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
The amendment to the claims filed after non-final office action on November 19, 2025 is acknowledged. Claims 3, 6, 9-10, 13, 15, were canceled and claims 1-2, 4-5, 7-8, 11-12, 14, 16-22 are pending in the instant application. The restriction was deemed proper and made final previous office action.
The was restriction deemed proper and made FINAL in the previous office action. Claims 7-8, 11, 17-19 remain withdrawn from consideration as being drawn to a non-elected invention/species. Claims 1-2, 4-5, 12, 14, 16 and 20-22 are examined on the merits of this office action.
Withdrawn Rejections/Objections
The rejection of claim(s) 1-2, 4-5, 12, 14, 16 and 20-22 under 35 U.S.C. 102(a)(1) as anticipated by Gelita (Collagen Peptides – Innovative technologies for innovative ideas!, published online November 2016, see previously attached handout with publication date) as evidenced by Gelita* (Collagen Peptides – Innovative technologies for innovative ideas!, published online 2019, 2019 updated brochure, cited previously) is withdrawn in view of Applicant’s arguments filed November 19, 2025.
Declaration under 37 C.F.R 1.132
The Declaration under 37 CFR 1.132 filed November 19, 2025 is insufficient to overcome the rejection of claims Claim(s) 1-2, 4-5, 12, 14, 16 and 20-22 under 35 U.S.C. 103 as obvious over Gelita (Collagen Peptides – Innovative technologies for innovative ideas!, published online November 2016, see previously attached handout with publication date) as evidenced by Gelita* (Collagen Peptides – Innovative technologies for innovative ideas!, published online 2019, 2019 updated brochure, cited previously) as set forth in the last Office action because:
Applicants assert that the claimed properties including hydration time of 7 seconds or less is not inherent in agglomerated collagen peptide products and argues that hydration time varies among commercially available product with same protein content, same moisture content and molecular weight.
Applicants arguments have been fully considered but not found persuasive.
Applicant submits a declaration reporting hydration and dissolution times for various commercially obtained agglomerated collagen peptide products and argues that variability in hydration time demonstrates that the claimed hydration time is not inherent. However, the declaration does not establish that the tested products are the same as, or materially indistinguishable from, the agglomerated collagen hydrolysate rendered obvious by Gelita (Peptiplus XB). While Applicant asserts similarity in molecular weight, protein content, moisture content, and bulk density, Applicant does not demonstrate that the tested products were produced using the same or substantially identical agglomeration processes as disclosed by Gelita, nor that they possess the same particle morphology or surface characteristics resulting from such processes.
Absent a showing that the tested products are identical or substantially identical in structure or produced by identical or substantially identical processes, differences in measured hydration time among commercial products do not rebut inherency or obviousness. See MPEP § 2112; In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Moreover, to the extent that Applicant’s data show variability in hydration time among different agglomerated collagen peptide products, such variability is consistent with routine processing differences/or the collagen protein itself and does not establish that the claimed hydration time is unexpected or non-inherent. Variability alone does not negate the reasonable expectation that the agglomerated collagen peptide powder rendered obvious by Gelita would sink and hydrate as claimed. The Examiner maintains that the agglomerated Peptiplus XB rendered obvious by Gelita would inherently have the hydration times (along with other physical properties involved with solubility such as dissolution time) of the instant claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Maintained/Revised Rejection
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 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(s) 1-2, 4-5, 12, 14, 16 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gelita (Collagen Peptides – Innovative technologies for innovative ideas!, published online November 2016, see previously attached handout with publication date) as evidenced by Gelita* (Collagen Peptides – Innovative technologies for innovative ideas!, published online 2019, 2019 updated brochure, cited previously).
Gelita teaches a collagen hydrolysate comprising a protein content of 97% or greater and a moisture content of 4-9% (see page 4, “Product Data”, Peptiplus XB).
Regarding claim 2, Gelita teaches a bulk density of 420 g/L (see page 4). Regarding claims 4 and 16, Gelita teaches a molecular weight of 3000 daltons (see page 4).
Regarding claim 12, Gelita teaches the powder for use in food (see page 7).
Gelita teaches the collagen peptide can be in agglomerated form (see page 5, collagen peptides are delivered as agglomerated or fine powder). Gelita teaches “Collagen peptides are delivered as agglomerated or fine powder. Both powder forms show excellent blending properties. Agglomerated powders offer the advantage of an improved solubility behavior. Due to its coarse powder structure the agglomerated powders offer several advantages in food processing including Rapid dissolution, No lump formation, Dust-free handling, Excellent flowability, No cohesion or clogging, High storage stability and High batch-to-batch consistency.
