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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed April 13, 2026 in reply to the Non-final Office Action mailed January 13, 2026. Claims 12-20, 23-25, and 28-56 have been canceled. Claims 2-5, 8-10, 27, and 59-61 have been withdrawn. Claims 1, 6, 7, 11, 21, 22, 26, 57, and 58 are under examination.
Claim Rejections - 35 USC § 103 (I and II)
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 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.
I. Claims 1, 6, 7, 11, 21, 22, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (Langmuir. 2011; 27: 11090-11097).
I. Applicant Claims
Applicant claims a particle comprising gold nanoparticles and sodium cholate; wherein the sodium cholate is present in the amount of about 70-99 wt%.
I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Qiao et al. disclose a particle consisting essentially of a core of gold nanoparticles, and sodium cholate as a capping agent; wherein the particle is formed by reacting e.g. 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate.
I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Qiao et al. do not explicitly disclose that the sodium cholate is present in the amount of about 70-99 wt%. This deficiency is cured by the teachings of Qiao et al.
I. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Qiao et al., outlined supra, to devise Applicant’s presently claimed particle.
Qiao et al. disclose a particle consisting essentially of a core of gold nanoparticles, and sodium cholate as a capping agent; wherein the particle is formed by reacting e.g. 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate. Since Qiao et al. disclose that the reaction proceeds to completion, and that a higher amount of sodium cholate means a higher capping of the core of gold nanoparticles by sodium cholate, one of ordinary skill in the art would thus understand that the resulting particle, produced from a 3 mL solution comprising 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate in which the reaction proceeds to completion, will thus contain about 5.91 mg of gold and 645 mg of sodium cholate. Hence, the total particle weight is about 651 mg, and sodium cholate is thus present in the amount of about 99 wt% of the particle.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
II. Claims 57 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (Langmuir. 2011; 27: 11090-11097), Hainfeld (U.S. Patent Application Pub. No. 2008/0089836), and Aziz et al. (U.S. Patent Application Pub No. 2017/0198216).
II. Applicant Claims
Applicant claims a microparticle comprising gold nanoparticles and sodium cholate; wherein the sodium cholate is present in the amount of about 70-99 wt%; and wherein the microparticle has a hexagonal prism shape with a diagonal length of 2.5-10 µm and a height of 2.5-6.5 µm.
II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Qiao et al. disclose a particle consisting essentially of a core of gold nanoparticles, and sodium cholate (i.e. a surfactant with a carboxylate functional group and a steroid moiety) as a capping agent; wherein the particle is formed by reacting e.g. 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate.
Hainfeld discloses a microparticle comprising gold nanoparticles coated with multiple layers of surface binding molecules and amphiphatic molecules; wherein the surface binding molecule has e.g. a hydroxyl or carboxylate moiety and e.g. a steroid moiety; wherein the amphiphatic molecule can be e.g. sodium cholate; and wherein the microparticle is about 1-100 µm in size, or e.g. about 5 µm in size (see e.g. abstract; paragraphs 0014, 0016, 0017, 0023, 0038, 0051, 0082, 0160, 0163, 0164, 0242, 0244, 0245, 0272, 0301, 0303) .
Aziz et al. disclose a microparticle comprising a gold nanoparticle core covered with a capping agent, which capping agent is a surfactant with a carboxylate functional group; wherein the particle can have a hexagonal prism shape (see e.g. abstract; paragraphs 0014, 0071, 0080, 0094, 0111, 0112; example 7)
II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Qiao et al. do not explicitly disclose that the sodium cholate is present in the amount of about 70-99 wt%, and that the microparticle has a hexagonal prism shape with a diagonal length of 2.5-10 µm and a height of 2.5-6.5 µm. These deficiencies are cured by the teachings of Qiao et al., Hainfeld, and Aziz et al.
II. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Qiao et al., Hainfeld, and Aziz et al., outlined supra, to devise Applicant’s presently claimed particle.
