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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/17/2026 has been entered.
Response to Amendment
The amendment filed 3/17/2026, amending claim(s) 58, 59, 65, 66, 68, 69, 71, 74 and 77, canceling claims 1-57, 60-64, and 76, and newly adding claim(s) 78-80 is acknowledged. Applicant’s amendments to the claims have overcome the claim objections to claims 58 and 74.
Claims 58, 59, 65-75, and 77-80 are pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application provisional application 62/864,379 filed on 06/20/2019 and PCT/US2020/038698 filed 6/19/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The nonprovisional application does not receive the domestic benefit to the prior-filed applications due to the nonprovisional not being timely filed (e.g., filed within 12 months of the provisional or up to 14 months if a petition to restore the benefit of the provisional application has been granted).
Accordingly, the effective priority date of the Claims 58-59, 65-75 and 77-80 is granted as the filing date of the instant application, 12/17/2021.
Information Disclosure Statement
The information disclosure statement filed 3/18/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claims 69 and 79 are objected to because of the following informalities:
Claim 69: there is an unnecessary comma after “amniotic fluid” and before “extract” in line 3.
Claim 79: “comprise” should recite “comprises” in line 1.
Appropriate correction is required.
Applicant is advised that should claim 58 be found allowable, claim 59 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 59 recites “the fetal support tissue product comprises native HC-HA/PTX3 (nHC-HA/PTX3) complex or reconstituted heavy chain-hyaluronan/pentraxin 3 (rcHC-HA/PTX3) complex.” However, the HC-HA/PYX3 in independent claim 58 are either native or reconstituted. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 112(a) – Written Description
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 58, 59, 65-75, and 77-80 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.
The Examiner incorporates herein the below 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Claim 58 recites a method of treating an ocular condition by promoting vasculogenesis and neurogenesis of an ocular tissue or condition of an individual in need thereof, the method comprising:
contacting limbal niche cells of the ocular tissue of the individual to a fetal support tissue product, wherein the fetal tissue product comprises a heavy chain 1 from inter-alpha-trypsin inhibitor-hyaluronic acid/pentraxin 3 (HC-HA/PTX3) complex, wherein the contacting reprograms the limbal niche cells to neural crest progenitor cells thereby treating the ocular condition by promoting vasculogenesis and neurogenesis.
The fetal support tissue product may be isolated from placenta, placental amniotic membrane, umbilical cord, umbilical cord amniotic membrane, amniotic stroma, amniotic jelly, Wharton's jelly, amniotic fluid extract, amniotic membrane extract, or any combination thereof (claim 69).
The fetal support tissue product may be a homogenate or an extract (claim 71).
The fetal support tissue product may comprise umbilical cord amniotic membrane (UCAM), and further comprise Wharton’s jelly (claims 72 and 73).
The fetal support tissue product may comprise an umbilical cord that is “substantially free” of a vein or an artery (claim 74).
The fetal support tissue product may be formulated for local administration, administration by injection, topical administration, or inhalation (claim 75).
The fetal support tissue product may comprise amniotic membrane, amniotic membrane extract (AME), or any combination thereof (claim 77).
The ocular condition may be an ocular surface disease with limbal stem cell deficiency (claim 79).
The ocular surface disease may comprise aniridia-related keratopathy (ARK) (claim 80).
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and 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. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,' to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
The claims are broad for reciting a genus of “fetal support tissue products”. As discussed below in the 112(b) rejection, fetal support tissue product is recited at a high level of generality and it is unclear what is considered a fetal support tissue product. Additionally, when searching the specification for more guidance on the term, [0061] broadly recites the following:
“As used herein, "fetal support tissue product" means any isolated product derived from tissue used to support the development of a fetus. Examples of fetal support tissue product includes, but are not limited to, (i) placental amniotic membrane (PAM), or substantially isolated PAM, (ii) umbilical cord amniotic membrane (UCAM) or substantially isolated UCAM, (iii) chorion or substantially isolated chorion, (iv) amnion-chorion or substantially isolated amnion- chorion, (v) placenta or substantially isolated placenta, (vi) umbilical cord or substantially isolated umbilical cord, or (vii) any combinations thereof.”
