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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statements (IDS), comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112
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 49-50 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 pre-AIA the applicant regards as the invention.
Claim 49 recites “such as” in the claim language. MPEP 2173.05(d) states that “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. The examiner should analyze whether the metes and bounds of the claim are clearly set forth. Note that the mere use of the phrase "such as" or "for example" in a claim does not by itself render the claim indefinite”.
So, the phrase “such as” and the parentheses render the claims indefinite because it is unclear whether the limitation following the phrase in parentheses are part of the claimed invention. Accordingly claim 49 and its dependents are rendered indefinite.
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 32-52 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 treating or supressing prostate cancer, non-small cell lung carcinomas, triple negative breast cancer, gastric cancer, ovarian cancer, oesophageal cancer, multiple myeloma, and fibrosarcoma, by administering claimed peptide drugs, (i) does not reasonably provide enablement for treating or suppressing all other possible known cancers and (ii) does not reasonably provide enablement for preventing cancer, with all possible mode of administrations and with all possible populations. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
By way of background, four cases are of particular relevance to the question of enablement of a method of treating cancers broadly or even generally:
(i) In In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, the claim was drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” using a small genus of compounds. The Court decided that human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed”.
. (ii) In Ex parte Jovanovics, 211 USPQ 907 the claims were drawn to “the treatment of certain specified cancers in humans” by the use of a genus of exactly two compounds, the N-formyl or N-desmethyl derivative of leurosine. Applicants submitted “affidavits, publications and data” for one of the compounds, and a dependent claim drawn to the use of that species was allowed. For the other, no data was presented, applicants said only that the other derivative would be expected to be less effective; claims to the genus were refused.
(iii) In Ex parte Busse, et al., 1 USPQ2d 1908, claims were drawn to “A therapeutic method for reducing metastasis and neoplastic growth in a mammal” using a single species. The decision notes that such utility “is no longer considered to be “incredible”, but that “the utility in question is sufficiently unusual to justify the examiner's requirement for substantiating evidence. Note also that there is also a dependent claim 5 which specified “wherein metastasis and neoplastic growth is adenocarcinoma, squamous cell carcinoma, melanoma, cell small lung or glioma.” The decision notes that “even within the specific group recited in claim 5 some of the individual terms used actually encompass a relatively broad class of specific types of cancer, which specific types are known to respond quite differently to various modes of therapy.”
(iv) In Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.”
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims; (2) The nature of the invention; (3) The state of the prior art; (4) The level of one of ordinary skill; (5) The level of predictability in the art; (6) The amount of direction provided by the inventor; (7) The existence of working examples; and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) Breadth of claims:
Claimed "treating or suppressing cancer" covers treating/suppressing all possible cancers.
Claimed “preventing” means eradication of all possible cancer completely, both existing as well as from the future occurrence.
However, cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. Different cancers have different properties. They can occur in pretty much every part of the body. There are many cellular and molecular factors, for example more than 100 oncogenes, associated with cancer, also, the cell signaling pathways for different cancers are different and very divergent.
(2) The nature of the invention:
Biological, involving a therapeutic agent given consideration of the preamble and its effect on a condition, i.e., preventing, treating or suppressing a condition characterized by the presence of cancer cells.
The specific nature of the invention is preventing, suppressing or treating cancer by administering to a patient a peptide ligand specific for EphA2, or a pharmaceutically acceptable salt or modified derivative thereof, wherein the peptide ligand comprises a polypeptide comprising at least three cysteine residues, separated by at least two loop sequences, and a non-aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, wherein the polypeptide comprises an amino acid sequence selected from the listed sequences in the claims. Thus, to be enabled for the full scope of the invention one of ordinary skill in the art must accept that all cancers can be treated with the recited sequences.
(3) State of the Prior Art:
So far as the examiner is aware, applicants’ recited sequences have not been successfully used for treating and preventing cancers.
Although the state of the art is relatively high with regard to the treatment of specific cancers, but the state of the art with regard to recited sequences, for treating cancers are not well established in the art.
Tognolini [Expert Opinion on Therapeutic Patents, 2024, vol.34, No.10, 1009-1018] in a review article states that “despite the availability of a plethora of chemically diverse agents, there are no approved anticancer drugs targeting EphA2 yet. However, these intellectual properties, some of which supported by strong preclinical evidence, keep the hope that, after more than 30 years from its discovery, we will finally see the first EphA2 targeting agent approved in clinical oncology”.
