DETAILED CORRESPONDENCE
Application Status
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Applicant’s amendment to the claims filed on 04/01/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 1-37 are pending.
Priority
4. Acknowledgement is made of this continuation of U.S. Non-provisional Application No. 16/930,766, filed on 07/16/2020, which is a continuation of U.S. Non-provisional Application No. 16/418,685, filed on 05/21/2019, which is a continuation of 13/385,528 of U.S. Non-provisional Application No. 13/385,528, filed on 02/22/2012, which is a continuation of U.S. Non-provisional Application No. 12/386,222, filed on 04/14/2009, which claims domestic priority to U.S. Provisional Application Nos. 61/195,624, filed on 10/08/2008, 61/130357, filed on 05/29/2008, and 61/124,278, filed on 04/14/2008.
Information Disclosure Statement
5. The IDSs filed on 09/11/2024 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action.
Drawings
6. The Drawings filed on 09/11/2024 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 112(b), or Second Paragraph
7. 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.
8. Claims 11 and 14-37 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 11, 14 (claims 15-18, 20-37 dependent therefrom) and 19, the term “about” in claims 11, 14 and 19 is a relative term which renders the claim indefinite. The term "about" is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
Regarding claim 22 (claims 23-24 dependent therefrom), the recitation of “if the hyaluronan is elevated and at a level indicative of the disease or condition, the soluble hyaluronidase enzyme is administered” is indefinite because the metes and bounds of what would be considered a level indicative of the disease or condition is relative, and it is unclear from the claims and specification what would be considered a level indicative of the disease. It is suggested that applicants clarify the meaning of claims.
Further regarding claim 22 (claims 23-24 dependent therefrom), the recitation of “if the hyaluronan is elevated and at a level indicative of the disease or condition, the soluble hyaluronidase enzyme is administered” is indefinite because claim 14 upon which claim 22 depends requires an active step of administering a soluble hyaluronidase; however, the “if” statement in claim 22 makes the administering step a conditional step. It is therefore unclear in claim 22 whether or not the administering step is a requirement of the claim. It is suggested that applicants clarify the meaning of the claims.
Claim Rejections - 35 USC § 103
9. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
10. Claims 1-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bookbinder et al. (US Patent Application Publication 2006/0104968 A1; cited on IDS filed 09/11/2024) in view of Udabage et al. (Experimental Cell Research, 2005; cited on IDS filed on 09/11/2024) and Paiva et al. (Gynecologic Oncology, 2005; cited on IDS filed on 09/11/2024).
11. Claims 1-13 are drawn to a method for treating a tumor with a polymer-congjuated soluble human PH20 hyaluronidase in a subject having cancer, comprising: a) measuring the expression or level of hyaluronan in a tumor sample from the subject; and the tumor sample is a tumor biopsy sample; b) determining the level of expression of hyaluronan in the tumor biopsy sample; c) identifying, for treatment, the subject, wherein hyaluronan is expressed in at least 30% of the tumoral area in the tumor biopsy sample from the subject, and then d) administering to the subject, the polymer-conjugated soluble hyaluronidase.
12. With respect to claim 1, Bookbinder et al. teach a method of administering a modified soluble, neutral active hyaluronidase PH-20 that has been covalently modified with a PEG moiety for treating a subject with cancer wherein the sample is a tumor [see paragraph 0538], wherein the soluble, neutral active hyaluronidase is for the treatment of metastatic and non-metastatic cancers, particularly metastatic cancer. Bookbinder et al. also teach that the administration of hyaluronidases decreases interstitial pressure in cancers wherein hyaluronan is highly elevated [see Abstract; paragraphs 0020-0021, 0052, 0078, and 0540]. Bookbinder et al. teach the method further comprising administering an anti-cancer agent, wherein the anti-cancer agent or treatment is a chemotherapeutic agent [see paragraph 0432]. Bookbinder et al. further teach wherein the soluble PH20 hyaluronidase is active at neutral pH [see Abstract; paragraph 0020].
With respect to claim 2, Bookbinder et al. teach the method wherein the polymer is super-sialation or pegylation moiety [see paragraph 0089].
