Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
Status of the Claims
Receipt of Applicants’ Response, filed 13 April 2026, is acknowledged. Claims 1 and 14 are amended therein. Upon finalization and entry of the Restriction/Election Requirement (see below), claims 1 – 13, 18, and 19 will be available for substantive examination.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 28 June 2023, 4 February 2025, 20 June 2025, and 4 March 2026, which are now of record in the file.
Response to Restriction Requirement
Applicant's election with traverse of the claims of Group I, claims 1 – 13, 18, and 19, in the Response 13 April 2026, is acknowledged. The traversal is on the grounds that the Restriction Requirement was based on the disclosures of Liu CN ‘336 to break unity of invention, and Applicants argue that “reliance on Liu to deny unity is misplaced, and the common alloy features in the orthopedic implant context remain special technical features linking the product and method claims.” Although not taking issue with Applicants’ comments concerning the Liu CN ‘336 reference, it is the Examiner’s position that, without regard to Liu CN ‘336, the obviousness rejections set forth below, which rejections do not rely on Liu CN ‘336, are sufficient to establish that unity of invention cannot be maintained. Consequently, Applicants’ arguments are unpersuasive, and the Restriction Requirement is hereby made FINAL.
Consequently, claims 14 – 17 and 20 are withdrawn from consideration pursuant to pursuant to 37 CFR §1.142(b).
claims 1 – 13, 18, and 19 are under consideration.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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.
Claims 1 – 9, 11, 13, 18, and 19 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2017/0000925 A1 to Imwinkelried, T., et al., published 5 January 2017 (“Imwinkelried ‘925”), in view of US 2017/0119922 A1 to Koo, J.-K., et al., published 4 May 2017 (“Koo ‘922”).
The Invention As Claimed
Applicants claim an implant comprising a biodegradable magnesium alloy consisting of magnesium, Ca in the range of 0.3 - 2 % wgt, Zn in the range of 0.5 - 6 % wgt, Fe in the range of 50 - 100 ppm, and Zr in the range of 100 - 900 ppm, wherein total impurities from Fe and Zr are in the range of 400 - 1000 ppm, or Ca in the range of 0.4 – 0.7% wgt, Zn in the range of 0.5 – 0.7% wgt, Fe in the range of 50 - 100 ppm, and Zr in the range of 100 - 900 ppm, wherein total impurities from Fe and Zr are in the range of 400 - 900 ppm, and wherein the magnesium alloy has an average grain size of 40 µm or less, or 20 µm or less, wherein total impurities from Mn, Cu, Ni, Al, Pb, Cd, and rare earth elements are less than 800 ppm, wherein the ratio of weight percentages of Ca:(Zn-0.2) is more than 0.1, wherein the ratio of weight percentages of Fe to Zr is in the range of 1:1 to 1:20, wherein the magnesium alloy comprises total impurities from Mn, Cu, Ni, Al, Pb, Cd, and rare earth elements that are below 600 ppm, or below 400 ppm, wherein the magnesium alloy and/or the implant does not contain rare earth metals, wherein the implant is in the form of a composite with one or more of biodegradable polymer(s), glass fiber(s), bioglass, and/or ceramic material(s), wherein the ceramic material comprises hydroxyapatite, tricalcium phosphate, calcium carbonate, or calcium sulphate, wherein the implant is an orthopedic implant, wherein the implant further comprises a screw, a plate, a pin, a tack, a nail, a suture anchor, a tack, a bolt, a clamp, a clip, a staple, a mesh, a scaffold, a cage, a Kirschner wire, or a stent, and wherein the orthopedic implant is a screw, an intramedullary nail, a pin, or a Kirschner wire.