Additionally, [0080] of the specification recites that HC-HA/PTX3 is purified from fetal support tissue. Therefore, HC-HA/PTX3 is considered a fetal tissue support tissue itself.
The working examples speak to not all fetal support tissue products achieving the same functional outcomes. [0107] recites that HC-HA/PTX3 promotes apoptosis, necrosis, or a combination thereof. Additionally, Example 1, specifically [0200] recites that HUVEC cultured only with HC-HA/PTX3 showed higher necrosis, while HUVEC co-cultured with LNC (limbal niche cells, which express a pericyte phenotype [0102]), appears to prevent HUVEC from necrosis. [0202] recites that HC-HA/PTX3 encouraged anti-angiogenesis effect by facilitating the apoptosis and necrosis in GFP-HUVEC alone. Reunion of GFP-HUVEC to LNC prevented GFP-HUVEC from apoptosis and necrosis induced by the HC-HA/PTX3. Additionally, the reference is silent to the ability of HC-HA/PTX3 to treat an ocular condition, to promote vasculogenesis, or to promote vasculogenesis. Therefore, as evidenced by the specification, not all fetal support tissue materials achieve the same functional properties.
Additionally, the claims are broad for reciting a genus of “limbal niche cells”. The specification offers little guidance on this genera. For example:
[0286] On the ocular surface, corneal epithelial stem cells (SCs) reside in limbus bordered between cornea and conjunctiva. From the limbal stroma subjacent to limbal epithelial SC, a subpopulation of limbal niche cells (LNC) that express SC markers such as Oct4, Sox2, Nanog, Rex1, Nestin, N-cadherin, and SSEA4 and exhibit differentiation potential into vascular endothelial cells, pericytes, osteoblasts, chondrocytes, and adipocytes. From the entire human limbal stroma, others have also isolated progenitors that can differentiate into neurons and retinal sensory cilia. It has been reported that limbal niche cells (LNC) in the stroma support limbal epithelial stem (progenitor) cells better by promoting holoclones and preventing corneal epithelial differentiation than that in central corneal stromal cells.
[0102] In some embodiments, the cells expressing a pericyte phenotype are limbal niche cells (LNCs).
Further, the working examples describe passaging LNCs. However, as passaged, the expression of these LNCs changes. When freshly isolated from limbal tissue, the cell population exhibited positive nuclear staining of Pax6 [0037]. However, the serial passage of LNC to P10 results in the loss of the NC progenitor status that is characterized by nuclear Pax6 staining, expression of ESC markers and NC progenitor markers such as Sox2, p75NTR, Musashi-1, Nestin, Msxl, and FoxD3, and neuroglial differentiation [0250-0251]. The specification also notes that LNC were expanded from four different limbal regions [0039].
Overall, the specification fails to provide further guidance on the genera “limbal niche cells”, and instead describes them by characteristics they possess (that can be altered, as noted in the working examples). For example, are “limbal niche cells” meant to encompass any cell originating from the limbal region, such as limbal epithelial stem cells (which are discussed as a separate cell population in the specification)? Or does “limbal niche cells” refer to a specific subpopulation?
The art also does not provide a consensus on what a “limbal niche cell” is.
Guo, Ping et al. “Limbal niche cells are a potent resource of adult mesenchymal progenitors.” Journal of cellular and molecular medicine vol. 22,7 (2018): 3315-3322. notes “Several types of cells enriched in the limbal niche may serve as niche cells, including melanocytes, blood vascular endothelial cells, and neural cells” (e.g., pg. 3316, col 1, para 2). Further, Guo et al. states “Limbal niche cells located in the limbal Palisades of Vogt are mesenchymal stem cells that reside next to limbal basal epithelial cells. Limbal niche cells are progenitors that express embryonic stem cell markers such as Nanog, Nestin, Oct4, Rex1, Sox2 and SSEA4, mesenchymal cell markers such as CD73, CD90 and CD105, and angiogenesis markers such as Flk-1, CD31, CD34, VWF, PDGFRb and a-SMA, but negative for CD45.” (e.g., Abstract).