Wilson [Oncogene, 2021, 40, 2483-2495] in a review article states that “In spite of extensive data to support its relevance, promising preclinical validation studies, and ongoing clinical trials testing novel and repurposed agents targeting EphA2, several challenges persist. EphA2’s broad expression in multiple cell and tissue types represents both a challenge and an opportunity. For example, targeting EphA2 in malignancies with a high microvascular density in which both tumor cells and tumor-associated endothelium overexpress EphA2 has the potential to disrupt tumor growth and neovascularization simultaneously with a single agent, but may also lead to unintended, toxic side effects due to the disruption of EphA2 function in normal host tissue. The multiple signaling modes of the EphA2 receptor also complicate targeting strategies, as there is no consensus on the relative efficacy of agonistic vs. antagonistic agents, and indeed the most appropriate approach is likely to vary by context.
There is no art which teaches preventing and treating all cancers. Also, there is no known drug, which prevents and treats or suppress all possible cancers.
(4) The level of one of ordinary skill:
An ordinary artisan in the area of drug development would have experience in screening compounds for particular activities. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against particular biological target is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems such as the cancer.
Determining how a particular chemical(s) will impact the cancer is not routine. There is no chemical targeting system at this time that can directly stimulate or block only a highly divergent cancer(s), each one has specific cell signaling pathways, while avoiding effects on other parts of the cells, where the same signal may have a different and unwanted effect. Further, the functioning of many networks and the pathology of many cancers involve complex systems involving more than one network. Thus, the level of ordinary skill in the art needs specialized knowledge of the complex nature of the cancer.
(5) The level of predictability in the art:
Substantially unpredictable as to preventing or to treating conditions related to cancer cells, as there as many genetic, epigenetic, immunological and other factors involved.
Established case laws state that with specific reference to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the “general unpredictability of the field [of] …anti-cancer treatment.” In re Application of Hozumi et al., 226 USPQ 353 notes the “fact that the art of cancer chemotherapy is highly unpredictable”. More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(6) The amount of direction provided by the inventor:
In view of unpredictability in the claimed subject matter as explained above, applicants have claimed wide range of cancers, subject population, peptide sequences and mode of administration etc., a skilled person in the art can expect unpredictability for broadly claimed subject matter. However, there is no guidance as to which of the large genus of claimed subject matter in the disclosure. There are no physical/chemical/structural features that applicants have tied to this property in a relevant teaching manner, making it impossible for an individual of ordinary skill in the art to determine which of the very large genus of claimed subject matter would be effective. Without a correlation between structure and function, the claims do little more than define the claimed invention by function.
(7) The existence of working examples:
Shown data is limited to testing of claimed peptide drug conjugate to cell lines related to lung cancer, fibrosarcoma, non-small cell lung cancer, prostate cancer, breast cancer, esophageal cancer, gastric carcinoma, multiple myeloma and ovarian cancer. The dosage range information have not been provided. Further, it is completely generic. No data is shown in any animal model studies. No examples demonstrate preventing cancer. No examples demonstrate to treat or suppress all possible cancers.
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
An excessive quantity of experimentation would be needed to meet the treating and preventing aspect of what is claimed for the breadth of the claim for all that preventing is stated to mean.
Given the fact that, historically, the development of new cancers drugs has been difficult and time consuming, and especially in view of above factors, the quantity of experimentation needed is expected to be exponential.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, before the effective filing date of the claimed invention, 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).” That conclusion is clearly justified here.
Accordingly, based on the above analysis, claims are rejected as failing to satisfy the enablement rejection.
Suggested claim language to overcome the rejection: Delete term “preventing” from the claim language. In corporate claim 49 into claim 32.
Nonstatutory Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(i) Claims 32-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,484,602 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of preventing, suppressing or treating cancer, the method comprising administering to a patient in need thereof a peptide ligand specific for EphA2, or a pharmaceutically acceptable salt or modified derivative thereof, wherein the peptide ligand comprises a polypeptide comprising at least three cysteine residues, separated by at least two loop sequences, and a non-aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, wherein the polypeptide comprises an amino acid sequence selected from the listed sequences in the claims.
