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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/2026 has been entered.
The rejection under section 112(a) is withdrawn in view of amendments limiting the 191P4D12 antibody to those that have support in the specification.
The rejection under section 103 is withdrawn in favor of the following new ground of rejection under this section:
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.
Claims 1, 25, 32, 35, 38, 41, 42, 44, 49, 52, 57-59 are rejected under 35 U.S.C. 103 as being unpatentable over obvious over Challita-Eid et al., Cancer Res (2016) 76 (10): 3003–3013 (Challita-Eid) or US 20150306245 A1 (hereinafter “Agensys”)
in view of Rajc et al., Pathology - Research and Practice. 2017, Vol. 213, No. 9, pages 1102-1108 (hereinafter “Rajc”)
in further view of Diamantis et al., British Journal of Cancer (2016) 114, 362–367 (hereinafter “Diamantis”).
Challita-Eid conducted immunohistochemical analysis of 2,394 patient specimens from bladder, breast, lung, pancreatic, ovarian, head/neck, and esophageal tumors and found that 69% of all specimens stained positive for nectin-4.
Agensys discloses a method of preventing or treating cancer in a subject (a method of preventing or treating cancer in. a subject; abstract; paragraphs [0030), [0046)), comprising administering to the subject an effective amount of an antibody drug conjugate (comprising administering to the subject an effective amount of an antibody drug conjugate; abstract; paragraphs [0046), [0424)), wherein the antibody drug conjugate comprises an antibody or antigen binding fragment thereof that binds to 191P4D12 conjugated to one or more units of monomethyl auristatin E (MMAE) (wherein the antibody drug conjugate comprises an antibody or antigen binding fragment thereof that binds to 191P4Dl2 conjugated to one or more units of monomethyl auristatin E; abstract; paragraph [0459)).
The antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising complementarity determining regions (CDRs) (wherein the antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising complementarity determining regions; paragraph [0150)) comprising the amino acid sequences of the CDRs of the heavy chain variable region set forth in SEQ ID NO: 22 (residues 20-136 of SEQ ID NO: 7 of the Agensys reference are 100% identical to Applicants' SEQ ID NO: 22, identified as Anti-191P4D12 mAb Ha22-2(2,4)6.1 variable heavy chain; figure 3A; claim 1) and a light chain variable region comprising CDRs (a light chain variable region comprising CDRs; paragraphs [0151]) comprising the amino acid sequences of the CDRs of the light chain variable region set forth in SEQ ID NO: 23 (residues 23-130 of SEQ ID NO: 8 of the Agensys reference are 100% identical to Applicants' SEQ ID NO: 23, identified as Anti-191P4D12 mAb Ha22-2(2,4)6.1 variable light chain; figure 3B; claim 1); and wherein the subject has breast cancer (paragraph [0047), [0175)).
Agensys does not disclose wherein the subject has hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer. However, Rajc discloses wherein the subject has hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer (wherein the subject has hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer; page 1103, second column, fourth paragraph) and 191P4D12 expression (Nectin-4 (191P4D12) expression in luminal B HER2 negative breast cancer; abstract).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the disclosure of Agensys, to include wherein the subject has hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer, as disclosed by Rajc, in order to better provide effective targeted therapy for a patient having said cancer.
Agensys and Rajc, in combination, disclose the method of claim 1. Agensys does not disclose wherein the HR+/HER2- breast cancer is estrogen receptor (ER) positive and/or progesterone receptor (PR) positive, and HER2 negative. Rajc discloses wherein the HR+/HER2- breast cancer is estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (the HR+/HER2- breast cancer is estrogen receptor (ER) positive and/or progesterone receptor (PR) positive; page 1103, second column, fourth paragraph), and HER2 negative (page 1103, second column, fourth paragraph). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the disclosure of Agensys, to include the HR+/HER2- breast cancer is estrogen receptor (ER) positive and/or progesterone receptor (PR) positive, as disclosed by Rajc, in order to better provide effective targeted therapy for a patient having said cancer.
