-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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 27, 2026 has been entered.
Priority
This application is a 371 of PCT/USl7/13256 filed on 01/12/2017, which claims benefit
in provisional application 62/411,391 filed on 10/21/2016, and provisional application
62/277,828 filed on 01/12/2016.
Claim Status
Claims 5-8, 30, 64, 65, 69, 72, 73, 77-81 are pending. Claims 5 and 69 were amended. Claims 1-4, 9-29, 31-63, 66-68, 70, 71, and 74-78 were cancelled. Claims 72 and 73 remain withdrawn. Claims 5-8, 30, 64, 65, 69, 77-81 are examined on the merits.
Withdrawn Claim Rejections - 35 USC § 112
Rejection of claim 69 is withdrawn because the rejection was obviated with claim amendments.
New Claim Rejections - 35 USC § 112
Necessitated by Amendment
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 5 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.
The claim is directed to a product, a device, but recites that the device is applied to the interposition of two objects when the layer of the adhesive composition of ii is in a pliable state, implying method steps for using the device. Per MPEP 2173.05(p), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. The claim is indefinite because it mixes statutory class product and a method of using the product.
See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C.
102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a
new ground of rejection if the prior art relied upon, and the rationale supporting the rejection,
would be the same under either status.
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.
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 CPR 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.
Claims 5-8, 30, 64, 65, 69, and 78-81 are rejected under 35 U.S.C. 103 as being
unpatentable over Garigapati (US 2012/0288446 Al Published November 15, 2012 - of record
in IDS dated 08/09/2023).
The claims encompass a device for reinforcing a structure, wherein the device comprises components as claimed.
The teachings of Garigapati are related to compositions and methods of their use to
adhere a variety of materials together. The compositions include at least multivalent metal
compound, an effective amount of a compound that is structurally similar to phosphoserine, and
can be mixed with an aqueous solution. The compositions provide adhesive and cohesive
strength in both wet and dry environments which exhibit bond strength upon curing (Abstract).
One embodiment comprises adhering an implant to bone comprising the step of applying
a composition comprising and effective amount of a multivalent metal compound and a
phosphoserine type of compound to at least one surf ace of the implant, placing the implant into
the bone structure, and allowing the composition to harden in situ (paragraph 0017). One
particular useful use of the composition is as a bone restorative composition. The term "bone
restorative composition" includes compositions that are useful to restore and/or repair bone such
as implants (paragraph 0040). Phosphoserine type compounds are described in paragraphs 0023-
0031. The mean particle size of the multivalent metal compound should be below 1000 microns
(paragraph 0048). The additives that affect bone healing rate driven by new bone ingrowth can
be influenced by the level of porosity of the cured cement. The rate can be manipulated by the
number of pores and size of the pores created within the cured cement. Achieving such porosity
up to 60% v/v was demonstrated by controlling the ratio of composition ingredients. The
porosity that develops during the curing process can be controlled by the amount of pore forming
agent added, the level of compound structurally similar to phosphoserine added, the level of
aqueous solution used, and/or the level of other agents added to the composition. Increasing the
porosity reduces the material intrinsic strength; however, a balance of porosity vs. strength is
critical for achieving the clinical application. Additives that increase the intrinsic material
strength can be incorporated to offset the loss of strength by creating porosity (paragraph 0053).
The additives that increase the intrinsic material properties, such as strength, toughness, and
flexibility, of the cured cement include silk, keratin, and collagen. These material additives
improve the intrinsic strength or toughness by preventing crack propagation in the cement when
under load. These material additives can be supplied as granules. An important aspect of these
fibers is the size. The fiber size can be defined by the aspect ratio (length:diameter), where the
preferred aspect ratio ranges from 2: 1 to 50: 1. The overall length of the fiber can be up to 5 mm
or up to 2 mm (paragraph 0054). In one embodiment, the composition has a thin, free flowing,
and pain table consistency. These embodiments of the composition are useful for coating on the
surf ace of an implant prior to insertion into a bone structure. The application of this embodiment
on an implant prior to insertion into a bone structure prevents micro motions of the implant
shortly after the implant is put in position in the patient and minimizes the implant failure
(paragraph 0064).
Regarding claims 5-7, it would have been prima facie obvious to a person of ordinary
skill in the art before the effective filing date of the claimed invention to have formed a device
comprising a solidified form of an adhesive composition and a layer of the adhesive composition
as a coating onto a surf ace of the device, with a reasonable expectation of success because
Garigapati teaches a composition comprising a multivalent metal salt, a phosphoserine type
compound, and water wherein the composition is suitable for making an implant for restoring a
bone and the composition is suitable for making a coating composition having a free flowing
consistency and further teaches coating the composition onto a surface of an implant prior to
insertion into a bone structure. It would have been obvious to have used the composition to make
an implant and then coated the implant with the composition having a free flowing consistency
prior to insertion into bone, with reasonable expectation of success because Garigapati teaches
that the composition is suitable for making an implant and that the composition is also suitable
for coating an implant prior to insertion into the bone.
