DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Pursuant to the amendment dated 08/25/2025, claim 39 has been cancelled. Claims 1-23, 29, and 40 had been cancelled in a previous communication. Claims 24-28, 30-38, 41, and 42 are pending. Claims 26 and 34-36 stand withdrawn without traverse.
A terminal disclaimer is on file for US Patent Nos. 10,973,865; 10,864,241; and 10,813,968.
Claims 24, 25, 27, 28, 30-33, 37, 38, 41, and 42 are under current examination.
All rejections not reiterated have been withdrawn.
Information Disclosure Statement
The information disclosure statement filed 080/25/2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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 24, 25, 27, 28, 30-33, 37, 38, 41, and 42 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.
Claim 24 recites the limitation "bioactive components (a), (b), and (c)" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Amending the claim to delete the word “bioactive” would obviate the rejection.
Claim 37 recites the limitation "the bioactive components" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive. On page 6, Applicant argues that the amendment to the claims has addressed the antecedent basis concerns in claims 24 and 37. This argument is not persuasive because the claims refer to “bioactive components” (claim 24) or “the bioactive components” (claim 37) without identifying any bioactive components previously. While “components” (a) – (c) in claim 24 are certainly bioactive, it is not clear that these are the only bioactive components in the composition. In claim 37, a Solanaceae extract would contain some bioactive components, but they are not previously identified in the claim, therefore, one cannot be certain which bioactive components the percentage of sugar is relative to, and the scope of the claim is unclear. As noted in the rejection above, the rejection could be overcome by amending claim 24 to remove the word “bioactive” preceding components. One way to overcome the rejection of claim 37 would be to identify bioactive components earlier in the claim; however, there are other possibilities to overcome the rejection. The examiner invites Applicant to contact her if discussion of this point would be helpful.
Claim Rejections - 35 USC § 101
Claims 24, 25, 27, 28, 30-33, 37, 38, 41, and 42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims recite a substantially lycopene-free extract of fruit of the Solanaceae family comprising a glycosylated phenolic acid or a phenolic ester, or derivatives thereof; a glycosylated flavonoid; and a nucleoside; wherein the extract contains <1% sugars and contains >95% of the bioactive components that are contained in a start mix from which the extract is prepared. This judicial exception is not integrated into a practical application because the claims only recite natural products (i.e., fruit extract), without any additional elements recited that are sufficient to amount to significantly more than the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims either only recite natural products, without any additional elements recited, or the additional elements (i.e., excipients) do not change the structure, function, or other properties of the natural product as to integrate the judicial exception into a practical application. A detailed analysis follows.
The claimed invention is directed to a substantially lycopene-free extract of fruit of the Solanaceae family comprising: (a) glycosylated phenolic acid or a phenolic ester, or derivatives thereof;(b) a glycosylated flavonoid; and (c) a nucleoside; wherein the extract contains <1% sugars and contains >95% of the bioactive components (a), (b) and (c) that are contained in a start mix from which the extract is prepared (e.g., see claim 24). Claims depending from claim 24 are drawn to more specific choices for the glycosylated phenolic acid or ester and the glycosylated flavonoid (e.g., claims 27 and 28), as well as forms of the composition (e.g., claims 30-32) and how the extract is made (e.g., claim 37). These compositions are not markedly different from their closest naturally occurring counterpart because there is no indication that extract has caused the fruit of the Solanaceae family (e.g., tomato) that comprise the claimed compositions to have any characteristics that are markedly different from the naturally occurring fruit of the Solanaceae family (tomato). For example, the tomato fruit is already known to have cardiovascular benefits, including inhibition of platelet aggregation (e.g., see Yamamoto et al., 2003; Dutta-Roy et al., 2001; both references are cited by Applicant in the IDS filed 16 July 2021). Therefore, the extract is not markedly different from the fruit, as the extract may contain the same active component(s) as the compounds as they exist in the fruit itself.