Qiao et al. disclose a particle consisting essentially of a core of gold nanoparticles, and sodium cholate as a capping agent; wherein the particle is formed by reacting e.g. 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate. Since Qiao et al. disclose that the reaction proceeds to completion, and that a higher amount of sodium cholate means a higher capping of the core of gold nanoparticles by sodium cholate, one of ordinary skill in the art would thus understand that the resulting particle, produced from a 3 mL solution comprising 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate in which the reaction proceeds to completion, will thus contain about 5.91 mg of gold and 645 mg of sodium cholate. Hence, the total particle weight is about 651 mg, and sodium cholate is thus present in the amount of about 99 wt% of the particle.
Moreover, since Hainfeld discloses that a gold nanoparticle can be coated with multiple layers of e.g. sodium cholate, and that the final product can be a microparticle about 1-100 µm in size, or e.g. about 5 µm in size, depending on e.g. factors that can be optimized in the reaction of chloroauric acid with the capping agent; and since Aziz et al. disclose that a microparticle comprising a gold nanoparticle core covered with a capping agent, which capping agent is a surfactant with a carboxylate functional group, can have a hexagonal prism shape, depending on e.g. the pH and other factors that can be optimized in the reaction of chloroauric acid with the capping agent; one of ordinary skill in the art would thus understand that the Qiao et al. method can be optimized as desired to achieve a microparticle with a hexagonal prism shape with a diagonal length of 2.5-10 µm and a height of 2.5-6.5 µm.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Potential Double Patenting Rejection
It is noted that co-pending U.S. Application No. 18/551,809 is directed to claims very similar to the present claims. However, it would appear that the claims of U.S. Patent Application No. 18/551,809 are directed to a composite particle comprising the compound with the steroid core structure and transition metal ions, which is substantially free of transition metal nanoparticles. The present claims are directed to a composite particle comprising the compound with the steroid core structure and transition metal nanoparticles. Hence, no double patenting rejection is being made at this time. However, depending on how claims get amended over the course of prosecution, a double patenting rejection may become necessary in the future.
Response to Arguments
Applicant's arguments filed April 13, 2026 have been fully considered but they are not found persuasive.
i) Applicant contends that “rather than providing affirmative evidence that Qiao’s particles contain 70-99 wt% cholate, the Office Action effectively requires Applicant to prove that Qiao’s particles cannot contain this amount”; that “this improperly shifts the burden”; that “the Office Action’s sole basis for the 99 wt% figure is a calculation that assumes all starting material in the reaction medium…ends up in the final particle product”; that “a…POSA…would have understood the purpose of Qiao’s purification step was to remove unadsorbed capping agent”; that “the Office Action does not explain why, in view of this step, a POSA would nonetheless have concluded that all cholate in the reaction medium ends up in the final product”; that “a POSA would have understood that it could not, given the finite surface area of the nanoparticles…the finite surface area available for cholate adsorption”; that “a POSA would have understood from Qiao, in view of the known packing density of capping agents on gold nanoparticle surfaces, that the maximum cholate content of Qiao’s particles is 2.66-5.73 wt%”; that “a POSA would have understood that a gold nanoparticle surface has a finite area and that each cholate molecule occupies a finite footprint, and once available adsorption sites are saturated, additional cholate is not incorporated…thus, the nanoparticle surface area is the limiting factor that governs cholate incorporation…the Office Action’s contrary assertion…that all cholate in solution becomes part of the final product…assumes an unlimited adsorption capacity that is physically unreasonable”; that “Qiao’s post-synthesis purification involved centrifugation and washing with deionized water” since “excess capping agent is removed during purification and not incorporated into the final nanoparticle product”; that “Hainfeld’s disclosure is directed to a…bilayer…in which a layer of surface binding molecules in direct contact with the nanoparticle…and a layer…which may include sodium cholate…are held together by hydrophobic interactions” and thus “Hainfeld’s layering mechanism thus depends on the interplay between two chemically distinct molecular components”; that “the Office Action does not explain why a POSA working with Qiao’s cholate-capped gold nanoparticles, which were designed for electrocatalysis and SERS, would have sought to combine Qiao with Hainfeld and Aziz to produce composite microparticles having the specific hexagonal prism dimensions”; and that “asserting that a method can be optimized as desired to reach the claimed result, without explaining why a POSA would have been motivated to pursue that optimization or would have reasonably expected it to succeed is insufficient to support a conclusion of obviousness”.
