sheet-forming peptide segment;
wherein the B-sheet-forming peptide segment is covalently attached to the targeting moiety; and
wherein the charged peptide segment is covalently attached to the targeting moiety.
14. (Original) The peptide amphiphile of claim 1, wherein the C-terminus of the B-sheet-forming peptide segment is covalently attached to the N-terminus of the charged peptide segment; and wherein the C-terminus of the charged peptide segment is covalently attached to the N-terminus of the targeting moiety.
Optional and optionally clause or language in a claim has been interpreted to give no additional weight to, nor to limit the claims. See MPEP 2111.04, which states in part, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.”
The transition phrase “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps., see MPEP 2111.03 I.
Please note that the italicized portions of the Kibbe claim 1 are set forth in instant claim 14.
Also please note that the double underlined portions of instant claim 1 – particularly “wherein the B-sheet-forming peptide segment is covalently attached to the targeting moiety” allows for intervening portions or sections, as made evident in instant claim 14.2
Kibbe para 39 teaches, “[0039] As used herein, the term "targeting peptide" refers to amino acid sequences which mediates the localization (or retention) of sequences, molecules, or supramolecular complexes associated therewith to a particular location or locations (e.g., sub-cellular location (e.g., organelle), an organ (e.g., heart), tissue (e.g., cardiovascular tissue), or localized with a receptor or binding partner for the targeting peptide). Peptide amphiphiles and structures (e.g., nanofibers) bearing targeting peptides have been reported to congregate in desired locations based on the identity and presence of the targeting peptide. A targeting peptide described in exemplary embodiments herein is the collagen-binding peptide. Such targeting peptides have been shown to delivery targeted nanofibers comprising such peptides to the site of arterial intervention.”
Kibbe also teaches “treating or preventing a disease or condition in a subject suffering from said disease or condition comprising administering to the subject a self-assembled nanofiber comprising a targeting moiety and a therapeutic agent, wherein the targeting moiety localizes the nanofiber to the site of the cause of the disease of condition and the therapeutic agent treats or prevents the disease or condition,” para 12, underline emphasis added, and teaches using “fluorescently-labeled nanostructures” that provide for detection of targeted tissues, including an injured vessel, Example 3.
Kibbe, in addition to the above, clearly teaches that “Peptide amphiphiles (Hartgerink et al. P Natl Acad Sci USA 99, 5133 (2002).; Hartgerink et al. Science 294, 1684 (2001).; herein incorporated by reference in their entireties) (PAs) are a class of self-assembling molecules that are composed of a hydrophobic segment conjugated to a sequence of amino acids. PAs can form long, high aspect ratio cylindrical filaments in water and have been studied for a range of applications in regenerative medicine (Mata et al., Biomaterials 31, 6004 (2010).; Shah et al., P Natl Acad Sci USA 107, 3293 (2010).; Huang et al. Biomaterials 31, 9202 (2010).; Webber et al., P Natl Acad Sci USA 108, 13438 (2011).; herein incorporated by reference in their entireties). PA bioactivity is derived from presentation of peptide sequences on the surface of self-assembled nanostructures that form in solution. The rheological properties of these materials can be tuned by concentration and peptide sequence (Pashuck et al. Journal of the American Chemical Society 132, 6041 (2010).; herein incorporated by reference in its entirety).”
Kibbe further clearly teaches that “Targeting moieties may direct PA structures (and therefore the therapeutics attached thereto or encapsulated therein) to specific organs, tissues, cell types, subcellular locations (e.g., organelles), pathogens (e.g., viruses, bacteria, etc.), diseases (e.g., to cancerous cells), etc.,” para 48, and “Embodiments are not limited to such conditions (e.g., cardiovascular intervention or damage), targeting moieties (e.g., vascular targeting, collagen IV targeting, etc.), or therapeutics (e.g., NO). One of skill in the art will understand how to select and test combinations of therapeutic agents and targeting moieties for prevention and/or treatment of a variety of diseases and conditions. For example, a PA comprising tumor targeting peptides and linked to chemotherapeutics find use in the treatment of cancer,” para 53, underlined emphasis added.
Kibbe’s PA structures assemble into nanofibers, see paras 10, 11, Figs. 1-3 and elsewhere, which are a type of nanoparticle.
However Kibbe does not explicitly teach wherein the targeting moiety localizes to MMP-2, the elected targeting moiety.
Although applicant focuses on MMP-2 targeting with regard to its presence and role(s) in abdominal aortic aneurism pathology, the prior art also has researched and developed technological advances with regard to targeting MMP-2 involving cancers and cancer treatments.
The level of ordinary skill in the art is moderately high.