Li, G., Zhang, Y., Cai, S. et al. Human limbal niche cells are a powerful regenerative source for the prevention of limbal stem cell deficiency in a rabbit model. Sci Rep 8, 6566 (2018) defines LNCs as “progenitor cells isolated from the corneal limbal niche using collagenase digestion and cultured in modified embryonic stem cell medium (MESCM)13 on Matrigel coated plastic surface. LNCs are characterized by a small spindle shape, high growth rate and expression of embryonic stem cell (ESC) markers. LNCs may be induced to differentiate into blood vessel endothelial cells, paracytes, osteoblasts, chondrocytes and adipocytes, expressing MSC markers like CD73, CD90, CD105, thus defined as mesenchymal progenitors.” (e.g., pg. 2, para 1). Li et al. is silent on Pax6 expression in LNCs.
Polisetti, Naresh et al. “Efficient Isolation and Functional Characterization of Niche Cells from Human Corneal Limbus.” International journal of molecular sciences vol. 23,5 2750. 2 Mar. 2022, doi:10.3390/ijms23052750 demonstrates that after the effective filing date of the claimed invention, a standard procedure to isolate and identify LNCs was still in development: “Research on freshly isolated LNC which mainly include limbal mesenchymal stromal cells (LMSC) and limbal melanocytes (LM) has been hampered by a lack of efficient protocols to isolate and purify these cells.” (e.g., Abstract). Polisetti et al. teaches LMSC and LM populations possessing different expression profiles, e.g., (CD117-CD90+) and (CD117+CD90-), respectively (e.g., Abstract). Polisetti et al. is silent on the expression of Pax6 in these cell populations.
Additionally, the claims are broad for generically reciting the genus “ocular conditions”. The specification provides no guidance on what conditions “ocular conditions” encompasses. The only mention of an ocular condition in the specification is “Patients with aniridia-related keratopathy (ARK) observed as typical ocular surface disease with limbal stem cells deficiency (LSCD)” in [0287], which does not provide an artisan further instruction on what may be considered an ocular condition. As written, the genera broadly encompasses any condition that impacts the eye.
Further, there is no recitation in the claims or disclosure in the specification for an artisan on the dose(s), route of administration(s), formulation(s) etc. that is necessary/sufficient to “treat an ocular condition by promoting vasculogenesis and neurogenesis of an ocular tissue” and “reprogramming the limbal niche cells to neural crest progenitor cells”. Additionally, there is no active method step involving the administration of a therapeutic to an individual. The specification provides no further guidance on how the contacting step alone, which results in reprograming the LNCs to neural crest progenitor cells, treats an ocular condition. Further, the instant disclosure does not clarify what the therapeutic of the method would even be. For example, would the administration of reprogrammed LNCs alone treat an ocular condition? claim 75 further limits the formulation of the fetal support tissue product to local administration, administration by injection, topical administration, or inhalation. So is the fetal support tissue product the only therapeutic? Additionally, how would a fetal support tissue formulated for inhalation, for example, contact the LNCs?
US 20070160588 A1 (published 07/12/2007) is considered relevant prior art for teaching a method of treating a patient having peripheral vascular disease by administering post-partum derived cells from human placenta or umbilical cord. In culture, these cells are able to differentiate into cells of a pericyte or vascular endothelium phenotype (claim 1).
Many prior publications by the applicant are considered relevant prior art, including but not limited to:
US 20130251684 A1 (published 09/26/2013) for teaching a method of culturing (i.e., contacting) and expanding a plurality of cells of a tissue sample with nHC-HA/PXT3 or rcHC-HA/PTX3 derived from umbilical cord or amniotic membrane (claims 87, 94, 96).
US 20140147511 A1 (published 05/29/2014) for teaching a method of preparing a fetal support tissue powder that is used to treat a wound, spinal condition, arthritic condition inflammation, regenerating or repairing bone, tissue, or cartilage in an individual by administering the powder to an individual (i.e., contacting tissue to a fetal support tissue product) (claims 1, 25-32).
US 20150166624 A1 (by applicant, published 06/18/2015) for teaching a method for producing a reconstituted HC-HA/PTX3 complex, with the complex being used for treatments via administration to a subject, and used to induce stem cell expansion by contacting a stem cell in vitro (claims 149, 177-185).
