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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Inventorship
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Troxler et al (WO 91/19193) in view of Premachandra (US 3,970,746).
With regards to claim 1, Troxler et al teach of a method and an apparatus for assaying a blood sample for an amount of apolipoprotein B found in both VLDL and LDL. In one embodiment of the method described in Example 1 in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al, a finger-stick blood sample is obtained from a subject in a standard large bore microcapillary tube, the capillary tube is capped and spun in a centrifuge to separate serum from the blood sample, a graduated smaller bore capillary tube having an outside diameter less than the inside diameter of the standard microcapillary tube is used to withdraw a specific volume of the serum into the smaller, graduated tube, a protein precipitating agent is mixed with the serum in the graduated tube by agitating the tube for a certain time period in order to precipitate proteins in the serum sample, and an amount of the precipitated proteins in the sample is determined by comparing the precipitate column in the graduated tube to a protein measurement correlation chart that plots precipitate volume in the form of precipitate column heights in a graduated tube vs. known amounts of protein in standard serum samples. See Figure 1 in Troxler et al which depicts a graduated tube B used in the method, and Figure 2 in Troxler et al which depicts a protein measurement chart with precipitate volume (i.e. VLDL/LDL) indicating corresponding amount of protein (i.e. apolipoprotein B (mg/dL) in serum samples having known amounts of proteins therein. Troxler et al teach that in this method described in the last two paragraphs on page 11 and in the first paragraph on page 12, either a volume of a precipitating agent can be preloaded into the smaller, graduated tube or alternatively, the precipitating agent can be added to the smaller, graduated tube after the serum is collected into the tube. When the precipitating agent is added to the smaller, graduated tube after the serum is collected into the tube, the precipitating agent is located in a separate, non-graduated container holding the precipitating agent. In this embodiment, the apparatus or “kit” (i.e. a collection of physical components) used to perform the method comprises a graduated tube with markings to measure an amount of protein precipitate (i.e. the smaller, graduated tube B depicted in Figure 1 of Troxler et al), a non-graduated tube containing a protein precipitation solution from which a volume of the protein precipitation solution is taken and added to the graduated tube containing a serum sample, and a protein measurement chart with precipitate volume in the graduated tube indicating corresponding amount of protein as a percentage (see Figure 2 in Troxler et al).
It is noted that claim 1 recites that the kit “consists of” the three recited components (i.e. the graduated tube, the non-graduated tube, and the protein measurement chart), which excludes the inclusion of any other additional components related to the invention. However, while the “kit” of components used to perform the method described above by Troxler et al includes a standard large bore microcapillary tube used to collect an initial blood sample in the method, which is an additional component to the graduated tube, the non-graduated tube and the protein measurement chart in the method and apparatus (i.e. kit) described in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al, this standard large bore microcapillary tube is not considered a part of the ”kit” of components required to perform the method, but rather, is an ancillary component unrelated to the claimed invention of precipitating proteins (i.e. VLDL and LDL) in a serum sample and measuring a volume of the resulting precipitate. See Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d 1508, 1516 (Fed. Cir. 2004) (holding that a bone repair kit "consisting of" claimed chemicals was infringed by a bone repair kit including a spatula in addition to the claimed chemicals because the presence of the spatula was unrelated to the claimed invention).
In the method and apparatus described in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al, Troxler et al fail to teach that the protein precipitating reagent located in the non-graduated tube and added to the small, graduated tube containing a serum sample can be a trichloroacetic acid (TCA) solution in an amount of 30% w/v.
Premachandra teaches that a 30% w/v trichloroacetic acid (TCA) solution can be used to precipitate proteins in a serum/plasma sample. See lines 32-34 in column 2 of Premachandra where it states “25 µL of serum are pipetted into tubes followed by the addition of 0.1 ml of 30% trichloroacetic acid (TCA) to precipitate plasma proteins”.