Under the 101 analysis for patent eligibility:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The claims are drawn to a composition of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
The claims are drawn to a lycopene-free extract of fruit of the Solanaceae family (e.g., tomato). The extract may be obtained by a process of separating a water-soluble fraction, followed by filtering, removing sugars, and concentrating the solution (e.g., see claim 37). However, the extraction process does not change the structure or function of the components obtained by such extraction process, and thus does not result in markedly different characteristics. Note that, with respect to extracts of natural products such as tomato fruit extract, the closest naturally-occurring counterpart is the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made by separating the extracted components from the non-extracted components, is a partitioning process that, absent any specific chemical modification, merely separates the compounds, leaving their activities unchanged, which appears to be the case here. In this case, the components recited in the claims are natural products that would occur naturally. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record that the components present have any structural differences in the extract(s) instantly claimed as compared to their nature-based counterparts. Additionally, the nature-based counterpart (i.e., the tomato fruit) is already known to have cardiovascular benefits, including inhibition of platelet aggregation (see references cited above), which function is also cited for the instantly claimed extracts (e.g., see as-filed specification, pages 2-3).
Step 2A, Prong 2: Does the claim recite additional elements that integrate the Judicial Exception into a practical application?
Claims 24, 27, 30-33, 37-39, and 41 do not recite additional elements, other than those which are naturally occurring.
When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. See MPEP 2016.04(c)(II)(A). The naturally occurring plant (in this case, the tomato fruit) is already known to have cardiovascular benefits, including inhibition of platelet aggregation (see references cited above). Therefore, the instantly claimed combinations do not possess “markedly different characteristics” from that of the prior art (i.e., having a property not found in the prior art). Inherent or innate characteristic of the naturally occurring counterpart cannot show a marked difference; see MPEP 2106.04(c)(II).
Claims 25 and 42 do not recite additional elements that integrate the judicial exception into a practical application, as the excipients do not change the structure or function as to integrate the extract into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
Each of the elements recited in the claims are natural products and additional elements which do not integrate the judicial exception into a practical application. No other limitations are recited in instant claims 1-9 that would add significantly more to the Judicial Exception.
Accordingly, the claimed composition recites a natural product that is not markedly different in structure from naturally occurring elements and hence reads on patent ineligible subject matter under the above guidelines. See MPEP 2106.07.
To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature. Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The Court provides long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U .S.C.§ 101. A claim that recites a law of nature or natural correlation, with additional steps that involve well- understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation for the reasons cited above.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
On pages 7-9, Applicant argues that the extract is not a natural product because it contains less than 1% of the sugar in the original fruit and greater than 95% bioactives of the original fruit. Applicant asserts that the claimed invention was applied to generate a novel extract with surprising uses for modulating platelet activity. Applicant argues further that the amendment to the claims to require that the extract be in the form of a powder overcomes the rejection under 35 USC 101 because naturally occurring fruit has markedly different characteristics from a powder. Naturally occurring fruit may spoil faster and the powder extract of the claimed invention has a longer shelf life.
This argument is not persuasive and appear to be cumulative. As explained previously, for clarity, the comparison under 35 USC 101 of a mixture of naturally occurring substances is to each naturally occurring substance separately. See MPEP 2106.04(c)(II)(A): Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281. Thus, although a dry powder has some physical differences from e.g. a tomato, comparison of the physical state of a mixture of compounds to the fruit from which they may be found is not the correct comparison. The claimed dry powder is a mixture of naturally occurring compounds that, each individually, can be found in e.g. a tomato. The record has not established that the mixture of compounds possesses markedly different properties from the individual compounds themselves. As noted in the rejection above as well as the obviousness rejection below, the claimed compounds each affect coagulation in isolation. The record does not establish any difference between the mixture and each component in isolation, therefore the argument that the claimed invention can modulate platelet activation is not persuasive.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 24, 25, 27, 28, 30-33, 37, 38, 41, and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dutta-Roy (WO 99/55350, cited by Applicant in the IDS filed 16 July 2021) in view of Moco et al. (“Moco”, Plant Physiology 141:1205-1218, 2006, cited by Applicant in the IDS filed 16 July 2021), Nardini et al. (“Nardini”, Platelets, 18(3), pp. 224-243, May 2007), and Dutta-Roy et al. (“Dutta-Roy 2001”, Platelets 2001, 18, pp. 218-227, cited by Applicant in the IDS filed 16 July 2021)..
Dutta-Roy teaches a fruit extract or active fraction thereof for use in the treatment of a disease state initiated or characterized by platelet aggregation (e.g., abstract). The compounds responsible for the anti-platelet-aggregation activity are water soluble compounds having a very different structure to the lipid soluble compounds such as lycopene (e.g., page 2), and thus are lycopene-free. The extracts are typically an aqueous extract, obtained by homogenizing the flesh of the fruit and removing solids, whereafter the aqueous extract is concentrated, enriched or condensed by standard techniques. The extracts can be fractionated to isolate one or more active fractions therein by molecular weight filtration or chromatography on a suitable solid support (e.g., see page 5). Preferred extracts include fruits from the Solanaceae family, such as tomato extract (e.g., page 6). An active fraction of a tomato extract contains a substantially heat stable colorless or straw-colored water-soluble nucleoside compound or compounds having a molecular weight of less than 1000 (e.g., see pages 6-7). Dutta-Roy teaches the extract may be further processed into a powder (e.g., pages 7-8).
