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, drawn to (i) a method of treating a damaged tendon or (ii) a method of differentiating stem cells into tendon lineage, in the reply filed on 6/2/2026 is acknowledged. Applicants further elected the species of (i) a method of treating a damaged tendon. Claims 36-48 read on the elected invention and species.
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Claims 49-54 are withdrawn from consideration as being directed to non-elected inventions.
Priority
Acknowledgement is made of Applicants’ claim for benefit under 35 USC 120 as a continuation of prior-filed US application 16/327402 (now USP 11596656), which is a national stage entry under 35 USC 371 of PCT/US2017/047731 (filed 8/21/2017), which claims benefit of US Provisional application 62/378392 (filed 8/23/2016).
Claim Interpretation
The claims involve production and administration of “vesicles” from MSCs. The original application does not use the term “vesicles”, but rather only “microvesicles”. “Vesicle” may be considered short hand for either “extracellular vesicles” or “microvesicles”. These have different meanings:
At the time the application was filed, the term “extracellular vesicle (EV)” was a generic/umbrella term used to describe all membrane-bound vesicles released from cells. There were three main species of EVs, the species differentiated based on mode of production and/or size. The three species are: exosomes, microvesicles, and apoptotic bodies. “Microvesicles” are formed from outward budding and fission of the plasma membrane. They are around 100-1000 nm in size. (See Urbanelli et al (Int’l J of Mol Sc, Aug 2016), see Pg 3-5; Abels et al (Cell Mol Neurobiol, 2016), “Introduction” and Pg. 305)).
Because the terms “extracellular vesicles” and “microvesicles” have different scopes, it is unclear what the abbreviated word “vesicles” is intended to refer to. This merits a rejection under 35 USC 112(a) and 35 USC 112(b) (below). However, for purposes of compact prosecution, for comparison to the prior art, the term “vesicles” will be interpreted as being short hand for “microvesicles”, as this is the term used throughout the specification.
Claim 37 requires the microvesicles to have been “secreted” from the MSCs. Microvesicles are not ‘secreted’ by cells, but rather are formed from outward budding and fission of the plasma membrane. Exosomes are ‘secreted’.
Claim 38 is interpreted as further limiting the culturing step to involve culturing the MSCs on the scaffold for at least three passages. “P1” and “P3” are understood to refer to “passage 1 cells” and “passage 3 cells”.
Claim 39 states the MSCs are adipose-derived MSCs, bone marrow-derived MSCs, bursa-derived MSC, or are tendon stem/progenitor cells (TSPCs). Official notice is taken that the minimum criteria for MSCs are: (1) plastic-adherent when maintained in standard culture conditions; (2) express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR surface molecules; (3) are able to differentiate to osteoblasts, adipocytes and chondroblasts in vitro. TSPCs do meet the minimum criteria for being considered an MSC (See Dai et al (World Journal of Stem cells, 2019).
Claim 41 defines the manner in which the tendon has been damaged. These are product-by-process limitations. The cause of the tendon damage is considered only in so far as it effects the final structure of the damaged tendon to be treated. In the instant case, a tendon damaged by tendinopathy (which covers any condition which can cause pain and swelling of the tendon, which will include any damage to the tendon), a tendon damaged by physical injury (which will cover any physical disruption or damage to the collagen content and/or structure of the tendon), or ruptured tendon (which is wherein the fibrous tissue that attaches to the muscle or bone tears or ruptures) will be a tendon which is painful, swollen, and/or physically damaged in any capacity.
Claim 44 states the vesicles have been cryopreserved prior to administration. This is interpreted as requiring a further step of cryopreserving the vesicles prior to administration.
Claim 48 states the vesicles are 40 nm to 100 nm average diameter. This limitation finds support on Pg 15 of the specification, which states “The Micro-vesicles-S had a diameter from 40-100 [sic: 1OO] nm …”. However, this size range describes exosomes, not microvesicles. Exosomes have a size of 30-100 nm. Microvesicles have a size range from 100-100 nm (See Urbanelli et al, Pg 4). This raises questions as to whether the application appropriately uses the term “microvesicle” or not.