Based upon a combination of Troxler et al and Premachandra, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a 30% w/v trichloroacetic acid solution as the protein precipitating solution in the non-graduated tube of the kit of components used to perform the method described in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al because the protein precipitating reagent taught by Troxler et al is for the purpose of precipitating proteins in a serum sample, and Premachandra teaches that a 30% w/v trichloroacetic acid solution is also effective at precipitating proteins in a serum sample in the same equivalent manner as the precipitating reagents taught by Troxler et al.
With regards to the recitation of the kit in instant claim 1 being used to determine a protein content in a whey protein supplement, it is noted that this is merely an intended use of the kit which has not been given patentable weight since it has been held that a recitation with respect to the manner in which a claimed apparatus/kit is intended to be employed does not differentiate the claimed apparatus/kit from a prior art apparatus satisfying the structural limitations of that claimed. A recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the apparatus taught by the combination of Troxler et al and Premachandra is capable of measuring any type of protein in a sample, including whey proteins that are present in whey protein supplements, since the kit of components taught by the combination of Troxler et al and Premachandra contains the same physical components as the kit of components recited in claim 1.
Response to Arguments
Applicant's arguments filed February 5, 2026 have been fully considered but they are not persuasive.
The filing of the certified priority Indian patent application on February 17, 2026 upon which foreign priority is claimed in the instant application is acknowledged. The previous rejection of the claims under 35 USC 112(b) in the last Office action mailed on November 6, 2025 has been withdrawn in view of the amendments made to the claims. Claims 3-8 and 10 remain withdrawn from consideration.
Applicant argues the rejection of the claims under 35 USC 103 as being obvious over Troxler et al (WO 91/19193) in view of Premachandra (US 3,970,746) by first stating that the instant invention can be used in a home setting by a consumer of a protein supplement whereas the method and kit taught by Troxler et al is intended to be used in a doctor’s office or small clinical laboratory. This argument is not persuasive since where a kit of components is intended to be used is irrelevant to what physical components actually make up the kit. Since the physical components of the kit recited in instant claim 1 are the same as the physical components of the kit taught by the combination of Troxler et al and Premachandra (see the rejection of claim 1 under 35 USC 103 above), both kits can be used in the same settings depending upon their intended use.
Applicant also argues that in Example 1 taught by Troxler et al in the last two paragraphs on page 11 and in the first paragraph on page 12, the kit comprises a standard large bore microcapillary tube and a centrifuge to collect a blood sample and then separate serum from the blood sample using the centrifuge, whereas the kit recited in instant claim 1 only consists of a graduated tube with markings to measure an amount of protein precipitate, a non-graduated tube containing a protein precipitation solution comprising trichloroacetic acid in an amount of 30% w/v, and a protein measurement chart. This argument is not persuasive since both the standard large bore microcapillary tube used to collect a blood sample from an individual and the centrifuge used to separate serum from the blood sample taught by Troxler et al are ancillary components unrelated to the claimed invention of precipitating proteins (i.e. VLDL and LDL) in a serum sample and measuring a volume of the resulting precipitate. See Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d 1508, 1516 (Fed. Cir. 2004) (holding that a bone repair kit "consisting of" claimed chemicals was infringed by a bone repair kit including a spatula in addition to the claimed chemicals because the presence of the spatula was unrelated to the claimed invention).
Applicant also argues that Examples 3 and 4 in Troxler et al teach of kits comprising many more components than are recited in the kit of instant claim 1 since the kits described in Examples 3 and 4 of Troxler et al comprise many large bore capillary tubes and many small bore graduated capillary tubes containing microcapsules of a protein precipitating agent. This argument is not persuasive since in order to perform the method taught in Example 1 of Troxler et al described in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al, the only necessary physical components required to perform the method are a small, graduated tube B depicted in Figure 1 of Troxler et al with markings to measure an amount of protein precipitate, a non-graduated tube containing a volume of a protein precipitating solution (i.e. when the precipitating agent is added to the smaller, graduated tube after the serum is collected into the graduated tube, the precipitating agent is located in a separate, non-graduated container holding the precipitating agent), and a protein measurement chart with precipitate volume in the graduated tube indicating corresponding amount of protein as a percentage (see Figure 2 in Troxler et al).
