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
Applicant’s election of Group I, encompassing claims 1, 5-6, 10-13 and 20 following claim amendments in the reply filed on 06/30/2026 is acknowledged. Examiner would like to point out that applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, and because applicants’ did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).The restriction requirement is still deemed proper and is therefore made FINAL. Amended Claims 1, 5-6, 10-13 and 20 are pending in this application and is now under consideration for examination.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/IB2022/056508 filed on 07/14/2022 and claims the priority date of Italy application 102021000018647 filed on 07/14/2021; however, no English translation of said foreign priority applications have been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/IB2022/056508 filed on 07/14/2022.
Information disclosure statement
The information disclosure statements (IDS) submitted on 01/10/2024 and 03/27/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Objections to Abstract/Specification
I. The Abstract of the disclosure is objected to because, Abstract should be on a separate sheet of paper. The abstract of the disclosure is objected to because the abstract is presented as part of the first page of a WO publication. The abstract should be presented as a single sheet apart from all other bibliographic material including the information included on the first page of a WO publication. If EFS is used to submit a replacement abstract, the appropriate abstract (ABST) document code should be used for the one-page document. Correction is required. See MPEP § 608.01 (b).
II. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification contains hyperlinks to various site domains, for example, line 15, page 11 of the instant application. Applicants’ are required to thoroughly scrutinize the specification and delete all embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. Appropriate correction is required.
Claim Objections
I. Claim 5 is objected to, due to the following informality: Claim 5 recites “…of Figure 1” in the claim. Examiner suggests incorporating the specific subject-matter in the claim. Appropriate correction is required.
II. Applicant is advised that should claim 10 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. Examiner takes the position that the scope of claim 10 and the rejected claim 20 are one and the same. See MPEP § 706.03(k).
Double Patenting rejection
Claim 20 is rejected to under 37 CFR 1.75 as being duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). Examiner takes the position that the scope of claim 10 and the rejected claim 20 are one and the same.
Claim Rejections: 35 USC § 112(b)
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.
Claim 5 is 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 applicant regards as the invention.
Claim 5 recites the phrase “…of Figure 1”. The metes and bounds of claim 5 are not clear and thus, it would not be possible to one of ordinary skill in the art to define the metes and bounds of the desired patent protection and hence the breadth of the claim is unclear. Where possible, claims are to be complete in themselves, incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. In other words, trying to incorporate by reference limitations that can be easily defined in the claims. Regarding specification/claims, as set forth in MPEP 2173.05(s) states that where possible, claims are to be complete in themselves and that in the instant case, there is clearly a practical way to define the desired limitations in words. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Clarification and correction is required.
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5).
Claim Rejections: 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(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 1, 5-6, 10-13 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sharma et al., (US 5,356,614) and further in view of Silver et al., (US 5,196,185), Masi L., (US 9,370,470 B2), Texier-Nogues et al., (WO 2016/198237 A1), Ahmad et al., (Pharm Dev Technol., 2014, Vol. 19(4): 460-467) and Berman et al., (Biochem. Biophys. Res. Commun., 1993, Vol. 194(1): 351-357).
Regarding claims 1, 5-6, 11-13 and 20, the disclosure of Sharma et al., (US 5,356,614) teach a collagen preparation of improved adhesive properties and formed of microparticulate collagen of a particle size from 0.5 to 2 mm, preferably 0.5 to 1.0 . mm preferably submicrosized in a delivery system, such as an aerosol, and thus in sprayable form as a wound dressing alone, or with releasing drugs or other active agents; the microparticulate collagen is formed by ball milling collagen for a time sufficient to form the microparticulate collagen having a particle size of from 0.5 to 2 mm, preferably 0.5 to 1 mm; and particle size 0.1 to 5 mm (see Abstract; Claims; and entire document). Sharma et al., disclose particulate collagen comprises up to about 10% by weight of the resulting delivery system in case of aerosol and about 25% by weight of the paste or gel (col. 2, lines 7-19); and the use of said reference collagen in clinical settings for treating wounds, burns and as a film for artificial skin or skin graft (col. 1, lines 30-67 to col. 2, lines 1-6).
Regarding claims 1, 5-6, 11-13 and 20, the disclosure of Silver et al., (US 5,196,185) teach collagen preparation formed from a collagen selected from the group consisting of Type I collagen, a particulate collagen of a particle size of from about 1 to 50 mm, preferably 5 to 25 mm into a delivery system, such as an aerosol, and in sprayable form as a wound dressing alone, or with releasing drugs or other active agents. The particulate collagen comprises up to about 20% by weight of the resulting delivery system (see Abstract; Claims; and entire document).