Agensys and Rajc, in combination, disclose the method of claim 1, and Agensys further discloses wherein the subject has locally advanced or metastatic cancer (paragraphs [0118), [0424), [04261).
Claims 49 and 52 cover effective amounts and treatment regiments. However, the amount of the recited ADC in the disclosed composition is a result-effective parameter that will affect the pharmacological and pharmacokinetic properties of the final composition. In this manner, the amount of a specific ingredient in a composition is clearly a result-effective parameter that a person of ordinary skill in the art would routinely optimize.
Specifically, it would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve a desired result. For any compound, the therapeutically effective dose can be estimated initially either in cell culture assays or in animal models, usually rats, rabbits, dogs, or pigs. The animal model also can be used to determine the appropriate concentration range and route of administration. Such information can then be used to determine useful doses and routes for administration in humans.
Therapeutic efficacy and toxicity, e.g., ED50 (the dose therapeutically effective in 50% of the population) and LD50 (the dose lethal to 50% of the population), can be determined by standard pharmaceutical procedures in cell cultures or experimental animals. The dose ratio of toxic to therapeutic effects is the therapeutic index, and it can be expressed as the ratio, LD50/ED5o. Pharmaceutical compositions which exhibit large therapeutic indices are preferred. The data obtained from cell culture assays and animal studies is used in formulating a range of dosage for human use. The dosage contained in such compositions is preferably within a range of circulating concentrations that include the ED50 with little or no toxicity. The dosage varies within this range depending upon the dosage form employed, sensitivity of the patient, and the route of administration. The exact dosage will be determined by the practitioner, in light of factors related to the subject that requires treatment. Dosage and administration are adjusted to provide sufficient levels of the active ingredient or to maintain the desired effect. Factors which can be taken into account include the severity of the disease state, general health of the subject, age, weight, and gender of the subject, diet, time and frequency of administration, drug combination(s), reaction sensitivities, and tolerance/response to therapy. Long-acting pharmaceutical compositions can be administered once or twice daily every 3 to 4 days, every week, or once every two weeks depending on the half-life and clearance rate of the particular formulation.
Normal dosage amounts can vary from micrograms to 100,000 micrograms, up to a maximum total dose, depending upon the route of administration. Guidance as to particular dosages and methods of delivery is provided in the literature and generally available to practitioners in the art.
Moreover, optimal drug regiments are also result-effective parameters that will affect the therapeutic value of the recited composition and are thus also subject to optimization.
In this way, optimization of these parameters is a routine practice, and consequently, would be prima facie obvious, absent factual evidence demonstrating an unexpected benefit of the claimed amount(s).
The rejected claims cover treatment of cancers or not specifically taught by the primary and secondary references and/or treatment of subjects that have previously received traditional therapies of these types of cancers. However, antibody-drug conjugates (ADCs) offer benefits in cancer therapy beyond traditional chemo-, hormone- and immune checkpoint-therapies by selectively targeting cancer cells and delivering potent cytotoxic drugs directly to cancer cells, increasing effectiveness and reducing side effects compared to traditional chemotherapy. This targeted delivery improves the "therapeutic index" by increasing drug concentration in the tumor while decreasing it in healthy tissues, see Diamantis (“Antibody-drug conjugates (ADCs) are an emerging novel class of anticancer treatment agents that combines the selectivity of targeted treatment with the cytotoxic potency of chemotherapy drugs. New linker technology associated with novel highly potent cytotoxic payloads has permitted the development of more effective and safe ADCs. In recent years, two ADCs have been licensed, T-DM1 and brentuximab vedotin, and are already establishing their place in cancer treatment. A plethora of ADCs are being investigated in phases I and II trials, emerging data of which appears promising. As we deepen our understanding of what makes a successful ADC, an increasing number of ADCs will likely become viable treatment options as single agents or in combination with chemotherapy. This review will present the philosophy underlying ADCs, their main characteristics and current research developments with a focus on ADCs in solid tumours.”).
