DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I and the species of voriconazole and AMD3100 in the reply filed on 6/5/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 8-9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 6-7,10 and 12-23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Samrah et al. “Fusarium-Induced Cellulitis in an Immunocompetent Patient With Sickle Cell Disease: A Case Report”, Journal of Investigative Medicine High Impact Case Reports Volume 8: 1–6, 2020.
Samrah discloses treating fungal infections in a patient with sickle cell disease (same patient population defined in claim 20 in need of modulating mobilization of hemopoietic stem and progenitor cells (HSPC) or hematopoietic stem cells (HSC)) with voriconazole, applicants elected CYP7B1 inhibitor. See entire disclosure, especially abstract, Fig 1 and ¶ bridging pages 2 and 3. Regarding the recitation on modulating mobilization of HSPC or HSC, including within marrow (claim 7), this effect will naturally occur when the same active (voriconazole) is administered to the same patient population (subjects with sickle cell anemia). Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972). In re Best, 562 F.2d 1252, 1255 (CCPA 1977)."[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,708 (Fed. Cir. 1990). A "prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference." SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005). Regarding the recitation of therapeutically effective amount, the examiner did not consider this recitation very limiting as any amount of active ingredient would have at least some therapeutic effect in vivo. Regarding claim 12, the patient was being treated for their immunocompromised conditions (sickle cell anemia) as well as fungal infection, reading on combination therapy. Claims 13-19,22-23 merely recite further limitations of an optional component (additional mobilization agent). Note claim 13 list additional mobilization agent in the alternative and claim 1 does not require an excipient as this limitation is also presented in the alternative.
Claim(s) 6-7,10 and 12-23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Liu et al. WO 2006004795 A2.
Liu discloses method of inhibiting angiogenesis in a subject suffering from various conditions including sickle cell anemia with a triazole including voriconazole and additional active agents. See entire disclosure, especially abstract and claims, specifically 30,32-34,43,48 and 49. Regarding the recitation on modulating mobilization of HSPC or HSC, including within marrow (claim 7), this effect will naturally occur when the same active (voriconazole) is administered to the same patient population (subjects with sickle cell anemia). See In re Ludtke, In re Best, In re Spada cited above. Regarding the recitation of therapeutically effective amount, the examiner did not consider this recitation very limiting as any amount of active ingredient would have at least some therapeutic effect in vivo. Claims 13-19,22-23 merely recite further limitations of an optional component (additional mobilization agent). Note claim 13 list additional mobilization agent in the alternative and claim 1 does not require an excipient as this limitation is also presented in the alternative.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6-7,10 and 12-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samrah et al., cited above, in view of Wagers et al. WO 2007118157 A1.
Samrah is cited above. Samrah does not teach applicants elected species of AMD3100 as a mobilizing agent. This rejection is made in the interest of compact prosecution as the claims in their current state do not actually require the elected species.
Wagers is used for its disclosure that AMD3100 was a well-known HSC mobilizing agent useful in treating subjects who have non-malignant disorders including sickle cell anemia. See entire disclosure, especially abstract, page 23 lines 7-9 and claims, especially 3,22,27-28.
Since the patient of Samrah had sickle cell anemia one of ordinary skill in the art would have a high expectation of success in adding AMD3100 to treat the symptoms of sickle cell anemia while treating the patients fungal infection with voriconazole. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 6-7,10 and 12-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. et al., cited above, in view of Wagers et al. WO 2007118157 A1.
Liu et al.is cited above. Liu et al. does not teach applicants elected species of AMD3100 as a mobilizing agent. This rejection is made in the interest of compact prosecution as the claims in their current state do not actually require the elected species.
Wagers is used for its disclosure that AMD3100 was a well-known HSC mobilizing agent useful in treating subjects who have non-malignant disorders including sickle cell anemia. See entire disclosure, especially abstract, page 23 lines 7-9 and claims, especially 3,22,27-28.
Since Liu and Wagers both teach compositions for treating for sickle cell anemia one of ordinary skill in the art would have a high expectation of success in adding AMD3100 in combination with voriconazole with an expected additive effect for therapy. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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