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 .
Applicant’s response (amendments and arguments) filed with the RCE is acknowledged.
Claim 23 has been cancelled and is amended into claim 14.
Claims 14, 17, 21-22, 29-33 are pending and examined on the merits post-amendments.
Applicant’s arguments (e.g. response page 7) and indicated support (sequence listing) versus the current claim scope have raised a new issue, which must be addressed before the support scope of the claims may be weighed with certainty relevant to the other pending rejections of record.
The examiner invites applicant to schedule an interview to advance prosecution on the merits.
THREE (3) PREVIOUS INFORMATION DISCLOSURE STATEMENTS –
Previously Noted, Retained
The examiner makes note of the following therefrom:
Applicant cites U.S. Patent No. 9937242 (Primary Examiner Bradley) directed to product SEQ ID NOS: 33, 37, and 66 and methods of use bearing specific functionality commensurate in scope with the test data therein. The examiner is open to similar amendments herein that align equivalently with that of ‘242 relevant to the test data herein.
Applicant also submits with the IDS’s, three (3) International Authority Office Actions over the Same/Similar Scope & Dispositions therein:
Japanese-Equivalent 35 USC 112(a) Lack of Enablment Rejection;
Chinese: Equivalent 35 USC 103 Obviousness Rejection (Lack of Inventive Step over a combination of 2 NPL References:
Heng Li et al., Enhanced regeneration and functional recovery after spinal root avulsion by manipulation of proteoglycan receptor PTPo. Scientific Reports, Vol. 5, 14923, 2015-10-14.
in view of
Mahsa Motavaf et al., Attempts to Overcome Remy Clination Failure: Toward Opening New Therapeutic Averues for Multiple Sclerosis, Cellular and Molecular Neurobiology Vol. 37, 1335-1348, 2017-02-21.
Korean-Equivalent 35 USC 112(a) Enablement Rejection and Equivalent 35 USC 103 Obviousness Rejection (Lack of Inventive Step, also over Lang (U.S. Patent Publication No. 20150366949)) as applied herein below.
Information Disclosure Statement Related Material to Examination, Missing
Until Provided, Examination on the Merits Cannot Be Fully Executed –
Still Pending
The Information Disclosure Statement filed 9/24/24 cited the related foreign counterpart application in Korea, which was further probed and found to have issued peptide SEQ ID NO: 58 only, which is still claimed here. However, no further Information Disclosure Documents as to why have been found filed. As such is material to examination and not been provided in translated form (like that of the Korean document provided in the 9/24/24 IDS), examination on the merits cannot go forward without submission of such and any other foreign disposition relevant to the subject matter scope here.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description
The following is a quotation 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.
Claims 14, 17, 21-22, 25, 29, and 30-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, the sequence listing – per the arguments response page 7 – only recite the transport peptide HIV Tat (GRKKRRQRRRC) as being attached to the wedge domain PTPalpha peptide fragments of SEQ ID NOS: 1-25, 32-33, in order to carry out the intended function of being able to ‘penetrate’ the 2 specific cell types claimed of oligodendrocyte progenitor cells or oligodendrocytes - . and achieve “conjugated to an intracellular transport moiety can bind to the wedge domain and be used to abolish PTPσ signaling in OLs/OPCs activated with CSPGs to promote cell growth, motility, and survival.” (see PGPUB para 77). There is insufficient support as present of record, that ‘any’ transport peptide – the current claimed scope – will achieve penetration into those 2 specific cell types, absent evidence to the contrary. Per specification para [0011] only one other transport peptide finds support for assertedly carrying out such: PRR5:
[0011] In other embodiments, the therapeutic agent includes a transport moiety that is linked to the therapeutic peptide and facilitates uptake of the therapeutic peptides by an oligodendrocyte (OL) or OPC. For example, the transport moiety can be an HIV Tat transport moiety or (PRR5) transport moiety.
However, in the absence of sufficient recitation of distinguishing identifying characteristics of what size, structure/sequence such a transport peptide must have to achieve the above, the specification does not provide adequate written description of the claimed genus, that ‘any’ transport peptide will achieve that claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
With the exception of the transport peptides of HIV Tat and PRR5, the skilled artisan cannot envision the detailed chemical structure of the encompassed variants of what other transport peptides may be able to carry out the intended claimed use of penetrating oligodendrocyte progenitor cells or oligodendrocyte cells, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovinesequence. As set forth above, and repeated here, the sequence listing – per the arguments response page 7 – only recites the transport peptide HIV Tat (GRKKRRQRRRC) as being attached to the wedge domain PTPalpha peptide fragments of SEQ ID NOS: 1-25, 32-33, in order to carry out the intended function of being able to ‘penetrate’ the 2 specific cell types claimed of oligodendrocyte progenitor cells or oligodendrocytes – and achieve “conjugated to an intracellular transport moiety can bind to the wedge domain and be used to abolish PTPσ signaling in OLs/OPCs activated with CSPGs to promote cell growth, motility, and survival.” (see PGPUB para 77). There is insufficient support as present of record, that ‘any’ transport peptide – the current claimed scope – will achieve penetration into those 2 specific cell types, absent evidence to the contrary. Per specification para [0011] only one other transport peptide finds support for assertedly carrying out such: PRR5:
[0011] In other embodiments, the therapeutic agent includes a transport moiety that is linked to the therapeutic peptide and facilitates uptake of the therapeutic peptides by an oligodendrocyte (OL) or OPC. For example, the transport moiety can be an HIV Tat transport moiety or (PRR5) transport moiety.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 103 – Maintained Over All Claims;
Disposition Held in Abeyance Until the Intended Claim Scope is Clarified
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
With regard to the obviousness rejections below, the examiner is also in agreement with the U.S. International Authorities disposition in the related PCT written opinion over these same claims filed (without any further amendments) here in the U.S. at the National Stage and applies the same prior art and reasoning here:
Claim(s) 14, 16-17 (SEQ ID NOS: 1-25, 32, 33), 18-22, and new claims 32-33 (SEQ ID NOS: 34-60) remain/are rejected under 35 U.S.C. 102(a)(1) as obvious over Case Western Reserve University (U.S. Patent Publication No. 20150366949 to Lang et al., hereafter “CWRU).