The Teachings of the Cited Art
Imwinkelried ‘925 discloses an implant having a three-dimensional structure based on a MgZnCa alloy comprising from 3.0 to 6% Zn, and a calcium content ranging from 0.0005 to 1.0% wgt, with less than 0.001 wt. % of one or more other elements, with the remainder being Mg (see Abstract), wherein the MgZnCa alloy contains less than 5 ppm of total other elements (see ¶[0011]), wherein the alloy has a grain size of less than 10 µm (see ¶[0019]), wherein the implant is an orthopedic implant comprising one or more of a nail, a screw, a staple, a plate, a rod, a tack, a bolt, a bolt to lock and IM nail, an anchor, a dowel, a plug, a peg, a sleeve, a mesh, a transconnector, a nut a shaped body, a spinal cage, a wire, a K-wire, a woven structure, a clamp, a splint, scaffold, or a foam and honeycomb structure (see ¶[0020]), wherein, in order to achieve the necessary purity level of the MgZnCa alloy, the acceptable amount of other elements within the alloy is limited (see ¶[0036]), wherein the alloy contains less than 5 ppm content of other elements such as Fe, Cu, Ni, Co, Si, Mn, Al, Zr, and P (see ¶[0040]), wherein impurity levels are maintained at low levels to control the corrosion rate of the implant in vivo so that the implant possesses sufficient strength over a period of time to allow healing and so not to interfere with the healing process (see ¶[0044]), wherein the rare earth content in the alloy is less than 0.05 ppm (see ¶[0045]), wherein the implants can vary in size, shape, and other physical and chemical characteristics depending upon the context of use (see ¶[0049]), and wherein the alloys are used in biodegradable bone fixation implants (see ¶[0058]). The reference does not expressly disclose an implant in the form of a composite with one or more biodegradable polymers, glass fibers, bioglass and/or ceramic materials, such as hydroxyapatite, tricalcium phosphate, calcium carbonate, or calcium sulphate. The teachings of Koo ‘922 remedy those deficiencies.
Koo ‘922 discloses a magnesium alloy having controlled corrosion resistance properties, which comprises magnesium (Mg) and an alloying element (see Abstract), wherein the alloying element can be calcium, or zinc, among others (see ¶[0019]), wherein the content of iron in the alloy is preferably 500 ppm or less because, when iron (Fe) is present in the alloy, it significantly increases the rate of corrosion of the magnesium (see ¶[0022]), wherein the alloy comprises greater than zero but less than 23% wgt Ca, and greater than zero but less than 10% wgt of Zn (see ¶[0023]), and wherein the surface of the magnesium alloy is coated with a corrosion-resistant ceramic product, such as a calcium phosphate, and may be further coated with a polymer (see ¶[0030]), such as poly(L-lactide), poly(glycolide), poly(DL-lactide), poly(dioxanone), poly(DL-lactide-co-L-lactide ), poly(DL-lactide co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(L-lactide-co-glycolide), poly(Ɛ-caprolactone), and combinations thereof (see ¶[0031]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare implants having a three-dimensional structure based on a MgZnCa alloy comprising from 3.0 to 6% wgt Zn and from 0.0005 to 1.0% wgt Ca, with less than 0.001 wt. % of one or more other elements, with the remainder being Mg, wherein the MgZnCa alloy contains less than 5 ppm of the total of other elements, wherein the alloy has a grain size of less than 10 µm, wherein the implant is an orthopedic implant comprising one or more of a nail, a screw, a staple, a plate, a rod, a tack, a bolt, a bolt to lock and IM nail, an anchor, a dowel, a plug, a peg, a sleeve, a mesh, a transconnector, a nut a shaped body, a spinal cage, a wire, a K-wire, a woven structure, a clamp, a splint, scaffold, or a foam and honeycomb structure, wherein, in order to achieve the necessary purity level of the MgZnCa alloy, the acceptable amount of other elements within the alloy is limited, wherein the alloy contains less than 5 ppm content of other elements such as Fe, Cu, Ni, Co, Si, Mn, Al, Zr, and P, wherein the rare earth content in the alloy is less than 0.05 ppm, wherein the implants can vary in size, shape, and other physical and chemical characteristics depending upon the context of use, and wherein the alloys are used in biodegradable bone fixation implants, as taught by Imwinkelried ‘925, wherein the surface of the magnesium alloy is coated with a corrosion-resistant ceramic product, such as a calcium phosphate, and may be further coated with a biodegradable polymer, such as poly(L-lactide), poly(glycolide), poly(DL-lactide), poly(dioxanone), poly(DL-lactide-co-L-lactide ), poly(DL-lactide co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(L-lactide-co-glycolide), poly(Ɛ-caprolactone), and combinations thereof (see ¶[0031]), as taught by Koo ‘922. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Koo ‘922 to the effect that applying coatings of ceramics such as calcium phosphates, and biodegradable polymers provides additional mechanisms to control the rate at which the alloy-based implants degrade in vivo (see ¶¶[0029] – [0032]).
