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 .
Claim Status
Claims 1, 4, 8-10, 12, 14, 28, 31-32, and 41-42 are pending. Claims 2-3 were canceled and claims 1, 8, 12, 14, and 28 were amended in the Reply filed 12/09/2025. Claims 1, 4, 8-10, 12, 14, 28, 31-32, and 41-42 are pending and presently considered.
Election/Restriction
Applicant’s election without traverse of Group I (original claims 1-4, 8-10, 12, 14, 16, 28-29, 31-32, 41-42, drawn to a hydrogel capsule) and the originally elected subgenus of patentably indistinct species as set forth at Example 231 in the reply filed on 4/30/2024 was previously acknowledged.
The originally elected species was previously deemed free of the prior art because it required ARPE19 cells modified to express FIX, which is understood to lead to blindness in view of Bastiaans2 and Hollborn3 (see, e.g., Action mailed 6/04/2024 at 5).
Per MPEP § 803.02(III), examination was extended to a non-elected species. The amended claims 2/04/2025 have been examined again, and deemed free of the prior art in view of the combination of limitations recited (e.g., RPE cells, modified alginate, two compartments). However, the claims are not currently indicated as allowable in view of non-statutory double patenting issues and issues under 35 USC §112, as set forth below.
Claims 1, 4, 8-10, 12, 14, 28, 31-32, and 41-42 are presently considered.
Priority
The Priority claim to PCT/US2019/053637 (filed 9/27/2019), US 62/824,768 (filed 3/27/2019) and US 62/737,835 (filed 9/27/2018) is acknowledged.
Information Disclosure Statement
The IDS filed 12/09/2025 is acknowledged and presently considered.
Claim Interpretation and Examination Notes
The applicable claim interpretation was set forth in a previous action (see, e.g., Action mailed 1/04/2024 at pages 4-9), and that discussion is incorporated into the instant action.
Withdrawn Claim Rejections
The rejection of claims 1-4, 8-10, 12, 14, 28, and 41-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, have been overcome in view of the amendments filed 12/09/2025. Remaining rejections applicable to claims 31-32 are maintained as set forth below.
The rejection of claims 2-3 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn as moot in view of the cancellation of claims 2-3.
Maintained or Revised Claim Rejections as Necessitated by Applicant Amendment.
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 31-32 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 31-32 are rejected as indefinite for either omission of missing elements or otherwise lack of antecedent basis, because the claims depend from cancelled claim 29.
This rejection may be overcome by canceling claims 31-32. Alternatively, claim 31 may be amended to depend from claim 1 and the phrase “the coding sequence” may be amended to refer to “the exogenous nucleotide sequence” consistent with instant claim 1.
Accordingly, claims 31-32 are rejected.
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 1, 4, 8-10, 12, 14, 28, 31-32, and 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,161,760 in view of Andersen4.
Claim interpretation: The applicable claim interpretation has been set forth in a separate section set forth above, and in preceding rejections under 35 USC 112, and those discussions and interpretations are incorporated herein. Additional claim interpretations are set forth below.
Legal analysis: The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph5: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
The issued claims overlap in scope with the pending claims as follows:
Regarding instant claims 1, 28, the first compartment: US’760 at claim 1 recites a “particle” (compare issued claims 1 with instant “hydrogel capsule”); wherein the particle comprises a first compartment comprising an alginate polymer and “a cell” (compare id. at claims 1 and 8 with instant claim 1, 28).
Regarding instant claims 1, 10, 14, 28, and RPE or cells derived from ARPE19 within the first compartment: US’760 identifies that the first compartment comprises cells (compare issued claims 1, 8, 22 with instant claim 1 and 28), and specifically RPE cells (compare id. at claims 1, 8 with instant claims 1, 28), and more specifically US’760 directs artisans to utilize “cells” that “are derived from ARPE19 cells” (compare issued claims 1, 8, and 22 with instant claims 1, 28).
Regarding instant claims 1, 28, 41-42, and the second compartment: US’760 at claim 1 recites a “particle” (compare issued claims 1 with instant “hydrogel capsule”); wherein the particle comprises a second compartment comprising an alginate polymer and a compound of Formula (I-a), wherein the second compartment surrounds the first compartment (compare id. at claims 1, 8, 16, and 23 with instant claim 1, 8, 28, 41-42).
Regarding instant claims 1, 8, 28, 41-42, and compounds of Formula (I-a): US’760 recites and encompasses the same or overlapping structures of Formula (I-a) (compare id. at claims 1, 8, 14-15, 18, 23, 24-25 with instant claim 1, 8, 12, 28, 41-42; esp. compare instant claims 8, 28, and 41-42 with issued claim 15).