Improper Markush Grouping
As set forth in the 4/3/2026 restriction requirement, claim 36 recites two alternative species. The species are distinguished by the steps performed and the outcomes. Recitation of two alternatives within a claim is considered a Markush claim. See MPEP 2117(I). All of the dependent claims incorporate all limitations of the parent independent claim, and thus are also considered Markush claims.
Claims 36-48 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. The Markush grouping of claim 36 (which is inherited by dependent claims 37-48) is improper because the two species are not ‘alternatively useable members’, but rather patentably distinct methods. The two methods do not share any “single structural similarity” nor do they have a common use as they have different effects (species (i) has the effect of treating a damaged tendon in a subject, whereas species (ii) has the effect of differentiating stem cells into a tendon lineage), and mutually exclusive steps (species (i) requires a step of producing vesicles and administering those vesicles, which is not required by species (ii), and species (ii) requires use of a specific scaffold, which is not required by species (i)).
To overcome this rejection, Applicant may set forth each alternative within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 36-48 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This application was filed 3/3/2023. The preliminary amendment received 9/19/2023 cancelled all original claims and presented new claims 36-48. Therefore claims 36-48 are not part of the original filing. New claims 36-48 require culturing MSCs to produce “vesicles” and then administration of said “vesicles”. The term “vesicles” does not appear in the original disclosure, only “microvesicle”. This is problematic because the shortened term “vesicle” can be shorthand for “extracellular vesicle” or “microvesicle”. These terms have different meanings. At the time the application was filed, the term “extracellular vesicle (EV)” was a generic/umbrella term used to describe all membrane-bound vesicles released from cells. There were three main species of EVs, the species differentiated based on mode of production and/or size. The three species are: exosomes, microvesicles, and apoptotic bodies. “Microvesicles” are formed from outward budding and fission of the plasma membrane. They are around 100-1000 nm in size. (See Urbanelli et al (Int’l J of Mol Sc, Aug 2016), see Pg 3-5; Abels et al (Cell Mol Neurobiol, 2016), “Introduction” and Pg. 305)). The original disclosure does not disclose “extracellular vesicles”, nor any type of extracellular vesicle beyond microvesicles. Because “vesicle” has an unclear scope and can be considered to refer to “extracellular vesicles”, which are not described in the original specification, the term “vesicles” is considered new matter. Applicants must remove the new matter in response to this office action.
Claim Rejections - 35 USC § 112
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.
Claims 36-48 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.
Claim 36 recites the term “vesicles”. The term “vesicles” could be shorthand for either “extracellular vesicles” or “microvesicles”. Extracellular vesicles and microvesicles are different. The term “extracellular vesicle (EV)” was a generic/umbrella term used to describe all membrane-bound vesicles released from cells. There were three main species of EVs, the species differentiated based on mode of production and/or size. The three species are: exosomes, microvesicles, and apoptotic bodies. “Microvesicles” are formed from outward budding and fission of the plasma membrane. They are around 100-1000 nm in size. (See Urbanelli et al (Int’l J of Mol Sc, Aug 2016), see Pg 3-5; Abels et al (Cell Mol Neurobiol, 2016), “Introduction” and Pg. 305)). It is thus unclear if the claim is attempting to cover production and administration of all extracellular vesicles, or only of microvesicles. This ambiguity renders the claim indefinite. All of claims 37-48 depend from claim 36, inherit the deficiency, and are rejected on the same basis.
Furthermore, if “vesicles” is interpreted as “microvesicles” (as is taught by the specification), then claim 37 is indefinite because claim 37 requires for the [micro]vesicles to be secreted by the MSCs. Microvesicles are not secreted from a cell, rather microvesicles are shed from cells, they bud off from the plasma membrane. Exosomes are secreted by cells (See Urbanelli et al, Int’l J Mol Sci, 2016; Abels et al Cell Mol Neurobiol, 2016). It is therefore unclear if Applicants are attempting to claim microvesicles or exosomes. Clarification/correction is required.