With respect to claim 3, Bookbinder et al. teach the method wherein the modified soluble hyaluronidase can be used for squamous cell carcinoma, breast cancer, pancreatic carcinomas, brain cancer, stomach (gastric), ovarian, and colon cancer [see paragraphs 0431, 0527].
With respect to claim 4, Bookbinder et al. teach the method further comprising administering an anti-cancer agent, wherein the anti-cancer agent or treatment is a chemotherapeutic agent [see paragraph 0432].
With respect to claim 5, Bookbinder et al. teach the method wherein the PH-20 is human soluble PH-20 engineered to lack the hydrophobic C-terminal GPI anchor [see paragraph 0685] [see paragraph 0020].
With respect to claim 6, Bookbinder et al. teach the method wherein the polymer-conjugated soluble PH20 hyaluronidase is a polypeptide consisting of an amino acid sequence that is 100% identical to SEQ ID NO: 48 [see alignment attached as APPENDIX A] and is N-glycosylated and neutral active [see Abstract; paragraphs 0020-0021, 0052, 0078, 0320, and 0540].
With respect to claim 7, Bookbinder et al. teach the method wherein the soluble hyaluronidase comprises an amino acid sequence 100% identical to SEQ ID NO: 1 and terminates at position 477, 482, and 483 [see paragraph 0687-0690 and alignment attached as Appendix B].
With respect to claim 8, Bookbinder et al. teach the method wherein the polymer-conjugated soluble PH20 hyaluronidase is a polypeptide consisting of an amino acid sequence that is 100% identical to SEQ ID NO: 48 [see alignment attached as APPENDIX A].
With respect to claim 9, Bookbinder et al. teach the method wherein the polymer conjugated to the soluble hyaluronidase comprises a pegylation moiety [see paragraph 0230] and wherein the PEG moiety results from reaction with methoxy-poly(ethylene glycol)-succinimidyl butanoate (mPEG-SBA (30 kDa)) [see paragraph 0801].
With respect to claim 10, Bookbinder et al. teach the method wherein the PEG is branched or linear [see paragraph 0783].
With respect to claim 11, Bookbinder et al. teach the method wherein the PEG has a weight of 30 kDa [see paragraph 0801].
With respect to claim 12, Bookbinder et al. teach the method wherein the modified soluble hyaluronidase is administered intravenously, subcutaneously, intraperitoneally, or intratumorally [see paragraphs 0430 and 0538].
With respect to claim 13, Bookbinder et al. teach the method wherein the modified soluble hyaluronidase is administered at 500-100,000 Units [see paragraph 0423].
However, Bookbinder et al. does not explicitly teach the method of claim 1 of a) measuring the expression or level of hyaluronan in a tumor sample from a subject and the tumor sample is a tumor biopsy sample b) determining the level of expression of hyaluronan in a tumor sample.
Udabage et al. teach that highly invasive breast cancer cell lines preferentially express hyaluronan synthase 2 and hyaluronidase 2 isoforms relative to less invasive breast cancer cells [see Abstract]. Udabage et al. also teach the quantitation of HAS2 mRNA by RT-PCR and demonstrates that highly invasive cells express up to 205 times more HAS2 mRNA than the non-invasive cell lines [see p. 210, column 1 bottom bridging to top of column 2; Table 2]. Udabage et al. also teach the synthesis and degradation rates of hyaluronan by ELISA using a HA binding protein assay coupled to the fluorescence chromophore 3,3’,5,5’-tetramethylbenzidine [see p. 208, column 2, paragraph 2] and that hyaluronan production is increased by 22-fold in invasive cell lines as opposed to non-invasive cell lines [see p. 210, column 1 bottom bridging to the top of column 2; Table 2]. Udabage et al. teach that hyaluronan synthesis and degradation plays an integral role in the invasiveness of breast cancer and highlights potential future biological targets where their modulation may be of therapeutic value [see p. 215, column 2, bottom].
Paiva et al. teach a method for examining the expression patterns of hyaluronan, hyaluronan synthases, and hyaluronidases in the progression of endometrial cancer by measuring the expression of and cellular localization of hyaluronan, hyaluronan synthases, and hyaluronidases by RT-PCR and immunohistochemistry and comparing it with normal cell endothelium (control) [see Abstract; p. 194, column 2, top] and demonstrate that expression of hyaluronan correlates well with tumor grade [see p. 198; Figure 1; Figure 4; p. 200]. Paiva et al. teach that hyaluronan staining intensity scores significantly correlated with the extent of myometrial invasion [see p. 197, column 2, bottom].