Regarding instant claims 1, 14, 28, the barrier compartment, and the implied or inherent diameter of the hydrogel capsules: US’760 reasonably identifies that the diameter (i.e., longest linear dimension)6 of the particles may vary from “about 0.75 mm” up to 5 mm (compare US’760 at claims 3 and 20). Although “diameter” was removed from the instant claim scope in the most recent reply, this weighs in favor of a determination of overlapping claim scope.
Regarding instant claim 1 and the requirement that the first compartment is “substantially free” of compound Formula (I-a): US’760 explicitly recites this limitation at claims 3 and 16.
Regarding instant claims 1, 14, 28, and the requirement that the RPE cells comprise and exogenous nucleotide sequence encoding a therapeutic polypeptide: US’760 explicitly recites and directs artisans to RPE cells (compare id. at claims 1, 8 with instant claims 1, 28), and more specifically US’760 directs artisans to utilize “cells” that “are derived from ARPE19 cells” (compare issued claims 1, 8, and 22 with instant claims 1, 28), wherein the cells comprise a sequence encoding and capable of expressing a therapeutic agent (see, e.g., US’760 at claim 10-12, 22, 27).
Regarding instant claims 8, 28, 41-42, and the compound of Formula (I): US’760 explicitly teaches and claims the same compound as a species of Formula (I-a) (compare US’760 at claims 1, 14-15, 18, and 23-24 with instant claims 1 and 8).
Regarding instant claim 9 and a therapeutic polypeptide selected from FVIII, FVII, and FIX: US’760 explicitly claims that the therapeutic agent may be a FVIII of FIX protein or variant thereof (compare US’760 at claim 11 with instant claim 9). In addition, although US’760 does not claim FVII explicitly, it does recite “therapeutic agent”, which is understood to encompass all possible clotting factors (see, e.g., US’760 at claim 1, 10-11, and col. 60 at lines 24-33)7.
Regarding instant claims 1, 12, 14 and modified or unmodified alginate with a molecular weight of 150-250 kDa and a G:M ratio of ≥ 1.5 within the barrier compartment: Although the claims of US’760 do not explicitly recite the limitations pertaining to molecular weight and G:M ratio, for purposes of non-statutory double patenting, it is permissible to use the specification as a dictionary to learn the meaning of terms within the claims8 (e.g., “alginate”), and to identify obvious variants9. Here, “alginate” is defined and exemplified as including low, medium, and high molecular weight alginate (≤75 kDa, 75-150 kDa, and 150-250 kDa, respectively) having a G:M ratio of ≥ 1.5, or “a blend” thereof (see, e.g., US’760 at col. 33 at lines 1-52, col. 34 at lines 8-23). Accordingly, such embodiments are understood to be fully encompassed by the issued claims and/or obvious variants of the claimed embodiments.
Regarding instant claims 12, 14, and modified alginate with a conjugation density of ≥2.0% but ≤9.0% nitrogen as determined by combustion analysis: US’760 explicitly claims the same identical compound (Compound 101) at the same density range (compare instant claims 1, 12, 14 with US’760 at claim 19).
Regarding instant claim 14 and the exogenous nucleotide sequence comprising a promoter sequence operably linked to a codon-optimized sequence encoding a FVIII-BDD protein and a poly A sequence, US’760 explicitly claims cell derived from ARPE19 cells that comprise exogenous nucleotide sequences comprising SEQ ID NOs: 9-17, 19-21, 23, 26-27, and 28 (see, e.g., US’760 at claim 22), wherein SEQ ID NOs: 9-17 are understood to be a promoter sequence operably linked to a codon-optimized FVIII-BDD coding sequence (see, e.g., US’760 at col. 64 at lines 47-56, Figs. 17A-17FF, col. 64 at line 65 to col. 65 at line 6).
Regarding instant claims 31-32, SEQ ID NOs: 9-17 or 19-21, and “about 35 to about 45 million cells per milliliter”: Claims 31-32 have been rejected under 35 USC §112 above. For purposes of the instant rejection, it is noted that US’760 explicitly claims cell derived from ARPE19 cells that comprise exogenous nucleotide sequences comprising SEQ ID NOs: 9-17, 19-21, 23, 26-27, and 28 (see, e.g., US’760 at claim 22) as noted above, and that such sequences appear to be substantially identical or otherwise not patentably distinct. Furthermore, US’760 explicitly claims particles having a density of “about 10… to about 300 million cells/ml” (compare instant claims 31-32 with US’760 at claim 21). Accordingly, claims 31-32 do not reasonably appear to materially or substantially differentiate the issued claim scope relative to the instant claims.
Accordingly, the issued claims substantially and materially overlap in scope as noted above, and because “particles” are understood to fully encompass hydrogels10.