The Examiner, however, would like to point out the following:
1. In the prior response, Dr. Eniola-Adefeso was acknowledged as a distinguished expert in the art, and, as noted, as a courtesy and in deference to her expertise, the points Dr. Eniola-Adefeso raised regarding well known basic chemistry concepts and the types of theoretical assumptions that could in general terms be made and the types of calculations that could be made based on such assumptions were effectively treated as facts in the art. In stark contrast to Applicant’s assertion, however, Applicant’s argument that the weight percent of cholate in Qiao’s particles is 2.66 wt% to 5.73 wt% has not been passively accepted as an irrefutable fact. On the contrary, even in view of the basic chemistry concepts presented, and the various assumptions and calculations that could possibly be made, even if these are accepted as facts, the Examiner is not yet persuaded that the chemistry concepts and assumptions discussed are clearly and unequivocally pertinent in this particular case, and thus that the claimed subject matter represents a patentable advance in the art, for reasons explained below.
2. In view of Qiao, one of ordinary skill in the art could certainly, without question, arrive at a particle consisting essentially of a core of gold nanoparticles, and sodium cholate. Further, Qiao teaches that their particle is made by combining 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate in a 3 mL solution. One of ordinary skill in the art would thus understand the Qiao particle to comprise or substantially comprise about 5.91 mg of gold and 645 mg of sodium cholate. One of ordinary skill in the art would thus combine 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate in a 3 mL solution, and let the reaction proceed for days, which reaction proceeds to completion. Again, the reaction involves about 5.91 mg of gold and 645 mg of sodium cholate. Hence, it can be determined that the total particle weight is therefore about 651 mg, and sodium cholate is thus present in the amount of about 99 wt% of the particle.
3. In stark contrast to Applicant’s assertion, there is nothing at all whatsoever about Qiao’s disclosed particle or the method of making it that defies the basic principles of chemistry or physics or mathematics. Qiao expressly discloses that their particle as they intend it is made by combining 1.0 mM chloroauric acid (HAuCl4) with 50 mM sodium cholate in a 3 mL solution and letting the reaction proceed to completion. It can only be reasonably assumed that all or substantially all of the starting material ends up in the final product. Indeed, why would Qiao teach these specific amounts of reactants if these precise numbers were completely meaningless and only some very small, unknown fraction of these reactants are involved in producing the final product, with a large proportion being washed away, as Applicant would want us to believe? This notion on its face makes no sense, and no one of ordinary skill in the art interprets references such as Qiao in this way. In stark contrast to Applicant’s assertion, the prior art rejection is not based on binding an infinite amount of cholate to the gold nanoparticle core, only 645 mg. Further, even if Qiao does disclose a wash step, in stark contrast to Applicant’s assertion, this is certainly no proof at all that Qiao does or even intends to wash away 95% or more of the cholate that they included in the reaction. Again, this makes no sense, and no one of ordinary skill in the art would interpret the teachings of Qiao in this way and come to Applicant’s final conclusion at all. While it can be acknowledged that this is not an absolutely perfect world, and as such most likely not every single cholate molecule in the reaction medium will bind, one of ordinary skill in the art would generally understand from the teachings of Qiao, and indeed from similar teachings in any scientific reference, that at least substantially all will become part of the final product, as Qiao intends. However, based on the Qiao disclosure, if all of the sodium cholate does become part of the final product, the amount of cholate is 99%. In the real world, which is not ideally perfect, and thus where not every single cholate molecule becomes part of the final product, but substantially all does, with a bit being washed away, one of ordinary skill in the art would reasonably understand that perhaps about 5-15% of the sodium cholate may be washed away, but certainly not 95% or more, as Applicant would want us to believe. Even if 15% of the sodium cholate gets washed away, the particle would still be about 84 wt% cholate, which falls squarely within the claimed range of about 70-99 wt% cholate.