Furthermore, if “vesicles” is interpreted as “microvesicles” (as is taught by the specification), then claim 48 is indefinite because claim 48 requires for the [micro]vesicles to have a diameter between 40 and 100 nm. Microvesicles have a size range from 100-100 nm(See Urbanelli et al, Pg 4). Exosomes have a diameter between 30 and 100 nm. It is therefore unclear if Applicants are attempting to claim microvesicles or exosomes.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 36-38, 41-44 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lange-Consiglio et al (Stem Cells Dev, 2013), as evidenced by Lange-Consiglio et al (Stem Cells Dev, 2016).
Lange-Consiglio (2013) study the immunomodulatory effect of amniotic membrane-derived mesenchymal cell (AMC) conditioned medium (AMC-CM) in vitro, as well as the therapeutic effect of AMC-CM on horse tendon injuries in vivo (See abstract). The in vivo use will be relied upon for this rejection.
Lange-Consiglio (2013) collect amniotic membrane from horses; isolate AMCs therefrom; expand the AMCs in culture in tissue flasks; collect and lyophilize the AMC-CM (See Lange-Consiglio (2013) Pg 3016). Lange-Consiglio (2013) treat sport horses having various tendon injuries. The lyophilized AMC-CM was dissolved in water and injected into the damaged tendon site (See Lange-Consiglio (2013), Pg. 3017-3018).
Lange-Consiglio (2013) report that the AMC-CM treated horses showed lack of worsening, improvement in lesional ecogenecity, increased neovascularization, and marked reduction in swelling (See Lange-Consiglio (2013), Pg. 3019 and paragraph spanning Pg. 3020-3021-end of discussion).
Lange-Consiglio (2016) is relied upon to evidence that the AMC-CM of Lange-Consiglio (2013) contained microvesicles. Lange-Consiglio (2016) generate the same AMC-CM, isolate and study the microvesicle content thereof (See Lange-Consiglio (2016), Pg. 612 “Isolation and measurements of MVs”).
Regarding claim 1: Lange-Consiglio (2013) teach a method of treating a damaged tending in a first mammalian subject (sport horses) comprising: isolating AMCs from horse amniotic membrane (reads on obtaining an amount of mesenchymal stem cells from a subject of the same species as the first mammalian subject);
culturing the AMCs (MSCs) on tissue culture flasks (read on scaffolds) so as to produce conditioned medium (Lange-Consiglio (2016) evidence the conditioned medium contains microvesicles; and then
administering to the first mammalian subject an amount of AMC-CM, which comprises microvesicles derived from mammalian (horse) mesenchymal stem cells. The method was effective to reduce inflammation and promote healing of the damaged tendons, thus the amount of microvesicles delivered was necessary an effective amount to achieve treatment.
Regarding claim 37: Claim 37 is indefinite for the reasons stated above. However, for purposes of compact prosecution, claim 37 is included in this rejection in so far as claim 37 could be interpreted as requiring the microvesicles to be produced by the MSCs.
Regarding claim 38: Lange-Consiglio (2013) teach culturing P3 AMCs for generation of the conditioned culture media (See Pg 611 “Preparation of AMC-CM”).
Regarding claim 41: Lange-Consiglio (2013) teach the sport horses being treated had tendon damage having physical damage thereto. The damaged tendons are considered physiologically the same as tendons which have been damaged by tendinopathy, a physical injury and/or tendon rupture.
Regarding claims 42 and 43: Lange-Consiglio (2013) teach directly injecting the AMC-CM into the injury site (local administration).
Regarding claim 44: Lange-Consiglio et al teach the AMC-CM can be stored at -80oC and the thawed preparation can be used (See Lange-Consiglio (2016) at Pg. 3016 “Preparation of AMC-CM”).
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 36 and 38-48 are rejected under 35 U.S.C. 103 as being anticipated by Ludlow et al (US 2018/0177828), evidenced by FiberCellSystems Info Sheet on 3D Hollow Fibers (2026).