Regarding claims 24, 27, and 28, while Dutta-Roy teaches the water-soluble tomato extract contains compounds having a molecular weight of less than 1000, and/or nucleoside compounds, Dutta-Roy does not specifically teach the presence of a glycosylated phenolic acid or a phenolic acid ester, or derivatives thereof, such as caffeic acid glucoside (Applicant’s elected species), and a glycosylated flavonoid, such as Rutin.
However, said compounds are already known to be present in tomato fruit, and also to be useful in for inhibiting platelet aggregation. For example, Moco teaches numerous phenolic acids and derivatives, including caffeic acid glucoside, and glycosylated flavonoids, including Rutin, are present in the tomato fruit (e.g., see Table 1). While Moco does not specifically teach said compounds are present in a water-soluble extract, the skilled artisan would reasonably expect these compounds to be present in a water-soluble extract, due to the water solubility of both compounds. Additionally, Nardini teaches caffeic acid (expected metabolite of caffeic acid glucoside) and Rutin both have platelet aggregation inhibiting properties (e.g., see Tables I and II; pages 225, 234).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to form a water-soluble lycopene-free extract of fruit of the Solanaceae family, such as tomato, containing a nucleoside, as taught by Dutta-Roy, as well as glycosylated phenolic acid such as caffeic acid glucoside and a glycosylated flavonoid such as rutin; thus arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because glycosylated phenolic acids such as caffeic acid glucoside and glycosylated flavonoids such as rutin are already known to be present in tomato fruit as taught by Moco, and are known to have platelet aggregation inhibiting properties, as taught by Nardini, and because Dutta-Roy teaches extracts can be fractionated to isolate one or more active fractions therein by molecular weight filtration or chromatography on a suitable solid support. Therefore, the skilled artisan would find it obvious to obtain a fraction of the extract containing compounds known to be present in tomato and having platelet aggregation inhibiting properties, with a reasonable expectation of success.
As noted above, Dutta-Roy further teaches the extracts contain a mixture of nucleosides, including cytidine (e.g., pages ), but does not specifically teach the presence of a nucleoside named in instant claim 24.
Dutta-Roy 2001 teaches that, from tomato extract, the fraction containing cytidine and adenosine had high anti-platelet activity (e.g., page 220).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to obtain an active fraction containing adenosine as one of the nucleosides present in the extract of Dutta-Roy; thus arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because adenosine, along with cytidine, have high anti-platelet activity, as taught by Dutta-Roy 2001, and Dutta-Roy already teaches that a mixture of nucleosides including cytidine are present in the extract.
Regarding amounts of sugars and active compounds, it is noted that, since Dutta-Roy teaches the extract may be fractionated to isolate one or more active fractions therein, and that the extract may be concentrated, e.g., at least 40-fold, 100-fold, 200-fold, or 1000-fold (e.g., page 5), the skilled artisan would find it obvious to reduce amounts of non-active components (such as sugars) and concentrate amounts of active fractions, with a reasonable expectation of success. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05 II.A.
Regarding claims 25, 30, 32, and 42, Dutta-Roy teaches the extracts may be formed into syrups or other solutions in the presence of one or more excipients (e.g., page 7).
Regarding claims 31 and 33, Dutta-Roy teaches a dosage form can contain up to about 1000mg of the dried extract, for example up to about 800mg (e.g., page 9). This range overlaps that instantly claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I. In this case, it would be within the purview of the skilled artisan to determine dosage amounts from within the ranges taught by Dutta-Roy, including amounts which overlap those instantly claimed, by routine optimization, in order to optimize the efficacy of the resultant composition.