With respect to claims 1 and 18, which claims recite quantitative limitations directed to the relative mass contents of elements within the alloy, the Examiner notes that the relative mass loadings disclosed in the cited references is not exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches a range of content of these components that significantly overlap with the recited limitations and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
Further with respect to the content of the minor/trace elements (Fe and Zr), the Examiner notes that the relevant claims recite lower limits for these elements, both individually and in combination (see claims 1 and 18). In comparison, the cited art discloses a maximum content of all contaminant elements at 5 ppm. In this regard, the Examiner further notes that one of ordinary skill in the art would recognize that alloys with contaminant content less than the minimum recited in claims 1 and 18 would possess mechanical and biochemical properties substantially the same as alloys with even lower levels of contaminants. As evidenced by Applicants’ specification (see ¶[0047]), the alloys of the claimed invention tolerate a higher content of recognized contaminants, thus providing the benefit of not needing extensive purification process to function properly in vivo. In light of this, it is the Examiner’s position that the recited lower limits are, in effect, a function of the method of making the alloys, and that critical properties of implants using the alloys would be the same regardless of how the alloys were prepared, particularly when the maximum content of the contaminants is so low.
With respect to claims 4 and 5, which claims recite limitations directed to ratios of weight percentages between pairs of components, the Examiner notes that the cited references do not explicitly disclose such ratios. However, it is the Examiner’s position that the references disclose weight percentages that would sufficiently overlap with the claimed ranges so as to yield ratios reading on the limitations at issue. For example, with respect to claim 4, directed to Ca and Zn, Imwinkelried ‘925 discloses a Ca content ranging from 0.0005 to 1.0% wgt, and a Zn content ranging from 3.0 to 6% wgt. The limitation in claim 4 is recited as the ratio between the Ca content and the Zn content, corrected by 0.2% wgt. Thus, using one extreme comprising the most calcium (1.0%) and the least zinc (3.0 – 0.2), would yield a ratio of 1:2.8, which ratio would convert to 0.4, thus reading on the limitation in question.
With respect to claim 5, which claim recites a limitation directed to a ratio between the relative weight percentages of Fe and Zr being in the range of 1:1 to 1:20, the Examiner notes that Koo ‘922, at ¶¶[0020] – [0022], discloses an expression for the mole fractions of Mg, Ca, and minor/contaminants, such as Fe and Zr, among others, and further discloses that the content of iron in the alloys is preferably 500 ppm, or less. In addition, the reference discloses that the Fe content results in a significant increase in the rate of corrosion of magnesium. Consequently, based on this disclosure, it is the Examiner’s position that the Fe content can be controlled in order to optimize the rate of decomposition of magnesium, effectively adjusting as a result-effective variable, the exercise of which would be well within the capability of one of ordinary skill in the relevant art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
Claim 7 recites a limitation directed to the alloy and/or the implant not containing any rare earth elements. In this regard, Imwinkelried ‘925, at ¶[0045], discloses rare earth content of the Mg alloys at “less than 0.05 ppm.” It is the Examiner’s position that such a low level of content is effectively no content or, in the alternative, the teaching can be reasonably read as from 0.0 to 0.005 ppm, thus reading on the limitation.