Ludlow et al discloses stem cell-derived ‘exosomes’ methods of generating said exosomes, and methods of using said exosomes to treat soft tissue damage (See ¶0010). In particular, Ludlow et al teach heat shocking the stem cells during culture in order to increase the level of heat shock stress-response molecules in the exosomes (See ¶0011-0012). The stem cells can be mesenchymal stem cells (MSCs); thus the exosomes are MSC-derived exosomes (See ¶0041).
Examples 1 and 10 are specifically relied upon for this rejection.
Example 1 teaches the preparation of the MSC-derived exosomes: MSCs (placental or adipose origin) were cultured in a FIBERCELL BIOSYSTEMS hollow fiber cartridge bioreactor. The MSCs were subject to heat shock during culture. The conditioned medium was recovered (See ¶0098). The exosomes were isolated from the conditioned media and were optionally cryopreserved again at -80oC prior to future use (See ¶0100).
In Example 10, isolated MSC-derived exosomes are produced via the method of Example 1. The exosome-containing composition was used to treat damaged Achilles tendon in rats. Specifically, rat Achilles tendons were damaged by collagenase treatment, then the exosome-containing composition was injected into the injury site. Ludlow et al report that the exosome-treatment greatly reduce or inhibit collagen degeneration and/or promote soft tissue and tendon healing after tendon injury (See ¶0131-0132).
While Ludlow et al use the term ‘exosomes’ (which are a different type of extracellular vesicle than microvesicles, Ludlow et al explicitly state the term “exosomes” is used interchangeably with “microvesicles”, “secreted microvesicles”, “extracellular vesicles” and “secreted vesicles” in their disclosure (See ¶0044, also relevant: ¶0006).
The FiberCell Systems info sheet on 3D hollow fiber cartridge bioreactors evidences that the FiberCell Biosystems hollow fiber cartridge bioreactor contains a plurality of fibers substantially aligned in a parallel manner along their longitudinal axes (See illustrations on page 1 and 3). The fibers are necessarily held under some level of tension in a longitudinal direction to maintain this position.
Regarding claims 36, 39, 40 and 46: In Example 10, Ludlow et al disclose treating a damaged tendon in a rat (a first mammalian subject). The method involves first producing exosomes (microvesicles) via the method of Example 1. In Example 1, adipose-derived MSCs are provided for culture. Thus adipose-derived MSCs are obtained from a subject. Ludlow et al does not specify what subject the adipose-derived MSCs are obtained from.
However, official notice is taken that, as of the effective filing date of the instant application, use of autologous cells for any cell-based therapy (including cell-product-based therapy) was the gold standard, followed by allogeneic cells. Use of autologous cells will remove concerns about immunorejection, whereas allogeneic cells will at least reduce the concerns. Therefore, it would have been prima facie obvious to have obtained the adipose-derived MSCs from the recipient rat (reads on from the same subject as the first mammalian subject) or at least from another rat of the same species (reads on from the same subject that is being treated). Alternatively, Ludlow et al does envisage use of their therapies for treatment of humans (See ¶0089). Therefore, it would at least have been prima facie obvious to have applied the method of tendon repair of Ludlow et al to human subjects, and to have used autologous MSCs. The motivation to do such is based on the desire to provide therapy for damaged tendon healing in humans, and use of autologous cells is always the most desirable. One would have had a reasonable expectation of success because methods of harvesting adipose-derived MSCs from a human were known, and Ludlow et al evidence that the MSC-derived exosomes produced via their method provide therapeutic benefit to damaged tendons. In treatment of a human with autologous adipose-derived MSCs reads on the MSCs are obtained from the same subject that is being treated.
In the method of Example 1 the step of culturing the adipose-derived MSCs in the FiberCell Biosystems hollow fiber cartridge bioreactor reads on culturing the MSCs on a scaffold so as to produce exosomes (microvesicles).
In Example 10, Ludlow teach administering to the rat (first mammalian subject) an amount of exosomes (microvesicles) derived from the MSCs. As discussed above, the method of Ludlow et al also renders obvious administration of the exosomes to humans (also reads on first mammalian subject). Ludlow et al report improvement of the tendon injury (demonstrated by reduced lack of degeneration and/or increased healing), thus the amount of vesicles administered was necessarily an amount effective to treat the damaged tendon.