Regarding claims 37-41, it is noted that said claims recite product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. Since the process of Dutta-Roy recites similar steps of a homogenization, centrifugation (remove solids), filtration, further fractionation to obtain active compounds (removing sugars), and concentrating (e.g., see Figure 1; page 5), wherein the active fraction may include other active water soluble compounds having a MW less than 1000, such as caffeic acid glucoside and glycosylated flavonoids, as taught by Moco and Nardini, the same composition would be expected to be present, absent evidence to the contrary.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
On page 9, Applicant argues that the presently claimed invention is an improvement over the extracts of the WO99/55350 document. Applicant asserts that the work involved a lot of trial and error, first identifying the active fractions and then devising a process of making a novel extract that was enriched in these bioactives.
The examiner respectfully maintains the position that identifying and enriching known bioactives was a routine process, and was prima facie obvious in view of the cited prior art for the reasons set forth in the rejection above. Moreover, purifying a compound does not render it patentable over the prior art, particularly when the beneficial effects of the compound had already been recognized in the prior art. (See 15 USPQ 45 Ex parte Adolf Windaus Patent Office Board of Appeals; 10 USPQ 2d 1922 Patent and Trademark Office Board of Patent Appeals and Interferences Ex parte Gray; and In re VOLWILER and TABERN, 46 USPQ 137 (C.C.P.A. 1940)).
On page 9, Applicant argues that the work resulted in a composition with surprising and unrivaled efficacy in the health food/nutraceutical sectors for modulating platelets to confer health benefits.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
The several experiments are described in the specification. In tables 3 and 4, physiochemical and antiplatelet activity of compounds identified from fruit extract are reported. Applicant describes AMP, glycosylated forms of p-coumaric and caffeic acids and derivatives of quercetin and naringenin as showing high anti-aggretory activity. Applicant states that an extract prepared according to the methods disclosed in WO 99/55350 may be fractionated to isolate three fractions identified as having antiplatelet activity. Examples 2 and 3 describe a method of enriching the bioactive compounds identified in the previous experiment. In example 4, the extract according to the invention is compared to “a control supplement”, whose content is not disclosed and Applicant states that a single dose of 3 g of tomato extract according to the present invention resulted in an inhibition of 3 mmol/L ADP-induced platelet aggregation of 28%, whereas the extract [according to WO 99/55350] resulted in an inhibition of ADP-induced platelet aggregation of approximately 25 % when a 9 g dose is given. Applicant concludes that the method of the present invention appears to enrich bioactives in the extract by approximately three-fold. Additional examples describe some formulation types into which the invention may be incorporated.
As noted above, in order to overcome an obviousness rejection with a persuasive showing of unexpected results, surprisingly improved performance must be shown in a side-by-side comparison to the closest prior art, have statistical and practical significance, and data must be commensurate in scope with the claims. Regarding the experiments described in the specification, only example 4 evaluates the property of modulating platelets to confer health benefits asserted to be beneficial in the arguments. In example 4, the composition according to the invention is compared to a control supplement. The identity of the control supplement is not disclosed; therefore the examiner cannot evaluate the extent to which any improvement would have been unexpected as of the instant effective filing date. For this reason, example 4.1 cannot be relied upon to overcome the obviousness rejection. As noted above, in the conclusion section for example 4, Applicant states on page 61 of the specification that a single dose of 3 g of tomato extract according to the present invention resulted in an inhibition of 3 mmol/L ADP-induced platelet aggregation of 28%, whereas the extract [according to WO 99/55350] resulted in an inhibition of ADP-induced platelet aggregation of approximately 25 % when a 9 g dose is given, implying that the “control” described in section 4.1 of example 4 was the tomato extract according to WO 99/55350. If this is the case, these data do not meet the burden on Applicant to overcome an obviousness rejection with unexpected results for the following reasons: Although a comparison to the closest prior art, WO00/55350 (i.e. Dutta-Roy cited in the rejection above) shows an improvement, Applicant has characterized their invention as an enrichment of the extract described by Dutta-Roy. The ability of Dutta-Roy’s extract to treat platelet aggregation was recognized in the prior art (see Dutta-Roy, abstract). Enriching the substances responsible would have been expected to create a more potent extract. Moreover, the prior art already recognized the substances identified that substances such as rutin and caffeic acid have anti-platelet activity. An extract enriched for these substances would have been expected to show more greater potency because the content of known active compounds was higher. Thus, no unexpected result has been made of record. Additionally, the examiner does not consider the data to be commensurate in scope with the claims, as claim 24, for example, embraces any compound having a phenolic acid or ester that has been glycosylated; however, the data evaluated the effect of only a handful of such molecules.