4. Hence, in stark contrast to Applicant’s assertion, the burden is in fact now on Applicant to show that Qiao’s particle cannot possibly contain this amount of sodium cholate that falls within the claimed range of 70-99 wt%. Applicant has not done so. Applicant raises the point that there is but a finite surface area of the gold nanoparticles. While that basic point is indeed true, this does not in any way prove that Qiao’s particle does not contain 70-99 wt% sodium cholate, and also does not in any way prove that Qiao’s particle contains only 2.66-5.73 wt% sodium cholate. Indeed, Qiao never discloses or suggests that their product contains only 3 wt% to 5.73 wt% cholate, and nobody of ordinary skill in the art would reasonably interpret and understand Qiao’s teachings in this way. Qiao never states that cholate is or should be employed in “vast excess” and that almost all of the sodium cholate, i.e. 95% or more, employed in the reaction is or should be washed away. Applicant simply has not proven, or even reasonably established, that Qiao’s final particle product does not, or cannot, contain 70-99 wt% cholate. Applicant has merely presented rather generic concerns and probabilities without properly establishing that any of the concerns or probabilities are actually applicable to the product of Qiao. Regarding the chemistry textbook, and the notion of side reactions and other complications, it’s unclear what Applicant is alluding to in this specific case of Qiao. Indeed, as Qiao expressly states on page 11093, “there are only three starting materials, namely sodium cholate, HAuCl4, and water”, and Qiao discloses how they react to form the product. There are no side reactions or complications mentioned anywhere in Qiao. Applicant has not clarified by mentioning any particulars either.
5. Regarding the assertion about “stoichiometric quantities” of reactants, such that “all reactants run out at the same time”, and the notion of “the limiting reactant being consumed first”, this appears to be another generic concept in chemistry merely thrown on the table with no explanation of how it is actually applicable in the present case to prove that Qiao’s final product does not or cannot contain 70-99 wt% cholate. Applicant is advised that cholate is not being consumed in the Qiao reaction. As Qiao explains, cholate’s hydroxyl groups serve to reduce Au(III) to Au, to thus form the gold nanoparticle core of the product. Upon oxidation, the cholate has carboxylate groups that facilitate capping of the cholate onto the surface of the gold nanoparticle core. Hence, even after the Au(III) are all reduced to Au, no cholate has been consumed, and the cholate then proceeds to cap the surface of the gold nanoparticles.
6. Moreover, while Qiao was chiefly focused on the cholate that caps the surface of the gold nanoparticle core, one of ordinary skill in the art, at the time the present application was filed, would have understood that cholate can form multiple layers on the gold nanoparticle core. Indeed, cholate is amphiphilic, and while the cholate compounds that reacted with Au(III) to acquire carboxylate groups will then directly bind the gold nanoparticle core to thus form a layer of cholate, additional cholate, even cholate without carboxyl groups, can layer upon the cholate bound directly to the gold nanoparticle core via hydrophobic interactions (see, for example, the cited Hainfeld reference). Cholate is well known to form multilayer films and coatings and there is no reason why one of ordinary skill in the art, at the time of filing the present application, would not reasonably assume that all of the cholate employed in Qiao’s reaction would not layer upon the gold nanoparticle core, such that the final product contained 70-99 wt% cholate.
