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 Objections
Claim 2 is objected to because of the following informalities: on line 2, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: on line 3, applicant need to change “the polymer arms” to --- the plurality of the polymer arms ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: on line 1, applicant need to change “the polymer arms” to --- the plurality of the polymer arms ---; on line 1, applicant need to change “comprise” to --- comprises ---; on line 2, applicant need to change “moicty” to --- moiety ---. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: on line 3, applicant need to change “an electrophilic group” to --- electrophilic groups ---. Appropriate correction is required.
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 1-20 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.
In claims 1, 4, 17 and 19, applicant recite “one or more types of linear hydrophilic polymers”. The addition of word “type” to an otherwise definite expression (e.g., linear hydrophilic polymers) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). Likewise, the phrase "ZSM-5-type aluminosilicate zeolites" was held to be indefinite because it was unclear what "type" was intended to convey. The interpretation was made more difficult by the fact that the zeolites defined in the dependent claims were not within the genus of the type of zeolites defined in the independent claim. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986).
Instant rejection can be overcome by deleting the term “types of” in each of the clams 1, 4, 17 and 19.
Claims 2 and 3 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 2 and 3 both recite the limitation "the linear hydrophilic polymer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Instant rejection can be overcome by changing “the linear hydrophilic polymer” in claims 2 and 3 to --- the one or more linear hydrophilic polymers ---.
Claim 20 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 20 recites the limitation "the hydrogel particle suspension" in line 1. There is insufficient antecedent basis for this limitation in the claim. Instant rejection can be overcome by changing “the hydrogel particle suspension” to --- the suspension comprising radiopaque crosslinked hydrogel particles ---.
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, 3-12 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell et al (US 2011/0142936 A1).
Campbell teaches (claim 1) a pharmaceutically acceptable implant system comprising a collection of pharmaceutically acceptable, covalently crosslinked hydrogel particles having a radiopaque agent covalently attached to a plurality of the crosslinked hydrogel particles in the collection, with the radiopaque agent being present in the collection at a concentration of at least about 0.1 wt.%. Campbell further teaches (claims 18-20) that its implant system contains (i) an applicator (a syringe – see [0132] and [0134]) in which the crosslinked hydrogel particles (dehydrated) are disposed; and (ii) a container of physiological saline fluidly connectable to the applicator to mix the saline and particles in the applicator. Thus, Campbell teaches an injectable suspension comprising radiopaque crosslinked hydrogel particles in a carrier fluid. With respect to instant one or more linear hydrophilic polymers, Campbell teaches (claim 12) that the implant system of claim 1 further comprise an osmotic agent comprising a linear hydrophilic polymer (as a means to improve the injectability of the crosslinked hydrogel particles through the catheter and/or needle of the syringe – see [0117]-[0119]).
Thus, Campbell teaches instant claims 1 and 16-18.
With respect to instant claim 3, as discussed above, Campbell teaches the use of an osmotic agent comprising a linear hydrophilic polymer. Specifically in its Example 5, Campbell uses linear PEG (a linear hydrophilic polymer) having molecular weight of 20kDa (which falls within instant range 1kDa – 60kDa of claim 3) as the osmotic agent. Thus, Campbell teaches instant claim 3.
With respect to instant claim 4, Campbell’s Fig.11A shows that the linear PEG (linear hydrophilic polymer) was used in its Example 5 in the amount of 5%, 10%, 15% and 20%. Thus, Campbell teaches instant claim 4.
With respect to instant claims 5 and 6, as discussed above, Campbell teaches (claim 1) that the radiopaque agent is covalently attached to a plurality of its crosslinked hydrogel particles. In claim 8, Campbell further teaches that the radiopaque agent comprises iodine. Thus, Campbell teaches instant claims 5 and 6.
With respect to instant claim 7, in Example 5 (see also [0054]), Campbell teaches covalently crosslinked multiarmed PEG hydrogel particles (instant crosslinked polymer comprising a poly(alkylene oxide) chain). Thus, Campbell teaches instant claim 7.