It would have been obvious to have formed the implant by combining water, a
multivalent metal salt having a particle size of below 1000 microns, a phosphoserine type
compound, and silk fibers, to form a composition and allowing the composition to cure, wherein
the cured composition is porous, with a reasonable expectation of success because Garigapati
teaches combining a multivalent metal salt with a phosphoserine type compound in the presence
of water to form a composition, in which the components react and form into putty, and over
time harden into a cement (paragraphs 0032- 0036). It would have been obvious to have shaped
the composition into an implant, with a reasonable expectation of success because Garigapti
teaches that the composition in the putty state can be shaped or sculpted into shapes used to fill a
void in a bone in a manner similar to putty (paragraph 0034). It would have been obvious to have
added alpha- and beta-TCP in granular form having an average pore diameter size in the range of
20-500 microns, into the composition in order to make the implant porous, with a reasonable
expectation of success because Garigapati teaches the bone healing rate driven by new bone
ingrowth can be influenced by the level of porosity of the cured cement and teaches a porosity of
up to 60% (paragraph 0053), and teaches adding alpha- and beta-TCP in granular form having an
average pore diameter size in the range of 20-500 microns, into the composition in order to make
the implant porous. The granules do not dissolve during the curing phase, but interact as a solid
particle with other components of the composition. The porosity and pore size listed here have an
impact on the resorption characteristics of the resultant compositions and to allow for bony
ingrowth and healing (paragraph 0051). In view of this teaching, it is apparent that TCP is added
in order to introduce porosity into the cured material. It would have been obvious to have added
silk fibers having an aspect ratio in the range of 2:1 to 50:1 and fiber length of up to 5 mm or up
to 2 mm into the composition in order to reinforce and increase the strength of the cured cement,
with a reasonable expectation of success because Garigapati teaches increasing the strength of
the cured cement by adding silk fibers wherein the fibers have an aspect ratio of 2: 1 to 50: 1 and a length of up to 5 mm or up to 2 mm. It would have been obvious to have selected phosphoserine type compound from compounds of formula
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79
175
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wherein R is
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61
100
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with a reasonable expectation of success because Garigapati teaches this compound as a suitable
phosphoserine type compound for making the implant (paragraph 0025).
Garigapati's product is an implant comprising a solidified adhesive comprising the
phosphoserine type compound as depicted above, a multivalent metal salt having particle size of
less than 1000 microns, silk fibers having an aspect ratio in the range of 2:1 to 50:1 and fiber
length of up to 5 mm, and alpha-TCP and beta-TCP having an average pore diameter size in the
range of 20-500 microns, and wherein the implant is coated with a free flowing composition
comprising water, the phosphoserine type compound as depicted above, and a multivalent metal
salt having particle size of less than 1000 microns. The solidified adhesive would have
comprised a three-dimensional interconnected silk fiber network impregnated with the mixture
of the multivalent metal salt, the phosphoserine type compound, and alpha- and beta-TCP, which
is the adhesive composition.
The claimed range of mean pore diameters of 10-500 microns is obvious because it
overlaps with 20-500 microns.
The claimed particle size range of multivalent metal salt of 0.005-0.250 mm is obvious
because it overlaps with a particle size range of less than 1000 microns, equivalent to less than 1
mm.
Compound of formula (I) is obvious over the compound depicted above, when Rla and
R2a are both hydrogen, L is 0, x is 1, y is 1, R2 is NR4aR4b, R4a and R4b are both hydrogen,
and R3 is an optionally substituted aryl.
The intended use of the device in claim 5 is for reinforcing a structure, the intended use
of the device in claim 6 is for joining separated objects, and intended use of the device in claim 7
is for filling space to connect and immobilize a structure. The device described by Garigapati
could have been used for the intended uses of claims 5, 6, and 7 because the device is structurally
identical to the claimed device and it would have been reasonable expect the device of
Garigapati to have the same properties as claimed device because a composition and its
properties are inseparable.