Applicant also argues the rejection of claim 1 under 35 USC 103 as being obvious over Troxler et al (WO 91/19193) in view of Premachandra (US 3,970,746) by stating that both Troxler et al and Premachandra are non-analogous art to instant claim 1 since claim 1 relates to a kit using TCA to precipitate protein in a whey protein supplement whereas both Troxler et al and
Premachandra relate to precipitating proteins in serum or plasma blood samples. This argument is not persuasive since instant claim 1 recites a kit consisting of physical components for precipitating proteins, and both Troxler et al and Premachandra also relate to protein precipitation methods and kits. Therefore, both Troxler et al and Premachandra are relevant and analogous to the kit recited in instant claim 1. Applicant’s argument is also not persuasive since the argument relates to the intended use of the kit recited in claim 1 to detect proteins in a whey protein supplement. This intended use of the kit has not been given patentable weight since it has been held that a recitation with respect to the manner in which a claimed apparatus/kit is intended to be employed does not differentiate the claimed apparatus/kit from a prior art apparatus satisfying the structural limitations of that claimed. A recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the apparatus taught by the combination of Troxler et al and Premachandra is capable of measuring any type of protein in a sample, including whey proteins that are present in whey protein supplements, since the kit of components taught by the combination of Troxler et al and Premachandra contains the same physical components as the kit of components recited in claim 1.
Applicant also argues that the combined disclosure of Troxler et al and Premachandra does not teach of all of the claimed features recited in claim 1, as required for a prima facie case of obviousness under 35 USC 103, since to arrive at the claimed invention, Troxler et al has to be modified to reduce the number of components in the kit, the combination has to be modified to be used for testing whey protein supplements, and the protein precipitating agents taught by Troxler et al have to be replaced with TCA for which no motivation is suggested or taught by either Troxler et al or Premachandra. This argument is not persuasive since as noted above, in Example 1 taught by Troxler et al described in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al, the only necessary physical components required to perform the method are a small, graduated tube B depicted in Figure 1 of Troxler et al with markings to measure an amount of protein precipitate, a non-graduated tube containing a volume of a protein precipitating solution (i.e. when the precipitating agent is added to the smaller, graduated tube after the serum is collected into the graduated tube, the precipitating agent is located in a separate, non-graduated container holding the precipitating agent), and a protein measurement chart with precipitate volume in the graduated tube indicating corresponding amount of protein as a percentage (see Figure 2 in Troxler et al). Therefore, the kit of components required to perform the method described in Example 1 of Troxler et al does not need to be drastically modified to reduce its components and to teach the same physical components of the kit recited in claim 1. In addition, as noted above, the use of the kit recited in instant claim 1 to detect proteins in a whey protein supplement relates to the intended use of the kit. The apparatus taught by the combination of Troxler et al and Premachandra is capable of measuring any type of protein in a sample, including whey proteins that are present in whey protein supplements, since the kit of components taught by the combination of Troxler et al and Premachandra contains the same physical components as the kit of components recited in claim 1. With regards to the lack of motivation to combine Troxler et al and Premachandra, this argument is not persuasive since both Troxler et al and Premachandra teach of methods for precipitating proteins in serum or plasma samples. Premachandra provides a teaching and motivation to substitute a 30% w/v TCA protein precipitation solution for the phosphotungstic acid precipitating agent taught by Troxler et al since TCA is equivalent in function to precipitating proteins in a serum or plasma sample as the phosphotungstic acid disclosed by Troxler et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a 30% w/v trichloroacetic acid solution as the protein precipitating solution in the non-graduated tube of the kit of components used to perform the method described in the last two paragraphs on page 11 and in the first paragraph on page 12 of Troxler et al because the protein precipitating reagent taught by Troxler et al is for the purpose of precipitating proteins in a serum sample, and Premachandra teaches that a 30% w/v trichloroacetic acid solution is also effective at precipitating proteins in a serum sample in the same equivalent manner as the precipitating reagents taught by Troxler et al.
For all of the above reasons, Applicant’s arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 March 24, 2026