With respect to instant claim 8, Campbell teaches ([0047]-[0048]) that the precursors (for the crosslinked hydrogel) may have, e.g., 2-100 arms, with each arm having a terminus. An arm on the hydrogel precursor refers to a linear chain of chemical groups that connect a crosslinkable functional group to a polymer core. Campbell teaches that hydrogels can be made from a multi-armed precursor with a first set of functional groups and a low molecular-weight precursor having a second set of functional groups. For example, a six- or eight-armed precursor may have hydrophilic arms (e.g., polyethylene glycol arms terminated with primary amines). Once these precursors are covalently crosslinked with each other, they form a crosslinked hydrogel ([0032]). Thus, Campbell teaches instant claim 8.
With respect to instant claim 9, Campbell gives an example (see Example 4 in [0154]; the footnote under Table III; and [0080]), an 8a20kSGA PEG with 3-4 terminal TIB (31% substitution) or about 5 terminal TIB (61% substitution), which refers to a 8-armed PEG of 20,000 Mw with SGA (succinimidyl glutarate) functional groups at the termini of arms, where 3-4 terminal SGA or 5 terminal SGA groups are substituted with TIB (triiodobenzoate which is a molecule that contains three iodines -instant radiopaque-atom). Thus, Campbell teaches instant claim 9.
With respect to instant claim 10, in Example 4, Campbell teaches that the 8a20kSGA PEG with 3-4 terminal TIB or about 5 terminal TIB was reacted with trilysine to make the hydrogels. The 8a20kSGA PEG teaches instant reactive multi-arm polymer containing a plurality of first reactive moieties that comprise an electrophilic group (see [0046] of present specification), and trilysine teaches instant reactive compound having a plurality of second reactive moieties that comprise nucleophilic groups (see [0054] of present specification). Therefore, Campbell teaches instant crosslinked reaction product of claim 10. Thus, Campbell teaches instant claim 10.
With respect to instant claim 11, in its Example 4 (see [0154]-[0155]), Campbell teaches injectable suspension containing 5% or 10% solids hydrogel (with bound iodine). Thus, Campbell teaches instant claim 11.
With respect to instant claim 12, Campbell teaches that the collection of the covalently crosslinked hydrogel particles are spheroidal with a maximum diameter of about 20-200 microns. Such range falls within instant range 10-1500 microns and thus teaches instant range of claim 12. Thus, Campbell teaches instant claim 12.
With respect to instant claim 14, Campbell teaches (claim 21) that its implant system further comprises a therapeutic agent. Thus, Campbell teaches instant claim 14.
With respect to instant claim 15, in Campbell’s Example 4, the injectable suspension of the radiopaque crosslinked hydrogel particles made by reacting 8a20kSGA PEG having 5 terminal TIB (61% substitution) with trilysine is shown to have a radiopacity of 155 HU (for 5% solids hydrogel) or 280 HU (for 10% solids hydrogel). Thus, Campbell teaches instant claim 15.
With respect to instant claims 19 and 20, Campbell teaches (claim 37) a method of treating a patient with its pharmaceutically acceptable implant system by implanting (injecting) the collection of the covalently-crosslinked hydrogel particles. Campbell further teaches ([0100], [0124] and [0125]) that such implanted crosslinked hydrogel particles can be used as a fiduciary marker, for tissue augmentation or as spacers (to separate tissues to reduce a dose of radioactivity received by one of the tissues). Thus, Campbell teaches instant claims 19 and 20.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 2011/0142936 A1).
Campbell first teaches ([0057] and [0134]) that buffers may be included in the hydrogels introduced into a body. Campbell also teaches in [0057] that the reaction rate of NHS (N-hydroxysulfosuccinimide)-based crosslinking reactions (such as the crosslinking reaction between SGA functional group and trilysine as discussed above) may be delayed by keeping the reactant solutions at lower pH (pH 4-7). Campbell teaches ([0069]) that increasing the number of crosslinks content will effect the mechanical properties of the hydrogel, with more crosslinks making the gel more brittle and stronger. Campbell teaches that these factors can also increase degradation time. Based on such teachings of Campbell, it would have been obvious to one skilled in the art to have the saline fluid in its implant system to contain an acidic buffer so as to achieve a lower pH (4-7) with a reasonable expectation of delaying further crosslinking reaction (between SGA group and trilysine) in the syringe and thus controlling the mechanical properties of the hydrogel to reduce the degradation time. The pH range of 4-7 overlaps with instant pH range 3-6.5, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Campbell renders obvious instant claim 13.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 2011/0142936 A1) in view of Adams et al (US 2018/0303945 A1) and Ramstack et al (US 6,495,164 B1).