Regarding claim 37: Claim 37 is indefinite for the reasons stated above. However, for purposes of compact prosecution, claim 37 is included in this rejection in so far as claim 37 could be interpreted as requiring the microvesicles to be produced by the MSCs.
Regarding claim 41: In Example 10, Ludlow et al induce tendon injury by injecting collagenase. This causes collagen degradation and disruption of collagen bundle orientation (See ¶0132). The tendon having degraded collagen and disruption of collagen bundle orientation is considered physiologically the same as a tendon which has been damaged by tendinopathy, a physical injury and/or tendon rupture.
Regarding claims 42 and 43: In Example 10, Ludlow et al teach injecting the exosome (microvesicles) directly to the injury site (tendon) (local administration).
Regarding claim 44: Ludlow et al state that the exosomes can be cryopreserved and thawed without any change in activity (See ¶0101). This at least renders obvious a further step of cryopreserving the microvesicles prior to administering them. This conclusion of obviousness is based off a teaching in the primary reference.
Regarding claim 45: As evidenced by the FiberCell Biosystems info sheet, the FiberCell Biosystems hollow fiber cartridge bioreactor contains a plurality of fibers substantially aligned in a parallel manner along their longitudinal axes (See illustrations on page 1 and 3). The fibers are necessarily held under some level of tension in a longitudinal direction to maintain this position.
Regarding claim 47: Ludlow et al does not teach the manner in which the adipose-derived MSCs were harvested. However, official notice is taken that, at least with human subjects, liposuctioned adipose tissue is a standard source for obtaining adipose-derived MSCs. Official notice is further taken that use of a cannula to perform the liposuction is one of several well-known techniques in liposuction. Therefore, use of a cannula to obtain adipose tissue, particularly human adipose tissue was an obvious step.
Regarding claim 48: Ludlow et al report the exosomes generated via the method of Example 1 had an average diameter of 152 nm, but a mode of 107 nm (See ¶0106). These values are slightly higher than the range claimed, however, the range is considered sufficiently close such that a prima facie case of obviousness is established. See MPEP 2144.05.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Lange-Consiglio et al (Stem Cells Dev, 2013), as evidenced by Lange-Consiglio et al (Stem Cells Dev, 2016).
The teachings of each Lange-Consiglio reference are set forth above.
Regarding claim 40: Lange-Consiglio (2013) appear to use allogenic AMC to generate the AMC-CM, not autologous AMC. However, as in the prior rejection, official notice is taken that in fields of therapy involving cell and/or tissue transplantation, use of autologous cells and/or tissue is the gold standard, with allogeneic cells and/or tissues being the next most desired. It therefore would have been prima facie obvious to have used autologous AMCs, if and when possible, to treat subjects having damaged tendons. The motivation to do such is based on the fact that use of autologous cells is always the most desirable in cell-based therapies One would have had a reasonable expectation of success because Lange-Consiglio (2013) teach how to harvest amniotic membrane, isolate AMCs, how to generate AMC-CM, and that the AMC-CM can be stored at -80oC, permitting for its use at a later point in time (a point in time in which the mother and/or offspring is in need of the treatment for a damaged tendon).
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 36-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11596656.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Regarding claim 1: Patented claim 1 renders obvious instant claim 1. Patented claim 1 is to a method of treating a damaged tendon in a mammalian subject, comprising administering to the subject an amount of microvesicles derived from mammalian MSCs. The claim goes on to specify that the MSCs were cultured on a silk scaffold. Though patented claim 1 does not recite active steps of obtaining and culturing, it is obvious that that mammalian MSCs must first be obtained, and then cultured on the silk scaffold to generate the microvesicles administered in the sole active step. Thus, active steps of obtaining the MSCs and culturing on a silk scaffold are at least prima facie obvious.
Regarding claims 38-48: Patented claims 2-13 teach, or at least render obvious, the remaining limitations of the dependent claims.
Conclusion
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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