Even though there is not an example of the specific powder on page 4 in agglomerated form, Gelita teaches the collagen peptides can be delivered in agglomerated form to improve solubility behavior…Thus, the claimed product would have been obvious to those of ordinary skill in the art with the meaning of 35 U.S.C. 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Regarding claim 1, Gelita doesn’t specifically teach a hydration time of 7 seconds or less with agglomerated collagen powders but does teach of agglomerated collagen powders with a dissolution time of 250 seconds or less (see page 5). However, properties such as solubility and hydration time are inherent properties of the agglomerated collagen hydrolysate (Peptiplus XB) rendered obvious by Gelita.
Regarding claims 5 and 14, Gelita teaches collagen agglomerated particles (page 5). Gelita provides an image of the particles with a scale bar 2 mm showing particles consistent with the claimed 100-1000 µM range. Such particle size is an inherent result of the production/agglomeration of the collagen hydrolysate and would have been obvious.
Regarding claims 20-21, as stated above, it would have been obvious to use the collagen peptide in agglomerated form. Gelita teaches a bulk density of 420 g/L (see page 4). Furthermore, as evidenced by the later published Gelita Brochure (referred to as Gelita*), the bulk density of the agglomerated collagen Peptiplus XB is 270-400 g/L (see page 5) and the agglomerated Peptiplus XB would inherently have the hydration times (along with other physical properties involved with solubility such as dissolution) of the instant claims.
Regarding the product-by-process steps found instant claim 22, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process” (see MPEP 2113).
Gelita teaches the protein hydrolysate with a moisture content of 4-12%, protein content of more than 85%. Furthermore, Gelita teaches enzymatic digestion of the collagen peptides, purification, concentration (which would necessarily include adjustment of the dry substance form), sterilization and spray drying along with agglomeration (see pages 2-3 and 5). MPEP 2113 states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." Because the prior art meets the structural limitations of the claim, the burden is shifted to Applicant to show an unobvious difference. *Please note that scope of claim 22 is readily understood in view of the recited drying step to obtain a dried protein hydrolysate, the subsequent agglomeration of the dried protein hydrolysate, and the specified moisture content of 4-12%, which is consistent with a dried material. Accordingly, references in claim 22 to “the protein hydrolysate” are understood to refer to the dried protein hydrolysate obtained by the recited drying step.
Response to Applicant’s Arguments
Applicant argues that “It is noted that the agglomerated powder in the pictures is not disclosed to be agglomerated Peptiplus® XB (neither in Gelita 2016, nor in Gelita*). The dissolution time exhibited in the picture series therefore cannot be relied upon to evidence any dissolution time of the agglomerated Peptiplus® XB product, let alone the non-agglomerated Peptiplus® XB product. These are separate disclosures, and should not be combined. There are at least three separate disclosures within Gelita and Gelita*: The non-agglomerated Peptiplus XB of Gelita, the agglomerated Peptiplus XB of Gelita*, 3) The agglomerated powder in the photo series.
The properties of these cannot be combined into a single embodiment, as these represent separate products. This is exemplified by the bulk density of the non-agglomerated Peptiplus XB being 420 g/L, whereas the bulk density of the agglomerated Peptiplus XB is 270-400 g/L.
Agglomeration will affect the bulk density of a powder, as explained in the application as filed. This section of the application further discusses various agglomeration methods, including rewetting, spray-bed drying, steam jet, and heat. These methods each will affect the moisture content, by either adding of water (rewetting, steam jet), or removal of water (spray-bed drying, heat). If a binder is used, the protein content may also be lowered through the addition of further components. Therefore, agglomeration may also affect the moisture content and protein content.
For these reasons, the bulk density, protein content and moisture content of the non- agglomerated Peptiplus XB of Gelita cannot be said to remain the same after agglomeration. These properties of the non-agglomerated Peptiplus XB can therefore not be relied upon.
The Examiner further relies on MPEP 2112, which discusses when claimed properties are presumed to be inherent:"Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977))
The Examiner refers to the properties of the (non-agglomerated) Peptiplus XB of Gelita, the agglomerated Peptiplus XB of Gelita*, and the agglomerated powder of the picture series, stating that as the moisture content, protein content, bulk density, average molecular weight and dissolution time are as defined in Claims 1, 2, 4, 16, 20, and 22, the hydration time would be inherently the same.