Claim 19 recites a limitation directed to the ceramic component of the implant being hydroxyapatite or tricalcium phosphate. In this regard, Koo explicitly discloses that the ceramic component can be a calcium phosphate, but does not specific calcium phosphates such as hydroxyapatite or tricalcium phosphate. However, it is the Examiner’s position that it would have been prim facie obvious to use any calcium phosphate, particularly in light of the art-recognized osteoinductive and osteoconductive properties of calcium phosphates.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 9, 11, 13, 18, and 19 would have been obvious within the meaning of 35 USC § 103.
Claims 10 and 12 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Imwinkelried ‘925, in view of Koo ‘922, as applied in the above rejection of claims 1 – 9, 11, 13, 18, and 19, and further in view of US 2022/0296789 A1 to Lähteenkorva, K. and T. Numminen, claiming priority to 21 August 2019 (“Lähteenkorva ‘789”).
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicants claim a fully biodegradable implant comprising a biodegradable magnesium alloy as a self-supporting core embedded in a bioresorbable glass fiber reinforced polymer matrix, and wherein the implant is an elongated bone fixation device having a length:diameter ratio of 2, or more.
The Teachings of the Cited Art
The teachings of Imwinkelried ‘925 and Koo ‘922 are relied upon as set forth in the above rejection of claims 1 – 9 , 11, 13, 18, and 19. The references do not disclose implants comprising a biodegradable magnesium alloy as a self-supporting core embedded in a bioresorbable glass fiber reinforced polymer matrix. The teachings of Lähteenkorva ‘789 remedy that deficiency.
Lähteenkorva ‘789 discloses a biodegradable composite material comprising a bioresorbable magnesium alloy embedded in bioresorbable glass fiber reinforced polymer matrix, and a bioresorbable implant comprising the composite material (see Abstract), wherein, by combining reinforcing bioresorbable magnesium or magnesium alloys with bioresorbable glass fiber reinforced polymer matrix, i.e. forming a hybrid composite, the major drawbacks in mechanical properties of both materials can be overcome and the corrosion rate of the magnesium can be controlled by a bioresorbable glass fiber reinforced polymer matrix (see ¶[0006]), wherein bioresorbable implants based upon magnesium and magnesium alloys provide the mechanical benefits of a metal combined with the degradable and biological advantages displayed by polymers and synthetic biomaterials (see ¶[0050]), wherein the composite materials are useful for structural fixation for load-bearing purposes, exhibiting improved mechanical properties as a result of their hybrid composite structure (see ¶[0056]), wherein a way to modify the strength and stability of implants is to use magnesium alloys in different forms, such as a rod, a plate, a core, a tube, or fibers, or other physical forms or shapes that bring a reinforcing effect to the hybrid composite embedded in a bioresorbable, fiber-reinforced polymer matrix, wherein the fibers comprise bioresorbable glass (see ¶[0060]), wherein the bioresorbable glass fibers are provided in continuous form and/or in discontinuous form (see ¶[0081]), wherein the hybrid composite material can be used in the preparation or manufacture of a medical device for an implant, the devices having high strength, modulus just above cortical bone, and retention of those properties in vivo being useful for manufacturing of, e.g., bone fracture fixation devices (see ¶[0092]), wherein the hybrid composite materials are particularly suitable for large or massive implants, and the like, medical devices, such as plates, nails or screws, or to any other implants and medical devices exposed to compression, tension and/or torsion forces, the nails or screws having a length of the least 10 cm, at least 15 cm or at least 20 cm, the nails or screws providing desired mechanical properties to such products, such as bending strength, torsion strength, impact strength, compressive strength, and tensile strength (see ¶[0096]), and wherein the most preferred alloying elements for the magnesium alloy include zinc and calcium (see ¶[0129]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare implants having a three-dimensional structure based on a MgZnCa alloy comprising from 3.0 to 6% wgt Zn and from 0.0005 to 1.0% wgt Ca, with less than 0.001 wt. % of one or more other elements, according to the teachings of Imwinkelried ‘925 and Koo ‘922, wherein the bioresorbable magnesium alloy is embedded in a bioresorbable glass fiber-reinforced polymer matrix, and is used in a bioresorbable implant, wherein a way to modify the strength and stability of implants is to use magnesium alloys in different forms, such as a rod, a plate, a core, a tube, or fibers, or other physical forms or shapes that bring a reinforcing effect to the hybrid composite embedded in a bioresorbable, fiber-reinforced polymer matrix, wherein the fibers comprise bioresorbable glass, provided in either continuous form or in discontinuous form, wherein the hybrid composite material can be used in the preparation or manufacture of a medical device for an implant, the devices having high strength, modulus just above cortical bone, and retention of those properties in vivo being useful for manufacturing of, e.g., bone fracture fixation devices, as taught by Lähteenkorva ‘789. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing by the express teachings of Lähteenkorva ‘789 to the effect that, by combining bioresorbable magnesium alloys with a bioresorbable glass fiber reinforced polymer matrix, i.e. forming a hybrid composite, the major drawbacks in mechanical properties of both materials can be overcome and the corrosion rate of the magnesium can be controlled by a bioresorbable glass fiber reinforced polymer matrix (see ¶[0006]).
With respect to claim 12, which claim recites a limitation directed to the implant being a bone fixation device having a length:diameter ratio of 2 or more, the Examiner notes that the cited reference does not expressly teach quantitative values of the aspect ratios of the disclosed implants. However, the reference, at ¶[0096], that the hybrid composite materials are particularly suitable for large or massive implants, and the like, as well as medical devices, such as nails or screws having lengths of at least 20 cm, the nails or screws providing desired mechanical properties to such products, such as bending strength, torsion strength, impact strength, compressive strength, and tensile strength. Although a specific aspect ratio is not provided for the nails or screws, a 20-cm length would require a diameter of 10 cm, or less, to come within the scope of the limitation, that would result in a nail or screw that be 4 inches in width. Given that these implants are for treating human patients, the widths would have to be considerably smaller than 4 inches, resulting in a length:diameter ratio that would necessarily be greater than 2.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 10 and 12 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 - 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4, 6, 7, 10, and 11 - 13 of U.S. Patent No. 11,969,519 (“the ‘519 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the enumerated claims of the ‘519 patent disclose an orthopedic implant comprising a biodegradable magnesium alloy that comprises Mg, and Ca in the range of 0.550 - 0.700% wgt, Zn in the range of 0.400 - 0.700% wgt, and Fe at 50 ppm, or less, wherein the biodegradable magnesium alloy comprises Fe at 20 ppm, or less, wherein the biodegradable magnesium alloy comprises total impurities, including Fe, in the range of 100 - 1000 ppm, wherein the biodegradable magnesium alloy has an average grain size of 40 µm, or less, wherein the ratio of weight percentages Ca:(Zn-0.2) is 1.1, or more, wherein the magnesium alloy comprises total impurities of Al, Cu, Fe, Mn, Si, Y, Zr, Cd, Pb, Ni, Co, V, Li, Sb, and rare earth elements of 1000 ppm, or less, wherein the orthopedic implant is in the form of a composite with one or more biodegradable polymer(s), glass fiber(s), bioglass, and/or ceramic material(s), wherein the implant is a fully biodegradable implant comprising the biodegradable magnesium alloy as a self-supporting core embedded in a bioresorbable glass fiber reinforced polymer matrix.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned ‘519 patent, discussed above, may form the basis for a rejection of the noted claims pursuant to 35 U.S.C. §§ 102 or 103 if the commonly assigned case qualifies as prior art pursuant to 35 U.S.C. § 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the Applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the Applicant or patent owner can provide a statement under 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. §§ 102 or 103 based upon the commonly assigned case. Alternatively, applicant may act to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
Prosecution Insights