At the time of the invention, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bookbinder et al., Udabage et al., and Paiva et al. according to the teachings of Udabage et al. and Paiva et al. to develop a method for measuring the expression of hyaluronan and selecting a subject with high levels of hyaluronan expressed as a candidate for administration of a modified soluble PH20 hyaluronidase as taught by Bookbinder et al. because Bookbinder et al. teach that modified soluble PH20 hyaluronidase is an effective therapeutic for metastatic cancer treatment. Both Udabage et al. and Paiva et al. teach that hyaluronan synthesis and degradation play an integral role in the invasiveness of cancers, and teach that hyaluronan is highly expressed in tumor cells. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Bookbinder et al., Udabage et al., and Paiva et al. to arrive at the claimed method and identify a subject for treatment with modified soluble PH20 hyaluronidase through a tumor biopsy sample because both Udabage et al. and Paiva et al. acknowledge that hyaluronan is highly expressed in metastatic cancer cells and its levels contribute to the invasiveness of the cancers and one of ordinary skill would be motivated to use the modified soluble PH20 hyaluronidase of Bookbinder et al. because it would degrade the hyaluronan in the tumorous cancer. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Regarding the threshold percentages and responsiveness to treatment, “in which hyaluronan is expressed in at least 30% tumoral area in the tumor sample”, MPEP 2144.05.II.A states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Accordingly, it is the examiner's position that with the disclosures of Bookbinder et al., Udabage et al., and Paiva et al. in hand that one of ordinary skill in the art could arrive at the appropriate threshold levels for administration of the polymer-conjugated soluble hyaluronidase and that these techniques are routine for one of ordinary skill in the art to practice. One of ordinary skill in the art would desire to determine appropriate thresholds for treatment in order to maximize treatment efficacy. Furthermore, based on the teachings of Udabage et al. and Paiva et al. that hyaluronan is highly expressed in metastatic cancers and plays a role in the invasiveness of the cancer, it would expected by one of ordinary skill in the art that administration of a soluble hyaluronidase that degrades hyaluronan would be more effective in cells where the substrate level is high because there is more substrate for the enzyme to degrade. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
13. Claims 14-21 and 25-37 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bookbinder et al. (US Patent Application Publication 2006/0104968 A1; cited on IDS filed 09/11/2024).
14. Claims 14-21 and 25-37 are drawn to a method for treating a disease or condition in which a hyaluronidase substrate accumulates, comprising administering a soluble hyaluronidase enzyme to a subject at least once a week for a predetermined number of weeks in an amount sufficient to maintain a pharmacologically active level of the hyaluronidase in the plasma of at least about or 3 U/mL to prevent resynthesis of the substrate, hyaluronan, to levels prior to treatment, wherein the hyaluronidase enzyme is modified by conjugation to a polymer; and the predetermined number of weeks is more than one week.
15. With respect to claim 14, Bookbinder et al. teach a method of administering a modified soluble, neutral active hyaluronidase PH-20 that has been covalently modified with a PEG moiety for treating a subject with cancer [see paragraph 0538], wherein the soluble, neutral active hyaluronidase is for the treatment of metastatic and non-metastatic cancers, particularly metastatic cancer. Bookbinder et al. also teach that the administration of hyaluronidases decreases interstitial pressure in cancers wherein hyaluronan is highly elevated [see Abstract; paragraphs 0020-0021, 0052, 0078, and 0540]. Bookbinder et al. teach wherein the hyaluronidase enzyme is administered up to 3-5 times a week [see paragraph 0581] and plasma concentrations of 3 U/mL [see paragraph 0708].
With respect to claim 18, Bookbinder et al. teach wherein the hyaluronidase enzyme is administered up to 3-5 times a week [see paragraph 0581].
With respect to claim 19, Bookbinder et al. teach plasma concentrations of 3 U/mL [see paragraph 0708].
With respect to claim 20, Bookbinder et al. teach wherein the hyaluronidase enzyme is administered up to 3-5 times a week [see paragraph 0581].