7. Qiao also does not talk about saturating receptor binding sites on the gold nanoparticles. Gold nanoparticles would not be understood by one of ordinary skill in the art as containing receptor binding sites. Applicant also tries to argue that citrate binding to gold nanoparticles is a suitable model to understand cholate binding to gold nanoparticles. However, this notion appears to be limited, at best, to the actual binding of the compound to the gold surface, but is an oversimplification as far as the complete reaction that proceeds. Indeed, as anyone of ordinary skill in the art would immediately recognize, citrate and cholate are completely different compounds with completely different properties. While cholate is amphiphilic and can form micelles, citrate is hydrophilic and cannot form micelles on its own. Even more directly pertinent to this particular case, cholate can form multilayer films via hydrophobic interactions, but citrate cannot. Even if, arguendo, it could be concluded that cholate’s capping of the gold nanoparticle core by direct surface contact is similar to that of citrate, this does not mean that in reality the final product with cholate is similar to the final product with citrate. Indeed, it can only be reasonably assumed that cholate will form multilayers via hydrophobic interactions, while citrate will not. Applicant has not explained how their assertion that 95% or more of the cholate present in Qiao’s reaction medium gets washed away when cholate forms multilayers on the gold nanoparticle core. In stark contrast to Applicant’s assertion, this is not a phenomenon that can be explained by the citrate model. Applicant’s theoretical calculations of the amount of cholate they guess is possible in the final product of Qiao appear to be based on the premise that the only cholate in the final product is the cholate capped in direct contact with the gold nanoparticle surface. But as just explained, this appears to be an oversimplification that ignores the fact that cholate can form multilayer coating on gold nanoparticle cores.
8. Regarding Applicant’s assertion that “Hainfeld’s layering mechanism thus depends on the interplay between two chemically distinct molecular components”, it is unclear what “interplay between two chemically distinct components” Applicant is even referring to and how this supports Applicant’s position that only 2-5 wt% of the Qiao final product is cholate. One of ordinary skill in the arty would understand that the cholate will form multilayer films on the gold nanoparticle core. This is a layer of cholate on a layer of cholate, and this layering is possible, at least in part, by hydrophobic interactions. This layering is a physico-chemical process that will proceed in the Qiao reaction medium regardless of whether or not Qiao “designed their particle for electrocatalysis and SERS”.
9. Aziz discloses a microparticle comprising a gold nanoparticle core covered with a capping agent, which capping agent is a surfactant with a carboxylate functional group; wherein the particle can have a hexagonal prism shape. Indeed, as anyone of ordinary skill in the art would know, cholate is a surfactant, and has a carboxylate functional group in the Qiao reaction. Hence, a gold nanoparticle core covered with cholate would reasonably be expected to have a hexagonal shape, such a hexagonal shape is a suitable shape, and thus such a shape is not a patentable advance in the art. Further, as explained in the prior art rejection, supra, since Aziz et al. disclose that a microparticle comprising a gold nanoparticle core covered with a capping agent, which capping agent is a surfactant with a carboxylate functional group, can have a hexagonal prism shape, depending on e.g. the pH and other factors that can be optimized in the reaction of chloroauric acid with the capping agent; one of ordinary skill in the art would thus understand that the Qiao et al. method can be optimized as desired to achieve a microparticle with a hexagonal prism shape with a diagonal length of 2.5-10 µm and a height of 2.5-6.5 µm. Clearly, this limitation is well within the skill of the ordinary mechanic in the art, and thus is not a patentable advance. Applicant has provided no evidence to the contrary.
10. Therefore, while some generic textbook chemistry concepts mentioned by Dr. Eniola-Adefeso are in general true, and while the “citrate model” for a citrate molecule binding directly to a gold nanoparticle surface could be representative of a cholate molecule’s binding directly to a gold nanoparticle surface, none of this proves that Qiao’s final product does not or cannot contain 70-99 wt% cholate, for reasons just discussed.
For the foregoing reasons, the 35 USC 103 rejections are hereby maintained.
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.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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