As previously explained, these are separate products, and therefore the features cannot be combined or extrapolated. The properties of the non-agglomerated Peptiplus XB product with respect to bulk density, protein content and moisture content moreover should not be considered to be present after agglomeration. However, even for agglomerated powders meeting each of these requirements, the hydration time is not inherently as claimed.
Applicant’s arguments have been fully considered but not found persuasive. The Examiner does not rely on the picture series as a standalone disclosure of a specific commercial product or as direct evidence of a measured dissolution or hydration time value. Rather, the images are relied upon as illustrative evidence of the known and expected behavior of agglomerated collagen peptide powders, as taught by Gelita, namely improved wettability, rapid sinking, and reduced lump formation. Gelita teaches that collagen peptides are provided in agglomerated powder form and that such agglomerated powders offer improved solubility behavior, including rapid dissolution and no lump formation (see page 5). These teachings are general to agglomerated collagen peptide powders of Gelita and are not limited to a single product designation. The picture series is consistent with these express teachings and demonstrates the ordinary behavior of agglomerated Gelita collagen peptide powders when contacted with water.
Applicants arguments that the properties of non-agglomerated Peptiplus XB cannot be extrapolated to agglomerated products is acknowledged. However, the Examiner’s rejection does not rely on extrapolating properties from the non-agglomerated product. Instead, the rejection is based on Gelita’s teaching of agglomerated collagen peptide powders combined with well understood effects of agglomeration on wettability, hydration and dissolution behavior.
With respect to inherency, the Examiner does not assert that agglomeration alone guarantees a specific hydration time in all cases. Rather, Gelita renders obvious the agglomerated peptiplus XB collagen hydrolysate (see above rejection) produced using conventional agglomeration techniques (which overlap with the product by process claim 22), and thus, the claimed hydration and dissolution behavior would have been an expected result. In this context, the claimed hydration time and dissolution time represent properties that naturally flow from producing the agglomerated collagen peptide powder (Peptiplus XB) rendered obvious by Gelita.
Applicants further argue that agglomeration “changes” bulk density, moisture and protein content such that the non-agglomerated properties cannot be relied upon. Applicant’s arguments have been fully considered but not found persuasive. The evidentiary reference Gelita* brochure further confirms that the agglomerated collagen peptide product, PeptiplusXB (the same collagen product of Gelita but agglomerated by the same methods), exhibits a protein content of 91-96%, a dry substance 91-96% and a bulk density of 270-400 g/L, all of which fall within the ranges recited in the claims. These values are comparable to those disclosed in the non-agglomerated product (97 wt% protein, 91-96% dry substance and 420 g/L bulk density), demonstrating that agglomeration does not materially alter the composition of the collagen hydrolysate, but results in properties that necessarily fall within the claimed ranges. Accordingly, the claimed characteristics are inherent to the agglomerated collagen peptide product rendered obvious by Gelita.
Moreover, to the extent that Applicant’s data show variability in hydration time among different agglomerated collagen peptide products, such variability is consistent with routine processing differences and does not establish that the claimed hydration time is unexpected or non-inherent. Variability alone does not negate the reasonable expectation that the agglomerated collagen peptide powder rendered obvious by Gelita would sink and hydrate as claimed. The Examiner maintains that the agglomerated Peptiplus XB rendered obvious by Gelita would inherently have the hydration times (along with other physical properties involved with solubility) of the instant claims.
Accordingly, applicant has not shown that the claimed hydration time and dissolution time are unexpected or unobvious results relative to the agglomerated collagen peptide powders taught by Gelita. The rejection under 35 U.S.C. § 103 is therefore maintained.
Applicants argue that “The data provided in the declaration of Dr. Roye show that for products being substantially identical in structure and composition as Gelita* and Gelita, the claimed characteristics are not met. Therefore, the prior art products cannot necessarily possess the characteristics of the claimed product. This proves that the presumed inherency does not exist, and there cannot be a primafacie case of anticipation or obviousness.
The Applicant has tested multiple agglomerated collagen peptide products, each having a protein content of over 95 wt.%, a moisture content of 4-12%, and having an average molecular weight of 2000 - 4000 Da. These characteristics are representative of the Peptiplus XB products, which are disclosed to have a molecular weight of 3000 Da (Gelita) or 2500- 4000 Da (Gelita*). The tested bulk densities were within the range of 309-493 g/L, which is representative of the bulk density of Gelita* (270-400 g/L).