With respect to claim 25, Bookbinder et al. also teach that the administration of hyaluronidases decreases interstitial pressure in cancers wherein hyaluronan is highly elevated [see Abstract; paragraphs 0020-0021, 0052, 0078, and 0540].
With respect to claim 26, Bookbinder et al. teach the method wherein the hyaluronidase is a soluble, neutral active hyaluronidase PH-20 that has been covalently modified with a PEG moiety for treating a subject with cancer [see paragraph 0538].
With respect to claim 27, Bookbinder et al. teach the method wherein the diseases or conditions is a cancer, disc pressure or edema [see 0052].
With respect to claim 28, Bookbinder et al. teach the method wherein the disease or condition is edema and is caused by organ transplant, stroke or brain trauma [see paragraph 0052, 0569-0570, 0574].
With respect to claim 29, Bookbinder et al. teach the method wherein the disease or condition is cancer and the cancer is a tumor that has increased cellular and/or stromal expression of a hyaluronan, compared to a non-cancerous tissue of the same tissue type or compared to a non-metastatic tumor of the same type [see paragraphs 0540, 0575-0576].
With respect to claim 30, Bookbinder et al. teach the method wherein the modified soluble hyaluronidase can be used for squamous cell carcinoma, breast cancer, pancreatic carcinomas, brain cancer, stomach (gastric), ovarian, and colon cancer [see paragraphs 0431, 0527].
With respect to claim 31, Bookbinder et al. teach the method wherein the PH-20 is human soluble PH-20 engineered to lack the hydrophobic C-terminal GPI anchor [see paragraph 0685] [see paragraph 0020].
With respect to claim 32, Bookbinder et al. teach the method wherein the polymer-conjugated soluble PH20 hyaluronidase is a polypeptide consisting of an amino acid sequence that is 100% identical to SEQ ID NO: 48 [see alignment attached as APPENDIX A].
With respect to claim 33, Bookbinder et al. teach the method wherein the soluble hyaluronidase comprises an amino acid sequence 100% identical to SEQ ID NO: 1 and terminates at position 477, 482, and 483 [see paragraph 0687-0690 and alignment attached as Appendix B].
With respect to claim 34, Bookbinder et al. teach the method wherein the polymer-conjugated soluble PH20 hyaluronidase is a polypeptide consisting of an amino acid sequence that is 100% identical to SEQ ID NO: 48 [see alignment attached as APPENDIX A].
With respect to claim 35, Bookbinder et al. teach the method wherein the polymer conjugated to the soluble hyaluronidase comprises a pegylation moiety [see paragraph 0230] and wherein the PEG moiety results from reaction with methoxy-poly(ethylene glycol)-succinimidyl butanoate (mPEG-SBA (30 kDa)) [see paragraph 0801].
With respect to claim 36, Bookbinder et al. teach the method wherein the PEG is branched or linear [see paragraph 0783].
With respect to claim 37, Bookbinder et al. teach the method wherein the PEG is a methoxyPEG or a linear N-hydroxysuccinimidyl ester of methoxy poly(ethylene glycol) butanoic acid [see paragraph 0801].
Although Bookbinder et al. does not explicitly teach wherein the predetermined number of weeks is more than one week, at least two weeks at least four weeks, administration is discontinued for a first predetermined period of time and then resumed for at least one week and dose of 0.05 mg/kg – 0.8 mg/kg, MPEP 2144.05.II.A states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” In the instant case, it is within the level of one of ordinary skill in the art to determine appropriate dosage and duration of said treatment depending on the patient and disease state that is being treated, and one of ordinary skill in the art would desire to do so in order to maximize the benefit of said treatment. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
16. Claims 22-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bookbinder et al. (US Patent Application Publication 2006/0104968 A1; cited on IDS filed 09/11/2024) as applied to claims 14-21 and 25-37 above, and further in view of Udabage et al. (Experimental Cell Research, 2005; cited on IDS filed on 09/11/2024) and Paiva et al. (Gynecologic Oncology, 2005; cited on IDS filed on 09/11/2024).