Claim 5 was amended to require a “wherein” clause that states the device is applied at the interposition of two objects when the layer of the adhesive composition of (ii) is in a pliable working state. This limitation describes use of the claimed device and the state of the claimed device during use, which does not structurally affect the scope of the claimed device. Garigapati’s device could have been applied at the interposition of two objects when the layer of the adhesive composition of (ii) is in a pliable working state. Paragraph 0064 in Garigapati 2012 describes coating the surface of the implant prior to insertion into a bone structure. The coating is described as having a thin, free flowing, and paintable consistency.
Regarding claim 8, the intended use of the implant is to fill a bone void, and it would
have been obvious to have shaped the implant according to the geometry or anatomy of the site
to be treated with the implant.
Regarding claim 30, the phosphoserine type compound depicted above is encompassed
by the compound of Formula I as described above.
Regarding claims 64 and 65, Garigapati teaches that the coating composition comprises
water.
Regarding claim 69, it would have been obvious to have added an additive to the
composition of the coating or the implant, with a reasonable expectation of success because Garigapati teaches that the compositions comprise further additives such as those described in paragraphs 0055 and 0056.
Regarding claims 78 and 79, silk fiber is biocompatible and non-bioresorbable, as
evidenced by applicant's specification paragraph bridging pages 4 and 5.
Regarding claim 80, a fiber having an aspect ratio in the range of 2: 1 to 50: 1 and a length of up to 5 mm renders the claimed mean fiber diameter obvious because it would have a range of mean fiber diameters that overlaps with the claimed range of fiber diameters. A fiber having a length of 5 mm would have had a diameter in the range of 2.5 mm to 0.1 mm, which is
equivalent to a range of 2500 microns to 100 microns. A fiber having a length of 2 mm would
have had a diameter in the range of 1 mm to 0.04 mm, which is equivalent to a range of 1000
microns to 40 microns.
Regarding claim 81, it would have been obvious to have formed the implant having a
porosity of up to 60%, with a reasonable expectation of success because Garigapati teaches the
range of up to 60% as suitable. The claimed porosity range is obvious because it encompasses
the range of up to 60%.
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over Garigapati 2012 as
applied to claims 5-8, 30, 64, 65, 69, and 78-81 above, and further in view of Garigapati
("Garigapati 2011" WO 2011/143226 Al Published November 17, 2011 - of record in IDS
dated 02/20/2024).
Claim 77 requires the device of claim 6 and further defines the three dimensional fiber
network.
The teachings of Garigapati 2012 are relied upon as summarized above. Garigapati 2012
does not teach the limitations of claim 77.
The teachings of Garigapati 2011 are related to a non-covalently bonded interpenetrating
network that comprises a reactive mixture of a small amino acid phosphate species, a multivalent
metal compound, and a polymeric material that contains functional groups that contain
electronegative atoms as the bonding sites of the polymer surfaces to the available metal ions, in
an aqueous environment. More specifically, the teachings relate to a non-covalently bonded
interpenetrating network comprising a reactive mixture of an amino acid phosphate species,
tetracalcium phosphate, and a polymeric material comprising electronegative atoms as the
bonding sites of the polymer surfaces to the available metal ions in an aqueous environment
(paragraph 0007).
It would have been prima facie obvious to a person of ordinary skill in the art at the time
of the claimed invention to have modified Garigapati 2012's composition by adding a mesh
made from a polymeric material in order to form a material with high intrinsic strength, with a
reasonable expectation of success because Garigapati 2011 teaches adding polymer materials in
the form of a mesh (paragraph 0015) to compositions that contain small molecule multivalent
metal compounds such as calcium phosphate, which react with organophosphate compounds to
form cements in the presence of water and when these cements are in the presence of polymeric
materials, the multivalent metal compounds and the organophosphate compounds form a
complex, interpenetrating network having high intrinsic strength. The resultant composition
would have comprised a mesh made from a polymeric material, which meets the limitation that
requires a three dimensional fiber network material in the form of a mesh.
Response to Arguments
Applicant's arguments submitted in the remarks dated July 27, 2026, were fully
considered but are not persuasive for the following reasons.
Argument that Garigapati 2012 does not teach all of the claimed limitations is not found persuasive for reasons of record. The newly added limitation to claim 5 does not affect the scope of the claimed device because the limitation describes the using the claimed device and the state of the claimed device during use. The claims are drawn to a product and not to a method of use. The newly added limitation does not affect the scope of the claimed device. Garigapati’s device could have been applied at the interposition of two objects when the layer of the adhesive composition of (ii) is in a pliable working state. Paragraph 0064 in Garigapati 2012 describes coating the surface of the implant prior to insertion into a bone structure. The coating is described as having a thin, free flowing, and paintable consistency.
Rejection of claim 77 is maintained because Garigapati 2012 is not deficient for reasons described above.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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