Regarding claims 1, 5-6, 11-13 and 20, the disclosure of Masi L., (US 9,370,470 B2) teach alloplastic implant compositions include microparticles, such as polymethylmethacrylate particles, and collagen as a suspending agent, wherein the collagen contains a reduced amount of low molecular weight gelatine compared to high molecular weight collagen and by controlling the molecular weight of the collagen in the compositions, the injectability, stability, and antigenicity of the alloplastic implant compositions can be improved (see Abstract; Claims; and entire document). Masi L., teach alloplastic implant composition comprises microparticles having a diameter of about 5 to about 400 μm suspended in an aqueous suspending agent, wherein the aqueous suspending agent comprises denatured atelocollagen, wherein the denatured atelocollagen has less than 40 wt % of the total weight as components of weight average molecular weight (Mw) 100,000 Daltons or lower (col. 1, lines 60-67); Masi L., disclose atelocollagen has less than 40 wt % of the total collagen weight as components of weight average molecular weight (Mw) 100,000 Daltons or lower. In one aspect, the denatured atelocollagen has 60 wt % or greater, specifically 60 to 100 wt %, components of weight average molecular weight 100 kDa to 258 kDa; atelocollagen having 60 wt % or greater components of weight average molecular weight 100 kDa or higher as described herein allows for improved water junction formation and subsequent physical properties for use in an alloplastic implant that were not previously achieved; atelocollagen has less than 40 wt % of the total collagen weight as components of weight average molecular weight (Mw) of less than 80 kDa, less than 60 kDa, less than 40 kDa or less than 20 kDa. In another aspect, the denatured atelocollagen has greater than 60% of the total weight as components of weight average molecular weight (Mw) of greater than 120 kDa, 150 kDa, 160 kDa, 175 kDa, 180 kDa or 200 kDa. In a yet further aspect, the denatured atelocollagen has less than 30 wt %, 25 wt %, 20 wt %, 15 wt %, 10 wt % or 5 wt % of the total collagen weight as components of weight average molecular weight (Mw) of less than 100 kDa. In a still further aspect, the denatured atelocollagen has 60 wt % or greater, 70 wt % or greater, 75 wt % or greater, 80 wt % or greater, 85 wt % or greater, 90 wt % or greater or 95 wt % or greater, components of weight average molecular weight 100 kDa to 258 kDa (col. 2, lines 16-67 to col. 3, lines 1-13).
However, Sharma et al., or Silver et al., or Masi L., do not teach wherein said collagen is equine (as in claim 1); wherein said collagen powder exhibits the particle size distribution of Figure 1 (as in claim 5); and suspending collagen of type I, deprived of the telopeptide fractions, in acidified water and subjecting it to proteolysis (as in claims 10 and 20).
Regarding claims 1, 5 and 10, type I collagen is equine (as in claim 1); wherein said collagen powder exhibits the particle size distribution of Figure 1 (as in claim 5); and suspending collagen of type I, deprived of the telopeptide fractions, in acidified water and subjecting it to proteolysis (as in claims 10 and 20) is known and well established in the art in the following combination of references:
Regarding claim 1, wherein type I collagen is equine; Texier-Nogues et al., (WO 2016/198237 A1), provide teaching, suggestion and motivation for the use of collagen obtained equine Achilles tendon (see pages 1-2; Example 1, page 17; and entire document).
Regarding claim 2, particle size distribution, Ahmad et al., (Pharm Dev Technol., 2014, Vol. 19(4): 460-467) teach collagen based nano-sized particles and method for obtaining desired size collagen nano-sized particles by the use of Zetasizer (Materials & Methods, col. 2, page 451; Fig. 2, page 464; and entire document).
Regarding claims 10 and 20, wherein collagen of type I, deprived of the telopeptide fractions, in acidified water and subjecting it to proteolysis of the instant invention, Berman et al., (Biochem. Biophys. Res. Commun., 1993, Vol. 194(1): 351-357), disclose telopeptide-devoid collagen obtained by proteolytic degradation of type I collagen caused disintegration of supramolecular aggregates and retained the cell adhesion behavior/property to cells (see Abstract; and entire document).