17. The relevant teachings of Bookbinder et al. as applied to claims 14-21 and 25-37 are set forth above.
With respect to claim 22, Bookbinder et al. teach a method of administering a modified soluble, neutral active hyaluronidase PH-20 that has been covalently modified with a PEG moiety for treating a subject with cancer [see paragraph 0538], wherein the soluble, neutral active hyaluronidase is for the treatment of metastatic and non-metastatic cancers, particularly metastatic cancer. Bookbinder et al. also teach that the administration of hyaluronidases decreases interstitial pressure in cancers wherein hyaluronan is highly elevated [see Abstract; paragraphs 0020-0021, 0052, 0078, and 0540]. Bookbinder et al. teach wherein the hyaluronidase enzyme is administered up to 3-5 times a week [see paragraph 0581] and plasma concentrations of 3 U/mL [see paragraph 0708].
With respect to claims 23-24, Bookbinder et al. teach the method wherein the sample is a tissue or body fluid such as a blood sample, tumor biopsy, cerebral spinal fluid, urine, semen, or saliva [see paragraph 0193].
However, Bookbinder et al. does not explicitly teach the method of claim 22 measuring the expression or level of hyaluronan in a sample from the subject prior to treatment.
Udabage et al. teach that highly invasive breast cancer cell lines preferentially express hyaluronan synthase 2 and hyaluronidase 2 isoforms relative to less invasive breast cancer cells [see Abstract]. Udabage et al. also teach the quantitation of HAS2 mRNA by RT-PCR and demonstrates that highly invasive cells express up to 205 times more HAS2 mRNA than the non-invasive cell lines [see p. 210, column 1 bottom bridging to top of column 2; Table 2]. Udabage et al. also teach the synthesis and degradation rates of hyaluronan by ELISA using a HA binding protein assay coupled to the fluorescence chromophore 3,3’,5,5’-tetramethylbenzidine [see p. 208, column 2, paragraph 2] and that hyaluronan production is increased by 22-fold in invasive cell lines as opposed to non-invasive cell lines [see p. 210, column 1 bottom bridging to the top of column 2; Table 2]. Udabage et al. teach that hyaluronan synthesis and degradation plays an integral role in the invasiveness of breast cancer and highlights potential future biological targets where their modulation may be of therapeutic value [see p. 215, column 2, bottom].
Paiva et al. teach a method for examining the expression patterns of hyaluronan, hyaluronan synthases, and hyaluronidases in the progression of endometrial cancer by measuring the expression of and cellular localization of hyaluronan, hyaluronan synthases, and hyaluronidases by RT-PCR and immunohistochemistry and comparing it with normal cell endothelium (control) [see Abstract; p. 194, column 2, top] and demonstrate that expression of hyaluronan correlates well with tumor grade [see p. 198; Figure 1; Figure 4; p. 200]. Paiva et al. teach that hyaluronan staining intensity scores significantly correlated with the extent of myometrial invasion [see p. 197, column 2, bottom].
At the time of the invention, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bookbinder et al., Udabage et al., and Paiva et al. according to the teachings of Udabage et al. and Paiva et al. to develop a method for measuring the expression of hyaluronan and selecting a subject with high levels of hyaluronan expressed as a candidate for administration of a modified soluble PH20 hyaluronidase as taught by Bookbinder et al. because Bookbinder et al. teach that modified soluble PH20 hyaluronidase is an effective therapeutic for metastatic cancer treatment. Both Udabage et al. and Paiva et al. teach that hyaluronan synthesis and degradation play an integral role in the invasiveness of cancers, and teach that hyaluronan is highly expressed in tumor cells. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Bookbinder et al., Udabage et al., and Paiva et al. to arrive at the claimed method and identify a subject for treatment with modified soluble PH20 hyaluronidase through measuring expression of hyaluronan expression in a sample because both Udabage et al. and Paiva et al. acknowledge that hyaluronan is highly expressed in metastatic cancer cells and its levels contribute to the invasiveness of the cancers and one of ordinary skill would be motivated to use the modified soluble PH20 hyaluronidase of Bookbinder et al. because it would degrade the hyaluronan in the tumorous cancer. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting
18. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
19. Claims 1-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,328,130. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-31 of the ‘130 patent recite a method for treating a tumor with a PEGylated soluble human PH20 hyaluronidase in a subject having pancreatic cancer comprising: a) measuring the expression or level of hyaluronan in a tumor sample from the subject, wherein the subject has pancreatic cancer, and the tumor sample is a pancreatic tumor biopsy sample; b) determining the level of expression of hyaluronan in the tumor biopsy sample; c) identifying, for treatment, the subject, wherein hyaluronan is expressed in at least 30% of the tumoral area in the tumor biopsy sample from the subject; and the administering to the subject, the PEGylated soluble PH20 hyaluronidase, and administering a second agent that is an anti-cancer agent or treatment for treating the tumor in the subject.