In this way, those of ordinary skill could have applied the instant ADC’s in the manner required and in a predictable fashion for the purposes of treating the recited cancers and treatment of subjects that have previously received traditional therapies of these types of cancers. As outlined above, the primary and secondary references teach treating cancers with anti-191P4D12 (MMAE) ADC’s. Diamantis is added for the proposition that these types of conjugates are applicable to treating the recited cancers or treating of subjects that have previously received traditional therapies. Specifically, Diamantis teaches the particular known technique of using ADC’s an alternate therapy for treating cancers was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to the recited cancers would have yielded predictable results. Accordingly, using the instant anti-191P4D12 (MMAE) ADC’s to treat the recited cancers and treatment of subjects that have previously received traditional therapies of these types of cancers would have been prima facie obvious.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over obvious over over obvious over Challita-Eid et al., Cancer Res (2016) 76 (10): 3003–3013 (Challita-Eid) or US 20150306245 A1 (hereinafter “Agensys”)
in view of Rajc et al., Pathology - Research and Practice. 2017, Vol. 213, No. 9, pages 1102-1108 (hereinafter “Rajc”); and
Diamantis et al., British Journal of Cancer (2016) 114, 362–367 (hereinafter “Diamantis”)
in further view of Chen et al., Determination of Drug-to-Antibody Ratio for Antibody-Drug Conjugates Purified from Serum, Agilent Technologies, pp. 1-9, 2016 (Agilent).
Claim 46 requires specific drug-antibody ratios (DAR) that may not be specifically taught by the primary or secondary references.
However, there are a limited and finite number of DAR’s for a given antibody- drug conjugate (ADC), around 8. The prior art demonstrates that optimization of the DAR is a critical part of ADC development, since the DAR value affects the efficacy of the drug, as low drug loading reduces the potency, while high drug loading can negatively affect pharmacokinetics (PK)1 and toxicity. At the time the invention was
made, easy, accurate and reproducible DAR calculation of ADC’s was within the
purview of those of ordinary skill, see Agilent:
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In this manner, it would have been obvious to one have ordinary skill in the art at the time that applicant’s inventions was made to have made ADC’s with the recited DAR with a reasonable expectation that the resulting ADC with a DAR of 2 would be useful in treating cancer. In this connection, it is well-settled that ADC’s with a DAR from 1-8 are well within the purview of those of ordinary skill; and it would have been obvious to one of ordinary skill in the art at the time the invention was made to choose from this finite number of DAR options with a reasonable expectation of success of producing a ADC functional with a functional DAR.
Specifically, it is well within the skill of the artisan to try any of the 1-8 DAR’s. As outlined above, a DAR value affects the efficacy of the drug, as low drug loading reduces the potency, while high drug loading can negatively affect pharmacokinetics (PK)1 and toxicity. Here, a skilled chemist at the time would simply make the known ADC’s of the known 8 DAR’s. Indeed, it would have been part and parcel to make the different DAR’s to find one that is pharmaceutically acceptable. Therefore, the applied references provide ample reason to make the recited ADC’s with a DAR in the required range.
With regard to any unpredictability associated with the DAR’s, the notion that unpredictability confers patentability in cases of DAR’s of known ADC’s should be disregarded since a rule of law equating unpredictability to patentability, applied in this case, would mean that any new ADC based on a different DAR would be separately patentable, simply because the formation and properties of each ADC must be verified through testing. This cannot be the proper standard since the expectation of success need only be reasonable, not absolute.
Here, the references provide the reasonable expectation of success, as outlined above. Namely, the references demonstrate the reasonable expectation of success since the references sufficiently characterize the instant ADC’s including the required heavy and light chains, see above. With regard to any alleged unexpected property possessed by those ADC’s with a specific DAR, it is error to assume that any superior property is unexpected, especially in the instant case, where the pharmacodynamic and pharmacokinetic properties of different DAR’s are not predictable. In this case, given the range of possible DAR’s, one skilled in the art would expect different DAR’s to provide ADC’s having a range of properties, some of which would be superior, and some of which would be inferior.