For claims 32-41:
Claims 1-5 of US patent teaches a peptide ligand specific for EphA2 comprising a polypeptide comprising three cysteine residues, separated by two loop sequences, and a non-aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that two polypeptide loops are formed on the molecular scaffold, wherein the peptide ligand comprises the amino acid sequence: Ci(HyP)LVNPLCiiLHP(D-Asp)W(HArg)Ciii (SEQ ID NO: 1); wherein HyP is hydroxyproline, HArg is homoarginine and Ci, Cii and Ciii represent first, second and third cysteine residues, respectively or a pharmaceutically acceptable salt thereof; wherein the molecular scaffold is 1,1′,1″-(1,3,5-triazinane-1,3,5-triyl)triprop-2-en-1-one (TATA). Further teaches a peptide ligand comprises the amino acid sequence: (β-Ala)-Sar10-A(HArg)D-Ci(HyP)LVNPLCiiLHP(D-Asp)W(HArg)Ciii (SEQ ID NO: 2) (BCY6099); wherein Sar is sarcosine, HArg is homoarginine and HyP is hydroxyproline;
wherein the pharmaceutically acceptable salt is selected from the free acid or the sodium, potassium, calcium, or ammonium salt.
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation at the end of this rejection.
For claims 42-48:
Claims 6-16 of US patent teaches a drug conjugates with recited limitations, which are identical to claims 42-48 of instant application.
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation at the end of this rejection.
For claims 49-52:
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation below.
Based on the above, the product is common in both cases. Difference is that the claims of US patent do not recited the method limitations. However, the specification of US patent discloses its benefits in treating cancer, specifically lung, breast, ovarian etc. [see abstract, summary of invention, and Table 17-57].
MPEP 804 as follows:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Accordingly, claims of instant application are obvious over the claims of copending application.
(ii) Claims 32-41 and 49-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,623,012 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of preventing, suppressing or treating cancer, the method comprising administering to a patient in need thereof a peptide ligand specific for EphA2, or a pharmaceutically acceptable salt or modified derivative thereof, wherein the peptide ligand comprises a polypeptide comprising at least three cysteine residues, separated by at least two loop sequences, and a non-aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, wherein the polypeptide comprises an amino acid sequence selected from the listed sequences in the claims.
For claims 32-41:
Claims 1-9 of US patent teaches a peptide ligand specific for EphA2 comprising a polypeptide comprising at least three cysteine residues, separated by at least two loop sequences, and an aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, wherein the molecular scaffold is 1,3,5-tris(bromomethyl)benzene (TBMB), and wherein the polypeptide comprises an amino acid sequence selected from the listed sequences, wherein the pharmaceutically acceptable salt is selected from the free acid or the sodium, potassium, calcium, or ammonium salt.
The listed sequences in US patent are identical to the sequences listed in the claims of instant application.
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation at the end of this rejection.
For claims 49-52:
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation below.
Based on the above, the product is common in both cases. Difference is that the claims of US patent do not recited the method limitations. However, the specification of US patent discloses its benefits in treating cancer, specifically lung, breast, ovarian etc. [see abstract, summary of invention, and Table 17-57].
MPEP 804 as follows:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Accordingly, claims of instant application are obvious over the claims of copending application.
(iii) Claims 32-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,696,956 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of preventing, suppressing or treating cancer, the method comprising administering to a patient in need thereof a peptide ligand specific for EphA2, or a pharmaceutically acceptable salt or modified derivative thereof, wherein the peptide ligand comprises a polypeptide comprising at least three cysteine residues, separated by at least two loop sequences, and a non-aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, wherein the polypeptide comprises an amino acid sequence selected from the listed sequences in the claims.
For claims 32-41:
Claims 1-13 of US patent teaches a peptide ligand specific for EphA2, or a pharmaceutically acceptable salt or modified derivative thereof, wherein the peptide ligand comprises a polypeptide comprising at least three cysteine residues, separated by at least two loop sequences, and a non-aromatic molecular scaffold which forms covalent bonds with the cysteine residues of the polypeptide such that at least two polypeptide loops are formed on the molecular scaffold, wherein the polypeptide comprises an amino acid sequence selected from the listed sequences in the claims.
The listed sequences and the recited limitations in the dependent claims in US patent are identical to the sequences and recited limitations listed in the claims of instant application.
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation at the end of this rejection.
For claims 42-48:
Claims 14-19 of US patent disclose the recited drug conjugates, which are identical claimed drug conjugates in the instant application.
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation at the end of this rejection.
For claims 49-52:
Claims of US patent is silent on method of treating cancer, which is required in the claims of instant application. However, this is found to be obvious according to MPEP 804 since specification of US patent teaches the utility of their claim compounds, which is treating cancer. See the explanation below.
Based on the above, the product is common in both cases. Difference is that the claims of US patent do not recited the method limitations. However, the specification of US patent discloses its benefits in treating cancer, specifically lung, breast, ovarian etc. [see abstract, summary of invention, and Table 17-57].
MPEP 804 as follows:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Accordingly, claims of instant application are obvious over the claims of copending application.
Conclusion
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658