US 11707492 B2 (published 07/25/2023, filed 01/27/2017) for teaching a method of treating a complex wound in an individual by administering an effective amount of fetal tissue support product (claim 1).
Although the prior art, including the applicant’s own, does teach the active method step (i.e., structure) of the independent claim of contacting tissue with a fetal support product, they do not provide further guidance on the relationship between the structure claimed in claim 58 of the instant case and its claimed resulting function(s).
Therefore, the claims fail to recite, and the specification fails to disclose the nexus of the structure (contacting LNCs to a fetal support tissue product) of claim 58 and the function of treating an ocular condition by promoting vasculogenesis or neurogenesis of an ocular tissue, nor reprogramming LNCs into neural crest progenitor cells.
Claim Rejections - 35 USC § 112(a) - Enablement
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 58, 59, 65-75, and 77-80 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The Examiner incorporates herein the analysis discussed above in the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description rejection.
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make and use the claimed invention. If not, whether an artisan would have required undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirements, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experimentation to make or use the invention based on the content of the disclosure is “undue” (In re Wands, 858 F.2d 731, 737, 8 USPQ2ds 1400, 1404 (Fed. Cir. 1988)). Furthermore, USPTO does not have laboratory facilities to test if an invention will function as claimed when working examples are not disclosed in the specification. Therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention. And thus, skepticism raised in the enablement rejections are those raised in the art by artisans of expertise.
The Breadth of the Claims and The Nature of the Invention
The claims are directed to a method of treating an ocular disease.
The claims are broad for encompassing the generically recited genera “fetal support tissue products”, “limbal niche cells” and “ocular diseases”.
The State of the Prior Art, The Level of One of Ordinary Skill and The Level of Predictability in the Art
As discussed in the 112(a) written description rejection above, the art teaches that methods of isolating and identifying LNCs are still being developed.
A search of the art returned no results on LNCs exposed to HC-HA/PTX3 being used to treat an ocular condition. Additionally, much of the research on this topic is still conducted in vitro, with no in vivo experimentation on the topic found.
Similar references included much of the author’s own work. For example, Ogawa, Y., He, H., Mukai, S. et al. Heavy Chain-Hyaluronan/Pentraxin 3 from Amniotic Membrane Suppresses Inflammation and Scarring in Murine Lacrimal Gland and Conjunctiva of Chronic Graft-versus-Host Disease. Sci Rep 7, 42195 (2017). teaches using a mouse model of chronic graft-versus-host disease (cGVHD) to examine whether HC-HA/PTX3 could attenuate dry eye disease elicited by cGVHD. Results indicated that subconjunctival and subcutaneous injection of HC-HA/PTX3 preserved tear secretion and conjunctival goblet cell density and mitigated inflammation and scarring of the conjunctiva. The author’s note that the pre-clinical data help prove the concept that subcutaneous and subconjunctival injection of HC-HA/PTX3 is a novel approach to prevent dry eye disease caused by cGVHD and allow us to test its safety and efficacy in future human clinical trials (Abstract). However, this reference differs from the claimed invention in no LNCs are present, and no fetal support tissue products are discussed.
In summary, the prior art appears to be entirely silent on LNCs exposed to a fetal support tissue product comprising a HC-HA/PTX3 complex as a therapeutic, let alone treating ocular diseases.
The Existence of Working Examples and The Amount of Direction Provided by the Inventor
The specification as filed does not provide any guidance or examples that would enable a skilled artisan to treat an ocular condition as claimed. Additionally, a person skilled in the art would recognize that assessing the probability of achieving a treatment effect using heretofore uncharacterized cells, compositions, etc. is highly unpredictable. This is particularly true in view of the lack of guidance in the specification and known unpredictability in gene therapy.
The instant specification provides no working examples regarding the therapeutic outcomes of a method comprising contacting LNCs with a fetal support tissue product comprising an HC-HA/PTX3 complex. In fact, no in vivo working examples are found at all in the specification. The working examples instead relate to in vitro experimentation of the phenotypic changes in LNCs during passaging and exposure to HUVEC and HC-HA/PTX3, for example. As such, there is no evidence that the claimed method would treat ocular conditions.
