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
Files 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.
Response to Restriction
Applicant's response to election of species without traverse, in the reply filed on 06/05/2026 is acknowledged.
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Claims 1, 4 and 8-16 read on the elected species.
Claims 2-3 and 5-7 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1, 4 and 8-16 are examined on merits in this office action.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 4 and 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Subramanian (Metab. Brain Dis., 2011, 26, 107-113).
For claims 1, 4 and 8-11:
Subramanian teaches that sustained levels of circulating hAAT profoundly inhibited induction of clinical signs, inflammatory lesions and demyelination observed in WT mice with experimental autoimmune encephalomyelitis, concomitant with enhanced levels of CD4+FoxP3+ Treg cells, reduced secretion of MOG peptide-induced pro-inflammatory cytokines, IL-17, IL-1β & IL-6, diminished expression of caspase-1 and enhanced expression of CCR6 and further Subramanian concludes that ‘these results implicate hAAT as a potent immunoregulatory agent worthy of further investigation as a potential therapy in human autoimmune diseases including multiple sclerosis’. [see Abstract and Discussion].
Difference is that Subramanian is silent on exemplifying their methodology in treating a patient having an inflammation disease or disorder of the nervous system.
Subramanian provided scientific evidence and established nexus between AAT and inflammation disease or disorder of the nervous system, such as multiple sclerosis etc. Therefore, it is obvious to extrapolate the same to a patient having inflammation disease or disorder of the nervous system. In fact, in the drug discovery, first step is testing the drug in vitro and in vivo, and if the results are positive, then it can be extended to treat a patient with the same condition(s), which is a common practice in the art.
For claims 12-13:
Subramanian teaches that AAT protein is human ATT, which is interpreted as ATT is obtained from human plasma. Alternatively, if the sequence is identical, it should behave similarly and so it should not matter whether the protein is synthetic or isolated from human plasma.
For claims 14:
In the teachings of Subramanian, the AAT in the cell is interpreted as AAT in the pharmaceutical composition, since water can be a carrier, which can be blood brain permeability enhancer.
For claim 16:
The limitation is a product by process claim format, since the “composition is formulated” fits in the definition of “product by process”, since composition is formulated (or produced) in a such a way which is suitable for the recited modes of administrations.
Subramanian teaches ATT (or product) and ‘how the product is formulated’ does not have any weight, because there are no characteristic limitations of the composition in the claim.
The recited modes of administration in the claim are intended use and it does not have weight.
See MPEP 2111.02(11) which states that when a claim recites a product with an intended use (i.e. A product “for use as_” or other similar language), that intended use is only given patentable weight if it results in any structural difference to the product itself. If, as is usually the case, the body of the claim fully sets forth all limitations of the claimed invention, and the preamble merely recites an intended use or purpose, then the preamble is not considered as a limitation and is of no significance to claim construction.
In this case, “for recited modes of administrations” does not add any structural limitation to the claimed composition. Therefore, this part of the claim is not given patentable weight.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components, viz., ATT and its property, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
Note that the motivation to modify the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
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.
Claims 1, 4 and 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 19-22 of US copending application # 18/862,432.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The subject matter claimed in the instant application is fully disclosed in the patents and is covered by the patent.
Claim 1 of copending application are drawn to a method of treating an inflammatory disease or disorder, comprising administering an effective amount of a pharmaceutical product to a subject, wherein the pharmaceutical product comprises: a) alpha 1-antitrypsin (AAT) protein, a variant, an isoform and/or a fragment thereof, wherein said variant, isoform and/or fragment has ADAM 17 inhibitory activity or a small molecule having ADAM 17 inhibitory activity; and/or b) a nucleic acid encoding AAT, a variant, an isoform and/or a fragment thereof, wherein said variant, isoform and/or fragment has inhibitory activity.
Dependent claims further limit claim 1 to recited inflammatory disease or disorder of the nervous system and source of ATT.
Therefore, the instant claims are anticipated by claims of US copending application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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