Rather, Applicant has conducted a common optimization of the known DAR’s to produce the claimed ADC, which is routine. Specifically, Applicant engaged in routine, verification testing to optimize selection of one of several known and clearly suggested DAR’s to prepare a pharmaceutically-acceptable conjugate. In this regard, creating a “product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient . . . to enhance commercial opportunities . . . is universal—and even common-sensical.” see DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356 at 1368. Therefore, the recited ADC’s with the recited DAR ‘s obvious, since DAR’s are routine and prima facie obvious.
Applicant argues that none of the cited references teaches or suggests treating this specific patient population with the recited ADC.
However, as outlined above, Challita-Eid demonstrates patients may benefit from nectin-4 targeted delivery of a potent cytotoxic agent to the tumor site, and specifically cites Enfortumab Vedotin. This provides the requisite expectation of success. Applicant suggests that the prior art provide an absolute expectation. However, all that is needed is a reasonable expectation, see MPEP 2143 (“Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) (“To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’”); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) (“This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness.” (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that “the expectation of success need only be reasonable, not absolute”)).”) Here, the references provide a reasonable expectation that the recited ADC’s can treat head and neck cancer.
Moreover, because of its targeted delivery, Diamantis teaches that antibody-drug conjugates (ADCs) offer benefits in cancer therapy beyond traditional chemo-, hormone- and immune checkpoint-therapies. In this way, those of ordinary skill would choose the recited ADC’s after chemo- or immune checkpoint therapy given the poor prognosis of head and neck therapy and alternate mechanism of action.
The double patenting rejections are withdrawn in favor of the following new grounds of rejection:
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, 25, 32, 35, 38, 41, 42, 44, 46, 49, 52, 57-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No.12257340 in view of Challita-Eid, Rajc, Diamantis and Agilent.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, the conflicting claims recite methods of treating cancer with anti-191P4D12 (MMAE) ADC’s which anticipate those methods of treating recited by the rejected claims. Alternatively, the difference between the methods covered in the rejected claims and those covered by the conflicting claims is that the conflicting claims may not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Nonetheless, Challita-Eid, Rajc, Diamantis and Agilent are applied for the proposition that the recited subject has hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer; and treatment of cancers or not specifically taught by the primary and secondary references and/or treatment of subjects that have previously received traditional therapies of these types of cancers; and the required DAR’s are within the purview of those of ordinary skill, and thus prima facie obvious, as outlined above.
Moreover, the conflicting claims may recite conjugates, whereas the rejected claims recite methods of treating. However, the specification of the conflicting patent discloses the utility of the recited conjugates as covered by the instant methods of using the conjugates, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of the conflicting conjugate claims for a double patenting rejection one must look to the specification to interpret the utility of the conjugates.
Claims 1, 25, 32, 35, 38, 41, 42, 44, 46, 49, 52, 57-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9314538 in view of Challita-Eid, Rajc, Diamantis and Agilent.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, the conflicting claims recite methods of treating cancer with anti-191P4D12 (MMAE) ADC’s which anticipate those methods of treating recited by the rejected claims. Alternatively, the difference between the methods covered in the rejected claims and those covered by the conflicting claims is that the conflicting claims may not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Nonetheless, Challita-Eid, Rajc, Diamantis and Agilent are applied for the proposition that the recited subject has hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer; and treatment of cancers or not specifically taught by the primary and secondary references and/or treatment of subjects that have previously received traditional therapies of these types of cancers; and the required DAR’s are within the purview of those of ordinary skill, and thus prima facie obvious, as outlined above.
Moreover, the conflicting claims may recite conjugates, whereas the rejected claims recite methods of treating. However, the specification of the conflicting patent discloses the utility of the recited conjugates as covered by the instant methods of using the conjugates, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of the conflicting conjugate claims for a double patenting rejection one must look to the specification to interpret the utility of the conjugates.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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