Accordingly, the claim scope at issue only differs as follows: The issued claims are silent regarding the presence of a cell-binding peptide (CBP) (e.g., “RGD” or “RGD-polymer”) conjugated to alginate via a linker in the cell-containing portion of the hydrogel, as required by instant claims 1, 4, 14, and 28.
Andersen is cited herein to establish that alginate hydrogels were well-known in the prior art for 3D cell culture and implantation into subjects (see, e.g., Andersen at title, abs, 134 at 1st ¶, 145 at penultimate ¶, 145 at final ¶, 151 at § 4.2.3). Regarding instant claims 1, 4, 14, 28, and the present of a CBP or an “RGD-polymer”, Andersen teaches and discloses that alginate derivatives were well-known in the prior art circa 2015 (see, e.g., Andersen at p. 139 at § 2.3, and p. 139-142 at §§ 2.3.1), wherein Andersen identifies that the use of alginate derivates desirably permits artisans to tune properties, including solubility, hydrophobicity, bioactivity, etc. (see, e.g., Andersen at p. 139 at § 2.3). Andersen expressly identifies that because “[human] cells do not have receptors that recognize alginate” (see id. at 140 at 1st ¶), that the “proliferation and differentiation of some cells within an alginate hydrogel” require modified alginate that permits matrix interactions (see id). Andersen expressly identifies that RGD-modified alginate is useful in tissue engineering and regenerative medicine applications because RGD-modified alginate “improve[s] cellular adaptability”, and has the “ability to initiate biological interactions between alginate hydrogels and cells” (see, e.g., Andersen at p. 139 at §§ 2.3.1). Critically, Andersen expressly exemplifies and discloses an RGD-alginate having the following structure:
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(see, e.g., Andersen at Fig. 3, noting that instant SEQ ID NO: 59 is covalently conjugated via the N-terminus via a single glycine residue to the alginate). Accordingly, an artisan would predictably and reasonably utilize a modified RGD-alginate in place of alginate within a hydrogel intended to comprise human cells in order to predictably and expectedly improve cellular adaptability and facilitate biological interactions between the hydrogel and the cells as taught and suggested by Andersen. Furthermore, the instant claims do not exclude the RGD-alginate of Andersen (i.e., the claims “comprise” such compounds), and furthermore the claims do not materially or substantially differentiate the Andersen compound relative to other RGD-polymers (see, e.g., MPEP § 2144.09, noting that the RGD sequence of Andersen has very close structural similarities and the same utility ascribable to the presence of “RGD”).
Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims (e.g., the CBP or RGD-polymer), amounted to a routine and well-known form of modified alginate in the prior art as established by the secondary reference (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims differ from the issued claims by merely reciting a more specific form of modified alginate known in the art to be suitable for use in cell-encapsulation. Therefore, such claims are not patentably distinct under an obviousness analysis because the primary reference explicitly claims, and thereby directs artisans to practice, the same or overlapping genus of products, and the difference would have been obvious in view of the secondary reference because such RGD-alginates facilitate desirably and improved results (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(A), (B), (E), and (G), MPEP § 2144.09).
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, claims 1, 4, 8-10, 12, 14, 28, 31-32, and 41-42 are rejected because they are not patentably distinct relative to the issued claims of the primary reference in view of the secondary reference.
Claims 1, 4, 8-10, 12, 28, and 41-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14-24 of copending Application No. 17/598,154 (corresponding to US 20230123802 A1).
This is a provisional nonstatutory double patenting rejection in view of the copending claims set forth in App’154 as filed 5/27/2025 and 11/26/2025.
Claim interpretation: The applicable claim interpretation has been set forth in a separate section set forth above, and in preceding rejections under 35 USC 112, and those discussions and interpretations are incorporated herein. Additional claim interpretations are set forth below.
Legal analysis: The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph11: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
Both copending claim sets are directed to overlapping subject matter: Specifically, App’154 is directed to implantable devices comprising engineered RPE cells (see, e.g., App’154 at claims 1, 14-18), and specifically alginate hydrogels comprising an inner compartment comprising engineered RPE cells, and a barrier compartment surrounding the inner compartment and comprising alginate covalently modified by compounds of instant Formula (I) (compare App’154 at claims 14-24 with instant claims 1, 8, 10, 28, 41-42), wherein the alginate in the cell-containing compartment may comprise RGD-polymer sequences such as GRGDSP or GGRGDSP (compare App’154 at claim 17 with instant claims 1, 4, and 28); and wherein the cells comprise an exogenous polynucleotide capable of expressing FVII (compare App’154 at claim 14-24 with instant claims 1, 9, 28). Although not explicitly claimed at this time, App’154 reasonably identifies that the particles implicitly have a diameter (i.e., longest linear dimension)12 of the particles may vary from 0.5 to 5 mm, and therefore the claim scope is understood to substantially and materially overlap13. Although not explicitly claimed at this time, App’154 reasonably identifies that the G:M ratios, alginate molecular weights, and density of the same compound as determined by combustion analysis substantially and materially overlap as obvious variants explicitly recited by the co-pending Application (see, e.g., App’154 at Spec. filed 9/24/2021 at p. 70 at embodiment #25 to p. 73 at embodiment 35) 14,15.