Cathcart summarizes previous efforts to develop and evaluate pharmaceutical compounds to target MMPs, primarily for cancer therapies, including past problems when evaluated in human subjects with regard to effectiveness and side effects, the latter stated at least in part due to non-specific targeting, pages 27-31. Particularly regarding MMP-2 and cancer, Cathcart teaches, “… MMP-2 levels detected in cancer tissue are significantly correlated to larger tumor size,” and “In a mouse xenograft model of melanoma, increased levels of MMP-2 correlated to a more malignant phenotype,” page 27, while also through the reference addressing challenges of targeting specific MMPs and cell types. Cathcart in the section beginning on page 31, bottom right column, then when looking ahead to designing targeted drug delivery systems, on page 32 teaches that “nanoparticles are another system which can be modified in order to selectively deliver a cytotoxic payload to cancer cells.”
Based at least on a therapeutic and also a commercial interest to improve targeted therapies for cancer treatment, to one of ordinary skill in the art Kibbe in view of Cathcart would suggest using an MMP-2 targeting moiety in a PA-based nanofiber type nanoparticle structured such as taught and claimed by Kibbe to better target cancer cells (a “cell type”) and related tissues and organs.
With regard to the elected sequence, neither Kibbe nor Cathcart explicitly teach the entire sequence, albeit Kibbe does teach that the beta-sheet forming portion of its PAs can comprise “AAVV”, see claim 5, and also teaches the use of glycine linkers/spacers in the PA, teaching these as part of the “charged peptide segment” and disposed “intermediately disposed between the charged residues and the functional peptide segment (e.g., targeting peptide),” para 38.
With regard to the structural alternatives of the hydrophobic non-peptidic segment, .beta.-sheet-forming peptide segment and charged peptide segment, Sharma teaches and claims
“1. A peptide amphiphile comprising:
(a) a hydrophobic non-peptidic segment;
(b) a structural peptide segment;
(c) a charged peptide segment; and
(d) an anti-inflammatory peptide segment; wherein the hydrophobic non-peptidic segment is covalently attached to the N-terminus of the structural peptide segment; wherein the C-terminus of the structural peptide segment is covalently attached to the N-terminus of the charged peptide segment; and wherein the C-terminus of the charged peptide segment is covalently attached to the N-terminus of the anti-inflammatory peptide segment,” and claim 16 includes a small genus of the alternatives for (a), (b) and (c):
“16. The peptide amphiphile of claim 1, comprising: TABLE-US-00006
(CH2) 10-20-V2-3A2-3E2-3 (SEQ ID NOS: 1, 17-23) MQMKKVLDS;
(CH2) 10-20-V2-3A2-3E2-3 (SEQ ID NOS: 2, 24-30) HDMNKVLDL;
(CH2) 10-20-V2-3A2-3E2-3 (SEQ ID NOS: 3, 31-37) KVLDPVKG;
(CH2) 10-20-V2-3A2-3E2-3 (SEQ ID NOS: 4, 38-44) KVLDGQDP; or
(CH2) 10-20-V2-3A2-3E2-3 (SEQ ID NOS: 5, 45-51) DPVKG.”
Applicant’s (C16)VVAAEE portion of the elected PA falls within what Sharma teaches and claims; please note that per Sharma para 10, “the structural peptide segment comprises a β-sheet-forming peptide segment”, this further supporting the similarities apart from different wording.
Also pertaining to glycine spacers, Kibbe’s teachings would suggest adding a diglycine as part of the “EE” structural/ β-sheet-forming peptide segment”, from para 38, “In another embodiment, the charged peptide segment has 2 to 4 Glu (E) residues and 1 to 2 Gly (G) residues.”
None of Kibbe, Cathcart and Sharma teach the elected targeting moiety sequence.
Regarding the targeting sequence RGAAPPKQEFLDIE (SEQ ID NO: 7), Morgunova teaches that this sequence is a major portion of the C-terminus end of TIMP-2, and that this linear sequence of the C-terminus tail confers several types of binding to Hemopexin domain of MMP-2, specifically by being inserted between the third and fourth beta-propeller blades, see Figs. 1, 2c, 3 and 4, and associated text, specifically the beta-propeller domain identified III in Fig. 1. Particularly instructive is Fig. 2c, which shows the key binding for the TIMP-2 C-terminal sequence from R179 to E192, which is RGAAPPKQEFLDIE, which is what is identified by applicant as the targeting sequence, SEQ ID NO:7, component of the elected species. Based on its research, Morgunova estimates that this section of the TIMP-2 C-terminus comprises amino acids that contribute to the formation of salt bridges and hydrogen bonding, and also hydrophobic interactions around Phe-188, Id., and see pages 7417-18.