Since the quantity of experimentation required to practice the invention as claimed is undetermined, one of skill in the art would have been unable to practice the invention without engaging in undue trial and error experimentation as presented in the specification over the scope claimed.
The Quantity of Any Necessary Experimentation to Make or Use the Invention
Thus, the quantity of necessary experimentation to make or use the invention as claimed, based upon what is known in the art and what has been disclosed in the specification, will create an undue burden for a person of ordinary skill in the art to necessarily and predictably use the claimed method comprising the broadly claimed genera of fetal support tissue products and LNCs to treat the generically claimed genus of ocular diseases.
In conclusion, the specification fails to provide any guidance as to how an artisan would have dealt with the art-recognized limitations of the claimed method commensurate with the scope of the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 58, 59, 65-75, and 77-80 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.
Claims 58, 59, 65, 66, 68-72, 74, 75, and 77 recite the term “fetal support tissue product”. [0061] of the specification recites the following:
“As used herein, "fetal support tissue product" means any isolated product derived from tissue used to support the development of a fetus. Examples of fetal support tissue product includes, but are not limited to, (i) placental amniotic membrane (PAM), or substantially isolated PAM, (ii) umbilical cord amniotic membrane (UCAM) or substantially isolated UCAM, (iii) chorion or substantially isolated chorion, (iv) amnion-chorion or substantially isolated amnion- chorion, (v) placenta or substantially isolated placenta, (vi) umbilical cord or substantially isolated umbilical cord, or (vii) any combinations thereof.”
The applicant’s lexicography fails to actually define the term, as the specification discloses the term using open language (e.g., “are not limited to”). What is considered a “product” of the tissue? What tissue is and is not considered to support the development of a fetus? The metes and bounds of the term “fetal support tissue product” are unclear. For examination purposes, “fetal support tissue product” is interpreted to read on any biomolecule, cell, tissue, that either originates from or is found in the placenta, umbilical cord, amnion, or uterus.
Claim 74 recites the phrase “substantially free”. It is unclear what is considered “substantially free”. The claim denotes that some amount of vein or artery may be present, so what amount is objectively “substantially free” and what amount is not objectively “substantially free’? The specification offers no further guidance on the meaning of the phrase. Therefore, the metes and bounds of “substantially free” are unclear. For examination purposes, the limitation of claim 74 is interpreted to be that the fetal support tissue product comprises tissue from the umbilical cord.
Claim 78 recites “the limbal niche cells are characterized by a loss of nuclear staining of Pax6.” The term “loss” implies that the limbal niche cells once expressed Pax6. As such, it is unclear what this “loss” is in comparison to. For example, at what point do the limbal niche cells have nuclear staining of Pax6 then lose it? When would an artisan determine this?
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
The Applicant argues that Examples 6 and 7 of the instant specification, related to investigating the effects of contacting late passage LNCs to fetal support product with HC-HA/PTX3 demonstrate possession of the claimed invention. This argument is not persuasive, as the Applicant provides no evidence or explanation as to how the in vitro experiment provides support for treating an ocular condition.
The Applicant argues “the specific tissues of the placenta that define "fetal support tissue product" are presented throughout the instant application for example in paragraph [0061]. Furthermore, a skilled artisan looking at "fetal support tissue product" as recited in the present claims and disclosed in the instant application at the time of filing would understand the metes and bounds of "fetal support tissue product" as presently claimed.”
This argument is not persuasive because the Examiner previously cited [0061] in the 112(b) rejection to demonstrate the lack of clarity for the term. The Applicant fails to distinctly point out how [0061] actually clearly defines “fetal support tissue product”. Additionally, the Applicant’s argument is contradictory to the instant specification and claims, as according to the instant disclosure, “fetal support tissue product” may encompass tissues not of the placenta, such as the umbilical cord, contrary to the Applicant’s statement quoted above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M JOHNSON whose telephone number is (703)756-1396. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ALLISON MARIE JOHNSON/ Examiner, Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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