Conclusion
20. Status of the claims:
Claims 1-37 are pending.
Claims 1-37 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
APPENDIX A
Bookbinder et al. with SEQ ID NO: 48
Query Match 100.0%; Score 2409; DB 6; Length 448;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
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Db 1 LNFRAPPVIPNVPFLWAWNAPSEFCLGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDR 60
Qy 61 LGYYPYIDSITGVTVNGGIPQKISLQDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWA 120
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Db 61 LGYYPYIDSITGVTVNGGIPQKISLQDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWA 120
Qy 121 RNWKPKDVYKNRSIELVQQQNVQLSLTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 RNWKPKDVYKNRSIELVQQQNVQLSLTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHL 180
Qy 181 WGYYLFPDCYNHHYKKPGYNGSCFNVEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAAT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 WGYYLFPDCYNHHYKKPGYNGSCFNVEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAAT 240
Qy 241 LYVRNRVREAIRVSKIPDAKSPLPVFAYTRIVFTDQVLKFLSQDELVYTFGETVALGASG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LYVRNRVREAIRVSKIPDAKSPLPVFAYTRIVFTDQVLKFLSQDELVYTFGETVALGASG 300
Qy 301 IVIWGTLSIMRSMKSCLLLDNYMETILNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 IVIWGTLSIMRSMKSCLLLDNYMETILNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSS 360
Qy 361 DYLHLNPDNFAIQLEKGGKFTVRGKPTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DYLHLNPDNFAIQLEKGGKFTVRGKPTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAV 420
Qy 421 DVCIADGVCIDAFLKPPMETEEPQIFYN 448
||||||||||||||||||||||||||||
Db 421 DVCIADGVCIDAFLKPPMETEEPQIFYN 448
APPENDIX B
Bookbinder et al. with SEQ ID NO: 1
Query Match 100.0%; Score 2704; DB 6; Length 509;
Best Local Similarity 100.0%;
Matches 509; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGVLKFKHIFFRSFVKSSGVSQIVFTFLLIPCCLTLNFRAPPVIPNVPFLWAWNAPSEFC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGVLKFKHIFFRSFVKSSGVSQIVFTFLLIPCCLTLNFRAPPVIPNVPFLWAWNAPSEFC 60
Qy 61 LGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDRLGYYPYIDSITGVTVNGGIPQKISL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDRLGYYPYIDSITGVTVNGGIPQKISL 120
Qy 121 QDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWARNWKPKDVYKNRSIELVQQQNVQLS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWARNWKPKDVYKNRSIELVQQQNVQLS 180
Qy 181 LTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHLWGYYLFPDCYNHHYKKPGYNGSCFN 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHLWGYYLFPDCYNHHYKKPGYNGSCFN 240
Qy 241 VEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAATLYVRNRVREAIRVSKIPDAKSPLPV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAATLYVRNRVREAIRVSKIPDAKSPLPV 300
Qy 301 FAYTRIVFTDQVLKFLSQDELVYTFGETVALGASGIVIWGTLSIMRSMKSCLLLDNYMET 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 FAYTRIVFTDQVLKFLSQDELVYTFGETVALGASGIVIWGTLSIMRSMKSCLLLDNYMET 360
Qy 361 ILNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSSDYLHLNPDNFAIQLEKGGKFTVRGK 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 ILNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSSDYLHLNPDNFAIQLEKGGKFTVRGK 420
Qy 421 PTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAVDVCIADGVCIDAFLKPPMETEEPQI 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 PTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAVDVCIADGVCIDAFLKPPMETEEPQI 480
Qy 481 FYNASPSTLSATMFIVSILFLIISSVASL 509
|||||||||||||||||||||||||||||
Db 481 FYNASPSTLSATMFIVSILFLIISSVASL 509