As discussed above, Campbell teaches that its implant system of claim 1 further comprises an osmotic agent comprising a linear hydrophilic polymer (such as a linear PEG) as a means to improve the injectability of the crosslinked hydrogel particles through the catheter and/or needle of the syringe. Campbell does not teach instant linear hydrophilic polymers of claim 2. As evidenced by Adams et al ([0470] and Ramstack et al (abstract and col.1, lines 59-62, col.12, lines 56-64), it is well known in the art that polymers, such as polyvinylpyrrolidone, can be used as a viscosity enhancer in injectable suspensions of particles in order to make it easier to inject the suspension of particles (with low force on the syringe plunger). Since a linear PEG and polyvinylpyrrolidone are individually taught to be useful for the same purpose (i.e., useful for improving the injectability of the suspensions of particles), it would have been obvious to one skilled in the art to use a linear PEG and polyvinylpyrrolidone together in Campbell’s implant system with a reasonable expectation of making it even easier to inject Campbell’s suspension of crosslinked hydrogel particles with low force on the syringe plunger. MPEP 2144.06 states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, Campbell in view of Adams and Ramstack renders obvious instant claim 2.
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 1-13 and 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-14, 17 and 20 of copending Application No. 19/214,553 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 9, 10 and 20 of App.’553 teach a hydrogel particle suspension in which the radiopaque crosslinked hydrogel particles (formed in the method of claim 1 of App.’553) are suspended in a carrier fluid comprising a linear polymer having Mw of 5-20 kDa, such as polyoxazoline, polyvinylpyrrolidone or polyacrylamide, all of which are hydrophilic polymers. Claim 11 of App.’553 teaches that the hydrogel particle suspension is contained in a preloaded syringe. Claim 12 of App.’553 teaches that the preloaded syringe is packaged together with a needle (instant delivery device). Claim 13 of App.’553 teaches that the radiocontrast agent (used in forming the radiopaque crosslinked hydrogel particles of claim 1) comprises an iodinated organic compound, and Thus, claims of App.’553 render obvious instant claims 1-6 and 15-18.
With respect to instant claims 4, 11 and 12, it is the Examiner’s position that determining instant range for the amount of the linear hydrophilic polymers contained in the carrier fluid, instant range for the amount of the radiopaque crosslinked hydrogel particles based on the total weight of the suspension and instant range for the longest dimension of the radiopaque crosslinked hydrogel particles that would give the optimal performance in injecting the suspension of the radiopaque crosslinked hydrogel particles would be within the realm of one of ordinary skill in the art. Thus claims of App.’553 render obvious instant claims 4, 11 and 12.
With respect to instant claim 7, claim 17 of App.’553 teaches that the reactive multifunctional compound of claim 1 can be a multi-arm amino-terminated PEG. Thus, claims of App.’553 render obvious instant claim 7 (instant crosslinked polymer comprising a poly(allylene oxide) chain).
With respect to instant claim 8, claim 14 of App.’553 teaches that the multi-arm polymer of claim 1 comprises 3 or more polymer arms linked to a core region and that each of the polymer arms comprises a hydrophilic polymer segment. Thus, claims of App.’553 render obvious instant claim 8.
With respect to instant claim 9, although claims of App.’’553 do not explicitly teach that a portion of the polymer arms comprise a radiopaque-atom-containing moiety at the end, claim 13 of App.’553 teaches that the radiocontrast agent of claim 1 comprises an iodinated organic compound, and since the method of forming radiopaque crosslinked hydrogel particles as described in claims of App.’553 is the same as that of applicant, it is the Examiner’s position that the radiopaque-atom-moiety (of the radiopaque crosslinked hydrogel particles in claims of App.’553) would naturally be located at the end of the polymer arms as instantly recited in claim 9. Thus, claims of App.’553 render obvious instant claim 9.
With respect to instant claim 10, claim 1 of App.’553 teaches a crosslinked reaction product of a multi-arm polymer comprising a plurality of cyclic imide ester groups (instant electrophilic group) and a reactive multifunctional compound comprising a plurality of amino groups (instant nucleophilic groups). Thus, claims of App.’553 render obvious instant claim 10.
With respect to instant claim 13, claim 8 of App.’553 teaches that the carrier fluid has a pH of 3.5-6.5 (which implies the presence of an acidic buffer). Thus, claims of App.’553 render obvious instant claim 13.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
February 21, 2026