As such, disclosure of strategy and methods including structural and functional elements for collagen preparation of improved adhesive properties and formed of microparticulate collagen and use of collagen obtained equine Achilles tendon; method for obtaining desired size collagen nano-sized particles by the use of Zetasizer; and telopeptide-devoid collagen obtained by proteolytic degradation of type I collagen caused disintegration of supramolecular aggregates and retained the cell adhesion behavior/property to cells in the claimed collagen preparation, such as that of references of Texier-Nogues et al., Ahmad et al., and Berman et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Sharma et al., or Silver et al., or Masi L., and incorporate the structural and functional elements of Texier-Nogues et al., and adopt the method for obtaining desired size collagen nano-sized particles by the use of Zetasizer and proteolytic degradation of type I collagen caused disintegration of supramolecular aggregates that retained the cell adhesion behavior/property to cells in the claimed microparticulate collagen, as provided in the teachings of Ahmad et al., and Berman et al., and the combined references Texier-Nogues et al., Ahmad et al., and Berman et al., also provide teaching, suggestion and motivation including the structural and functional elements of the instant invention and are well known in the art (for details see the rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claimed hydrolyzed collage powder, as suggested by the teachings of Texier-Nogues et al., Ahmad et al., and Berman et al., and to modify the teachings of Sharma et al., or Silver et al., or of Masi L. A person of ordinary skill in the art is motivated to make such change depending on the experimental need i.e., hydrolyzed collagen powder having the following particle size distribution:- at most 10% of the particles have a mean diameter lower than 2.5 microns;- at least 50% of the particles have a mean diameter lower than 10 microns;- at least 90% of the particles have a mean diameter lower than 20 microns, wherein said hydrolyzed collagen consists of oligopeptides having the following molecular weights:- at least 30% of the oligopeptide molecules have a weight average molecular weight from 80 to 120 kDa;- at least 25% of the oligopeptide molecules have a weight average molecular weight from 50 to 70 kDa;- at least 25% of the oligopeptide molecules have a weight average molecular weight from 25 to 45 kDa;- at least 85% of said collagen has a molecular weight from 25 to 120 kD,- wherein said collagen is of type I and wherein said collagen is equine, because a skilled artisan would realize such a modification would be useful to efficiently produce and for generating different hydrolyzed collagen powders of interest. One of ordinary skill in the art has a reasonable expectation of success at adding the steps i.e., wherein said collagen is equine; wherein said collagen powder exhibits the particle size distribution; and suspending collagen of type I, deprived of the telopeptide fractions, in acidified water and subjecting it to proteolysis in the claimed hydrolyzed collagen powder of interest, as suggested in the teachings of Texier-Nogues et al., Ahmad et al., and Berman et al., and are well known in the art. Therefore, the invention as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings of Sharma et al., or Silver et al., or Masi L., Texier-Nogues et al., Ahmad et al., and Berman et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Regarding specific choice of particle size and molecular weight of claimed collagen preparation are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in particle size and molecular weight will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating is critical. "[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". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two compositions or two methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Given this extensive teaching in prior art (Sharma et al., or Silver et al., or Masi L., Texier-Nogues et al., Ahmad et al., and Berman et al.,) the claimed hydrolyzed collagen powder having the following particle size distribution…, as taught by the instant invention and as claimed in claims 1, 5-6, 10-13 and 20 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Thus, given that the cited the prior art provides scientific basis and reduction to practice of hydrolyzed collagen powder having the desired particle size distribution for therapeutic purposes, examiner takes the position that the claimed hydrolyzed collagen powder having the desired particle size distribution as claimed herein in claims 1, 5-6, 10-13 and 20, is a simple combination of known elements from the prior art.
THE EXPECTATION OF SOME ADVANTAGE IS THE STRONGEST RATIONALE FOR COMBINING REFERENCES
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, scientific principles or legal precedent, that some advantage or expected beneficial result would 217USPQ 1, 5-6 (Fed. Cir. 1983). >See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651(Fed. Cir. 2006) (“Indeed, we have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.”).
The cited references render claims 1, 5-6, 10-13 and 20 prima facie obvious to one of ordinary skill in the art when one applies the Teaching, Suggestion and Motivation (TSM) test under the rationale for arriving at a conclusion of obviousness as suggested by the KSR ruling. The rationale applied for this rejection is as follows:
(1) Combining prior art elements according to known method to yield predictable results.
(2) Simple substitution of one known element for another to obtain predictable results.
(3) "Obvious to try"- choosing from a finite number of identified, predictable solution, with a reasonable expectation of success.
Hence, claims 1, 5-6, 10-13 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sharma et al., (US 5,356,614) and further in view of Silver et al., (US 5,196,185), Masi L., (US 9,370,470 B2), Texier-Nogues et al., (WO 2016/198237 A1), Ahmad et al., (Pharm Dev Technol., 2014, Vol. 19(4): 460-467) and Berman et al., (Biochem. Biophys. Res. Commun., 1993, Vol. 194(1): 351-357).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
Prosecution Insights