Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The provisional application filed 05/04/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2024 and 08/23/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election of Group I (claims 1-7 and 16-18) in the reply filed on 05/29/2026 is acknowledged. 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)). As such the restriction is made final.
Specification
The use of the term NERL™ (para. [0035]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1-3,4a, 4b, and 5-12 (of Figure 4B, 4C, 5B, 6B). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
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.
Claim 1 is 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 1 contains the trademark/trade name L. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific clay compositions and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1-7 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (US 20220305171 A1).
Liu describes an injectable composition that is in the form of a gel, that functions to lift the tissue.
Regarding claim 1, the injectable composition described in Liu comprises a modifier, which is polyethylene glycol (see claim 9), as well as sodium chloride (i.e. biocompatible salt, see claim 18). Liu further describes that the composition’s viscosity changes as the composition is a liquid, and becomes a gel after it is injected (para. [0047]). Liu also discloses injectable compositions for lifting the submucosal tissue comprising a biocompatible salt with sodium alginate (see Table 1), and a biocompatible salt with chitosan and gelatin (see Table 10). The composition of instant claim 1 has components that are all the same as those described in Liu, and both compositions are injectable. As such, the properties of the instant invention, such as the change in viscosity over time, will be the same as the composition in Liu, even if Liu does not explicitly state these properties. See MPEP § 2112.01 (II).
Regarding claims 2 and 3, the modifier described in Liu (i.e. polyethylene glycol) is in an amount of 0.25-5% w/v (see claim 15), which is further limited to 0.001-5% w/v (see para. [0070]). The concentrations of the polyethylene glycol of instant claims 2 and 3 are fully encompassed by the concentrations disclosed in Liu, and as such are anticipated. MPEP § 2131.03(II).
Regarding claims 4-6, Liu describes that the polyethylene glycol in the composition has a molecular weight ranging from 500-10,000 Da (see claim 12; [0068]). The range of the molecular weight of polyethylene glycol described in instant claims 4-6 overlaps almost entirely by that disclosed in Liu, and as such they are anticipated. MPEP § 2131.03(II).
Regarding claim 7, Liu discloses that sodium chloride is the salt in the composition (see claim 18). Further, Liu describes that the salt in the composition is at a concentration less than 0.9% w/v (see claim 19).
Regarding claim 16 and 18, as discussed above, Liu teaches an injectable composition that once injected forms a gel to separate tissue layers. The composition comprises polyethylene glycol in an amount of 0.25-5% w/v (see claim 15), or 0.001-5% w/v (see para. [0070]). Further, Liu describes that the polyethylene glycol of the composition has a molecular weight of 500-10,000 Da (see claim 12), and that the composition can comprise sodium chloride (see claim 18).
Regarding claim 17, as discussed in detail above, Liu does not describe that the composition has a viscosity that decreases by 50% over time, but does disclose all the elements of the composition, including each component and their concentration. As such, Liu would have the same properties of instant invention regarding changes in viscosity of the composition overtime.
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 1-7 and 16-18 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Application No. 18/654,634 (hereafter App’ 634) in view of Liu (US 20220305171 A1).
Regarding claim 1 of instant invention, App’ 634 describes an injectable composition for submucosal lifting (see claim 1) that comprises polyethylene glycol (see claim 2) and saline (see claim 4). Further, the composition forms a gel when injected into the tissue (see claim 1). The composition of instant claim 1 has the same components as those described in App’ 634, and both compositions are injected before they become a gel. As such, the properties of the instant invention, such as the change in viscosity over time, will be the same as the composition taught in App’ 634, even if these properties are not explicitly stated in App’ 634.
Regarding claim 2 and 3 of instant invention, App’ 634 teaches that the concentration of the polyethylene glycol is 0.1-20% w/v (see claim 5). The range of concentrations of polyethylene glycol in instant claims 2 and 3 are fully encompassed by that taught in App’ 634, and as such they are obvious.
Regarding claim 4-6 of instant invention, App’ 634 does not teach the molecular weight of the polyethylene glycol. However, as discussed in detail above, Liu teaches an injectable composition in the form of a gel, that functions to lift the tissue. The composition described in Liu comprises polyethylene glycol that has a molecular weight in the range of 500-10,000 Da (see claim 12). The range of the molecular weight of polyethylene glycol described in instant claims 4-6 overlaps almost entirely by that disclosed in Liu. The person of ordinary skill in the art at the time of the effective filing date would be motivated to optimize the molecular weight of the PEG to be within the range disclosed in Liu, because Liu teaches that this molecular weight is effective in compositions that function to form a gel and lift submucosal tissue.
Regarding claim 7 of instant invention, App’ 634 teaches that saline is present in the composition (see claim 4). However, App’ 634 does not disclose the concentration of the saline that makes up the composition. As discussed above, Liu teaches that the composition comprises saline (see claim 18) in a concentration less than 0.9% w/v (see claim 19). The range of instant claim 7 is overlapping with that taught in Liu, and as such it is obvious. It would have been obvious to one of ordinary skill in the art to optimize the concentration of saline in the composition to be within the concentration range disclosed in Liu, because Liu teaches that this concentration is effective for an injectable composition that becomes a gel when it enters the body.
Regarding claims 16-18 of instant invention, App’ 634 teaches an injectable composition for submucosal tissue separation, that becomes a gel when injected into the body (see claim 1). The composition contains polyethylene glycol (see claim 2) in an amount ranging from 0.1-20% w/v (see claim 5). App’ 634 also discloses that the composition further comprises saline (see claim 4). While App’ 634 fails to teach the molecular weight of the polyethylene glycol, as above Liu teaches that the PEG has a molecular weight in the range of 500-10,000 Da (see claim 12). The range of the molecular weight of polyethylene glycol described in instant claims 4-6 overlaps with that disclosed in Liu. As above, one of ordinary skill in the art would be motivated to optimize the molecular weight of the PEG to be within the range disclosed in Liu, because Liu teaches that this molecular weight is effective in injectable compositions. Further, the properties of the instant invention, such as change in viscosity over time, will be the same as the composition taught in App’ 634 because the components and their concentrations in the composition are the same.
The conflicting claims of instant invention and App’ 634 differ only marginally in scope from claims 1-7 and 16-18 of the present application. Claims 12, 18, and 19 of Liu, which are discussed above in the rejections under 35 U.S.C. 103, compensate for the deficiency in the conflicting claims concerning the molecular weight of the polyethylene glycol and the concentration of the saline in the composition.
Conclusion
Claims 1-7 and 16-18 are rejected.
Claims 8-15 and 19-20 are withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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