On page 9, Applicant argues that the presently claimed extracts are not obvious over the prior art, and that the cited references would not have enabled one of ordinary skill through routine experimentation to arrive at the presently claimed extract (i.e. one over ordinary skill would have lacked reasonable expectation of success in removing sugars from the extract such that it contains less than 1% of the sugar in the homogenized fruit that it had been derived from).
As explained previously, the examiner respectfully disagrees. As noted in the rejection supra, since Dutta-Roy teaches the extract may be fractionated to isolate one or more active fractions therein, and that the extract may be concentrated, e.g., at least 40-fold, 100-fold, 200-fold, or 1000-fold (e.g., page 5). The examiner considers Dutta-Roy’s disclosure that the extract may be fractionated to provide sufficient expectation of success to meet this prong of the obviousness analysis under 35 USC 103. That Dutta-Roy states separation of the components of the extract is possible is sufficient to establish expectation of success. See MPEP 2121(I): Prior art is presumed to be operable/enabling. Also, conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367-68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). (MPEP 2143.02(I)).
Moreover, the claims are directed to a product, not to a method of manufacture. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the prior art does not teach the method used to generate the instant invention, as claimed) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 24, 25, 27, 28, 30-33, 37, 38, 41, and 42 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28 and 40-45 of copending Application No. 18532215 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Inter alia, the claims of the ‘215 application embrace a method of using a composition according to the instant claims. Specifically, the composition consists essentially of a therapeutically effective amount of a water-soluble tomato extract and a therapeutically effective amount of a dietary nitrate to the human in need thereof; wherein the lycopene content of the water-soluble tomato extract is less than 0.5% by dry weight of the water-soluble tomato extract, and the water insoluble particulate material is less than 0.1% by dry weight of the water-soluble tomato extract. The water soluble tomato extract is made by a process consisting essentially of: preparing a start mix of homogenized tomato, wherein the pH of the start mix does not exceed pH 5.5, the holding temperature of the start mix does not exceed 35° C. and the start mix is diluted with water such that less than 33% tomato solids are in the start mix, separating a water soluble fraction from the solids of the tomato by a procedure that does not raise the temperature of the water soluble tomato fraction above 60° C. to yield a water soluble tomato fraction, filtration of the water soluble tomato fraction to remove particles larger than 1000 Daltons to yield a filtered water soluble tomato fraction, removal of free sugars from the filtered water soluble tomato fraction. The composition may be formulated into a gel, dispersible tablet, powder, drink, and food, and therefore also contains an excipient. As the extract is formed by an identical method as the extract claimed in the instant application (see e.g. instant claim 37), it must possess the same properties.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 24, 25, 27, 28, 30-33, 37, 38, 41, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-30 of copending Application No. 17064984 as evidenced by O’Kennedy (WO2010/049707; publication date: 05/06/2010; cited in the IDS filed 07/16/2021).
Inter alia, the claims of the ‘984 application embrace a method of using a tomato extract having a nucleoside and/or a glycosylated phenolic acid or phenolic ester. The extract is produced by the same method used to generate the extract claimed in the instant invention: The ‘984 specification indicates that the extract is produced according to the method described in WO2010/049707 (O’Kennedy), the publication of PCT/GB2009/002593, which, in turn is the international PCT application to which the instant application claims priority (the instant application is a continuation of 15866900, which is a continuation of 14030533, which is a continuation of 13124512, which is the national stage under 35 USC 371 of PCT/GB2009/002593). Specifically, the method of the O’Kennedy international application employs the following method:
A fruit is processed to optimize the platelet aggregation inhibiting activity of the extract comprising the steps of:
(a) preparing a start mix of homogenized fruit;
(b) separating a water-soluble fraction from fruit solids;
(c) filtration of the water-soluble fraction; and
(d) concentration of active agents in the filtration permeate;
wherein the holding temperature of the start mix does not exceed 35C;
the pH of the start mix does not exceed 5.5;
the browning index of the start mix, defined as the absorbance of the soluble portion at 420 nm, does not exceed 0.4 AU at 4% solids;
wherein step (b) does not involve a procedure that raises the temperature of the fraction above 60C;
and including a further step after step (c) for removing free sugars from the water-soluble extract by resin- mediated separation of the extract components.
As the extract is formed by an identical method as the extract claimed in the instant application (see e.g. instant claim 37), it must possess the same properties.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive. Applicant’s statement of willingness to address the provisional nonstatutory double patenting rejections upon identification of otherwise allowable subject matter on page 11 of the remarks is noted.
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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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617