Accordingly, although the copending claim scope is not identical, the copending claim scope cannot be said to be patentably distinct at this time. Accordingly, claims 1, 4, 8-10, 12, 28, and 41-42 are provisionally rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive. Examiner notes that arguments directed to withdrawn rejections have been rendered moot. Remaining pertinent arguments and issues are addressed below.
Regarding the remaining rejections under 35 USC 112(b) pertaining to instant claims 31-32, although Applicant acknowledges that claims 31-32 were rejected (see, e.g., Reply filed 12/09/2025 at 13 at final ¶), Applicant does not dispute the indefiniteness of claims 31-32, and Applicant has not canceled claims 31-32. Accordingly, the rejection is maintained.
Regarding the non-statutory double-patenting rejection over U.S. Patent No. 12,161,760 in view of Andersen, it is the Examiner’s understanding that Applicant acknowledges the rejection, but fails to dispute the rejection by addressing the merits (see, e.g., Reply filed 12/09/2025 at 14 at § Double Patenting). Rather, it is the Examiner’s understanding that Applicant “requests that the rejection be held in abeyance” (see id). Accordingly, the rejection is maintained.
Regarding the provisional non-statutory double-patenting rejection over copending Application No. 17/598,154, it is the Examiner’s understanding that Applicant acknowledges the rejection, but fails to dispute the rejection by addressing the merits (see, e.g., Reply filed 12/09/2025 at 14 at § Double Patenting). Rather, it is the Examiner’s understanding that Applicant “requests that the rejection be held in abeyance” (see id). Accordingly, the rejection is maintained.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive at this time for the reasons set forth above.
Examiner notes that it is his current understanding that this Application could potentially be placed in form for allowance in an After-Final response by
(i) cancelling claims 31-32,
(ii) filing an eTD over U.S. Patent No. 12,161,760, and then
(iii) asserting that per MPEP § 804(I)(B)(1)(b)(i) the remaining provisional rejection should be withdrawn since the instant Application has an earlier patent term filing date.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Examiner notes that extensive pertinent prior art has previously been made of record (see, e.g., Action mailed 8/14/2025 at 31-39), and that disclosure is incorporated into the instant action, but not repeated.
US 20050180960 A1 pertains to alginate capsules for use in the treatment of brain tumors (see, e.g., US’960 at title, abs).
US 20110033504 A1 pertains to alginate gels encapsulating cells, wherein the gels may be coated, and wherein the cells may encode and produce a therapeutic product (see, e.g., US’504 at title, abs, claims 1-6).
Conclusion
No claims are allowed.
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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 Described in Action mailed 6/04/2024 at 2-5.
2 Bastiaans et al., Factor Xa and thrombin stimulate proinflammatory and profibrotic mediator production by retinal pigment epithelial cells: a role in vitreoretinal disorders?, Graefes Arch Clin Exp Ophthalmol 251, 1723–1733 (2013); https://doi.org/10.1007/s00417-013-2335-2; hereafter “Bastiaans”; cited in previous action.
3 Hollborn et al., Activated blood coagulation factor X (FXa) induces angiogenic growth factor expression in human retinal pigment epithelial cells. Invest Ophthalmol Vis Sci. 2012 Aug 31;53(9):5930-9. doi: 10.1167/iovs.11-9214. PMID: 22871831; hereafter “Hollborn”; cited in previous action.
4 Andersen et al., 3D Cell Culture in Alginate Hydrogels. Microarrays (Basel). 2015 Mar 24;4(2):133-61. PMID: 27600217; PMCID: PMC4996398); hereafter “Andersen”; cited in previous action.
5 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
6 See, e.g., US’760 at col. 29 at lines 19-53. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
7 Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
8 See, e.g., MPEP § 804(II)(B)(1), noting that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim.
9 See, e.g., MPEP § 804(II)(B)(1), noting that “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”.
10 See, e.g., US’760 at col. 3 at line 60 to col. 4 at line 13. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
11 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
12 See, e.g., App’154 at Spec. filed 9/24/2021 at 3 at 1st full ¶, 7-8 at bridging ¶, 70-71 at embodiment 25. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
13 See, e.g., MPEP § 804(II)(B)(1), noting that “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”.
14 See, e.g., MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim.
15 See, e.g., MPEP § 804(II)(B)(1), noting that “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”.