These ranges also meet the ranges for protein content, moisture content, average molecular weight and bulk density of the Claims 1, 2, 4, 16 and 22.
One of the products did meet the dissolution time as claimed, but not the claimed hydration time (Sample 1). The other products did not meet the dissolution time or the claimed hydration time.
It can be moreover observed that hydration time and dissolution time are not correlated to the bulk density. The longest dissolution time was observed for a sample which had a bulk density in the middle of the range. The hydration time also differed across the bulk density range. Hydration time and dissolution time were also found not to be correlated.
These findings are not surprising. As previously explained, the hydration time is determined by the surface of the agglomerated powder particles, i.e. surface activity, surface area, surface charge, as well as other particle properties such as particle size, density, and porosity. Thus, the hydration time of a collagen hydrolysate powder is a function of many variables besides the composition and bulk density of the material. Hydration time depends on the surface activity, surface area and surface charge of the powder, and these properties are not disclosed by the composition and bulk density of the powder, but determined i.a. by the processing and agglomeration conditions. Dissolution time is similarly dependent on processing conditions and agglomeration conditions.
In conclusion, there is no inherent relationship between the claimed characteristics of hydration time and dissolution time with bulk density, moisture content, protein content, and molecular weight. Therefore, there cannot be a prima facie case for anticipation or obviousness based on this alleged inherent relationship. Moreover, as these samples are representative for the Gelita and Gelita* products with respect to moisture content, protein content, molecular weight and bulk density, the evidence also shows that the Gelita or Gelita* products do not necessarily possess the claimed hydration time (nor dissolution time), and the prima facie case for anticipation or obviousness therefore fails.
Thus, as Gelita does not disclose a product having the claimed dissolution time and hydration time, and these characteristics cannot be presumed to be inherently present, the claims are not anticipated by, nor obvious over, Gelita.
Applicants arguments have been fully considered but not found persuasive. The declaration states that Applicant tested “multiple agglomerated collagen peptide products” having protein content, moisture content, average molecular weight, and bulk density within the ranges disclosed for Gelita and Gelita*. However, the declaration does not establish that the tested samples are the same as, or were produced by the same or substantially identical processes as, the agglomerated collagen peptide products taught by Gelita. In particular, the declaration acknowledges that hydration time is influenced by processing and agglomeration conditions, including surface properties, porosity, and particle morphology. As such, absent evidence that the tested products were produced using the same agglomeration techniques disclosed by Gelita (e.g., spray drying and agglomeration as taught in the reference), the results do not demonstrate that the Gelita products themselves lack the claimed hydration time. Accordingly, the declaration does not rebut the Examiner’s position that the claimed hydration time is an inherent property of the agglomerated collagen peptide rendered obvious by Gelita when produced according to the disclosed processes.
Applicant further argues that because hydration time is dependent on multiple variables, it cannot be inherent. However, inherency may be relied upon in an obviousness rejection where the prior art teaches a product or process that necessarily results in the claimed properties, even if those properties are not expressly recognized. See MPEP § 2112.
In the instant case, Gelita renders obvious an agglomerated collagen peptide powder (Peptiplus XB), moisture content within the claimed range, protein content within the claimed range, molecular weight within the claimed range, and processing steps including drying and agglomeration that necessarily produce powders exhibiting rapid wetting and no lump formation. Gelita further teaches that in general, agglomerated collagen peptide powders exhibit rapid dissolution and no lump formation, which corresponds directly to the claimed hydration behavior (i.e., rapid sinking without persistent floating agglomerates). Thus, even if hydration time is influenced by processing variables, the Gelita reference teaches the same type of product produced by the same class of agglomeration processes, such that the claimed hydration time would necessarily result.
Furthermore, Applicant’s data show variability among tested samples. However, variability does not negate inherency where the prior art teaches a process that necessarily produces the claimed property. The fact that some agglomerated products fall outside the claimed hydration time does not establish that the agglomerated collagen peptide rendered obvious by Gelita lacks the claimed hydration time.
Accordingly, Applicant has not provided sufficient evidence to rebut the Examiner’s prima facie case. The declaration does not establish that the agglomerated collagen peptide rendered obvious by Gelita would not inherently exhibit the claimed hydration time when produced according to the disclosed processes. Therefore, the claims remain rejected under 35 U.S.C. § 103.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/ Examiner, Art Unit 1654