The examiner has now modified the U.S. International Authorities disposition in the related PCT written opinion based on amendments here in the U.S. at the National Stage:
PNG
media_image1.png
126
797
media_image1.png
Greyscale
PNG
media_image2.png
163
793
media_image2.png
Greyscale
Further, even if the peptides above of CWRU do not in fact exert direct mylenation/remylenation effect, CWRU equally teaches the addition of other agents that do so and based on the open “comprising” transition phrase, the “therapeutic agent” that exerts such effect could equally be one of these:
[0202] The methods described herein can further include administration or contacting a cell (e.g., a neuron) with an agent that blocks regeneration inhibitors, e.g., a compound that inhibit myelin derived blockage of neural generation. Known inhibitors of neuronal outgrowth (e.g., of regeneration at a CNS injury site) are myelin-derived inhibitors (e.g., Nogo-A, MAG, OMgp, Ehprin B3, Sema 4D and Sema 5A), astrocyte derived inhibitors (e.g., CSPG, KSPG, Ephrin B2 and Slit), fibroblast derived inhibitors (e.g., Sema 3A). The second agent may be an antagonist to any of these inhibitors. In one embodiment, the cell is further contacted with one or more such agents. In one embodiment, the agent inhibits a myelin inhibitor of neural regeneration (e.g., myelin-associated glycoprotein (MAG), Nogo, oligodendrocyte myelin glycoprotein (OMgp)). Inhibitors of MAG are disclosed in U.S. Pat. No. 5,932,542. Inhibitors of Nogo are disclosed in U.S. Patent Application Pub No. 2009/0215691. Inhibitors of OMgp are disclosed in U.S. Patent Application Pub. No. 2008/0188411. The cell can be contacted with this agent before, after, and/or concurrently with the agent that inhibits the interaction of CSPG with PTPcs.
Claim 23 remains rejected under 35 U.S.C. 103 as being unpatentable as obvious over Case Western Reserve University (U.S. Patent Publication No. 20150366949 to Lang et al., hereafter “CWRU”), based on the above, further in view of Bernardelli et al. (U.S. Patent Publication No. 20090281084).
PNG
media_image3.png
137
971
media_image3.png
Greyscale
Claims 20, 21, and 25-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case Western Reserve University (U.S. Patent Publication No. 20150366949 to Lang et al., hereafter “CWRU”) in view of Kirkham et al. (“Neural stem cells from protein tyrosine phosphatase sigma knockout mice generate an altered neuronal phenotype in culture”. BMC Neuroscience 2006, Vol 7, page 50 (pp 1-9)).
PNG
media_image4.png
424
967
media_image4.png
Greyscale
PNG
media_image5.png
282
968
media_image5.png
Greyscale
As for new claims 26-30, claims 26-27 fall within the scope of that taught by the prior art based on the 70% sequence identity added limitations (claims 26-27). Claims 25 is drawn to a natural pathophysiology of the administered product; claims 27-33 are drawn to one or more subject matter classes already taught/suggested by the prior art based on the scope claimed.
Thus, the claims are deemed prima facie obvious over the references of record.
Response to Amendments/Arguments
Applicant’s arguments have been fully considered but not yet found persuasive for the reasons of record. The rejection is maintained for the reasons above, as modified based on amendments, as to any peptide at least 70% identity to peptide SEQ ID NOS: 32-33, which the prior art of record is still deemed to read on and prima facie obvious to employ for such (and the dependent claims that depend thereto).
Prior Art Made of Record But Not Previously Relied On - Previously Noted
Regarding the below, see the relevant reasons for reliance in the related PCT written opinion carried out by the EU International Authority (which also noted the three (3) applied references above relied upon by the U.S. International Authority; see file wrapper IDS filed 9/26/21).
Oy Liheng et al. "Enhanced regeneration and functional recovery after spinal root avulsion by manipulation of the proteoglycan receptor PTP[sigma]”, SCIENTIFIC REPORTS, vol. 5, no. 1, 14 October 2015.
De Motavap Mahsa et al. “Attempts to Qvercome Remyelination Failure: Toward Opening New Therapeutic Avenues for Multiple Sclerosis", CELLULAR AND MOLECULAR NEUROBIOLOGY, SPRINGER NEW YORK, vol 37, no. 8; 21 February 2017, pages 1335-1448.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
Prosecution Insights