Thus, Morgunova provides reasonable bases to utilize the particular portion of the C-terminus section of TIMP-2, RGAAPPKQEFLDIE, identified as extending from R179 to E187 inclusive in Fig. 2c, as a targeting peptide for MMP-2 because this peptide comprises multiple amino acids that provide for binding to MMP-2.
One of ordinary skill in the art, desiring to better target MMP-2s as part of cancer therapies, monitoring and/or diagnosing, would reasonably have combined the teachings of the references to arrive at the elected PA species because Kibbe teaches and claims the same type of PA structures that assemble into nanofibers, teaches the use and location of glycine spacers, and teaches that “PA comprising tumor targeting peptides and linked to chemotherapeutics find use in the treatment of cancer,” Cathcart teaches the relevance and interest in targeting MMPs for cancer therapies, including MMP-2, so suggesting this as a suitable target, and Sharma teaches and claims in claim 16 a small genus of what corresponds to instant claim 1’s (a), (b) and (c). Selecting the particular (C16)VVAAEE portion of the elected species is selecting from one of two alternatives for each of “V”, “A” and “E”, and selecting one of 11 lengths of acyl chain of the Sharma claim 16 corresponding portions. At least because Kibbe teaches, “In various embodiments, the relative lengths of the peptide segment and hydrophobic segment result in differing PA molecular shape and nanostructural architecture,” para 45, one of ordinary skill in the art would be motivated to optimize the structure of this (a) + (b) + (c) portion when combining it with a particular targeting portion/moiety, such as the RGAAPPKQEFLDIE from the C-terminus of TIMP-2, in order to improve the specific targeting effectiveness. The particular selected alternatives are readily identified from the small number of alternatives in Sharma’s claim 16. The motivation for using the RGAAPPKQEFLDIE peptide as a targeting portion/moiety for MMP-2 is from Morgunova because Morgunova teaches that this peptide segment comprises multiple amino acids that provide for binding to MMP-2, and is one of two portions of TIMP-2 that bind to MMP-2, additionally this also the most compact of the two portions with regard to number of amino acids that confer binding. The overall rationale for combining these teachings is combining prior art elements according to known methods to yield predictable results, based on the examiner’s finding that the prior art included each element claimed, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, that one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately, and that one of ordinary skill in the art would have recognized that the results of the combination were predictable, this supported by the teachings and examples of PAs in both Kibbe and Sharma for different applications, as well as the teachings of Morgunova for the binding characteristics of the peptide RGAAPPKQEFLDIE to MMP-2.
Accordingly, claims 1, 4 and 14 when examining the elected species would have been obvious.
Claims 2 and 3 also would have been obvious on the same bases as claim 1 given the focus on MMP-2 in the claim 1 rejection.
Claim 8 is directed to the peptide amphiphile of claim 1, further comprising a therapeutic agent, and claim 9 depends from claim 8 and lists five specific types of therapeutic agents, one being “an MMP inhibitor.”
Cathcart is focused on therapeutics that inhibit MMPs, “As information regarding the structure and function of these proteinases [MMPs] is compiled and biotechnology evolves, tools to develop better inhibitors are within our grasp,” Abstract, also see Table 2, Hemopexin domain inhibitors section pages 30-31, and the last sentence of Conclusions, page 32, “Taking this into consideration, it is clear that the time is now ripe for the industry to once again begin investing in MMPI programs” (MMPI an abbreviation for MMP inhibitors). Returning to Kibbe claim 1, where the last component is (e) a therapeutic agent, when considering Cathcart and the claim 1 portion for the targeting moiety of the elected species targeting MMP-2, see Morgunova above, one of ordinary skill in the art reasonably would have combined a targeting of MMP-2 with an inhibitor of MMP-2 so as to limit the activity of MMP-2 to improve cancer therapies. There would have been a reasonable expectation of success given the teachings and evaluations of the references, particularly Cathcart and Morgunova as to the added limitations in claims 8 and 9 that include “an MMP inhibitor”. Accordingly, claims 8 and 9 would have been obvious.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH FISCHER whose telephone number is (571)270-7925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Wednesday-Friday and on Monday/Tuesday on alternating weeks, but will promptly answer messages upon his return to work.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER, can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
1 Please note that US Patent No. 9517275, which issued from Kibbe, retained the generic terms for (a)-(c) and (e), and provided greater specificity for the (d) targeting moiety. More generally, the examiner has identified a number of other prior art publications and patents that retain one or more of these routine, conventional and well-known generic limitations while specifying others.
2 Alternatively, it is possible that applicant meant for claim 1 to state, “wherein the B-sheet-forming peptide segment is covalently attached to the charged peptide segment”.
Prosecution Insights